medicines for human use 2019 register s/no product …...cefixime 400mg tablets cefixime trihydrate...

320
ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER S/No Product Name Generic Name Category of Distribution Dosage Form Marketing Authorisation Number Marketing Authorisation Holder 1 Miconazole Nitrate Ceam - 1 A Pharma cream Miconazole Nitrate 20mg POM Cream Topical 046/002 1 A Pharma Gmbh, Germany 2 Cetirizine 10 - 1 A Pharma tablets Cetirizine Dihydrochloride 10mg POM Tablet Uncoated 046/003 1 A Pharma Gmbh, Germany 3 Ateblock - 25 Tablets Atenolol 25mg POM Tablet Uncoated 116/001 AB Lifesciences, India 4 Ateblock - 50 Tablets Atenolol 50mg POM Tablet Uncoated 116/002 AB Lifesciences, India 5 Ateblock - 100 Tablets Atenolol 100mg POM Tablet Uncoated 116/003 AB Lifesciences, India 6 Nosieze Tablets Carbamazepine 400mg POM Tablet Uncoated 116/004 AB Lifesciences, India 7 Neumox Capsules Amoxicillin Trihydrate 500mg POM Capsule Oral 116/006 AB Lifesciences, India 8 RL-500 Compound Sodium Lactate Infusion Sodium Lactate + Sodium Chloride + Potassium Chloride + Calcium Chloride Dihydrate POM Solution for infusion 316/001 Abacus Parenteral Drugs Ltd, India 9 NS - 500 Sodium Chloride BP Infusion Sodium Chloride 0.9%w/v POM Solution for infusion 316/002 Abacus Parenteral Drugs Ltd, India 10 DS-500 Glucose Infusion Dextrose 5.0g POM Solution for infusion 316/003 Abacus Parenteral Drugs Ltd, India 11 X-Beta Eye/Ear Drops Betamethasone Soduim Phosphate 0.1% w/v POM Solution for Topical Use 316/004 Abacus Parenteral Drugs Ltd, India 12 X- Beta - N Eye/Ear Drops Betamethasone Soduim Phosphate 0.1% w/v + Neomycin sulphate 0.5% w/v POM Solution for Topical Use 316/005 Abacus Parenteral Drugs Ltd, India 13 X-Sone -N Eye/Ear Drops Neomycin Sulphate 0.35% w/v + Dexamethasone Phosphate 0.1% w/v POM Solution for Topical Use 316/006 Abacus Parenteral Drugs Ltd, India 14 Abnal Nasal Drops Sodium Chloride 0.9% w/v P Solution for Topical Use 316/007 Abacus Parenteral Drugs Ltd, India 15 Abtol 20% Intravenous Infusion Mannitol 20 %w/v POM Solution for infusion 316/008 Abacus Parenteral Drugs Ltd, India 16 Kaletra Solution Lopinavir 80mg + Ritonavir 20mg, per 5ml POM Solution for Oral Use 128/002 Abbott Laboratories S.A (Pty) Ltd, South Africa Page 1 of 320

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Page 1: MEDICINES FOR HUMAN USE 2019 REGISTER S/No Product …...Cefixime 400mg Tablets Cefixime Trihydrate 400mg POM Tablet Uncoated 137/005 Aegis Limited, Cyprus 70 Lasoprol 30 Capsules

ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

S/No Product Name Generic Name Category of

Distribution

Dosage Form Marketing

Authorisation

Number

Marketing Authorisation Holder

1

Miconazole Nitrate Ceam - 1 A

Pharma cream

Miconazole Nitrate 20mg POM Cream Topical 046/002 1 A Pharma Gmbh, Germany

2

Cetirizine 10 - 1 A Pharma

tablets

Cetirizine Dihydrochloride

10mg

POM Tablet Uncoated 046/003 1 A Pharma Gmbh, Germany

3 Ateblock - 25 Tablets Atenolol 25mg POM Tablet Uncoated 116/001 AB Lifesciences, India

4 Ateblock - 50 Tablets Atenolol 50mg POM Tablet Uncoated 116/002 AB Lifesciences, India

5 Ateblock - 100 Tablets Atenolol 100mg POM Tablet Uncoated 116/003 AB Lifesciences, India

6 Nosieze Tablets Carbamazepine 400mg POM Tablet Uncoated 116/004 AB Lifesciences, India

7Neumox Capsules

Amoxicillin Trihydrate

500mg

POM Capsule Oral 116/006 AB Lifesciences, India

8

RL-500 Compound Sodium

Lactate Infusion

Sodium Lactate +

Sodium Chloride +

Potassium Chloride +

Calcium Chloride

Dihydrate

POM Solution for

infusion

316/001 Abacus Parenteral Drugs Ltd, India

9

NS - 500 Sodium Chloride BP

Infusion

Sodium Chloride

0.9%w/v

POM Solution for

infusion

316/002 Abacus Parenteral Drugs Ltd, India

10DS-500 Glucose Infusion

Dextrose 5.0g POM Solution for

infusion

316/003 Abacus Parenteral Drugs Ltd, India

11X-Beta Eye/Ear Drops

Betamethasone Soduim

Phosphate 0.1% w/v

POM Solution for Topical

Use

316/004 Abacus Parenteral Drugs Ltd, India

12

X- Beta - N Eye/Ear Drops

Betamethasone Soduim

Phosphate 0.1% w/v +

Neomycin sulphate 0.5%

w/v

POM Solution for Topical

Use

316/005 Abacus Parenteral Drugs Ltd, India

13

X-Sone -N Eye/Ear Drops

Neomycin Sulphate

0.35% w/v +

Dexamethasone

Phosphate 0.1% w/v

POM Solution for Topical

Use

316/006 Abacus Parenteral Drugs Ltd, India

14Abnal Nasal Drops

Sodium Chloride 0.9%

w/v

P Solution for Topical

Use

316/007 Abacus Parenteral Drugs Ltd, India

15Abtol 20% Intravenous Infusion

Mannitol 20 %w/v POM Solution for

infusion

316/008 Abacus Parenteral Drugs Ltd, India

16Kaletra Solution

Lopinavir 80mg +

Ritonavir 20mg, per 5ml

POM Solution for Oral

Use

128/002 Abbott Laboratories S.A (Pty) Ltd, South

Africa

Page 1 of 320

Page 2: MEDICINES FOR HUMAN USE 2019 REGISTER S/No Product …...Cefixime 400mg Tablets Cefixime Trihydrate 400mg POM Tablet Uncoated 137/005 Aegis Limited, Cyprus 70 Lasoprol 30 Capsules

ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

17

Klacid P 125 Granules for

Suspension

Clarithromycin 125mg POM Granules for

Suspension

128/004 Abbott Laboratories S.A (Pty) Ltd, South

Africa

18

Klacid P 250 Granules for

Suspension

Clarithromycin 250mg POM Granules for

Suspension

128/005 Abbott Laboratories S.A (Pty) Ltd, South

Africa

19Forane Liquid

Isoflurane 99.9% w/w POM Solution for

Inhalation

128/015 Abbott Laboratories S.A (Pty) Ltd, South

Africa

20Aluvia 250/50mg Tablets

Lopinavir 200mg +

Ritonavir 50mg

POM Tablet Film Coated 128/026 Abbott Laboratories S.A (Pty) Ltd, South

Africa

21Aluvia 100/25mg Tablets

Lopinavir 100mg +

Ritonavir 25mg

POM Tablet Film Coated 128/027 Abbott Laboratories S.A (Pty) Ltd, South

Africa

22Ultane Liquid

Sevoflurane 100% v/v POM Solution for

Inhalation

128/029 Abbott Laboratories S.A (Pty) Ltd, South

Africa

23Norvir 100 Tablets

Ritonavir USP 100mg POM Tablet, Film Coated 128/030 Abbott Laboratories S.A (Pty) Ltd, South

Africa

24Hidrasec Capsules

Racecaggherdotril 100mg POM Capsule, Oral 128/031 Abbott Laboratories S.A (Pty) Ltd, South

Africa

25Hidrasec Children Sachets

Racecaggherdotril 30mg POM Powder for

Suspension, Oral

128/032 Abbott Laboratories S.A (Pty) Ltd, South

Africa

26Hidrasec Infant Sachets

Racecaggherdotril 10mg POM Powder for

Suspension, Oral

128/033 Abbott Laboratories S.A (Pty) Ltd, South

Africa

27

Survanta Intratracheal

Suspension, 4ml Vial

Total Phospholipids

25mg, per ml

POM Suspension,

Intratracheal

128/034 Abbott Laboratories S.A (Pty) Ltd, South

Africa

28

Calmettes Nite 45mg tablets Valerian Dry Root extract

45mg

P Tablet Film coated 128/035L Abbott Laboratories S.A (Pty) Ltd, South

Africa

29

Calmettes Nite 125mg tablets Valerian Dry Root extract

45mg

P Tablet Film coated 128/036L Abbott Laboratories S.A (Pty) Ltd, South

Africa

30Mariprist Combikit Tablets

Mifepristone 200mg +

Misoprostal 200mcg

POM Tablet, Uncoated 296/001 Acme Formulation Pvt Ltd, India

31 Misoclear Tablets Misoprostal 200mcg POM Tablet Uncoated 296/002 Acme Formulation Pvt Ltd, India

32Sabax Osmitrol 20% Injection

Mannitol 20% w/v POM Solution, Infusion 097/004 Adcock Ingram Pharmaceuticals Ltd, South

Africa

33

Sabax Sodium Chloride 0.9%

Injection

Sodium Chloride 0.9%

w/v

POM Solution, Infusion 097/005 Adcock Ingram Pharmaceuticals Ltd, South

Africa

34

Sabax Glucose 5% + Sodium

Chloride 0.9% Injection

Dextrose 5 %w/v +

Soduim Chloride 0.9

%w/v

POM Solution, Infusion 097/006 Adcock Ingram Pharmaceuticals Ltd, South

Africa

Page 2 of 320

Page 3: MEDICINES FOR HUMAN USE 2019 REGISTER S/No Product …...Cefixime 400mg Tablets Cefixime Trihydrate 400mg POM Tablet Uncoated 137/005 Aegis Limited, Cyprus 70 Lasoprol 30 Capsules

ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

35

Sabax Ringer Lactate Injection

Sodium chloride +

Sodium lactate +

Potassium chloride +

Calcium chloride

POM Solution, Infusion 097/007 Adcock Ingram Pharmaceuticals Ltd, South

Africa

36Sabax Dianeal Injection, 1.5%

Peritoneal dialysis

solution 1.5%

POM Solution, Injection 097/008 Adcock Ingram Pharmaceuticals Ltd, South

Africa

37Sabax Dianeal Injection, 2.5%

Peritoneal dialysis

solution 2.5%

POM Solution, Injection 097/009 Adcock Ingram Pharmaceuticals Ltd, South

Africa

38Sabax Dianeal Injection, 4.25%

Peritoneal dialysis

solution 4.25%

POM Solution, Injection 097/010 Adcock Ingram Pharmaceuticals Ltd, South

Africa

39

Myprodol Capsules

Paracetamol 250mg +

Ibuprofen 200mg +

Codeine 10mg

P Capsule Oral 097/011 Adcock Ingram Pharmaceuticals Ltd, South

Africa

40Lotem Suspension

Paracetamol 250mg +

Ibuprofen 200mg

P Suspension for

Oral Use

097/012 Adcock Ingram Pharmaceuticals Ltd, South

Africa

41

Syndol Tablets

Caffeine 30 mg +

Codeine 10 mg +

Doxylamine 5 mg +

Paracetamol 450 mg

P Tablet oral 111/005 Adcock Ingram Pharmaceuticals Ltd, South

Africa

42

Betapyn Tablets

Paracetamol 450 mg +

Codeine phosphate 10

mg + Doxylamine

succinate 5 mg +

Caffeine alkaloid 50

mg

P Tablet oral 111/008 Adcock Ingram Pharmaceuticals Ltd, South

Africa

43

Medikeel A Throat Lozenges

Cetylpyridinium chloride

1.5 mg + benzocaine 12

mg

GS Lozenges 111/009 Adcock Ingram Pharmaceuticals Ltd, South

Africa

44

Cepacol Throat Regular

Lozenges

Benzocaine 10 mg +

Cetylpyridinium chloride

1.47 mg

GS Lozenges 111/014 Adcock Ingram Pharmaceuticals Ltd, South

Africa

45

Alcophyllex Mixture

Theophylline 16.667 mg

+ Hydroxyethyl

Theophylline 1.667 mg +

Diphenhydramine HCl

6.667 mg + Ammonium

Chloride 120 mg +

Sodium Citrate 50 mg/5

ml

POM Syrup 111/022 Adcock Ingram Pharmaceuticals Ltd, South

Africa

Page 3 of 320

Page 4: MEDICINES FOR HUMAN USE 2019 REGISTER S/No Product …...Cefixime 400mg Tablets Cefixime Trihydrate 400mg POM Tablet Uncoated 137/005 Aegis Limited, Cyprus 70 Lasoprol 30 Capsules

ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

46

Cepacol Antibacterial

Mouthwash

Cetylpyridinium Chloride

50 mg + Alcohol 15.8 %

v/v

GS Solution for Topical

Use

111/023 Adcock Ingram Pharmaceuticals Ltd, South

Africa

47

Cepacol Throat Menthol

Lozenges

Cetylpyridinium Chloride

1.47 mg + Benzyl Alcohol

6.5 mg

GS Lozenges 111/024 Adcock Ingram Pharmaceuticals Ltd, South

Africa

48

Bronchoped Syrup

Terbutaline 1.25mg +

Ammonium Chloride

60mg + Sodium Citrate

25mg

P Syrup 111/025 Adcock Ingram Pharmaceuticals Ltd, South

Africa

49

Citro Soda Orange Granules

Sodium bicarbonate

1.716mg + Tartaric acid

856mg + Citric acid

702mg + Sodium citrate

613mg

P Granules for

Suspension

111/026 Adcock Ingram Pharmaceuticals Ltd, South

Africa

50

Citro Soda Granules

Sodium bicarbonate

1.716mg + Tartaric acid

856mg + Citric acid

702mg + Sodium citrate

613mg

P Granules for

Suspension

111/027 Adcock Ingram Pharmaceuticals Ltd, South

Africa

51

Adco-Senna Tablets

Sennosides dry extract

60% eq. to 13.50mg

Senoside A & B

P Tablet Uncoated 111/028 Adcock Ingram Pharmaceuticals Ltd, South

Africa

52

Locaine A Injection

Lignocaine Hydrochloride

20mg + Adrenaline

Tartrate 12ug/ml

POM Solution for

Injection

111/029 Adcock Ingram Pharmaceuticals Ltd, South

Africa

53Adco - Efavirenz 600 Tablets

Efavirenz 600mg POM Tablet Film Coated 111/030 Adcock Ingram Pharmaceuticals Ltd, South

Africa

54Adco Efavirenz 200 Capsules

Efavirenz 200mg POM capsule Oral 111/031 Adcock Ingram Pharmaceuticals Ltd, South

Africa

55

Medi - keel A Blackcurrant

Throat Lozenges

Benzocaine 12.0mg +

Cetylpyridinium 1.5mg

P Lozenges 111/032 Adcock Ingram Pharmaceuticals Ltd, South

Africa

56

Medi - Keel A Honey and Lemon

Throat Lozenges

Benzocaine 12.0mg +

Cetylpyridinium 1.5mg

P Lozenges 111/033 Adcock Ingram Pharmaceuticals Ltd, South

Africa

57

Actophlem Cough Syrup

Theophylline 100mg +

Etofyline 10mg +

Diphenylpyramine 8mg +

Ammonium 720mg

P Syrup 111/034 Adcock Ingram Pharmaceuticals Ltd, South

Africa

Page 4 of 320

Page 5: MEDICINES FOR HUMAN USE 2019 REGISTER S/No Product …...Cefixime 400mg Tablets Cefixime Trihydrate 400mg POM Tablet Uncoated 137/005 Aegis Limited, Cyprus 70 Lasoprol 30 Capsules

ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

58Prelone Syrup

Prednisolone 15mg/5ml POM Syrup 111/035 Adcock Ingram Pharmaceuticals Ltd, South

Africa

59

Dilinct Dry Cough Syrup

Dextromethophan

Hydrobromide Ph. Eur

15mg/5ml

P Syrup 111/036 Adcock Ingram Pharmaceuticals Ltd, South

Africa

60Dolo Doc Capsules

Tramadol Hydrochloride

BP 50mg

POM Capsule Oral 060/001 Adlife Healthare Pvt Ltd, India

61Amoxycillin Oral Suspension

Amoxycillin Trihdyrate

125mg/5ml

POM Suspension for

Oral Use

060/002 Adlife Healthare Pvt Ltd, India

62

SNP IMMUNOboost Tablets Sida cordiflia (Bala)

150mg + Tinospora

cordiflia (Giloya)

P Capsule oral 449/001L Adventura Investments Limited

63

SNP JOINTcare Tablets Shallaki (Boswelia

serrata) 300mg + Rasna

(Pluchea lanceolat

P Tablet Uncoated 449/002L Adventura Investments Limited

64

Snp Allergy Care Tablets Inula racemose

(Pushkarmool) 75mg +

Pistacia integerrima (Ka

P Tablet Uncoated 449/003L Adventura Investments Limited

65

SNP Brain Tonic Tablets Ocimum sanctum (Tulsi)

200mg + Centella

asiatica (Mandukparn

P Tablet Uncoated 449/004L Adventura Investments Limited

66 Oxacid 200mg Capsules Ofloxacin 200mg POM Capsule oral 137/002 Aegis Limited, Cyprus

67Cifex Suspension

Cefixime Trihydrate

100mg/5ml

POM Suspension for

Oral Use

137/003 Aegis Limited, Cyprus

68 Cifex 200 Tablets Cefixime 200mg POM Tablet Uncoated 137/004 Aegis Limited, Cyprus

69Cefixime 400mg Tablets

Cefixime Trihydrate

400mg

POM Tablet Uncoated 137/005 Aegis Limited, Cyprus

70 Lasoprol 30 Capsules Lansoprazole 30 mg POM Capsule oral 137/001 Aegis Limited,Cyprus

71

Selenaid Forte Nutritional

Supplement Capsules

Alpha Lipoic Acid

18.75mg + Beta

Carotene 0.31mg +

Betaine (TMG) 12.5mg +

Bioperine 0.3mg + Biotin

3mcg

P Capsule Hard

Gelatin

368/001L African Health Solutions Ltd

72 Chlorosim - 250 Capsules Chlorampehicol 250mg POM Capsule oral 090/011 Africure Pharmaceuticals Ltd

73 Doxyrone - 100 Capsules Doxycycline 100mg POM Capsule oral 090/012 Africure Pharmaceuticals Ltd

74 Metrosim 200mg Tablets Metronidazole 200mg POM Tablet 286/002 Africure Pharmaceuticals Ltd

75 Simfen 200mg Tablets Ibuprofen 200mg P Tablet 286/003 Africure Pharmaceuticals Ltd

Page 5 of 320

Page 6: MEDICINES FOR HUMAN USE 2019 REGISTER S/No Product …...Cefixime 400mg Tablets Cefixime Trihydrate 400mg POM Tablet Uncoated 137/005 Aegis Limited, Cyprus 70 Lasoprol 30 Capsules

ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

76

Compound Magnesium

Trisilicate Tablets BP

Magnesium Trisilicate

250mg + Aluminium

Hydroxide 120mg

GS Tablet 286/007 Africure Pharmaceuticals Ltd

77 Erythone 250mg Tablets Erythromycin 250mg POM Tablet 286/011 Africure Pharmaceuticals Ltd

78 Cipone 500mg Tablets Ciprofloxacin 500mg POM Tablet 286/012 Africure Pharmaceuticals Ltd

79 Simdol 500mg Tablets Paracetamol 500 mg P Tablet 286/014 Africure Pharmaceuticals Ltd

80Celltriaxon Injection

Ceftriaxone Sodium USP

1g

POM Powder for

Injection

406/002 Agila Specialties Pvt Limited.

81Agisept Antiseptic Lozenges

Dichlorobenzyl alcohol +

Amyl metacresol

GS Lozenges 176/001 Agio Pharmaceutical Limited, India

82Agisept Antiseptic Lozenges

Dichlorobenzyl alcohol +

Amyl metacresol

GS Lozenges 176/002 Agio Pharmaceutical Limited, India

83

Agisept Antiseptic (Classical)

Lozenges

Dichlorobenzyl alcohol +

Amyl metacresol

GS Lozenges 176/003 Agio Pharmaceutical Limited, India

84Diclogen Tablets

Diclofenac Sodium

100mg

P Tablet Uncoated 176/004 Agio Pharmaceutical Limited, India

85 Salbutamol Lifeforce Tablets Salbutamol 2mg POM Tablet Uncoated 176/005 Agio Pharmaceutical Limited, India

86 Griseofulvin 500 Tablets Griseofulvin 500mg POM Tablet Uncoated 176/006 Agio Pharmaceutical Limited, India

87

Sepralin Tablets

Sulfamethoxazole BP

400 mg + Trimethoprim

BP 80mg

POM Tablet Uncoated 176/007 Agio Pharmaceutical Limited, India

88 Nalidixic Acid Lifeforce tablets Nalidixic Acid 500mg POM Tablet Uncoated 176/008 Agio Pharmaceutical Limited, India

89 Cloxacillin Lifeforce Capsules Cloxacllin 250mg POM Capsule Oral 176/009 Agio Pharmaceutical Limited, India

90Tetracycline Lifeforce Capsules

Tetracycline 250mg POM Capsule Oral 176/010 Agio Pharmaceutical Limited, India

91 Para Force Tablets Paracetamol BP 500mg GS Tablet Uncoated 176/011 Agio Pharmaceutical Limited, India

92 Ferrous Sulphate Tablets Ferrous Sulphate 200mg P Tablet Film coated 176/012 Agio Pharmaceutical Limited, India

93

Chloramphenicol Lifeforce

Capsules

Chloramphenicol BP

250mg

POM Capsule oral 176/013 Agio Pharmaceutical Limited, India

94Paraforce Suspension

Paracetamol 125mg/5ml GS Suspension for

Oral Use

176/015 Agio Pharmaceutical Limited, India

95Paracetamol Agio Suspension

Paracetamol 125mg/5ml GS Suspension for

Oral Use

176/015 Agio Pharmaceutical Limited, India

96

Ferrous Sulphate and Folic Acid

tablets

Ferrous Sulphate 200mg

+ Folic Acid 0.25mg

P Tablet Film coated 176/016 Agio Pharmaceutical Limited, India

97 Moxforce Capsules Amoxicillin 250mg POM Capsule oral 176/017 Agio Pharmaceutical Limited, India

98 Doxycycline Life Capsules Doxycycline 100mg POM Capsule oral 176/018 Agio Pharmaceutical Limited, India

99 Doxycycline Life Capsules Doxycline 100mg BP POM Capsule oral 176/018 Agio Pharmaceutical Limited, India

100 Metroforce Tablets Metronidazole 200mg POM Tablet Uncoated 176/019 Agio Pharmaceutical Limited, India

Page 6 of 320

Page 7: MEDICINES FOR HUMAN USE 2019 REGISTER S/No Product …...Cefixime 400mg Tablets Cefixime Trihydrate 400mg POM Tablet Uncoated 137/005 Aegis Limited, Cyprus 70 Lasoprol 30 Capsules

ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 101 Metronidazole Agio Tablets Metronidazole 200mg POM Tablets 176/019 Agio Pharmaceutical Limited, India

102

Compound Magnesium

Trisilicate Tablets

Aluminium Hydroxide

120mg + Magnesium

Trisilscate 250mg

P Tablet Uncoated 176/020 Agio Pharmaceutical Limited, India

103 Ibufen Tablets Ibuprofen 200mg P Tablet Uncoated 176/021 Agio Pharmaceutical Limited, India

104 Nuamp Capsules Ampicillin 250mg POM Capsule oral 176/022 Agio Pharmaceutical Limited, India

105

Albendazole Lifeforce

Suspension

Albendazole BP

400mg/10ml

P Suspension for

Oral Use

176/023 Agio Pharmaceutical Limited, India

106Gentamicin Lifeforce Injection

Gentamicin 40mg/ml POM Solution for

Injection

176/024 Agio Pharmaceutical Limited, India

107

Metoclopramide Lifeforce

Injection

Metoclopramide BP

10mg/2ml

POM Solution for

Injection

176/025 Agio Pharmaceutical Limited, India

108Mobiram Injection

Diclofenac Sodium BP

75mg/3ml

POM Solution for

Injection

176/026 Agio Pharmaceutical Limited, India

109Dicyclone Lifeforce Injection

Dicyclomine

Hydrochloride 20mg/2ml

POM Solution for

Injection

176/027 Agio Pharmaceutical Limited, India

110 Clovirax Cream Acyclovir 5%w/v POM Cream Topical 176/028 Agio Pharmaceutical Limited, India

111 Micoson 2% Cream Miconazole 2% w/v POM Cream Topical 176/029 Agio Pharmaceutical Limited, India

112Micoson 2% Cream

Miconazole Nitrate 2%

w/v

POM Topical cream 176/029 Agio Pharmaceutical Limited, India

113Erycin Tablets

Erythromycin Stearate

BP 250mg

POM Tablet Uncoated 176/030 Agio Pharmaceutical Limited, India

114 Methyldopa Lifeforce Tablets Methyldopa BP 250mg POM Tablet Film coated 176/031 Agio Pharmaceutical Limited, India

115

Salbutamol Lifeforce 4mg

Tablets

Salbutamol 4mg POM Tablet Uncoated 176/032 Agio Pharmaceutical Limited, India

116 Rulicin 150mg Tablets Roxithromycin 150mg POM Tablet Uncoated 176/033 Agio Pharmaceutical Limited, India

117B-Complex Agio Injection

B-Complex 10ml POM Solution for

Injection

176/034 Agio Pharmaceutical Limited, India

118Dexamethasone - Agio Injection

Dexamethasone BP

4mg/ml

POM Solution for

Injection

176/035 Agio Pharmaceutical Limited, India

119 Agovir Tablets Aciclovir 200mg POM Tablet Uncoated 202/001 Agog Pharma Ltd, India

120

Compound Magnesium Tablets

Aluminium Hydroxide

120mg + Magnesium

Trisiliscate 250mg

GS Tablet Uncoated 202/002 Agog Pharma Ltd, India

121 Indo-25 Capsules Indomethacin BP 25mg P Capsule oral 202/003 Agog Pharma Ltd, India

122 Cipro 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 202/004 Agog Pharma Ltd, India

123

Trimago 480 Tablets

Sulfamethoxazole 400mg

+ Trimethoprim 80mg

POM Tablet Uncoated 202/005 Agog Pharma Ltd, India

Page 7 of 320

Page 8: MEDICINES FOR HUMAN USE 2019 REGISTER S/No Product …...Cefixime 400mg Tablets Cefixime Trihydrate 400mg POM Tablet Uncoated 137/005 Aegis Limited, Cyprus 70 Lasoprol 30 Capsules

ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 124 Agofen 200mg Tablets Ibuprofen 200mg P Tablet Film coated 202/006 Agog Pharma Ltd, India

125 Agoxic Tablets Nalidixic Acid 500mg POM Tablet Uncoated 202/007 Agog Pharma Ltd, India

126 Metronidazole Tablets Metronidazole 200mg POM Tablet Film coated 202/008 Agog Pharma Ltd, India

127Diclofenac Sodium Tablets

Diclofenac Sodium

100mg

P Tablet Film coated 202/009 Agog Pharma Ltd, India

128

Trimago 240 Tablets

Sulfamethoxazole 200mg

+Trimethoprim 40mg

POM Tablet Film coated 202/010 Agog Pharma Ltd, India

129 Ibuprofen Tablets Ibuprofen 200mg P Tablet Uncoated 202/011 Agog Pharma Ltd, India

130 Heath E.Tonic Syrup Haematinic preparation P Syrup 202/012 Agog Pharma Ltd, India

131Agometro Suspension

Metronidazole

125mg/5ml

POM Suspension for

Oral Use

202/013 Agog Pharma Ltd, India

132 B-Cox Tablets B Complex P Tablet Film coated 202/015 Agog Pharma Ltd, India

133 Agomol Tablets Paracetamol 500mg GS Tablet Uncoated 202/016 Agog Pharma Ltd, India

134 Fluconazole Capsules Fluconazole 200mg POM Capsule oral 202/017 Agog Pharma Ltd, India

135Ago-C 100mg Tablets

Ascorbic Acid BP 100mg GS Tablet Uncoated 202/018 Agog Pharma Ltd, India

136Ago-C 500mg Tablets

Ascorbic Acid BP 500mg GS Tablet Chewable 202/019 Agog Pharma Ltd, India

137 B-twin Tablets B Complex P Tablet Film coated 202/020 Agog Pharma Ltd, India

138Metronidazole Injection

Metronidazole 5mg/ml POM Solution for

infusion

203/001 Ahlcon Parenterals (India) Ltd, India

139Fluconazole Injection

Fluconazole 2mg/ml POM Solution for

infusion

203/002 Ahlcon Parenterals (India) Ltd, India

140Ciprofloxacin Injection

Ciprofloxacin 2mg/ml POM Solution for

infusion

203/003 Ahlcon Parenterals (India) Ltd, India

141

Darrow's Solution

Potassuim chloride +

Sodium chloride +

Sodium lactate

POM Solution for

infusion

203/004 Ahlcon Parenterals (India) Ltd, India

142

Compound Sodium Lactate

Solution

Potassuim Chloride +

Sodium Chloride +

Sodium Lactate

POM Solution for

infusion

203/005 Ahlcon Parenterals (India) Ltd, India

143 Quinine Sulphate Tablets Quinine Sulphate 300mg POM Tablet Uncoated 115/001 Ajanta Pharma Limited, India

144 Fingurin Capsules Herbal extracts 407mg P Capsule Oral 115/001H Ajanta Pharma Limited, India

145 Indoflam Capsules Indomethacin BP 25mg P Capsule oral 115/002 Ajanta Pharma Limited, India

146 Apdyl-H Syrup Herbal extracts 335mg GS Syrup 115/002H Ajanta Pharma Limited, India

147 Apkef Capsules Cephalexin 250mg POM Capsule oral 115/003 Ajanta Pharma Limited, India

148 Tyflox Capsules Ciprofloxacin 250mg POM Capsule oral 115/004 Ajanta Pharma Limited, India

149 Thirty Plus Capsules Ginseng extract 1000mg P Capsule oral 115/004H Ajanta Pharma Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 150 Apthromycin Tablets Erythromycin 250mg POM Tablet Uncoated 115/005 Ajanta Pharma Limited, India

151Pinkoo Gripe Water

Herbal extracts 45mg GS Solution for Oral

Use

115/005H Ajanta Pharma Limited, India

152 Optifenac Tablets Diclofenac 25mg P Tablet Uncoated 115/006 Ajanta Pharma Limited, India

153 Rheumanib Ointment Herbal extracts 14% w/w GS Ointment topical 115/006H Ajanta Pharma Limited, India

154 Optifenac Tablets Diclofenac 50mg P Tablet Uncoated 115/007 Ajanta Pharma Limited, India

155 Apcillin 250 Capsules Ampicillin 250mg POM Capsule oral 115/008 Ajanta Pharma Limited, India

156 Apcillin 500 Capsules Ampicillin 500mg POM Capsule oral 115/009 Ajanta Pharma Limited, India

157 Novaten 50 Tablets Atenonol 50mg POM Tablet Uncoated 115/010 Ajanta Pharma Limited, India

158 Mobaid Tablets Herbal extracts 950mg P Tablet Uncoated 115/010H Ajanta Pharma Limited, India

159 Novaten 100 Tablets Atenolol 100mg POM Tablet Uncoated 115/011 Ajanta Pharma Limited, India

160 Cloxil 250 Capsules Cloxacillin 250mg POM Capsule oral 115/012 Ajanta Pharma Limited, India

161Anthalben Tablets

Mebendazole USP

100mg

P Tablet Uncoated 115/013 Ajanta Pharma Limited, India

162 Apmox 250 Capsules Amoxicillin 250mg POM Capsule oral 115/014 Ajanta Pharma Limited, India

163

Cloxa-Plus Capsules

Cloxacillin Sodium BP

250mg + Ampicillin

Trihydrate BP 250mg

POM Capsule oral 115/015 Ajanta Pharma Limited, India

164

Supreme S.S. Tablet

Sulfamethoxazole 400mg

+ Trimethoprim 80mg

POM Tablet Uncoated 115/017 Ajanta Pharma Limited, India

165 Apcalis 10 Tablets Tadalafil 10mg POM Tablet Film coated 115/018 Ajanta Pharma Limited, India

166 Apcalis Plus 20 Tablets Tadalafil 20mg POM Tablet Film coated 115/019 Ajanta Pharma Limited, India

167Atorfit-10 Tablets

Artovastatin Calcium

10mg

POM Tablet Film coated 115/020 Ajanta Pharma Limited, India

168Atorfit-20 Tablets

Artovastatin Calcium

20mg

POM Tablet Film coated 115/021 Ajanta Pharma Limited, India

169Ather Injection

Alpha-ß Artemether

75mg/2ml

POM Solution for

Injection

115/030 Ajanta Pharma Limited, India

170 Kamagra Oral Gel Sildenafil Citrate 50mg POM Gel Oral 115/031 Ajanta Pharma Limited, India

171Anacox Plus LD Tablets

Isoniazid BP 75mg +

Rifampicin BP 150mg

POM Tablet Film coated 115/035 Ajanta Pharma Limited, India

172 Kamagra 100 Tablets Sildenafil Citrate 100mg POM Tablet Uncoated 115/036 Ajanta Pharma Limited, India

173 Kamagra 50 Tablets Sildenafil Citrate 50mg POM Tablet Uncoated 115/037 Ajanta Pharma Limited, India

174Artefan 20/120mg Tablets

Artemether 20 mg +

Lumefantrine 120mg

POM Tablet Uncoated 115/038 Ajanta Pharma Limited, India

175

Kamagra Oral Jelly 50mg

OrangeSildenafil Citrate 50mg

POMGel Oral

115/039Ajanta Pharma Limited, India

176 Tibinil-P Tablets Pyrazinamide 500mg POM Tablet Uncoated 115/040 Ajanta Pharma Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 177 Apoxin Tablets Amoxicillin 250mg POM Tablet Uncoated 115/041 Ajanta Pharma Limited, India

178 Tibinil-E 200 Tablets Ethambutol 200mg POM Tablet Uncoated 115/042 Ajanta Pharma Limited, India

179 Tibnil E-400 Tablets Ethambutol 400mg POM Tablet Uncoated 115/043 Ajanta Pharma Limited, India

180

Combisunate Forte Kit Tablets

Sulfadoxine 500mg +

Pyrimethamine 25mg +

Artesunate 100mg

POM Tablet Uncoated 115/044 Ajanta Pharma Limited, India

181

Combisunate Tablets

Sulphadoxine 500mg +

Pyrimethamine 25mg +

Artesunate 100mg

POM Tablet Uncoated 115/045 Ajanta Pharma Limited, India

182Artefan 40/240mg Tablets

Artemether 40 mg+

Lumefantrine 240mg

POM Tablet Uncoated 115/046 Ajanta Pharma Limited, India

183

Artefan Dispersible 20/120

Tablets

Artemether 20mg +

Lumefantrine 120mg

POM Tablet Dispersible 115/047 Ajanta Pharma Limited, India

184Adrops Eye Drops

Moxifloxacin HCl 0.5%

w/v

POM Eye Drops 115/048 Ajanta Pharma Limited, India

185 Lacoma Eye Drops Lantanoprost 50mcg POM Eye Drops 115/048 Ajanta Pharma Limited, India

186Lacoma - T Eye Drops

Lantanoprost 50mcg +

Timolol 6.834mg

POM Eye Drops 115/049 Ajanta Pharma Limited, India

187

Apmod 100/270 Tablets

Artesunate 100mg +

Amodiaquine

Hydrochloride 270mg

POM Tablet Uncoated 115/050 Ajanta Pharma Limited, India

188Apmod 50/135 Tablets

Artesunate 50mg +

Amodiaquine 135mg

POM Tablet Uncoated 115/051 Ajanta Pharma Limited, India

189Apmod 25/67.5 Tablets

Artesunate 25mg +

Amodiaquine 67.5mg

POM Tablet Uncoated 115/052 Ajanta Pharma Limited, India

190Artefan 80/480 Tablets

Artemether 80 mg +

Lumefantrine 480mg

POM Tablet Uncoated 115/053 Ajanta Pharma Limited, India

191Artefan Suspension

Artemether 180mg +

Lumefantrine 1080mg

POM Suspension for

Oral Use

115/054 Ajanta Pharma Limited, India

192 Levotop 500 Tablets Levofloxacin 500mg POM Tablet Uncoated 115/055 Ajanta Pharma Limited, India

193

Nurifer Capsules

Folic acid 100mg + Iron

1.5mg + Vit B12 0.015mg

+ Vit C 75mg + Zinc

61.8mg

P Capsule oral 115/056 Ajanta Pharma Limited, India

194 Zaha-250 Tablets Azithromycin 250mg POM Tablet Uncoated 115/057 Ajanta Pharma Limited, India

195 Zaha-500 Tablets Azithromycin 500mg POM Tablet Uncoated 115/058 Ajanta Pharma Limited, India

196 Zolanas-15 Capsules Lansoprazole 15mg POM Capsule oral 115/059 Ajanta Pharma Limited, India

197 Zolanas-30 Capsules Lansoprazole 30mg POM Capsule oral 115/060 Ajanta Pharma Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

198Ciprozole Forte Tablets

Ciprofloxacin 500mg +

Tinidazole 600mg

POM Tablet Uncoated 115/061 Ajanta Pharma Limited, India

199

Apflu Syrup

Paracetamol 120mg +

ChlorphenIramine

0.525mg + Vitamin C

50mg

P Syrup 115/062 Ajanta Pharma Limited, India

200

Apflu Tablet

Paracetamol 350mg +

Chlorpheniramine 2mg +

Vitamin C 100mg

POM Tablet Uncoated 115/063 Ajanta Pharma Limited, India

201 Aprazole Tablets Omeprazole 20mg POM Tablet Uncoated 115/064 Ajanta Pharma Limited, India

202Atorfit-EZ Tablets

Atorvastatin 10mg +

Ezetimibe 10mg

POM Tablet Uncoated 115/065 Ajanta Pharma Limited, India

203 Fedate Syrup B Complex + Minerals P Syrup 115/066 Ajanta Pharma Limited, India

204

Dazel-Kit Tablets

Fluconazole 150mg +

Azithromycin 1g +

Secnidazole 1g

POM Tablet Uncoated 115/067 Ajanta Pharma Limited, India

205Ridmal 40/320 Tablets

Dihydoartimimine 40mg +

Piperaquine 320mg

POM Tablet Uncoated 115/068 Ajanta Pharma Limited, India

206

Kamagra -100 Efferscent

Tablets - Orange Flavour

Sildenafil Citrate 100mg POM Tablet Effervescent 115/069 Ajanta Pharma Limited, India

207 Kamagra Oral Jelly Sildenafil Citrate 100mg POM Gel Oral 115/070 Ajanta Pharma Limited, India

208

Kamagra Oral Jelly - Pineapple

Flavour

Sildenafil Citrate 100mg POM Gel Oral 115/071 Ajanta Pharma Limited, India

209

Kamagra Oral Jelly - Strawberry

Flavour

Sildenafil Citrate 100mg POM Gel Oral 115/072 Ajanta Pharma Limited, India

210 Instaclop 75 Tablets Clopidogrel USP 75mg POM Tablet Film coated 115/073 Ajanta Pharma Limited, India

211 Talimus 0.03% Ointment Tacrolimus 0.03% w/w POM Ointment topical 115/074 Ajanta Pharma Limited, India

212 Talimus 0.1% Ointment Tacrolimus 0.1% w/w POM Ointment topical 115/075 Ajanta Pharma Limited, India

213Aderan 8 Tablets

Candesartan cilexetil

8mg

POM Tablet Uncoated 115/076 Ajanta Pharma Limited, India

214Aderan 16 Tablets

Candesartan cilexetil

16mg

POM Tablet Uncoated 115/077 Ajanta Pharma Limited, India

215Aderan 32 Tablets

Candesartan cilexetil

32mg

POM Tablet Uncoated 115/078 Ajanta Pharma Limited, India

216Acinac Plus Tablets

Aceclofenac 100mg +

Paracetamol 350mg

P Tablet oral 115/079 Ajanta Pharma Limited, India

217 Apcalis SX 20 Orange Jelly Tadalafil 20mg POM Gel Oral 115/080 Ajanta Pharma Limited, India

218 Apcalis SX 20 Mint Jelly Tadalafil 20mg POM Gel Oral 115/081 Ajanta Pharma Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

219Zaha Suspension

Azithromycin Dihydrate

USP 200mg

POM Suspension for

Oral Use

115/089 Ajanta Pharma Limited, India

220

Instaclop Plus Capsules

Aspirin BP 75mg +

Clopidogrel Bisulphate

USP 75mg

POM Capsule oral 115/090 Ajanta Pharma Limited, India

221Met-XL 100 Tablets

Metoprolol Succinate

100mg

POM Tablet extended

release

115/091 Ajanta Pharma Limited, India

222Adacin Gel

Adapalene 0.1% w/w +

Clindamycin 1% w/w

POMGel Topical

115/092Ajanta Pharma Limited, India

223Addrops DX Eye Drops

Moxifloxacin +

Dexamethasone

POMEye Drops

115/093Ajanta Pharma Limited, India

224Artefan 80/480 Tablets

Artemether 80mg +

Lumefantrine 480 mg

POMTablet Film Coated

115/094Ajanta Pharma Limited, India

225

Melacare Cream 15mg

Tritinoin 0.025%w/w +

Mometasone Furoate

0.1%w/w + Hydroquinone

2% w/w

POM

Cream Topical

115/095

Ajanta Pharma Limited, India

226 Ajanta's Stamina Herbal Extract P Capsule oral 115/HM008 Ajanta Pharma Limited, India

227

Colirucus Gentadexa Ear/Eye

Drops

Gentamicin +

Dexamethasone +

Tetryzoline

(0.65mg/100ml)

POM Ear/Eye Drops 158/001 Alcon Cusi SA Spain

228Oftalmotrin Eye Drops

Trimethoprim +

Polymyxin B (1.1g)

POM Eye Drops 158/002 Alcon Cusi SA Spain

229Curicrom Eye Drops

Sodium Cromoglycate

2% w/v

POM Eye Drops 158/003 Alcon Cusi SA Spain

230Cusicrom Eye Drops

Disodium cromoglycate

4% w/v

POM Eye Drops 158/004 Alcon Cusi SA Spain

231

Colircusi Chloramphenicol Eye

Drops

Chloramphenicol 0.5% POM Eye Drops 158/005 Alcon Cusi SA Spain

232 Cusimolol Eye Drops Timolol 0.5% w/v POM Eye Drops 158/006 Alcon Cusi SA Spain

233Cusicrom 4% Eye Drops

Sodium Cromoglycate

4% w/v

POM Eye Drops 009/004 Alcon Laboratories SA Pty Ltd

234Cyclogyl 15 Eye Drops

cyclopentolate

Hydrochloride 1% w/v

POM Eye Drops 009/024 Alcon Laboratories SA Pty Ltd

235Maxidex Ointment

Dexamethasone 0.1%

w/w

POM Ointment topical 009/031 Alcon Laboratories SA Pty Ltd

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

236

Maxitrol Ointment

Neomycin sulphate

3,500IU +

Dexamethasone 1mg +

Polymyxin B sulphate

6,000 IU

POM Ointment topical 009/033 Alcon Laboratories SA Pty Ltd

237 Mydriacyl Eye Drops Tropicamide 0.5% w/v POM Solution 009/034 Alcon Laboratories SA Pty Ltd

238

Naphcon Eye Drops

Naphazoline

Hydrochloride 0.025% +

Pheniramine maleate

0.3%

POM Eye Drops 009/035 Alcon Laboratories SA Pty Ltd

239 Tetracaine 0.5% Eye Drops Lignocaine 0.5% w/v POM Eye Drops 009/037 Alcon Laboratories SA Pty Ltd

240 Tobrex Ointment Tobramycin 0.3% w/v POM Ointment topical 009/039 Alcon Laboratories SA Pty Ltd

241Tobradex Ointment

Tobramycin 0.3% +

Dexamethasone 0.1%

POM Ointment topical 227/001 Alcon Laboratories SA Pty Ltd

242Tobradex Eye Drops

Tobramycin 0.3% +

Dexamethasone 0.1%

POM Eye Drops 227/002 Alcon Laboratories SA Pty Ltd

243

Brozeet Solution

Bromhexine 4.2mg +

Terbutaline 1.575mg, per

5ml

P Solution for Oral

Use

215/001 Alembic Chemical Works Co. Limited, India

244

Benzathine Penicillin 2.4 MU

Injection

Benzathine Penicillin 2.4

Mega Units

POM Powder for

Injection

215/002 Alembic Chemical Works Co. Limited, India

245

Zeet Expectorant Syrup

Bromhexine 4mg +

Guaiphenesin 50mg +

Diphenylhydramine 8mg,

per 5ml

P Syrup 215/003 Alembic Chemical Works Co. Limited, India

246Clarithro-250 Tablets

Clarithromycin 250mg POM Tablet Uncoated 215/004 Alembic Chemical Works Co. Limited, India

247

Glycodin Cough Syrup

Codeine Phosphate

3.75mg + Alcohol 10mg +

Menthol 0.07ml +

Terpene Hydrate 10mg

per 5ml

P Syrup 215/005 Alembic Chemical Works Co. Limited, India

248Lomeg 10 Tablets

Loratadine 10mg POM Tablet Uncoated 215/006 Alembic Chemical Works Co. Limited, India

249Procain Penicillin 3MU Injection

Procaine Penicillin 3MU POM Powder for

Injection

215/007 Alembic Chemical Works Co. Limited, India

250

Fortified Procaine Penicillin

4MU Injection

Procain Penicillin 4MU POM Powder for

Injection

215/008 Alembic Chemical Works Co. Limited, India

Page 13 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

251Benzyl Penicillin 5MU Injection

Benzyl Penicillin 5MU POM Powder for

Injection

215/009 Alembic Chemical Works Co. Limited, India

252Sparta Tablets

Sparfloxacin 200mg POM Tablet Uncoated 215/010 Alembic Chemical Works Co. Limited, India

253Azithral 200 Liquid

Azithromycin 200mg POM Solution for Oral

Use

215/011 Alembic Chemical Works Co. Limited, India

254Althrocin S 250 Oral Solution

Azithromycin 2050mg POM Solution for Oral

Use

215/012 Alembic Chemical Works Co. Limited, India

255Omezol-20 Capsules

Omeprazole 20mg POM Capsule oral 215/013 Alembic Chemical Works Co. Limited, India

256Ciprown-500 Tablets

Ciprofloxacin 500mg POM Tablet Uncoated 215/014 Alembic Chemical Works Co. Limited, India

257Azithral-250 Tablets

Azithromycin 250mg POM Tablet Uncoated 215/015 Alembic Chemical Works Co. Limited, India

258

Ugel Liquid

Magaldrate 84mg +

Simethicone 4.080mg,

per ml

POM Suspension for

Oral Use

215/016 Alembic Chemical Works Co. Limited, India

259Ugel Chewable Tablets

Magaldrate 400mg +

Simethicone 20mg

P Tablet Chewable 215/017 Alembic Chemical Works Co. Limited, India

260Fortafen Tablets

Aceclofenac 100mg POM Tablet Film coated 215/018 Alembic Chemical Works Co. Limited, India

261Azithral - 500 Tablets

Azithromycin Dihydrate

500mg

POM Tablet Film coated 215/019 Alembic Chemical Works Co. Limited, India

262

Glisen MF 2 Tablets

Glimepiride USP 2mg +

Metformin Hydrochloride

USP 500mg

POM Tablet Film coated 215/020 Alembic Chemical Works Co. Limited, India

263

Glisen MF 1 Tablets

Glimepiride USP 1mg +

Metformin Hydrochloride

USP 500mg

POM Tablet Film coated 215/021 Alembic Chemical Works Co. Limited, India

264

Neolap Eye Drops

Olopatadine

Hydrochloride USP 0.2%

w/v

POM Eye Drops 215/022 Alembic Chemical Works Co. Limited, India

265Moxofi Eye Drops

Moxifloxacin

Hydrochloride 5.4mg

POM Eye Drops 215/023 Alembic Chemical Works Co. Limited, India

266Dorembic Eye Drops

Doizolamide HCl USP

2.0%w/v

POM Eye Drops 215/024 Alembic Chemical Works Co. Limited, India

267

Augdor Eye Drops

Dozolamide Hcl USP 2%

w/v + Timolol maleate

USP 0.5%w/v

POM Eye Drops 215/025 Alembic Chemical Works Co. Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

268Vel Drop Gel

Carboxymethylcellulose

Sodium 1%/w/v

POM Eye Drops 215/026 Alembic Chemical Works Co. Limited, India

269Alemtob Eye Drops

Tobramycin USP

0.3%w/v

POM Solution for Topical

Use

215/027 Alembic Chemical Works Co. Limited, India

270

Alemtob-D Eye Drops

Tobramycin 0.3%w/v +

Dexamethasone 0.1%w/v

POM Solution for Topical

Use

215/028 Alembic Chemical Works Co. Limited, India

271

Owin D Eye Drops

Ofloxacin 0.3%w/v +

Dexamethasone 0.1%w/v

POM Solution for Topical

Use

215/029 Alembic Chemical Works Co. Limited, India

272Vel Eye Drops

Carboxymethylcellulose

Sodium 0.5%w/v

POM Eye Drops 215/030 Alembic Chemical Works Co. Limited, India

273 Erythromycin Tablets Erythromycin 250mg POM Tablet Uncoated 166/001 Alkem Laboratories Ltd, India

274Erythromycin Suspension

Erythromycin 125mg, per

5ml

POM Suspension for

Oral Use

166/002 Alkem Laboratories Ltd, India

275 Broadmex-250 Capsules Amoxicillin 250mg POM Capsule oral 166/003 Alkem Laboratories Ltd, India

276 Formin-500mg Tablets Metformin 500mg POM Tablet Uncoated 166/004 Alkem Laboratories Ltd, India

277 Cloxacillin Capsules Cloxacillin 250mg POM Capsule oral 166/005 Alkem Laboratories Ltd, India

278Taxim 1g Injection

Cefotaxime 1g POM Powder for

Injection

166/006 Alkem Laboratories Ltd, India

279Decacef Suspension

Cephalexin 125mg, per

5ml

POM Powder for Oral

Suspension

166/007 Alkem Laboratories Ltd, India

280 Decacef 500 Capsules Cephalexin 500mg POM Capsule oral 166/008 Alkem Laboratories Ltd, India

281

Chloramphenicol Oral

Suspension

Chloramphenicol 125mg,

per 5ml

POM Suspension for

Oral Use

166/009 Alkem Laboratories Ltd, India

282 Alcipro 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 166/010 Alkem Laboratories Ltd, India

283Amoxicillin Suspension

Amoxicillin 125mg, per

5ml

POM Powder for Oral

Suspension

166/011 Alkem Laboratories Ltd, India

284Anpicillin Oral Suspension

Ampicillin 125mg, per

5ml

POM Suspension for

Oral Use

166/012 Alkem Laboratories Ltd, India

285Cloxacillin Oral Suspension

Cloxacillin 125mg, per

5ml

POM Powder for Oral

Suspension

166/013 Alkem Laboratories Ltd, India

286 Omeprazole-20 Capsules Omeprazole 20mg POM Capsule oral 166/014 Alkem Laboratories Ltd, India

287

T-Prim 80/400mg Tablets

Trimethoprim 80mg +

Sulfamethoxazole 400mg

POM Tablet Uncoated 166/015 Alkem Laboratories Ltd, India

288Cloxacillin 250 Injection

Cloxacillin 250mg POM Powder for

Injection

166/016 Alkem Laboratories Ltd, India

289 Decacef 250 Capsules Cephalexin 250mg POM Capsule oral 166/017 Alkem Laboratories Ltd, India

Page 15 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

290Broadclox-500 Capsules

Ampicillin + Cloxacillin

500mg

POM Capsule oral 166/018 Alkem Laboratories Ltd, India

291Amitriptylline Tablets

Amitriptylline

Hydrochloride 25mg

POM Tablet Uncoated 252/001 Alpharma Ltd, United Kingdom

292 Allopurinol Tablets Allopurinol 100mg POM Tablet Uncoated 252/002 Alpharma Ltd, United Kingdom

293 Atenolol 25 Tablets Atenolol 25mg POM Tablet Film coated 252/003 Alpharma Ltd, United Kingdom

294 Atenolol 50 Tablets Atenolol 50mg POM Tablet Film coated 252/004 Alpharma Ltd, United Kingdom

295 Atenolol Tablets Atenolol 100mg POM Tablet Film coated 252/005 Alpharma Ltd, United Kingdom

296 Bendrofluazide Tablets Bendrofluazide 5mg POM Tablet Uncoated 252/006 Alpharma Ltd, United Kingdom

297 Captopril Tablets Captopril 25mg POM Tablet Uncoated 252/007 Alpharma Ltd, United Kingdom

298Co-Amilozide Tablets

Hydrochlorothiazide

50mg + Amiloride 5mg

POM Tablet Uncoated 252/008 Alpharma Ltd, United Kingdom

299 Glibenclamide Tablets Glibenclamide 5mg POM Tablet Uncoated 252/009 Alpharma Ltd, United Kingdom

300 Glyceryl Trinitrate Tablets Glyceryl Trinitrate 0.5mg POM Tablet Uncoated 252/010 Alpharma Ltd, United Kingdom

301Isosorbide Mononitrate Tablets

Isosorbide mononitrate

10mg

POM Tablet Uncoated 252/011 Alpharma Ltd, United Kingdom

302 Metformin Tablets Metformin 500mg POM Tablet Uncoated 252/012 Alpharma Ltd, United Kingdom

303Verapamil Tablets

Verapamil Hydrochloride

40mg

POM Tablet Uncoated 252/013 Alpharma Ltd, United Kingdom

304 Spironolactone 25 Tablets Spironolactone 25mg POM Tablet Uncoated 252/014 Alpharma Ltd, United Kingdom

305 Spironolactone 50 Tablets Spironolactone 50mg POM Tablet Uncoated 252/015 Alpharma Ltd, United Kingdom

306 Contempo Bareback Condom Latex Condom GS Protective barrier 439/001L Alston Garrard uk

307

Contempo Erotica Ribbed

Condom

Latex Condom GS Protective barrier 439/002L Alston Garrard uk

308 Contempo Flavours Condoms Latex Condom GS Protective barrier 439/003L Alston Garrard uk

309 Contempo King Size Condoms Latex Condom GS Protective barrier 439/004L Alston Garrard uk

310

Contempo Power Play Condom Latex Condom GS Protective barrier 439/005L Alston Garrard uk

311

Contempo Rough Rider

Condom

Latex Condom GS Protective barrier 439/006L Alston Garrard uk

312

Contempo Wet N Wild Condom Latex Condom GS Protective barrier 439/007L Alston Garrard uk

313 Lifestyle Fantasy Condom Latex Condom GS Protective barrier 439/008L Alston Garrard uk

314 Lifestyles sensations Condom Latex Condom GS Protective barrier 439/009L Alston Garrard uk

315 Lifestyles Sensitive Condom Latex Condom GS Protective barrier 439/010L Alston Garrard uk

316Amovit C Calcium Tablets

Ascorbic Acid 500 +

Calcium Carbonate 1000

P Tablet Uncoated 020/003 Amoun Pharmaceuticals Company, Egypt

317 Amovit C Tablets Ascorbic Acid 1000mg P Tablet Uncoated 020/004 Amoun Pharmaceuticals Company, Egypt

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

318

B.B.C Spray

Benzocaine 1500 mg+

Benzydamine

hydrochloride 150mg +

Cetalkonium chloride, per

100ml

GS Spray for Topical

Use

020/005 Amoun Pharmaceuticals Company, Egypt

319Baby Cream

Olive Oil 10mg + Zinc

Oxide 20mg, per 100g

GS Cream Topical 020/006 Amoun Pharmaceuticals Company, Egypt

320Collycrom 4% Eye Drops

Sodium Cromoglycate

4.0% w/v

POM Eye Drops 020/007 Amoun Pharmaceuticals Company, Egypt

321

Enemax Enema Solution

Monosodium phosphate

6mg + Disodium

phosphate 16mg

POM Solution for Topical

Use

020/008 Amoun Pharmaceuticals Company, Egypt

322

Xenos Fruit Effervescent

Granules

Sodium Bicarbonate

2.7mg + Citric Acid

0.76mg + Tartaric Acid

1.257mg

GS Granules for Oral

Use

020/009 Amoun Pharmaceuticals Company, Egypt

323 For Hair and Nails Capsules GS Capsule oral 020/010 Amoun Pharmaceuticals Company, Egypt

324Glucose Tablets

Glucose 3mg+ Ascorbic

Acid 120mg

GS Tablet Uncoated 020/011 Amoun Pharmaceuticals Company, Egypt

325

Michaelon Tablets

Paracetamol 400mg+

Pseudoephedrine 60mg

+ Carbinoxaine Maleate

4mg

P Tablet Uncoated 020/012 Amoun Pharmaceuticals Company, Egypt

326

Minalax Tablets

Bisacodyl 3mg + Dioctyl -

Sodium Sulphosuccinate

100mg

P Tablet Uncoated 020/013 Amoun Pharmaceuticals Company, Egypt

327

My Sweet Baby Syrup

Dill Oil + Caraway Oil +

Cardamon Oil +

Peppermint Oil

GS Syrup 020/014 Amoun Pharmaceuticals Company, Egypt

328Vitamount for Women Capsules

Multivitamin GS Capsule oral 020/015 Amoun Pharmaceuticals Company, Egypt

329 Vitamount Syrup Multivitamin GS Syrup 020/016 Amoun Pharmaceuticals Company, Egypt

330Viva-Max 3mg Tablets

Melatonin + Pyrodoxine

Hcl 3mg

POM Tablet Uncoated 020/017 Amoun Pharmaceuticals Company, Egypt

331

Bevacizumab Amring 400mg/

4ml

Bevacizumab 440mg/4ml POM Solution for

Injection

441/002 Amring Farma SRL

332

Paracetamol Amring Infusion Paracetamol 10mg/ml POM Solution for

infusion

441/004 Amring Farma SRL

Page 17 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

333

Zoledronic Acid Amring Infusion Zoledronic Acid 0.8mg/ml POM Solution for

infusion

441/003 Amring Farma SRL

334

Bevacizumab Amring 100mg/

4ml

Bevacizumab 25mg/ml POM Solution for

Injection

441/001 Amring Farma SRL

335 Safe Pill Levonorgestrel 1.5mg P Tablet Film coated 404/001 Anant Pharmaceuticals Ltd

336

Enerject-12 Injection

Vitamin B12 2500mcg,

Folic acid 0.7mg,

Niacinamide 12 mg,

Benzyl Alcohol 1% v/v

POM Solution for

Injection

279/001 Anglo-French Drugs & Industries Ltd,India

337Beplex Forte Tablets

Vit B Complex + Vit C+

Biotin 260mcg

GS Tablet Film coated 279/002 Anglo-French Drugs & Industries Ltd,India

338Beplex Forte Injection

Multivitamin POM Solution for

Injection

279/003 Anglo-French Drugs & Industries Ltd,India

339 Maxamin Forte Tablets Vitamins + Minerals GS Tablet Uncoated 279/004 Anglo-French Drugs & Industries Ltd,India

340 Zincofer Capsules Haematinic preparation P Capsule oral 248/001 Apex Laboratories Ltd, India

341

Betzee Cream

Betamethasone

0.05%w/w + Zinc

2.5%w/w

POM Cream Topical 248/002 Apex Laboratories Ltd, India

342

Betzee G Cream

Betamethasone

0.05%w/w + Gentamicin

0.10%w/w+ Zinc

2.5%w/w

POM Cream Topical 248/003 Apex Laboratories Ltd, India

343

Betzee-M Cream

Betamethasone

0.05%w/w + Miconazole

2%w/w + Zinc 2.5%w/w

POM Cream Topical 248/004 Apex Laboratories Ltd, India

344

Betzee-GM Cream

Betamethasone

0.05%w/w+

Miconazole2%w/w +

Gentamicin 0.10%w/w+

Zinc 2.5%w/w

POM Cream Topical 248/005 Apex Laboratories Ltd, India

345

Betzee-S Ointment

Betamethasone0.05%w/

w + Salicylic acid

3%w/w+ Zinc 2.5%w/w

POM Ointment topical 248/006 Apex Laboratories Ltd, India

346 Lozee Cream clobetasone 0.05% w/w POM Cream Topical 248/007 Apex Laboratories Ltd, India

347

Lozee-GM Cream

Clobetasone 0.05% +

Gentamicin 0.10% +

Miconazole 2.0% + Zinc

1.0%w/w

POM Cream Topical 248/008 Apex Laboratories Ltd, India

Page 18 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

348Zincovit Syrup

Multivitamins GS Syrup for Oral Use 248/009 Apex Laboratories Ltd, India

349 Zincovit Tablets Multivitamins GS Tablet Uncoated 248/010 Apex Laboratories Ltd, India

350Zincovit Drops

Multivitamins GS Suspension for

Oral Use

248/011 Apex Laboratories Ltd, India

351Zincofer Liquid

Haematinic preparation P Suspension for

Oral Use

248/012 Apex Laboratories Ltd, India

352 Nalidixic Acid Tablets Nalidixic acid 500mg POM Tablet Uncoated 248/013 Apex Laboratories Ltd, India

353 Monocef-O Tablets Cefpodoxine 200mg POM Tablet Uncoated 256/001 Aristo Pharmaceuticals Ltd, India

354 Tobacin Eye Drops Tobramycin 0.3% w/v POM Eye Drops 256/003 Aristo Pharmaceuticals Ltd, India

355Ar- Ampi Powder

Ampicillin 125mg, per

5ml

POM Powder for

suspension

187/001 Arubhi International, India

356 Ar-Grisco 125mg Tablets Griseofulvin 125mg POM Tablet Uncoated 187/002 Arubhi International, India

357 Ar-Griseo 250 Tablets Griseofulvin 250mg POM Tablet Uncoated 187/003 Arubhi International, India

358Ar-Ampicloc Capsules

Ampicillin 250mg +

Cloxacillin 250mg

POM Capsule Oral 187/004 Arubhi International, India

359Ar-Ampiclox 125 Syrup

Ampicillin 62.5mg +

Cloxacillin 62.5mg

POM Syrup 187/005 Arubhi International, India

360 Ar-Clovir Tablets Acyclovir 200mg POM Tablet Uncoated 187/006 Arubhi International, India

361 Ar-Clox Capsules Cloxacillin 250mg POM Capsule Oral 187/009 Arubhi International, India

362Ar-Cloxa Syrup

Cloxacillin 125mg, per

5ml

POM Syrup 187/010 Arubhi International, India

363 Ar-Fol 5 Tablets Folic acid 5mg P Tablet Uncoated 187/011 Arubhi International, India

364

Arol Solution

Sodium chloride +

Sodium citrate + Possium

chloride + Glucose

GS Powder for Oral

Solution

187/012 Arubhi International, India

365 Ar-Cetamol Tablets Paracetamol 500mg P Tablet Uncoated 187/013 Arubhi International, India

366 Ar-Sal Tablets Salbutamol 4mg POM Tablet Uncoated 187/014 Arubhi International, India

367 Ar-Ibu Tablets Ibuprofen 200mg P Tablet Film coated 187/015 Arubhi International, India

368 Ar-Zole Capsules Fluconazole 150mg POM Capsule oral 187/016 Arubhi International, India

369 Ar-Ozine Tablets Promethazine 25mg P Tablet Film coated 187/017 Arubhi International, India

370

Ar-Cotri Tablets

Trimethoprim 80mg +

Sulphamethoxazole

400mg

POM Tablet Uncoated 187/018 Arubhi International, India

371Ar-Pyra Tablets

Pyrantel pamoate 125mg P Tablet Uncoated 187/019 Arubhi International, India

372 Ar Cee Tablets Ascorbic Acid 200mg GS Tablet Uncoated 187/020 Arubhi International, India

373 Ar-Gliben - 5 Tablets Glibenclamide 5mg POM Tablet Uncoated 187/021 Arubhi International, India

Page 19 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 374 Ar-Pred Tablets Prednisolone 5mg POM Tablet Uncoated 187/022 Arubhi International, India

375Ar-Dar Tablets

Pyrimethamine 25mg +

Sulphadoxine 500mg

P Tablet Uncoated 187/023 Arubhi International, India

376 Ar-Peridol Tablets Haloperidol 5mg POM Tablet Uncoated 187/024 Arubhi International, India

377 Ar-Omycin Tablets Erythromycin 250mg POM Tablet Uncoated 187/025 Arubhi International, India

378 AR-Zole Capsules Fluconazole 200mg POM Capsule Oral 187/026 Arubhi International, India

379 Ar-Floxacin Tablets Ciprofloxacin 500mg POM Tablet Film coated 187/027 Arubhi International, India

380 Ar-Tetra Capsules Tetracycline 250mg POM Capsule Oral 187/028 Arubhi International, India

381 Ar-Diclo Tablets Diclofenac 100mg P Tablet Uncoated 187/029 Arubhi International, India

382 Ar- Pramide Tablets Loperamide 2mg POM Tablet Uncoated 187/030 Arubhi International, India

383 Ar-Mazepine Tablets Carbamazepine 200mg POM Tablet Uncoated 187/031 Arubhi International, India

384 Ar-Thylodopa Tablets Methyldopa 250mg POM Tablet Film coated 187/032 Arubhi International, India

385

Ar-Antacid Tablets

Aluminium hydroxide BP

120mg + Magnesium

trisilscate BP 250mg

GS Tablet Chewable 187/033 Arubhi International, India

386Ar-Hyoscine Tablets

Hyoscine Butybromide

10mg

POM Tablet Uncoated 187/034 Arubhi International, India

387 Ar-Grisceo 500 Tablets Griseofulvin 500mg POM Tablet Uncoated 187/035 Arubhi International, India

388 Ar-Metro Tablets Metronidazole 200mg POM Tablet Uncoated 187/036 Arubhi International, India

389 Ar-Vitacee Tablets Ascorbic Acid 100mg GS Tablet Uncoated 187/037 Arubhi International, India

390 Arbimazole Tablets Carbimazole 5mg POM Tablet Uncoated 187/038 Arubhi International, India

391 Ardidol Tablets Propranolol 40mg POM Tablet Uncoated 187/039 Arubhi International, India

392 Arhexol 2mg Tablets Benzhexol 2mg POM Tablet Uncoated 187/040 Arubhi International, India

393 Arhexol 5mg Tablets Benzhexol 5mg POM Tablet Uncoated 187/041 Arubhi International, India

394 Arnadix Tablets Nalidixic Acid 500mg POM Tablet Uncoated 187/042 Arubhi International, India

395 Arphen Tablets Chlorpheniramine 4mg P Tablet Uncoated 187/043 Arubhi International, India

396 Artopril Tablets Captopril 25mg POM Tablet Uncoated 187/044 Arubhi International, India

397 Paradol Tablets Paracetamol 500mg GS Tablet Uncoated 187/045 Arubhi International, India

398Ar-Pyron Suspension

Pyrantel Pamoate 50mg,

per 1ml

P Suspension for

Oral Use

187/046 Arubhi International, India

399 AR-INDO 25 Capsules Indomethacin 25mg P Capsule oral 187/047 Arubhi International, India

400 Ar-Ampi 250 Caspules Ampicillin 250mg POM Capsule oral 187/048 Arubhi International, India

401 Ar-Amox 250 Capsules Amoxicillin 250mg POM Capsule oral 187/049 Arubhi International, India

402 Diclonac Tablets Diclofenac 50mg P Tablet Uncoated 187/050 Arubhi International, India

403 Formin Tablets Metformin 500mg POM Tablet Uncoated 187/051 Arubhi International, India

404 Sharp Shoot Tablets Sildenafil 50mg POM Tablet Uncoated 187/052 Arubhi International, India

405 Sharp Shoot Tablets Sildenafil 100mg POM Tablet Uncoated 187/053 Arubhi International, India

406 Aramino Tablets Aminophylline 100mg POM Tablet Uncoated 187/054 Arubhi International, India

407 Armide Tablets Furosemide 40mg POM Tablet Uncoated 187/055 Arubhi International, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

408Ar-Pirin Tablets

Aspirin 75mg POM Tablet Sustained

Release

187/056 Arubhi International, India

409 Chloprazin Tablets Chlorpromazine 25mg POM Tablet Uncoated 187/057 Arubhi International, India

410 Cimedin Tablets Cimetidine 200mg POM Tablet Uncoated 187/058 Arubhi International, India

411 Digox Tablets Digoxin 0.25mg POM Tablet Uncoated 187/059 Arubhi International, India

412 Vita - B6 Tablets Pyridoxine 50 mg POM Tablet Uncoated 187/060 Arubhi International, India

413 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 184/001 Arvind Remedies Limited, India

414 Cloxacillin Capsules Cloxacillin 250mg POM Capsule Oral 184/002 Arvind Remedies Limited, India

415 Phenobarbital Tablets Phenobarbitone 30mg POM Tablet Uncoated 184/003 Arvind Remedies Limited, India

416Rifampicin + Isoniazid Tablets

Rifampicin 150mg+

Isoniazid 75mg

POM Tablet Uncoated 184/004 Arvind Remedies Limited, India

417 Propranolol Tablets Propranolol 40mg POM Tablet Uncoated 184/005 Arvind Remedies Limited, India

418 Promethazine Tablets Promethazine 25mg P Tablet Uncoated 184/006 Arvind Remedies Limited, India

419 Methyldopa Tablets Methyldopa 250mg POM Tablet Uncoated 184/007 Arvind Remedies Limited, India

420

Diclofenac BP Enteric Coated

Tablets

Diclofenac 50mg P Tablet Enteric

Coated

184/008 Arvind Remedies Limited, India

421

Sulfadoxine USP +

Pyrimethamine Tablets

Pyrimethamine 25mg +

Sulfadoxine USP 500mg

P Tablet Uncoated 184/010 Arvind Remedies Limited, India

422 Suganril Tablets Piroxicam 20mg POM Tablet Uncoated 101/001 Asence Pharma Pvy Ltd., India.

423Zodid Injection

Diclofenac 75mg, per 3ml POM Solution for

Injection

101/002 Asence Pharma Pvy Ltd., India.

424 Zobid SR Tablets Diclofenac 100mg P Tablet Uncoated 101/003 Asence Pharma Pvy Ltd., India.

425 Nifedipine 10 Tablets Nifedipine 10mg POM Tablet Uncoated 101/004 Asence Pharma Pvy Ltd., India.

426Pocilin 4 Mega Injection

Penicillin G + Procaine

Benzylpenicillin 4MU

POM Powder for

Injection

101/005 Asence Pharma Pvy Ltd., India.

427Trimin Injection

B Complex POM Solution for

Injection

101/006 Asence Pharma Pvy Ltd., India.

428Amoxicillin Oral Suspension

Amoxicillin 25mg, per 5ml POM Powder for Oral

Suspension

101/007 Asence Pharma Pvy Ltd., India.

429

Compound Magnesium Tablets

Aluminium hydroxide 120

+ Magnesium trisilscate

250mg

GS Tablet Uncoated 101/008 Asence Pharma Pvy Ltd., India.

430

Cofnil-N Expectorant Syrup

Codein 10mg +

Chlorpheniramine 4mg +

Methol 1.5mg, per 5ml

P Syrup 101/009 Asence Pharma Pvy Ltd., India.

431Amphotericin B Injection

Amphotericin B 5mg POM Solution for

Injection

101/010 Asence Pharma Pvy Ltd., India.

432Streptocin Injection

Streptomycin 5 g POM Powder for

Injection

101/011 Asence Pharma Pvy Ltd., India.

Page 21 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 433 Amoxicillin Trihydrate Capsules Amoxicillin 250mg POM Capsule oral 101/012 Asence Pharma Pvy Ltd., India.

434 Hemomin Capsules Haemantic preparation P Capsule oral 101/013 Asence Pharma Pvy Ltd., India.

435

Oral Rehydration Salt

Sodium Chloride +

Sodium Citrate +

Possium Chloride +

Glucose

GS Powder for Oral

Solution

101/014 Asence Pharma Pvy Ltd., India.

436

Phenoxymethyl Penicillin V

Tablets

Phenoxymethyl Penicillin

V 250mg

POM Tablet Uncoated 101/015 Asence Pharma Pvy Ltd., India.

437

Fluphenazine Decanoate

Injection

Fluphenazine 25mg POM Solution for

Injection

101/017 Asence Pharma Pvy Ltd., India.

438

Sulphabiotic Dusting Powder

Sulphacetamide 75mg +

Neomycin 5mg +

Gramicidin 0.5mg

POM Powder for Topical

use

101/018 Asence Pharma Pvy Ltd., India.

439 Tetracycline Eye Ointment Tetracycline 1%w/w POM Eye Ointment 101/019 Asence Pharma Pvy Ltd., India.

440 Neuclar - 500 Tablets Clarithromycin 500mg POM Tablet Uncoated 101/020 Asence Pharma Pvy Ltd., India.

441Nipine SR Tablets

Nifedipine 20mg POM Tablet extended

release

101/021 Asence Pharma Pvy Ltd., India.

442

Trimin Tablets

Thiamine Mononitrate

USP 100mg + Pyridoxine

Hydrochloride BP30mg +

Cyanocobalamine

100mcg

P Tablet Film coated 101/022 Asence Pharma Pvy Ltd., India.

443

Maxiplex Tablets

Thiamine Mononitrate

10mg + Riboflavine +

Pyridoxine Hydrochloridel

+ Niacinamide

P Tablet Film coated 101/023 Asence Pharma Pvy Ltd., India.

444 Quinine Sulphate Tablets Quinine Sulphate 300mg POM Tablet Uncoated 145/001 Aspen Pharmacare Limited, South Africa

445Amiloretic H.S Tablets

Hydrochlorothiazide

2.5mg + Amiloride 25mg

POM Tablet Uncoated 145/002 Aspen Pharmacare Limited, South Africa

446 Arthrexin 25 Suppositories Indomethacin 25mg P Suppository 145/003 Aspen Pharmacare Limited, South Africa

447

Panamor 100 SR Tablets

Diclofenac 100mg P Tablet Film coated,

Sustained Release

145/005 Aspen Pharmacare Limited, South Africa

448

Purbac Adult Tablets

Sulphamethoxazole

400mg + Trimethoprim

80mg

POM Tablet Uncoated 145/006 Aspen Pharmacare Limited, South Africa

449 Purata -10 Tablets Oxazepam 10mg POM Tablet Uncoated 145/007 Aspen Pharmacare Limited, South Africa

Page 22 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 450 Pur-Bloka Tablets Propranolol 40mg POM Tablet Uncoated 145/008 Aspen Pharmacare Limited, South Africa

451

Mybulen Tablets

Codeine 10mg +

Paracetamol 350mg +

Ibuprofen 200mg

P Tablet Uncoated 145/009 Aspen Pharmacare Limited, South Africa

452 Degramol 200 Tablets Carbamazepine 200mg POM Tablet Uncoated 145/010 Aspen Pharmacare Limited, South Africa

453 Arthrexin-100 Suppositories Indomethacin 100mg P Suppository 145/011 Aspen Pharmacare Limited, South Africa

454 Wormgo Tablets Mebendazole 100mg P Tablet Uncoated 145/013 Aspen Pharmacare Limited, South Africa

455 Cardifen-10 Capsules Nifedipine 10mg POM Capsule oral 145/014 Aspen Pharmacare Limited, South Africa

456Venteze Syrup

Salbutamol 2mg, per 5ml POM Syrup 145/015 Aspen Pharmacare Limited, South Africa

457Venteze Inhaler

Salbutamol 100mcg POM Powder for

Inhalation

145/016 Aspen Pharmacare Limited, South Africa

458Purmycin 125 Suspension

Erythromycin 125mg, per

5ml

POM Suspension for

Oral Use

145/017 Aspen Pharmacare Limited, South Africa

459 Hypotone Tablets Methyldopa 250mg POM Tablet Uncoated 145/018 Aspen Pharmacare Limited, South Africa

460 Trichazole Tablets Metronidazole 5mg POM Tablet Uncoated 145/020 Aspen Pharmacare Limited, South Africa

461 Glycomin Tablets Glibenclamide 5mg POM Tablet Uncoated 145/021 Aspen Pharmacare Limited, South Africa

462Amiloretic Tablets

Amiloride Hydrochloride

50mg

POM Tablet Uncoated 145/022 Aspen Pharmacare Limited, South Africa

463Woodward's Gripe Water

Sodium Bicarbonate +

Dill oil

GS Solution for Oral

Use

145/023 Aspen Pharmacare Limited, South Africa

464 Lenisolone Tablets Prednisolone 5mg POM Tablet Uncoated 145/024 Aspen Pharmacare Limited, South Africa

465 AP Stavudine15 Capsules Stavudine 15mg POM Capsule oral 145/025 Aspen Pharmacare Limited, South Africa

466Aspen Lamizid Tablets

Lamivudine 150mg +

Zidovudine 300mg

POM Tablets 145/029 Aspen Pharmacare Limited, South Africa

467 Aspen Lamivudine Tablets Lamivudine 150mg POM Tablet Uncoated 145/030 Aspen Pharmacare Limited, South Africa

468Aspen Lamivudine Syrup

Lamivudine 10mg, per ml POM Syrup 145/031 Aspen Pharmacare Limited, South Africa

469 Aspen Zidovudine Tablets Zidovudine 300mg POM Tablet Uncoated 145/032 Aspen Pharmacare Limited, South Africa

470Aspen Zidovudine Syrup

Zidovudine 50mg, per

5ml

POM Syrup 145/033 Aspen Pharmacare Limited, South Africa

471 Aspen Nevirapine Tablets Nevirapine 200mg POM Tablet Uncoated 145/034 Aspen Pharmacare Limited, South Africa

472

Aspen Lamzid + Nevirapine

Combipack Tablets

Lamivudine 150mg +

Zidovudine

300mg/Nevirapine

200mg

POM Tablet Uncoated 145/035 Aspen Pharmacare Limited, South Africa

473

Aspen Didanosine 50mg

Tablets

Didanosine 50mg POM Tablet Uncoated 145/036 Aspen Pharmacare Limited, South Africa

Page 23 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

474

Aspen Didanosine 100mg

Tablets

Didanosine 100mg POM Tablet Uncoated 145/037 Aspen Pharmacare Limited, South Africa

475

Aspen Didanosine 150mg

Tablets

Didanosine 150mg POM Tablet Uncoated 145/038 Aspen Pharmacare Limited, South Africa

476 Viread Tablets Tenofovir 300mg POM Tablet Film coated 145/039 Aspen Pharmacare Limited, South Africa

477Truvada Tablets

Emtricitabine 200mg +

Tenofovir 300mg

POM Tablet Film coated 145/040 Aspen Pharmacare Limited, South Africa

478

Aspen Didanosine 25mg

Tablets

Didanosine 25mg POM Tablet Uncoated 145/041 Aspen Pharmacare Limited, South Africa

479 Prezista Tablets Darunavir 300mg POM Tablet Uncoated 145/042 Aspen Pharmacare Limited, South Africa

480 Intelence Tablets Etravirine 100mg POM Tablet Uncoated 145/043 Aspen Pharmacare Limited, South Africa

481 Prezista Tablets Darunavir 600mg POM Tablet Film coated 145/044 Aspen Pharmacare Limited, South Africa

482Hycorcin 100mg Injection

Hydrocortisone 100mg POM Powder for

Injection

145/045 Aspen Pharmacare Limited, South Africa

483Isolift 10mg Tablets

Escitalopram oxalate

10mg

POM Tablet Film coated 145/046 Aspen Pharmacare Limited, South Africa

484Isolift 20mg Tablets

Escitalopram oxalate

20mg

POM Tablet Film coated 145/047 Aspen Pharmacare Limited, South Africa

485Tracruim Injection

Atracurium 10mg, per ml POM Solution for

Injection

179/024 Aspen Pharmacare Limited, South Africa

486 Lanoxin Tablets Digoxin 0.25mg POM Tablet Uncoated 179/029 Aspen Pharmacare Limited, South Africa

487 Topilept 25 Tablets Topiramate 25mg POM Tablet Film coated 179/053 Aspen Pharmacare Limited, South Africa

488 Topilept 50 Tablets Topiramate 50mg POM Tablet Film coated 179/054 Aspen Pharmacare Limited, South Africa

489 Topilept 100 Tablets Topiramate 100mg POM Tablet Film coated 179/055 Aspen Pharmacare Limited, South Africa

490Nimbex Injection

Cisatracurium besylate

2mg, per ml

POM Solution for

Injection

179/060 Aspen Pharmacare Limited, South Africa

491 Lanzine (ODT) Tablets Olanzepine 10mg POM Tablet Film coated 179/070 Aspen Pharmacare Limited, South Africa

492

Co-Rampil Tablets

Ramipril BP 5mg +

Hydrochlorothiazide USP

12.5mg

POM

Tablet Uncoated

179/070

Aspen Pharmacare Limited, South Africa

493

Lanprox Solution For Infusion

Levofloxacin

Hemihydrate 250mg, per

50ml

POM Solution for

infusion

179/071 Aspen Pharmacare Limited, South Africa

494Bidogrel 75mg Tablets

Clopidogrel Bisulfate

75mg

POM Tablet Film coated 179/072 Aspen Pharmacare Limited, South Africa

495

Co-Rampil Tablets

Ramipril 5mg +

Hydrochlorothiazide

25mg

POM Tablet Uncoated 179/073 Aspen Pharmacare Limited, South Africa

Page 24 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

496

Stavudine 30mg +

Lamivudine/Nevirapine Tablets

Stavudine 150mg +

Lamivudine + Nevirapine

300mg

POM Tablet Uncoated 222/007MT Aspen Pharmacare Limited, South Africa

497 Quinas Tablets Quinine 300mg POM Tablet Film coated 290/004 Astra Lifecare Pvt Limited

498

Astrim Tablets

Trimethoprim 80mg +

Sulfamethoxazole 400mg

POM Tablet Uncoated 290/010 Astra Lifecare Pvt Limited

499Aspiclox Capsules

Ampicillin 250mg +

Cloxacillin 250mg

POM Capsule oral 290/012 Astra Lifecare Pvt Limited

500Asmox Capsules

Amoxicilin Trihydrate

250mg

POM Capsule oral 290/013 Astra Lifecare Pvt Limited

501 Asfulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 290/014 Astra Lifecare Pvt Limited

502

As-B Tablets

Nicotinamide15mg +

Riboflavin 1mg +

Thiamine Mononitrate

1mg

P Tablet 290/015 Astra Lifecare Pvt Limited

503 Femin-P Pessaries Nystatin 100,000 IU P Tablet Vaginal 290/016 Astra Lifecare Pvt Limited

504Lumether Tablets

Artemether 120mg +

Lumefantrine 20mg

POM Tablet Uncoated 290/001 Astra Lifecare Pvt Limited, India

505 Ascodyl Tablets Bisacodyl 5mg P Tablet Film coated 290/002 Astra Lifecare Pvt Limited, India

506Ascopan Tablets

Hyocine butylbromide

10mg

POM Tablet Film coated 290/003 Astra Lifecare Pvt Limited, India

507 Asmol Tablets Paracetamol 500mg P Tablet Uncoated 290/005 Astra Lifecare Pvt Limited, India

508 Asdoxin Capsules Doxycycline 100mg POM Capsule oral 290/006 Astra Lifecare Pvt Limited, India

509 Asid Capsules Omeprazole 20mg POM Capsule oral 290/007 Astra Lifecare Pvt Limited, India

510 Gynest Pessaries Clotrimazole 100mg POM Tablet Vaginal 290/008 Astra Lifecare Pvt Limited, India

511Painol - P Tablets

Paracetamol 650mg +

Caffeine 50mg

P Tablet Uncoated 290/009 Astra Lifecare Pvt Limited, India

512 Asfen -FC Tablets Ibuprofen 200mg P Tablet Uncoated 290/011 Astra Lifecare Pvt Limited, India

513 Inderal 10mg Tablets Propranolol 10mg POM Tablet Uncoated 023/009 Astra Zeneca UK Limited

514 Inderal 40mg Tablets Propranolol 40mg POM Tablet Uncoated 023/010 Astra Zeneca UK Limited

515 Nolvadex 10mg Tablets Tamoxifen 10mg POM Tablet Uncoated 023/013 Astra Zeneca UK Limited

516 Paludrine 100mg Tablets Proguanil 100mg POM Tablet Uncoated 023/014 Astra Zeneca UK Limited

517 Tenormin 50mg Tablets Atenolol 50mg POM Tablet Uncoated 023/021 Astra Zeneca UK Limited

518 Tenormin 100mg Tablets Atenolol 100mg POM Tablet Uncoated 023/022 Astra Zeneca UK Limited

519Tenoretic 100/25mg Tablets

Atenolol 100mg +

Chlorthalidone 25mg

POM Tablet Uncoated 023/023 Astra Zeneca UK Limited

520Tenoret 50/12.4mg Tablets

Atenolol 50mg +

Chlorthalidone 12.4mg

POM Tablet Uncoated 023/024 Astra Zeneca UK Limited

Page 25 of 320

Page 26: MEDICINES FOR HUMAN USE 2019 REGISTER S/No Product …...Cefixime 400mg Tablets Cefixime Trihydrate 400mg POM Tablet Uncoated 137/005 Aegis Limited, Cyprus 70 Lasoprol 30 Capsules

ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 521 Zestril 5mg Tablets Lisinopril 5mg POM Tablet Uncoated 023/026 Astra Zeneca UK Limited

522 Zestril 10mg Tablets Lisinopril 10mg POM Tablet Uncoated 023/027 Astra Zeneca UK Limited

523 Zestril 20mg Tablets Lisinopril 20mg POM Tablet Uncoated 023/028 Astra Zeneca UK Limited

524 Nolvadex 10mg Tablets Tamoxifen 10mg POM Tablet Uncoated 023/031 Astra Zeneca UK Limited

525Oxis Turbuhaler

Formoterol 4.5mg POM Powder for

Inhalation

023/039 Astra Zeneca UK Limited

526Oxis 9mg Turbuhaler

Formoterol 9mg POM Powder for

Inhalation

023/040 Astra Zeneca UK Limited

527Pulmcort 100 Turbuhaler

Budesonide 100mg POM Powder for

Inhalation

023/041 Astra Zeneca UK Limited

528Pulmcort 200 Turbuhaler

Budesonide 200mg POM Powder for

Inhalation

023/042 Astra Zeneca UK Limited

529Pulmcort 400 Turbuhaler

Budesonide 400mg POM Powder for

Inhalation

023/043 Astra Zeneca UK Limited

530 Losec Mumps 20 Tablets Omeprazole 20mg POM Tablet Film coated 023/044 Astra Zeneca UK Limited

531

Zestrorectic Tablets

Hydrochlorothiazide

12.5mg + Lisinopril 20mg

POM Tablet Uncoated 023/045 Astra Zeneca UK Limited

532Zoladex 3.6mg Injection

Goserelin acetate implant

3.6mg

POM Implant, Injection 023/046 Astra Zeneca UK Limited

533Symbicort Turbuhaler

Formoterol 4.5mcg +

Budesonide 80mcg

POM Powder for

Inhalation

023/047 Astra Zeneca UK Limited

534 Arimidex 10mg Tablets Anastrozole 10mg POM Tablet Uncoated 023/051 Astra Zeneca UK Limited

535 Nexium 20 Tablets Esomeprazole 20mg POM Tablet Film coated 023/052 Astra Zeneca UK Limited

536 Nexium 40 Tablets Esomeprazole 40mg POM Tablet Film coated 023/053 Astra Zeneca UK Limited

537 Zmox Capsules Amoxicillin 250mg POM Capsule oral 127/001 Aurobindo Pharma Limited, India

538 Recipro 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 127/002 Aurobindo Pharma Limited, India

539 Recipro 250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 127/003 Aurobindo Pharma Limited, India

540Zcil 250 Injection

Ampicillin 250mg POM Powder for

Injection

127/004 Aurobindo Pharma Limited, India

541 Renor 400 Tablets Norfloxacin 400mg POM Tablet Uncoated 127/005 Aurobindo Pharma Limited, India

542 Aurocef Capsules Cephalexin 250mg POM Capsule oral 127/006 Aurobindo Pharma Limited, India

543Zuclox Capsules

Cloxacillin 250mg +

Ampicillin 250mg

POM Capsule oral 127/007 Aurobindo Pharma Limited, India

544 Cloxil Capsules Cloxacillin 250mg POM Capsule oral 127/008 Aurobindo Pharma Limited, India

545 Zolcer Capsules Omeprazole 200mg POM Capsule oral 127/009 Aurobindo Pharma Limited, India

546 Lamivox 150 Tablets Lamivudine 150mg POM Tablet Uncoated 127/010 Aurobindo Pharma Limited, India

547 Stavex 40 Capsules Stavudine 40mg POM Capsule oral 127/011 Aurobindo Pharma Limited, India

548 Nevirex 200 Tablets Nevirapine 200mg POM Tablet Uncoated 127/012 Aurobindo Pharma Limited, India

Page 26 of 320

Page 27: MEDICINES FOR HUMAN USE 2019 REGISTER S/No Product …...Cefixime 400mg Tablets Cefixime Trihydrate 400mg POM Tablet Uncoated 137/005 Aegis Limited, Cyprus 70 Lasoprol 30 Capsules

ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 549 Indivex 400 Tablets Indinavir 400mg POM Tablet Uncoated 127/013 Aurobindo Pharma Limited, India

550 Didavex 100 Chewable Tablets Didanosine 100mg POM Tablet Chewable 127/014 Aurobindo Pharma Limited, India

551Zidovex - L Tablets

Lamivudine 150mg +

Zidovudine 300mg

POM Tablet Uncoated 127/015 Aurobindo Pharma Limited, India

552Stavex 30 L Tablets

Lamivudine 150mg +

Stavudine 30mg

POM Tablet Uncoated 127/016 Aurobindo Pharma Limited, India

553Stavex 40 L Tablets

Lamivudine 150mg +

Stavudine 40mg

POM Tablet Uncoated 127/017 Aurobindo Pharma Limited, India

554 Nelvex 250 Tablets Nelfinavir 250mg POM Tablet Uncoated 127/018 Aurobindo Pharma Limited, India

555Aurocef 250 Oral Suspension

Cephalexin 250mg, per

5ml

POM Suspension for

Oral Use

127/019 Aurobindo Pharma Limited, India

556Aurocef 125 Oral Suspension

Cephalexin 125mg, per

5ml

POM Suspension for

Oral Use

127/020 Aurobindo Pharma Limited, India

557Cetax 1000 Injection

Cefotaxime 1000mg POM Powder for

Injection

127/021 Aurobindo Pharma Limited, India

558Erythromycin Suspension

Erythromycin 125mg, per

5ml

POM Suspension for

Oral Use

127/022 Aurobindo Pharma Limited, India

559Chloramphenicol Injection

Chloramphenicol 1000mg POM Powder for

Injection

127/023 Aurobindo Pharma Limited, India

560Triaxone 1000 Injection

Ceftriaxone 1000mg POM Powder for

Injection

127/024 Aurobindo Pharma Limited, India

561Cloxil 500 Injection

Cloxacillin 500mg POM Powder for

Injection

127/025 Aurobindo Pharma Limited, India

562

Lamivudine + Zidovudine

Tablets

Lamivudine 150mg +

Zidovudine 300mg

POM Tablet Uncoated 127/026 Aurobindo Pharma Limited, India

563 Nevirapine Tablets Nevirapine 200mg POM Tablet Uncoated 127/027 Aurobindo Pharma Limited, India

564 Stavudine 30 Capsules Stavudine 30mg POM Capsule oral 127/028 Aurobindo Pharma Limited, India

565 Stavudine 40 Capsules Stavudine 40mg POM Capsule oral 127/029 Aurobindo Pharma Limited, India

566 Efavirenz 600 Tablets Efavirenz 600mg POM Tablet Uncoated 127/030 Aurobindo Pharma Limited, India

567 Lamivudine 150mg Tablets Lamivudine 150mg POM Tablet Uncoated 127/031 Aurobindo Pharma Limited, India

568 Lamivudine 300mg Tablets Lamivudine 300mg POM Tablet Uncoated 127/032 Aurobindo Pharma Limited, India

569Zidovudine Oral Solution

Zidovudine 50mg, per

5ml

POM Solution for Oral

Use

127/033 Aurobindo Pharma Limited, India

570Lamivudine Oral Solution

Lamivudine 10mg, per ml POM Solution for Oral

Use

127/034 Aurobindo Pharma Limited, India

571Nevirapine Oral Solution

Nevirapine 50mg, per

5ml

POM Solution for Oral

Use

127/035 Aurobindo Pharma Limited, India

572 Zidovudine Tablets Zidovudine 200mg POM Tablet Uncoated 127/036 Aurobindo Pharma Limited, India

Page 27 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

573

Stavudine + Lamivudine

30/150mg Tablets

Stavudine 30mg +

Lamivudine150mg

POM Tablet Uncoated 127/037 Aurobindo Pharma Limited, India

574Stavudine + Lamivudine Tablets

Stavudine 40mg +

Lamivudine 150mg

POM Tablet Uncoated 127/038 Aurobindo Pharma Limited, India

575 Abacavir Tablets Abacavir 300mg POM Tablet Uncoated 127/039 Aurobindo Pharma Limited, India

576Stavudine Oral Solution

Stavudine 1mg, per ml POM Solution for Oral

Use

127/040 Aurobindo Pharma Limited, India

577Abacavir Sulphate Oral Solution

Abacavir 20mg, per ml POM Solution for Oral

Use

127/041 Aurobindo Pharma Limited, India

578 Stavudine 20mg Capsules Stavudine 20mg POM Capsule oral 127/042 Aurobindo Pharma Limited, India

579 Stavudine 15mg Capsules Stavudine 15mg POM Capsule oral 127/043 Aurobindo Pharma Limited, India

580 Efavirenz 100mg Capsules Efavirenz 100mg POM Capsule oral 127/044 Aurobindo Pharma Limited, India

581

Lamivudine + Zidovudine +

Nevirapine Tablets

Lamivudine 150mg +

Zidovudine 300mg +

Nevirapine 200mg

POM Tablet Uncoated 127/045 Aurobindo Pharma Limited, India

582

Lamivudine + Zidovudine +

Efavirenz Tablets

Lamivudine 150mg +

Zidovudine 300mg +

Efavirenz 600mg

POM Tablet Uncoated 127/046 Aurobindo Pharma Limited, India

583 Efavirenz 200mg Capsules Efavirenz 200mg POM Capsule oral 127/047 Aurobindo Pharma Limited, India

584 Kardam 10 Tablets Amlodipine 10mg POM Tablet Uncoated 127/049 Aurobindo Pharma Limited, India

585 Kardam 5 Tablets Amlodipine 5mg POM Tablet Uncoated 127/050 Aurobindo Pharma Limited, India

586

Koact Oral Suspension

Amoxicillin 125mg +

Clavulanic acid 31.25mg

, per 5ml

POM Suspension for

Oral Use

127/051 Aurobindo Pharma Limited, India

587

Koact Oral Suspension

Amoxicillin 250mg +

Clauvulanic acid 62.5mg,

per 5ml

POM Suspension for

Oral Use

127/052 Aurobindo Pharma Limited, India

588Cefurxime 750 Injection

Cefuroxime 750mg POM Powder for

Injection

127/053 Aurobindo Pharma Limited, India

589Cefurxime 1500 Injection

Cefuroxime 1500mg POM Powder for

Injection

127/054 Aurobindo Pharma Limited, India

590 Didanosine Chewable Tablets Didanosine 100mg POM Tablet Chewable 127/055 Aurobindo Pharma Limited, India

591 Didanosine Chewable Tablets Didanosine 150mg POM Tablet Chewable 127/056 Aurobindo Pharma Limited, India

592 Didanosine Chewable Tablets Didanosine 200mg POM Tablet Chewable 127/057 Aurobindo Pharma Limited, India

593Zcil 500mg Injection

Ampicillin 500mg POM Powder for

Injection

127/059 Aurobindo Pharma Limited, India

594 Aurocef 500mg Capsules Cephalexin 500mg POM Capsule oral 127/060 Aurobindo Pharma Limited, India

595Zmox Oral Suspension

Amoxicillin 125mg, per

5ml

POM Suspension for

Oral Use

127/061 Aurobindo Pharma Limited, India

Page 28 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

596Zcil Oral Suspension

Ampicillin 125mg, per

5ml

POM Suspension for

Oral Use

127/062 Aurobindo Pharma Limited, India

597

Combact 480mg Tablets

Sulphamethoxazole

400mg +Trimethoprim

80mg

POM Tablet Uncoated 127/063 Aurobindo Pharma Limited, India

598

Combact Suspension

Trimethoprim 40mg +

Sulfamethoxazole 200mg

POM Suspension for

Oral Use

127/064 Aurobindo Pharma Limited, India

599 Cefuxime 125 Tablets Cefuroxime 125mg POM Tablet Uncoated 127/065 Aurobindo Pharma Limited, India

600 Cefuxime 250 Tablets Cefuroxime 250mg POM Tablet Uncoated 127/066 Aurobindo Pharma Limited, India

601 Cefuxime 500 Tablets Cefuroxime 500mg POM Tablet Uncoated 127/067 Aurobindo Pharma Limited, India

602Koact 375 Tablets

Amoxicillin 250mg +

Clavulanic acid 125mg

POM Tablet Uncoated 127/068 Aurobindo Pharma Limited, India

603Koact 625 Tablets

Amoxicillin 500mg +

Clavulanic acid 125mg

POM Tablet Uncoated 127/069 Aurobindo Pharma Limited, India

604Koact 1000 Tablets

Amoxicillin 875mg +

Clavulanic acid 125mg

POM Tablet Uncoated 127/070 Aurobindo Pharma Limited, India

605

Stavudine + Lamivudine +

Nevirapine Tablets

Stavudine 30mg +

Lamivudine 150mg +

Nevirapine 200mg

POM Tablet Uncoated 127/071 Aurobindo Pharma Limited, India

606

Didanosine Delayed Released

Capsules

Didanosine 400mg POM Capsule oral 127/072 Aurobindo Pharma Limited, India

607 Didanosine Capsules Didanosine 250mg POM Capsule oral 127/073 Aurobindo Pharma Limited, India

608

Emtricitabine + Tenofovir

Tablets

Tenofivir Disoproxil

Fumerate 200mg +

Emtricitabine 300mg

POM Tablet Uncoated 127/074 Aurobindo Pharma Limited, India

609Lopinavir/Ritonavir Tablets

Lopinavir 200mg +

Ritonavir 50mg

POM Tablet Uncoated 127/075 Aurobindo Pharma Limited, India

610 Angiram 2.5 Tablets Ramipril 2.5mg POM Tablet Uncoated 127/076 Aurobindo Pharma Limited, India

611 Angiram 5 Tablets Ramipril 5mg POM Tablet Uncoated 127/077 Aurobindo Pharma Limited, India

612 Angiram 10 Tablets Ramipril 10mg POM Tablet Uncoated 127/078 Aurobindo Pharma Limited, India

613 Aroxicam 7.5 Tablets Meloxicam 7.5mg POM Tablet Uncoated 127/079 Aurobindo Pharma Limited, India

614 Aroxicam 15 Tablets Meloxicam 15mg POM Tablet Uncoated 127/080 Aurobindo Pharma Limited, India

615 Auro Metformin 500 Tablets Metformin 500mg POM Tablet Uncoated 127/081 Aurobindo Pharma Limited, India

616 Auro Metformin 850 Tablets Metformin 850mg POM Tablet Uncoated 127/082 Aurobindo Pharma Limited, India

617

Tenofivir Disoproxil Fumarate

Tablets

Tenofovir 300mg POM Tablet Film coated 127/083 Aurobindo Pharma Limited, India

Page 29 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

618

Lamivudine & Tenofovir

Disoproxil Fumarate Tablets

Lamivudine 300mg +

Tenofovir Disoproxil

Fumarate 300mg

POM Tablet Film coated 127/084 Aurobindo Pharma Limited, India

619

Efavirenz + Emtricitabine +

Tenofovir Tablets

Efavirenz 600mg +

Emtricitabine 200mg +

Tenofovir 300mg

POM Tablet Uncoated 127/085 Aurobindo Pharma Limited, India

620

Efavirenz + Lamivudine +

Tenofovir Tablets

Efavirenz 600mg +

Emtricitabine 300mg +

Tenofovir 300mg

POM Tablet Uncoated 127/086 Aurobindo Pharma Limited, India

621

Dolutegravir 50mg + Lamivudine

300mg + Tenofovir Disoproxil

Fumarate 300mg

Dolutegravir 50mg +

Lamivudine 300mg +

Tenofovir Disoproxil

Fumarate 300mg

POM Tablet Film coated 127/087 Aurobindo Pharma Limited, India

622 Tissop Capsules Indomethacin 25mg P Capsule oral 178/001 Aurochem Laboratories Pvt, Limited, India

623 Feverlet Tablets Paracetamol 500mg GS Tablet Uncoated 178/002 Aurochem Laboratories Pvt, Limited, India

624Nutrigel Suspension

Antacid 550mg GS Suspension for

Oral Use

178/003 Aurochem Laboratories Pvt, Limited, India

625 Perfopil 50 Tablets Sildenafil 50mg POM Tablet Uncoated 178/004 Aurochem Laboratories Pvt, Limited, India

626 Cerocip 250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 178/005 Aurochem Laboratories Pvt, Limited, India

627 Cerocip 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 178/006 Aurochem Laboratories Pvt, Limited, India

628 Rumifen 200 Tablets Ibuprofen 200mg P Tablet Uncoated 178/007 Aurochem Laboratories Pvt, Limited, India

629Melamine Tablets

Sulfadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 178/008 Aurochem Laboratories Pvt, Limited, India

630 Defnil-SR Tablets Diclofenac 100mg P Tablet Uncoated 178/009 Aurochem Laboratories Pvt, Limited, India

631Telmentic Suspension

Pyrantel Pamoate

250mg, per 5ml

P Suspension for

Oral Use

178/010 Aurochem Laboratories Pvt, Limited, India

632Telmentic Tablets

Pyrantel Pamoate 125mg P Tablet Uncoated 178/011 Aurochem Laboratories Pvt, Limited, India

633 Mucof Cough Lozenges Herbal Extracts P Lozenges 178/012 Aurochem Laboratories Pvt, Limited, India

634 Repisprin-300 Tablets Aspirin 300mg P Tablet Uncoated 178/013 Aurochem Laboratories Pvt, Limited, India

635Betaclox Solution

Cloxacillin 125mg, per

5ml

POM Solution for Oral

Use

178/014 Aurochem Laboratories Pvt, Limited, India

636

Dr Home Cough Syrup

Paracetamol 120mg +

Chlorpheniramine 0.5mg

+ Phenylephrine 2.5mg,

per 5ml

P Syrup 178/015 Aurochem Laboratories Pvt, Limited, India

637Lymphocin Suspension

Erythromycin 125mg, per

5ml

POM Suspension for

Oral Use

178/016 Aurochem Laboratories Pvt, Limited, India

Page 30 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

638

Alcof Syrup

Chlorpheniramine 2.2mg

+ Ammonium Chloride

110mg + Sodium citrate

50mg + Menthol 1.1mg,

per 5ml

P Syrup 178/017 Aurochem Laboratories Pvt, Limited, India

639 Chlorpheniramine 4 Tablets Chlorpheniramine 4mg P Tablet Uncoated 178/018 Aurochem Laboratories Pvt, Limited, India

640 Chlorpheniramine 2 Tablets Chlorpheniramine 2mg P Tablet Uncoated 178/019 Aurochem Laboratories Pvt, Limited, India

641 Welvit Syrup Multivitamins GS Syrup 178/023 Aurochem Laboratories Pvt, Limited, India

642Zobinace Solution

Metronidazole 125mg,

per 5ml

POM Solution for Oral

Use

178/024 Aurochem Laboratories Pvt, Limited, India

643 Neuroflex Tablets Vitamin B Complex P Tablet Uncoated 178/025 Aurochem Laboratories Pvt, Limited, India

644 Rocort-H Cream Hydrocortisone 2%w/w POM Cream Topical 178/026 Aurochem Laboratories Pvt, Limited, India

645 Adnicor Tablets Prednisolone 5mg POM Tablet Uncoated 178/027 Aurochem Laboratories Pvt, Limited, India

646 Bisix Tablets Pyridoxine 50mg POM Tablet Uncoated 178/028 Aurochem Laboratories Pvt, Limited, India

647 Aurovir Cream Acyclovir 5%w/w POM Cream Topical 178/029 Aurochem Laboratories Pvt, Limited, India

648Normal Saline Solution

Sodium chloride 0.9%

w/v

POM Solution for

infusion

015/001 Autosterile (EA) Limited, Kenya

649

Autosterile 10% Glucose

Injection

Dextrose 10% w/v POM Solution for

infusion

015/002 Autosterile (EA) Limited, Kenya

650

Autosterile 5% Glucose + 0.9%

Sodium Chloride Injection

Dextrose 5% w/v +

Sodium Chloride 0.9%

w/v

POM Solution for

infusion

015/003 Autosterile (EA) Limited, Kenya

651

Autosterile Half Strength

Darrows Injection

Sodium Chloride +

Sodium lactate +

Potassium Chloride

POM Solution for

infusion

015/004 Autosterile (EA) Limited, Kenya

652Glucose 5% Injection

Dextrose 5% w/v POM Solution for

Injection

015/005 Autosterile (EA) Limited, Kenya

653

Ringers Lactate Injection

Sodium Chloride +

Sodium Lactate +

Potassium Chloride +

Calcium Chloride

POM Solution for

infusion

015/006 Autosterile (EA) Limited, Kenya

654

Ringers Lactate Infusion

Sodium Chloride +

Sodium Lactate +

Calcium Chloride +

Potassium Chloride

POM Solution for

infusion

096/001 Autosterile Pvt Limited, Zimbabwe

655Glucose Infusion

Glucose 5% w/v POM Solution for

infusion

096/002 Autosterile Pvt Limited, Zimbabwe

656Sodium Chloride Infusion

Sodium chloride 0.9%

w/v

POM Solution for

infusion

096/003 Autosterile Pvt Limited, Zimbabwe

Page 31 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

657

Stamaril Vaccine

Yellow Fever virus strain

17D/AB 237- Live

attenuated

POM Suspension for

Injection

049/001 Aventis Pasteur SA Pty Limited

658Imovax Meningo A + C Vaccine

Meningococcal A + C

Polysaccharide vaccine

POM Solution for

Injection

049/002 Aventis Pasteur SA Pty Limited

659Trimovax Vaccine

Measles + Mumps +

Rubella - Live attenuated

POM Suspension for

Injection

049/003 Aventis Pasteur SA Pty Limited

660

Typhim VI Vaccine

Purified VI capsular

polysaccaride of

Salmonella typhi type 2

POM Suspension for

Injection

049/004 Aventis Pasteur SA Pty Limited

661Tetavax Vaccine

Tetanus toxoid- Purified POM Suspension for

Injection

049/005 Aventis Pasteur SA Pty Limited

662 Diabend Tablets Gliclazide 80mg POM Tablet Uncoated 288/001 Bal Pharma Limited, India

663 Grisoral 250mg Tablets Griseofulvin 250mg POM Tablet oral 288/002 Bal Pharma Limited, India

664 Regamol 500mg Tablets Paracetamol 500mg GS Tablet oral 288/003 Bal Pharma Limited, India

665 Dynamox - 250 Capsules Amoxicillin 250mg POM Capsule oral 288/004 Bal Pharma Limited, India

666 Dynamox - 500 Capsules Amoxicillin 500mg POM Capsule oral 288/005 Bal Pharma Limited, India

667 Ibuprofen Tablets Ibuprofen 400mg P Tablet Film coated 288/006 Bal Pharma Limited, India

668 Seregra-50 Tablets Sildenafil 50mg POM Tablet Uncoated 288/007 Bal Pharma Limited, India

669 Seregra-100 Tablets Sildenafil 100mg POM Tablet Uncoated 288/008 Bal Pharma Limited, India

670Diclofenac Sodium Tablets

Diclofenac 50mg P Tablet Enteric

Coated

288/009 Bal Pharma Limited, India

671Mycoral Oral Gel

Miconazole 2% w/w POM Gel Oral 009/014 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

672Hyoscine Butyl Bromide Tablets

Hyoscine butyl bromide

20mg

POM Tablet Uncoated 009/047 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

673Cephalexin Suspension

Cephalexin 125mg/5mls POM Suspension for

Oral Use

009/074 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

674Cephalexin 250mg Capsules

Cephalexin 250mg POM Capsule oral 009/075 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

675Cephalexin 500mg Capsules

Cephalexin 500mg POM Capsule oral 009/076 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

676Ampicillin 250mg Capsules

Ampicillin 250mg POM Capsule oral 009/077 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

677Ampicillin 500mg Capsules

Ampicillin 500mg POM Capsule oral 009/078 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

678Rifampicin Capsules

Rifampicin 150mg POM Capsule oral 009/079 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

679Rifampicin Capsules

Rifampicin 300mg POM Capsule oral 009/080 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

680Amoxycillin Capsules

Amoxycillin 250mg POM Capsule oral 009/081 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

681Amoxycillin 250mg Capsules

Amoxycillin 500mg POM Capsule oral 009/082 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

682Doxycycline Capsules

Doxycycline 100mg POM Capsule oral 009/083 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

683Piroxicam Capsules

Piroxicam 10mg POM Capsule oral 009/084 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

684Cloxamp Granules

Cloxacillin 250mg +

Ampicillin 250mg

POM Suspension for

Oral Use

009/085 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

685Mefenamic Acid Capsules

Mefenamic acid 250mg POM Capsule oral 009/086 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

686Tetracycline Capsules

Tetracycline 250mg POM Capsule oral 009/087 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

687Paracetamol 500mg Tablets

Paracetamol 500mg GS Tablet Uncoated 009/089 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

688Glibenclamide Tablets

Glibenclamide 5mg POM Tablet Uncoated 009/090 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

689Pyrazinamide Tablets

Pyrazinamide 500mg POM Tablet Uncoated 009/091 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

690Gamsidar Tablets

Sulphadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 009/092 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

691Paracetamol 100mg Tablets

Paracetamol 100mg GS Tablet Uncoated 009/093 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

692Alluopurinol Tablets

Allopurinol 300mg POM Tablet Uncoated 009/094 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

693Metronidazole Tablets

Metronidazole 200mg POM Tablet Uncoated 009/095 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

694Ethambutol Tablets

Ethambutol 400mg POM Tablet Uncoated 009/097 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

695

Gamuretic Tablets

Amiloride 5mg +

Hydrochlorothiazide

50mg

POM Tablet Uncoated 009/098 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

696Griseofulvin Tablets

Griseofulvin 500mg POM Tablet Uncoated 009/099 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

697Promethazine Injection

Promethazine 25mg, per

ml

POM Solution for

Injection

009/100 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

Page 33 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

698Streptomycin Injection

Streptomycin 1g POM Powder for

Injection

009/101 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

699Cloxacillin Injection

Cloxacillin 250mg POM Powder for

Injection

009/102 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

700Atropine Injection

Atropine 0.6mg, per ml POM Solution for

Injection

009/103 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

701Gentamycin Injection

Gentamycin 10mg, per ml POM Solution for

Injection

009/104 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

702Gentamycin Injection

Gentamycin 40mg, per ml POM Solution for

Injection

009/105 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

703Kanamycin Injection

Kanamycin 1g POM Powder for

Injection

009/107 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

704Allopurinol Tablets

Allopurinol 100mg POM Tablet Uncoated 009/109 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

705Ketamine Injection

Ketamine 50mg, per ml POM Solution for

Injection

009/110 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

706Frusemide Injection

Frusemide 10mg, per ml POM Solution for

Injection

009/111 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

707Metoclopramide Injection

Metoclopramide 5mg, per

ml

POM Solution for

Injection

009/112 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

708Chlorpromazine Injection

Chlorpromazine 25mg,

per ml

POM Solution for

Injection

009/113 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

709Praziquantel Tablets

Praziquantel 600mg POM Tablet Uncoated 009/114 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

710Metronidazole Injection

Metronidazole 0.5% w/v POM Solution for

Injection

009/115 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

711Isoniazid Tablets

Isoniazid 100mg POM Tablet Uncoated 009/117 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

712Ibuprofen Tablets

Ibuprofen 400mg P Tablet Uncoated 009/118 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

713Pethidine 50mg/ml Injection

Pethidine 50mg, per ml POM Solution for

Injection

009/119 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

714Propranolol Tablets

Propranolol 40mg POM Tablet Uncoated 009/120 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

715Phenobarbitone Tablets

Phenobarbitone 30mg POM Tablet Uncoated 009/123 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

716Phenobarbitone Tablets

Phenobarbitone 60mg POM Tablet Uncoated 009/124 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

Page 34 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

717Pethidine 25mg/Ml Injection

Pethidine 25mg, per ml POM Solution for

Injection

009/125 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

718Cloxamp Injection

Cloxacillin + Ampicillin

500mg

POM Powder for

Injection

009/126 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

719Cefotaxime Injection

Cefotaxime 500mg POM Powder for

Injection

009/128 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

720Ampicilllin Injection

Ampicillin 250mg POM Powder for

Injection

009/130 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

721Glucose Injection

Glucose 50% w/v POM Solution for

infusion

009/131 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

722Ciprofloxacin Tablets

Ciprofloxacin 250mg POM Tablet Uncoated 009/134 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

723Diazepam Injection

Diazepam 5mg, per ml POM Solution for

Injection

009/135 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

724

Hyoscine Butyl Bromide

Injection

Hyoscine butyl bromide

20mg, per ml

POM Solution for

Injection

009/136 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

725Norethisterone Tablets

Norethisterone 5 mg POM Tablet Uncoated 009/137 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

726Proguanil Tablets

Proguanil 100mg POM Tablet Uncoated 009/138 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

727Propantheline Tablets

Propantheline 15mg POM Tablet Uncoated 009/139 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

728

Quinine Dihydrochloride

Injection

Quinine 300mg, per ml POM Solution for

Injection

009/140 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

729Quinine Suphate Tablets

Quinine 300mg POM Tablet Uncoated 009/141 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

730Wormcid Suspension

Mebendazole 100mg, per

5ml

P Suspension for

Oral Use

009/142 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

731Metformin Tablets

Metformin 500mg POM Tablet Uncoated 009/143 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

732Ketazole Gel

Ketoconazole 100mg POM Gel Oral 009/145 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

733

Gamma Cough Syrup

Diphenhydramine

Hydrochloride 14mg +

Ammonium Chloride

135mg + Sodium Citrate

52mg Menthol 1.1mg, per

5mls

P Syrup 009/146 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

Page 35 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

734

Phytomenadione 10mg, per ml

Injection

Phytomenadione 10mg,

per ml

POM Solution for

Injection

009/148 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

735Ketoconazole Tablets

Ketoconazole 200mg POM Tablet Uncoated 009/149 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

736Benzhexol Tablets

Benzhexol 2mg POM Tablet Uncoated 009/150 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

737Promethazine Injection

Promethazine 10mg, per

ml

POM Solution for

Injection

009/151 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

738Dexmethasone Injection

Dexmethasone 4mg, per

ml

POM Solution for

Injection

009/152 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

739

Phytomenadione 2mg, per ml

injection

Phytomenadione 2mg,

per ml

POM Solution for

Injection

009/153 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

740Enalapril Tablets

Enalapril 5mg POM Tablet Uncoated 009/154 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

741Benzhexol Tablets

Benzhexol 5mg POM Tablet Uncoated 009/155 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

742Nifedipine Tablets

Nifedipine 10mg POM Tablet Uncoated 009/156 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

743Bendroflumethiazide Tablets

Bendroflumethiazide 5mg POM Tablet Uncoated 009/157 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

744

Theophylline Compound Tablets

Theophylline 120mg +

Ephedrine hydrochloride

11mg

POM Tablet Uncoated 009/158 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

745Acyclovir Tablets

Acyclovir 200mg POM Tablet Uncoated 009/159 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

746Timolol Eye Drops

Timolol 0.25% w/v POM Eye Drops 009/160 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

747Gentamycin Eye Drops

Gentamycin 0.3% w/v POM Eye Drops 009/161 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

748Acetazolamide Tablets

Acetazolamide 250mg POM Tablet Uncoated 009/162 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

749Chloramphenicol Suspension

Chloramphenicol 125mg,

per 5ml

POM Suspension for

Oral Use

009/163 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

750Biscodyl Tablets

Bisacodyl 5mg POM Tablet Uncoated 009/165 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

751Metoclopramide Tablets

Metoclopramide 10mg POM Tablet Uncoated 009/166 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

752Nystatin Tablets

Nystatin 500,000 I.U. POM Tablet Uncoated 009/167 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

Page 36 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

753Nitrofurantoin Tablets

Nitrofurantoin 100mg POM Tablet Uncoated 009/168 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

754Loperamide Tablets

Loperamide 2mg POM Tablet Uncoated 009/169 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

755Mebendazole Tablets

Mebendazole 100mg P Tablet Uncoated 009/170 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

756Fluconazole 2mg Injection

Fluconazole 2mg, per ml POM Solution for

Injection

009/171 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

757

Cetylpyridinium Throat

Lozenges

Cetylpyridinium 1.4mg P Tablet Uncoated 009/172 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

758Aminophylline Tablets

Aminophylline 100mg POM Tablet Uncoated 009/173 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

759Ascobic Acid Tablets

Ascorbic acid 100mg GS Tablet Uncoated 009/174 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

760Atenolol 100mg Tablets

Atenolol 100mg POM Tablet Uncoated 009/175 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

761Betasone Eye Drops

Betamethasone 0.1% w/v POM Eye Drops 009/176 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

762Diclofenac 50mg Tablets

Diclofenac 50mg P Tablet Uncoated 009/177 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

763Digoxin 0.25mg Tablets

Digoxin 0.25mg POM Tablet Uncoated 009/178 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

764Digoxin 0.25mg Injection

Digoxin 0.25mg POM Solution for

Injection

009/179 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

765

Duosept Hospital Concentration

Solution

Chlorhexidine 1.5% w/v +

Cetrimide 15% w/v

GS Solution for

sterilisation

009/180 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

766Eyecrom Eye/Ear Drops

Sodium Cromoglycate

2% w/v

POM Eye Drops 009/181 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

767Fentanyl 50mcg/2ml Injection

Fentanyl 50mcg, per 2ml POM Solution for

Injection

009/182 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

768Fungicid Cream

Clotrimazole 1% w/w POM Cream Topical 009/183 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

769Gammcort Cream

Hydrocortisone 1% w/w POM Cream Topical 009/184 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

770Nalbuphine Injection

Nalbuphine 10mg, per

2mls

POM Solution for

Injection

009/185 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

771Sterdidex Solution

Glutaraldehyde 2% w/v GS Solution for

sterilisation

009/186 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

Page 37 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

772

Tac Cough Syrup

Chlorpheniramine 2mg +

Ammonium chloride

135mg + Sodium citrate

59.26mg

P Syrup 009/187 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

773Waxpel Ear Drops

Dioctly Sulphosuccinate

sodium 312mg

P Ear Drops 009/188 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

774Atenolol 50mg Tablets

Atenolol 50mg POM Tablet Uncoated 009/189 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

775B Zinc Dispersible Tablets

Zinc sulphate 20mg P Tablet Dispersible 009/190 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

776

Baxylin 4Flu Cough Syrup

Diphenhydramine

Hydrochloride 6.25mg +

Paracetamol 250mg +

Pseudoephedrine 11.5mg

P Syrup 009/191 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

777Baxylin Dry Cough Syrup

Dextromethophan

Hydrobromide 15mg

P Syrup 009/192 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

778

Baxylin Pediatric Cough Syrup

Diphenhydramine

Hydrochloride 7mg, per

5ml

P Syrup 009/193 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

779Baxylin Wet Cough Syrup

Guaphenesin 100mg, per

5ml

P Syrup 009/194 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

780

Baxylin with Codeine Cough

Syrup

Diphenhydramine

Hydrochloride 12.5mg +

Codeine Phosphate

10mg + Ammonium

Chloride 125mg

P Syrup 009/195 Baxy Pharmaceutical Manufacturing Ltd,

Zambia

781Ultravist 300 Injection

Iopromide 300mg, per ml POM Solution for

infusion

140/015 Bayer (Pty) Limited, South Africa

782

Gadovist® (1.0 mmol/ml)

Injection

Gadobutrol 604 mg, per

ml (1.0 mmol/, per ml)

POM Solution for

infusion

140/017 Bayer (Pty) Limited, South Africa

783

Microgynon Tablets

Ethinylestradiol 0.03mg +

Levonorgestrel 0.15mg

POM Tablet Uncoated 140/004 Bayer East Africa Ltd

784 Primolut – N Tablets Norethisterone 5mg POM Tablet Uncoated 140/005 Bayer East Africa Ltd

785Diane – 35 Tablets

Ethinyestradiol 0.035mg

+ Cyproterone 2mg

POM Tablet Uncoated 140/007 Bayer East Africa Ltd

786Noristerat Injection

Norethisterone 200mg,

per ml

POM Solution for

injection

140/008 Bayer East Africa Ltd

Page 38 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

787Gyno Trovogen Ovules

Isoconazole Nitrate

600mg

POM Suppositories

Vaginal

140/009 Bayer East Africa Ltd

788Bayer Aspirin Cardio 1 tablets

Acetyl Salicylic Acid

100mg

POM Tablet Enteric

Coated

227/005 Bayer East Africa Ltd

789 Claritine Syrup Loratidine 5mg, per 5ml POM Syrup 042/001 Bayer Health Care

790

PRIMOVIST 10ml Infusion Sodium Gadoxetate

Solution 0.25mol/L

POM Solution for

infusion

140/021L Bayer Schering Pharma

791

UROGRAFIN 60% Solution for

Infusion

Meglumine amidotrizoate

0.52 g/ml plus sodium

amidotrizoate 0.080g/ml

POM Solution for

infusion

140/019L Bayer Schering Pharma

792

UROGRAFIN 30% Solution for

Infusion

meglumine amidotrizoate

0,26 g/ml and

sodiumamidotrizoate 0,04

g/ml

POM Solution for

infusion

140/018L Bayer Schering Pharma

793

UROGRAFIN 76% Solution for

Injection

Meglumine amidotrizoate

0.26 g/ml plus sodium

amidotrizoate 0,040g/ml

POM Solution for

infusion

140/020L Bayer Schering Pharma

794Neo - Penotran Forte Ovules

Metronidazole 750mg +

Miconazole 200mg

POM Ovule Vaginal 140/010 Bayer Schering Pharma, Germany

795

Combination 3 Tablets

Ethinylestradiol 0.15mg +

Levonogestrel 0.03mg +

Ferrous Fumurate 75mg

POM Tablet Film coated 140/011 Bayer Schering Pharma, Germany

796Yaz Tablets

Ethinylestradiol 0.02mg +

Drospirenone 3.00mg

POM Tablet Film coated 140/012 Bayer Schering Pharma, Germany

797

Microgynon ED Fe Tablets

Levonogesterel 0.15mg +

Ethinylestradiol 0.03mg +

Ferrous Sulphate 75mg

POM Tablet Film coated 140/013 Bayer Schering Pharma, Germany

798 Microlut Tablets Levonogestrel 0.03mg POM Tablet Film coated 140/014 Bayer Schering Pharma, Germany

799 Praziquantel Tablets Praziquantel 600mg POM Tablet Uncoated 199/001 BDH Industries Ltd, India

800

Hydrocortisone Ophthalmic

Suspension

Hydrocortisone 1%w/v POM Eye Suspension 199/002 BDH Industries Ltd, India

801Chloramphenicol Eye Drops

Chloramphenicol

0.5%w/v

POM Eye Drops 199/003 BDH Industries Ltd, India

802 Atenol Tablets Atenolol 50mg POM Tablet Uncoated 199/004 BDH Industries Ltd, India

Page 39 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 803 Atenol Tablets Atenolol 100mg POM Tablet Uncoated 199/005 BDH Industries Ltd, India

804 Folid Tablets Folic acid 5mg GS Tablet Uncoated 199/006 BDH Industries Ltd, India

805

Fortrim-A Tablets

Sulfamethoxazole 400mg

+ Trimethoprim 80mg

POM Tablet Uncoated 199/007 BDH Industries Ltd, India

806 Hydrocortisone Acetate Cream Hydrocortisone 1%w/v POM Cream Topical 199/008 BDH Industries Ltd, India

807 Hydrocortisone Ointment Hydrocortisone 1% POM Ointment topical 199/009 BDH Industries Ltd, India

808 Indosule Capsules Indomethacin 25mg P Tablet Uncoated 199/010 BDH Industries Ltd, India

809 Metadil Tablets Chlorpheniramine 4mg P Tablet Uncoated 199/011 BDH Industries Ltd, India

810 Metamol Tablets Paracetamol 500mg GS Tablet Uncoated 199/012 BDH Industries Ltd, India

811 Metapred Tablets Prednisolone 5mg POM Tablet Uncoated 199/013 BDH Industries Ltd, India

812 Acyclovir Cream Acyclovir 5%w/w POM Tablet Uncoated 199/014 BDH Industries Ltd, India

813 Micozol Cream Miconazole 2% POM Cream Topical 199/015 BDH Industries Ltd, India

814Tolfet Solution

Tolnaftate 1%w/v POM Solution for Topical

Use

199/016 BDH Industries Ltd, India

815 Metacycline Ointment Tetracycline 1%w/v POM Eye Ointment 199/017 BDH Industries Ltd, India

816 Ciprofloxacin Eye Drops Ciprofloxacin 0.3% POM Eye Drops 199/018 BDH Industries Ltd, India

817

Metaskinton Ointment

Benzoic Acid BP 6%w/w

+ Salicylic Acid BP

3%w/w

P Ointment topical 199/019 BDH Industries Ltd, India

818

Hydrocortisone Acetate

Ophthalmic Ointment

Hydrocortisone 1%w/w POM Eye topical 199/020 BDH Industries Ltd, India

819 Cevin Tablets Ascorbic Acid 500mg GS Tablet Uncoated 199/021 BDH Industries Ltd, India

820 Mebendazole Tablets Mebendazole 200mg P Tablet Uncoated 199/022 BDH Industries Ltd, India

821 Metagliben Tablets Glibenclamide 5mg POM Tablet Uncoated 199/023 BDH Industries Ltd, India

822 Salbamol-4 Salbutamol 4mg POM Tablet Uncoated 199/024 BDH Industries Ltd, India

823 Metamycin Ointment Chloramphehicol 1%w/v POM Eye Ointment 199/025 BDH Industries Ltd, India

824 Xiprox 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 199/026 BDH Industries Ltd, India

825 Acyclovir Tablets Acyclovir 200mg POM Tablet Uncoated 199/027 BDH Industries Ltd, India

826 Metazole Tablets Metronidazole 200mg POM Tablet Uncoated 199/028 BDH Industries Ltd, India

827 Nalop-20mg Tablets Enalapril 20mg POM Tablet Uncoated 199/029 BDH Industries Ltd, India

828 Napril-10 Tablets Enalapril 10mg POM Tablet Uncoated 199/030 BDH Industries Ltd, India

829 Acetazolamide Tablets Acetazolamide 250mg POM Tablet Uncoated 199/031 BDH Industries Ltd, India

830 Praziquantel Tablets Praziquantel 600mg POM Tablet Uncoated 199/032 BDH Industries Ltd, India

831Hydrex-50 Tablets

Hydrochlorothiazide

50mg

POM Tablet Uncoated 199/033 BDH Industries Ltd, India

832 CTM Cream Clotrimazole 1%w/w POM Cream Topical 199/034 BDH Industries Ltd, India

833

Ferrous Sulphate and Folic Acid

Tablets

Ferrous sulphate 200mg

+ Folic acid 5mg

POM Tablet Uncoated 199/035 BDH Industries Ltd, India

834 Metalax Tablets Bisacodyl 5mg POM Tablet Uncoated 199/036 BDH Industries Ltd, India

Page 40 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 835 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 199/037 BDH Industries Ltd, India

836 Fluconazole Capsules Fluconazole 200mg POM Capsule oral 199/038 BDH Industries Ltd, India

837 Metphage - 500 Tablets Metformin 500mg POM Tablet Uncoated 199/039 BDH Industries Ltd, India

838Alkay - ER Tablets

Potassium chloride

600mg

POM Tablet extended

release

199/040 BDH Industries Ltd, India

839Pi-dine Solution

Povidone Iodine 10%w/v GS Solution for Topical

Use

199/041 BDH Industries Ltd, India

840Quinine Sulphate BP Tablets

Quinine Sulphate BP

300mg

POM Tablet Uncoated 310/007 BDH Industries Ltd, India

841Mifepristone 25mg Tablets

Mifepristone 25mg POM Tablet Uncoated 001/001 Beijing Zizhu Pharmaceutical Company Ltd,

China

842Misoprostol 200mg Tablets

Misoprostol 200mg POM Tablet Uncoated 001/002 Beijing Zizhu Pharmaceutical Company Ltd,

China

843Mifepristone 200mg Tablets

Mifepristone 200mg POM Tablet Uncoated 001/003 Beijing Zizhu Pharmaceutical Company Ltd,

China

844Miconazole Cream

Miconazole cream 2%

w/w

POM Cream Topical 241/001 Beltapharm SPA, Italy

845

Anti-Haemorrhoid Ointment

Betamethasone

dipropionate 0.5%w/w +

Phenylephrine

ch/orhydrate 0.1 %w/w +

Lidocaine chlorhydrate

2w/w

POM Ointment topical 241/002 Beltapharm SPA, Italy

846

Clotrimazole Powder

Trimethoprim 40mg +

Sulphamethoxazole

200mg/5ml

POM Powder for Oral

Solution

241/003 Beltapharm SPA, Italy

847Metronidazole Powder

Metronidazole 125mg,

per 5ml

POM Powder for Oral

Solution

241/004 Beltapharm SPA, Italy

848Nystatin Suspension

Nystatin 100,000I.U., per

ml

POM Suspension for

Oral Use

241/005 Beltapharm SPA, Italy

849

Action Tablets

Aspirin 600mg + Caffeine

50mg + Paracetamol

300mg

GS Tablet Uncoated 102/001 Beta Healthcare International Limited,

Kenya

850

Action Junior Strawberry

Flavoured Tablets

Paracetamol 120mg GS Tablet Uncoated 102/002 Beta Healthcare International Limited,

Kenya

851

Strepsils Regular Lozenges

Amylmetacresol 0.6mg +

2,4 Dichlorobenzyl

alcohol 1.2mg

GS Lozenges 102/003 Beta Healthcare International Limited,

Kenya

Page 41 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

852

Strepsils Honey & Lemon

Lozenges

Amylmetacresol 0.6mg +

2,4 Dichlorobenzyl

alcohol 1.2mg

GS Lozenges 102/004 Beta Healthcare International Limited,

Kenya

853Paracetamol Tablets

Paracetamol 500mg GS Tablet Uncoated 102/005 Beta Healthcare International Limited,

Kenya

854

Goodmorning Cough Tablet

Tolu 0.04ml + Capsium

Oleoresin 0.03ml +

Creosote 2.2mg + Anise

oil 1.1mg + Liquorice

56.35mg

GS Tablet Uncoated 102/006 Beta Healthcare International Limited,

Kenya

855

Goodmorning Lung Tonic

Tolu 0.56ml + Capsium

Ticnture 0.25ml +

Creosote 66.65mg +

Anise oil 13.85mg +

Liquorice 25mg

GS Syrup 102/007 Beta Healthcare International Limited,

Kenya

856Asprin Tablets

Aspirin 300mg P Tablet Uncoated 102/009 Beta Healthcare International Limited,

Kenya

857Aspro Tablets

Aspirin 324mg GS Tablet Uncoated 102/010 Beta Healthcare International Limited,

Kenya

858Betaquine Tablets

Amodiaquine 260mg POM Tablet Uncoated 102/011 Beta Healthcare International Limited,

Kenya

859Opele Lotion

Benzyl benzoate 25g, per

100ml

P Lotion for Topical

Use

102/012 Beta Healthcare International Limited,

Kenya

860

Salimia Linment Ointment

Methyl salicylate 5.0ml +

Turpentine oil 25ml +

Capiscum oleoresin

2.25mg + Camphor

2.0mg

GS Ointment topical 102/013 Beta Healthcare International Limited,

Kenya

861

Beta Gripe Water

Sodium bicarbonate

60mg + Dill seed oil

2.15mg

GS Solution for Oral

Use

102/014 Beta Healthcare International Limited,

Kenya

862Prunol Cough Syrup

Tincture Ipecacuanha

0.12ml, per 5ml

GS Syrup 102/015 Beta Healthcare International Limited,

Kenya

863

Glucolin Powder

Vitamin D 125IU +

Calcium

Glycerophosphate 0.5g +

Dextrose Monohydrate qs

to100g

GS Powder for Oral

Solution

102/016 Beta Healthcare International Limited,

Kenya

Page 42 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

864

Glucolin Dynomite Powder

Vitamin C 0.012g +

Dextrose Monohydrate qs

to 15g

GS Powder for Oral

Solution

102/017 Beta Healthcare International Limited,

Kenya

865

Betasil Regular Lozenges

Amylmetacresol 0.6mg+

2,4 Dichlorobenzyl

Alcohol 1.2

GS Lozenges 102/019 Beta Healthcare International Limited,

Kenya

866

Beta Herbal Lozenges

Amylmetacresol 0.6mg +

2.4 Dichlorobenzyl Alchol

1.2mg

GS Lozenges 102/020 Beta Healthcare International Limited,

Kenya

867

Memcap Tablets

Glycyrrhiza Globra 20mg

+ Terminalia 5mg +

Zingiber 5mg + Curcuma

2mg + Metha 7mg

P Tablet Uncoated 102/021L Beta Healthcare International Limited,

Kenya

868Salima Cream

Herbal Extracts GS Cream Topical 102/022L Beta Healthcare International Limited,

Kenya

869

Woodwards Gripe Water

Dill Seed Oil 2.15mg +

Sodium Bicarbonate

60mg

GS Solution for Oral

Use

102/023 Beta Healthcare International Limited,

Kenya

870Betabs Prednisolone Tablets

Prednisolone 5mg POM Tablet Uncoated 168/001 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

871Betapen Suspension

Phenoxymethyl Penicillin

V 125mg, per 5ml

POM Suspension for

Oral Use

168/002 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

872Betapen Tablets

Phenoxymethyl Penicillin

V 250mg

POM Tablet Uncoated 168/003 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

873Candarspor Cream

Clotrimazole 1gm, per

100gm

POM Cream Topical 168/004 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

874

Clear Cough Syrup

Sodium Citrate 135mg +

Ammonium Chloride

135mg +

Diphenhydramine HCL

14.1mg/5ml

P Syrup 168/005 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

875

Codef Syrup

Codeine 7.5mg +

Ephedrine 15mg +

Mepyramine 20mg/15ml

P Syrup 168/006 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

876Drilix Syrup

Pseudoephedrine 30mg P Syrup 168/007 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

Page 43 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

877

Lo-acid Suspension

Dried Aluminium

Hydrochloride 120mg +

Magnesium Trisilicate

250mg

GS Suspension 168/008 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

878

B-dol Tablets SC

Codeine Phosphate

10mg + Caffeine 30mg +

Doxylamine Succinate

5mg + Paracetamol

450mg

P Tablet Uncoated 168/009 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

879Betabs Chewy Tablets

Ascorbic Acid 250mg GS Tablet Uncoated 168/010 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

880

Betafed Syrup

Pseudoephedrine

Hydrochloride 30mg/5ml

+ Tripiolidine

Hydrochloride 1.25mg,

per 5ml

P Syrup 168/011 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

881

Betalin Syrup

Ammonium chloride

136mg +

Diphenhydramine HCL

14mg/5ml

P Syrup 168/012 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

882

Trifen Expectorant Adult Syrup

Pseudoephedrine

Hydrochloride 20mg +

Codeine Phosphare

7.5mg + Trivrolidine

Hydrochloride 1.25mg

P Syrup 168/013 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

883

Trifen Expectorant Child Syrup

Pseudoephedrine

Hydrochloride 12mg +

Codeine Phosphate 3mg

+ Triprolidine

Hydrochloride 0.6mg +

Guaiphenesin, per 5ml

P Syrup 168/014 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

884Viteral Syrup

Multivitamins GS Syrup 168/015 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

885Septadine Solution

Povidone Iodine 10%w/v GS Solution for Topical

Use

168/016 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

886Septadine Ointment

Povidone Iodine 10%w/v GS Ointment topical 168/017 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

887Betaretic Tablets

Hydrochlorthiazide 50mg

+ Amiloride 5mg

POM Tablet Uncoated 168/018 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

Page 44 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

888

Painagon Tablets

Paracetamol 320mg +

Codeine 8mg +

Promethazine

P Tablet Uncoated 168/019 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

889Pre-Natal Forte Capsules

Vitamins + Minerals P Capsule oral 168/020 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

890Painagon Syrup

Paracetamol + Codeine +

Caffeine

P Syrup 168/021 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

891

Flustat Syrup

Paracetamol 500mg +

Dextromethorphan

Hydrobromide 15mg +

Phenylpropanolamine

HCL 25mg/20ml

P Syrup 168/022 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

892

Flustat Capsules

Ascorbic Acid 75mg +

Paracetamol 300mg +

Caffeine 30mg +

Chlorpheniramine

Maleate 2mg +

Phenylephrine HCL 5mg

P Capsule oral 168/023 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

893Be-Tabs Mepyraderm Cream

Mepyramine maleate

0.2g, per 10g

P Cream Topical 168/024 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

894Be-Tabs Pyridoxine Tablets

Pyridoxine Hydrochloride

25mg

POM Tablet Uncoated 168/025 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

895

Be-Tabs Antacids Suspension

Magnesium Triscillate

500mg + Magnesium

Carbonate Light 500mg +

Sodium Carbonate

500mg, per 10ml

GS Suspension for

Oral Use

168/026 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

896Be-Tabs Folic Acid Tablets

Folic Acid 5mg POM Tablet Uncoated 168/027 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

897

Crystacist Solution 100mg

Potassium Citrate 1.2g +

Citric acid Monohydrate

200mg, per 15ml

P Solution for Oral

Use

168/028 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

898Wormstop Tablets

Mebendazole 500mg P Tablet Uncoated 168/029 Be-Tabs Pharmaceuticals (Pty) Ltd, South

Africa

899Propovan Injection

Propofol 1% POM Solution for

Injection

233/001 Bharat Biotech Ltd, India

900

Thymogam Globulin Injection

Antihymocyte Globulin-

equine 250mg, per

100mg

POM Solution for

Injection

233/003 Bharat Biotech Ltd, India

Page 45 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

901

Regen-D Gel

Recombinant Human

Epidermal Growth Factor

150mcg, per gram

POM Gel Topical 279/046 Bharat Biotech Ltd, India

902

Indirab Rabies Vaccine BP +

Diluent for Indirab Injection

Rabies vaccine BP 2.5IU,

05ml + Sodium Chloride

IP 0.3% w/v,

POM Solution for

Injection

233/004 Bharat Biotech Ltd, India

903

Rhomo Oil

Rhus toxicodendron 10%

+ Bryonia alba 20% +

Terebinthena oleum 20%

+ Camphor 20% +

Menthol 10% + Thymol

10% + Symphytum

officinalis 10%

GS Solution for Topical

Use

371/001 Bhargava Phytolab Pvt, India

904 Angel Gloss Cream Herbal Preparation P Cream Topical 389/001L Bhargava Phytolab Pvt, India

905

Gass Off Tablets

Aluminium Hydroxide

100mg + Bismuth

Carbonicum 75mg +

Magnesium Hydroxide

100mg + Natrum

Bicarbonicum 75mg +

Herbal Extracts

GS Tablets chewable 389/002L Bhargava Phytolab Pvt, India

906 Meniphib Tablets Herbal preparation P Tablets film coated 389/003L Bhargava Phytolab Pvt, India

907 Co-Ex Syrup Herbal Preparation P Syrup 389/004 Bhargava Phytolab Pvt, India

908Ciplast 10mg Injection

Cisplatin 10mg POM Powder for

Injection

240/001 Biochem Pharmaceuticals industries Ltd,

India

909Cycloxan 1g Injection

Cyclophosphamide 1g POM Solution for

Injection

240/002 Biochem Pharmaceuticals industries Ltd,

India

910Cycloxan 500mg Injection

Cyclophosphamide

500mg

POM Powder for

Injection

240/003 Biochem Pharmaceuticals industries Ltd,

India

911Flucracil 500mg/10ml Injection

Fluorouracil 500mg, per

10ml

POM Solution for

Injection

240/004 Biochem Pharmaceuticals industries Ltd,

India

912Tamodex Citrate Tablets

Tamoxifen 10mg POM Tablet Uncoated 240/005 Biochem Pharmaceuticals industries Ltd,

India

913Bioposide 100mg Injection

Etoposide 100mg, per

5ml

POM Powder for

Injection

240/006 Biochem Pharmaceuticals industries Ltd,

India

914Biotrexate 2.5mg Tablets

Methotrexate 2.5mg POM Tablet Uncoated 240/007 Biochem Pharmaceuticals industries Ltd,

India

Page 46 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

915Biotrexate Injection

Methotrexate 25mg, per

ml

POM Solution for

Injection

240/008 Biochem Pharmaceuticals industries Ltd,

India

916Cisplat 50mg Injection

Cisplatin 50mg POM Powder for

Injection

240/010 Biochem Pharmaceuticals industries Ltd,

India

917Cycloxan 50mg Injection

Cyclophosphamide 50mg POM Solution for

Injection

240/011 Biochem Pharmaceuticals industries Ltd,

India

918Doxorubicin Injection

Doxorubicin 50mg POM Solution for

Injection

240/012 Biochem Pharmaceuticals industries Ltd,

India

919Fluracil 250mg/10ml Injection

Fluorouracil 500mg, per

10ml

POM Solution for

Injection

240/013 Biochem Pharmaceuticals industries Ltd,

India

920Petaxel 30mg/5ml Injection

Paclitaxel 6mg, per ml POM Powder for

Injection

240/015 Biochem Pharmaceuticals industries Ltd,

India

921Biocristin Injection

Vincristine 1mg POM Powder for

Injection

240/016 Biochem Pharmaceuticals industries Ltd,

India

922Tamodex 20 Tablets

Tamoxifen 20mg POM Tablet Uncoated 240/017 Biochem Pharmaceuticals industries Ltd,

India

923Pataxel 260 Injection

Paclitaxel 6mg, per ml POM Powder for

Injection

240/018 Biochem Pharmaceuticals industries Ltd,

India

924Biovorin Injection

Folic acid 50mg, per 5ml POM Solution for

Injection

240/019 Biochem Pharmaceuticals industries Ltd,

India

925Biocarb 150 Injection

Carboplatin 10mg, per ml POM Powder for

Injection

240/020 Biochem Pharmaceuticals industries Ltd,

India

926Biocarb 450 Injection

Carboplatin 450mg POM Powder for

Injection

240/021 Biochem Pharmaceuticals industries Ltd,

India

927Cycloxan 50mg Tablets

Cyclophosphamide 50mg POM Tablet Uncoated 240/022 Biochem Pharmaceuticals industries Ltd,

India

928Cycloxan 200 Injection

Cyclophosphamide

200mg

POM Solution for

Injection

240/023 Biochem Pharmaceuticals industries Ltd,

India

929Oncolet Tablets

Letrozole 2.5mg POM Tablet Film coated 240/024 Biochem Pharmaceuticals industries Ltd,

India

930Cycloxan Tablets

Cyclophosphamide 50mg POM Tablet Film coated 290/022 Biochem Pharmaceuticals industries Ltd,

India

931Insugen -R Injection

Insulin 100IU, per ml POM Suspension for

Injection

305/001 Biocon Limited, India

932

Insugen -30/70 (Biphasic)

Injection

Insulin 30/70 POM Suspension for

Injection

305/002 Biocon Limited, India

933Insugen - N (NPH) Injection

Insulin 100IU POM Suspension for

Injection

305/003 Biocon Limited, India

934 Biomol Tablets Paracetamol BP 500mg P Tablet Uncoated 020/001 Biodeal Laboratories Pvt Ltd, India

Page 47 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 935 Biovir Cream Aciclovir BP 5% w/w POM Cream Topical 020/002 Biodeal Laboratories Pvt Ltd, India

936

One Q Gummy with Colostrum

(Lemon Flavour)

Colostrum Powder 30mg P Capsule oral 353/001L Biofact Life SND. BHD Ltd, Malysia

937

One Q Gummy with Vitamin C

(Orange Flavour)

Vitamin C 40mg P Capsule oral 353/002L Biofact Life SND. BHD Ltd, Malysia

938

One Q Gummy with

Multivitamins (Strawberry

Flavour)

Multivitamins & Minerals P Capsule oral 353/003L Biofact Life SND. BHD Ltd, Malysia

939One Q Gummy with Omega 3

Omega 3 8.6mg Total

EPA& DHA 7.9mg

P Capsule oral 353/004L Biofact Life SND. BHD Ltd, Malysia

940

One Q Gummy with Acai Berry

And Luten

Acai Berry 25mg +

Lutein 10% powder

10mg

P Capsule oral 353/005L Biofact Life SND. BHD Ltd, Malysia

941Synalar Gel

Fluocinolone Acetonide

Ph. Eur. 0.025% w/w

P Gel Topical 023/018 Bioglan Laboratories Limited, UK

942Synalar C Cream

Fluocinolone Acetonide

0.025% + Clioquinol 3%

P Cream Topical 023/019 Bioglan Laboratories Limited, UK

943Synalar Cream

Fluocinolone Acetonide

Ph. Eur. 0.025% w/w

P Cream Topical 023/032 Bioglan Laboratories Limited, UK

944Synalar Ointment

Fluocinolone Acetonide

Ph. Eur. 0.025% w/w

P Ointment topical 023/033 Bioglan Laboratories Limited, UK

945

Synalar N Cream

(Fluocinolone Acetonide

0.25mg + Neomycin

Sulphate 3500 IU), per

gram)

P Cream Topical 023/034 Bioglan Laboratories Limited, UK

946

Synalar N Ointment

Fluocinolone Acetonide

0.25mg, per g) +

Neomycin Sulphate

(3500 IU, per g)

P Ointment topical 023/035 Bioglan Laboratories Limited, UK

947 Cetavlex Antiseptic Cream Cetrimide Solution BP P Cream Topical 235/001 Bioglan Laboratories Limited, UK

948

Supracal Tablets

Calcium Citrate 1000mg

+ Magnesium Hydroxide

239.9mg + Zinc Sulphate

Monohydrate 10.978mg

P Tablet Uncoated 304/001 Bioplus Lifesciences Ltd, India

949 Gvfluc 200 Capsules Fluconazole 200mg POM Capsule oral 245/001 Bliss GVS Pharma Ltd, India

950Gvither Oral Suspension

Artemether 300mg, per

100ml

POM Suspension for

Oral Use

245/002 Bliss GVS Pharma Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

951

Funbact A Cream

Clotrimazole 1.0%w/w +

Neomycin sulphate

0.5%w/w +

Betamethasone

0.05%w/w

POM Cream Topical 245/003 Bliss GVS Pharma Ltd, India

952 Comit-50 Tablets Sildenafil 50mg POM Tablet Uncoated 245/004 Bliss GVS Pharma Ltd, India

953 Lofnac 100 Tablets Diclofenac 100mg P Tablet Uncoated 245/005 Bliss GVS Pharma Ltd, India

954

Lofnac Gel

Diclofenac 1.16%w/w +

Linseed Oil 3%w/w +

Methyl Salicylate

10%w/w + Menthol

5%w/v

P Gel Topical 245/006 Bliss GVS Pharma Ltd, India

955Gvither Forte Injection

Artemether 80mg, per ml POM Powder for

Injection

245/010 Bliss GVS Pharma Ltd, India

956

Gsunate Kit Tablets

Artesunate tablet 200mg

+ Amodiaquine HCl BP

tablet 600mg

POM Tablet Uncoated 245/011 Bliss GVS Pharma Ltd, India

957

Alaxin Kit Tablets

Amodiaquine BP 600mg

tablet +

Dihydroartemisinin

160mg tablets

POM Tablet Uncoated 245/012 Bliss GVS Pharma Ltd, India

958Lonart Tablets

Artemether 20mg +

Lumefantrine 120mg

POM Tablet Uncoated 245/013 Bliss GVS Pharma Ltd, India

959Lonart Forte Tablets

Artemether 40mg +

Lumefantrine 240mg

POM Tablet Uncoated 245/014 Bliss GVS Pharma Ltd, India

960

Lonart Suspension

Artemether 20mg +

Lumefantrine 120mg, per

5ml

POM Suspension for

Oral Use

245/015 Bliss GVS Pharma Ltd, India

961

Clamoxin 125 Suspension

Amoxicillin 125mg +

Clavulanic Acid 125mg,

per 5ml

POM Suspension for

Oral Use

245/016 Bliss GVS Pharma Ltd, India

962

Clamoxin 250 Suspension

Amoxicillin 250mg +

Clavulanic Acid 62.5mg,

per 5ml

POM Suspension for

Oral Use

245/017 Bliss GVS Pharma Ltd, India

963 Today Pill Levonorgestrel 0.75mg POM Tablet Uncoated 245/018 Bliss GVS Pharma Ltd, India

964 Lofnac - 50 Tablets Diclofenac 50mg P Tablet Uncoated 245/019 Bliss GVS Pharma Ltd, India

965Lofnac - P Tablets

Diclofenac 50mg +

Paracetamol 500mg

P Tablet Uncoated 245/020 Bliss GVS Pharma Ltd, India

Page 49 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

966Paludoxin Tablets

Sulfadoxine 500mg +

Pyrimethamine 25mg

POM Tablet Uncoated 245/021 Bliss GVS Pharma Ltd, India

967

Lonart Dispersible Tablets For

Infants And Children

Artemether 20mg +

Lumefantrine120mg

POM Tablet Dispersible 245/022 Bliss GVS Pharma Ltd, India

968Vagid -CL Suppositories

Clindamycin 100mg +

Clotrimazole 200mg

POM Suppository 245/023 Bliss GVS Pharma Ltd, India

969 Glycerin Suppositories Glycerin 90%w/w P Suppository 245/024 Bliss GVS Pharma Ltd, India

970 Slipizem -5 Suppositories Diazepam 5mg POM Suppository 245/025 Bliss GVS Pharma Ltd, India

971

Amitone Syrup

Vitamin B12 2.5 mg +

Vitamin B1 1mg +

Niacinamide 15mg +

Vitamin B2 1.5mg +

Vitamin B 6 0.5mg +

Sorbitol 70% + Lysine

50mg + Choline 30mg

P Syrup 245/026 Bliss GVS Pharma Ltd, India

972

Gynofer B12 Syrup

Ferric Ammonium Citrate

200mg + Folic Acid

1.5mg + Vitamin B12

50mg

P Syrup 245/028 Bliss GVS Pharma Ltd, India

973 Sirofen Syrup Ibuprofen 20mg P Syrup 245/031 Bliss GVS Pharma Ltd, India

974

Rinogrip Granules

Paracetamol 0.500g +

Chlorpheniramine 0.025g

+ Ascorbic Acid 0.2g

P Granules for

Suspension

245/032 Bliss GVS Pharma Ltd, India

975 Recticin 100 Suppositories Indomethacin 100mg POM Suppository 264/001 Bliss GVS Pharma Ltd, India

976

Anomex Suppositories

Allantoin 0.5% + Zinc

Oxide 5% + Lidocaine

3% + Hydrocortisone

0.25%

POM Suppository 264/002 Bliss GVS Pharma Ltd, India

977 Vagid Pessaries Clotrimazole 100mg POM Tablet Vaginal 264/003 Bliss GVS Pharma Ltd, India

978Alaxin Oral Suspension

Dihydroartemisinin

160mg, per 80ml

POM Suspension 245/007 BlissGVS Pharma Ltd, India

979 Alaxin Tablets Dihydroartemisinin 60mg POM Tablet Uncoated 245/008 BlissGVS Pharma Ltd, India

980 Gsunate Forte Tablets Artesuate 100mg POM Tablet Uncoated 245/009 BlissGVS Pharma Ltd, India

981 Bgmet Tablets Metformin 500mg POM Tablet Uncoated 245/027 BlissGVS Pharma Ltd, India

982 Azitrine Tablets Azithromycin 250mg POM Tablet Uncoated 245/029 BlissGVS Pharma Ltd, India

983

P-Alaxin Tablets

Dihydroartemisinin 80mg

+ Piperaquine Phosphate

320mg

POM Tablet Uncoated 245/030 BlissGVS Pharma Ltd, India

984 Glycoben Tablets Glibenclamide 5mg POM Tablet Uncoated 245/030 BlissGVS Pharma Ltd, India

Page 50 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

985

Chloramphenicol 1% Opthalmic

Ointment USP

Chloramphehicol 10mg POM Eye Ointment 245/033 BlissGVS Pharma Ltd, India

986

Hilderm - CH Cream

Silver Sulphadiazine

1%w/w + Chitosan2%w/w

POM Cream Topical 245/034 BlissGVS Pharma Ltd, India

987

Tetracycline 1% Opthalmic

Ointment USP

Tetracycline 10mg POM Eye Ointment 245/035 BlissGVS Pharma Ltd, India

988BG-Sol Cream

Clobetasol propionate

0.05%w/w

POM Cream Topical 245/036 BlissGVS Pharma Ltd, India

989Maitri Vaginal Lubricant

PEG 1500 80%w/w +

PEG 1000 20%w/w

P Tablet Vaginal 245/037 BlissGVS Pharma Ltd, India

990 Asnorbin - 1000 Tablets Ascorbic Acid 1000mg P Tablet Uncoated 245/038 BlissGVS Pharma Ltd, India

991

BG-Cold Tablets

Paracetamol 500mg +

Caffeine 30mg +

Chlorpheniramine 5mg +

Phenylephrine 2mg

P Tablet Uncoated 245/039 BlissGVS Pharma Ltd, India

992Pip - Off Gel

Clindamycin Phosphate

1.0%w/v

POM Gel Topical 245/040 BlissGVS Pharma Ltd, India

993

BG-Glutamin Syrup

L-Glutamic Acid 100mg +

Thiamine Hydrochloride

4.5mg + Pyridoxine

Hydrochloride 1.5mg +

Cyano 5mcg

P Syrup 245/041 BlissGVS Pharma Ltd, India

994

P-Alaxin Suspension

Dihydroartemisinin 80mg

+ Piperaquine Phosphate

640mg

POM Suspension 245/042 BlissGVS Pharma Ltd, India

995Lonart DS Tablets

Artemether 80mg +

Lumefantrine 480mg

POM Tablet Uncoated 245/043 BlissGVS Pharma Ltd, India

996BG - Fenamex Suspesion

Mefenamic Acid 100mg,

per 5ml

P Suspension for

Oral Use

245/046 BlissGVS Pharma Ltd, India

997 Gacet - 500mg Tablets Paracetamol 500mg GS Tablet Uncoated 254/045 BlissGVS Pharma Ltd, India

998

BG-Glutamin Tablets

L-Glutamic Acid BP

250mg + Thiamine

Hydrochloride BP 10mg +

Pyridoxine Hydrochloride

BP 3mg +

Cyanocobalamine 10mcg

P Tablet Oral 254/046 BlissGVS Pharma Ltd, India

Page 51 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 999 Secnagyl Tablets Secnidazole 1.0g POM Tablet Uncoated 254/047 BlissGVS Pharma Ltd, India

1000

Vitavit Multivitamin Syrup

Vitamin A 1000IU +

Vitamin D3 200IU +

Vitamin B1 1.5mg +

Vitamin B2 1.0 mg +

Vitamin B6 1.0mg +

Vitamin C 30.0mg +

Nicotinamide 10.0mg +

Panthenol 5.0mg

P Syrup 254/048 BlissGVS Pharma Ltd, India

1001

Broxol Syrup

Ambroxol Hydrochloride

BP 15mg + Guaiphenesin

BP 50mg + Terbutaline

Sulphate BP 1.5mg +

Menthol BP 1mg

P Syrup 254/049 BlissGVS Pharma Ltd, India

1002Upracid -40 Tablets

Pantoprazole sodium

sesquihydrate BP 40mg

POM Tablet Uncoated 254/050 BlissGVS Pharma Ltd, India

1003Sanfurox - DS 125 Suspension

Cefuroxime Axetil USP

125mg, per 5ml

POM Powder for Oral

Suspension

254/051 BlissGVS Pharma Ltd, India

1004Comit -100 Tablets

Sildenafil Citrate I.H

100mg

POM Tablet Uncoated 254/052 BlissGVS Pharma Ltd, India

1005BG - MET 850 Tablets

Metformin Hydrochloride

BP 850mg

POM Tablet Uncoated 254/053 BlissGVS Pharma Ltd, India

1006X-Tone Forte Syrup

Amino Acids and

Minerals

POM Syrup 254/054 BlissGVS Pharma Ltd, India

1007Agycin 500 Tablets

Azithromycin Dihydrate

USP 500mg

POM Tablet Uncoated 254/055 BlissGVS Pharma Ltd, India

1008

Finmol Plus Capsules

Paracetamol 325mg +

Ibuprofen BP 200mg +

Caffeine 30mg

P Tablet Uncoated 254/056 BlissGVS Pharma Ltd, India

1009 Vagid 500 Clotrimazole BP 500mg POM Tablet Vaginal 254/057 BlissGVS Pharma Ltd, India

1010Prodone Imazole Capsules

Pantoprazole 40mg +

Domperidone BP 30mg

POM Capsule oral 254/058 BlissGVS Pharma Ltd, India

1011 Conlax-5 Suppositories Bisacodyl USP 5mg POM Suppository 254/059 BlissGVS Pharma Ltd, India

1012 Conlax-10 Suppositories Bisacodyl USP 10mg POM Suppository 254/060 BlissGVS Pharma Ltd, India

1013 Fibrotin Tablets Fenofibrate BP 160mg POM Tablet Film coated 254/061 BlissGVS Pharma Ltd, India

1014 Comit-100 Oral Jelly Sildenafil 100mg POM Gel Oral 254/062 BlissGVS Pharma Ltd, India

Page 52 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1015

LOFNAC BALM Mentha piperita 6%w/w +

Cinnamomum camhora

5.5%w/w + Pinus

longifolia roxb 5%w/w +

Pytchotis ajowan 2%w/w

+ Wintergreen oil

24%w/w Eucalyptus

globulus labill 5%w/w

P Ointment topical 254/071L BlissGVS Pharma Ltd, India

1016

LOFNAC ROLL - ON Pytchotis ajowan

0.5%w/v + Mentha

piperita 3%w/v +

Cinnamomum camhora

2%w/v + Eucalyptus

globulus labill 0.5%w/v +

Wintergreen oil 15%wv/v

Pinus longifolia roxb

1%w/v

P Gel Topical 254/072L BlissGVS Pharma Ltd, India

1017 Sunfurox 500 Tablets Cefuroxime axetil 500mg POM Tablet Film coated 254/066 BlissGVS Pharma Ltd, India

1018

X-pro 500 Tablets Ciprofloxacin

hydrochloride 500mg

POM Tablet Film coated 254/067 BlissGVS Pharma Ltd, India

1019

Clamoxin 625 Tablets Amoxicillin trihydrate

500mg + Clavulanate

Potassium 125mg

POM Tablet Film coated 254/068 BlissGVS Pharma Ltd, India

1020

Clamoxin 1g Tablets Amoxicillin trihydrate

875mg + Clavulanate

Potassium 125mg

POM Tablet Film coated 254/069 BlissGVS Pharma Ltd, India

1021 Uprone 20 capsules Omeprazole 20mg POM Capsule oral 254/070 BlissGVS Pharma Ltd, India

1022 Agycin Suspension Azithromycin 40mg/ml POM Suspension 254/073 BlissGVS Pharma Ltd, India

1023

Gacet 250 Suppositories Acetaminophen USP

250mg

POM Suppository 254/076 BlissGVS Pharma Ltd, India

1024

Gacet 125 Suppositories Acetaminophen USP

125mg

POM Suppository 254/075 BlissGVS Pharma Ltd, India

1025

G-SUNATE Injection Artesunate BP 60mg POM Solution for

Injection

254/074 BlissGVS Pharma Ltd, India

1026Adrenaline-Fresenius Injection

Adrenaline 1.0mg, per ml POM Solution for

Injection

254/001 Bodene(PTY) Ltd, South Africa

1027

Chlorpromazine Hydrochloride

Injection

Chlorpromazine 25mg,

per ml

POM Solution for

Injection

254/002 Bodene(PTY) Ltd, South Africa

Page 53 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1028Dextrose-Fresenius Injection

Dextrose 50% w/v POM Solution for

infusion

254/003 Bodene(PTY) Ltd, South Africa

1029Dobutamine-Fresenius Injection

Dobutamine 250mg, per

20ml

POM Solution for

Injection

254/004 Bodene(PTY) Ltd, South Africa

1030

Ergometrine Maleate -Fresenius

Injection

Ergometrine 0.5mg, per

ml

POM Solution for

Injection

254/005 Bodene(PTY) Ltd, South Africa

1031Fentanyl-Frenesius Injection

Fentanyl 100mcg, per

2ml

POM Solution for

Injection

254/006 Bodene(PTY) Ltd, South Africa

1032Furosemide-Fresenius Injection

Furosemide 20mg, per

2ml

POM Solution for

Injection

254/007 Bodene(PTY) Ltd, South Africa

1033

Heparin sodium 25,000IU, per

ml Injection

Heparin 25000IU , per ml POM Solution for

Injection

254/008 Bodene(PTY) Ltd, South Africa

1034

Heparin 5,000IU, per ml Sodium

Injection

Heparin 5000IU, per ml POM Solution for

Injection

254/009 Bodene(PTY) Ltd, South Africa

1035Intramed Mannitol 20 Injection

Mannitol 100g, per 500ml POM Solution for

infusion

254/010 Bodene(PTY) Ltd, South Africa

1036

Intramed Sodium Bicarbonate

Injection

Sodium Bicarbonate

4.25g, per 50ml

POM Solution for

infusion

254/011 Bodene(PTY) Ltd, South Africa

1037Intramed Trichazole Injection

Metronidazole 500mg,

per 100ml

POM Solution for

infusion

254/012 Bodene(PTY) Ltd, South Africa

1038Ketamine Injection

Ketamine 50mg, per ml POM Solution for

Injection

254/013 Bodene(PTY) Ltd, South Africa

1039Lignocaine 1% Injection

Lignocaine 10mg, per

2ml

POM Solution for

Injection

254/014 Bodene(PTY) Ltd, South Africa

1040Lignocaine 2% Injection, 20ml

Lignocaine 20mg, per ml POM Solution for

Injection

254/015 Bodene(PTY) Ltd, South Africa

1041Lignocaine 2% Injection, 5ml

Lignocaine 100mg, per

5ml

POM Solution for

Injection

254/016 Bodene(PTY) Ltd, South Africa

1042Morphine Sulphate 10 Injection

Morphine 10mg, per ml POM Solution for

Injection

254/017 Bodene(PTY) Ltd, South Africa

1043Morphine Sulphate 15 Injection

Morphine 15mg, per ml POM Solution for

Injection

254/018 Bodene(PTY) Ltd, South Africa

1044

Naloxone Neonatal-Fresenius

0.02mg/ml Injection

Naloxone 0.042mg, per

2ml

POM Solution for

Injection

254/019 Bodene(PTY) Ltd, South Africa

1045

Naloxone-Fresenius 0.4mg/ml

Injection

Naloxone 0.42mg, per ml POM Solution for

Injection

254/020 Bodene(PTY) Ltd, South Africa

1046Neostigmine 0.5 Injection

Neostigmine 0.5mg, per

ml

POM Solution for

Injection

254/021 Bodene(PTY) Ltd, South Africa

Page 54 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1047Neostigmine 2.5 Injection

Neostigmine 2.5mg, per

ml

POM Solution for

Injection

254/022 Bodene(PTY) Ltd, South Africa

1048Pancuronium Bromide Injection

Pancuronium 4mg, per

2ml

POM Solution for

Injection

254/023 Bodene(PTY) Ltd, South Africa

1049Pethidine 100 Injection

Pethidine 100mg, per 2ml POM Solution for

Injection

254/024 Bodene(PTY) Ltd, South Africa

1050Pethidine 50 Injection

Pethidine 50mg, per ml POM Solution for

Injection

254/025 Bodene(PTY) Ltd, South Africa

1051Promethazine Injection

Promethazine 25mg, per

ml

POM Solution for

Injection

254/026 Bodene(PTY) Ltd, South Africa

1052Quinine Injection

Quinine 300mg, per ml POM Solution for

Injection

254/027 Bodene(PTY) Ltd, South Africa

1053

Suxamethonium Chloride

Injection

Suxamethonium 100mg,

per 2ml

POM Solution for

Injection

254/028 Bodene(PTY) Ltd, South Africa

1054Thiopentone Sodium Injection

Thiopentone 500mg, per

20ml

POM Solution for

Injection

254/029 Bodene(PTY) Ltd, South Africa

1055

Fresenius - Hyoscine Butyl

Bromide Injection

Hyoscine ButylBromide

20mg, per ml

POM Solution for

Injection

254/040 Bodene(PTY) Ltd, South Africa

1056

Promethazine Hydrochloride

Fresenius Injection

Promethazine 50mg, per

2ml

POM Solution for

Injection

254/042 Bodene(PTY) Ltd, South Africa

1057Viramune Tablets

Nevirapine 200mg POM Tablet Uncoated 119/001 Boehringer Ingelheim Pharmaceuticals (Pty)

Ltd, SA

1058Viramune Suspension

Nevirapine 50mg, per

5ml

POM Suspension 119/002 Boehringer Ingelheim Pharmaceuticals (Pty)

Ltd, SA

1059

Acidex Oral Suspension

Sodium Bicarbonate

133.5mg + Sodium

Alginate 250mg +

Calcium Carbonate

80mg

P Suspension for

Oral Use

318/001 Bricved Ltd,Republic of Ireland

Page 55 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1060

Pinoplex Fortified Blood Tonic

Vitamin B1 5mg +

Vitamin B2 2mg +

Vitamin B6 2mg +

Vitamin B12 6mcg +

Nicotinamide 20mg +

Calcium Pantothenate

10mg +Liver extract

1.175% w/v + Folic Acid

0.3mg +Sodium

Glycerophosphate 300mg

+Potassium

Glycerophosphate BPC

49 20mg +Manganese

Sulphate 4mg + Ferric

Ammonium Sulphate

73mg + Caffeine 57mg

Citric Acid 177mg/30mls

P Syrup 318/002 Bricved Ltd,Republic of Ireland

1061

HB 12 Syrup

Haemoglobin powder

0.5g + Vitamin B12

20mcg, per 5mls

P Syrup 318/003 Bricved Ltd,Republic of Ireland

1062Emitino Injection

Ondansetron 2mg POM Powder for

Injection

065/001 Cachet Pharmaceuticals Ltd, India

1063

Emitino Mouth Dissolving

Tablets

Ondansetron 4mg POM Tablet Uncoated 065/002 Cachet Pharmaceuticals Ltd, India

1064Emitino Solution

Ondansetron 2mg, per

5ml

POM Solution for Oral

Use

065/003 Cachet Pharmaceuticals Ltd, India

1065I-Up Injection

Iron Sucrose 100mg, per

5ml

POM Solution for

Injection

065/004 Cachet Pharmaceuticals Ltd, India

1066Canem 500mg Injection

Meropenem 500mg POM Powder for

Injection

065/005 Cachet Pharmaceuticals Ltd, India

1067Erycach Suspension

Erythromycin 125mg, per

5ml

POM Suspension for

Oral Use

065/006 Cachet Pharmaceuticals Ltd, India

1068 Erycach 250 Tablets Erythromycin 250mg POM Tablet Film coated 065/007 Cachet Pharmaceuticals Ltd, India

1069 Celza 250mg Tablets Cefuroxime 250mg POM Tablet Uncoated 065/008 Cachet Pharmaceuticals Ltd, India

1070 Celza 500mg Tablets Cefuroxime 500mg POM Tablet Uncoated 065/009 Cachet Pharmaceuticals Ltd, India

1071

Acinet 600mg Tablets

Amoxycillin Trihydrate

500mg + Clavulanate

Potassium 100mg

POM Tablet Uncoated 065/010 Cachet Pharmaceuticals Ltd, India

Page 56 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1072

Acinet 625mg Tablets

Amoxicillin Trihydrate

500mg + Clavulanate

Potassium 125mg

POM Tablet Uncoated 065/011 Cachet Pharmaceuticals Ltd, India

1073

Acinet 228.5mg Suspension

Amoxycillin Trihydrate

200mg + Clavulanate

Potassium 28.5mg

POM Suspension for

Oral Use

065/012 Cachet Pharmaceuticals Ltd, India

1074

Cachnerve Capsules

Alpha Lipoic Acid 100mg

+ Gamma Linolenic Acid

60mg + Pyridoxine 3mg +

Methycobalamin 1.5mg +

Chromium 50mg

P Capsule oral 065/013 Cachet Pharmaceuticals Ltd, India

1075

Eascof Expectorant Syrup

Bromhexine 4mg +

Salbutamol 2mg +

Guaifenesin 100mg +

Menthol 1mg

P Syrup 065/014 Cachet Pharmaceuticals Ltd, India

1076 Trama 50 Capsules Tramadol 50mg POM Capsule oral 065/015 Cachet Pharmaceuticals Ltd, India

1077Tramacetal Tablets

Tramadol 37.5mg +

Paracetamol 25mg

POM Tablet Uncoated 065/016 Cachet Pharmaceuticals Ltd, India

1078Cach - ART 20/120 Tablets

Artemether 20mg +

Lumefantrine 120mg

POM Tablet Uncoated 065/017 Cachet Pharmaceuticals Ltd, India

1079Cachpar Suspension

Paracetamol 125mg, per

5mg

GS Suspension for

Oral Use

065/018 Cachet Pharmaceuticals Ltd, India

1080Celza Dry Syrup

Cefuroxime 125mg, per

5ml

POM Powder for Oral

Suspension

065/019 Cachet Pharmaceuticals Ltd, India

1081Acinet 1000mg Tablets

Amoxycillin 875mg +

Clavulanate 125mg

POM Tablet Uncoated 065/020 Cachet Pharmaceuticals Ltd, India

1082 Cabalin -75 Capsules Pregabalin 75mg POM Capsule oral 065/021 Cachet Pharmaceuticals Ltd, India

1083

Actilosa Dry Syrup

(Probiotics: L.Acidophi/u

+ B.longum + B.bifidum +

B.lactis) 5 billions

Prebiotics

inulin(FOS)Fructo

Oligosaccharide 25mq)

P Powder for Oral

Suspension

065/022 Cachet Pharmaceuticals Ltd, India

Page 57 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1084

Actilosa Capsules

(Probiotics:

L.Acidophilu+B.longum +

B.bifidughm + Blactice) 5

billions prebiotics

inulin(FOS)Fructo

Oliqosaccharide) 25mq

P Capsule oral 065/023 Cachet Pharmaceuticals Ltd, India

1085Canem Powder For Injection

Meropenem Trihydrate

1g

POM Powder for

Injection

065/024 Cachet Pharmaceuticals Ltd, India

1086Moximon Capsules

Amoxicillin Trihydrate

250mg

POM Caplets oral

Uncoated

065/025 Cachet Pharmaceuticals Ltd, India

1087

Lysoflam Gel

Linseed oil 3.0% w/v +

Diclofenac Diethylamine

1.16% w/v + Methyl

Salicylate 12.0% w/v +

Menthol 5.5% w/v

P Gel Topical 065/026 Cachet Pharmaceuticals Ltd, India

1088Traxol 1000

Ceftriaxone for Injection

USP 1000mg

POM Solution for

Injection

065/027 Cachet Pharmaceuticals Ltd, India

1089 Perflobid 400 Tablets Pefloxacin 400mg POM Tablet Uncoated 113/001 Cadilla Pharmaceuticals Limited, India

1090 Vivorax Tablets Acyclovir 200mg POM Tablet Uncoated 113/002 Cadilla Pharmaceuticals Limited, India

1091 Aciloc 300 Tablets Ranitidine 300mg POM Tablet Film coated 113/003 Cadilla Pharmaceuticals Limited, India

1092 Aciloc 150 Tablets Ranitidine 150mg POM Tablet Uncoated 113/004 Cadilla Pharmaceuticals Limited, India

1093 Amdepin 10 Tablets Amlodipine 10mg POM Tablet Uncoated 113/005 Cadilla Pharmaceuticals Limited, India

1094Amidepin 5 Tablets

Amlodipine Besylate 5mg POM Tablet Uncoated 113/006 Cadilla Pharmaceuticals Limited, India

1095Ciprodac Infusion

Ciprofloxacin 2mg, per ml POM Solution for

Infusion

113/007 Cadilla Pharmaceuticals Limited, India

1096 Lovalip 20mg Tablets Lovastatin 20mg POM Tablet Uncoated 113/009 Cadilla Pharmaceuticals Limited, India

1097 Ciprodac 250mg Tablets Ciprofloxacin 250mg POM Tablet Uncoated 113/011 Cadilla Pharmaceuticals Limited, India

1098 Olit 20 Capsules Omeprazole 20mg POM Capsule oral 113/012 Cadilla Pharmaceuticals Limited, India

1099 Pirofen 20 Capsules Piroxicam 20mg POM Capsule oral 113/013 Cadilla Pharmaceuticals Limited, India

1100Fluzon Infusion

Fluconazole 2mg, per

1ml

POM Solution for

infusion

113/014 Cadilla Pharmaceuticals Limited, India

1101 Fluzon 150mg Tablets Fluconazole 150mg POM Tablet Uncoated 113/015 Cadilla Pharmaceuticals Limited, India

1102 Fluzon 100mg Tablets Fluconazole 100mg POM Tablet Uncoated 113/016 Cadilla Pharmaceuticals Limited, India

1103 Wormin A 400mg Tablets Albendazole 400mg POM Tablet Uncoated 113/017 Cadilla Pharmaceuticals Limited, India

1104 Roxibid 150 Tablets Roxithromycin 150mg POM Tablet Uncoated 113/018 Cadilla Pharmaceuticals Limited, India

1105 Gempar 300 Capsules Gemfibrozil 300mg POM Capsule oral 113/019 Cadilla Pharmaceuticals Limited, India

1106Oritaxim 1000mg Injection

Cefotaxime 1000mg POM Powder for

Injection

113/020 Cadilla Pharmaceuticals Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 1107 Envas 2.5mg Tablets Enalapril 2.5mg POM Tablet Uncoated 113/021 Cadilla Pharmaceuticals Limited, India

1108 Cefamor 250mg Capsules Cephalexin 250mg POM Capsule oral 113/022 Cadilla Pharmaceuticals Limited, India

1109Wormin Suspension

Mebendazole 100mg, per

5ml

P Suspension for

Oral Use

113/023 Cadilla Pharmaceuticals Limited, India

1110 Cefamor 500mg Capsules Cephalexin 500mg POM Capsule oral 113/024 Cadilla Pharmaceuticals Limited, India

1111 Dolac 10mg Tablets Ketorolac 10mg POM Tablet Uncoated 113/025 Cadilla Pharmaceuticals Limited, India

1112

Vasograin Tablets

Ergotamine Tartrate 1mg

+ Prochlorperazine

Maleate 2.5mg +

Caffeine 100mg +

Paracetamol 250mg

POM Tablet Uncoated 113/026 Cadilla Pharmaceuticals Limited, India

1113 Pirofen 10mg Capsules Piroxicam 10mg POM Capsule oral 113/027 Cadilla Pharmaceuticals Limited, India

1114 Glamide 5mg Tablets Glibenclamide 5mg POM Tablet Uncoated 113/028 Cadilla Pharmaceuticals Limited, India

1115 Fludac 20mg Capsules Fluxetine 20mg POM Capsule oral 113/029 Cadilla Pharmaceuticals Limited, India

1116 Wormin 100mg Tablets Mebendazole 100mg P Tablet Uncoated 113/030 Cadilla Pharmaceuticals Limited, India

1117 Norfen 400mg Tablets Norfloxacin 400mg POM Tablet Uncoated 113/031 Cadilla Pharmaceuticals Limited, India

1118

Cadiprim 480mg Tablets

Sulphamethoxazole

400mg + Trimethoprim

80mg

POM Tablet Uncoated 113/032 Cadilla Pharmaceuticals Limited, India

1119

Cadiprim 240 Mg Suspension

Trimethoprim 40mg +

Sulphamethoxazole

200mg

POM Suspension for

Oral Use

113/033 Cadilla Pharmaceuticals Limited, India

1120Wormin-A Suspension

Albendazole 200mg, per

5ml

POM Suspension 113/035 Cadilla Pharmaceuticals Limited, India

1121 Cadiphen 4mg Tablets Chlorpheniramine 4mg P Tablet Uncoated 113/037 Cadilla Pharmaceuticals Limited, India

1122 Decon Nasal Drops Xylometazoline 0.1%w/v POM Nasal drops 113/039 Cadilla Pharmaceuticals Limited, India

1123 Decon Pediatric Nasal Drops Xylometazoline 0.05% POM Nasal drops 113/040 Cadilla Pharmaceuticals Limited, India

1124 Ibunate 400 Tablets Ibuprofen 400mg P Tablet Uncoated 113/041 Cadilla Pharmaceuticals Limited, India

1125 Nilide 100mg Tablets Nimesulide 100mg POM Tablet Uncoated 113/042 Cadilla Pharmaceuticals Limited, India

1126

Dexasone Eye/Ear Drops

Neomycin Sulphate

0.35%w/v +

Dexamethasone Sodium

Phosphate 0.1%w/v

POM Ear/Eye Drops 113/043 Cadilla Pharmaceuticals Limited, India

1127Trigan-D Tablets

Paracetamol 500mg +

Dicyclomine 20mg

P Tablet Uncoated 113/044 Cadilla Pharmaceuticals Limited, India

1128

EC-350 Capsules

Ascorbic Acid 150mg +

Vitamin E 25mg

+Selenium 75mg +Alpha

Lipoic Acid 100mg

POM Capsule oral 113/045 Cadilla Pharmaceuticals Limited, India

Page 59 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1129Mycocox Tablets

Isoniazid 150mg +

Rifampicin 150mg

POM Tablet Uncoated 113/046 Cadilla Pharmaceuticals Limited, India

1130 Scat 200mg Tablets Sparfloxacin 200mg POM Tablet Uncoated 113/047 Cadilla Pharmaceuticals Limited, India

1131Domperon Suspension

Domperidone 5mg, per

5ml

POM Solution for Oral

Use

113/049 Cadilla Pharmaceuticals Limited, India

1132 Herbisept Herbal Cream Herbal extract 30mg P Cream Topical 113/050 Cadilla Pharmaceuticals Limited, India

1133Oritaxim 250mg Injection

Cefotaxime 250mg POM Powder for

Injection

113/051 Cadilla Pharmaceuticals Limited, India

1134Axone 1000 Injection

Ceftriaxone 1g POM Powder for

Injection

113/052 Cadilla Pharmaceuticals Limited, India

1135Zycin Dry Syrup

Azithromycin 200mg, per

5ml

POM Syrup 113/053 Cadilla Pharmaceuticals Limited, India

1136 Zycin Capsules Azithromycin 250mg POM Capsule oral 113/054 Cadilla Pharmaceuticals Limited, India

1137 Zycin DT Tablets Azithromycin 100mg POM Tablet Uncoated 113/055 Cadilla Pharmaceuticals Limited, India

1138 Lorcap Eye/Ear Drops Pilocarpine 20mg POM Ear/Eye Drops 113/056 Cadilla Pharmaceuticals Limited, India

1139PVA Tears Eye Drops

Polyvinyl alcohol 14mg,

per 10ml

P Eye Drops 113/057 Cadilla Pharmaceuticals Limited, India

1140 Gentamycin Eye Drops Gentamicin 3mcg, per ml POM Ear/Eye Drops 113/058 Cadilla Pharmaceuticals Limited, India

1141

Cadiprim Eye/Ear Drops

Polymyxin B 10000iu +

Trimethroprim 1mg, per

ml + Polyvinyl Alcohol

1%v/v

POM Ear/Eye Drops 113/059 Cadilla Pharmaceuticals Limited, India

1142 Cadilac Eye Drops Ketoralac 5mcg, per ml POM Ear/Eye Drops 113/060 Cadilla Pharmaceuticals Limited, India

1143

Sanvic Opthalmic Solutions Eye

Drops.

Hydroxypropylmethyl

cellulose 2%w/v

POM Eye Drops 113/061 Cadilla Pharmaceuticals Limited, India

1144Cefogen 750 Injection

Cefuroxime 750mg POM Powder for

Injection

113/062 Cadilla Pharmaceuticals Limited, India

1145Sanbeta Eye Drops

Betamethasone 1mg, per

ml

POM Eye Drops 113/063 Cadilla Pharmaceuticals Limited, India

1146 Mycobutol 800mg Tablets Ethambutol 800mg POM Tablet Uncoated 113/065 Cadilla Pharmaceuticals Limited, India

1147Decon Eye Drops

Naphazoline

Hydrochloride 0.01%w/w

POM Eye Drops 113/066 Cadilla Pharmaceuticals Limited, India

1148

Tmide Plus Eye Drops

Benzalkonuim Chloride

0.01%w/v +

Phenylephrine 5%w/v +

Tropicamide 0.8%w/v

POM Eye Drops 113/067 Cadilla Pharmaceuticals Limited, India

1149Rabeloc Injection

Rabeprazole 20mg, per

ml

POM Solution for

Injection

113/068 Cadilla Pharmaceuticals Limited, India

1150 Rabeloc 10 Tablets Rabeprazole 10mg POM Tablet Uncoated 113/069 Cadilla Pharmaceuticals Limited, India

Page 60 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 1151 Rabeloc-20 Tablets Rabeprazole 20mg POM Tablet Uncoated 113/070 Cadilla Pharmaceuticals Limited, India

1152 Scat Eye/Ear Drops Sparfloxacin 0.3% POM Ear/Eye Drops 113/071 Cadilla Pharmaceuticals Limited, India

1153

Locid Suspension

Aluminium Hydroxide +

Magnesium Trisilscate

474mg

GS Suspension for

Oral Use

113/072 Cadilla Pharmaceuticals Limited, India

1154Tambac 50 Suspension

Cefpodoxime 50mg, per

5ml

POM Suspension for

Oral Use

113/073 Cadilla Pharmaceuticals Limited, India

1155 Nodon 5 Tablets Nebivolol 5mg POM Tablet Uncoated 113/074 Cadilla Pharmaceuticals Limited, India

1156 Piozulin 15 Tablets Pioglitazone 15mg POM Tablet Uncoated 113/075 Cadilla Pharmaceuticals Limited, India

1157 Piozulin 30 Tablets Pioglitazone 30mg POM Tablet Uncoated 113/076 Cadilla Pharmaceuticals Limited, India

1158

Cadiphen Expectorant

Chlorpheniramine 80mg

+ Ammonium 100mg +

Sodium Citrate 44mg +

Menthol 0.8mg

P Solution for Oral

Use

113/077 Cadilla Pharmaceuticals Limited, India

1159

Haem-Up Gems Capsules

Folic Acid 1.5mg +

Ferrous Fumarate 200mg

+ Cupric Sulfate 2.5mg +

Manganese Sulfate

2.5mg

P Capsule oral 113/078 Cadilla Pharmaceuticals Limited, India

1160

Haem-Up Syrup

Folic Acid 0.5mg + Ferric

Ammonium Citrate

160mg + Cupric Sulphate

30 mcg + Manganese

Sulphate 30 mcg

P Solution for Oral

Use

113/079 Cadilla Pharmaceuticals Limited, India

1161Aciloc Injection

Ranitidine 25mg POM Powder for

Injection

113/080 Cadilla Pharmaceuticals Limited, India

1162 Amtba 500 Tablets Tinidazole 500mg POM Tablet Uncoated 113/081 Cadilla Pharmaceuticals Limited, India

1163 Calnif Retard Nifedipine 20mg POM Tablet Uncoated 113/082 Cadilla Pharmaceuticals Limited, India

1164Cefamor Dry Syrup

Cephalexin 125 mg, per 5

ml

POM Syrup 113/083 Cadilla Pharmaceuticals Limited, India

1165

Dexaquin Ointment

Idochlorohydroxyquinolon

e 3%w/w +

Dexamethasone

0.05%w/w

POM Ointment topical 113/084 Cadilla Pharmaceuticals Limited, India

1166 Domperon Tablets Domperidone 10mg POM Tablet Uncoated 113/085 Cadilla Pharmaceuticals Limited, India

1167 Envas 10mg Tablets Enalapril 10mg POM Tablet Uncoated 113/086 Cadilla Pharmaceuticals Limited, India

1168 Envas 5mg Tablets Enalapril 5mg POM Tablet Uncoated 113/087 Cadilla Pharmaceuticals Limited, India

Page 61 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1169

Ocupress 2.5mg/ml Ophthalmic

Solution

Timolol 2.5mg, per ml POM Eye Drops 113/088 Cadilla Pharmaceuticals Limited, India

1170

Ocupress 5mg/ml Ophthalmic

Solution

Timolol 5mg, per ml POM Eye Drops 113/089 Cadilla Pharmaceuticals Limited, India

1171Tricort Injection

Triamcinolone 40mg POM Solution for

Injection

113/090 Cadilla Pharmaceuticals Limited, India

1172 Wormin 500mg Tablets Mebendazole 500mg P Tablet Uncoated 113/091 Cadilla Pharmaceuticals Limited, India

1173 Allerstat 180 Tablets Fexofenadine 180mg P Tablet Uncoated 113/092 Cadilla Pharmaceuticals Limited, India

1174 Allerstat 120 Tablets Fexofenadine 120mg P Tablet Uncoated 113/093 Cadilla Pharmaceuticals Limited, India

1175 Cupid 50 Tablets Sildenafil 50mg POM Tablet Film coated 113/094 Cadilla Pharmaceuticals Limited, India

1176

Polycap Capsules

Simvastatin 20mg +

Ramipril 5mg + Atenolol

50mg +

Hydrochlorothiazide

12.5mg

POM Capsule oral 113/095 Cadilla Pharmaceuticals Limited, India

1177 Cadigrel Tablets Clopidogrel 75mg POM Tablet Uncoated 113/096 Cadilla Pharmaceuticals Limited, India

1178

Onsett 2ml Injection

Ondansetron

hydrochloride 2mg, per

ml

POM Solution for

Injection

113/097 Cadilla Pharmaceuticals Limited, India

1179Onsett 4 Tablets

Ondansetron

Hydrochloride 4mg

POM Tablet Uncoated 113/098 Cadilla Pharmaceuticals Limited, India

1180Onsett 8 Tablets

Ondansetron

Hydrochloride 8mg

POM Tablet Uncoated 113/099 Cadilla Pharmaceuticals Limited, India

1181 Teli -80 Tablets Telmisartan 80mg POM Tablet Uncoated 113/100 Cadilla Pharmaceuticals Limited, India

1182 Teli-40 Tablets Telmisartan 40mg POM Tablet Uncoated 113/101 Cadilla Pharmaceuticals Limited, India

1183

Teli -H Tablets

Telmisartan 40mg +

Hydrochlorothiazide

12.5mg

POM Tablet Uncoated 113/102 Cadilla Pharmaceuticals Limited, India

1184Caditor 20 Tablets

Atorvastalin Calcium

20mg

POM Tablet Uncoated 113/103 Cadilla Pharmaceuticals Limited, India

1185Tambac 100 Tablets

Cefpodoxime Proxetil

100mg

POM Tablet Uncoated 113/104 Cadilla Pharmaceuticals Limited, India

1186Tambac 200 Tablets

Cefpodoxime Proxetil

200mg

POM Tablet Uncoated 113/105 Cadilla Pharmaceuticals Limited, India

1187Dolac 30 Injection

Ketorolac Tromethamine

USP 30mg

POM Solution for

Injection

113/106 Cadilla Pharmaceuticals Limited, India

1188Procticad

Lactitol Monohydrate

10gm, per 15ml

POM Solution for Oral

Use

113/107 Cadilla Pharmaceuticals Limited, India

1189 Zealargy Tablets Rupatadine 10mg P Tablet Uncoated 113/109 Cadilla Pharmaceuticals Limited, India

Page 62 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 1190 Camedol Tablets Paracetamol 500mg GS Tablet Uncoated 271/001 Cameo Healthcare(L) Pvt Ltd, India

1191 Cafem- 200 Tablets Ibuprofen 200mg P Tablet Uncoated 271/002 Cameo Healthcare(L) Pvt Ltd, India

1192 Camelox-250 Capsules Cloxacillin BP 250mg POM Capsule oral 271/003 Cameo Healthcare(L) Pvt Ltd, India

1193Camelox-125 Oral Suspension

Cloxacillin BP 125mg,

per 5ml

POM Powder for Oral

Suspension

271/004 Cameo Healthcare(L) Pvt Ltd, India

1194 Camecillin-250 Capsules Ampicillin BP 250mg POM Capsule oral 271/005 Cameo Healthcare(L) Pvt Ltd, India

1195Camecillin-125 Oral Suspension

Ampicillin BP 125mg, per

5ml

POM Powder for Oral

Suspension

271/006 Cameo Healthcare(L) Pvt Ltd, India

1196 Camoxy-250mg Capsule Amoxicillin 250mg POM Capsule oral 271/007 Cameo Healthcare(L) Pvt Ltd, India

1197Camoxy-125 Oral Suspension

Amoxicillin BP 125mg,

per 5ml

POM Powder for Oral

Suspension

271/008 Cameo Healthcare(L) Pvt Ltd, India

1198 Indocame Capsules Indomethacin 25mg P Capsule oral 271/009 Cameo Healthcare(L) Pvt Ltd, India

1199Cotricam 240 Oral Suspension

Co-trimoxazole 240mg POM Powder for Oral

Suspension

271/010 Cameo Healthcare(L) Pvt Ltd, India

1200Vitacam B6 Tablets

Pyridoxine Hydrochloride

50mg

P Tablet Uncoated 271/011 Cameo Healthcare(L) Pvt Ltd, India

1201 Camvit-B Tablets Vitamin B complex P Tablet Uncoated 271/012 Cameo Healthcare(L) Pvt Ltd, India

1202 Cametrin Tablets Pyrantel Pamoate POM Tablet Uncoated 271/013 Cameo Healthcare(L) Pvt Ltd, India

1203Cold Off Junior Syrup

Paracetamol +

Chlopheniramine

P Syrup 271/014 Cameo Healthcare(L) Pvt Ltd, India

1204Camflam Tablets

Paracetamol BP +

Ibuprofen BP

P Tablet Uncoated 271/015 Cameo Healthcare(L) Pvt Ltd, India

1205Fenacam 50 Tablets

Diclofenac Sodium 50mg P Tablet Uncoated 271/016 Cameo Healthcare(L) Pvt Ltd, India

1206

Malsycam Tablets

Sulfadoxine BP +

Pyrimethamine BP

525MG

POM Tablet Uncoated 271/017 Cameo Healthcare(L) Pvt Ltd, India

1207Dixicam 500 Tablets

Nalidixic Acid 500mg POM Suspension for

Oral Use

271/018 Cameo Healthcare(L) Pvt Ltd, India

1208

Cotricam Tablets

Trimethoprim 80 +

Sulphamethoxazole

400mg

POM Tablet Uncoated 271/019 Cameo Healthcare(L) Pvt Ltd, India

1209Metrocam Tablets

Metronidazole BP 200mg POM Tablet Uncoated 271/020 Cameo Healthcare(L) Pvt Ltd, India

1210 Flucocam 200 Capsules Fluconazole 200mg POM Capsule oral 271/022 Cameo Healthcare(L) Pvt Ltd, India

1211Vitacam C Tablets

Ascorbic Acid BP 100mg GS Tablet Uncoated 271/023 Cameo Healthcare(L) Pvt Ltd, India

1212 Maxivit Tablets Multivitamin GS Tablet Uncoated 271/024 Cameo Healthcare(L) Pvt Ltd, India

1213 Amocillin 250mg Capsules Amoxicillin 250mg POM Capsule oral 024/001 Caps (Private) Ltd, Zimbabwe

Page 63 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 1214 Amocillin 500mg Capsules Amoxicillin 500mg POM Capsule oral 024/002 Caps (Private) Ltd, Zimbabwe

1215

Amocillin 125mg/5ml

Suspension

Amoxicillin 125mg, per

5ml

POM Suspension for

Oral Use

024/003 Caps (Private) Ltd, Zimbabwe

1216

Amocillin 250mg/5ml

Suspension

Amoxicillin 250mg, per

5ml

POM Suspension for

Oral Use

024/004 Caps (Private) Ltd, Zimbabwe

1217Benzylpencillin 1 Mega Injection

Benzyl Penicillin 1 MU POM Powder for

Injection

024/005 Caps (Private) Ltd, Zimbabwe

1218Benzylpencillin 5 Mega Injection

Benzyl Penicillin 5 MU POM Powder for

Injection

024/006 Caps (Private) Ltd, Zimbabwe

1219 Capcycline 250mg Capsules Cloxacillin 250mg POM Capsule oral 024/007 Caps (Private) Ltd, Zimbabwe

1220 Chlornicol 250mg Capsules Chloramphenicol 250mg POM Capsule oral 024/008 Caps (Private) Ltd, Zimbabwe

1221Chlornicol 1g Injection

Chloramphenicol 1g POM Powder for

Injection

024/009 Caps (Private) Ltd, Zimbabwe

1222

Chlornicol 125mg/5ml

Suspension

Chloramphenicol 125mg,

per 5ml

POM Suspension for

Oral Use

024/010 Caps (Private) Ltd, Zimbabwe

1223

Co-Trimoxazole Peadiatric

Tablets

Trimethoprim 40mg +

Sulphamethoxazole

200mg

POM Tablet Uncoated 024/014 Caps (Private) Ltd, Zimbabwe

1224Co-Trimoxazole Suspension

Trimethoprim +

Sulphamethoxazole

POM Suspension for

Oral Use

024/015 Caps (Private) Ltd, Zimbabwe

1225

Co-Trimoxazole Tablets

Trimethoprim 80mg +

Sulphamethoxazole

400mg

POM Tablet Uncoated 024/016 Caps (Private) Ltd, Zimbabwe

1226Dizam Injection

Diazepam 10mg, per ml POM Solution for

Injection

024/017 Caps (Private) Ltd, Zimbabwe

1227 Dizam 2mg Tablets Diazepam 2mg POM Tablet Uncoated 024/018 Caps (Private) Ltd, Zimbabwe

1228 Dizam 5mg Tablets Diazepam 5mg POM Tablet Uncoated 024/019 Caps (Private) Ltd, Zimbabwe

1229Dolex 200mg Capsules

Oflaxacin + Aflaxacin

200mg

POM Capsule oral 024/020 Caps (Private) Ltd, Zimbabwe

1230Dolex 400mg Capsules

Oflaxacin + Aflaxacin

400mg

POM Capsule oral 024/021 Caps (Private) Ltd, Zimbabwe

1231 Doxyclin Capsules Doxycycline 100mg POM Capsule oral 024/022 Caps (Private) Ltd, Zimbabwe

1232 Equemote 50mg Capsules Sulpiride 50mg POM Capsule oral 024/023 Caps (Private) Ltd, Zimbabwe

1233 Famicillin 250mg Capsules Ampicillin 250mg POM Capsule oral 024/024 Caps (Private) Ltd, Zimbabwe

1234 Famicillin 500mg Capsules Ampicillin 500mg POM Capsule oral 024/025 Caps (Private) Ltd, Zimbabwe

1235

Famicillin 125mg/5ml

Suspension

Ampicillin 125mg, per

5ml

POM Suspension for

Oral Use

024/026 Caps (Private) Ltd, Zimbabwe

1236Famicillin Injection

Ampicillin POM Powder for

Injection

024/027 Caps (Private) Ltd, Zimbabwe

Page 64 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1237

Famicillin 250mg/5ml

Suspension

Ampicillin 250mg, per

5ml

POM Suspension for

Oral Use

024/028 Caps (Private) Ltd, Zimbabwe

1238 Ferous Sulphate Tablets Ferrous Sulphate 200mg P Tablet Uncoated 024/029 Caps (Private) Ltd, Zimbabwe

1239Hydrochlorothiazide Tablets

Hydrochlorothiazide

25mg

POM Tablet Uncoated 024/030 Caps (Private) Ltd, Zimbabwe

1240Hydrochlorothiazide Tablets

Hydrochlorothiazide

50mg

POM Tablet Uncoated 024/031 Caps (Private) Ltd, Zimbabwe

1241 Hypotens Tablets Trifluoperazine 250mg POM Tablet Uncoated 024/032 Caps (Private) Ltd, Zimbabwe

1242Kanamycin Injection

Kanamycin 250mg POM Powder for

Injection

024/033 Caps (Private) Ltd, Zimbabwe

1243Malasone Tablets

Pyrimethamine +

Dapsone

P Tablet Uncoated 024/034 Caps (Private) Ltd, Zimbabwe

1244 Methocid 25mg Capsules Indomethacin 25mg P Capsule oral 024/035 Caps (Private) Ltd, Zimbabwe

1245 Methocid 50mg Caspules Indomethacin 50mg P Capsule oral 024/036 Caps (Private) Ltd, Zimbabwe

1246 Methocid Suppositories Indomethacin 100mg POM Suppository 024/037 Caps (Private) Ltd, Zimbabwe

1247Metronidazole Suspension

Metronidazole 200mg,

per 5mls

POM Suspension for

Oral Use

024/038 Caps (Private) Ltd, Zimbabwe

1248 Metronidazole 200mg Tablets Metronidazole 200mg POM Tablet Uncoated 024/039 Caps (Private) Ltd, Zimbabwe

1249 Metronidazole 400 Mg Tablets Metronidazole 400mg POM Tablet Uncoated 024/040 Caps (Private) Ltd, Zimbabwe

1250Mezenol DS Tablets

Trimethoprim +

Sulphamethoxazole

POM Tablet Uncoated 024/041 Caps (Private) Ltd, Zimbabwe

1251Paracetamol Syrup

Paracetamol 120mg, per

5ml

GS Syrup 024/042 Caps (Private) Ltd, Zimbabwe

1252 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 024/043 Caps (Private) Ltd, Zimbabwe

1253Parecon Forte Injection

Cyanocobalamine 1mg,

per ml

POM Solution for

Injection

024/044 Caps (Private) Ltd, Zimbabwe

1254Procillin Injection

Procaine Benzyl Penicillin

300mg/ml

POM Solution for

Injection

024/045 Caps (Private) Ltd, Zimbabwe

1255 Purinol Tablets Allopurinol 100mg POM Tablet Uncoated 024/046 Caps (Private) Ltd, Zimbabwe

1256 Rexigen 10mg Tablets Propranalol 10mg POM Tablet Uncoated 024/047 Caps (Private) Ltd, Zimbabwe

1257 Rexigen 40mg Tablets Propranalol 40mg POM Tablet Uncoated 024/048 Caps (Private) Ltd, Zimbabwe

1258 Rexigen 80mg Tablets Propranalol 80mg POM Tablet Uncoated 024/049 Caps (Private) Ltd, Zimbabwe

1259 Rexigen 160mg Tablets Propranalol 160mg POM Tablet Uncoated 024/050 Caps (Private) Ltd, Zimbabwe

1260Streptosol 5g/15ml Injection

Streptosol 5g, per 15ml

injection

POM Solution for

Injection

024/051 Caps (Private) Ltd, Zimbabwe

1261

Tetracycline Eye Ointment

Tetracycline

Hydrochloride 30mg, per

g

POM Eye Ointment 024/052 Caps (Private) Ltd, Zimbabwe

Page 65 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1262Ultracillin LA Injection

Benzathine Penicillin

2.4MU

POM Tablet Uncoated 024/053 Caps (Private) Ltd, Zimbabwe

1263

Urazide Tablets

Amiloride Hydrochloride

5mg +

Hydrochlorothiazide

50mg

POM Tablet Uncoated 024/054 Caps (Private) Ltd, Zimbabwe

1264Water For Injection

Water for injection POM Solution for

Injection

024/055 Caps (Private) Ltd, Zimbabwe

1265

Xylonor Injection

Lignocaine Hydrochloride

2% + Norepinephrine

POM Solution for

Injection

024/056 Caps (Private) Ltd, Zimbabwe

1266 Prednisolone Tablets Prednisolone 5mg POM Tablet Uncoated 024/057 Caps (Private) Ltd, Zimbabwe

1267

Histalix D Syrup

Dextromethorphan

Hydrobromide 9mg +

Diphenylhydramine

10mg+ Ammonium

Chloride 90mg

P Syrup 024/058 Caps (Private) Ltd, Zimbabwe

1268 Phenobarbitone Tablets Phenobarbitone 30mg POM Tablet Uncoated 024/059 Caps (Private) Ltd, Zimbabwe

1269 Allergon Cream Mepyramine 400mg P Cream Topical 024/060 Caps (Private) Ltd, Zimbabwe

1270

Flumel Tablets

Paracetamol 500mg +

Chlorpheniramine 2mg +

Phenylephrine 10mg

P Tablet Uncoated 024/061 Caps (Private) Ltd, Zimbabwe

1271

4C's Cold Syrup

Paracetamol 120mg +

Chlorpheniramine 2mg +

Phenylephrine 2.5mg +

Dextromethorphan 0.5mg

per 5mls

P Syrup 024/062 Caps (Private) Ltd, Zimbabwe

1272

Histalix Syrup

Codeine Phosphate 9mg

+ Ammonium Chloride

90mg +

Diphenhydramine 10mg,

per 5ml

P Syrup 024/063 Caps (Private) Ltd, Zimbabwe

1273Kefrox Oral Suspension

Cefuroxime Axetil

125mg, per 5ml

POM Powder for Oral

Suspension

343/001 CCL Pharmaceuticals (PVT) Ltd, India

1274Kefrox Tablets

Cefuroxime Axetil 500mg POM Tablet Uncoated 343/002 CCL Pharmaceuticals (PVT) Ltd, India

1275Lucal 15 Injection

Leucovorin 15mg, per

3ml

POM Solution for

Injection

073/001MT Celon Laboratories Limited

Page 66 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

12765 Flucel 500 Injection

Fluorouracil 500mg, per

10ml

POM Powder for

Injection

073/002MT Celon Laboratories Limited

1277Celginase 1000 Injection

L-Asparaginase 10,000

IU

POM Powder for

Injection

073/003MT Celon Laboratories Limited

1278

Centavit Syrup

Vitamin A USP 1000 IU +

Vitamin B1 BP 1.5 mg +

Riboflavine Sodium

Phosphate BP 1.5 mg +

Nicotinamide BP 10 mg +

Vitamin B12 USP 2.5

mcg + Vitamin C BP 40

mg+ Vitamin D3 BP 200

IU, per 5ml

GS Syrup 061/001 Centaur Pharmaceuticals (Pvt Limited, India

1279

Protobex Syrup

Soya Protein Hydrolysate

1.0g + Iron Choline

Citrate 15mg+

Cyanocobalamine 5mcg

+ Thiamine Nitrate

2.5mg + Riboflavin 2.5mg

+ Pyridoxine

Hydrochloride 1.5mg +

Niacinamide 25mg +

Panthenol 3mg + Zinc

Sulphate eq to zinc

7.5mg

P Syrup 061/002 Centaur Pharmaceuticals (Pvt Limited, India

1280

Sinarest Linctus

Dextromethorphan 10mg

+ Chlopheniramine 2mg

+ Menthol 1.5mg

P Solution for Oral

Use

061/003 Centaur Pharmaceuticals (Pvt Limited, India

1281

Kofarest Syrup

Terbutalin Sulphate

2.5mg + Ambroxol

Hydrochloride 30mg +

Guaiphenesin 100mg +

Menthol 5mg, per 10ml

P Syrup 061/004 Centaur Pharmaceuticals (Pvt Limited, India

1282

Diclogenta Eye Drops

Diclofenac Sodium 1mg +

Gentamycin Sulphate

3mg

POM Solution for Topical

Use

061/005 Centaur Pharmaceuticals (Pvt Limited, India

1283Eyevir Eye Ointment

Acyclovir 3% POM Eye Ointment 061/006 Centaur Pharmaceuticals (Pvt Limited, India

Page 67 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1284I-Gesic Eye Drops

Diclofenac Sodium USP

0.1%w/v

POM Eye Drops 061/007 Centaur Pharmaceuticals (Pvt Limited, India

1285

Kofarest Lozenges

Dextromethorphan 5mg +

Cetylpyridium 1.3mg +

Menthol 5.2mg

P Lozenges 061/008 Centaur Pharmaceuticals (Pvt Limited, India

1286Leeflox Eye/Ear Drops

Levofloxacin 0.5% POM Ear/Eye Drops 061/009 Centaur Pharmaceuticals (Pvt Limited, India

1287

Ocurest - AH Eye Drops

Phenylephrine

Hydrochloride 0.12% w/v

+ Naphazoline

Hydrochloride 0.05%w/v

+ Chlorpheniramine

Maleate 0.1% w/v +

Menthol 0.0005% w/v +

Camphor 0.01%w/v

POM Solution for Topical

Use

061/010 Centaur Pharmaceuticals (Pvt Limited, India

1288

Ocutob D Eye Drops

Tobramycin Sulphate

0.3% + Dexamethasone

0.1% + Benzalkonium

Chloride 0.01%

POM Eye Drops 061/011 Centaur Pharmaceuticals (Pvt Limited, India

1289

Ocuwet Eye Drops

Polyvinyl Alcohol 1.4% +

Povidone 0.6% +

Benzalkonium Chloride

0.01%

POM Eye Drops 061/012 Centaur Pharmaceuticals (Pvt Limited, India

1290Opticol Eye Drops

Chloramphenicol

0.5%w/v

POM Solution for Topical

Use

061/013 Centaur Pharmaceuticals (Pvt Limited, India

1291

Catarest Eye Drops

Potassium Iodide

3.3%w/v + Sodium

Chloride 0.83%w/v +

Calcium Chloride

1.0%w/v

POM Eye Drops 061/014 Centaur Pharmaceuticals (Pvt Limited, India

1292

Livosil-B Capsules

Silymarin 70 mg +

Thiamine Mononitrate 5

mg + Riboflavin 5 mg +

Pyridoxine Hydrochloride

1.5 mg + Niacinamide 25

mg +Calcium

Panthothenate 7.5 mg

+Vitamin B12 5 mcg

P Capsule oral 061/015 Centaur Pharmaceuticals (Pvt Limited, India

Page 68 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 1293 Manoll Syrup Herbal Extracts P Syrup 370/001L Charak Pharma Pvt Ltd.

1294 Ojus Syrup Herbal Extracts P Syrup 370/002L Charak Pharma Pvt Ltd.

1295 Addyzoa Tablets Herbal Extracts P Tablet Uncoated 370/003L Charak Pharma Pvt Ltd.

1296 M2 Tone Tablets Herbal Extracts P Tablet Uncoated 370/004L Charak Pharma Pvt Ltd.

1297 Hyponidd Tablets Herbal Extracts P Tablet Uncoated 370/005L Charak Pharma Pvt Ltd.

1298 Arthrelia Tablets Herbal Extracts P Tablet Uncoated 370/006L Charak Pharma Pvt Ltd.

1299 Vigomax Forte Tablets Herbal Extracts P Tablet Film coated 370/007L Charak Pharma Pvt Ltd.

1300 LO.Ivomyn Tablets Herbal Extracts P Tablet Uncoated 370/008L Charak Pharma Pvt Ltd.

1301 Pilief Tablets Herbal Extracts P Tablet Uncoated 370/009L Charak Pharma Pvt Ltd.

1302 Richelth Tablets Herbal Extracts P Tablet Uncoated 370/010L Charak Pharma Pvt Ltd.

1303 Kofol SF Syrup Herbal Extracts P Tablet Uncoated 370/011L Charak Pharma Pvt Ltd.

1304 Paedritone Syrup Herbal Extracts P Syrup 370/012L Charak Pharma Pvt Ltd.

1305 Athrella Ointment Herbal Extracts P Ointment topical 370/014L Charak Pharma Pvt Ltd.

1306 Pilief Ointment Herbal Extracts P Ointment topical 370/015L Charak Pharma Pvt Ltd.

1307Vitamin A 1500µg Tablets

Vitamin A acetate 1500µg P Tablet Film coated 402/001 Chempure Pty Ltd

1308

Iron Plus Capsules

Iron BisGlycinate Chelate

10mg + Activated Folate

400mcg + Vtamin B12

100mcg

P Capsule oral 402/002 Chempure Pty Ltd

1309

Chromium Polynicotinate

Tablets

Chromium Polynicotinate

200mcg

P Tablet Uncoated 402/003L Chempure Pty Ltd

1310

Full Spectrum Vitamin E 400mg

Capsules

Mixed Tocotrienols +

Mixed Tocopherols

400mg

P Capsule oral 402/004L Chempure Pty Ltd

1311 Ubiquinol CO-Q10 Capsules Ubiquinol 50mg P Capsule oral 402/005L Chempure Pty Ltd

1312

Calcium Glycinate with Vitamin

D3 and Boron Tablets

Calcium Glycinate 750mg

+ Vitamin D3 200IU +

Boron 500µg

P Tablet Film coated 402/006L Chempure Pty Ltd

1313Krill Oil Omega-3 Capsules

500mg + 110mg + 60mg P Capsule oral 402/007L Chempure Pty Ltd

1314

Magnesium Glycinate Tablets

Magnesium Glycinate

1110mg + Boron 500mcg

P Tablet Film coated 402/008L Chempure Pty Ltd

1315

Irvingia Plus Fat Burner

Capsules

Irvingia extract 100mg +

Berberine 200mg + Kelp

extract 17mg + Zinc 5mg

+ Panax

P Capsule oral 402/009L Chempure Pty Ltd

Page 69 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1316

Libido & Performance Enhancer

for Men Capsules

L-arginine Hydrochloride

4425mg + Tongkat ali

37.5mg + Tribulus

terrestris 125mg + Pana

P Capsule oral 402/010L Chempure Pty Ltd

1317

Double Vitamin C Capsules

Vitamin C-water soluble

233mg + Vitamin C-fat

soluble 100mg

GS Capsule oral 402/011L Chempure Pty Ltd

1318

Methyl-Sulfonyl-Methane (MSM)

Capsules

Methylsulfonylmethane

700mg

Pharmacy

Medicine

Capsule oral 402/012L Chempure Pty Ltd

1319

Calmlite with Relora® and

Theanine Capsules

Relora 250mg +

Theanine 125mg

P Capsule oral 402/013L Chempure Pty Ltd

1320Folic Acid Natural Folate Tablets

Folic Acid 500mcg Pharmacy

Medicine

Tablet Uncoated 402/014L Chempure Pty Ltd

1321Iodin Plus Ointment

Povidone-Iodine 5 % w/w P Ointment topical 381/001 Cian Health Care Pvt Ltd.

1322

Stogel Forte Tablets Methyl Sulfonyl Methane

350mg + Glucosamine

Sulfate 150mg

+Tricalcium Phosphate

150mg + Guggul 100mg

+ Bromelain 60mg +

Chondroitin Sulfate 50mg

+ Ashwagandha 40mg +

Hadjod 40mg + Rutin

25mg + Boswellia Serrata

Gum Powder Extract

25mg + Lecithin Granular

15mg + Cat’s Claw Bark

Powder 15mg +

Hyaluronic Acid

7.5mg+Boron Aspartate

3mg

P Tablet Uncoated 381/002L Cian Health Care Pvt Ltd.

1323

Lycogel Extra Capsules Lycopene 10mg +

Multivitamin + Multi

mineral + Ginseng

Extract Powder 30mg +

Grape Seed Extract

10mg + Green Tea

Extract 10mg

P Capsule oral 381/004L Cian Health Care Pvt Ltd.

Page 70 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1324

G - Biloba Tablets Multivitamin +

Multimineral + Beta-

Carotene 400mcg +

Ginseng Extract Powder

200mg + Ginkgo Biloba

125mg

P Tablet Uncoated 381/003L Cian Health Care Pvt Ltd.

1325 Zidovir 100 Capsules Zidovudine 100mg POM Capsule oral 099/001 Cipla Limited, India

1326 Ciplox 250mg Tablets Ciprofloxacin 250mg POM Tablet Uncoated 099/002 Cipla Limited, India

1327 Ciplox 500mg Tablets Ciprofloxacin 500mg POM Tablet Uncoated 099/003 Cipla Limited, India

1328 Ciplox Eye Ointment Ciprofloxacin 0.3%w/w POM Eye Ointment 099/004 Cipla Limited, India

1329 Ciplox Eye/Ear Drops Ciprofloxacin 0.3%w/v POM Ear/Eye Drops 099/005 Cipla Limited, India

1330 Profenac Eye Drops Diclofenac 0.1%w/v POM Eye Drops 099/006 Cipla Limited, India

1331 Fungicip Cream Clotrimazole 1%w/v POM Cream Topical 099/007 Cipla Limited, India

1332 Fungicip - 100 Tablets Clotrimazole 100mg POM Tablet Vaginal 099/008 Cipla Limited, India

1333 Fungicip 200 Tablets Clotrimazole 200mg POM Tablet Vaginal 099/009 Cipla Limited, India

1334

Triomune 30 Tablets

Stavudine 30mg +

Nevirapine 200mg +

Lamivudine 150mg

POM Tablet Uncoated 099/010 Cipla Limited, India

1335Lamivir-S 30 Tablets

Lamivudine 150mg +

Stavudine 30mg

POM Tablet Uncoated 099/011 Cipla Limited, India

1336Lamivir-S 40 Tablets

Lamivudine 150mg +

Stavudine 40mg

POM Tablet Uncoated 099/012 Cipla Limited, India

1337 Efivir -200 Tablets Efavirenz 200mg POM Tablet Uncoated 099/013 Cipla Limited, India

1338 Nelvir Tablets Nelfinavir 250mg POM Tablet Uncoated 099/014 Cipla Limited, India

1339 Lamivir Tablets Lamivudine 150mg POM Tablet Uncoated 099/015 Cipla Limited, India

1340Zidovir Solution

Zidovudine 50mg, per

5ml

POM Solution for Oral

Use

099/016 Cipla Limited, India

1341Nevimune Oral Suspension

Nevirapine 50mg, per

5ml

POM Suspension for

Oral Use

099/018 Cipla Limited, India

1342 Indivan 200mg Capsules Indinavir 200mg POM Capsule oral 099/019 Cipla Limited, India

1343

Duovir N Tablets

Zidovudine 300mg +

Lamivudine 150mg +

Nevirapine 200mg

POM Tablet Uncoated 099/020 Cipla Limited, India

1344 Stavir 30 Tablets Stavudine 30mg POM Tablet Uncoated 099/021 Cipla Limited, India

1345 Stavir 40 Tablets Stavudine 40mg POM Tablet Uncoated 099/022 Cipla Limited, India

1346Lamivir 50mg/ml Oral Solution

Lamivudine 50mg, per

5ml

POM Solution for Oral

Use

099/023 Cipla Limited, India

1347 Divir 100 Tablets Didanosine 100mg POM Tablet Uncoated 099/024 Cipla Limited, India

Page 71 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1348Spectin Injection

Spectinomycin 2g POM Powder for

Injection

099/025 Cipla Limited, India

1349 Tadacip 10 Tablets Tadalafil 10mg POM Tablet Uncoated 099/026 Cipla Limited, India

1350 Lovacard 20 Tablets Levostatin 20mg POM Tablet Uncoated 099/027 Cipla Limited, India

1351 Cipril 5 Tablets Lisinopril 5mg POM Tablet Uncoated 099/028 Cipla Limited, India

1352Novatax 1000 Injection

Cefotaxime 1000mg POM Powder for

Injection

099/029 Cipla Limited, India

1353 Simcard 10 Tablets Simvastatin 10mg POM Tablet Uncoated 099/030 Cipla Limited, India

1354 Acivir 200 Dispersible Tablets Acyclovir 200mg POM Tablet Uncoated 099/032 Cipla Limited, India

1355Asthalin 100mcg/Spray Inhaler

Salbutamol 100mcg POM Solution for

Inhalation

099/033 Cipla Limited, India

1356Falcithar 40 Injection

Artemether 40mg POM Solution for

Injection

099/034 Cipla Limited, India

1357Falcithar 80 Injection

Artemether 80mg POM Solution for

Injection

099/035 Cipla Limited, India

1358 Forcan 150mg Capsules Fluconazole 150mg POM Capsule oral 099/036 Cipla Limited, India

1359 Forcan 200mg Capsules Fluconazole 200mg POM Capsule oral 099/037 Cipla Limited, India

1360 Vasopril -10 Tablets Enalapril 10mg POM Tablet Uncoated 099/038 Cipla Limited, India

1361 Vasopril 5 Tablets Enalapril 5mg POM Tablet Uncoated 099/039 Cipla Limited, India

1362 Acivir Eye Ointment Acyclovir 3% POM Eye Ointment 099/040 Cipla Limited, India

1363 Alerid Tablets Cetirizine 10mg POM Tablet Uncoated 099/041 Cipla Limited, India

1364

Cipcal 250 Tablets

Calcium Carbonate

625mg + Vitamin D3

1.66mg

P Tablet Uncoated 099/042 Cipla Limited, India

1365Ciplacef Injection

Ceftriaxone 1000mg POM Powder for

Injection

099/043 Cipla Limited, India

1366Cytocristin Injection

Vincristine 1g POM Solution for

Injection

099/044 Cipla Limited, India

1367

Dr Smiths Evening Primrose

Capsules

Evening Primrose extract P Capsule oral 099/045 Cipla Limited, India

1368 Falcinil 100 Tablets Artesunate 100mg POM Tablet Uncoated 099/046 Cipla Limited, India

1369 Fincar 5mg Tablets Finasteride 5mg POM Tablets oral 099/047 Cipla Limited, India

1370 Gentacip Eye Drops Gentamycin 0.35%w/v POM Eye Drops 099/048 Cipla Limited, India

1371 Glinil Tablets Glibenclamide 5mg POM Tablet Uncoated 099/049 Cipla Limited, India

1372 Hipres-100 Tablets Atenolol 100mg POM Tablet Uncoated 099/050 Cipla Limited, India

1373 Hipres-50 Tablets Atenolol 50mg POM Tablet Uncoated 099/051 Cipla Limited, India

1374Ocutin 0.25% Ophthalmic Drops

Timolol 0.25%w/v POM Eye Drops 099/052 Cipla Limited, India

1375 Ocutin 0.5% Ophthalmic Drops Timolol 0.5%w/v POM Eye Drops 099/053 Cipla Limited, India

Page 72 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1376Osteocip Tablets

Chondroitin 400mg +

Glucosamine 663.2mg

P Tablet Enteric

Coated

099/054 Cipla Limited, India

1377Photericin B Injection

Amphotericin B 50mg,

per 15ml

POM Solution for

Injection

099/055 Cipla Limited, India

1378 Profenac 100 SR Tablets Diclofenac 100mg P Tablet Uncoated 099/056 Cipla Limited, India

1379Quinarsol Injection

Quinine 300mg POM Solution for

Injection

099/057 Cipla Limited, India

1380 Roko 2 Tablets Loperamide 2mg POM Tablet Uncoated 099/058 Cipla Limited, India

1381 Synclar 250 Tablets Clarithromycin 250mg POM Tablet Uncoated 099/059 Cipla Limited, India

1382 Theoday 400mg Tablets Theophylline 2mg POM Tablet Uncoated 099/060 Cipla Limited, India

1383 Ultac 300 Tablets Ranitidine 300mg POM Tablet Uncoated 099/061 Cipla Limited, India

1384 Zinoral Shampoo Ketoconazole 2% POM Shampoo 099/062 Cipla Limited, India

1385

Triomune 30 Tablets

Lamivudine 150mg +

Stavudine 30mg +

Nevirapine 200mg

POM Tablet Uncoated 099/063 Cipla Limited, India

1386 Acivir Cream Acyclovir 5%w/w POM Cream Topical 099/064 Cipla Limited, India

1387 Natucil Powder Isphagula Husk 3.25g P Sachet 099/065 Cipla Limited, India

1388 Ciproric-100 Tablets Allopurinol 100mg POM Tablet Uncoated 099/067 Cipla Limited, India

1389Ergogin Injection

Methylergonovine

0.208mg, per ml

POM Solution for

Injection

099/068 Cipla Limited, India

1390Dexacip Injection

Dexamethasone 4.38mg,

per ml

POM Solution for

Injection

099/069 Cipla Limited, India

1391Spasmocip Capsules

Paracetamol 325mg +

Dextromethophan 65mg

P Capsule oral 099/070 Cipla Limited, India

1392 Cipladine Ointment Povidone Iodine 5%w/w GS Ointment topical 099/071 Cipla Limited, India

1393

Digusil MPS Tablets

Aluminium Hydroxide +

Magnesium Hydroxide +

Dimethicone 400mg

GS Tablet Uncoated 099/072 Cipla Limited, India

1394

Burnheal Cream

Silver Sulfadiazine

1%w/w + Chlorhexidine

0.2%w/w

P Cream Topical 099/073 Cipla Limited, India

1395 Proflox 400 Tablets Profloxacin 400mg POM Tablet Uncoated 099/075 Cipla Limited, India

1396Theo Asthalin Tablets

Salbutamol 2mg +

Theophylline 100mg

POM Tablet Uncoated 099/076 Cipla Limited, India

1397

Aerocort Inhaler

Salbutamol 110 mg +

Beclometasone

51.67mcg

POM Powder for

Inhalation

099/077 Cipla Limited, India

1398 Silagra-50 Tablets Sildenafil 50mg POM Tablet Uncoated 099/078 Cipla Limited, India

Page 73 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1399

Aqua Tears Drops

Povidone 6mg + polyvinyl

alchol 14mg, per ml

POM Eye Drops 099/079 Cipla Limited, India

1400 Alerid Syrup Cetirizine 5mg, per 5ml POM Syrup 099/080 Cipla Limited, India

1401 Ciplactin Tablet Cyproheptadine 4mg P Tablet Uncoated 099/081 Cipla Limited, India

1402

Novaclav 625 Tablets

Amoxicillin 500 +

Clavulanate Potassium

125mg

POM Tablet Uncoated 099/083 Cipla Limited, India

1403Pyradox Tablets

Sulphadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 099/084 Cipla Limited, India

1404Halotrin Tablets

Halofantrine

Hydrochloride 250mg

POM Tablet Uncoated 099/085 Cipla Limited, India

1405Dr Smith Vitamin Capsules

Alpha Tocopherol 400mg POM Capsule oral 099/087 Cipla Limited, India

1406Theo Asthalin Tablets

Theophylline 300mg +

Salbutamol 4.8mg

POM Tablet Uncoated 099/088 Cipla Limited, India

1407

Novaclav 375 Tablets

Amoxicillin 250mg +

Clavulanate Potassium

125mg

POM Tablet Uncoated 099/089 Cipla Limited, India

1408Vitacip Capsules

Ginseng + Minerals +

Multivitamins

GS Capsule oral 099/090 Cipla Limited, India

1409 Asthalin SR Tablets Salbutamol 4mg POM Tablet Uncoated 099/092 Cipla Limited, India

1410 Cephadex-500 Tablets Cephalexin 500mg POM Capsule oral 099/093 Cipla Limited, India

1411 Cephadex 250 Capsules Cephalexin 250mg POM Capsule oral 099/094 Cipla Limited, India

1412

C-Vit Chewable Tablets

Sodium Ascorbate 394

mg + Ascorbic Acid

150mg

GS Tablet Chewable 099/095 Cipla Limited, India

1413 Betavit AFR Capsules Vitamins P Capsule oral 099/096 Cipla Limited, India

1414 Ritomune Tablets Ritonavir 100mg POM Tablet Uncoated 099/099 Cipla Limited, India

1415Duovir Tablets

Lamivudine 150mg +

Zidovudine 300mg

POM Tablet Uncoated 099/101 Cipla Limited, India

1416 Nevimune 200 Tablets Nevirapine 200mg POM Tablet Uncoated 099/102 Cipla Limited, India

1417

Ciplin Tablets

Sulfamethoxazole 400mg

+ Trimethoprim 80mg

POM Tablet Uncoated 099/103 Cipla Limited, India

1418Lumartem Tablets

Artemether 20mg +

Lumefantrine 120mg

POM Tablet Uncoated 099/104 Cipla Limited, India

1419 Dr Smith's Garlic Oil Capsules Garlic Oil 0.25%w/w GS Capsule oral 099/105 Cipla Limited, India

Page 74 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1420

Urisoda Granules

Sodium Bicarbonate

44.03 % + Sodium Citrate

15.75 % + Tartaric Acid

22.25 % + Citric Acid

17.88 %

GS Powder for Oral

Solution

099/106 Cipla Limited, India

1421Dr. Smith's Vitamin E Capsules

Alpha Tocopherol 200mg POM Capsule oral 099/107 Cipla Limited, India

1422

Triomune Baby Tablets

Lamivudine 30mg +

Nevirapine 50mg +

Stavudine 6mg

POM Tablet Uncoated 099/108 Cipla Limited, India

1423

Triomune Junior Tablets

Lamivudine 60mg +

Nevirapine 100mg +

Stavudine 12mg

POM Tablet Uncoated 099/109 Cipla Limited, India

1424

Lamivir S Baby Dispersible

Tablets

Lamivudine 30mg +

Stavudine 6mg

POM Tablet Dispersible 099/110 Cipla Limited, India

1425

Lamivir S Junior Dispersible

Tablets

Lamivudine USP 12mg +

Stavudine USP 60mg

POM Tablet Dispersible 099/111 Cipla Limited, India

1426 Stavir Dry Syrup Stavudine 1mg, per ml POM Syrup 099/112 Cipla Limited, India

1427

Novaclav Dry Syrup

Amoxicillin 125mg +

Clavulanic Acid 31.25mg,

per 5ml

POM Syrup 099/113 Cipla Limited, India

1428Ciplox IV Infusion

Ciprofloxacin 2mg, per

ml

POM Solution for

infusion

099/115 Cipla Limited, India

1429Flazole Injection

Metronidazole 500mg,

per 100ml

POM Solution for

Injection

099/116 Cipla Limited, India

1430Cipcorlin Injection

Hydrocortisone 100mg POM Powder for

Injection

099/117 Cipla Limited, India

1431Cytoplatin Injection

Cisplatin 50mg POM Powder for

Injection

099/118 Cipla Limited, India

1432 Cytotam 10mg Tablets Tamoxifen 10mg POM Tablet Uncoated 099/119 Cipla Limited, India

1433Bleomcip Injection

Bleomycin 15 units POM Powder for

Injection

099/120 Cipla Limited, India

1434Etosid Injection

Etoposide 100mg, per

5ml

POM Powder for

Injection

099/121 Cipla Limited, India

1435 Cytotam 20g Tablets Tamoxifen 20mg POM Tablet Uncoated 099/122 Cipla Limited, India

1436Cytocarb 150 Injection

Carboplatin 150mg, per

15ml

POM Powder for

Injection

099/123 Cipla Limited, India

1437Decarb 200 Injection

Dacarbazine 200mg POM Powder for

Injection

099/124 Cipla Limited, India

Page 75 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 1438 Ciplactin Syrup Cyproheptadine 2mg P Syrup 099/125 Cipla Limited, India

1439 Naxid Tablets Nalidixic Acid 500mg POM Tablet Uncoated 099/126 Cipla Limited, India

1440Tenvir Tablets

Tenofovir Disoproxil

Fumarate 300 mg

POM Tablet Film coated 099/127 Cipla Limited, India

1441 Abacavir Sulphate Tablets Abacavir 300mg POM Tablet Uncoated 099/128 Cipla Limited, India

1442

Lamivudine 10mg/ml Oral

Solution

Lamivudine 10mg, per ml POM Solution for Oral

Use

099/129 Cipla Limited, India

1443 Efavirenz 600mg Tablets Efavirenz 600mg POM Tablet Uncoated 099/130 Cipla Limited, India

1444 Nevirapine 200mg Tablets Nevirapine 200mg POM Tablet Film coated 099/131 Cipla Limited, India

1445 Tinidazole Tablets Tinidazole 500mg POM Tablet Uncoated 099/138 Cipla Limited, India

1446

Pylokit Tablets

Lansoprazole 30mg +

Tinidazole 500mg +

Clarithromycin 250mg

POM Tablet Uncoated 099/139 Cipla Limited, India

1447Ibugesic Plus Tablets

Paracetamol 200mg +

Ibuprofen 325mg

P Tablet Uncoated 099/140 Cipla Limited, India

1448Urimax 0.2mg Tablets

Tamsulosin

Hydrochloride 0.2mg

POM Tablets oral 099/141 Cipla Limited, India

1449Ergogin Tablets

Methylergonovine

0.125mg

POM Tablet Uncoated 099/142 Cipla Limited, India

1450Synclar Dry Syrup

Clarithromycin 125mg,

per 5ml

POM Syrup 099/143 Cipla Limited, India

1451Nystatin Oral Suspension

Nystatin 100,000 IU, per

ml

POM Suspension for

Oral Use

099/144 Cipla Limited, India

1452Profenac Injection

Diclofenac 25mg, per

3ml

POM Solution for

Injection

099/146 Cipla Limited, India

1453Gentacip Injection

Gentamycin 40mg, per ml POM Solution for

Injection

099/147 Cipla Limited, India

1454Asthalin CFC-Free Inhaler

Salbutamol 100mcg, per

spray

POM Powder for

Inhalation

099/148 Cipla Limited, India

1455

Ciplin Suspension

Sulphamethoxazole

200mg + Trimethoprim

40mg

POM Suspension for

Oral Use

099/151 Cipla Limited, India

1456Beclate 50 Inhaler

Beclomethasone 50mcg,

per spray

POM Powder for

Inhalation

099/152 Cipla Limited, India

1457Beclate 50 Inhaler

Beclomethasone 50mcg,

per dose

POM Powder for

Inhalation

099/153 Cipla Limited, India

1458

Sulfamon Plus Tablets

Artesunate 50mg +

Pyrimethamine 25mg +

Sulfadoxine 500mg

POM Tablet Uncoated 099/154 Cipla Limited, India

Page 76 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1459

Sulphamon Plus Tablets

Pyrimethamine 25mg +

Sulphadoxine 500mg +

Artesunate 50mg

POM Tablet Uncoated 099/155 Cipla Limited, India

1460 Abacavir Tablets 300mg Abacavir tablets 300mg POM Tablet Film coated 099/157 Cipla Limited, India

1461 Indivan 400mg Capsules Indinavir 400mg POM Capsule oral 099/158 Cipla Limited, India

1462 Stavir 15 Capsules Stavudine 15mg POM Capsule oral 099/159 Cipla Limited, India

1463 Stavir 20 Capsules Stavudine 20mg POM Capsule oral 099/160 Cipla Limited, India

1464 Divir 25 Tablets Didanosine 25mg POM Tablet Dispersible 099/161 Cipla Limited, India

1465 Divir 150 Tablets Didanosine 150mg POM Tablet Dispersible 099/162 Cipla Limited, India

1466 Divir 200 Tablets Didanosine 200mg POM Tablet Dispersible 099/163 Cipla Limited, India

1467 Zidovudine 100mg Capsules Zidovudine 100mg POM Capsule oral 099/164 Cipla Limited, India

1468Oncodox 10 Injection

Doxorubicin 10mg, per

2.5ml

POM Powder for

Injection

099/165 Cipla Limited, India

1469Oncodox 50 Injection

Doxorubicin 50mg, per

5ml

POM Powder for

Injection

099/166 Cipla Limited, India

1470Amoxicillin Oral Suspension

Amoxicillin 125mg, per

5ml

POM Powder for Oral

Suspension

099/167 Cipla Limited, India

1471 Amoxicillin Capsules Amoxicillin 250mg POM Capsule oral 099/168 Cipla Limited, India

1472

Ginette 35 Tablets

Ethinyl Estradiol 0.035mg

+ Cyproterone 2mg

POM Tablet Uncoated 099/169 Cipla Limited, India

1473Cefix Ds Oral Suspension

Cefixime 50mg, per 5ml POM Powder for Oral

Suspension

099/170 Cipla Limited, India

1474 Warf 5 Tablets Warfarin 5mg POM Tablet Uncoated 099/171 Cipla Limited, India

1475Chloraxin Injection

Chloramphenicol 1g POM Powder for

Injection

099/172 Cipla Limited, India

1476 Paracip 500 Tablets Paracetamol 500mg GS Tablet Uncoated 099/173 Cipla Limited, India

1477Frusix Injection

Furosemide 10mg, per ml POM Solution for

Injection

099/174 Cipla Limited, India

1478 Ibugesic- 400 Tablets Ibuprofen 400mg P Tablet Uncoated 099/175 Cipla Limited, India

1479Tenvir-EM Tablets

Tenofovir 300mg +

Emtricitabine 200mg

POM Tablet Uncoated 099/177 Cipla Limited, India

1480 Lanzol 30 Capsules Lansoprazole 30mg POM Capsule oral 099/178 Cipla Limited, India

1481

Digusil MPS Liquid

Alumimium Hydroxide

250mg + Magnesium

Hydroxide 250mg +

Dimethicone 50mg, per

5ml

GS Solution for Oral

Use

099/179 Cipla Limited, India

Page 77 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1482Flomist Nasal Spray

Fluticasone 50mcg, per

spray

POM Solution for

Inhalation

099/180 Cipla Limited, India

1483Lumet Forte Tablets

Artemether 40mg +

Lumefantrine 240mg

POM Tablet Uncoated 099/181 Cipla Limited, India

1484Seaking Cod Liver Oil Capsules

Cod-liver oil 300mg GS Capsule oral 099/182 Cipla Limited, India

1485Terbi Spray

Terbinafine 1%w/w POM Spray for Topical

Use

099/183 Cipla Limited, India

1486 Divir-50 Tablets Didanosine 50mg POM Tablet Dispersible 099/184 Cipla Limited, India

1487

Viraday Tablets

Tenofovir 300mg +

Emtricitabine 200mg +

Efavirenz 600mg

POM Tablet Film coated 099/185 Cipla Limited, India

1488 Gatiquin-400mg Tablets Gatifloxacin 400mg POM Tablet Uncoated 099/186 Cipla Limited, India

1489 Gatiquin-200mg Tablets Gatifloxacin 200mg POM Tablet Uncoated 099/187 Cipla Limited, India

1490

Prolyte Oral Rehydration

Sodium chloride +

Sodium citrate +

Patassium chloride +

Dextrose

GS Powder for Oral

Solution

099/188 Cipla Limited, India

1491C-Fizz 500 Tablets

Ascorbic Acid 500mg GS Effervescent

Tablets

099/189 Cipla Limited, India

1492Parafizz Tablets

Paracetamol 500mg GS Effervescent

Tablets

099/190 Cipla Limited, India

1493Falcimon B/L Tablets

Artesunate 50mg +

Amodiaquine 153mg

POM Tablet Film coated 099/191 Cipla Limited, India

1494Abacavir Sulfate Oral Solution

Abacavir 20mg, per ml POM Solution for Oral

Use

099/192 Cipla Limited, India

1495Lopimune Tablets

Lopinavir 200mg +

Ritonavir 50mg

POM Tablet Film coated 099/193 Cipla Limited, India

1496 Misoprost -25 Tablets Misoprostol 25mcg POM Tablet Uncoated 099/194 Cipla Limited, India

1497 Misoprost - 200 Tablets Misoprostol 200mcg POM Tablet Uncoated 099/195 Cipla Limited, India

1498 C - Fizz 1000 Tablets Ascorbic Acid 1000mg GS Tablet Dispersible 099/196 Cipla Limited, India

1499 Oflox-200 Tablets Ofloxacin 200mg POM Tablet Film coated 099/197 Cipla Limited, India

1500 Oflox -400 Tablets Ofloxacin 400mg POM Tablet Film coated 099/198 Cipla Limited, India

1501 Levofloxacin 250 Tablets Levofloxacin 250mg POM Tablet Uncoated 099/199 Cipla Limited, India

1502 Levofloxacin 500 Tablets Levofloxacin 500mg POM Tablet Uncoated 099/200 Cipla Limited, India

1503Zoldria Injection

Zoledronic Acid 4.0mg POM Solution for

Injection

099/201 Cipla Limited, India

1504

Ethionamide Tablets USP

250mg

Ethionamide 250mg POM Tablet Enteric

Coated

099/202 Cipla Limited, India

Page 78 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 1505 Glimcip - 1 Tablets Glimepiride 1mg POM Tablet Uncoated 099/203 Cipla Limited, India

1506 Glimcip-2 Tablets Glimepiride 2mg POM Tablet Uncoated 099/204 Cipla Limited, India

1507 Atorlip-20 Tablets Atorvastatin 20mg POM Tablet Uncoated 099/205 Cipla Limited, India

1508 Cresar - 40 Tablets Telmisartan 40mg POM Tablet Uncoated 099/206 Cipla Limited, India

1509 Cresar - 20 Tablets Telmisartan 20mg POM Tablet Uncoated 099/207 Cipla Limited, India

1510 Atorlip - 40 Tablets Atorvastatin 40mg POM Tablet Uncoated 099/208 Cipla Limited, India

1511 Atorlip- 10 Tablets Atorvastatin 10mg POM Tablet Uncoated 099/209 Cipla Limited, India

1512 Minovit - P Tablets Multivitamins GS Tablet Uncoated 099/210 Cipla Limited, India

1513Rapid Relief Lozenges

Menthol 7.1mg +

Peppermint 7.1mg

GS Lozenges 099/211 Cipla Limited, India

1514 Abamune 60 Tablets Abacavir 60mg POM Tablet Dispersible 099/212 Cipla Limited, India

1515Cof-Ryl Cough Syrup

Diphenhydramine 25mg P Solution for Oral

Use

099/213 Cipla Limited, India

1516

Sinu Flu Tablets

Paracetamol 400mg +

Phenylephrine 5mg +

Mepyramine 8mg

P Tablet Uncoated 099/214 Cipla Limited, India

1517

Ciplin DS Tablets

Trimethoprim 800mg +

Sulphamethoxazole

180mg

POM Tablet Uncoated 099/215 Cipla Limited, India

1518Abamune-L Baby Tablets

Abacavir 60mg +

Lamivudine 30mg

POM Tablet Uncoated 099/216 Cipla Limited, India

1519

Abacavir Sulphate & Lamivudine

Tablets 600/300mg

Abacavir Sulphate 600mg

+ Lamivudine 300mg

POM Tablet Film coated 099/217 Cipla Limited, India

1520Duovir Baby Tablets

Lamivudine 30mg +

Zidovudine 60mg

POM Tablet Film coated 099/218 Cipla Limited, India

1521PILL 72

Levonogestrel BP

0.75mg

POM Tablet Uncoated 099/219 Cipla Limited, India

1522 I-Pill Tablets Levonorgestrel 1.5mg POM Tablet Uncoated 099/220 Cipla Limited, India

1523Montair-5 CW Tablets

Montelukast Sodium BP

5mg

POM Tablet Uncoated 099/221 Cipla Limited, India

1524

Praziquantel Tablets USP

600mg

Praziquantel USP

600mg

POM Tablets oral 099/222 Cipla Limited, India

1525Seroflo 250 Inhaler

Salmeterol 25mcg +

Fluticasone 250mcg

POM Solution for

Inhalation

099/223 Cipla Limited, India

1526

Paraffiz 1000 Effervescent

Tablets

Paracetamol 1000mg POM Tablet Effervescent 099/224 Cipla Limited, India

Page 79 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1527

Efavirenz, Lamivudine and

Tenofovir Disoproxil Fumarate

Tablets

Efavirenz 600mg +

Lamivudine 300mg +

Tenofovir Disoproxil

Fumarate 300mg

POM Tablet Film coated 099/225 Cipla Limited, India

1528Nasehaler Nasal Spray

Mometasone Furoate

Nasal Spray 50 mcg

POM Nasal spray 099/227 Cipla Limited, India

1529Seroflo 125 Inhaler

Salmeterol 25mcg +

Fluticasone 125mcg

POM Solution for

Inhalation

099/228 Cipla Limited, India

1530

Q-TIB Tablets

Sulfamethoxazole 800mg

+ Trimethoprim 160mg +

Isoniazid 300mg +

Pyridoxine Hydrochloride

25mg

POM Tablet Uncoated 099/228 Cipla Limited, India

1531

Lamivudine and Tenofovir

Disoproxil Fumarate Tablets

300/300 Mg

Lamivudine 300 mg and

Tenofovir Disoproxil

Fumarate Tablets 300mg

POM Tablet Film coated 099/229 Cipla Limited, India

1532 Nifelat Retard Tablet Nifedipine 20mg POM Tablet Film Coated 099/230 Cipla Limited, India

1533

Atazanavir Sulfate and Ritonavir

Tablets 300mg/ 100mg

Atazanavir Sulfate 300mg

+ Ritonavir 100mg

POM Tablet Film coated 099/240 Cipla Limited, India

1534

Imatib 100 Capsules Imatinib Mesylate 100mg

Capsules

POM Capsule oral 099/241 Cipla Limited, India

1535

Imatib 400 Capsules Imatinib Mesylate 400mg

Capsules

POM Capsule oral 099/242 Cipla Limited, India

1536

Trioday Tablets

Efavirenz 600mg +

Lamivudine 300mg +

Tenofivir Disoproxyl

Fumurate 300mg

POM Tablet Film coated 099/226 Cipla Quality Chemical Industries Limited

(Cipla QCIL)

1537Anmol Syrup

Paracetamol 125mg, per

5ml

GS Syrup 002/001 Ciron Drugs & Pharmaceuticals Ltd, India

1538Betnew Ear/Eye Drops

Betamethasone 0.1% +

Neomycin 0.5% w/v

POM ear/eye Drops 002/002 Ciron Drugs & Pharmaceuticals Ltd, India

1539Chlorpheniramine Tablets

Chlorpheniramine

Maleate 4mg

P Tablet Uncoated 002/003 Ciron Drugs & Pharmaceuticals Ltd, India

1540

Cirogan Syrup

Promethazine

Hydrochloride oral

solution 5mg, per 5ml

P solution 002/004 Ciron Drugs & Pharmaceuticals Ltd, India

1541 Cirovit Syrup Multivitamins GS Syrup 002/005 Ciron Drugs & Pharmaceuticals Ltd, India

Page 80 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1542

Cold Plus Syrup

Paracetamol BP 125mg +

Chlopheniramine Maleate

BP 2.5mg +

Phenylephirine HCL BP

2.5mg

P Syrup 002/006 Ciron Drugs & Pharmaceuticals Ltd, India

1543

Co-trimoxazole Paediatric Oral

Suspension

Sulfamethoxazole 200

mg + Trimethoprime 40

mg

POM Suspension for oral

use

002/007 Ciron Drugs & Pharmaceuticals Ltd, India

1544

Dexamethasone Ear/Eye Drops

Dexamethasone Sodium

Phosphate Ophthalmic

Solution USP 0.1%w/v

POM Ear/Eye Drops 002/008 Ciron Drugs & Pharmaceuticals Ltd, India

1545Dextrose Injection

Dextrose 50% USP POM Solution for

Injection

002/009 Ciron Drugs & Pharmaceuticals Ltd, India

1546

Kofex Syrup

Menthol 0.55mg +

Diphenhydramine

Hydrochloride 7mg +

Ammonium Chloride

67.50mg + Sodium

Citrate 28.50mg

P Syrup 002/010 Ciron Drugs & Pharmaceuticals Ltd, India

1547

Kofex Cough Tablets

Menthol + Eucalyptus +

Liquorice + Anise oil +

Metha oil

P Tablet Uncoated 002/011 Ciron Drugs & Pharmaceuticals Ltd, India

1548

Kofmint Syrup

Peppermint oil BP

0.035ml + Menthol

BP5mg + Alcohol

2.4%w/v + Benzoic Acid

BP 0.18%w/v

P Syrup 002/012 Ciron Drugs & Pharmaceuticals Ltd, India

1549Mebendazole Oral Suspension

Mebendazole 100mg, per

5ml

P Suspension for

Oral Use

002/013 Ciron Drugs & Pharmaceuticals Ltd, India

1550Cirovin Nasal Drops 0.1%

Xylometazoline

Hydrochloride 0.1%

P Nasal drops 002/014 Ciron Drugs & Pharmaceuticals Ltd, India

1551Cirovin Nasal Drops 0.5%

Xylometazoline

Hydrochloride 0.5%

P Nasal drops 002/015 Ciron Drugs & Pharmaceuticals Ltd, India

1552Chloramphenicol Eye Drops 0.5

Chloramphenicol 0.5w/v POM Eye Drops 002/016 Ciron Drugs & Pharmaceuticals Ltd, India

1553Chlorpheniramine Tablets

Chlopheniramine Maleate

USP 4mg

POM Tablet Uncoated 002/017 Ciron Drugs & Pharmaceuticals Ltd, India

1554 Ibuprofen Tablets Ibuprofen BP 200mg P Tablet Film coated 002/018 Ciron Drugs & Pharmaceuticals Ltd, India

Page 81 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1555Erythromycin Dry Powder

Erythromycin 125mg, per

5ml

POM Powder for Oral

Suspension

002/019 Ciron Drugs & Pharmaceuticals Ltd, India

1556 Propranolol Tablets Propranolol BP 40mg POM Tablet Uncoated 002/021MT Ciron Drugs & Pharmaceuticals Ltd, India

1557Hydralazine Tablets

Hydralazine

Hydrochloride BP 25mg

POM Tablet Uncoated 002/022MT Ciron Drugs & Pharmaceuticals Ltd, India

1558 Fluconazole Capsules Fluconazole 200mg POM Capsule oral 002/023 Ciron Drugs & Pharmaceuticals Ltd, India

1559Ket Injection

Ketamine Hydrochloride

IP 50mg, per ml

POM Solution for

Injection

002/024 Ciron Drugs & Pharmaceuticals Ltd, India

1560Cirowax Ear Drops

Paradichlorobenzene

2%w/v

P Solution for Topical

Use

002/025 Ciron Drugs & Pharmaceuticals Ltd, India

1561

Amphotericin B 50mg/ Vial

Injection

Amphotericin B 50mg POM Powder for

Injection

002/025MT Ciron Drugs & Pharmaceuticals Ltd, India

1562Metronidazole Oral Suspension

Metronidazole 250mg,

per 5ml

POM Suspension for

Oral Use

002/026 Ciron Drugs & Pharmaceuticals Ltd, India

1563 Digoxin Tablets Digoxin 0.25mg POM Tablet Uncoated 002/026MT Ciron Drugs & Pharmaceuticals Ltd, India

1564 Ciprofloxacin Tablets Ciprofloxacin BP 250mg POM Tablet Uncoated 002/027MT Ciron Drugs & Pharmaceuticals Ltd, India

1565 Peridol Tablets Haloperidol 5mg POM Tablet Uncoated 002/028 Ciron Drugs & Pharmaceuticals Ltd, India

1566Oparin Injection

Heparin Sodium BP 5000

IU, per ml

POM Solution for

Injection

002/029MT Ciron Drugs & Pharmaceuticals Ltd, India

1567

Hydrocortisone Injection

Hydrocortisone Sodium

Succinate BP 100mg, per

ml

POM Powder for

Injection

002/030MT Ciron Drugs & Pharmaceuticals Ltd, India

1568Flucanol Injection

Fluconazole USP 2mg,

per ml

POM Solution for

Injection

194/002 Claris injectable Ltd, India

1569

Propofol 1% Intravenous

Injection

Propofol 10mg POM Solution for

Injection

194/003 Claris injectable Ltd, India

1570Ketajex IV Injection

Ketamine BP 50mg, per

ml

POM Solution for

Injection

194/004 Claris injectable Ltd, India

1571Cefo Injection

Cefotaxime 1gm POM Powder for

Injection

194/005 Claris injectable Ltd, India

1572Thiopental Injection

Thiopental Sodium 1g POM Powder for

Injection

194/006 Claris injectable Ltd, India

1573Bupican Injection

Bupivacaine

Hydrochloride BP 0.5w/v

POM Solution for

Injection

194/007 Claris injectable Ltd, India

1574Curaxone Injection

Ceftriaxone Sodium

1000mg

POM Solution for

Injection

194/010 Claris injectable Ltd, India

1575Dflam Injection

Diclofenac Sodium 25mg,

per ml

POM Solution for

Injection

194/012 Claris injectable Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1576Remetin Injection

Metoclopramide 5mg, per

ml

POM Solution for

Injection

194/014 Claris injectable Ltd, India

1577Dopamine Injection

Dopamine concentrate

BP 40mg, per ml

POM Solution for

Injection

194/008 Claris injectableLtd, India

1578

Tamin Intravenous infusion Paracetamol 10mg/ml POM Powder for

Injection

194/019 Claris Life Sciences Ltd, India

1579Hestar 200 Pestastarch Infusion

Hydroxyethyl Starch

6%w/v

POM Solution for

Injection

194/001 Claris Otsuka Private Limited

1580Sensinil Injection

Lidocaine BP 21.3mg,

per ml

POM Solution for

Injection

194/011 Claris Otsuka Private Limited

1581 Protex Men Fresh Bar Soap Anti bacterial soap GSL Solid Soap 383/001L Colgate-Palmolive. RSA

1582

Protex Men Herbal 100 Bar

Soap

Anti bacterial soap with

herbal extracts

GSL Solid Soap 383/002L Colgate-Palmolive. RSA

1583

Protex Men Herbal 175g Bar

Soap

Anti bacterial soap with

herbal extracts

GSL Solid Soap 383/003L Colgate-Palmolive. RSA

1584Protex Men Aloe Bar Soap

Antibacterial soap with

Aloe vera

GSL Solid Soap 383/004L Colgate-Palmolive. RSA

1585 Protex Men Power Bar Soap Antibacterial soap GSL Solid Soap 383/005L Colgate-Palmolive. RSA

1586

Protex African Therapy Bar

Soap

Antibacterial soap GSL Solid Soap 383/006L Colgate-Palmolive. RSA

1587

Protex Deep Clean 100g Bar

Soap

Antibacterial soap GSL Solid Soap 383/007L Colgate-Palmolive. RSA

1588 Protex Men Sport Bar Soap Antibacterial soap GSL Solid Soap 383/008L Colgate-Palmolive. RSA

1589 Protex Men Energy Bar Soap Antibacterial soap GSL Solid Soap 383/009L Colgate-Palmolive. RSA

1590Protex Men Propolis Bar Soap

Antibacterial soap with

Propolis

GSL Solid Soap 383/010L Colgate-Palmolive. RSA

1591 Protex Men Classic Bar Soap Antibacterial soap GSL Solid Soap 383/011L Colgate-Palmolive. RSA

1592

Protex Deep Clean 175g Bar

Soap

Antibacterial soap GSL Solid Soap 383/012L Colgate-Palmolive. RSA

1593 Protex Fresh Shower Gel Antibacterial shower gel GSL Gel Topical 383/013L Colgate-Palmolive. RSA

1594Protex Vit E Shower Gel

Antibacterial shower gel

with Vitamin E

GSL Gel Topical 383/014L Colgate-Palmolive. RSA

1595Protex Men Sport Shower Gel

Antibacterial shower gel

with Vitamin E

GSL Gel Topical 383/015L Colgate-Palmolive. RSA

1596

Protex Fresh Men Energy

Shower Gel

Antibacterial shower gel

with Vitamin E

GSL Gel Topical 383/016L Colgate-Palmolive. RSA

1597Ferrous Sulphate Tablets

Dried Ferrous Sulphate

200mg

P Tablet Film coated 201/001 Colorama Pharmaceuticals Ltd, UK

1598 Loperamide Tablets Loperamide 2mg POM Tablet Uncoated 201/002 Colorama Pharmaceuticals Ltd, UK

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1599Tetracycline Eye Ointment

Tetracycline

Hydrochloride 1%w/w

POM Ointment topical 201/003 Colorama Pharmaceuticals Ltd, UK

1600 Tetracyline Capsules Tetracycline 1% POM Capsule oral 201/004 Colorama Pharmaceuticals Ltd, UK

1601Forzid Tablets

Metformin 500mg +

Gliclazide 80mg

POM Tablet Uncoated 201/005 Colorama Pharmaceuticals Ltd, UK

1602Pymint Oral Suspension

Pyrantel Pamoate 25mg,

per ml

POM Suspension for

Oral Use

201/008 Colorama Pharmaceuticals Ltd, UK

1603Trolox Tablets

Metronidazole 100mg +

Norfloxacin 200mg

POM Tablets Oral 201/009 Colorama Pharmaceuticals Ltd, UK

1604

Tocure Skin Cream 15mg Tube

Tolnaftate 10mg +

Iodochlorhydroxyquinolon

e 10mg + Gentamycin

1mg + Betamethasone

0.61mg

POM Topical cream 201/010 Colorama Pharmaceuticals Ltd, UK

1605

Trolox Suspension

Metronidazole 100mg +

Norfloxacin 100mg, per

5ml

POM Suspension for

Oral Use

201/011 Colorama Pharmaceuticals Ltd, UK

1606Pymint Tablets

Pyrantel pamoate 125mg POM Tablets oral 201/012 Colorama Pharmaceuticals Ltd, UK

1607 Odopa Tablets Methyldopa 250mg POM Tablet Uncoated 201/013 Colorama Pharmaceuticals Ltd, UK

1608Lopine Tablets

Amlodipine 5mg +

Atenolol 50mg

POM Tablet Uncoated 201/014 Colorama Pharmaceuticals Ltd, UK

1609Pymint Oral Suspension

Pyrantel pamoate 25mg,

per ml

P Suspension for

Oral Use

201/015 Colorama Pharmaceuticals Ltd, UK

1610Trolox Tablets

Metronidazole 200mg +

Norfloxacin 200mg

POM Tablet Uncoated 201/016 Colorama Pharmaceuticals Ltd, UK

1611

Tocure Cream

Tolnaftate +

Iodochlorhydroxyquinolon

e + Gentamycin +

Betamethazone

POM Cream Topical 201/017 Colorama Pharmaceuticals Ltd, UK

1612

Trolox Suspension

Metronidazole 100mg +

Norfloxacin 100mg, per

5ml

POM Suspension for

Oral Use

201/018 Colorama Pharmaceuticals Ltd, UK

1613Pymint Tablets

Pyrantel Pamoate 125mg P Tablet Uncoated 201/019 Colorama Pharmaceuticals Ltd, UK

1614 Hydrocortisone Acetate Cream Hydrocortisone 1% POM Cream Topical 201/021 Colorama Pharmaceuticals Ltd, UK

1615 Canaderm-V6 Tablets Clotrimazole BP 100mg POM Tablet Uncoated 201/023 Colorama Pharmaceuticals Ltd, UK

1616 Onystin-V Tablets Nystatin 100,000 IU POM Tablet Uncoated 201/024 Colorama Pharmaceuticals Ltd, UK

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1617Cobet Cream

Betamethasone

Valearate BP 0.1%w/w

P Cream Topical 201/025 Colorama Pharmaceuticals Ltd, UK

1618 Onapril Tablets Enalapril Maleate 20mg POM Tablet Uncoated 201/026 Colorama Pharmaceuticals Ltd, UK

1619 Onapril Tablets Enalapril Maleate 5mg POM Tablet Uncoated 201/027 Colorama Pharmaceuticals Ltd, UK

1620 Onapril Tablets Enalapril Maleate 10mg POM Tablet Uncoated 201/028 Colorama Pharmaceuticals Ltd, UK

1621

Recartix Capsules

Diacerein 50 mg +

Glucosamine 750 mg +

Methylsulfonylmethane

250 mg

P Capsule oral 263/001 Comed chemicals Ltd, India

1622Caldob Capsules

Calcium Dobesilate

500mg

P Capsule oral 263/002 Comed chemicals Ltd, India

1623Lyser D Tablets

Diclofenac 50mg +

Serrapeptase 10mg

POM Tablet Uncoated 263/003 Comed chemicals Ltd, India

1624 Simvax 20 Tablets Simvastatin 20mg POM Tablet Film coated 263/004 Comed chemicals Ltd, India

1625 Simvax 10 Tablets Simvastatin 10mg POM Tablet Film coated 263/005 Comed chemicals Ltd, India

1626 Ceso-40 Tablets Esomeprazole 40mg POM Tablet Uncoated 263/006 Comed chemicals Ltd, India

1627 Osex Capsules Hydroxyapatite P Capsule oral 263/007 Comed chemicals Ltd, India

1628

Recartix Forte Tablets

Glucosamine 250mg +

Condroitin 200mg +

Minerals

P Tablet Uncoated 263/008 Comed chemicals Ltd, India

1629Proloc D Capsules

Pantoprazole +

Domperidone

POM Capsule oral 263/009 Comed chemicals Ltd, India

1630

Dolomed MR Tablets

Chlorzoxazone 250mg +

Paracetamol 325mg +

Ibuprofen 400mg

P Tablet Uncoated 263/010 Comed chemicals Ltd, India

1631Cornizole Denta Gel

Metronidazole Benzoate

BP 1% w/v

POM Gel Topical 379/001 Coral Laboratories Ltd

1632Dermagaurd Cream

Clotrimazole USP 1%w/w POM Cream Topical 379/002 Coral Laboratories Ltd

1633Power Appetite Syrup

Cyproheptidine 2mg, per

5ml

PSyrup

379/003Coral Laboratories Ltd

1634 Mylax-L Syrup Lactulose 10gm P Syrup 303/001 Corona Remedies Pvt Limited

1635Asera P Tablets

Aceclofenac 100mg +

Paracetamol 500mg

P Tablet Uncoated 303/002 Corona Remedies Pvt Limited

1636 Cetcor Tablets Cetirizine 10mg P Tablet Uncoated 303/003 Corona Remedies Pvt Limited

1637Varinil 5 Tablets

Amlodipine Besylate 5mg POM Tablet Uncoated 317/001 Cosmos Limited, Kenya

1638Avastatin-10 Tablets

Atorvastalin Calcium

Trihydrate 10mg

POM Tablet Film coated 317/002 Cosmos Limited, Kenya

Page 85 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1639Avastatin-20 Tablets

Atorvastalin Calcium

Trihydrate 20mg

POM Tablet Uncoated 317/003 Cosmos Limited, Kenya

1640 Vidol Film Coated Tablets Carvedilol BP 6.25mg POM Tablet Film coated 317/004 Cosmos Limited, Kenya

1641Varinil 10 Tablets

Amlodipine Besylate USP

10mg

POM Tablet Uncoated 317/005 Cosmos Limited, Kenya

1642 Vidol 25 Tablets Carvedilol BP 25mg POM Tablet Film coated 317/006 Cosmos Limited, Kenya

1643 Zithrox 500 Tablets Azithromycin 500mg POM Tablet Uncoated 317/007 Cosmos Limited, Kenya

1644 Celprotec 200 Mcg Misoprostol 200 mcg POM Tablet Uncoated 405/001 Cospharm Investments (Pty) Ltd

1645

Softrim Tablets

Trimethoprim 25mg +

Sulfamethoxazole 500mg

POM Tablet Uncoated 180/001 Crown Exports, India

1646Quintex Tablets

Pyrimthamine 80mg +

Sulfadoxine 400mg

POM Tablet Uncoated 180/002 Crown Exports, India

1647Crogyl 200 Tablets

Metronidazole BP 200mg POM Tablet Uncoated 180/003 Crown Exports, India

1648 Paridol 500 Tablets Paracetamol BP 500mg P Tablet Uncoated 180/004 Crown Exports, India

1649Amicare 250 Capsules

Ampicillin Trihydrate

250mg

POM Capsule oral 180/005 Crown Exports, India

1650Cromin Tablets

Chlorpheniramine

Maleate 4mg

P Tablet Uncoated 180/006 Crown Exports, India

1651Ciprocrown 500 Tablets

Ciprofloxacin

Hydrochloride 500mg

POM Tablet Uncoated 180/007 Crown Exports, India

1652 Ibusoft 200 Tablets Ibuprofen 200mg P Tablet Uncoated 180/008 Crown Exports, India

1653

Claricid Tablets

Dried Aluminium

Hydrochloride 120mg +

Magnesium Trisilicate

250mg

P Tablet Uncoated 180/010 Crown Exports, India

1654 Vitacrown Syrup Multivitamin P Syrup 180/011 Crown Exports, India

1655 Becofit Tablets Vitamon B Complex P Tablet Uncoated 180/012 Crown Exports, India

1656Erysoft Syrup

Betamethasone

0.05%w/w

POM Tablet Uncoated 180/013 Crown Exports, India

1657

Cofdry Syrup

Diphenhydramine

Hydrochloride 14mg +

Ammonium Chloride

138mg + Sodium Citrate

57.03mg + Menthol

1.14mg/5ml

P Syrup 180/014 Crown Exports, India

1658Amoxicillin Suspension

Amoxicillin 125mg, per

5ml

POM Suspension for

Oral Use

079/001 CSPC Ouyi Pharmaceuticals Co. Ltd, China

Page 86 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1659Cefotaxime Injection

Cefotaxime 1.0g POM Powder for

Injection

079/002 CSPC Ouyi Pharmaceuticals Co. Ltd, China

1660Diclofenac Injection

Diclofenac Sodium

75mg, per 5ml

POM Solution for

Injection

079/003 CSPC Ouyi Pharmaceuticals Co. Ltd, China

1661Doxycycline Tablets

Doxycycline 100mg POM Tablet Uncoated 079/004 CSPC Ouyi Pharmaceuticals Co. Ltd, China

1662Magnesium Sulphate Injection

Magnesium Sulphate

50%, per 10ml

POM Solution for

Injection

079/005 CSPC Ouyi Pharmaceuticals Co. Ltd, China

1663Promethazine Injection

Promethazine 50mg, per

2ml

POM Solution for

Injection

079/006 CSPC Ouyi Pharmaceuticals Co. Ltd, China

1664Benzylpenicillin Injection

Benzyl Penicillin 5000000

IU

POM Powder for

Injection

079/007 CSPC Ouyi Pharmaceuticals Co. Ltd, China

1665Ciprofloxacin Tablets

Ciprofloxacin 250mg POM Tablet Uncoated 079/008 CSPC Ouyi Pharmaceuticals Co. Ltd, China

1666Acyclovir Tablets

Acyclovir 200mg POM Tablet Uncoated 079/009 CSPC Ouyi Pharmaceuticals Co. Ltd, China

1667Oxytocin Injection

Oxytocin 10 IU, per 10ml POM Solution for

Injection

079/010 CSPC Ouyi Pharmaceuticals Co. Ltd, China

1668

Procaine Benzyl Penicillin

Injection

Procaine Benzyl Penicillin

3000000 IU

POM Powder for

Injection

079/011 CSPC Ouyi Pharmaceuticals Co. Ltd, China

1669Atenolol Tablets

Atenolol 50mg POM Tablet Uncoated 079/012 CSPC Ouyi Pharmaceuticals Co. Ltd, China

1670Aminophylline Injection

Aminophylline 200mg,

per 10ml

POM Solution for

Injection

079/013 CSPC Ouyi Pharmaceuticals Co. Ltd, China

1671Penicillin G Benzathine Injection

Penicillin G Benzathine

2.4000000 IU

POM Powder for

Injection

079/014 CSPC Ouyi Pharmaceuticals Co. Ltd, China

1672

Dexamethasone Sodium

Phosphate Injection

Dexamethasone 8mg,

per 2ml

POM Solution for

Injection

079/015 CSPC Ouyi Pharmaceuticals Co. Ltd, China

1673Artesian 20 Injection

Artemether 20mg, per ml POM solution for

injection

151/001 Dafra Pharma GmbH, Switzerland

1674 Artesiane Suppositories Artemether 40 mg POM Suppository 151/002 Dafra Pharma GmbH, Switzerland

1675Artesiane Oral Suspension

Artemether 300mg, per

100ml

POM Suspension 151/003 Dafra Pharma GmbH, Switzerland

1676

Co-Artesian® Powder for Oral

Suspension 60ml

Artemether 180mg, per

60ml + Lumefantrine

1080mg, per 60ml

POM Powder for

Suspension oral

151/006 Dafra Pharma GmbH, Switzerland

1677

Co-Artesian® Powder for Oral

Suspension 120ml

Artemether 360mg, per

120ml + Lumefantrine

2160mg, per 120ml

POM Powder for

Suspension oral

151/006 Dafra Pharma GmbH, Switzerland

Page 87 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1678

Co-Arinate 100 Tablets

Artesunate +

Pyrimethamine +

Sulfamethoxypyrazine

POM Tablet Uncoated 151/008 Dafra Pharma GmbH, Switzerland

1679 Arinate 50 Tablets Artesuate 50mg POM Tablet Uncoated 151/009 Dafra Pharma GmbH, Switzerland

1680 Arinate 100 Tablets Artesuate 100mg POM Tablet Uncoated 151/010 Dafra Pharma GmbH, Switzerland

1681 Artesiane 80 Injection Artemether 80mg, per ml POM Tablet 151/011 Dafra Pharma GmbH, Switzerland

1682Dafra Vit Powder

Multivitamin P Powder for Oral

Use

151/012 Dafra Pharma GmbH, Switzerland

1683Aneaban Capsules

Bacillus Subtilis PB6

complex

POM Capsule oral 151/015 Dafra Pharma GmbH, Switzerland

1684Amonate FDC Junior Tablets

Amodiaquine +

Artesunate

POM Tablet Uncoated 151/016 Dafra Pharma GmbH, Switzerland

1685Fortaline® (Omega-3) Capsules

OMega 3 oils POM Syrup 151/018 Dafra Pharma GmbH, Switzerland

1686

Pico Stick Insect Repellent

Diethyl-M-Toluamide

10% + P-Methane-3,8-

diol 10%

GS Solution for Topical

Use

151/019 Dafra Pharma GmbH, Switzerland

1687Artesian 100 Injection

Artemether 100mg, per

ml

POM injection 151/020 Dafra Pharma GmbH, Switzerland

1688 Parol Syrup Paracetamol 250mg GS Syrup 151/021 Dafra Pharma GmbH, Switzerland

1689 Parol Tablets Paracetamol 500mg GS Tablet Uncoated 151/022 Dafra Pharma GmbH, Switzerland

1690 Cipronat 250mg Tablets Ciprofloxacin 250mg POM Tablet Uncoated 151/023 Dafra Pharma GmbH, Switzerland

1691 Cipronat 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 151/024 Dafra Pharma GmbH, Switzerland

1692 Cipronat 700 Tablets Ciprofloxacin 700mg POM Tablet Uncoated 151/025 Dafra Pharma GmbH, Switzerland

1693Dafraclav 228 Tablets

Amoxicillin 200mg +

Clavulanic Acid 28mg

POM Tablet Uncoated 151/026 Dafra Pharma GmbH, Switzerland

1694Dafraclav Suspension

Amoxicillin 400mg +

Clavulanic Acid 57mg

POM Suspension for

Oral Use

151/027 Dafra Pharma GmbH, Switzerland

1695Dafraclav 625 Tablets

Amoxicillin 500mg +

Clavulanic Acid 125mg

POM Tablet Uncoated 151/028 Dafra Pharma GmbH, Switzerland

1696Dafraclav 1000 Tablets

Amoxicillin 875mg +

Clavulanic Acid 125mg

POM Tablet Uncoated 151/029 Dafra Pharma GmbH, Switzerland

1697 Pedifen Tablets Ibuprofen 400mg P Tablet Uncoated 151/030 Dafra Pharma GmbH, Switzerland

1698 Amifer Iron Syrup Iron 40mg, per ml P Syrup 151/031 Dafra Pharma GmbH, Switzerland

1699Artesiane 40 Injection

Artemether 40mg, per ml POM Solution for

Injection

151/032 Dafra Pharma GmbH, Switzerland

1700Pico Roll-On Insect Repellant

Diethyl-M-Toluamide

20%

GS Solution for Topical

Use

151/034 Dafra Pharma GmbH, Switzerland

Page 88 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1701Pico Spray

Diethy-M-Toluamide 50% GS Solution for Topical

Use

151/035 Dafra Pharma GmbH, Switzerland

1702

Co-Arinate® Junior

Artesunate 100 mg +

Sulfamethoxypyrazine

250 mg + Pyrimethamine

12.5 mg

POM Tablet Uncoated 151/121 Dafra Pharma GmbH, Switzerland

1703

Co-Arinate® Adult

Artesunate 200 mg +

Sulfamethoxypyrazine

500 mg + Pyrimethamine

25 mg

POM Tablet Uncoated 151/122 Dafra Pharma GmbH, Switzerland

1704 Loratan 10 Tablets Loratadine 10mg P Tablet Uncoated 322/001 Dar Al Dawa Pharmaceuticals

1705Aphrodil - 50 Tablets

Sildenafil Citrate I.H

50mg

POM Tablet Uncoated 322/002 Dar Al Dawa Pharmaceuticals

1706Clomifert Tablets

Clomiphene Citrate BP

50mg

POM Tablet Uncoated 322/003 Dar Al Dawa Pharmaceuticals

1707 Risdone 1mg Tablet Risperidone USP 1mg POM Tablet Uncoated 322/004 Dar Al Dawa Pharmaceuticals

1708 Risdone 2mg Tablets Risperidone USP 2mg POM Tablet Uncoated 322/005 Dar Al Dawa Pharmaceuticals

1709 Diapride 2mg Tablets Glimepiride 2mg POM Tablet Uncoated 322/006 Dar Al Dawa Pharmaceuticals

1710

Dad Teething Gel

Lignocaine Hydrochloride

3.3mg + Cetylpridinium

Chloride 1.0mg

P Gel Oral 322/007 Dar Al Dawa Pharmaceuticals

1711Proctoheal New Ointment

Lidocaine BP 20mg +

Fluocinolone 0.1mg

P Ointment rectal 322/008 Dar Al Dawa Pharmaceuticals

1712 Mycoheal Oral Gel Miconazole Nitrate 40g POM Gel Oral 322/009 Dar Al Dawa Pharmaceuticals

1713 Loratan Syrup Loratadine 5mg, per 5ml P Syrup 322/010 Dar Al Dawa Pharmaceuticals

1714

Ibugesic Cold and Sinus F.C.

Tablets

Ibuprofen Ph Eur 200mg

+ Pseudoephedrine

Hydrochloride BP 30mg

P Tablet Film coated 322/012 Dar Al Dawa Pharmaceuticals

1715 Liblab Cough Mixture Ivy Leaf Extracts P Syrup 322/011L Dar Al Dawa Pharmaceuticals

1716 Paracetamol 500 Tablets Paracetamol 500mg GS Tablet Uncoated 055/002 Dawa Phamaceuticals Limited, Kenya

1717 Multivitamin Tablets Multivitamins GS Tablet Uncoated 055/003 Dawa Phamaceuticals Limited, Kenya

1718 Eflaron 200 Tablets Metronidazole 200mg POM Tablet Uncoated 055/004 Dawa Phamaceuticals Limited, Kenya

1719Eflaron 0.5 Infusion

Metronidazole 0.5%w/v POM Solution for

infusion

055/006 Dawa Phamaceuticals Limited, Kenya

1720Penicillin V Tablets

Phenoxymethyl Penicillin

250mg

POM Tablets oral 055/007 Dawa Phamaceuticals Limited, Kenya

1721 Fidemycin Capsules Tetracycline 250mg POM Capsule oral 055/010 Dawa Phamaceuticals Limited, Kenya

Page 89 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1722Dawacin Injection

Kanamycin 1gm POM Powder for

Injection

055/011 Dawa Phamaceuticals Limited, Kenya

1723Hycin Tablets

Hyoscine ButylBromide

10mg

P Tablet Uncoated 055/012 Dawa Phamaceuticals Limited, Kenya

1724Dawagenta Injection

Gentamycin 80mg, per

2ml

POM Solution for

Injection

055/013 Dawa Phamaceuticals Limited, Kenya

1725 Cindomet Capsules Indomethacin 25mg P Capsule oral 055/014 Dawa Phamaceuticals Limited, Kenya

1726Dawasprin Tablets

Acetyl Salicylic Acid

300mg

P Tablet Uncoated 055/015 Dawa Phamaceuticals Limited, Kenya

1727Amidiostat Powder

Amprolium Sulphate

100g

POM Powder for Oral

Solution

055/017 Dawa Phamaceuticals Limited, Kenya

1728Aphaquine Suspension

Amodiaquine 65.30mg POM Suspension for

Oral Use

055/018 Dawa Phamaceuticals Limited, Kenya

1729Fanlar Tablets

Sulfadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 055/019 Dawa Phamaceuticals Limited, Kenya

1730Dawanol Tablets

Aspirin + Paracetamol +

Caffeine

GS Tablet Uncoated 055/020 Dawa Phamaceuticals Limited, Kenya

1731Curamol Plus Caplets

Paracetamol + Caffeine GS Caplets oral

Uncoated

055/021 Dawa Phamaceuticals Limited, Kenya

1732Dawacort Injection

Hydrocortisone 100mg POM Powder for

Injection

055/022 Dawa Phamaceuticals Limited, Kenya

1733 Vitamin B Tablets B Complex 12mg P Tablet Uncoated 055/023 Dawa Phamaceuticals Limited, Kenya

1734 Dablin Tablets Salbutamol 4mg POM Tablet Uncoated 055/024 Dawa Phamaceuticals Limited, Kenya

1735Dawastin Suspension

Nystatin 100,000iu POM Suspension for

Oral Use

055/025 Dawa Phamaceuticals Limited, Kenya

1736Dawaphenicol Injection

Chloramphenicol 1g POM Powder for

Injection

055/026 Dawa Phamaceuticals Limited, Kenya

1737 Dawa-CPM Tablets Chlorpheniramine 4mg P Tablet Film coated 055/027 Dawa Phamaceuticals Limited, Kenya

1738 Dawa Ascorbic Acid Tablets Ascorbic Acid 100mg GS Tablet Uncoated 055/028 Dawa Phamaceuticals Limited, Kenya

1739 Rinacet Syrup Cetirizine 5mg P Syrup 055/029 Dawa Phamaceuticals Limited, Kenya

1740

Stopacid Chewable Tablets

Aluminium Hydroxide

120mg + Magnesium

Trisilicate 250mg +

Peppermint 0.003ml

POM Tablet Chewable 055/030 Dawa Phamaceuticals Limited, Kenya

1741Dermazine Cream

Silver Sulphadiazine

1%w/w

P Cream Topical 055/031 Dawa Phamaceuticals Limited, Kenya

1742Ibupar Suspension

Ibuprofen 100mg +

Paracetamol 120mg

P Suspension for

Oral Use

055/032 Dawa Phamaceuticals Limited, Kenya

Page 90 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1743

Fast Act Gel

Diclofenac Diethyl Amine

1.16%w/w + Methyl

Salicylate 10% w/w +

Menthol 5% w/w +

Linseed Oil 3% w/w

P Gel Topical 055/033 Dawa Phamaceuticals Limited, Kenya

1744Topquine Mixture

Quinine dihydrochloride

50mg, per 5ml

POM Suspension for

Oral Use

055/034 Dawa Phamaceuticals Limited, Kenya

1745

Dacough Mucolytic Syrup

Salbutamol 2mg +

Bromohexine

Hydrochloride 4mg +

Guaiphenesin 100mg +

Menthol 1mg

P Syrup 055/035 Dawa Phamaceuticals Limited, Kenya

1746

Dacold Syrup

Paracetamol 120mg +

Chlopheniramine 2mg +

Psuedoephedrine 10mg

P Syrup 055/036 Dawa Phamaceuticals Limited, Kenya

1747

Dacold Capsules

Paracetamol 400mg +

Cafeine 30mg +

Psuedoephedrine 30mg

+ Chlorpheniramine 4mg

P Capsule oral 055/037 Dawa Phamaceuticals Limited, Kenya

1748

Dawavite Syrup

Vitamin A 1500 IU +

Thiamine 0.5mg +

Riboflavin 0.5mg

GS Syrup 055/038 Dawa Phamaceuticals Limited, Kenya

1749

Dazole B Cream

Clotrimazole 1.0%w/w +

Betamethasone

0.1%w/w

POM Cream Topical 055/039 Dawa Phamaceuticals Limited, Kenya

1750

DAWADUR 2.4 Injection

Benzathine

BenzylPenicillin 2.4 Mega

POM Powder for

Injection

055/040 Dawa Phamaceuticals Limited, Kenya

1751Penicillin G Sodium 5 Injection

Benzyl Penicillin Sodium

BP 5Mega Units

POM Powder for

Injection

055/041 Dawa Phamaceuticals Limited, Kenya

1752

Procaine Penicillin Fortified

Injection

Procaine Benzyl Penicillin

BP 4 Mega Units

POM Powder for

Injection

055/042 Dawa Phamaceuticals Limited, Kenya

1753

Dawadoxyn Capsules

Doxycycline

Hydrochloride BP 100mg

POM Capsule oral 055/043 Dawa Phamaceuticals Limited, Kenya

Page 91 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1754

Miclocin Cream

Miconazole Nitrate

2.0%w/w + Clobetasol

0.5%w/w + Gentamicin

0.1%w/w

POM Cream Topical 055/044 Dawa Phamaceuticals Limited, Kenya

1755 Topquine Tablets Quinine Sulphate 300mg POM Tablet Film coated 055/045 Dawa Phamaceuticals Limited, Kenya

1756Curamol Suspension

Paracetamol BP 100mg,

per 5ml

GS Suspension for

Oral Use

055/046 Dawa Phamaceuticals Limited, Kenya

1757

Acepar Caplets

Paracetamol BP 500mg +

Aceclofenac BP 100mg

GS Caplets oral

Uncoated

055/047 Dawa Phamaceuticals Limited, Kenya

1758

Dawalyte Oral Rehydration Salt

Sodium Chloride BP +

Potassium Chloride BP +

TriSodium Citrate BP

GS Powder for Oral

Solution

055/048 Dawa Phamaceuticals Limited, Kenya

1759

ALLERDROP EYE DROPS

Boric Acid 1.25% +

Sodium Chloride 0.05% +

Zinc Sulphate 0.12% +

Chlorpheniramine

Maleate 0.01% +

Naphazoline

Hydrochloride 0.056% +

Chlorbutol 0.35%

POM Solution for Topical

Use

362/001 DCI Pharmaceuticals Limited

1760Cynocob Forte Injection

Cyanocobalamine

1000mcg

POM Solution for

Injection

362/002 DCI Pharmaceuticals Limited

1761Diciran Injection

Ranitidine Hydrochloride

25mg, per ml

POM Solution for

Injection

362/003 DCI Pharmaceuticals Limited

1762 Dicimycin Eye Drops Chloraphenicol POM Ear Drops 362/004 DCI Pharmaceuticals Limited

1763

Betnor Eye/Ear Drop

Betamethasone Soduim

Phosphate BP +

Neomycin Sulphate BP

POM Solution for Topical

Use

362/005 DCI Pharmaceuticals Limited

1764 Dicinac Eye Drop Diclofenac BP POM Eye Drops 362/006 DCI Pharmaceuticals Limited

1765B-Plus Injection

Vitamin B Complex POM Solution for

Injection

362/007 DCI Pharmaceuticals Limited

1766Optob Eye Drops

Tobramycin USP POM Solution for Topical

Use

362/008 DCI Pharmaceuticals Limited

Page 92 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1767

Deltavit Syrup Appetite

Stimulant And General Tonic

Cyproheptadine

Hydrochloride 2mg +

Thiamine Hydrochloride

1.2mg + Riboflavin (as 5-

phosphate) 1.2mg +

Pyridoxine Hydrochloride

1.2mg + Nicotinamide

1.2mg

P Solution for Oral

Use

067/001 Deltapharm, Egypt

1768 Kids Vitamin Syrup Multivitamins GS Syrup 067/002 Deltapharm, Egypt

1769Dolphin 12.5 Suppository

Diclofenac Sodium

12.5mg

POM Suppository 067/003 Deltapharm, Egypt

1770Dolphin 25 Suppository

Diclofenac Sodium 25mg POM Suppository 067/004 Deltapharm, Egypt

1771Dolphin 75 Suppository

Diclofenac Sodium 75mg POM Suppository 067/005 Deltapharm, Egypt

1772Nifedi-Denk 10 Retard Tablets

Nifedipine 10mg POM Tablet Enteric

Coated

130/001 Denk Pharma, Germany

1773Nifedi-Denk 20 Retard Tablets

Nifedipine 20mg POM Tablet Enteric

Coated

130/002 Denk Pharma, Germany

1774Diclo-Denk 25 Tablets

Diclofenac 25mg P Tablet Enteric

Coated

130/003 Denk Pharma, Germany

1775 Diclo-Denk 50 Tablets Diclofenac 50mg P Tablet Film coated 130/004 Denk Pharma, Germany

1776Diclo-Denk 100 Retard Tablets

Diclofenac 100mg P Tablet Enteric

Coated

130/005 Denk Pharma, Germany

1777Diclo-Denk 75mg Injection

Diclofenac 75mg, per 3ml POM Solution for

Injection

130/006 Denk Pharma, Germany

1778Diclo-Denk 100 Suppositories

Diclofenac Sodium

100mg

P Suppository 130/007 Denk Pharma, Germany

1779Rani-Denk 150 Tablets

Ranitidine Hydrochloride

150mg

POM Tablet Film coated 130/008 Denk Pharma, Germany

1780Rani-Denk 300 Tablets

Ranitidine Hydrochloride

300mg

POM Tablet Film coated 130/009 Denk Pharma, Germany

1781 Acyclovir-Denk 200 Tablets Acyclovir 200mg POM Tablet Uncoated 130/010 Denk Pharma, Germany

1782 Acyclovir Denk Cream Acyclovir 5%w/w POM Cream Topical 130/011 Denk Pharma, Germany

1783Clotri-Denk 100 Vaginal Tablets

Clotrimazole 100mg POM Tablet Vaginal 130/012 Denk Pharma, Germany

1784 Clotri-Denk 1% Cream Clotrimazole 1% POM Cream Topical 130/013 Denk Pharma, Germany

1785Loperamide Denk Tablets

Loperamide

Hydrochloride 2mg

POM Tablet Enteric

Coated

130/014 Denk Pharma, Germany

Page 93 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 1786 Metformin-Denk 500 Tablets Metformin 500mg POM Tablet Film coated 130/015 Denk Pharma, Germany

1787Dolo-Denk Gel

Etofenamate 100mg, per

g

P Gel Topical 130/016 Denk Pharma, Germany

1788Para-Denk 125mg Suppositories

Paracetamol 125mg P Suppository 130/019 Denk Pharma, Germany

1789Para-Denk 250mg Suppositories

Paracetamol 250mg P Suppository 130/020 Denk Pharma, Germany

1790 Atenolol Denk Tablets Atenolol 50mg POM Tablet Uncoated 130/021 Denk Pharma, Germany

1791Paradenk 4% Syrup

Paracetaoml syrup 4mg,

per 100mg

P Syrup 130/022 Denk Pharma, Germany

1792 Para-Denk 500 Tablets Paracetamol 500mg P Tablet Uncoated 130/023 Denk Pharma, Germany

1793

Captopril/Hydrochlorothiazide

Tablets

Hydrochlorothiazide

50mg + Captopril 25mg

POM Tablet Uncoated 130/024 Denk Pharma, Germany

1794 Furodenk 40 Tablets Frusemide 40mg POM Tablet Uncoated 130/025 Denk Pharma, Germany

1795 Vera-Denk 240 Retard Tablets Verapamil 240mg POM Tablet Uncoated 130/026 Denk Pharma, Germany

1796 Famotidine Denk Tablets Famotidine 40mg POM Tablet Film coated 130/027 Denk Pharma, Germany

1797 Amoxi-Denk 500 Tablets Amoxicillin 500mg POM Tablet Uncoated 130/028 Denk Pharma, Germany

1798 Cipro-Denk Tablets Ciprofloxacin 500mg POM Tablet Film coated 130/029 Denk Pharma, Germany

1799 Ibuprofen Denk 400 Tablets Ibuprofen 400mg P Tablets oral 130/030 Denk Pharma, Germany

1800

Asunate Denk 100 Plus Tablets

Pyrimethamine 12.5mg +

Sulphamethoxypyrazine

250mg + Artesuate

100mg

POM Tablet Uncoated 130/032 Denk Pharma, Germany

1801 Asunate Denk 200 Tablets Artesunate 200mg POM Tablet Uncoated 130/033 Denk Pharma, Germany

1802Vit-B-Denk Tablets

Pyridoxine 200mg +

Thiamine 100mg

POM Tablet Uncoated 130/034 Denk Pharma, Germany

1803Armether Denk 180 Suspension

Beta Artemether 180mg ,

per 100ml

POM Suspension for

Oral Use

130/035 Denk Pharma, Germany

1804 Simva-Denk 40mg Tablets Simvastatin 40mg POM Tablet Uncoated 130/039 Denk Pharma, Germany

1805 Simva-Denk 20mg Tablets Simvastatin 20mg POM Tablet Uncoated 130/040 Denk Pharma, Germany

1806 Amilo-Denk 5mg Tablets Amlodipine 5mg POM Tablet Uncoated 130/041 Denk Pharma, Germany

1807 Amilo-Denk 10mg Tablets Amlodipine 10mg POM Tablet Uncoated 130/042 Denk Pharma, Germany

1808 Ena-Denk 10mg Tablets Enalapril 10mg POM Tablet Uncoated 130/043 Denk Pharma, Germany

1809 Ena-Denk 20mg Tablets Enalapril 20mg POM Tablet Uncoated 130/044 Denk Pharma, Germany

1810 Toras-Denk 5mg Tablets Torasemide 5mg POM Tablet Uncoated 130/046 Denk Pharma, Germany

1811 Toras Denk 10 Tablets Torasemide 10mg POM Tablet Uncoated 130/047 Denk Pharma, Germany

1812 Amether-Denk Suppocap Artemether 40mg POM Suppository 130/048 Denk Pharma, Germany

Page 94 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1813Paraco-Denk 500/30mg Tablets

Paracetamol 500mg +

Codeine 30mg

P Tablet Uncoated 130/049 Denk Pharma, Germany

1814Paraco-Denk1000/60mg Tablets

Paracetamol 1000mg +

Codeine 60mg

P Suppository 130/050 Denk Pharma, Germany

1815

Asu -Denk Fixed Dose Tablets

Artesunate 200mg +

Sulfamethoxypyrazine

500mg + Pyrimethamine

25mg

POM Tablet Uncoated 130/052 Denk Pharma, Germany

1816Losar Denk 50 Tablets

Losartan 50mg POM Tablet Enteric

Coated

130/053 Denk Pharma, Germany

1817Losar - Denk 100 Tablets

Losartan 100mg POM Tablet Enteric

Coated

130/054 Denk Pharma, Germany

1818

Colosar -Denk 50/12.5mg

Tablets

Lorsartan 50mg +

Hydrochlorothiazide

12.5mg

POM Tablet Uncoated 130/055 Denk Pharma, Germany

1819 Metformin Denk 1000 Tablets Merformin 1000mg POM Tablet Uncoated 130/056 Denk Pharma, Germany

1820 Glimepride Denk Tablets Glimepiride 2mg POM Tablet Uncoated 130/058 Denk Pharma, Germany

1821 Flucona-Denk 100 Capsules Fluconazole 100mg POM Capsule oral 130/060 Denk Pharma, Germany

1822 Flucona -Denk 150 Capsules Fluconazole 150mg POM Capsule oral 130/061 Denk Pharma, Germany

1823

Amoxicalv -Denk 500/62.5

Tablets

Amoxicillin Trihydrate

500mg + Clavulanic Acid

62.5mg

POM Tablet Uncoated 130/062 Denk Pharma, Germany

1824Tramadol Denk 50 Tablets

Tramadol Hydrochloride

50mg

P Tablet Uncoated 130/063 Denk Pharma, Germany

1825

Zolendro - Denk Injection

Zoledronic Acid

anhydrous BP 4mg, per

5ml

POM Solution for

Injection

130/064 Denk Pharma, Germany

1826

Grani - Denk Inject

Granisetron

Hydrochloride USP 1mg,

per ml

POM Solution for

infusion

130/065 Denk Pharma, Germany

1827 Clopi-Denk 75 Tablets Clopidogrel 75mg POM Tablet Uncoated 130/066 Denk Pharma, Germany

1828 Ibuprofen Denk 600mg Tablets Ibuprofen 600mg POM Tablet Film coated 130/067 Denk Pharma, Germany

1829

Colosar - Denk100/12.5 Tablets

Lorsartan Potassium

Eur.Ph 100mg +

Hydrochlorothiazide

Eur.Ph 12.5mg

POM Tablet Uncoated 130/068 Denk Pharma, Germany

1830 Anastrazole Denk 1 Tablets Anastrozole 1mg POM Tablet Uncoated 130/069 Denk Pharma, Germany

1831Losar-Denk 25 Tablets

Lorsatan Potassium

25mg

POM Tablet Uncoated 130/070 Denk Pharma, Germany

Page 95 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1832Levo- Denk 500 Tablets

Levofloxacin

Hemihydrate 500mg

POM Tablet Uncoated 130/071 Denk Pharma, Germany

1833Panto-Denk 40 Tablets

Pantoprazole Sodium BP

40mg

POM Tablet Uncoated 130/072 Denk Pharma, Germany

1834Panto-Denk 20 Tablets

Pantoprazole Sodium BP

40mg

POM Tablet Uncoated 130/073 Denk Pharma, Germany

1835Levo Denk -250 Tablets

Levofloxacin

Hemihydrate 250mg

POM Tablet Uncoated 130/074 Denk Pharma, Germany

1836

Amoxiclav-Denk 1000/125

Tablets

Amoxicillin 1000mg+

Clavulanic Acid 125mg

POM Tablet Uncoated 130/075 Denk Pharma, Germany

1837 Valsar-Denk 320 Tablets Valsartan 320mg POM Tablet Film coated 130/076 Denk Pharma, Germany

1838 Valsr- Denk 80 Tablets Valsartan 80mg POM Tablet Film coated 130/077 Denk Pharma, Germany

1839Magnes Active Powder

Magnesium 300 mg P Powder for Oral

Solution

130/078 Denk Pharma, Germany

1840Calcium Active Denk Tablets

Calcium 500 mg P Tablet,

Effervescent

130/079 Denk Pharma, Germany

1841

Fertilio Denk Tablets

Selenium, Zinc, Folic

Acid, Vitamin E, L-

arginine, L-carnitine and

Coenzyme Q10

P Powder for Oral

Solution

130/080 Denk Pharma, Germany

1842

Ferro Vital+Denk CW

Iron 15 mg + Folic Acid

400 µg + Vitamin C

30mg

P Tablet Uncoated 130/081 Denk Pharma, Germany

1843Magnes Direct Denk Sachets

Magnesium Hydroxide

400mg

P Powder for Oral

Solution

130/083 Denk Pharma, Germany

1844

Prenatal Denk

Folic Acid 800 µg, all B-

vitamins and Iodine 150

µg

P Tablet Uncoated 130/084 Denk Pharma, Germany

1845 Valsar-Denk 160 Tablets Valsartan 160mg POM Tablet Uncoated 130/085 Denk Pharma, Germany

1846 Valsar- Denk 40 Tablets Valsartan 40mg POM Tablet Uncoated 130/086 Denk Pharma, Germany

1847

Covalsar-Denk

Valsartan 320mg +

Hydrochlorothiazide

12.5mg

POM Tablet Uncoated 130/087 Denk Pharma, Germany

1848

Covalsar-Denk

Valsartan 160mg +

Hydrochlorothiazide

12.5mg

POM Tablet Uncoated 130/088 Denk Pharma, Germany

1849 Metformin Denk 850 Tablets Metformin 850mg POM Tablets oral 130/131 Denk Pharma, Germany

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1850

Timodor Eye Drops Dorzolamide HCLL

20mg/ml + Timolol

Maleate 5mg/ml

POM Ear/Eye Drops 447/001 Diamond pharma

1851 Mycoten® Cream Clotrimazole BP 1% 20g P topical cream 399/002 Drug International Limited

1852

Biocoten® Cream

Gentamycin BP 1.0mg +

Dexamethasone BP

0.4mg + Chlotrimazole

BP 10.0mg

POM topical cream 399/001 Drugfield Pharmaceuticals Ltd

1853

Neurogesic® Greaseless

Ointment

Methylsalicylate BP

15% + Menthol BP 5%

GS topical ointment 399/003 Drugfield Pharmaceuticals Ltd

1854Chlorxy-G Gel

Chlorhexidine

Digluconate 7.1%

GS topical gel 399/004 Drugfield Pharmaceuticals Ltd

1855 Goat's Milk Tablets Goat Milk 250mg P Tablet Uncoated 031/001L Dynapharm International (Zambia) Limited

1856 Di Sprulina Tablets Sprulina 300mg P Tablet Uncoated 031/002L Dynapharm International (Zambia) Limited

1857Yeeginkgo Tablets

Ginkgoo Biloba Extract

40mg

P Tablet Uncoated 031/003L Dynapharm International (Zambia) Limited

1858Tongkat Ali Tablets

Tongkat Ali Extract

100mg

P Capsule oral 031/004L Dynapharm International (Zambia) Limited

1859

Di Liquid Chlorophyll Plus

Guarana Solution

Herbal Extracts P Solution for Oral

Use

031/005L Dynapharm International (Zambia) Limited

1860 Dyna Tonic Syrup Herbal Extracts P Syrup 031/006L Dynapharm International (Zambia) Limited

1861 Bee Pollen Capsule Bee Pollen 450mg P Capsule oral 031/007L Dynapharm International (Zambia) Limited

1862 Dyna Rh Capsules D-glucosamine 250mg P Capsule oral 031/008L Dynapharm International (Zambia) Limited

1863 Ginseng Capsules Ginseng Powder 300mg P Capsule oral 031/009L Dynapharm International (Zambia) Limited

1864 Yeegarlic Capsules Garlic 160mg P Capsule oral 031/010L Dynapharm International (Zambia) Limited

1865Yeeyangyen Tablets

Grape Seed Dry Extract

50mg

P Tablet Uncoated 031/011L Dynapharm International (Zambia) Limited

1866 Dyna C 250 Tablets Ascobic Acid 250mg P Tablet Uncoated 031/012L Dynapharm International (Zambia) Limited

1867 Mancare Plus Capsules Herbal Extracts P Capsule oral 031/013L Dynapharm International (Zambia) Limited

1868

Daily-Vite Multivitamin Syrup

Vit A 2000IU + Vit D

400IU + Vit B2 1.5mg +

Vit B6 1.0mg + Vit B12

3.0mcg + Niacinamide

10mg + Vit C 50mg + L-

37.5mg

P Syrup 031/014 Dynapharm International (Zambia) Limited

1869 Herba Warisani Maharani Herbal Preparation P Tablet Film coated 031/014L Dynapharm International (Zambia) Limited

1870 Dyanil Tablets Glibenclamide 5mg POM Tablet Uncoated 031/015 Dynapharm International (Zambia) Limited

1871 Dyna Calcium Tablets Calcium Lactate 39mg P Tablet Uncoated 031/016 Dynapharm International (Zambia) Limited

1872 Metformin Tablets Metformin 500mg POM Tablet Uncoated 031/017 Dynapharm International (Zambia) Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1873Milk Thistle Tablets

Silybum marianum

100mg

P Tablet Uncoated 031/018L Dynapharm International (Zambia) Limited

1874 Amoxicillin Capsules 250mg Amoxicillin 250mg POM Capsule oral 031/019 Dynapharm International (Zambia) Limited

1875 Amoxicillin Capsules 500mg Amoxicillin 500mg POM Capsule oral 031/020 Dynapharm International (Zambia) Limited

1876 Cloxacillin Capsules 250mg Cloxacillin 250mg POM Capsule oral 031/021 Dynapharm International (Zambia) Limited

1877 Dynafucin 500 Tablet Griseofulvin 500mg POM Tablet Uncoated 031/022 Dynapharm International (Zambia) Limited

1878 Doxycycline Capsule 100mg Doxycycline 100mg POM Capsule oral 031/023 Dynapharm International (Zambia) Limited

1879 Dynidazole Tablet 200mg Metronidazole 200mg POM Tablet Uncoated 031/024 Dynapharm International (Zambia) Limited

1880 Lomodium Tablets 2mg Loperamide 2mg POM Tablet Uncoated 031/025 Dynapharm International (Zambia) Limited

1881 Prednisolone Tablet Prednisolone 5mg POM Tablet Uncoated 031/026 Dynapharm International (Zambia) Limited

1882 PRO- LSB Tablets Probiotics P Tablet Uncoated 031/027 Dynapharm International (Zambia) Limited

1883 Dyna Serenoa Tablets Serenoa repens 80mg P Tablet Uncoated 031/028L Dynapharm International (Zambia) Limited

1884 Dyna S Tablets Herbal Preparation P Tablet Uncoated 031/029L Dynapharm International (Zambia) Limited

1885 Sea Cucamber Plus Syrup Herbal Preparation P Syrup 031/030L Dynapharm International (Zambia) Limited

1886 Green Tea Extract Capsules Herbal Preparation P Capsule oral 031/031L Dynapharm International (Zambia) Limited

1887Diproson Lotion

Betamethasone

0.05%w/w

POM Lotion for Topical

Use

075/031 Dynapharm International (Zambia) Limited

1888Edmark Ginseng Coffee

Ginseng Powder 1.5%

per Sachet

GS Granules for Oral

Use

312/001L Edmark International (Z) Ltd,Malaysia

1889

Edmark Splina Liquid

Chlorophyll Drink

Chlorophyll 4 gms P Solution for Oral

Use

312/002L Edmark International (Z) Ltd,Malaysia

1890

Edmark MRT Complex

Chocolate Drink

Isolated Soya Protein

39.83% + Low Fat Milk

29.9% + L-Carnit 1.82%

GS Powder for Oral

Suspension

312/003L Edmark International (Z) Ltd,Malaysia

1891Edmark Red Yeast Coffee

Red Yeast Rice Powder

1.5%

P Granules for Oral

Use

312/004L Edmark International (Z) Ltd,Malaysia

1892

Edmark Shake Off

Instant Oat 45% +

Psyllium Husk 19.5% +

Inulin 2%

P Granules for Oral

Use

312/005L Edmark International (Z) Ltd,Malaysia

1893DEC Tablets

Diethyl Carbamazine

Citrate 100mg

POM Tablet Film coated 348/001 Eisai Pharmatechnology & Manufacturing

Pvt. Ltd

1894Shelcal-250 Tablets

Calcium 250mg + Vitamin

D3 125iu

P Tablet Uncoated 285/001 Elder Pharmaceuticals Ltd, India

1895 Alonurish Acne Gel Herbal Extracts GS Gel Topical 285/001HM Elder Pharmaceuticals Ltd, India

1896

A.M. P.M. Plus Dental Rinse

Triclosan 0.03% +

Sodium Benzoate 2% +

Sodium Fluoride 0.05%

w/v + Alcohol

GS Solution for Oral

Use

285/002HM Elder Pharmaceuticals Ltd, India

1897 Venex 300 Tablets Diosmin 300mg POM Tablet Uncoated 285/003 Elder Pharmaceuticals Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 1898 Alonurish Moisturising Cream Herbal extracts GS Cream Topical 285/003HM Elder Pharmaceuticals Ltd, India

1899 Venex 500 Tablets Diosmin 500mg POM Tablet Uncoated 285/004 Elder Pharmaceuticals Ltd, India

1900Alonurish Scalp Cleanser

Herbal Extracts GS Solution for Topical

Use

285/004HM Elder Pharmaceuticals Ltd, India

1901Conjugate 0.625 Tablets

Conjugated Oestrogen

0.625mg

POM Tablet Film coated 285/005 Elder Pharmaceuticals Ltd, India

1902

A.M. P.M. Plus Junior Dental

Rinse

Triclosan 0.03%+ Sodium

Benzoate 0.05% +

Sodium Fluoride +

Alcohol

GS Solution for Oral

Use

285/005HM Elder Pharmaceuticals Ltd, India

1903Shelcal-500 Tablets

Calcium 500mg + Vitamin

D3 125IU

P Tablet Uncoated 285/006 Elder Pharmaceuticals Ltd, India

1904 Alonurish Alnite Cream Herbal Extracts P Cream Topical 285/006HM Elder Pharmaceuticals Ltd, India

1905Deviry 10 Tablets

Medroxyprogesterone

10mg

POM Tablet Uncoated 285/007 Elder Pharmaceuticals Ltd, India

1906Alonurish Sunscreen Lotion

Herbal Extracts P Lotion for Topical

Use

285/007HM Elder Pharmaceuticals Ltd, India

1907 Edge 400 Capsules Vitamin E 400IU POM Capsule oral 285/008 Elder Pharmaceuticals Ltd, India

1908Alonurish Face Cleanser

Herbal Extracts GS Solution for Topical

Use

285/008HM Elder Pharmaceuticals Ltd, India

1909

New Zephrol Syrup

Ambroxol 15mg +

Terbutaline 1.2mg +

Guaiphenesin 50mg +

Menthol 2.5mg

POM Syrup 285/009 Elder Pharmaceuticals Ltd, India

1910

A.M. P.M. Special Dental Rinse

Triclosan 0.03%w/v +

Sodium Benzoate

2.0%w/v + Sodium

Fluoride 0.05%w/v +

Thymol 0.2%w/v

GS Solution for Oral

Use

285/009HM Elder Pharmaceuticals Ltd, India

1911 Tiger Balm White Ointment Herbal Extracts GS Ointment topical 285/010HM Elder Pharmaceuticals Ltd, India

1912Shelcal Syrup

Calcium 250mg + Vitamin

D3 125IU

P Syrup 285/011 Elder Pharmaceuticals Ltd, India

1913 Mucodyne Syrup Carbocisteine 260mg P Syrup 285/011HM Elder Pharmaceuticals Ltd, India

1914

Chymoral Forte Tablets

Proteolytic Enzyme

Eoncentrate 100,000 I.U.

POM Tablet Uncoated 285/012 Elder Pharmaceuticals Ltd, India

1915 Solo Cough Syrup Herbal extracts 605mg P Syrup 285/012HM Elder Pharmaceuticals Ltd, India

1916 Eldervit Capsules Vitamins 349.5mg P Capsule oral 285/013 Elder Pharmaceuticals Ltd, India

1917 Jetmox - 250 Capsules Amoxicillin 250mg POM Capsule oral 285/014 Elder Pharmaceuticals Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1918

Amifru-40 Tablets

Furosemide 40mg +

Amiloride Hydrochoride

5mg

POM Tablet Uncoated 285/015 Elder Pharmaceuticals Ltd, India

1919

Hormorin Soft Gel Capsules

200mg

Progesterone 200mg POM Capsule oral 285/016 Elder Pharmaceuticals Ltd, India

1920Xtra-P Tablets

Aceclofenac 100mg +

Paracetamol 500mg

P Tablet Film coated 285/017 Elder Pharmaceuticals Ltd, India

1921

Elder Vit -12 Injection

Vitamin C 150mg +

Vitamin B12 2500mcg +

Folic Acid 0.7mg +

Niacinamide 1.2mg

POM Solution for

infusion

285/018 Elder Pharmaceuticals Ltd, India

1922 Carnisure-500 Tablets Levocarnitine 500mg POM Tablet Uncoated 285/019 Elder Pharmaceuticals Ltd, India

1923 Powertad 20 Tablets Tadalafil 20mg POM Tablet Uncoated 285/020 Elder Pharmaceuticals Ltd, India

1924 Powertad 10 Tablets Tadalafil 10mg POM Tablet Uncoated 285/021 Elder Pharmaceuticals Ltd, India

1925 Clair 500mg Tablets Clarithromycin 500mg POM Tablet Uncoated 285/022 Elder Pharmaceuticals Ltd, India

1926 Clair 250mg Tablets Clarithromycin 250mg POM Tablet Uncoated 285/023 Elder Pharmaceuticals Ltd, India

1927Eprin -75 Tablets

Aspirin 75mg POM Tablet Enteric

Coated

285/024 Elder Pharmaceuticals Ltd, India

1928 Vitessen C Tablets Ascorbic Acid 500mg P Tablet Chewable 285/025 Elder Pharmaceuticals Ltd, India

1929 Antizip Capsules Nizatidine 150mg POM Capsule oral 174/001 Eli Lilly (SA) Pty Ltd

1930Prozac Tablets

Fluoxetine Hdyrochloride

EurP 20mg

POM Tablet Uncoated 174/002 Eli Lilly (SA) Pty Ltd

1931 Lilly-Cefador Tablets Cefaclor 375mg POM Tablet Uncoated 174/003 Eli Lilly (SA) Pty Ltd

1932Lilly-Cefaclor Suspension

Cefaclor 375mg, per 5ml POM Powder for Oral

Suspension

174/004 Eli Lilly (SA) Pty Ltd

1933Lilly Cefaclor Granules

Cefaclor Monohydrate

USP 187mg, per ml

POM Suspension 174/005 Eli Lilly (SA) Pty Ltd

1934

Alugel Suspension

Aluminium Hydrochloride

120mg + Magnesium

Trisilicate 250mg

GS Suspension for

Oral Use

188/001 Elys Chemicals Industries Ltd, Kenya

1935 Ampicillin Capsules Ampicillin 250mg POM Capsule oral 188/002 Elys Chemicals Industries Ltd, Kenya

1936Bukol Tablets

Hyoscine Butyl Bromide

10mg

POM Tablet Uncoated 188/003 Elys Chemicals Industries Ltd, Kenya

1937

Chestcof Syrup

Glycyrrhiza + Menthol +

Aniseed oil + Peppermint

oil + Ipecacuanha +

Capsicum

GS Syrup 188/004 Elys Chemicals Industries Ltd, Kenya

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1938Elyclox Capsules

Ampicillin 250mg +

Cloxacillin 250mg

POM Capsule oral 188/005 Elys Chemicals Industries Ltd, Kenya

1939 Elymox Capsules Amoxicillin POM Capsule oral 188/006 Elys Chemicals Industries Ltd, Kenya

1940 Elyvate Ointment Betamethasone 0.5% POM Ointment topical 188/007 Elys Chemicals Industries Ltd, Kenya

1941 Elyvate Cream Betamethasone 0.5% POM Cream Topical 188/008 Elys Chemicals Industries Ltd, Kenya

1942 Fungistin Vaginal Tablets Nystatin 1000000IU POM Tablet Vaginal 188/009 Elys Chemicals Industries Ltd, Kenya

1943Junior Aspirin Tablets

Acetyl Salicylic Acid

80mg

GS Tablet Uncoated 188/010 Elys Chemicals Industries Ltd, Kenya

1944 Nitrofurantoin Tablets Nitrofurantoin 100mg POM Tablet Uncoated 188/011 Elys Chemicals Industries Ltd, Kenya

1945Orodar Tablets

Sulfadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 188/012 Elys Chemicals Industries Ltd, Kenya

1946 Promethazine Tablets Promethazine 25mg P Tablet Uncoated 188/013 Elys Chemicals Industries Ltd, Kenya

1947 Quinine Tablets Quinine Sulphate 300mg POM Tablet Film coated 188/014 Elys Chemicals Industries Ltd, Kenya

1948 Elycort Ointment Hydrocortisone 0.1g POM Ointment Topical 188/015 Elys Chemicals Industries Ltd, Kenya

1949Elymox Powder

Amoxicillin 125mg, per

5ml

POM Suspension for

Oral Use

188/016 Elys Chemicals Industries Ltd, Kenya

1950

Cloxacillin Powder For

Suspension

Cloxacillin 125mg, per

5ml

POM Suspension for

Oral Use

188/017 Elys Chemicals Industries Ltd, Kenya

1951Ampicillin Powder

Ampicillin 125mg, per

5ml

POM Suspension for

Oral Use

188/018 Elys Chemicals Industries Ltd, Kenya

1952Elypen Tablets

Phenoxymethyl Penicillin

V 250mg

POM Tablet Uncoated 188/019 Elys Chemicals Industries Ltd, Kenya

1953Whitefield Ointment

Salicylic Acid + Benzoic

Acid

P Ointment topical 188/020 Elys Chemicals Industries Ltd, Kenya

1954

Lyte Oral Rehydration Salt

Sodium Chloride +

Sodium Citrate +

Patassium Chloride +

Glucose

GS Powder for Oral

Solution

188/021 Elys Chemicals Industries Ltd, Kenya

1955 Wormol Tablets Mebendazole 100mg P Tablet Uncoated 188/022 Elys Chemicals Industries Ltd, Kenya

1956

Elydac Syrup

Vit A + Thiamine +

Riboflavin + Nicotinamide

+ Vit C + Vit D3

P Syrup 188/023 Elys Chemicals Industries Ltd, Kenya

1957 Frusemide Tablets Frusemide 40mg POM Tablet Uncoated 188/024 Elys Chemicals Industries Ltd, Kenya

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1958

Tripacof Syrup

Chlorpheniramine 1mg +

Diphenhydramine 5mg +

Promethazine 2.5mg +

Ephedrine 7.5mg +

Ammonium Chloride

40mg

P Syrup 188/025 Elys Chemicals Industries Ltd, Kenya

1959 Vulmtrex Tablets Levamisole 40mg P Tablet Uncoated 188/026 Elys Chemicals Industries Ltd, Kenya

1960Vumtrex Suspension

Levamisole 40mg, per

5ml

P Suspension for

Oral Use

188/027 Elys Chemicals Industries Ltd, Kenya

1961Mifupen Tablets

Aspirin 350mg BP +

Caffeine 30mg BP

GS Tablet Uncoated 188/028 Elys Chemicals Industries Ltd, Kenya

1962

Chestcof Lozenges

Glycyrrhiza + Menthol +

Aniseed oil + Peppermint

oil

GS Lozenges 188/029 Elys Chemicals Industries Ltd, Kenya

1963 Antihistamin Cream Mepyramine 0.306 gm P Cream Topical 188/030 Elys Chemicals Industries Ltd, Kenya

1964 Elytetra Ointment Tetracycline 0.495gm POM Cream Topical 188/031 Elys Chemicals Industries Ltd, Kenya

1965 Ibufen Tablets Ibuprofen 200mg P Tablet Uncoated 188/032 Elys Chemicals Industries Ltd, Kenya

1966Multivitamin Tablets

Multivitamins GS Tablet Enteric

Coated

188/033 Elys Chemicals Industries Ltd, Kenya

1967 Elytetra Capsules Tetracycline 250MG POM Capsule oral 188/034 Elys Chemicals Industries Ltd, Kenya

1968 Doxycycline Caps Doxycycline 100mg POM Capsule oral 188/035 Elys Chemicals Industries Ltd, Kenya

1969 Sulphur Ointment Sulphur 2g P Cream Topical 188/036 Elys Chemicals Industries Ltd, Kenya

1970 Fungistat Cream Miconazole 0.3%w/v POM Cream Topical 188/037 Elys Chemicals Industries Ltd, Kenya

1971 Elocin Tablets Erythromycin 250mg POM Tablet Uncoated 188/038 Elys Chemicals Industries Ltd, Kenya

1972

Himani Fast Relief Herbal Pain

Relief Ointment

Herbal Extracts GS Ointment topical 369/001L Emami Limited, India

1973

Himani Fast Relief Herbal Pain

Balm

Herbal Extracts GS Ointment topical 369/002L Emami Limited, India

1974

Himani Boroplus Antiseptic

Cream

Herbal Extracts GS Cream Topical 369/003L Emami Limited, India

1975Emami Mentho Plus Balm

Herbal Extracts GS Lotion for Topical

Use

369/004L Emami Limited, India

1976

Himani Fast Relief Herbal Pain

Relief Spray

Herbal Extracts GS Spray for Topical

Use

369/005L Emami Limited, India

1977

Himani Fast Relief Herbal

Vapour Rub

Herbal Extracts GS Ointment topical 369/006L Emami Limited, India

1978 Rosiz 4 Tablets Rosiglitazone 4mg POM Tablet Film coated 125/040 Emcure Pharmaceuticals Limited, India

1979Augpen 375 Tablets

Amoxicillin + Clavulanate

Potassium 375mg

POM Tablet Film coated 195/001 Emcure Pharmaceuticals Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

1980Augpen 625 Tablets

Amoxicillin + Clavulanate

Potassium 625mg

POM Tablet Film coated 195/002 Emcure Pharmaceuticals Limited, India

1981 Ciprobiotic Eye/Ear Drops Ciprofloxacin 3mg POM Ear/Eye Drops 195/003 Emcure Pharmaceuticals Limited, India

1982 Zeflox Eye/Ear Drops Norfloxacin 15mg POM Ear/Eye Drops 195/004 Emcure Pharmaceuticals Limited, India

1983 Diclomove NDS Gel Diclofenac 1%w/w P Gel Topical 195/005 Emcure Pharmaceuticals Limited, India

1984C-Tri Injection

Ceftriaxone 1g POM Powder for

Injection

195/006 Emcure Pharmaceuticals Limited, India

1985 Orofer Chewable Tablets Folic Acid + Iron P Tablet Film coated 195/008 Emcure Pharmaceuticals Limited, India

1986 Nusar 50 Tablets Losartan 50mg POM Tablet Film coated 195/010 Emcure Pharmaceuticals Limited, India

1987Orofer Drops

Ferric oxide 50mg P Solution for Oral

Use

195/011 Emcure Pharmaceuticals Limited, India

1988

Emtri Tablets

Lamivudine 200mg +

Nevirapine 150mg +

Stavudine 40mg

POM Tablet Uncoated 195/012 Emcure Pharmaceuticals Limited, India

1989

Ciprobiotic FC Cream

Ciprofloxacin 0.5%w/w +

Clotrimazole +

Fluocinolone Acetonide

POM Cream Topical 195/014 Emcure Pharmaceuticals Limited, India

1990 Zosec Capsules Omeprazole 20mg POM Capsule oral 195/015 Emcure Pharmaceuticals Limited, India

1991 Ciprobiotic Forte Tablets Ciprofloxacin 500mg POM Tablet Film coated 195/017 Emcure Pharmaceuticals Limited, India

1992

Agupen Suspension

Amoxicillin Trihydrate

500mg + Clavulanic Acid

125mg

POM Suspension for

Oral Use

195/018 Emcure Pharmaceuticals Limited, India

1993Orofer Syrup

Cyanocobalamin 5mcg +

Elemental Iron 50mg

P Syrup 195/019 Emcure Pharmaceuticals Limited, India

1994 Orofer Cap Folic Acid + Iron P Capsule Oral 195/020 Emcure Pharmaceuticals Limited, India

1995 Orofer Capsules Folic Acid + Iron P Capsule oral 195/021 Emcure Pharmaceuticals Limited, India

1996Beclasone C Cream

Clioquinol BP +

Beclomethasone BP 15g

POM Cream Topical 195/022 Emcure Pharmaceuticals Limited, India

1997

Vifex Syrup

Salbutamol 1mg +

Bromhexine 2mg +

Guaiphenesin 50mg +

Menthol 0.5mg

P Syrup 195/024 Emcure Pharmaceuticals Limited, India

1998Caloshel Tablets

Colecalciferol 500mg +

Elemental Calcium

P Tablet Uncoated 195/026 Emcure Pharmaceuticals Limited, India

1999 C-Tax 200 Tablets Cefixime 200mg POM Tablet Film coated 195/028 Emcure Pharmaceuticals Limited, India

2000C-Tax P 50 Dry Syrup

Cefixime 50mg POM Suspension for

Oral Use

195/029 Emcure Pharmaceuticals Limited, India

2001 Atorec 10 Tablets Atorvastatin 10mg POM Tablet Film coated 195/030 Emcure Pharmaceuticals Limited, India

2002 Atorec 20 Tablets Atorvastatin 20mg POM Tablet Film coated 195/031 Emcure Pharmaceuticals Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 2003 Acem-500mg Clarithromycin 500mg POM Tablet Uncoated 195/033 Emcure Pharmaceuticals Limited, India

2004 Asomex-2.5 Tablets Amlodipine 2.5mg POM Tablet Uncoated 195/034 Emcure Pharmaceuticals Limited, India

2005 Asomex- 5 Tablets Amlodipine 5mg POM Tablet Uncoated 195/035 Emcure Pharmaceuticals Limited, India

2006Nusar H Tablets

Losartan +

Hydrochlorothiazide

POM Tablets Oral 195/036 Emcure Pharmaceuticals Limited, India

2007 Sylate 500 Tablets Etamsylate 500mg POM Tablet Uncoated 195/038 Emcure Pharmaceuticals Limited, India

2008 Rosiz 2 Tablets Rosiglitazone 2mg POM Tablet Film coated 195/039 Emcure Pharmaceuticals Limited, India

2009 Diclomove SR Tablets Diclofenac POM Tablet Uncoated 195/041 Emcure Pharmaceuticals Limited, India

2010 Dinor Tablets Didanosine 100mg POM Tablet Chewable 195/042 Emcure Pharmaceuticals Limited, India

2011 Lamir -150 Tablets Lamivudine 150mg POM Tablet Film coated 195/043 Emcure Pharmaceuticals Limited, India

2012 Zidine Capsules Zidovudine 100mg POM Capsule oral 195/044 Emcure Pharmaceuticals Limited, India

2013 Stadine - 40 Capsules Stavudine 40mg POM Capsule oral 195/045 Emcure Pharmaceuticals Limited, India

2014 Efcure Tablets Efavirenz 600mg POM Tablet Uncoated 195/046 Emcure Pharmaceuticals Limited, India

2015Emduo-40 Tablets

Lamivudine 150mg +

Stavudine 40mg

POM Tablet Uncoated 195/047 Emcure Pharmaceuticals Limited, India

2016 Zidine Tablets Zidovudine 300mg POM Tablet Uncoated 195/048 Emcure Pharmaceuticals Limited, India

2017Zidine Oral Solution

Zidovudine 50mg, per

5ml

POM Solution for Oral

Use

195/049 Emcure Pharmaceuticals Limited, India

2018

Emtri Suspension

Stavudine 10mg +

Lamivudine 40mg +

Nevirapine 70mg

POM Suspension for

Oral Use

195/051 Emcure Pharmaceuticals Limited, India

2019

Vintor Injection

Alpha-Recombinant

Human Erythropoietin

2000IU

POM Solution for

Injection

195/052 Emcure Pharmaceuticals Limited, India

2020

Emtri Junior Tablets

Lamivudine 40mg +

Stavudine 10mg +

Nevirapine 70mg

POM Tablet Uncoated 195/053 Emcure Pharmaceuticals Limited, India

2021Encifer Injection

Ferric Hydroxide complex

2g, per ml

POM Solution for

Injection

195/054 Emcure Pharmaceuticals Limited, India

2022 Metpure-XL S-(-) Metoprolol 25mg POM Tablet Uncoated 195/056 Emcure Pharmaceuticals Limited, India

2023 Metpure-XL S-(-) Metoprolol 50mg POM Tablet Uncoated 195/057 Emcure Pharmaceuticals Limited, India

2024 Panpure Tablets S-Pantoprazole 20mg POM Tablet Uncoated 195/058 Emcure Pharmaceuticals Limited, India

2025 Ibusoft 300 Dexibuprofen 300mg P Tablet Film coated 195/059 Emcure Pharmaceuticals Limited, India

2026 Ibusoft 400 Dexibuprofen 400mg P Tablet Film coated 195/060 Emcure Pharmaceuticals Limited, India

2027

Lomoh-40 (Low Molecular

Weight Heparin) Injection

Enoxaparin 40mg POM Solution for

Injection

195/061 Emcure Pharmaceuticals Limited, India

2028

Lomoh -60 (Low Molecular

Weight Heparin) Injection

Enoxaparin 60mg POM Solution for

Injection

195/062 Emcure Pharmaceuticals Limited, India

2029 MOFILET - 500 Tablets Mycophenolate 500mg POM Tablet Uncoated 195/063 Emcure Pharmaceuticals Limited, India

Page 104 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 2030 Atazor 100 Capsules Atazanavir 100mg POM Capsule oral 195/064 Emcure Pharmaceuticals Limited, India

2031 Atazor 150 Capsules Atazanavir 150mg POM Capsule oral 195/065 Emcure Pharmaceuticals Limited, India

2032 Atazor 200 Capsules Atazanavir 200mg POM Capsule oral 195/066 Emcure Pharmaceuticals Limited, India

2033

Emtri Tablets

Lamivudine 150mg +

Stavudine 30mg +

Nevirapine 200mg

POM Tablet Uncoated 195/067 Emcure Pharmaceuticals Limited, India

2034Vintor 4000 Injection

Erythropoietin 4000 iu POM Solution for

Injection

195/068 Emcure Pharmaceuticals Limited, India

2035Atazor 300 Capsules

Atazanavir Sulphate

300mg

POM Capsule oral 195/069 Emcure Pharmaceuticals Limited, India

2036Antiplar Tablets

Clopidogrel BiSulphate

75mg

POM Tablet Uncoated 195/070 Emcure Pharmaceuticals Limited, India

2037

Atazor - R Tablets

Atazanavir Sulphate

300mg + Ritonivir 100mg

POM Tablet Uncoated 195/071 Emcure Pharmaceuticals Limited, India

2038

Xplode Tablets

Cyanocobalamin 0.4 mcg

+ Elemental Zinc 4 mg +

Folic Acid 45 mcg +

Panax ginseng extract

42.5 mg + Resveratrol 75

mg + Vitamin C 20 mg

P Tablet Film coated 195/072 Emcure Pharmaceuticals Limited, India

2039Cerizine Tablets

Levocetirizine

Hydrochloride BP 5mg

P Tablet Uncoated 195/073 Emcure Pharmaceuticals Limited, India

2040 Sustinex 30 Tablets Dapoxetine 30mg POM Tablet Uncoated 195/074 Emcure Pharmaceuticals Limited, India

2041 Proxym 300 Tablets Etodolac 300mg POM Tablet Film coated 195/075 Emcure Pharmaceuticals Limited, India

2042Asomex-LT Tablets

Losartan Pottassium

+Amilodipine Besilate

POM Tablet Uncoated 195/076 Emcure Pharmaceuticals Limited, India

2043Panpure IV Injection

S (-) Pantoprazole

Sodium

POM Powder for

Injection

195/077 Emcure Pharmaceuticals Limited, India

2044

Pause Injection Tranexamic acid

500mg/5ml

POM Solution for

Injection

195/078 Emcure Pharmaceuticals Limited, India

2045Zoocef-200 Tablets

Cefixime Trihydrate USP

200mg

POM Tablet Uncoated 030/001 Emzor Exports Pvt Ltd, India

2046Zoocef-100 Tablets

Cefixime Trihydrate USP

100mg

POM Tablet Uncoated 030/002 Emzor Exports Pvt Ltd, India

2047Azith-250 Tablets

Azithromycin Dihydrate

USP 250mg

POM Tablet Uncoated 030/003 Emzor Exports Pvt Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2048Azith-500 Tablets

Azithromycin Dihydrate

USP 500mg

POM Tablet Uncoated 030/004 Emzor Exports Pvt Ltd, India

2049 Rancip Tablets Ciprofloxacin 500mg POM Tablet Film coated 278/001 Erica Pharma Pvt Ltd, India

2050

Ericef Injection Ceftriaxone 1g POM Powder for

Injection

278/002 Erica Pharma Pvt Ltd, India

2051

Ryvakelfin Tablets Pyrimthamine 25 +

Sulfadoxine 500 mg

POM Tablet Uncoated 278/003 Erica Pharma Pvt Ltd, India

2052

Erisunat Suspension Artesunate 160mg, per

80ml

POM Suspension for

Oral Use

278/004 Erica Pharma Pvt Ltd, India

2053

Lumether Suspension Lumefantrine 120mg +

Artemether 20mg

POM Suspension for

Oral Use

278/005 Erica Pharma Pvt Ltd, India

2054

Erinin Suspension Dihydroartemisinin

160mg, per 80ml

POM Suspension 278/006 Erica Pharma Pvt Ltd, India

2055 Ucon Capsules Fluconazole 200mg POM Capsule oral 278/007 Erica Pharma Pvt Ltd, India

2056 Optragen Eye Drops Gentamycin 0.3 % POM Eye Drops 278/008 Erica Pharma Pvt Ltd, India

2057

Eriamp Suspension Ampicillin 250mg, per

5ml

POM Suspension for

Oral Use

278/009 Erica Pharma Pvt Ltd, India

2058

Erither Oral Suspension Artemether 180mg, per

5ml

POM Solution for Oral

Use

278/010 Erica Pharma Pvt Ltd, India

2059

Erilife Powder Oral Rehydration Salts

10.5g

GS Powder for Oral

Solution

278/011 Erica Pharma Pvt Ltd, India

2060 Erinin Tablets Dihydroartemisin 60mg POM Tablet Uncoated 278/012 Erica Pharma Pvt Ltd, India

2061

Eridol Oral Suspension Paracetamol 120mg, per

5ml

GS Suspension for

Oral Use

278/013 Erica Pharma Pvt Ltd, India

2062 Erisunat Tablets Arthemether 100mg POM Tablet Uncoated 278/014 Erica Pharma Pvt Ltd, India

2063

Erither Injection Artemether 80mg, per ml POM Solution for

Injection

278/015 Erica Pharma Pvt Ltd, India

2064

Lumether Tablets Lumefantrine 120mg +

Artemether 20mg

POM Tablet Film coated 278/016 Erica Pharma Pvt Ltd, India

2065

Rypanta Tablets Pantoprazole

Sesquihydrate 40mg

POM Tablet Enteric

Coated

278/017 Erica Pharma Pvt Ltd, India

2066 Ryvazole Capsules Omeprazole 20mg POM Capsule oral 278/018 Erica Pharma Pvt Ltd, India

2067

Amoxer Oral Suspension Amoxicillin BP 250mg,

per 5ml

POM Suspension for

Oral Use

278/019 Erica Pharma Pvt Ltd, India

2068

Tolybion Injection Vitamin B Complex POM Solution for

Injection

278/020 Erica Pharma Pvt Ltd, India

2069

Ryvakelfin Oral Drops Pyrimthamine 25 +

Sulfadoxine 500mg, per

10ml

POM Solution for Oral

Use

278/021 Erica Pharma Pvt Ltd, India

Page 106 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 2070 Erither Capsules Artemether 40mg POM Capsule oral 278/022 Erica Pharma Pvt Ltd, India

2071

Erixime Injection Cefotaxime 1g POM Powder for

Injection

278/023 Erica Pharma Pvt Ltd, India

2072

Oral Rehydration Salt Oral Rehydration Salt GS Powder for Oral

Solution

278/024 Erica Pharma Pvt Ltd, India

2073 Furosemide Tablets Furosemide BP 40mg POM Tablet Uncoated 278/025 Erica Pharma Pvt Ltd, India

2074

Erimet 850 Tablets Metformin Hydrochloride

850mg

POM Tablet Uncoated 278/026 Erica Pharma Pvt Ltd, India

2075

Erion K Syrup Ferric Ammonium Citrate

USP + Folic Acid BP +

Cynocobalamin

P Syrup 278/027 Erica Pharma Pvt Ltd, India

2076

Clauviax 625mg Tablets Amoxicillin USP +

Clavulanic Acid USP

POM Tablet Uncoated 278/028 Erica Pharma Pvt Ltd, India

2077

Chloramphenicol Sodium

Succinate Injection

Chloramphenicol Sodium

Succinate 1g

POM Powder for

Injection

278/032 Erica Pharma Pvt Ltd, India

2078

Furosemide Injection Furosemide BP 10mg,

per ml

POM Solution for

Injection

278/033 Erica Pharma Pvt Ltd, India

2079

Gentamycin Sulphate Injection Gentamycin Sulphate

40mg, per ml

POM Solution for

Injection

278/034 Erica Pharma Pvt Ltd, India

2080

Rancip 250 Tablets Ciprofloxacin

Hydrochloride 250mg

POM Tablet Uncoated 278/035 Erica Pharma Pvt Ltd, India

2081

Cefax -250 Tablets Cefuroxime Axetil 250mg POM Tablet Uncoated 278/036 Erica Pharma Pvt Ltd, India

2082

Erimal Capsules Amodiquine

Hydrochloride 300mg +

Artesunate 100mg

POM Capsule oral 278/038 Erica Pharma Pvt Ltd, India

2083

Erither 40 Injection Artemether 40mg, per ml POM Solution for

Injection

278/041 Erica Pharma Pvt Ltd, India

2084

Vagiclin Suppositories Clindamycin+

Clotrimazole

POM Suppository 278/042 Erica Pharma Pvt Ltd, India

2085 Optracip Drops Ciprofloxacin 0.3% POM Eye Drops 278/043 Erica Pharma Pvt Ltd, India

2086 Vagiclo Tablets Clotrimazole 100mg POM Tablet Vaginal 278/044 Erica Pharma Pvt Ltd, India

2087

Erimet Tablets Metformin Hydrochloride

500mg

POM Tablet Uncoated 278/045 Erica Pharma Pvt Ltd, India

2088

Clauviax -375 Amoxicillin 250mg +

Clavulanate 125mg

POM Tablet Uncoated 278/047 Erica Pharma Pvt Ltd, India

2089

Clauviax Suspension Amoxicillin 125mg +

Clavulanate 31.25mg

POM Suspension 278/048 Erica Pharma Pvt Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 2090 Psyclocare Tablets Resperidone 2mg POM Tablet Uncoated 278/049 Erica Pharma Pvt Ltd, India

2091

Flucolife Infusion Fluconazole 200mg, per

100ml

POM Solution for

infusion

307/001 Eurolife Healthcare PVT Ltd, India

2092

Mannilfe Infusion Mannitol 20g, per 100ml POM Solution for

infusion

307/002 Eurolife Healthcare PVT Ltd, India

2093

Metlife Infusion Metronidazole 500mg,

per 100ml

POM Solution for

infusion

307/003 Eurolife Healthcare PVT Ltd, India

2094

Sterile Water for Injection Water For Injection POM Solution for

Injection

307/004 Eurolife Healthcare PVT Ltd, India

2095

Ciplife Infusion Ciprofloxacin 200mg, per

100ml

POM Solution for

infusion

307/005 Eurolife Healthcare PVT Ltd, India

2096

Virecta Tablets Sildenafil Citrate I.H

100mg

POM Tablet Uncoated 358/001 Eva Pharma

2097

Vendexine Syrup Dexamethasone 0.5mg +

Chlorpheniramine 2mg

P Syrup 358/002 Eva Pharma

2098 Fusiderm Cream Fusidic acid 2% POM Cream Topical 358/003 Eva Pharma

2099

Electral Forte Powder Sodium

Chloride,Potassium

Chloride, Sodium Citrate,

Dextrose 24g

GS Powder for Oral

Solution

197/001 FDC Limited, India

2100

Co-trimoxazole Tablets Sulphamethoxazole

400mg + Trimethoprim

80mg

POM Tablet Uncoated 197/002 FDC Limited, India

2101

Moisol Eye Drops Hydroxypropylmethyl

Cellulose 0.7%w/v

P Eye Drops 197/003 FDC Limited, India

2102 Pilocar Eye Drops Pilocarpine 2%w/v POM Eye Drops 197/004 FDC Limited, India

2103

Pyricort Eye/Ear Drops Dexamethasone +

Gentamycin 0.1%w/v

POM Ear/Eye Drops 197/005 FDC Limited, India

2104

Pyrimon Eye/Ear Drops Dexamethasone +

Chloramphenicol

1.1%w/v

POM Ear/Eye Drops 197/006 FDC Limited, India

2105 Zoxan Eye/Ear Drops Ciprofloxacin 0.3%w/v POM Ear/Eye Drops 197/007 FDC Limited, India

2106 Ibuprofen Tablets Ibuprofen 200mg P Tablet Uncoated 197/008 FDC Limited, India

2107 Paracetamol Tablets Paracetamol BP 500mg GS Tablet Uncoated 197/010 FDC Limited, India

2108

Nucleo CMP Forte Capsules Cytidine -5 Disodium

Monophosphate +

Uridine Triphosphate

POM Capsule oral 366/001 Ferrer International S.A

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2109

Nucleo Forte C.M.P Forte

Injection

Cytidine -5-Disodium

Monophosphate (CMP -

Disodium Salt Urid

POM Solution for

Injection

366/002 Ferrer International S.A

2110

Zalain Vaginal Suppository Sertaconazole Nitrate

300mg

POM Suppository 366/003 Ferrer International S.A

2111

Peitel 0.25% Cream Prednicarbate E.P.

0.25% w/w

POM Cream Topical 366/006 Ferrer International S.A

2112

Amoxycillin Oral Suspension Amoxycillin 250mg, per

5ml

POM Suspension for

Oral Use

126/001 Flamingo Pharmaceuticals Limited, India

2113

Ampicillin 1000 Injection Ampicillin 1g POM Powder for

Injection

126/002 Flamingo Pharmaceuticals Limited, India

2114

Ampicillin 500 Injection Ampicillin 500mg POM Powder for

Injection

126/003 Flamingo Pharmaceuticals Limited, India

2115 Medampi Capsules Ampicillin 500mg POM Capsule oral 126/004 Flamingo Pharmaceuticals Limited, India

2116

Benzyl Penicillin Injection Benzyl Penicillin 1 Mega POM Powder for

Injection

126/005 Flamingo Pharmaceuticals Limited, India

2117 Tetra 500 Capsules Tetracycline 500mg POM Capsule oral 126/006 Flamingo Pharmaceuticals Limited, India

2118

Kanamycin Injection Kanamycin 1g POM Powder for

Injection

126/007 Flamingo Pharmaceuticals Limited, India

2119

Fortified Procaine Penicillin

Injection

Procain Penicillin POM Powder for

Injection

126/008 Flamingo Pharmaceuticals Limited, India

2120 Ibuprofen 200mg Tablets Ibuprofen 200mg P Tablet Uncoated 126/009 Flamingo Pharmaceuticals Limited, India

2121

Compound Magnesuim

Trisilicate Tablets

Aluminium Hydroxide

125mg + Magnesium

Trisilicate 250mg

GS Tablet Uncoated 126/010 Flamingo Pharmaceuticals Limited, India

2122

Co-trimoxazole Suspension Sulphamethoxazole +

Trimethoprim 240mg, per

5ml

POM Suspension for

Oral Use

126/011 Flamingo Pharmaceuticals Limited, India

2123 Cephalexin 500 Capsules Cephalexin 500mg POM Capsule oral 126/012 Flamingo Pharmaceuticals Limited, India

2124 Amoxin 500 Capsules Amoxicillin 500mg POM Capsule oral 126/013 Flamingo Pharmaceuticals Limited, India

2125 Indo 25 Capsules Indomethacin 25mg P Capsule oral 126/014 Flamingo Pharmaceuticals Limited, India

2126

Erycin 125 Suspension Erythromycin 125mg, per

5ml

POM Suspension for

Oral Use

126/015 Flamingo Pharmaceuticals Limited, India

2127 Quinine Tablets Quinine Sulphate 300mg POM Tablet Uncoated 126/016 Flamingo Pharmaceuticals Limited, India

2128

Metronidazole Suspension Metronidazole 125mg,

per 5ml

POM Suspension for

Oral Use

126/017 Flamingo Pharmaceuticals Limited, India

2129 Medfulin Tablets Griseofulvin 500mg POM Tablet Uncoated 126/018 Flamingo Pharmaceuticals Limited, India

2130 Metroforce 200 Tablets Metronidazole 200mg POM Tablet Uncoated 126/019 Flamingo Pharmaceuticals Limited, India

2131 Reduced 300 Tablets Ranitidine 300mg POM Tablet Uncoated 126/020 Flamingo Pharmaceuticals Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 2132 Flamodip 10 Tablets Amlodipine 10mg POM Tablet Uncoated 126/021 Flamingo Pharmaceuticals Limited, India

2133 Flamodip 5 Tablets Amlodipine 5mg POM Tablet Uncoated 126/022 Flamingo Pharmaceuticals Limited, India

2134 Reduced 150 Tablets Ranitidine 150mg POM Tablet Uncoated 126/023 Flamingo Pharmaceuticals Limited, India

2135 Ibuprofen 400mg Tablets Ibuprofen 400mg P Tablet Uncoated 126/024 Flamingo Pharmaceuticals Limited, India

2136 Cardipril 2.5 Capsules Ramipril 2.5mg POM Capsule oral 126/025 Flamingo Pharmaceuticals Limited, India

2137 Mefenamic Acid Capsules Mefenamic Acid 500mg P Capsule oral 126/026 Flamingo Pharmaceuticals Limited, India

2138

Neumicin B Injection Benzathine Penicillin

2.5Mega

POM Powder for

Injection

126/027 Flamingo Pharmaceuticals Limited, India

2139 Kamox 250 Capsules Amoxycillin 250mg POM Capsule oral 126/028 Flamingo Pharmaceuticals Limited, India

2140 Aziflam 250 Capsules Azithromycin 250mg POM Capsule oral 126/029 Flamingo Pharmaceuticals Limited, India

2141

Sodipen-5 Injection Benzyl Penicillin 5 Mega POM Powder for

Injection

126/030 Flamingo Pharmaceuticals Limited, India

2142 Corin 50 Tablets Atenolol 50mg POM Tablet Uncoated 126/031 Flamingo Pharmaceuticals Limited, India

2143 Metformin Tablets Metformin 850mg POM Tablet Uncoated 126/032 Flamingo Pharmaceuticals Limited, India

2144 Glibetics Tablets Glibenclamide 5mg POM Tablet Uncoated 126/033 Flamingo Pharmaceuticals Limited, India

2145

Medichlor Injection Chloramphenicol 1g POM Powder for

Injection

126/034 Flamingo Pharmaceuticals Limited, India

2146 Aziflam 500 Capsules Azithromycin 500mg POM Capsule oral 126/035 Flamingo Pharmaceuticals Limited, India

2147

Chloramphenicol Suspension Chloramphenicol 125mg,

per 5ml

POM Suspension for

Oral Use

126/036 Flamingo Pharmaceuticals Limited, India

2148 Acenopril 5 Tablets Enalapril 5mg POM Tablet Uncoated 126/037 Flamingo Pharmaceuticals Limited, India

2149 Quinone G-500 Tablets Nalidixic acid 500mg POM Tablet Uncoated 126/038 Flamingo Pharmaceuticals Limited, India

2150

Magacid Oral Suspension Aluminium Hydroxide

200mg + Magnesium

Hydroxide 200mg +

Simethicone 135mg, per

5ml

P Suspension for

Oral Use

126/039 Flamingo Pharmaceuticals Limited, India

2151 Acenopril 10 Tablets Enalapril 10mg POM Tablet Uncoated 126/040 Flamingo Pharmaceuticals Limited, India

2152 Corin 100 Tablets Atenolol 100mg POM Tablet Uncoated 126/041 Flamingo Pharmaceuticals Limited, India

2153

Coughex Syrup Salbutamol 1mg +

Bromhexine 2mg +

Guaiphenisin 50mg +

Menthol 0.5mg

GS Syrup 126/042 Flamingo Pharmaceuticals Limited, India

2154 Paracetamol BP Tablets Paracetamol 500mg GS Tablet Uncoated 126/043 Flamingo Pharmaceuticals Limited, India

2155

Trixone 1 Injection Cefotaxime 1g POM Powder for

Injection

126/044 Flamingo Pharmaceuticals Limited, India

2156

Trixol 250 Injection Ceftriaxone 250mg POM Powder for

Injection

126/045 Flamingo Pharmaceuticals Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2157

Lexin 125 Oral Suspension Cephalexin 125mg, per

5ml

POM Suspension 126/047 Flamingo Pharmaceuticals Limited, India

2158 Lanocid 30 Capsules Lansoprazole 30mg POM Capsule oral 126/048 Flamingo Pharmaceuticals Limited, India

2159 Healz Tablets Serrapeptase 10mg POM Tablet Uncoated 126/049 Flamingo Pharmaceuticals Limited, India

2160 Profit Syrup Protein Syrup GS Syrup 126/051 Flamingo Pharmaceuticals Limited, India

2161

Hyomide 10 Tablets Hyoscine Butyl Bromide

10mg

POM Tablet Uncoated 126/052 Flamingo Pharmaceuticals Limited, India

2162

Cloxacillin Sodium Injection Cloxacillin 500mg, per ml POM Powder for

Injection

126/053 Flamingo Pharmaceuticals Limited, India

2163

Cardilan Injection Hydrocortisone 100mg POM Powder for

Injection

126/054 Flamingo Pharmaceuticals Limited, India

2164 Loperamide Capsules Loperamide 2mg POM Capsule oral 126/055 Flamingo Pharmaceuticals Limited, India

2165

Cefotax Powder for Injection Cefotaxime 1g POM Powder for

Injection

126/056 Flamingo Pharmaceuticals Limited, India

2166

Ferrous Sulphate Tablets Ferrous Sulphate 200mg P Tablet Enteric

Coated

126/057 Flamingo Pharmaceuticals Limited, India

2167

Cloxin DS Cloxacillin Sodium

125mg

POM Powder for

Suspension

126/058 Flamingo Pharmaceuticals Limited, India

2168 Flamivit Syrup Multivitamins GS Syrup 126/059 Flamingo Pharmaceuticals Limited, India

2169

Kamox 125 Oral Suspension Amoxicillin 25mg, per 5ml POM Suspension for

Oral Use

126/060 Flamingo Pharmaceuticals Limited, India

2170 Erycin Tablets Erythromycin 250mg POM Tablet Uncoated 126/063 Flamingo Pharmaceuticals Limited, India

2171

Angitan 50 Tablet Losartan Potassium

50mg

POM Tablet oral 126/064 Flamingo Pharmaceuticals Limited, India

2172

Co-trimoxazole Tablets Trimethoprim 80mg +

Sulphamethoxazole

400mg

POM Tablet Uncoated 139/046 Flamingo Pharmaceuticals Limited, India

2173 Roxto-25 Tablets Rofecoxib 25mg POM Tablet Uncoated 139/050 Flamingo Pharmaceuticals Limited, India

2174

Aruj'a Hot Cream Menthol (Menta Piperita)

5.91% + Eucalyptus Oil

(Eucalyptus

P Cream Topical 408/008L Forest Gold Products (P) Ltd.

2175

Aruj'a Cool Gel Menthol (Menta Piperita

2.0% w/w)

P Gel Topical 408/009L Forest Gold Products (P) Ltd.

2176

Forever Kids Chewable

Multivitamins Tablets

Multivitamins P Tablet Uncoated 080/001 Forever Living Products, USA

2177 Forever Nature Min Tablets Minerals P Tablet Uncoated 080/002 Forever Living Products, USA

2178 Forever Absorbent-C Tablets Vitamin C 60mg P Tablet Uncoated 080/003L Forever Living Products, USA

2179

Forever Royal Jelly Tablets Royal Jelly powder

250mg

P Powder for Oral

Solution

080/004L Forever Living Products, USA

Page 111 of 320

Page 112: MEDICINES FOR HUMAN USE 2019 REGISTER S/No Product …...Cefixime 400mg Tablets Cefixime Trihydrate 400mg POM Tablet Uncoated 137/005 Aegis Limited, Cyprus 70 Lasoprol 30 Capsules

ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 2180 Forever Bee Pollen Capsules Bee Pollen 500mg P Capsule oral 080/005L Forever Living Products, USA

2181 Forever Bee Propolis Tablets Bee Propolis 500mg P Tablet Uncoated 080/006L Forever Living Products, USA

2182

Forever Garlic- Thyme SoftGel

Capsules

Garlic Oil 10mg + Thyme

Powdered 50mg

P Tablet Uncoated 080/007L Forever Living Products, USA

2183

Forever Gin -Chia Tablets Premium Ginseng +

80mg Oriental Ginseng

40mg + Siberian Ginseng

20mg

P Tablet Uncoated 080/008L Forever Living Products, USA

2184

Ulgicid Suspension Alginic Acid BP 200 mg +

Magnesium Hydroxide

BP 250 mg + Dried

Aluminium Hydroxide BP

250 mg + Magnesium

Trisilicate BP 250 mg +

Activated Dimethicone

BP 125 mg/ 15ml

P Suspension 246/006 Fountil Life Sciences, India

2185

Purecal Tablets Vitamin + Mineral

Preparation

P Tablets 246/007 Fountil Life Sciences, India

2186

Ulgicid Antacid Tablets Alginic Acid BP 200 mg +

Magnesium Hydroxide

BP 250 mg + Dried

Aluminium Hydroxide BP

250 mg + Magnesium

Trisilicate BP 250 mg +

Activated Dimethicone

BP 125 mg

P Tablets 246/008 Fountil Life Sciences, India

2187

Capisfenac Gel Capsaicin 0.025%w/w +

Diclofenc Diethylalamine

1.160%w/w +

Levomenthol 1.00%w/w

P Gel Topical 246/021 Fountil Life Sciences, India

2188 Diszinc Dispersible Tablets Zinc Sulfate 20mg POM Tablet Dispersible 246/022 Fountil Life Sciences, India

2189

Aminogard Granules Minerals + Vitamins P Granules for Oral

Use

246/023 Fountil Life Sciences, India

2190 Primox 250 Capsules Amoxicillin 250mg POM Capsule oral 265/003 Fountil Life Sciences, India

2191

Pedifen Suspension Ibuprofen 100mg P Suspension for

Oral Use

151/033 Fourrts (India) Laboratories (Pvt) Limited

2192 Omfil 20 Capsules Omeprazole 20mg POM Capsule oral 177/001 Fourrts (India) Laboratories (Pvt) Limited

2193 Ampifil 250 Capsules Ampicillin 250mg POM Capsule oral 177/002 Fourrts (India) Laboratories (Pvt) Limited

2194 Doxefil 100 Capsules Doxycycline 100mg POM Capsule oral 177/003 Fourrts (India) Laboratories (Pvt) Limited

Page 112 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 2195 Indoril 25 Capsules Indomethacin 25mg P Capsule oral 177/004 Fourrts (India) Laboratories (Pvt) Limited

2196

Gramofil Suspension Nalidixic Acid 300mg, per

5ml

POM Suspension for

Oral Use

177/005 Fourrts (India) Laboratories (Pvt) Limited

2197

Malafil Tablets Pyrimethamine 25mg +

Sulphadoxine 500mg

P Tablet Uncoated 177/006 Fourrts (India) Laboratories (Pvt) Limited

2198 Griseofil Tablets Griseofulvin 500mg POM Tablet Uncoated 177/007 Fourrts (India) Laboratories (Pvt) Limited

2199 Micofil Cream Miconazole 2%w/w POM Cream Topical 177/008 Fourrts (India) Laboratories (Pvt) Limited

2200

Megatrim Suspension Sulphamethoxazole

200mg + Trimethoprim

40mg

POM Suspension for

Oral Use

177/009 Fourrts (India) Laboratories (Pvt) Limited

2201 Prednifil Tablets Prednisolone 5mg POM Tablet Uncoated 177/010 Fourrts (India) Laboratories (Pvt) Limited

2202

Combifil 125 Tablets Pyrantel Pamoate 125mg P Tablet Uncoated 177/011 Fourrts (India) Laboratories (Pvt) Limited

2203 Diclofil 50 Tablets Diclofenac 50mg P Tablet Uncoated 177/012 Fourrts (India) Laboratories (Pvt) Limited

2204 Parafil Tablets Paracetamol 500mg GS Tablet Uncoated 177/013 Fourrts (India) Laboratories (Pvt) Limited

2205

Clopen 500 Capsules Cloxacillin 250mg +

Ampicillin 250mg

POM Capsule oral 177/014 Fourrts (India) Laboratories (Pvt) Limited

2206

Gelfil Tablets Aluminium Hydrochloride

120mg + Magnesium

Trisilicate 250mg

GS Tablet Uncoated 177/015 Fourrts (India) Laboratories (Pvt) Limited

2207 Fungifen Cream Clotrimazole 1%w/w POM Cream Topical 177/016 Fourrts (India) Laboratories (Pvt) Limited

2208

Mebfil Suspension Mebendazole 100mg,

per 30ml

P Suspension for

Oral Use

177/017 Fourrts (India) Laboratories (Pvt) Limited

2209 Felcine Capsules Piroxicam 20mg POM Capsule oral 177/018 Fourrts (India) Laboratories (Pvt) Limited

2210

Filobex Tablets Thiamine 1mg +

Riboflavine 1mg +

Niacinamide 10mg

P Tablet Uncoated 177/019 Fourrts (India) Laboratories (Pvt) Limited

2211

Gliclan M Tablets Metformin 250mg +

Gliclazide 80mg

POM Tablet Uncoated 177/020 Fourrts (India) Laboratories (Pvt) Limited

2212 Gramofil Tablets Nalidixic acid 500mg POM Tablet Uncoated 177/021 Fourrts (India) Laboratories (Pvt) Limited

2213 Ibufil Tablets Ibuprofen 200mg P Tablet Uncoated 177/022 Fourrts (India) Laboratories (Pvt) Limited

2214 Mebfil Tablets Mebendazole 100mg P Tablet Uncoated 177/023 Fourrts (India) Laboratories (Pvt) Limited

2215

Megatrim Tablets Sulfamethoxazole 400mg

+ Trimethoprim 80mg

POM Tablet Uncoated 177/024 Fourrts (India) Laboratories (Pvt) Limited

2216 Metfil 850 Tablets Metformin 850mg POM Tablet Uncoated 177/025 Fourrts (India) Laboratories (Pvt) Limited

2217 Salfil 4 Tablets Salbutamol 4mg POM Tablet Uncoated 177/026 Fourrts (India) Laboratories (Pvt) Limited

2218 Salfil 2 Tablets Salbutamol 2mg POM Tablet Uncoated 177/027 Fourrts (India) Laboratories (Pvt) Limited

2219 Cipfil 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 177/028 Fourrts (India) Laboratories (Pvt) Limited

Page 113 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2220

Fourts B Tablets Multivitamins + Amino

Acids + Minerals

P Tablet Uncoated 177/029 Fourrts (India) Laboratories (Pvt) Limited

2221 Metfil 500 Tablets Metformin 500mg POM Tablet Uncoated 177/030 Fourrts (India) Laboratories (Pvt) Limited

2222

Salbutamol Oral Solution Salbutamol 2mg POM Solution for Oral

Use

177/031 Fourrts (India) Laboratories (Pvt) Limited

2223

Fogyl Suspension Metronidazole 100mg POM Suspension for

Oral Use

177/032 Fourrts (India) Laboratories (Pvt) Limited

2224 Profil 25 Tablets Promethazine 25mg P Tablet Uncoated 177/033 Fourrts (India) Laboratories (Pvt) Limited

2225 Cloxafil 250 Capsules Cloxacillin 250mg POM Capsule oral 177/035 Fourrts (India) Laboratories (Pvt) Limited

2226

Parafil 120 Oral Solution Paracetamol 120mg GS Solution for oral

use

177/036 Fourrts (India) Laboratories (Pvt) Limited

2227 Betafil-50 Tablets Atenolol 50mg POM Tablet Uncoated 177/037 Fourrts (India) Laboratories (Pvt) Limited

2228 Gliclan 80 Tablets Gliclazide 80mg POM Tablet Uncoated 177/038 Fourrts (India) Laboratories (Pvt) Limited

2229 Fomycetin 250 Capsules Chlorampenicol 250mg POM Capsule oral 177/039 Fourrts (India) Laboratories (Pvt) Limited

2230 Fogyl-S Tablets Metronidazole 200mg POM Tablet Uncoated 177/040 Fourrts (India) Laboratories (Pvt) Limited

2231 Multivitamin Tablets Multivitamin Tablets P tablets 177/041 Fourrts (India) Laboratories (Pvt) Limited

2232

Glifil-M Forte Tablets Glibenclamide 5mg +

Metformin 500mg

POM Tablet Uncoated 177/042 Fourrts (India) Laboratories (Pvt) Limited

2233

Quadrajel Chlorhexidine 1% +

Gluconate Solution 1% +

Metronidazole Benzoate

2%

P Gel Oral 177/043 Fourrts (India) Laboratories (Pvt) Limited

2234

Combifil Suspension Pyrantel Pamoate

250mg, per 5ml

P Suspension for

Oral Use

177/044 Fourrts (India) Laboratories (Pvt) Limited

2235 Kontrac- 200 Tablets Misoprostol 200mcg POM Tablet Uncoated 177/045 Fourrts (India) Laboratories (Pvt) Limited

2236 Tinifil Tablets Tinidazole 500mg POM Tablet Uncoated 177/046 Fourrts (India) Laboratories (Pvt) Limited

2237

Redin plus Capsules Iron+ Folic Acid 1000mg

+ Zinc Sulphate 5mg +

Selenium 30mg +

Histidine 50mg

POM Capsule oral 177/048 Fourrts (India) Laboratories (Pvt) Limited

2238

Cold Fortinsa Tablets Paracetamol 500mg +

Phenylephrine 5mg +

Chlorpheniramine 2mg +

Caffeine 30mg

P Tablets Uncoated 177/049 Fourrts (India) Laboratories (Pvt) Limited

2239

Ambcet Syrup Ambroxol Hydrochloride

30mg + Cetirizine

Hydrochloride 5mg

P Syrup 177/050 Fourrts (India) Laboratories (Pvt) Limited

Page 114 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2240

Ambcet Tablets Ambroxol Hydrochloride

60mg + Cetirizine

Hydrochloride 5mg

P Tablet Uncoated 177/051 Fourrts (India) Laboratories (Pvt) Limited

2241

Ibufil Suspension Ibuprofen 100mg, per 5ml P Suspension for

Oral Use

177/052 Fourrts (India) Laboratories (Pvt) Limited

2242

L-Montus Tablets Levocetirizine

Hydrochloride 5mg +

Montelukast Sodium

10mg

P Tablet Uncoated 177/053 Fourrts (India) Laboratories (Pvt) Limited

2243 Cipfil 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 3129/05 Fourrts (India) Laboratories (Pvt) Limited

2244

Redin PN liquid Haematenic + Calcium +

Protein + Minerals

POM Solution for Oral

Use

177/047 Fourrts (India) Laboratories (Pvt) Limited,

india

2245

Surfaz® Dusting Powder Clotrimazole 1%w/w P Powder for Topical

use

062/007 Franco-Indian Remedies Pvt Ltd, India

2246

Diavit Plus Capsules Alpha Lipoic Acid

USP.NF 200 mg + Beta

Carotene USP

(200mg+3mg+1500mcg+

20mg+70mcg+50mcg+40

mg+2mg+0.5mg+)

P Capsule oral 222/005 Franco-Indian Remedies Pvt Ltd, India

2247

Stimuliv Syrup Kalmegh (Andrographis

paniculata) 60mg +

Bhringaraj (Eclipta

100mg+100mg

P Syrup 222/006 Franco-Indian Remedies Pvt Ltd, India

2248

Omilcal Forte Tablets Tribasic Calcium

Phosphate BP 1032mg +

Heavy Magnesium Oxide

66.32mg+26.40mg+6mg

P Tablet Uncoated 222/007 Franco-Indian Remedies Pvt Ltd, India

2249 Glyciphage Tablets Metformin 500mg POM Tablet Uncoated 274/001 Franco-Indian Remedies Pvt Ltd, India

2250 Beneuron Forte Tablets Multivitamin GS Tablet Film coated 274/002 Franco-Indian Remedies Pvt Ltd, India

2251 Beetrion Tablets Multivitamin & Minerals GS Tablet Film coated 274/003 Franco-Indian Remedies Pvt Ltd, India

2252

Propofol 1% Infusion Propofol 10mg, per ml POM Solution for

infusion

253/001 Frenesius Kabi S.A (Pty) Ltd, South Africa

2253 Voluven Emulsion Hydroxyethyl 60g, per L POM Emulsion 253/002 Frenesius Kabi S.A (Pty) Ltd, South Africa

2254

CAPD/DPCA 2 Stay safe

Solution

Peritoneal Dialysis

Solution

POM Solution for

infusion

254/030 Frenesius Kabi S.A (Pty) Ltd, South Africa

2255

CAPD/DPCA 3 Stay safe

Solution

Peritoneal Dialysis

Solution

POM Solution for

infusion

254/031 Frenesius Kabi S.A (Pty) Ltd, South Africa

Page 115 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2256

CAPD/DPCA 4 Stay safe

Solution

Peritoneal Dialysis

Solution

POM Solution for

infusion

254/032 Frenesius Kabi S.A (Pty) Ltd, South Africa

2257

Gemita Injection Gemcitabine 1g POM Solution for

Injection

254/033 Frenesius Kabi S.A (Pty) Ltd, South Africa

2258

Gemita 200 mg Injection Gemcitabine 200mg POM Solution for

Injection

254/034 Frenesius Kabi S.A (Pty) Ltd, South Africa

2259

Intaxel Injection Paclitaxel 30mg, per 5ml POM Solution for

Injection

254/035 Frenesius Kabi S.A (Pty) Ltd, South Africa

2260

Irinotel Injection Irinotecan 100mg POM Solution for

Injection

254/036 Frenesius Kabi S.A (Pty) Ltd, South Africa

2261

Kemocarb Injection Carboplatin 150mg POM Solution for

Injection

254/037 Frenesius Kabi S.A (Pty) Ltd, South Africa

2262

Oxitan Injection Oxaliplatin 50mg POM Solution for

Injection

254/038 Frenesius Kabi S.A (Pty) Ltd, South Africa

2263 Trozet Tablets Letrozole 2.5mg POM Tablet Uncoated 254/039 Frenesius Kabi S.A (Pty) Ltd, South Africa

2264

Kabiven Emulsion for Injection Glucose + Amino acids+

Minerals + Lipids

POM Emulsion 254/041 Frenesius Kabi S.A (Pty) Ltd, South Africa

2265

Vitalipid Novum Adult Retinol palmitate 194.1

mcg + dl-a-tocopherol

0.91mcg + Ergocalc

0.5mcg

POM Emulsion for

infusion

254/043 Fresenius Kabi S.A (Pty) Ltd, South Africa

2266

paracetamol Fresenius Infusion Paracetamol 1000mg POM Solution for

infusion

254/044 Fresenius Kabi S.A (Pty) Ltd, South Africa

2267

Smofkabiven® 800 SMOFlipid 20% /

Aminoven 10% (with or

without electrolytes) /

glucose 42% - 800 kcal

POM Emulsion for

infusion

254/045 Fresenius Kabi S.A (Pty) Ltd, South Africa

2268

Smofkabiven® 1100 SMOFlipid 20% /

Aminoven 10% (with or

without electrolytes) /

glucose 42% - 1100 kcal

POM Emulsion for

infusion

254/046 Fresenius Kabi S.A (Pty) Ltd, South Africa

2269

Paracetamol Fresenius Infusion Paracetamol 1000mg POM Solution for

Infusion

254/044 Fresenius Kabi South Africa

2270

Vincristine Sulphate Liquid

Injection

Vincristine 1mg, per ml POM Solution for

Injection

299/001MT Furen Pharmaceuticals Group Co. Limited

2271

Water for Injection BP Water For Injection BP POM Solution for

Injection

299/002MT Furen Pharmaceuticals Group Co. Limited

Page 116 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2272

MZ – CAL Tablets Calcium

Carbonate1000mg+Miner

als

P Tablet Uncoated 372/001 Galaxy Pharmaceuticals Ltd

2273

MZ – CAL Suspension Calcium carbonate BP

equi. To Calcium

150mg+Minerals

Pharmacy

Medicine

Suspension for

Oral Use

372/002 Galaxy Pharmaceuticals Ltd

2274

Foetasafe Capsuless Omega 3 Fish Oil 600mg

+Vitamins + Minerals

Pharmacy

Medicine

Capsule oral 372/003 Galaxy Pharmaceuticals Ltd

2275

Ginesomega Soft Capsuless Ginseng extract BP 50mg

+ Cod liver Oil BP 50mg

+ Omega -3 F

Pharmacy

Medicine

Capsule oral 372/004 Galaxy Pharmaceuticals Ltd

2276

Cardiocare SoftGel Capsuless Alpha Lipoic Acid USP

50mg + Coenzyme Q10

USP 50mg + Citrus

Pharmacy

Medicine

Capsule oral 372/005 Galaxy Pharmaceuticals Ltd

2277

Neurocare Plus SoftGel

Capsules

Methycobalanin 750mcg+

Alpha Lipoic Acid USP

100mg+ B6 BP 3mg +FA

1.5mg +Pregabalin

7.5mg

Pharmacy

Medicine

Capsule oral 372/006 Galaxy Pharmaceuticals Ltd

2278

Vita UVD3 60000 SoftGel

Capsuless

Vitamin D3 BP 60000 IU Pharmacy

Medicine

Capsule oral 372/007 Galaxy Pharmaceuticals Ltd

2279

Cartilomega SoftGel Capsuless Glucosamine Sulphate

USP 500mg +

Chondroitin Sulphate

USP 200mg + Sodium H

3mg

Pharmacy

Medicine

Capsule Softgel 372/009L Galaxy Pharmaceuticals Ltd

2280 Fungigen Cream Miconazole 1%w/w POM Cream Topical 218/001 Galentic Pharma Limited, India

2281 Derm Keta Cream Ketoconazole 2.0%w/w POM Cream Topical 218/002 Galentic Pharma Limited, India

2282 Netracort Ointment Hydrocortisone 10mg POM Ointment topical 218/003 Galentic Pharma Limited, India

2283

Sylvadex Cream Silver Sulfadiazine

1.0%w/w

P Cream Topical 218/004 Galentic Pharma Limited, India

2284 Kloraxin Eye Ointment Chloramphenicol 1%w/w POM Eye Ointment 218/005 Galentic Pharma Limited, India

2285 Diclofenac Gel Diclofenac 1.0%w/w P Gel Topical 218/006 Galentic Pharma Limited, India

2286

Tetracycline Hydrochloride

Ointment

Tetracycline 1%w/w POM Ointment topical 218/007 Galentic Pharma Limited, India

2287

Tetracycline Hydrochloride

Ointiment

Tetracycline 3%w/w POM Ointment topical 218/008 Galentic Pharma Limited, India

2288 Netracort Skin Ointment Hydrocortisone 1%w/w POM Ointment topical 218/009 Galentic Pharma Limited, India

Page 117 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2289

Pyloocain Ointment Bethametasone 0.5mg +

Phenylephrine 1mg +

Lidocaine 25mg

POM Ointment topical 218/010 Galentic Pharma Limited, India

2290

Caladine lotion Calamine 5% P Lotion for Topical

Use

218/011 Galentic Pharma Limited, India

2291

Neurocare SoftGel Capsules Methylcobalanin

1500mcg + Gamma

Linolenic Acid 60mg +

Alpha Lipoic Acid USP

100mg +1.5mg + 3mg +

100mcg + 10mg

P Capsule oral 372/008L Galentic Pharma Limited, India

2292

Helmanil Oral Suspension Albendazole 200mg, per

5ml

POM Suspension for

Oral Use

200/001 Galpha Laboratories Ltd,India

2293

Odicef Injection Ceftriaxone 1gm POM Powder for

Injection

200/002 Galpha Laboratories Ltd,India

2294

Aben Oral Suspension Mebendazole 100mg, per

5ml

P Suspension for

Oral Use

200/003 Galpha Laboratories Ltd,India

2295 Galmox Capsuless Amoxicillin 250mg POM Capsule oral 200/004 Galpha Laboratories Ltd,India

2296

Clanoxy 375 Tablets Amoxicillin 250mg +

Clavulanate Potassium

125mg

POM Tablet Film coated 200/005 Galpha Laboratories Ltd,India

2297 Galexin 250 Capsuless Cephalexin 250mg POM Capsule oral 200/006 Galpha Laboratories Ltd,India

2298

Galmox 125 Oral Suspension Amoxicillin 125mg, per

5ml

POM Powder for Oral

Suspension

200/008 Galpha Laboratories Ltd,India

2299

Malartem Injection Artemether 80mg, per ml POM Solution for

Injection

200/009 Galpha Laboratories Ltd,India

2300

Gallin Oral Suspension Ampicillin 125mg, per

5ml

POM Powder for Oral

Suspension

200/010 Galpha Laboratories Ltd,India

2301

Potamp 500 Capsuless Cloxacillin 250mg +

Ampicillin 250mg

POM Capsule oral 200/011 Galpha Laboratories Ltd,India

2302 Galin Capsuless Ampicillin 250mg POM Capsule oral 200/012 Galpha Laboratories Ltd,India

2303

Metrogal Oral Suspension Metronidazole 200mg,

per 5ml

POM Suspension for

Oral Use

200/014 Galpha Laboratories Ltd,India

2304

Clanoxy Dry Syrup Amoxicillin 200mg +

Clavulanic acid 28.5mg ,

per 5ml

POM Powder for Oral

Suspension

200/015 Galpha Laboratories Ltd,India

2305 Galdic SR 100 Tablets Diclofenac 100mg P Tablet Film coated 200/016 Galpha Laboratories Ltd,India

2306

Hydrocortisone Sodium Injection Hydrocortisone 100mg,

per 7.5ml

POM Powder for

Injection

200/017 Galpha Laboratories Ltd,India

Page 118 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 2307 Restum 500 Tablets Cefuroxime 500mg POM Tablet Uncoated 200/018 Galpha Laboratories Ltd,India

2308 Restum 250 Tablets Cefuroxime 250mg POM Tablet Uncoated 200/019 Galpha Laboratories Ltd,India

2309

Altax Powder for Injection Cefotaxime 1gm POM Powder for

Injection

200/020 Galpha Laboratories Ltd,India

2310

Galprim-P Suspension Trimethoprim 40mg +

Sulphamethoxazole

200mg, per 5ml

POM Suspension 200/022 Galpha Laboratories Ltd,India

2311

Ecocin Suspension Paracetamol 125mg, per

5ml

GS Suspension for

Oral Use

200/023 Galpha Laboratories Ltd,India

2312

Clanoxy 625 Tablets Amoxycillin 500mg +

Clavulanate Potassium

125mg

POM Tablet Uncoated 200/024 Galpha Laboratories Ltd,India

2313

Galclox Oral Suspension Cloxacillin 125mg, per

5ml

POM Suspension for

Oral Use

200/025 Galpha Laboratories Ltd,India

2314

Galthrox 125 Oral Suspension Erythromycin 125mg, per

5ml

POM Suspension for

Oral Use

200/026 Galpha Laboratories Ltd,India

2315 Dr-x 50 Tablets Sildenafil 50mg POM Tablet Uncoated 200/027 Galpha Laboratories Ltd,India

2316

Galexin 125 Suspension Cefalexin 125mg, per 5ml POM Suspension for

Oral Use

200/028 Galpha Laboratories Ltd,India

2317 Azvit-M Syrup Multivitamins GS Syrup 200/029 Galpha Laboratories Ltd,India

2318

Galgin Capsules Dimethicone +

Magnesium + Aluminium

Hydroxide

P Suspension 200/030 Galpha Laboratories Ltd,India

2319 Galamine P Syrup Chlorpheniramine 2mg P Syrup 200/031 Galpha Laboratories Ltd,India

2320

Desol Ear Drops Paradichlorobenzene

21.5mg + Benzocaine

25mg + Chlorobutanol

55mg + Turpentine

157mg

P Ear Drops 273/001 Geno Pharmaceuticals Ltd, India

2321

Cypon Syrup Cyproheptadine +

Tricholine

P Syrup 273/002 Geno Pharmaceuticals Ltd, India

2322

Brupal Tablets Ibuprofen 400mg +

Paracetamol 325mg

P Tablet Uncoated 273/003 Geno Pharmaceuticals Ltd, India

2323

Peptica Gel Aluminium Hydroxide

225mg + Magnesium

Hydroxide 200mg +

Simethicone U 50mg

P Suspension for

Oral Use

273/004 Geno Pharmaceuticals Ltd, India

Page 119 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2324

Respira Cough Formula Ambroxol Hydrochloride

1.65mg + Salbutamol

Sulphate 1.3mg +

Guafene 50mg

P Syrup 273/005 Geno Pharmaceuticals Ltd, India

2325

Myloxin - D Gel Oleoresin Capiscum

0.075%w/w + Methyl

Salicylate 20%w/w +

Menthol 10%w/w +

Camph 5%w/w

GS Gel Topical 273/006 Geno Pharmaceuticals Ltd, India

2326

Respira - D Cough Formula Dextromethophan

Hydrobromide BP 10mg

+ Chlorpheinramine

Maleate BP 2mg

P Syrup 273/007 Geno Pharmaceuticals Ltd, India

2327

Deriphyllin 300 Retard Tablets Theophylline Anhydrous

BP + Etofylline BP

300mg

POM Tablet Film coated 159/001 Germany Remedies, India

2328

Deriphyllin 150 Retard Tablets Theophylline Anhydrous

BP + Etofylline BP

150mg

POM Tablet Film coated 159/002 Germany Remedies, India

2329

Deriphylline Tablets Theophylline Anhydous

BP + Etofylline BP

POM Tablet Uncoated 159/003 Germany Remedies, India

2330

Deriphylline Injection Theophylline Anhydrous

BP + Etofylline BP

POM Solution for

Injection

159/004 Germany Remedies, India

2331

Deriphylline Syrup Theophylline Anhydrous

BP + Etofylline BP

POM Syrup 159/005 Germany Remedies, India

2332

Kalzana Tablets Ascobic acid 40mg +

Cholecalciferol BP

200iu+ Dibasic Calcium

Phosphate BP 100mg

P Tablet Uncoated 159/006 Germany Remedies, India

2333

Carbotin Injection Carboplatin 150mg, per

15ml

POM Powder for

Injection

302/001 Getwell Pharmaceuticals Limited

2334

Doxoruba Injection Doxorubicin 50mg, per

25ml

POM Powder for

Injection

302/002 Getwell Pharmaceuticals Limited

2335

Pacliwel Injection Paclitaxel 30mg, per 5ml POM Powder for

Injection

302/003 Getwell Pharmaceuticals Limited

2336

Platicin Injection Cisplatin 10mg, per 10ml POM Powder for

Injection

302/004 Getwell Pharmaceuticals Limited

2337

Taxewell Injection Docetaxel 120mg, per

3ml

POM Powder for

Injection

302/005 Getwell Pharmaceuticals Limited

Page 120 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2338

Zoldron Injection Zoledronic Acid 4mg, per

4ml

POM Powder for

Injection

302/006 Getwell Pharmaceuticals Limited

2339

Viread 150 Tablets Tenofovir Fumarate

150mg

POM Tablet Film coated 440/001 Gilead Sciences Inc. USA

2340

Viread 200mg Tablets Tenofovir Disoproxil

Fumarate 200mg

POM Tablet Film coated 440/002 Gilead Sciences Inc. USA

2341

Viread 250mg Tablets Tenofovir Disoproxil

Fumarate 250mg

POM Tablet Film coated 440/003 Gilead Sciences Inc. USA

2342

Frusemide Injection Frusemide 10mg, per ml POM Solution for

Injection

403/001 Gland Pharma Ltd. India

2343

Hyoscine Butylbromide Injection Hyoscine Butylbromide

20mg

POM Solution for

Injection

403/002 Gland Pharma Ltd. India

2344

Actifed Cold Tablets Tripolidine Hydrochloride

1.25mg + Pseudoephrine

Hydrochloride 3.00mg

P Tablets 025/004 GlaxoSmithKline Consumer Healthcare

(Pty) Ltd, South Africa

2345

Eno Active Fruit Salts Citric Acid 2.16g +

Sodium Bicarbonate

2.29g + Sodium

Carbonate 0.5g

GS Powder for Oral

Solution

025/016 GlaxoSmithKline Consumer Healthcare

(Pty) Ltd, South Africa

2346

Grandpa Tablets Aspirin 226.8mg +

Caffeine 32.4mg +

Paracetamol 162.0mg

GS Tablet Uncoated 025/017 GlaxoSmithKline Consumer Healthcare

(Pty) Ltd, South Africa

2347

Calpol Paediatric Suspension Paracetamol 120 mg, per

5ml

GS Suspension for

Oral Use

025/018 GlaxoSmithKline Consumer Healthcare

(Pty) Ltd, South Africa

2348

Grandpa Headache Powder Aspirin 453.6mg +

Caffeine 64.5mg +

Paracetamol 324mg

GS Powder for Oral

Suspension

025/019 GlaxoSmithKline Consumer Healthcare

(Pty) Ltd, South Africa

2349

Med Lemon Sachets Aspirin 800mg + Caffeine

50mg + Ascorbic Acid

48mg

GS Powder for Oral

Solution

179/067 GlaxoSmithKline Consumer Healthcare

(Pty) Ltd, South Africa

2350

Actifed Compound Linctus Triprolidine +

Pseudoephedrine +

Dextromethorphen

P Syrup 025/001 GlaxoSmithKline Consumer Healthcare SA

Limited

2351

Actifed Syrup Triprolidine +

Pseudoephedrine

P Syrup 025/003 GlaxoSmithKline Consumer Healthcare SA

Limited

2352

Eltroxin Tablets Thyroxine 100mcg POM Tablet Uncoated 179/052 GlaxoSmithKline Consumer Healthcare SA

Limited

Page 121 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2353

Corsodyl Mouthwash - Mint Chlorhexidine Gluconate

2mg, per ml

GS Solution for Oral

Use

179/061 GlaxoSmithKline Consumer Healthcare SA

Limited

2354

Med-Lemon HM with Vitamin C

Powder for Suspension

Aspirin 800 mg +

Caffeine 50 mg +

Ascorbic Acid 45 mg +

Menthol 2.6mg

GS powder for

Suspension

179/067 GlaxoSmithKline Consumer Healthcare SA

Limited

2355

Vibrocil Nasal Drops Phenylephrine +

Dimethendene

P Nasal drops 242/003 GlaxoSmithKline Consumer Healthcare SA

Limited

2356

Proctoglyvenol Cream Lidocaine + Tribenocide POM Cream Topical 242/004 GlaxoSmithKline Consumer Healthcare SA

Limited

2357

Otrivin Spray Xylometazoline 0.1%w/v POM Spray For Nasal

Use

242/006 GlaxoSmithKline Consumer Healthcare SA

Limited

2358

Lamisil Cream Terbinafine 10% POM Cream Topical 242/008 GlaxoSmithKline Consumer Healthcare SA

Limited

2359

Eurax Cream Crotamiton 10% POM Cream Topical 242/012 GlaxoSmithKline Consumer Healthcare SA

Limited

2360

Otrivin Nasal Drops Xylometazoline

Hydrochloride 0.05% w/v

P Nasal drops 242/013 GlaxoSmithKline Consumer Healthcare SA

Limited

2361

Otrivin Nasal Drops-Adults Xylometazoline

Hydrochloride 0.1% w/v

P Nasal drops 242/014 GlaxoSmithKline Consumer Healthcare SA

Limited

2362

Voltaren Gel Diclofenac Diethylamide

corresponding to 1g

Diclofenac Sodium per

100g

POM Topical gel 242/015 GlaxoSmithKline Consumer Healthcare SA

Limited

2363

Calcium Forte Effervescent

Tablets

Calcium Carbonate 0.3g

+ Calcium lactate

Gluconate 2.94g

equivalent to 500mg

elemental Calcium

P Effervescent

Tablets

242/016 GlaxoSmithKline Consumer Healthcare SA

Limited

2364

Calcium + Vitamin C Tablets Ascorbic Acid 1000mg +

Calcium Lactate

Gluconate 1000mg +

Calcium Carbonate

327mg

P Tablets Uncoated 242/017 GlaxoSmithKline Consumer Healthcare SA

Limited

2365

Panado Advance Tablets Paracetamol 500mg GS Tablets Uncoated 242/019 GlaxoSmithKline Consumer Healthcare SA

Limited

2366

Panado Extra Tablets Paracetamol 500mg +

Caffeine

GS Tablets Uncoated 242/020 GlaxoSmithKline Consumer Healthcare SA

Limited

Page 122 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2367

Rotarix Vaccine Live attenauted Human

Rotovirus RIX 4414

1000000 CCID 50

POM Oral Suspension 025/034 GlaxoSmithKline SA (Pty) Ltd

2368

Clavulin Suspension Amoxicillin + Clavulanic

Acid 156mg, per 5ml

POM Suspension for

Oral Use

179/001 GlaxoSmithKline SA (Pty) Ltd

2369 Bactroban Cream Mupirocin 10.5% POM Cream Topical 179/003 GlaxoSmithKline SA (Pty) Ltd

2370 Ziagen Tablets Abacavir 300mg POM Tablet Uncoated 179/004 GlaxoSmithKline SA (Pty) Ltd

2371

Combivir Tablets Lamivudine 150mg +

Zidovudine 300mg

POM Tablet Uncoated 179/005 GlaxoSmithKline SA (Pty) Ltd

2372

Epivir Oral Solution Lamivudine 10mg, per ml POM Solution for Oral

use

179/006 GlaxoSmithKline SA (Pty) Ltd

2373 Epivir Tablets Lamivudine 150mg POM Tablet film coated 179/007 GlaxoSmithKline SA (Pty) Ltd

2374 Alben 400 Tablets Albendazole 400mg POM Tablet Uncoated 179/008 GlaxoSmithKline SA (Pty) Ltd

2375

Augmentin Oral Suspension Amoxicillin + Clavulanic

Acid

POM Suspension for

Oral Use

179/009 GlaxoSmithKline SA (Pty) Ltd

2376

Telzir Suspension Fosamprenavir 50mg,

per ml

POM Suspension for

Oral Use

179/010 GlaxoSmithKline SA (Pty) Ltd

2377

Kivexa Tablets Abacavir 600mg +

Lamivudine 300mg

POM Tablet film coated 179/011 GlaxoSmithKline SA (Pty) Ltd

2378

Zinnat Suspension Cefuroxime 125mg, per

5ml

POM Suspension for

Oral Use

179/013 GlaxoSmithKline SA (Pty) Ltd

2379

Flixonase Aqueous Nasal Spray

(Micronized fluticasone

propionate 0.5% w/w)

Fluticasone Propionate POM Nasal spray 179/014 GlaxoSmithKline SA (Pty) Ltd

2380 Zinnat 500 Tablets Cefuroxime 500mg POM Tablet Uncoated 179/015 GlaxoSmithKline SA (Pty) Ltd

2381

Zinacef Injection Cefuroxime 750mg POM Solution for

Injection

179/016 GlaxoSmithKline SA (Pty) Ltd

2382 Zinnat 250 Tablets Cefuroxime 250mg POM Tablet Uncoated 179/017 GlaxoSmithKline SA (Pty) Ltd

2383

Engerix B Paediatric Tablets Hepatitis B 10mcg, per

0.5ml

POM Tablet Uncoated 179/018 GlaxoSmithKline SA (Pty) Ltd

2384

Engerix B Adult Injection Hepatitis B 20mcg, per

ml

POM Tablet Uncoated 179/019 GlaxoSmithKline SA (Pty) Ltd

2385

Halfan Suspension Halofantrine 125mg, per

5ml

POM Suspension for

Oral Use

179/020 GlaxoSmithKline SA (Pty) Ltd

2386 Halfan Tablets Halofantrine 250mg POM Tablet Uncoated 179/021 GlaxoSmithKline SA (Pty) Ltd

2387 Zentel 400 Tablets Albendazole 400mg POM Tablet Uncoated 179/022 GlaxoSmithKline SA (Pty) Ltd

2388

Otosporin Ear Drops Hydrocortisone +

Neomycin + Polymixin B

POM Ear Drops 179/028 GlaxoSmithKline SA (Pty) Ltd

Page 123 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2389

Augmentin SF Suspension Amoxicillin 200mg +

Potassium Clavulanate

28.50mg

POM Tablet Uncoated 179/030 GlaxoSmithKline SA (Pty) Ltd

2390

Augmentin BD Suspension Amoxicillin + Potassium

Clavulanate 375mg

POM Suspension for

Oral Use

179/032 GlaxoSmithKline SA (Pty) Ltd

2391

Zentel Suspension Albendazole 125mg POM Suspension for

Oral Use

179/033 GlaxoSmithKline SA (Pty) Ltd

2392 Flixotide Inhaler Fluticasone 1g POM Capsule oral 179/034 GlaxoSmithKline SA (Pty) Ltd

2393 Flixotide 125 Inhaler Fluticasone 125mcg POM Capsule oral 179/035 GlaxoSmithKline SA (Pty) Ltd

2394

Flixotide Inhaler Fluticasone 50mcg POM Solution for

Injection

179/036 GlaxoSmithKline SA (Pty) Ltd

2395

Augmentin BD Tablets Amoxicillin + Potassium

Clavulanate 1g

POM Suspension for

Oral Use

179/037 GlaxoSmithKline SA (Pty) Ltd

2396

Ventolin cfc Inhaler Salbutamol 100mcg POM Solution for

Inhalation

179/038 GlaxoSmithKline SA (Pty) Ltd

2397

Seretide Inhaler Salmeterol 25mg +

Fluticasone 100mg

POM Solution for

Inhalation

179/039 GlaxoSmithKline SA (Pty) Ltd

2398

Seretide Inhaler Salmeterol 25mg +

Fluticasone 125mg

POM Solution for

Inhalation

179/040 GlaxoSmithKline SA (Pty) Ltd

2399

Seretide Inhaler Salmeterol 25mg +

Fluticasone 250mg

POM Solution for

Inhalation

179/041 GlaxoSmithKline SA (Pty) Ltd

2400

Seretide Inhaler Salmeterol 50mg +

Fluticasone 100mg

POM Solution for

Inhalation

179/042 GlaxoSmithKline SA (Pty) Ltd

2401

Seretide Inhaler Salmeterol 50mg +

Fluticasone 250mg

POM Solution for

Inhalation

179/043 GlaxoSmithKline SA (Pty) Ltd

2402

Seretide Inhaler Salmeterol 50mg +

Fluticasone 500mg

POM Solution for

Inhalation

179/044 GlaxoSmithKline SA (Pty) Ltd

2403

Augmentin Suspension Amoxicillin 125mg +

Potassium Clavulanate

31mg

POM Suspension for

Oral Use

179/045 GlaxoSmithKline SA (Pty) Ltd

2404

Augmentin BD SF Suspension Amoxicillin 400mg +

Potassium Clavulanate

59.85mg

POM Suspension for

Oral Use

179/046 GlaxoSmithKline SA (Pty) Ltd

2405 Bactroban Ointment Mupirocin 2%w/w POM Cream Topical 179/049 GlaxoSmithKline SA (Pty) Ltd

2406 Eltroxin Tablets Thyroxine 50mcg POM Cream Topical 179/051 GlaxoSmithKline SA (Pty) Ltd

2407

Rotarix Liquid Oral Vaccine Live Attenauted Human

Rotovirus RIX 4414

POM Solution for Oral

Use

179/056 GlaxoSmithKline SA (Pty) Ltd

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2408

Synflorix Vaccine Pneumococcal

polysaccharide serotype

1, 4, 5, 6B, 7F, 9V, 14,

18C, 19F & 23F

POM Suspension for

Injection

179/057 GlaxoSmithKline SA (Pty) Ltd

2409

Ventolin Rotacaps Salbutamol 200mcg POM Capsule for

Inhalation

179/058 GlaxoSmithKline SA (Pty) Ltd

2410

Aropax 20 Tablets Paroxetine Hydrochloride

Hemihdrate 20mg

POM Tablet Uncoated 179/059 GlaxoSmithKline SA (Pty) Ltd

2411

Augumentin - 600 Suspension Amoxicillin 600mg +

Clavulanic Acid 42.9mg

POM Powder for Oral

Suspension

179/062 GlaxoSmithKline SA (Pty) Ltd

2412

Cervarix Human Papilomavirus

Vaccine

Human Papillomavirus

type 16 L1 and 18 L1

POM Suspension for

Injection

179/066 GlaxoSmithKline SA (Pty) Ltd

2413

Avamys Nasal Spray Fluticasone Furoate POM Spray For Nasal

Use

179/068 GlaxoSmithKline SA (Pty) Ltd

2414

Polio Sabin One and Three

(Oral) Bivalent Oral Poliomyelitis

Vaccine T

Oral Poliomyelitis

Vaccine

POM Suspension for

Oral Use

179/069 GlaxoSmithKline SA (Pty) Ltd

2415

Tivicay 50 Tablets Dolutegravir Sodium

50mg

POM Tablet Film coated 179/075 GlaxoSmithKline SA (Pty) Ltd

2416

Candid B Cream Clotrimazole 1%w/w +

Beclometasone

Dipropionate 0.025 %

w/w.

POM Cream Topical 093/001 Glenmark Pharmaceuticals Limited, India

2417

Candid B lotion Clotrimazole 1% w/v +

Beclomethasone

Dipropionate 0.025% w/v

POM Lotion for Topical

Use

093/002 Glenmark Pharmaceuticals Limited, India

2418 Candid Cream Clotrimazole 1% w/w POM Cream Topical 093/003 Glenmark Pharmaceuticals Limited, India

2419

Candiderm Cream Gentamicin 0.1% w/w +

Beclometasone

Dipropionate 0.025% w/w

+ Clotrimazole 1% w/w

POM Cream Topical 093/004 Glenmark Pharmaceuticals Limited, India

2420

Candid Dusting Powder Clotrimazole 1% w/w POM Powder for Topical

use

093/005 Glenmark Pharmaceuticals Limited, India

2421

Candid Ear Drops Clotrimazole 1% w/v +

Lignocaine Hydrochloride

2% w/v

POM Ear Drops 093/006 Glenmark Pharmaceuticals Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2422

Candid lotion Clotrimazole 1% w/v POM Lotion for Topical

Use

093/007 Glenmark Pharmaceuticals Limited, India

2423

Candid Mouth Paint Clotrimazole 1%w/v POM Suspension for

Oral Use

093/008 Glenmark Pharmaceuticals Limited, India

2424

Candid TV Lotion Selenium sulfide 2.5%

w/v + Clotrimazole 1%

w/v

POM Lotion for Topical

Use

093/009 Glenmark Pharmaceuticals Limited, India

2425 Candid V Gel Clotrimazole 2% w/w POM Gel Vaginal 093/010 Glenmark Pharmaceuticals Limited, India

2426 CandidV-1 Vaginal Tablets Clotrimazole 500mg POM Tablet Vaginal 093/011 Glenmark Pharmaceuticals Limited, India

2427 CandidV-3 Vaginal Tablets Clotrimazole 200mg POM Tablet Vaginal 093/012 Glenmark Pharmaceuticals Limited, India

2428 Candid V-6 Vaginal Tablets Clotrimazole 100mg POM Tablet Vaginal 093/013 Glenmark Pharmaceuticals Limited, India

2429 Diziron Tablets Cinnarizine 25mg POM Tablet Uncoated 093/014 Glenmark Pharmaceuticals Limited, India

2430

Scaboma Cream Benzocaine 2% w/w +

Lindane 2% w/w

P Cream Topical 093/015 Glenmark Pharmaceuticals Limited, India

2431

Scaboma lotion Lindane 1%w/w P Lotion for Topical

Use

093/016 Glenmark Pharmaceuticals Limited, India

2432

Supricort Cream Fluocinolone Acetonide

0.025% w/w

POM Cream Topical 093/017 Glenmark Pharmaceuticals Limited, India

2433

Supricort N Cream Neomycin Sulphate 0.5%

+ Fluocinolone Acetonide

0.025%

POM Cream Topical 093/018 Glenmark Pharmaceuticals Limited, India

2434

Supricort Skin lotion Fluocinolone Acetonide

0.025%

POM Lotion for Topical

Use

093/019 Glenmark Pharmaceuticals Limited, India

2435

Syntran DS Tablets Sulphamethoxazole

800mg + Trimethoprim

160mg

POM Tablet Uncoated 093/020 Glenmark Pharmaceuticals Limited, India

2436

Syntran Paediatric Syrup Sulfamethoxazole 200mg

+ Trimethoprim 40mg

POM Syrup 093/021 Glenmark Pharmaceuticals Limited, India

2437 Vorth 10 Tablets Valdecoxib 10mg POM Tablet Uncoated 093/022 Glenmark Pharmaceuticals Limited, India

2438 Vorth 20 Tablets Valdecoxib 20mg POM Tablet Uncoated 093/023 Glenmark Pharmaceuticals Limited, India

2439 Deriva Aqueous Gel Adapalene 0.1%w/v P Gel Topical 093/024 Glenmark Pharmaceuticals Limited, India

2440 Rosicon-2mg Tablets Rosiglitazone 2mg POM Tablet Uncoated 093/025 Glenmark Pharmaceuticals Limited, India

2441 Rosicon-4 Tablets Rosiglitazone 4mg POM Tablet Uncoated 093/026 Glenmark Pharmaceuticals Limited, India

2442

Mumfer Syrup Haematinic preparation

(Ferric Hydroxide 50mg,

per 5ml)

P Syrup 093/027 Glenmark Pharmaceuticals Limited, India

Page 126 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2443

Mumfer Drops Haematinic preparation

(Ferric Hydroxide 50mg,

per ml)

P Solution for Oral

Use

093/028 Glenmark Pharmaceuticals Limited, India

2444 Esoz Tablets Esomeprazole 20mg POM Tablet Uncoated 093/029 Glenmark Pharmaceuticals Limited, India

2445 Esoz-40 Tablets Esomeprazole 40mg POM Tablets oral 093/030 Glenmark Pharmaceuticals Limited, India

2446 Glevo-250 Tablets Levofloxacin 250mg POM Tablet Uncoated 093/031 Glenmark Pharmaceuticals Limited, India

2447 Glevo-500 Tablets Levofloxacin 500mg POM Tablet Uncoated 093/032 Glenmark Pharmaceuticals Limited, India

2448

Glevo 500 Infusion Levofloxacin 500mg POM Solution for

infusion

093/033 Glenmark Pharmaceuticals Limited, India

2449

Powercort Cream Clobetasol Propionate

0.05%

POM Cream Topical 093/034 Glenmark Pharmaceuticals Limited, India

2450

Mumfer Chewable Tablets Haematinic Preparation

(Folic Acid 500 mcg +

Iron (II) Hydroxide

Polymaltose Complex

100mg)

P Tablet Chewable 093/035 Glenmark Pharmaceuticals Limited, India

2451

Elovera Cream Tecopherol Acetate 0.5%

w/w + Aloe crude extract

10.0 %w/w

P Cream Topical 093/036 Glenmark Pharmaceuticals Limited, India

2452

Relcer Gel Suspension Aluminium Hydroxide 6g

+ Magnesium Hydroxide

80mg + Acitvated

Dimethicone 100mg +

Deglycyrrhized Liquorice

400 mg/5 mL.

P Suspension for

Oral Use

093/038 Glenmark Pharmaceuticals Limited, India

2453 Glenseng Capsules Ginseng extract 500mg GS Capsule oral 093/039 Glenmark Pharmaceuticals Limited, India

2454

Ascoril Expectorant Sabutamol Sulphate 2mg

+ Bromhexine

Hydrochloride 4mg +

Menthol 1mg +

Guaiphenesin 100mg,

per 5ml

POM Solution for Oral

Use

093/040 Glenmark Pharmaceuticals Limited, India

2455

Altacef Suspension Cefuroxime Axetil

125mg, per 5ml

POM Powder for Oral

Suspension

093/041 Glenmark Pharmaceuticals Limited, India

2456

Altacef Tablets Cefuroxime Axetil

250mg

POM Tablet Film coated 093/042 Glenmark Pharmaceuticals Limited, India

2457

Altacef Tablets Cefuroxime Axetil 500mg POM Tablet Uncoated 093/043 Glenmark Pharmaceuticals Limited, India

2458 Ciproglen Tablets Ciprofloxacin 500mg POM Tablet Uncoated 093/044 Glenmark Pharmaceuticals Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 2459 Glimulin Tablets Glimepiride 2mg POM Tablet Uncoated 093/045 Glenmark Pharmaceuticals Limited, India

2460 Enamate 10 Tablets Enalapril 10mg POM Tablet Uncoated 093/046 Glenmark Pharmaceuticals Limited, India

2461

Altacef 750 Injection Cefuroxime 750mg POM Powder for

Injection

093/047 Glenmark Pharmaceuticals Limited, India

2462

Altacef 250mg Injection Cefuroxime 250mg POM Powder for

Injection

093/048 Glenmark Pharmaceuticals Limited, India

2463 Glucar Tablets Acarbose 50mg POM Tablet Uncoated 093/049 Glenmark Pharmaceuticals Limited, India

2464

Erythromycin Tablets Erythromycin

Stearate250mg

POM Tablet Film coated 093/050 Glenmark Pharmaceuticals Limited, India

2465 Perigard 2 Tablets Perindopril 2mg POM Tablet Uncoated 093/051 Glenmark Pharmaceuticals Limited, India

2466 Perigard 4 Tablets Perindopril 4mg POM Tablet Uncoated 093/052 Glenmark Pharmaceuticals Limited, India

2467 Telma 20 Tablets Telmisartan 20mg POM Tablet Uncoated 093/053 Glenmark Pharmaceuticals Limited, India

2468 Telma 40 Tablets Telmisartan 40mg POM Tablet Uncoated 093/054 Glenmark Pharmaceuticals Limited, India

2469

Telma-H Tablets Hydrochlorothiazide

12.5mg + Telmisartan

40mg

POM Tablet Uncoated 093/055 Glenmark Pharmaceuticals Limited, India

2470

Valus AP Tablets Paracetamol 500mg +

Aceclofenac 100mg

P Tablet Uncoated 093/056 Glenmark Pharmaceuticals Limited, India

2471

Doxetaxel 80mg Injection Doxetaxel 80mg POM Powder for

Injection

093/057 Glenmark Pharmaceuticals Limited, India

2472

Doxetaxel 20mg Injection Doxetaxel 20mg POM Powder for

Injection

093/058 Glenmark Pharmaceuticals Limited, India

2473

Irinotecan 100mg Servycal

Injection

Irinotecan Hydrochloride

Trihydrate 100mg

POM Powder for

Injection

093/059 Glenmark Pharmaceuticals Limited, India

2474

Irinotecan 40mg Servycal

Injection

Irinotecan Hydrochloride

Trihydrate 40mg

POM Powder for

Injection

093/060 Glenmark Pharmaceuticals Limited, India

2475

Oxaliplatino Servycal 100mg

Injection

Oxaliplatin 100mg POM Powder for

Injection

093/061 Glenmark Pharmaceuticals Limited, India

2476

Oxaliplatino Servycal 50mg

Injection

Oxaliplatin 50mg POM Powder for

Injection

093/062 Glenmark Pharmaceuticals Limited, India

2477

Doxorubicina 50mg Servycal

Injection

Doxorubicin

Hydrochloride 50mg

Vial Vial 093/063 Glenmark Pharmaceuticals Limited, India

2478

Doxorubicina 10mg Servycal

Injection

Doxorubicin

Hydrochloride 10mg

POM Powder for

Injection

093/064 Glenmark Pharmaceuticals Limited, India

2479

Carboplastino Servycal 450mg

Injection

Carboplatin 450mg POM Powder for

Injection

093/065 Glenmark Pharmaceuticals Limited, India

2480

Carboplastino Servycal 150mg

Injection

Carboplatin 150mg POM Powder for

Injection

093/066 Glenmark Pharmaceuticals Limited, India

Page 128 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2481

Paclitaxel Servycal 30 mg

Injection

Paclitaxel 30mg POM Powder for

Injection

093/067 Glenmark Pharmaceuticals Limited, India

2482

Paclitaxel Servycal 100mg

Injection

Paclitaxel 100mg POM Powder for

Injection

093/068 Glenmark Pharmaceuticals Limited, India

2483

Leucovorina servycal 50mg

Injection

Leucovorin Calcica 50mg POM Lyophilised

concentrate for

Injection

093/069 Glenmark Pharmaceuticals Limited, India

2484

Ondansetron Servycal 8mg

Injection

Ondansetron 8mg, per

4ml

POM Solution for

Injection

093/070 Glenmark Pharmaceuticals Limited, India

2485 Supirocin Ointment Mupirocin 2% w/w POM Cream Topical 093/071 Glenmark Pharmaceuticals Limited, India

2486

X-met Tablets Metformin Hydrochloride

500mg

POM Tablet extended

release

093/072 Glenmark Pharmaceuticals Limited, India

2487

Ascovent Syrup Acebrophylline 50mg, per

5ml

P Syrup 093/073 Glenmark Pharmaceuticals Limited, India

2488

Halovate Ointment Halobetasol Propionate

0.05%w/w

POM Ointment topical 093/074 Glenmark Pharmaceuticals Limited, India

2489

Artiglen+ Tablets Artemether 80mg +

Lumefantrine 480mg

POM Tablet Uncoated 093/075 Glenmark Pharmaceuticals Limited, India

2490

Artiglen + Dry Syrup 60mls Artemether180mg +

Lumefantrine 1080mg

POM Powder for Oral

Suspension

093/076 Glenmark Pharmaceuticals Limited, India

2491

Beclometasone Pressurised

Inhalation

Beclamethasone

Dipropionate Anhydrous

250mcg

POM Solution for

Inhalation

093/077 Glenmark Pharmaceuticals Limited, India

2492

Relcer Gel Vanilla Flavour Aluminium Hydroxide

365mg + Magnesium

Hydroxide 80mg +

Simethicone 100mg

+Deglycyrrhized

Liquorice 400 mg

POM Suspension for

Oral Use

093/078 Glenmark Pharmaceuticals Limited, India

2493

Relcer Gel Mango Flavour Aluminium Hydroxide

365mg + Magnesium

Hydroxide 80mg +

Simethicone 100mg

+Deglycyrrhized

Liquorice 400 mg

POM Suspension for

Oral Use

093/079 Glenmark Pharmaceuticals Limited, India

Page 129 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2494

Relcer Gel Strawberry Flavour Aluminium Hydroxide

365mg + Magnesium

Hydroxide 80mg +

Simethicone 100mg

+Deglycyrrhized

Liquorice 400 mg

POM Suspension for

Oral Use

093/080 Glenmark Pharmaceuticals Limited, India

2495 Flexilor 4 Tablets Lornoxicam 4mg P Tablet Uncoated 093/081 Glenmark Pharmaceuticals Limited, India

2496 Flexilor 8 Tablets Lornoxicam 8mg P Tablet Uncoated 093/082 Glenmark Pharmaceuticals Limited, India

2497

Flexilor -SR Tablets Lornoxicam 16mg P Tablet sustained

release

093/083 Glenmark Pharmaceuticals Limited, India

2498

Ascoril D Syrup Dextromethorphan

Hydromide 10.00mg +

Triprolidine Hydrochloride

1.25mg + Phenylephrine

Hydrochloride 30.00mg

P Solution for Oral

Use

093/084 Glenmark Pharmaceuticals Limited, India

2499

Esoz Fast Tablets 20mg Esomeprazole

Magnesium 20mg

POM Tablet Film coated 093/085 Glenmark Pharmaceuticals Limited, India

2500

Esoz Fast Tablets 40mg Esomeprazole

Magnesium 40mg

POM Tablet Film coated 093/086 Glenmark Pharmaceuticals Limited, India

2501

Airtec SF 50 Inhaler Salmeterol Xinafoate BP

25mcg + Fluticasone

Propionate BP 50mcg

POM Solution for

Inhalation

093/087 Glenmark Pharmaceuticals Limited, India

2502

Airtec SF-125 Inhaler Salmeterol Xinafoate BP

25mcg + Fluticasone

Propionate BP 125mcg

POM Solution for

Inhalation

093/088 Glenmark Pharmaceuticals Limited, India

2503

Airtec SF 250 Inhaler Salmeterol Xinafoate BP

25mcg + Fluticasone

Propionate BP 250mcg

POM Solution for

Inhalation

093/089 Glenmark Pharmaceuticals Limited, India

2504

Dermikelp Topical Cream Ecklonia maxima extract

375mg/g

GS Cream Topical 093/090 Glenmark Pharmaceuticals Limited, India

2505 V Wash Plus Lactic Acid 1.2% w/v GSL Liquid soap 093/091 Glenmark Pharmaceuticals Limited, India

2506

Razel 20 Tablets Rosuvastatin (as

calcium) 20mg

POM Tablet Uncoated 093/095 Glenmark Pharmaceuticals Limited, India

2507

Razel 10 Tablets Rosuvastatin (as

calcium) 10mg

POM Tablet Uncoated 093/096 Glenmark Pharmaceuticals Limited, India

2508 Tacroz Forte Ointment Tacrolimus 0.1% w/w POM Ointment topical 093/097 Glenmark Pharmaceuticals Limited, India

2509

Glemont - CT4 Tablets Monteleukast Sodium

4mg

POM Tablet Chewable 093/099 Glenmark Pharmaceuticals Limited, India

Page 130 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2510

Glemont- CT5 Tablets Monteleukast Sodium

5mg

POM Tablet Chewable 093/100 Glenmark Pharmaceuticals Limited, India

2511

Demelan 15g Cream Glycolic Acid 100mg +

Alpha- Albutin 50 mg +

Kojic Dipalmitate 20mg

GS Cream Topical 093/101 Glenmark Pharmaceuticals Limited, India

2512

Razel 40 Tablets Rosuvastatin (as

Calcium) 40mg

POM Tablet Uncoated 093/102 Glenmark Pharmaceuticals Limited, India

2513 Sensur Lotion Wintergreen oil 12 % w/v

+ Peppermint oil 1 % w/v

GS Lotion for Topical

Use

093/103L Glenmark Pharmaceuticals Limited, India

2514

Sensur Rubefacient Mentha Piperita 14 %

w/w + Eucalyptus Oil 7.5

% w/v + Camphor 14.7 %

w/w + Clove Oil 7.8 % v/v

+ Cinnamon Oil 2 % w/v

+ Peppermint Oil 8 %

w/v.

GS Ointment topical 093/104L Glenmark Pharmaceuticals Limited, India

2515

Sensor Roll Mentha Piperita 14 % w/v

+ Wintergreen Oil 40 %

v/v + Camphor 17 % v/v

+ Eucalyptus Oil 6.5 %

v/v.

GS Solution for Topical

Use

093/105L Glenmark Pharmaceuticals Limited, India

2516

Burnstart Dressing Medical grade

Aluminosilicate powder

46.5% w/w

P Paste Topical 027/001L Global Natural Products

2517

G-Vit Tablets with Minerals

Tablets

Multivitamin + Minerals P Tablet Uncoated 291/001 Global Pharma Healthcare

2518 Rabazole - 20 Tablets Rabeprazole 20mg POM Tablet Uncoated 291/003 Global Pharma Healthcare

2519 D-Lor Tablets Desloratadine 5mg P Tablet Uncoated 291/004 Global Pharma Healthcare

2520 Priloten - 5 Tablets Enalapril 5mg POM Tablet Uncoated 291/005 Global Pharma Healthcare

2521

Feramin Tablets Folic Acid 500mg +

Methylcobalamin 50mg +

Elemental Iron 1mg +

Zinc 61.8mg

P Tablet Uncoated 291/002 Global Pharma Healthcare, India

2522

TiniTablets- N Tablets Tinidazole 600mg +

Norfloxacin 400mg

POM Tablet Uncoated 291/006 Global Pharma Healthcare, India

2523 Anaflam Tablets Ibuprofen 400mg P Tablet Uncoated 291/007 Global Pharma Healthcare, India

2524

Tryzin Tablets Cetirizine Dihydrochloride

10mg

P Tablet Uncoated 291/008 Global Pharma Healthcare, India

Page 131 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2525

Polybac -N Ointment Bactricine Zinc 5000units

+ Neomycin Sulphate

400units + Polymixin B

Su 3400units

POM Ointment topical 291/009 Global Pharma Healthcare, India

2526

Dolmax Gel Diclofenac Sodium

1%w/w

P Gel Topical 291/010 Global Pharma Healthcare, India

2527

LA - DS Tablets Artemether 40mg +

Lumefantrine 240mg

POM Tablet Uncoated 291/011 Global Pharma Healthcare, India

2528 Ferrous Sulphate Tablets Ferrous Sulphate 200mg POM Tablet Uncoated 221/001 Glow Export Trading Pvt Ltd, India

2529

Cetrol ORS Powder Sodium Chloride 3.5g +

Sodium Citrate 2.9g +

Potassium Chloride 1.5g

+ Anhydrous Glucose

20g

POM Powder for Oral

Solution

221/002 Glow Export Trading Pvt Ltd, India

2530 Artesunate Tablets Artesunate 100mg POM Tablet Uncoated 221/003 Glow Export Trading Pvt Ltd, India

2531 G-Prop Tablets Propranolol 40mg POM Tablet Uncoated 221/004 Glow Export Trading Pvt Ltd, India

2532

Pharmadar Tablets Sulphadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 169/001 Glumex Pharmaceuticals (Pvt) Ltd, India

2533

Eryomycin Syrup Erythromycin 125mg, per

5ml

POM Syrup 169/002 Glumex Pharmaceuticals (Pvt) Ltd, India

2534

C.P.Mex Syrup Chlorpheniramine 2mg,

per 5ml

P Syrup 169/003 Glumex Pharmaceuticals (Pvt) Ltd, India

2535

Glucain Tablets Aluminium Hydrochloride

120mg + Magnesium

trisilicate 250 mg

GS Tablet Uncoated 169/004 Glumex Pharmaceuticals (Pvt) Ltd, India

2536

Pharmadar Suspension Sulphadoxine 250 mg +

Pyrimethamine 12.50mg

P Suspension for

Oral Use

169/005 Glumex Pharmaceuticals (Pvt) Ltd, India

2537 Biovit-Z-Syrup Multivitamins + Minerals P Syrup 169/006 Glumex Pharmaceuticals (Pvt) Ltd, India

2538

Cold care Tablets Chlorpheniramine 2mg +

Caffeine 30mg +

Paracetamol 500mg

P Tablet Uncoated 169/007 Glumex Pharmaceuticals (Pvt) Ltd, India

2539 Gluvit Syrup Multivitamins + Minerals GS Syrup 169/008 Glumex Pharmaceuticals (Pvt) Ltd, India

2540 Lopamet Capsules Loperamide 2mg POM Capsule oral 169/010 Glumex Pharmaceuticals (Pvt) Ltd, India

2541 Apectin Tablets Cyproheptadine 4mg P Tablet Uncoated 169/011 Glumex Pharmaceuticals (Pvt) Ltd, India

2542

Clopin Syrup Ampicillin 125mg +

Cloxacillin 125mg, per

5ml

POM Powder for Oral

Solution

169/012 Glumex Pharmaceuticals (Pvt) Ltd, India

Page 132 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2543

Cephamex Syrup Cephalexin 125mg, per

5ml

POM Powder for Oral

Solution

169/013 Glumex Pharmaceuticals (Pvt) Ltd, India

2544 Flucomex Capsules Fluconazole 200mg POM Capsule oral 169/014 Glumex Pharmaceuticals (Pvt) Ltd, India

2545 Eromycin Tablets Erythromycin 250mg POM Tablet Uncoated 169/015 Glumex Pharmaceuticals (Pvt) Ltd, India

2546

Amizide Tablets Hydrochlorothiazide

50mg + Amiloride

Hydrochloride 5mg

POM Tablet Uncoated 169/017 Glumex Pharmaceuticals (Pvt) Ltd, India

2547 Methyldopa Tablets Methyldopa 250mg POM Tablet Uncoated 169/018 Glumex Pharmaceuticals (Pvt) Ltd, India

2548 Zovex Tablets Acyclovir 200mg POM Tablet Uncoated 169/019 Glumex Pharmaceuticals (Pvt) Ltd, India

2549 Carbamax Tablets Carbamazepine 200mg POM Tablets 169/020 Glumex Pharmaceuticals (Pvt) Ltd, India

2550 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 169/021 Glumex Pharmaceuticals (Pvt) Ltd, India

2551 Pyridoxine Tablets Pyridoxine 50mg POM Tablet Uncoated 169/022 Glumex Pharmaceuticals (Pvt) Ltd, India

2552

Nalidiixic Acid Oral Suspension Nalidixic acid 300mg, per

5ml

POM Oral Suspension 169/023 Glumex Pharmaceuticals (Pvt) Ltd, India

2553 Aminophylline Tablets Aminophylline 100mg POM Tablet Uncoated 169/024 Glumex Pharmaceuticals (Pvt) Ltd, India

2554 Glibenclamide Tablets Glibenclamide 5mg POM Tablet Uncoated 169/025 Glumex Pharmaceuticals (Pvt) Ltd, India

2555 Viengray Tablets Sildenafil 50mg POM Tablet Uncoated 169/026 Glumex Pharmaceuticals (Pvt) Ltd, India

2556

Apectine Syrup Cyproheptidine 2mg, per

5ml

P Syrup 169/027 Glumex Pharmaceuticals (Pvt) Ltd, India

2557

Ebut Capsules Paracetamol 325mg +

Ibuprofen 200mg +

Caffeine 40mg

P Capsule oral 169/028 Glumex Pharmaceuticals (Pvt) Ltd, India

2558

Polyinosinic-polycytidylic Acid

Injection

Polyinosinic-polycytidylic

acid 2mg, per 2ml

POM Solution for

Injection

261/001 Guangdong Bang Min Pharmaceutical Co.

Ltd,China

2559

Artescore for Children Tablets Pyrimethamine 25mg +

Artesunate 50mg +

Sulfadoxine 500mg

POM Tablet Uncoated 043/001 Guilin Pharmaceuticals Co Ltd,China

2560

Artescore Tablets Artesunate 100 +

Sulfadoxine 500 +

Pyrimethamine 25mg

POM Tablet Uncoated 043/002 Guilin Pharmaceuticals Co Ltd,China

2561

Artesun 60 Injection Artesunate 60mg POM Solution for

Injection

043/003 Guilin Pharmaceuticals Co Ltd,China

2562 G - Abzole Tablets Albendazole 400mg POM Tablet Uncoated 043/004 Guilin Pharmaceuticals Co Ltd,China

2563

G-ciprox Tablets Ciprofloxacin 500mg POM Tablet Enteric

Coated

043/005 Guilin Pharmaceuticals Co Ltd,China

2564

Sulphamethoxazole 800mg+

Trimethoprim 160mg USP

Tablets

Sulfamethoxazole 800mg

+ Trimethoprim 160mg

POM Tablet Uncoated 043/006 Guilin Pharmaceuticals Co Ltd,China

Page 133 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2565

Sulphamethoxazole 400mg+

Trimethoprim 80mg USP

Tablets

Sulfamethoxazole 400mg

+ Trimethoprim 160mg

POM Tablet Uncoated 043/007 Guilin Pharmaceuticals Co Ltd,China

2566

Artesun Injection 30mg Artesunate 30mg POM Solution for

Injection

043/008 Guilin Pharmaceuticals Co Ltd,China

2567

Artesun Injection 120mg Artesunate 120mg POM Solution for

Injection

043/009 Guilin Pharmaceuticals Co Ltd,China

2568

Dufenac 75mg Dual Release

Enteric Capsules

Diclofenac Sodium 75mg P Caplets oral Enteric

Coated

043/019 Guilin Pharmaceuticals Co Ltd,China

2569

Zathenza Powder for Injection Benzathin 2.4 mega units POM Powder for

Injection

043/020 Guilin Pharmaceuticals Co Ltd,China

2570

G-Cospe Tablets Sulfadoxine 500mg +

Pyrimethamine 25mg

POM Tablet Uncoated 043/010 Guilin Pharmaceuticals Co. Ltd, China

2571

G-Ceftria Injection Ceftriaxone Sodium 1.0g POM Powder for

Injection

043/011 Guilin Pharmaceuticals Co. Ltd, China

2572

D-Artepp Tablets Dihydroartemisinin 40mg

+ Piperaquine Phosphate

320mg

POM Tablet Uncoated 043/012 Guilin Pharmaceuticals Co. Ltd, China

2573

Ferro Booster Capsules Iron 100mg + Vitamin C

75mg + Zinc 22.5mg +

Folic Acid 1.5mg +

Selenium 60mcg + Vit

B12 5mcg + Vit E 15I.U

P Capsule oral 360/001 Hanson canada

2574

Rejuvin Tablets Methylcobalamin 500

mcg +Vitamin A (as

acetate) 5000IU + Asc

P Tablet Uncoated 360/002 Hanson canada

2575

Miracle Detox Tablets Biotin USP 100mcg +

Calcium D Pantothenate

BP 10mg + Folic A

P Tablet Uncoated 360/003 Hanson canada

2576 Omega 369 Capsules Flax Seed Oil 500mg P Capsule oral 360/004 Hanson canada

2577

Povidone Iodine Topical

Solution

Povidone Iodine USP

5%w/v

P Solution for Topical

Use

360/005L Hanson canada

2578

Alatrol Tablets Cetirizine Hydrochloride

10mg

P Tablet Uncoated 345/001 Hasafa Health Sciences,Tanzania

2579

Anadol 100 Injection Tramadol Hydrochloride

100mg

POM Solution for

Injection

345/002 Hasafa Health Sciences,Tanzania

2580

Osmolax Oral Solution Lactulose 3.4mg, per 5ml P Solution for Oral

Use

345/003 Hasafa Health Sciences,Tanzania

Page 134 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2581

Trupan 20 Tablets Pantoprazole Sodium

20mg

POM Tablet Film coated 345/004 Hasafa Health Sciences,Tanzania

2582

Zimax 500 Tablets Azithromycin Dihydrate

500mg

POM Tablet Uncoated 345/005 Hasafa Health Sciences,Tanzania

2583 Hecmetro 200 Tablets Metronidazole 200mg POM Tablet Film coated 190/002 Healthy Life Pharma (Pvt) Ltd, India

2584 Jantrax Tablets Levamisole 40mg P Tablet Film coated 190/003 Healthy Life Pharma (Pvt) Ltd, India

2585

Trimoxazole Oral Suspension Trimethoprim 40mg +

Sulphamethoxazole

200mg

POM Suspension for

Oral Use

190/005 Healthy Life Pharma (Pvt) Ltd, India

2586

Chloramphenicol Sodium

Injection

Chloramphenicol 1g, per

10ml

POM Powder for

Injection

190/013 Healthy Life Pharma (Pvt) Ltd, India

2587 Indometacin Capsules Indomethacin 25mg P Capsule oral 190/019 Healthy Life Pharma (Pvt) Ltd, India

2588

Amoxicillin Oral Suspension Amoxicillin 125mg, per

5ml

POM Suspension for

Oral Use

190/020 Healthy Life Pharma (Pvt) Ltd, India

2589 Vita+ Iron Tablets Multivitamins + Iron P Tablet Uncoated 190/022 Healthy Life Pharma (Pvt) Ltd, India

2590 Folic Acid 5mg Tablets Folic acid 5mg P Tablet Uncoated 292/001 Hebei Jiheng Pharmaceuticals Co Limited

2591 Paracare 500 Tablets Paracetamol 500mg GS Tablet Uncoated 292/002 Hebei Jiheng Pharmaceuticals Co Limited

2592

Rapid 1-2-3 Hema HIV Whole

Format Test Kit

Diagnostic Test Kits P HDPE Strips 021/001L Hema Diagnostic Systems, USA

2593

Rapid 1-2-3 Hema express HIV

(Whole Blood) Kit

Diagnostic Test Kits P HDPE Strips 021/002L Hema Diagnostic Systems, USA

2594

Rapid 1-2-3 Hema express HIV

(Serum/Plasma) Strip Format

Test Kit

Diagnostic Test Kits P HDPE Strips 021/003L Hema Diagnostic Systems, USA

2595

Rapid 1-2-3 Hema express HIV

(Serum/Plasma) Test Kit

Diagnostic Test Kits P HDPE Strips 021/004L Hema Diagnostic Systems, USA

2596

Rapid 1-2-3 Hema Syphilis

Dipstick Test Kit

Diagnostic Test Kits P HDPE Strips 021/005L Hema Diagnostic Systems, USA

2597

Rapid 1-2-3 Hema express

Syphilis Test

Diagnostic Test Kits P HDPE Strips 021/006L Hema Diagnostic Systems, USA

2598

Rapid 1-2-3 Hema Malaria

Plasmodium Falciparum(pf)Strip

Format Test K

Diagnostic Test Kits P HDPE Strips 021/007L Hema Diagnostic Systems, USA

2599

Rapid 1-2-3 Hema Malaria

Plasmodium Falciparum(pf)Strip

Format Test K

Diagnostic Test Kits P HDPE Strips 021/008L Hema Diagnostic Systems, USA

Page 135 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2600

Rapid 1-2-3 Hema Malaria 9pf

Dipstick Test

Diagnostic Test Kits P HDPE Strips 021/009L Hema Diagnostic Systems, USA

2601

Rapid 1-2-3 Hema express

Malaria Plasmodium

Falciparum/Plasmodium Vivax

Diagnostic Test Kits P HDPE Strips 021/010L Hema Diagnostic Systems, USA

2602

Rapid 1-2-3 Hema Malaria

Dipstick Test for Multiple

Malaria Species

Diagnostic Test Kits P HDPE Strips 021/011L Hema Diagnostic Systems, USA

2603

Rapid 1-2-3 Hema express

Malaria pfv-Multiple Test

Diagnostic Test Kits P HDPE Strips 021/012L Hema Diagnostic Systems, USA

2604 Zido-H 300 Tablets Zidovudine 300mg POM Tablet Uncoated 150/001 Hetero Drugs Limited, India

2605 Heptavir 150 Tablets Lamivudine 150mg POM Tablet Uncoated 150/002 Hetero Drugs Limited, India

2606 Indivir -400 Capsules Indinavir 400mg POM Capsule oral 150/003 Hetero Drugs Limited, India

2607 Nevivir 200 Tablets Nevirapine 200mg POM Tablet Uncoated 150/006 Hetero Drugs Limited, India

2608

Zidolam Tablets Lamivudine 150mg +

Zidovudine 300mg

POM Tablet Uncoated 150/007 Hetero Drugs Limited, India

2609

Nevilast 30 Tablets Lamivudine 150mg +

Nevirapine 200mg +

Stavudine 30mg

POM Tablet Uncoated 150/008 Hetero Drugs Limited, India

2610

Nevilast - 40 Tablets Lamivudine 150mg +

Nevirapine 200mg +

Stavudine 40mg

POM Tablet Uncoated 150/009 Hetero Drugs Limited, India

2611

Zidolam-N Tablets Zidovudine 300mg +

Lamivudine 150mg +

Nevirapine 200mg

POM Tablet Uncoated 150/010 Hetero Drugs Limited, India

2612 Estiva-600 Tablets Efavirenz 600mg POM Tablet Uncoated 150/011 Hetero Drugs Limited, India

2613 Ciproplus -250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 150/012 Hetero Drugs Limited, India

2614 Ciproplus 500mg Tablets Ciprofloxacin 500mg POM Tablet Uncoated 150/013 Hetero Drugs Limited, India

2615 Clarigen 250mg Tablets Clarithromycin 250mg POM Tablet Uncoated 150/014 Hetero Drugs Limited, India

2616 Clarigen 500mg Tablets Clarithromycin 500mg POM Tablet Uncoated 150/015 Hetero Drugs Limited, India

2617

Tenof Tablets Tenofivir disoproxil

fumurate 300mg

POM Tablet Uncoated 150/018 Hetero Drugs Limited, India

2618

Tenolam Tablets Tenofivir Disoproxil

Fumurate 300mg +

Lamivudine 300mg

POM Tablet Uncoated 150/022 Hetero Drugs Limited, India

2619

Efavirenz/Emtricitabine/Tenofivir

Tablets

Efavirenz 600mg +

Emtricitabine 200mg +

Tenofivir Disoproxil

Fumurate 300mg

POM Tablet Film coated 150/023 Hetero Drugs Limited, India

Page 136 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2620

Lopinavir & Ritonavir

200mg/50mg Tablets

Lopinavir 200mg +

Ritonavir50mg

POM Tablet Film coated 150/024 Hetero Drugs Limited, India

2621

Amlo - H 10 Tablets Amlodipine Besylate

10mg

POM Tablet Uncoated 150/025 Hetero Drugs Limited, India

2622

Amlo - H 5 Tablets Amlodipine Besylate 5mg POM Tablet Uncoated 150/026 Hetero Drugs Limited, India

2623

Gemtero 1g Injection Gemcitabine

Hydrochloride 1g

POM Solution for

Injection

150/027 Hetero Drugs Limited, India

2624

Gemtero 200mg Injection Gemcitabine

Hydrochloride 200 mg

POM Solution for

Injection

150/028 Hetero Drugs Limited, India

2625

Levin 500 Tablets Levofloxacin

Hemihydrate 500mg

POM Tablet Uncoated 150/029 Hetero Drugs Limited, India

2626

Levin 250 Tablets Levofloxacin

Hemihydrate 250mg

POM Tablet Uncoated 150/030 Hetero Drugs Limited, India

2627 Penvir-750 Tablets Famcyclovir 750mg POM Tablet Film coated 150/031 Hetero Drugs Limited, India

2628 Penvir-250 Tablets Famcyclovir 250mg POM Tablet Film coated 150/033 Hetero Drugs Limited, India

2629 Irbis-H 300 Tablets Irbesartan 300mg POM Tablet Uncoated 150/035 Hetero Drugs Limited, India

2630 Irbis-H 150 Tablets Irbesartan 150mg POM Tablet Uncoated 150/036 Hetero Drugs Limited, India

2631

Atazanavir + Ritonavir Tablets Atazanavir Sulphate

300mg + Ritonivir 100mg

POM Tablet Film coated 150/038 Hetero Drugs Limited, India

2632

Emtricitabine & Tenofivir

Disoproxil Fumarate Tablets

Emtricitabine 200mg +

Tenofivir Disoproxil

Fumarate300mg

POM Tablet Film coated 150/039 Hetero Drugs Limited, India

2633 Acyclovir Tablets Acyclovir 200mg POM Tablet Uncoated 150/040 Hetero Drugs Limited, India

2634 Flugen-150 Tablets Fluconazole 150mg POM Tablet Uncoated 150/041 Hetero Drugs Limited, India

2635 Flugen 200 Tablets Fluconazole 200mg POM Tablet Uncoated 150/042 Hetero Drugs Limited, India

2636 Giagra 100 Tablets Sildenafil Citrate 100mg POM Tablet Uncoated 150/043 Hetero Drugs Limited, India

2637 Giagra 50 Tablets Sildenafil Citrate 50mg POM Tablet Uncoated 150/044 Hetero Drugs Limited, India

2638

Lamivudine Oral Solution Lamivudine 10mg, per ml POM Syrup 150/045 Hetero Drugs Limited, India

2639

Abacavir Sulphate 300mg

Tablets

Abacavir Sulphate 300mg POM Tablet Uncoated 150/046 Hetero Drugs Limited, India

2640 Anatero Tablets Anastrozole 1mg POM Tablet Uncoated 150/047 Hetero Drugs Limited, India

2641

Efavirenz/Lamivudine/Tenofovir

Tablets

Efavirenz 600mg +

Lamivudine 300mg +

Tenofivir Disoproxil

Fumurate 300mg

POM Tablet Uncoated 150/048 Hetero Drugs Limited, India

Page 137 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2642

Diclofenac Sodium Delayed

Release Tablets

Diclofernac Sodium 50

mg

P Capsule oral 150/049 Hetero Drugs Limited, India

2643 Omegenix 20 Capsules Omeprazole 20mg POM Capsule oral 150/050 Hetero Drugs Limited, India

2644 Ibuprofen Tablets 400mg Ibuprofen 400mg P Tablet oral 150/051 Hetero Drugs Limited, India

2645 Bicatero 50 Tablets Bicalutamide 50mg POM Tablet Uncoated 150/052 Hetero Drugs Limited, India

2646 Binfin 5 Tablets Finastride 5mg POM Tablet oral 150/053 Hetero Drugs Limited, India

2647 Zolid Tablets Linezolid 600mg POM Tablet Uncoated 150/054 Hetero Drugs Limited, India

2648

Abacavir Sulphate and

Lamivudine Tablets

Abacavir sulphate 600mg

+ Lamivudine 300mg

POM Tablet Film coated 150/056 Hetero Drugs Limited, India

2649Paclitero 300 Injection Paclitaxel 300mg

POM Solution for

Injection

150/057Hetero Drugs Limited, India

2650Monte H 4 Tablets

Montelukast Sodium

4mg

POMTablet Film Coated

150/059Hetero Drugs Limited, India

2651Monte H 5 Tablets

Montelukast Sodium

5mg

POMTablet Film Coated

150/060Hetero Drugs Limited, India

2652Monte H 10 Tablets

Montelukast Sodium

10mg

POMTablet Film Coated

150/061Hetero Drugs Limited, India

2653

Ferrich Syrup Ferric Ammonium Citrate

+ Folic acid BP +

Cyanocobalamin

P Syrup 150/062L Hetero Drugs Limited, India

2654 Sofgen Tablets Sofosbuvir 400mg POM Tablet Uncoated 150/064 Hetero Drugs Limited, India

2655 Prega 150 Capsules Pregabalin 150mg POM Capsule oral 150/065 Hetero Drugs Limited, India

2656

Tecavir 0.5 Tablets Entecavir monohydrate

0.5mg

POM Tablet Uncoated 150/066 Hetero Drugs Limited, India

2657

Tecavir 1 Tablets Entecavir monohydrate

1mg

POM Tablet Uncoated 150/067 Hetero Drugs Limited, India

2658

Zoldro 4mg Injection Zoledronic Acid

Monohydrate 4mg

POM Solution for

Injection

150/068 Hetero Drugs Limited, India

2659 Cycloz Ophthalmic Ointment Acyclovir 5% w/w POM Eye Ointment 157/001 Highnoon Laboratories Ltd, Pakistan

2660 Cycloz Cream Acyclovir 5%w/w POM Cream Topical 157/002 Highnoon Laboratories Ltd, Pakistan

2661 Cycloz Tablets Acyclovir 200mg POM Tablet Uncoated 157/003 Highnoon Laboratories Ltd, Pakistan

2662

Loprin 75 mg Tablets Acetyl Salicylic Acid

75mg

P Tablet Uncoated 157/004 Highnoon Laboratories Ltd, Pakistan

2663

Loprin 150mg Tablets Acetyl Salicylic Acid

150mg

P Tablet Uncoated 157/005 Highnoon Laboratories Ltd, Pakistan

2664

Loprin 300mg Tablets Acetyl Salicylic Acid

300mg

P Tablet Uncoated 157/006 Highnoon Laboratories Ltd, Pakistan

Page 138 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2665

Evacef Suspension Cefadroxil Monohydrate

125mg, per 5ml

POM Suspension for

Oral Use

157/007 Highnoon Laboratories Ltd, Pakistan

2666

Evacef Suspension Cefadroxil Monohydrate

250mg, per 5ml

POM Suspension for

Oral Use

157/008 Highnoon Laboratories Ltd, Pakistan

2667

Tramadol Injection Tramadol Hydrochloride

100mg, per ml

POM Solution for

Injection

157/009 Highnoon Laboratories Ltd, Pakistan

2668 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 157/010 Highnoon Laboratories Ltd, Pakistan

2669

Ciprofloxacin Tablets Ciprofloxacin

Hydrochloride 250mg

POM Tablet Uncoated 157/011 Highnoon Laboratories Ltd, Pakistan

2670 Cyprocin Tablets Ciprofloxacin 500mg POM Tablet Uncoated 157/012 Highnoon Laboratories Ltd, Pakistan

2671

Tamadol Capsules Tramadol Hydrochloride

50mg

P Capsule oral 157/013 Highnoon Laboratories Ltd, Pakistan

2672

Tamadol Injection Tramadol Hydrochloride

100mg, per 2ml

POM Solution for

Injection

157/014 Highnoon Laboratories Ltd, Pakistan

2673

Beprosone Cream Betamethasone

Dipropionate 0.064%w/w

POM Cream Topical 146/001 Hoe Pharmaceuticals Sdn Bud, Malaysia

2674

Beprosone Ointment Betamethasone

Dipropionate 0.064%w/w

POM Ointment topical 146/002 Hoe Pharmaceuticals Sdn Bud, Malaysia

2675

BeproGel Topical Solution Betamethasone

Dipropionate 0.064%w/v

POM Solution for Topical

Use

146/003 Hoe Pharmaceuticals Sdn Bud, Malaysia

2676

Beprosalic Ointment Salicylic acid 3% +

Betamethasone

Dipropionate 0.064%w/w

POM Ointment topical 146/004 Hoe Pharmaceuticals Sdn Bud, Malaysia

2677

Cloderm Cream Clobetasol Propionate

0.0568%w/w

POM Cream Topical 146/005 Hoe Pharmaceuticals Sdn Bud, Malaysia

2678

Cloderm Ointment Clobetasol Propionate

0.0568%w/v

POM Ointment topical 146/006 Hoe Pharmaceuticals Sdn Bud, Malaysia

2679

Cloderm Scalp Application

Solution

Clobetasol Propionate

0.0568%w/v

POM Solution for Topical

Use

146/007 Hoe Pharmaceuticals Sdn Bud, Malaysia

2680 Candazole Cream Clotrimazole 1%w/v POM Cream Topical 146/008 Hoe Pharmaceuticals Sdn Bud, Malaysia

2681

Candazole lotion Clotrimazole 1%w/v POM Lotion for Topical

Use

146/009 Hoe Pharmaceuticals Sdn Bud, Malaysia

2682

Candacort Cream Hydrocortisone 10mg +

Clotrimazole 10 mg

POM Cream Topical 146/010 Hoe Pharmaceuticals Sdn Bud, Malaysia

Page 139 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2683

Ecocort Cream Triamcinolone Acetonide

0.1%w/w + Econazole

1%w/w

POM Cream Topical 146/011 Hoe Pharmaceuticals Sdn Bud, Malaysia

2684 Dezor Cream Ketoconazole 2.0 %w/w POM Cream Topical 146/012 Hoe Pharmaceuticals Sdn Bud, Malaysia

2685 Dezor Shampoo Ketoconazole 2%w/v POM Shampoo 146/013 Hoe Pharmaceuticals Sdn Bud, Malaysia

2686

Decozol Cream Miconazole Nitrate 2%

w/w

POM Cream Topical 146/014 Hoe Pharmaceuticals Sdn Bud, Malaysia

2687

Decocort Cream Hydrocortisone 1% w/w +

Miconazole Nitrate 2.0%

w/w

POM Cream Topical 146/015 Hoe Pharmaceuticals Sdn Bud, Malaysia

2688

Tolnaderm lotion Tolnaftate 1% w/v POM Lotion for Topical

Use

146/017 Hoe Pharmaceuticals Sdn Bud, Malaysia

2689 Foban Cream Fusidic acid 2% w/w POM Cream Topical 146/018 Hoe Pharmaceuticals Sdn Bud, Malaysia

2690 Foban Ointment Sodium Fusidate 2%w/w POM Ointment topical 146/019 Hoe Pharmaceuticals Sdn Bud, Malaysia

2691

Fobancort Ointment Betamethasone

Dipropionate 0.064%

w/w + Sodium

Fusidate2.0% w/w

POM Ointment topical 146/020 Hoe Pharmaceuticals Sdn Bud, Malaysia

2692 Declovir Cream Acyclovir 5% w/w POM Cream Topical 146/021 Hoe Pharmaceuticals Sdn Bud, Malaysia

2693

A-Lices Shampoo Malathion 1.0% w/v POM Solution for Topical

Use

146/022 Hoe Pharmaceuticals Sdn Bud, Malaysia

2694

Gentamicin Cream Gentamicin Sulphate

0.17%w/w

POM Cream Topical 146/023 Hoe Pharmaceuticals Sdn Bud, Malaysia

2695

Beprosalic lotion Betamethasone

Dipropionate 0.064% w/v

+ Salicyclic acid 2%w/v

POM Lotion for Topical

Use

146/024 Hoe Pharmaceuticals Sdn Bud, Malaysia

2696

Poviderm Ointment Povidone Iodine 10%w/w GS Ointment topical 146/027 Hoe Pharmaceuticals Sdn Bud, Malaysia

2697 U-closone Ointment Clobetasone 0.05% POM Ointment topical 146/028 Hoe Pharmaceuticals Sdn Bud, Malaysia

2698

Menzze Cream Methyl salicylate 25%w/w GS Cream Topical 146/029 Hoe Pharmaceuticals Sdn Bud, Malaysia

2699

Zellox-DS Suspension Aluminium Hydroxide +

Simethicone

P Suspension for

Oral Use

146/030 Hoe Pharmaceuticals Sdn Bud, Malaysia

2700 Rhuma Gel Piroxicam 0.5% POM Gel Topical 146/031 Hoe Pharmaceuticals Sdn Bud, Malaysia

2701 C-mycin Gel Clindamycin 1.2% POM Gel Topical 146/032 Hoe Pharmaceuticals Sdn Bud, Malaysia

2702

C-mycin lotion Clindamycin 1.2% POM Lotion for Topical

Use

146/033 Hoe Pharmaceuticals Sdn Bud, Malaysia

2703 H-cort Ointment Hydrocortisone 1% POM Ointment topical 146/034 Hoe Pharmaceuticals Sdn Bud, Malaysia

Page 140 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2704

Beprogent Cream Betamethasone +

Gentamycin

POM Cream Topical 146/035 Hoe Pharmaceuticals Sdn Bud, Malaysia

2705

Oxy-nase 0.05% Nasal Spray Oxymetazoline 0.05% POM Spray For Nasal

Use

146/036 Hoe Pharmaceuticals Sdn Bud, Malaysia

2706 Oxy-nase Drops Oxymetazoline 0.025% POM Nasal drops 146/037 Hoe Pharmaceuticals Sdn Bud, Malaysia

2707

Oxy-Nase 0.025% Nasal Spray Oxymetazoline 0.025% POM Spray For Nasal

Use

146/038 Hoe Pharmaceuticals Sdn Bud, Malaysia

2708

U-closone Cream Clobetasone Butyrate

0.05% w/w

POM Cream Topical 146/039 Hoe Pharmaceuticals Sdn Bud, Malaysia

2709

OrrePaste Oral Paste Triamcinolone Acetonide

0.1%

POM Oral paste 146/040 Hoe Pharmaceuticals Sdn Bud, Malaysia

2710

Oxy-Nase 0.025% Nasal Drops Oxymetazoline

Hydrochloride

0.025%w/v

P Solution for Topical

Use

146/041 Hoe Pharmaceuticals Sdn Bud, Malaysia

2711

Fobancort Cream Fusidic acid 2% w/w

Dipropionate +

Betamethasone

Dipropionate 0.064% w/w

POM Cream Topical 146/042 Hoe Pharmaceuticals Sdn Bud, Malaysia

2712 Paracetamol 500mg Tablets Paracetamol 500mg GS Tablet Uncoated 059/001 Holden Medicals B.V, The Netherlands

2713

Acetyl Salicylic Acid Acetyl Salicylic acid

300mg

P Tablet Uncoated 059/002 Holden Medicals B.V, The Netherlands

2714 Folic Acid Tablets Folic acid 5mg P Tablet Uncoated 059/003 Holden Medicals B.V, The Netherlands

2715 Ferrous Sulphate Tablets Ferrous sulphate 200mg P Tablet Film coated 059/004 Holden Medicals B.V, The Netherlands

2716

Oral Rehydration Salt Sodium Chloride 3.5g +

Sodium Citrate 2.9g +

Potassium Chloride 1.5g

+ Anhydrous Glucose

20g

GS Powder for Oral

Solution

059/005 Holden Medicals B.V, The Netherlands

2717 Albendazole Albendazole 400mg POM Tablet Uncoated 059/006 Holden Medicals B.V, The Netherlands

2718 Tetracycline Eye Ointment Tetracycline 1% w/w POM Eye Ointment 059/007 Holden Medicals B.V, The Netherlands

2719 Paracetamol 100mg Tablets Paracetamol 100mg GS Tablet Uncoated 059/008 Holden Medicals B.V, The Netherlands

2720

Mebendazole 500mg Chewable

Tablets

Mebendazole 500mg P Tablet Uncoated 059/009 Holden Medicals B.V, The Netherlands

2721 Hope C Tablets Chlorpheniramine 4mg P Tablet Uncoated 087/005 Hope Pharmaceuticals

2722

Hope - C Syrup Chlorpheniramine 2mg,

per 5ml

P Syrup 087/006 Hope Pharmaceuticals

2723 Hope-O Capsules Omeprazole 20mg POM Capsule oral 087/009 Hope Pharmaceuticals

Page 141 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2724

4CC Syrup Paracetamol 120mg +

Phenylepherine

Hydrochloride 2.5mg +

Dextromethophan

2.00mg +

Chlorpheniramine

0.50mg, per 5ml

P Syrup 087/001 Hope Pharmaceuticals Limited

2725 Blue Strength Tablets Sildenafil 50mg POM Tablet Uncoated 087/002 Hope Pharmaceuticals Limited

2726

DIABEST Suspension Metronidazole 100mg +

Furazolidone 30mg

POM Suspension for

Oral Use

087/003 Hope Pharmaceuticals Limited

2727

DIAFREE Suspension Metronidazole 100mg +

Norfloxacin 100mg

POM Suspension for

Oral Use

087/004 Hope Pharmaceuticals Limited

2728

Hopedom Suspension Domperidone 5mg, per

5ml

POM Suspension for

Oral Use

087/007 Hope Pharmaceuticals, India

2729 Hopedom Tablets Domperidone 10mg POM Tablet Uncoated 087/008 Hope Pharmaceuticals, India

2730

Hopenac Tablets Diclofenac sodium

100mg

POM Tablet Film coated 087/010 Hope Pharmaceuticals, India

2731

I-Plus Tablets Ibuprofen 400mg +

Paracetamol 500mg

P Tablet Uncoated 087/011 Hope Pharmaceuticals, India

2732 Cloveg Tablets Clotrimazole 100mg POM Tablet Uncoated 225/001 Household Pharmaceuticals Ltd, India

2733 Cloveg 1%Cream Clotrimazole 1.0%w/w POM Cream Topical 225/002 Household Pharmaceuticals Ltd, India

2734

Trioderm Cream Gentamycin 0.1% w/w +

Fluocinolone Acetonide

0.01% w/w + Miconazole

2% w/w

POM Cream Topical 225/003 Household Pharmaceuticals Ltd, India

2735

Ampigran Granules for

Suspension

Ampicillin 125mg, per

5ml

POM Granules for

Suspension

173/001 Hovid Sdn Bhd, Malaysia

2736 Griseofulvin 500 Tablets Griseofulvin 500mg POM Tablet Uncoated 173/002 Hovid Sdn Bhd, Malaysia

2737 Nutrivit Syrup Multivitamins GS Syrup 173/003 Hovid Sdn Bhd, Malaysia

2738 Hostan 250 Capsules Mefenamic Acid 250mg P Capsule oral 173/004 Hovid Sdn Bhd, Malaysia

2739 Prozotab Tablets Prazosin 1mg POM Tablet Uncoated 173/006 Hovid Sdn Bhd, Malaysia

2740

Amoxiclav 625 Tablets Amoxicillin 500mg +

Clavulanic Acid 125mg

POM Tablet Film coated 173/007 Hovid Sdn Bhd, Malaysia

2741 Nizole Tablets Metronidazole 200mg POM Tablet Uncoated 173/008 Hovid Sdn Bhd, Malaysia

2742 Feloxicam 20 Capsules Piroxicam 20mg POM Capsule oral 173/009 Hovid Sdn Bhd, Malaysia

2743 Clofenac SR Tablets Diclofenac 100mg P Tablet Film coated 173/010 Hovid Sdn Bhd, Malaysia

2744

Clofenac 50 SR Tablets Diclofenac 50mg P Tablet sustained

release

173/011 Hovid Sdn Bhd, Malaysia

2745 Amoxicap 250mg Capsules Amoxicillin 250mg POM Capsule oral 173/012 Hovid Sdn Bhd, Malaysia

Page 142 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2746

Suprim 480 Tablets Trimethoprim 80mg +

Sulphamethoxazole

400mg

POM Tablet Uncoated 173/013 Hovid Sdn Bhd, Malaysia

2747

Thelmin Tablets Pyrantel Pamoate 125mg P Tablet Film coated 173/014 Hovid Sdn Bhd, Malaysia

2748 Ternolol Tablets Atenolol 100mg POM Tablet Uncoated 173/015 Hovid Sdn Bhd, Malaysia

2749

Chloramphenicol Eye Drops Chloramphenicol 0.5%

w/v

POM Eye Drops 173/016 Hovid Sdn Bhd, Malaysia

2750 Ternolol 50 Tablets Atenolol 50mg POM Tablet Film coated 173/017 Hovid Sdn Bhd, Malaysia

2751 Dapatab M 250 Tablets Methyldopa 250mg POM Tablet Film coated 173/018 Hovid Sdn Bhd, Malaysia

2752 Omezole 20 Capsules Omeprazole 20mg POM Capsule oral 173/019 Hovid Sdn Bhd, Malaysia

2753 Horamine Syrup Chlorpheniramine 4mg P Syrup 173/020 Hovid Sdn Bhd, Malaysia

2754 Hopranolol Tablets Propranolol 40mg POM Tablet Film coated 173/021 Hovid Sdn Bhd, Malaysia

2755 Norelut Tablets Norethisterone 5mg POM Tablet Uncoated 173/023 Hovid Sdn Bhd, Malaysia

2756 Ampicap 250 Capsules Ampicillin 250mg POM Capsule oral 173/026 Hovid Sdn Bhd, Malaysia

2757 Virest 200mg Tablets Acyclovir 200mg POM Tablet Film coated 173/027 Hovid Sdn Bhd, Malaysia

2758 Tinazole 2% Cream Miconazole 2%w/w POM Cream Topical 173/028 Hovid Sdn Bhd, Malaysia

2759 Celexin Capsules Cephalexin 250mg POM Capsule oral 173/029 Hovid Sdn Bhd, Malaysia

2760 Doxicap Capsules Doxycycline 100mg POM Capsule oral 173/030 Hovid Sdn Bhd, Malaysia

2761 Tetracap 250mg Capsules Tetracycline 250mg POM Capsule oral 173/031 Hovid Sdn Bhd, Malaysia

2762 Cortisone Cream Hydrocortisone 1%w/w POM Cream Topical 173/032 Hovid Sdn Bhd, Malaysia

2763 Virest Cream Acyclovir 5%w/w POM Cream Topical 173/033 Hovid Sdn Bhd, Malaysia

2764

Betasone Cream Betamethasone 0.1%w/w POM Cream Topical 173/034 Hovid Sdn Bhd, Malaysia

2765 Ventamol 2mg Tablets Salbutamol 2mg POM Tablet Uncoated 173/035 Hovid Sdn Bhd, Malaysia

2766 Ventamol 4mg Tablets Salbutamol 4mg POM Tablet Uncoated 173/036 Hovid Sdn Bhd, Malaysia

2767 Prednisolone Tablets Prednisolone 5mg POM Tablet Uncoated 173/037 Hovid Sdn Bhd, Malaysia

2768

Hostan Paediatric Suspension Mefenamic Acid 125mg,

per 5ml

P Suspension for

Oral Use

173/038 Hovid Sdn Bhd, Malaysia

2769 Neurovit Tablets B Complex P Tablet Uncoated 173/039 Hovid Sdn Bhd, Malaysia

2770 Colodium Capsules Loperamide 2mg POM Capsule oral 173/040 Hovid Sdn Bhd, Malaysia

2771

Hovid Betaton Capsules Beta Caraotene +

Multivitamin

P Capsule oral 173/041 Hovid Sdn Bhd, Malaysia

2772 Erotab Erythromycin Tablets Erythromycin 250mg POM Tablet Film coated 173/042 Hovid Sdn Bhd, Malaysia

2773 Cloxamp 250mg Capsules Cloxacillin 250mg POM Capsule oral 173/043 Hovid Sdn Bhd, Malaysia

2774 Ventamol Syrup Salbutamol 2mg, per 5ml POM Syrup 173/044 Hovid Sdn Bhd, Malaysia

2775 Diabetmin Tablets Metformin 500mg POM Tablet Film coated 173/045 Hovid Sdn Bhd, Malaysia

2776

Amoxigram Granules Amoxicillin 125mg, per

5ml

POM Granules for

Suspension

173/046 Hovid Sdn Bhd, Malaysia

Page 143 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2777

Colospan Tablets Hyoscine Butyl Bromide

10mg

POM Tablet Film coated 173/048 Hovid Sdn Bhd, Malaysia

2778 Clamide-5 Tablets Glibenclamide 5mg POM Tablet Uncoated 173/049 Hovid Sdn Bhd, Malaysia

2779 Praziquantel Tablets Praziquantel 600mg POM Tablet Uncoated 222/001 IDA Foundation, The Netherlands

2780 Aciclovir Eye Ointment Aciclovir 3% w/w POM Eye Ointment 222/001MT IDA Foundation, The Netherlands

2781

Ceftriaxone Injection Ceftriaxone 1g POM Powder for

Injection

222/002MT IDA Foundation, The Netherlands

2782

Chloramphenicol Sodium

succinate Injection

Chloramphenicol 1g POM Powder for

Injection

222/003MT IDA Foundation, The Netherlands

2783 Ciprofloxacin Tablets Ciprofloxacin 250mg POM Tablet Uncoated 222/004MT IDA Foundation, The Netherlands

2784 Erythromycin Stearate Tablets Erythromycin 250mg POM Tablet Uncoated 222/005MT IDA Foundation, The Netherlands

2785

Co-trimoxazole Tablets Sulfamethoxazole 400mg

+ Trimethoprim 80mg

POM Tablet Uncoated 222/006MT IDA Foundation, The Netherlands

2786

Nystatin 100,000 IU Oral

Suspension

Nystatin 100,000 IU POM Suspension for

Oral Use

222/008MT IDA Foundation, The Netherlands

2787

Cotrimoxazole Tablets Trimethoprim 80mg+

Sulphamethoxazole

400mg

POM Tablet Uncoated 222/009MT IDA Foundation, The Netherlands

2788

Co-trimoxazole Tablets Sulphamethoxazole

800mg + Trimethoprim

160mg

POM Tablet Uncoated 222/010MT IDA Foundation, The Netherlands

2789

Cotrimoxazole Tablets Sulphamethoxazole

100mg + Trimethoprim

20mg

POM Tablet Uncoated 222/011MT IDA Foundation, The Netherlands

2790

Artesunate + Amodiaquine

Tablets

Amodiaquine 50mg +

Artesunate 200mg

POM Tablet Uncoated 222/013MT IDA Foundation, The Netherlands

2791

Ceftriaxone Injection Ceftriaxone 250mg POM Powder for

Injection

222/014MT IDA Foundation, The Netherlands

2792 Cefixime Tablets Cefixime 200mg POM Tablet Uncoated 222/015MT IDA Foundation, The Netherlands

2793 Fluconazole Capsules Fluconazole 200mg POM Capsule oral 222/016MT IDA Foundation, The Netherlands

2794 Fluconazole Capsules Fluconazole 50mg POM Capsule oral 222/017MT IDA Foundation, The Netherlands

2795 Fluconazole Capsules Fluconazole 150mg POM Capsule oral 222/018MT IDA Foundation, The Netherlands

2796 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 222/019 IDA Foundation, The Netherlands

2797 Erythromycin Tablets Erythromycin 250mg POM Tablet Uncoated 222/020MT IDA Foundation, The Netherlands

Page 144 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2798

Multivitamin Tablets Vitamin A2500IU +

Vitamin B 37.5mg +

Vitamin B1 1mg +Vitamin

C 0.15mg +Vitamin B2

0.5mg + Vitamin 300IU

GS Tablet Film coated 222/021MT IDA Foundation, The Netherlands

2799

Amoxiciliin BP 250mg Capsules Amoxicillin 250mg POM Capsule oral 222/022MT IDA Foundation, The Netherlands

2800 Metronidazole 200mg Tablets Metronidazole 200mg POM Tablet Uncoated 222/023 IDA Foundation, The Netherlands

2801 Amoxicillin BP 250mg Tablets Amoxicillin 250mg POM Tablet Uncoated 222/024MT IDA Foundation, The Netherlands

2802

Gentamycin Injection Gentamycin 80mg, per

2ml

POM Solution for

Injection

222/025MT IDA Foundation, The Netherlands

2803

Erythromycin Suspension Erythromycin 125mg, per

5ml

POM Powder for Oral

Suspension

222/026MT IDA Foundation, The Netherlands

2804

Metronidazole 125mg/5ml

Powder for Oral Suspension

Metronidazole 125mg POM Powder for Oral

Suspension

222/027MT IDA Foundation, The Netherlands

2805 Doxycycline Capsules Doxycycline 100mg POM Capsule oral 222/028MT IDA Foundation, The Netherlands

2806

Abhayrab Vaccine Inactivated Rabies

Antigen 2.5IU, per 0.5ml

POM Solution for

Injection

088/001 Indian Immunological limited

2807

Abay tox IP Vaccine Tetanus Toxoid Vaccine

0.5ml

Suspension for

Injection

088/002 Indian Immunological limited

2808 Metaplex Syrup B Complex P Syrup 152/001 Indoco Remedies Limited, India

2809

Flamar Cream Methyl Salicylate 8.0%

w/w + Mephenesin 5.0%

w/w + Methyl Nictinate

1.0% w/w + Methanol

2.05 w/w

P Cream Topical 152/002 Indoco Remedies Limited, India

2810 Indo 250 Tablets Erythromycin 250mg POM Tablet Film coated 152/003 Indoco Remedies Limited, India

2811 Concise 50 Tablets Fluconazole 50mg POM Tablet Uncoated 152/004 Indoco Remedies Limited, India

2812 Ciprind 250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 152/005 Indoco Remedies Limited, India

2813 Nimind Tablets Nimesulide 100mg POM Tablet Uncoated 152/006 Indoco Remedies Limited, India

2814 Dexoren Eye/Ear Drops Chlorampenicol 0.5%w/v POM Ear/Eye Drops 152/007 Indoco Remedies Limited, India

2815 Tamigen Eye/Ear Drops Gentamycin 0.3%w/v POM Ear/Eye Drops 152/008 Indoco Remedies Limited, India

2816 Atropen-P Eye Drops Atropine 1%w/v POM Eye Drops 152/009 Indoco Remedies Limited, India

2817

Cyclopam Tablets Paracetamol +

Dicyclomine

P Tablet Uncoated 152/010 Indoco Remedies Limited, India

2818

Metchek Tablets Metformin Hydrochloride

500mg

POM Tablet Uncoated 152/011 Indoco Remedies Limited, India

2819 Triz Tablets Cetirizine 10mg POM Tablet Uncoated 152/012 Indoco Remedies Limited, India

Page 145 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2820

Febrex Plus Tablets Paracetamol 500mg +

Phenylephrine

Hydrochloride 10mg +

Chlopheniramine 2mg

P Tablet Uncoated 152/013 Indoco Remedies Limited, India

2821

Febrex Plus Syrup Paracetamol 125mg +

Sodium Citrate 60mg

+Phenylephrine

Hydrocloride 2.5mg

P Syrup 152/014 Indoco Remedies Limited, India

2822

Otorex Ear Drops Paradichlorobenzene

2.0%w/v + Benzocaine

2.7%w/v + Chlorobutanol

5.0%w/v

P Solution for Topical

Use

152/015 Indoco Remedies Limited, India

2823

Cital Solution Disodium Hydrogen

Citrate 1.37 mg

P Solution for Oral

Use

152/016 Indoco Remedies Limited, India

2824

DentoGel Choline Salicylate

8.7%w/w + Lignocaine

Hcl 2.0% w/w

P Gel Topical 152/017 Indoco Remedies Limited, India

2825

Rexidin - M Gel Metronidazole Benzoate

10mg/g + Chlorhexidine

Gluconate Solutio

0.25%w/w

P Gel Oral 152/018 Indoco Remedies Limited, India

2826

Cloben G Cream Clotrimazole 1% w/w +

Gentamycin 0.1%w/w +

Beclomethasone

Dipropionate 0.025% w/w

POM Cream Topical 152/019 Indoco Remedies Limited, India

2827 Clob Cream Clotrimazole 1.0%w/w POM Cream Topical 152/020 Indoco Remedies Limited, India

2828 Ibuflamar 200 Tablets Ibuprofen 200mg P Tablet Uncoated 152/021 Indoco Remedies Limited, India

2829 Megyl Tablets Metronidazole 200mg POM Tablet Uncoated 152/022 Indoco Remedies Limited, India

2830

Flamar MX Tablets Diclofenac potassium

50mg + Paracetamol

325mg + Chlorzoxazone

250mg

P Tablet Uncoated 152/023 Indoco Remedies Limited, India

2831

Cloben Skin Cream Clotrimazole 1% w/w +

Beclomethasone

Dipropionate 0.025% w/w

Cream Topical 152/024 Indoco Remedies Limited, India

Page 146 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2832

Nosic Tablets Doxylamine Succinate 10

mg + Pyridoxine

Hydrochloride 10 mg

POM Tablets 152/025 Indoco Remedies Limited, India

2833

Viscid Gel Aluminium Hydroxide

400mg + Magnesium

Hydroxide 100mg +

Simethicone 25mg

GS Oral suspension 152/026 Indoco Remedies Limited, India

2834

Lignox 2% Injection  Lidocaine 20 mg , per ml POM Solution for

Injection

152/027 Indoco Remedies Limited, India

2835

Karvol Plus Inhalant Capsules Camphor 25mg +

Chlorothymol 5mg +

Eucalyptol 125mg +

Menthol 55mg +

 Terpineol 120mg

GS Liquid capsule for

Inhalation

152/028 Indoco Remedies Limited, India

2836 Clarie-250 Tablets Clarithromycin 250mg POM Tablet Uncoated 260/001 Ind-Swift Limited, India

2837 Netazox 500 Tablets Nitazoxanide 500mg POM Tablet Uncoated 260/002 Ind-Swift Limited, India

2838

Netazox Oral Suspension Nitazoxanide 100mg, per

5ml

POM Suspension for

Oral Use

260/003 Ind-Swift Limited, India

2839 Candez 4 Tablets Candesartan 4mg POM Tablet Uncoated 260/004 Ind-Swift Limited, India

2840 Atstat 10 Tablets Atorvastatin 10mg POM Tablet Uncoated 260/005 Ind-Swift Limited, India

2841 Atstat 20 Tablets Atorvastatin 20mg POM Tablet Uncoated 260/006 Ind-Swift Limited, India

2842

Fexidine 120 Tablets Fexofenadine

Hydrocloride 120mg

POM Tablet Uncoated 260/007 Ind-Swift Limited, India

2843

Fexidine 180 Tablets Fexofenadine

Hydrochloride 180mg

POM Tablet Uncoated 260/008 Ind-Swift Limited, India

2844 Glitter 15 Tablets Pioglitazone 15mg POM Tablet Uncoated 260/009 Ind-Swift Limited, India

2845 Glitter 30 Tablets Pioglitazone 30mg POM Tablet Uncoated 260/010 Ind-Swift Limited, India

2846

Lamitar - AM Tablets Lumefantrine 120mg +

Artemether 20mg

POM Tablet Uncoated 260/011 Ind-Swift Limited, India

2847

Levoset Levocetrizine

Dihydrochloride 5mg

POM Tablet Film coated 376/001 Innovata Pharmaceuticals (Pty) Ltd

2848

Paratram Tramadol hydrochloride

37.5mg + Paracetamol

325mg

P Tablet Film coated 376/002 Innovata Pharmaceuticals (Pty) Ltd

2849 Citara 250 Tablets Levetiracetam 250mg POM Tablet Film coated 376/003 Innovata Pharmaceuticals (Pty) Ltd

2850 Citara 500 Tablets Levetiracetam 500mg POM Tablet Film coated 376/004 Innovata Pharmaceuticals (Pty) Ltd

2851 Citara 750 Tablets Levetiracetam 750mg POM Tablet Film coated 376/005 Innovata Pharmaceuticals (Pty) Ltd

2852 Citara 1000 Tablets Levetiracetam 1000mg POM Tablet Film coated 376/006 Innovata Pharmaceuticals (Pty) Ltd

Page 147 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2853

Avalife Colon Care Capsules Lactobacillus acidophilus

La14 + Lactobacillus

casei Lc11+

Lactobacillus lactis Ll23,

Bifidobacterium bifidium

Bb01 +

Fructooligosaccharide

50mg)

P Capsule oral 376/019L Innovata Pharmaceuticals (Pty) Ltd

2854

Avalife Femilora Capsules Lactobacillus acidophilus

La14 + Lactobacillus

plantarum LP115 +

Lactobacillus rhamnosus

Lr32 + Lactobacillus

salivarisLs33+Fructooligo

saccharide 30mg +

organic cranberry fruit

juice powder 500mg + D-

Mannose 100mg

P Capsule oral 376/022L Innovata Pharmaceuticals (Pty) Ltd

2855

Avalife Proreuteri-D Drops Lactobacillus reuteri LRE

2mg + Ergocalceferol (Vit

D3) 10mcg + Sunflower

oil 0.364ml + MCT Oil

0.135ml + Silicon dioxide

0.0025mg/ 0.5ml

P Solution for Oral

Use

376/021L Innovata Pharmaceuticals (Pty) Ltd

2856

Sweloze Herbal Cough Syrup Leaf of Vasa 800mg +

Leaf of Tulsi 120mg +

Plant of Kantakar

P Syrup 376/020L Innovata Pharmaceuticals (Pty) Ltd

2857

Ducym 20 Capsules Duloxetine hydrochloride

20mg

POM Capsule oral 376/019 Innovata Pharmaceuticals (Pty) Ltd

2858

Ducym 30 capsules Duloxetine hydrochloride

30mg

POM Capsule oral 376/020 Innovata Pharmaceuticals (Pty) Ltd

2859

Ducym 60 Capsules Duloxetine hydrochloride

60mg

POM Capsule oral 376/021 Innovata Pharmaceuticals (Pty) Ltd

2860 Innrika 25 Capsules Pregabalin 25mg POM Capsule oral 376/032 Innovata Pharmaceuticals (Pty) Ltd

2861 Innrika 75 Capsules Pregabalin 75mg POM Capsule oral 376/033 Innovata Pharmaceuticals (Pty) Ltd

2862 Innrika 150 Capsules Pregabalin 150mg POM Capsule oral 376/034 Innovata Pharmaceuticals (Pty) Ltd

2863

Innofer 100 Injection Iron Sucrose 100mg POM Suspension for

Injection

376/025 Innovata Pharmaceuticals (Pty) Ltd

Page 148 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2864

Irocan 40 Injection Irinotecan hydrochloride

trihydrate 40mg

POM Solution for

infusion

376/026 Innovata Pharmaceuticals (Pty) Ltd

2865

Irocan 100 Injection Irinotecan hydrochloride

trihydrate 100mg

POM Solution for

infusion

376/027 Innovata Pharmaceuticals (Pty) Ltd

2866

Irocan 300 Injection Irinotecan hydrochloride

trihydrate 300mg

POM Solution for

infusion

376/028 Innovata Pharmaceuticals (Pty) Ltd

2867

Irocan 500 injection Irinotecan hydrochloride

trihydrate 500mg

POM Solution for

infusion

376/029 Innovata Pharmaceuticals (Pty) Ltd

2868

Valvasc 5/160 FC Tablets Amlodipine 5mg

+Valsartan 160mg

POM Tablet Film coated 376/023 Innovata Pharmaceuticals (Pty) Ltd

2869

Valvasc 10/160 Film Coated

Tablets

Amlodipine 10mg +

Valsartan 160mg

POM Tablet Film coated 376/024 Innovata Pharmaceuticals (Pty) Ltd

2870 Furocsem 250 Tablets Cefuroxime axetil 250mg POM Tablet Film coated 376/030 Innovata Pharmaceuticals (Pty) Ltd

2871 Furocsem 500 Tablets Cefuroxime axetil 500mg POM Tablet Film coated 376/031 Innovata Pharmaceuticals (Pty) Ltd

2872

Canol Infusion Topetecan hydrochloride

4mg

POM Powder for

Injection

376/022 Innovata Pharmaceuticals (Pty) Ltd

2873

Dicloflame Tablets Diclofenac 50mg P Tablet Enteric

Coated

085/002 Intas International Pharmaceuticals Co. Ltd,

India

2874

Presilone Tablets Prednisolone 5mg POM Tablet Uncoated 085/003 Intas International Pharmaceuticals Co. Ltd,

India

2875

Methyldopa Tablets Methyldopa 282 mg (as

Levo isomer)

POM Tablet Uncoated 085/004 Intas International Pharmaceuticals Co. Ltd,

India

2876

Amoxycillin Tablets Amoxycillin 250mg POM Capsule oral 085/005 Intas International Pharmaceuticals Co. Ltd,

India

2877

Intacillin Tablets Ampicillin 250 mg POM Tablet Uncoated 085/006 Intas International Pharmaceuticals Co. Ltd,

India

2878

Binimycin Tablets Erythromycin Stearate

440mg

POM Tablet Uncoated 085/007 Intas International Pharmaceuticals Co. Ltd,

India

2879

Asthamol Tablets Salbutamol Sulphate

4.820mg

POM Tablet Uncoated 085/008 Intas International Pharmaceuticals Co. Ltd,

India

2880

Intrim 480 Tablets Sulphamethoxazole

400mg+ Trimethoprim

80mg

POM Tablet Uncoated 085/009 Intas International Pharmaceuticals Co. Ltd,

India

2881

Piroflame Tablets Piroxicam 10mg POM Tablet Uncoated 085/010 Intas International Pharmaceuticals Co. Ltd,

India

2882

Intafen Tablets Ibuprofen 200mg P Tablet Uncoated 085/011 Intas International Pharmaceuticals Co. Ltd,

India

2883

Intalol 100mg Tablets Atenolol 100mg POM Tablet Uncoated 085/012 Intas International Pharmaceuticals Co. Ltd,

India

Page 149 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2884

Intalol 50 mg Tablets Atenolol 50mg POM Tablet Uncoated 085/015 Intas International Pharmaceuticals Co. Ltd,

India

2885

Spasmine Injection Hyoscine Butyl Bromide

20mg

POM Solution for

Injection

085/017 Intas International Pharmaceuticals Co. Ltd,

India

2886

Ranloc Tablets Ranitidine 150mg POM Tablet Film coated 085/018 Intas International Pharmaceuticals Co. Ltd,

India

2887

Carditas Retard Tablets Nifedipine 20mg POM Tablet Film coated 085/019 Intas International Pharmaceuticals Co. Ltd,

India

2888

Monit-10 Tablets Isosorbide 10mg POM Tablet Uncoated 085/020 Intas International Pharmaceuticals Co. Ltd,

India

2889

Monit-20 Tablets Isosorbide 20mg POM Tablet Uncoated 085/021 Intas International Pharmaceuticals Co. Ltd,

India

2890

Astem-10 Tablets Astemizole 10mg POM Tablet Uncoated 085/023 Intas International Pharmaceuticals Co. Ltd,

India

2891

Enapril - 10mg Tablets Enalapril 10mg POM Tablet Uncoated 085/024 Intas International Pharmaceuticals Co. Ltd,

India

2892

Enapril 5mg Tablets Enalapril 5mg POM Tablet Uncoated 085/025 Intas International Pharmaceuticals Co. Ltd,

India

2893

FCN Tablets Fluconazole 200mg POM Capsule oral 085/026 Intas International Pharmaceuticals Co. Ltd,

India

2894

Kwinil-300 Tablets Quinine 300mg POM Tablet Film coated 085/027 Intas International Pharmaceuticals Co. Ltd,

India

2895

Intagenta Injection Gentamycin 80mg, per

2ml

POM Solution for

Injection

085/028 Intas International Pharmaceuticals Co. Ltd,

India

2896

Dicloflame Injection Diclofenac 75mg, per 3ml POM Solution for

Injection

085/029 Intas International Pharmaceuticals Co. Ltd,

India

2897

Ciflox Tablets Ciprofloxacin 250mg POM Tablet Uncoated 085/030 Intas International Pharmaceuticals Co. Ltd,

India

2898

Malostat Tablets Mefloquine 250mg POM Tablet Uncoated 085/031 Intas International Pharmaceuticals Co. Ltd,

India

2899

Zen-200 Tablets Carbamazepine 200mg POM Tablet Uncoated 085/032 Intas International Pharmaceuticals Co. Ltd,

India

2900

Cimecid Tablets Cimetidine 200mg POM Tablet Uncoated 085/033 Intas International Pharmaceuticals Co. Ltd,

India

2901

Doxytas Capsules Doxycycline 100mg POM Capsule oral 085/035 Intas International Pharmaceuticals Co. Ltd,

India

2902

Meflostats Tablets Mefloquine 250mg POM Tablet Uncoated 085/038 Intas International Pharmaceuticals Co. Ltd,

India

Page 150 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2903

Praziquantel Tablets Praziquantel 600mg POM Tablet Uncoated 085/039 Intas International Pharmaceuticals Co. Ltd,

India

2904

Rifampicin + Isoniazid Tablets Rifampicin 150mg +

Isoniazid 100mg

POM Tablet Uncoated 085/040 Intas International Pharmaceuticals Co. Ltd,

India

2905

Spasmintas-10 Tablets Hyoscine Butyl Bromide

10mg

POM Tablet Enteric

Coated

085/041 Intas International Pharmaceuticals Co. Ltd,

India

2906

Intavita Capsules Minerals + Mutivitamin P Tablet Uncoated 085/043 Intas International Pharmaceuticals Co. Ltd,

India

2907

Aclotas SR Tablets Aceclofenac 200mg P Tablet Uncoated 085/044 Intas International Pharmaceuticals Co. Ltd,

India

2908

Lipitas-20 Atorvastatin 20mg POM Tablet Uncoated 085/045 Intas International Pharmaceuticals Co. Ltd,

India

2909

Valtas OD-500 Tablets Valproic acid 500mg POM Tablet Uncoated 085/046 Intas International Pharmaceuticals Co. Ltd,

India

2910

Amtas 5 Tablets Amlodipine 5mg POM Tablet Uncoated 085/047 Intas International Pharmaceuticals Co. Ltd,

India

2911

Amtas-10 Tablets Amlodipine 10mg POM Tablet Uncoated 085/048 Intas International Pharmaceuticals Co. Ltd,

India

2912

Lan-30 Capsules Lansoprazole 30mg POM Capsule oral 085/049 Intas International Pharmaceuticals Co. Ltd,

India

2913

Lovastin-10 Tablets Lovastatin 10mg POM Tablet Uncoated 085/050 Intas International Pharmaceuticals Co. Ltd,

India

2914

Risdone 1mg Tablets Risperidone 1mg POM Tablet Uncoated 085/051 Intas International Pharmaceuticals Co. Ltd,

India

2915

Risdone 2mg Tablets Risperidone 2mg POM Tablet Film coated 085/052 Intas International Pharmaceuticals Co. Ltd,

India

2916

Doverin 80 Tablets Drotaverin Hydrochloride

80mg

POM Tablet Uncoated 085/053 Intas International Pharmaceuticals Co. Ltd,

India

2917

Tortas 10 Tablets Torasemide 10mg POM Tablet Uncoated 085/054 Intas International Pharmaceuticals Co. Ltd,

India

2918

Mims Co-trimoxazole Tablets Trimethoprim 80mg +

Sulfamethoxazole 400mg

POM Tablet Uncoated 155/001 International Drug Company Limited

2919

Mims Pain Rub Ointment Menthol + Camphor +

Eucalyptus + Pine Oil +

Nutmeg + Methyl

Salicylate

GS Ointment topical 155/002 International Drug Company Limited

2920

Mims AntAcid Suspension Aluminium Hydroxide +

Magnesium Trisilicate

GS Suspension for

Oral Use

155/003 International Drug Company Limited

Page 151 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2921

Mims Children Cough Syrup Guaiphenesin +

Paracetamol

P Syrup 155/004 International Drug Company Limited

2922 Mims metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 155/005 International Drug Company Limited

2923

Mims vitamin B complex Tablets B Complex P Tablet Uncoated 155/006 International Drug Company Limited

2924

Mims Co-trimoxazole

Suspension

Sulphamethoxazole 200

+ Trimethoprim 40mg,

per 5ml

POM Suspension for

Oral Use

155/007 International Drug Company Limited

2925

Mims No-Coff Syrup Guaiphenesin + Race

Menthol + Creosate wood

oil + Pine

P Syrup 155/008 International Drug Company Limited

2926

Mims Fastamol Syrup Paracetamol 120mg, per

5ml

GS Syrup 155/009 International Drug Company Limited

2927

Mims Gripe Water Solution Dill oil + Sodium

Bicarbonate + Sodium

Citrate

GS Solution for Oral

Use

155/010 International Drug Company Limited

2928 Mims Pheniramine Tablets Chlorpheniramine 4mg P Tablet Uncoated 155/011 International Drug Company Limited

2929

Mims Salbutamol Syrup Salbutamol 2.5mg, per

5ml

POM Syrup 155/012 International Drug Company Limited

2930 Mims GV Paint Suspension Methylrosanilinium P Suspension 155/013 International Drug Company Limited

2931

Mims Whitefield Ointment Salicylic acid 6%w/w +

Benzoic Acid 3%w/w

P Ointment topical 155/014 International Drug Company Limited

2932

Mims Metronidazole Suspension Metronidazole 30mg, per

5ml

POM Suspension for

Oral Use

155/016 International Drug Company Limited

2933

Dextrose 5% Intravenous Fluid Dextrose 5%w/v POM Solution for

infusion

155/017 International Drug Company Limited

2934

Sodium Chloride Intravenous

Fluid

Sodium Chloride

0.9%w/v

POM Solution for

infusion

155/018 International Drug Company Limited

2935

Darrows Solution for Injection Sodium Chloride 2g +

Sodium Lactate 2.95g +

Potassium Chloride 1.3g,

per 500ml

POM Solution for

infusion

155/019 International Drug Company Limited

2936

Ringer's Lactate Intravenous

Fluid

Sodium Chloride 6g +

Sodium Lactate 3.1g +

Potassium Chloride 0.3g

+ Calcium Chloride 0.2g,

per L

POM Solution for

infusion

155/020 International Drug Company Limited

2937

Dextrose 10% Intravenous

Fluid

Dextrose 10%w/v POM Solution for

Injection

155/021 International Drug Company Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2938

Dextrose 2.5%+ Half Strength

Darrows I.V Infusion

Dextrose 2.5% + Sodium

Chloride 2g + Sodium

Lactate 2.95g +

Potassium Chloride 1.3g,

per 1000ml

POM Solution for

Injection

155/022 International Drug Company Limited

2939

Dextrose + Sodium Chloride

Infusion

Dextrose 5% w/v +

Sodium Chloride

0.9%w/v

POM Solution for

infusion

155/023 International Drug Company Limited

2940

Mims Idphen Syrup Ammonium Chloride

200mg + Menthol 2mg +

Chlorpheniramine 2mg

P Solution for Oral

Use

155/024 International Drug Company Limited

2941 Mims Mutivitamins Syrup Multivitamins GS Syrup 155/025 International Drug Company Limited

2942

Mims Benzyl Benzoate

Application 25% w/w

Benzyl Benzoate 25

%w/w

P Solution for Topical

Use

155/026 International Drug Company Limited

2943

Mims Phenamine Syrup Chlorpheniramine 2mg,

per 5ml

P Syrup 155/027 International Drug Company Limited

2944

Fenelyn Expectorant Diphenhydramine

Hydrochloride 12.5mg +

Ammonium Chloride

125mg + Sodium Citrate

50mg + Menthol 1mg

P Solution for Oral

Use

155/028 International Drug Company Limited

2945

Mims Promine Elixir Promethazine 5mg, per

5ml

P Elixir 155/029 International Drug Company Limited

2946

Mims Calamine Lotion Calamine 15% w/v + Zinc

Oxide 5% w/v + Liquified

Phenol 0.4% w/v

P Lotion for Topical

Use

155/030 International Drug Company Limited

2947

Mims Peppermint Coughs and

Cold Syrup

Peppermint Oil 0.02mg +

Menthol 3.5mg

P Syrup 155/031 International Drug Company Limited

2948

Mims Zinc &Castor Oil Ointment Arachis Oil 30.50%w/w +

Zinc Oxide 7.50% w/w+

Castor Oil 50% w/w

P Ointment topical 155/032 International Drug Company Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2949

Mims Vapour Rub Ointment Menthol 3% w/w +

Camphor 3% w/w +

Eucalyptus oil 1.25% w/w

+ Pine oil 0.5% w/w +

Thymol crystals 0.10%

w/w + Nutmeg oil 0.55%

w/w + Terpentine oil 5%

w/w

GS Ointment topical 155/033 International Drug Company Limited

2950 Mims Mobilub Capsules Glucosamine 500mg P Capsule oral 155/034 International Drug Company Limited

2951 Mims Rejuva Capsules Multivitamin P Capsule oral 155/037 International Drug Company Limited

2952

Mims Cod liver Oil Capsules Cod Liver Oil 300mg GS Capsule oral 155/035 International Drug Company Limited,

Zambia

2953

Mims cod liver oil + vitamin E

Capsules

Cod Liver Oil 300mg +

Vitamin E 400mg

GS Capsule oral 155/036 International Drug Company Limited,

Zambia

2954

Bupacin Injection 50mg/ml -

20ml

Buparvaquone 50 mg,

per ml (VET)

POM Solution for

Injection

382/001 Intracin Pharmaceuticals Pvt Ltd

2955

Bupacin Injection 50mg/ml -

50ml

Buparvaquone 50 mg,

per ml (VET)

POM Solution for

Injection

382/002 Intracin Pharmaceuticals Pvt Ltd

2956

Butafen-400 Tablets Ibuprofen 400mg P Tablet Enteric

Coated

114/001 IPCA Laboratories Ltd, India

2957 Butafen-200 Tablets Ibuprofen 200mg P Tablet Uncoated 114/002 IPCA Laboratories Ltd, India

2958 Cimet-200 Tablets Cimetidine 200mg POM Tablet Uncoated 114/003 IPCA Laboratories Ltd, India

2959 Cimet-400 Tablets Cimetidine 400mg POM Tablet Uncoated 114/004 IPCA Laboratories Ltd, India

2960 Chloramphenicol Capsules Chloramphenicol 250mg POM Capsule oral 114/005 IPCA Laboratories Ltd, India

2961 Tetracycline 250mg Capsules. Tetracycline 250mg POM Capsule oral 114/006 IPCA Laboratories Ltd, India

2962

Giardyl Suspension Metronidazole 200mg,

per 5ml

POM Suspension for

Oral Use

114/007 IPCA Laboratories Ltd, India

2963

Nebagin Injection Dipyron 500mg, per ml POM Solution for

Injection

114/008 IPCA Laboratories Ltd, India

2964 Prednisolone Tablets Prednisolone 5mg POM Tablet Uncoated 114/009 IPCA Laboratories Ltd, India

2965

Metoclopromide Solution Metoclopramide 5mg, per

5ml

POM Solution for Oral

Use

114/010 IPCA Laboratories Ltd, India

2966

Perinan Injection Metoclopramide 5mg, per

ml

POM Solution for

Injection

114/011 IPCA Laboratories Ltd, India

2967

Nemocid Tablets Pyrantel Pamoate 125mg P Tablet Uncoated 114/012 IPCA Laboratories Ltd, India

2968

Pyrantel Pamoate Suspension Pyrantel Pamoate

125mg, per 5ml

P Suspension for

Oral Use

114/013 IPCA Laboratories Ltd, India

Page 154 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

2969

Erythromycin Suspension Erythromycin 125mg, per

5ml

POM Suspension for

Oral Use

114/014 IPCA Laboratories Ltd, India

2970 Pacimol 500mg Tablets Paracetamol 500mg P Tablet Uncoated 114/015 IPCA Laboratories Ltd, India

2971

Pacimol Syrup Paracetamol 125mg, per

5ml

GS Syrup 114/016 IPCA Laboratories Ltd, India

2972 Clarbact 250 Tablets Clarithromycin 250mg POM Tablet Uncoated 114/018 IPCA Laboratories Ltd, India

2973 Clarbact 500 Tablets Clarithromycin 500mg POM Tablet Uncoated 114/019 IPCA Laboratories Ltd, India

2974 Normax Tablets Norfloxacin 400mg POM Tablet Uncoated 114/020 IPCA Laboratories Ltd, India

2975

Stericef Injection Cefuroxime 1g POM Powder for

Injection

114/021 IPCA Laboratories Ltd, India

2976

Larither 40 Injection Artemether 40mg, per ml POM Solution for

Injection

114/022 IPCA Laboratories Ltd, India

2977

Cincoma Injection Quinine 300mg, per 1ml POM Solution for

Injection

114/023 IPCA Laboratories Ltd, India

2978

Imox Trihydrate Capsules Amoxicillin Trihydrate

250mg

POM Capsule oral 114/024 IPCA Laboratories Ltd, India

2979

Imox Dry Syrup Amoxicillin Trihydrate

125mg, per 5ml

POM Suspension for

Oral Use

114/025 IPCA Laboratories Ltd, India

2980 Ipcacillin Capsules Ampicillin 250mg POM Capsule oral 114/026 IPCA Laboratories Ltd, India

2981 Ipcavite-m Multivitamins GS Syrup 114/027 IPCA Laboratories Ltd, India

2982

Laridox Tablets Pyrimethamine 25mg +

Sulphadoxine 500mg

P Tablet Uncoated 114/028 IPCA Laboratories Ltd, India

2983

Larither-80 Injection Artemether 80mg POM Solution for

Injection

114/029 IPCA Laboratories Ltd, India

2984 Procip-250 Capsules Ciprofloxacin 250mg POM Tablet Uncoated 114/030 IPCA Laboratories Ltd, India

2985 Tenolol Tablets Atenolol 100mg POM Tablet Uncoated 114/031 IPCA Laboratories Ltd, India

2986 Tenolol-50 Tablets Atenolol 50mg POM Tablet Uncoated 114/032 IPCA Laboratories Ltd, India

2987 Zerodol Tablets Aceclofenac 100mg P Tablet Uncoated 114/033 IPCA Laboratories Ltd, India

2988

Lumerax 20/120 Tablets Artemether 20mg +

Lumefantrine 120mg

POM Tablet Uncoated 114/034 IPCA Laboratories Ltd, India

2989 Pari -CR 12.5 Tablets Paroxetine 12.5mg POM Tablet Uncoated 114/035 IPCA Laboratories Ltd, India

2990 Pari-CR 25 Tablets Paroxetine 25mg POM Tablet Uncoated 114/036 IPCA Laboratories Ltd, India

2991 Lisoril-5 Tablets Lisinopril 5mg POM Tablet Uncoated 114/037 IPCA Laboratories Ltd, India

2992 Glyree-1 Tablets Glimepiride 1mg POM Tablet Uncoated 114/038 IPCA Laboratories Ltd, India

2993 Glyree-2 Tablets Glimepiride 2mg POM Tablet Uncoated 114/039 IPCA Laboratories Ltd, India

2994 Glimepiride 3mg Tablets Glimepiride 3mg POM Tablet Uncoated 114/040 IPCA Laboratories Ltd, India

2995 Glimepiride 4mg Tablets Glimepiride 4mg POM Tablet Uncoated 114/041 IPCA Laboratories Ltd, India

2996 Nilitis 750mg Tablets Nabumetone 750mg POM Tablet Uncoated 114/042 IPCA Laboratories Ltd, India

2997 Nilitis 500mg Tablets Nabumetone 500mg POM Tablet Uncoated 114/043 IPCA Laboratories Ltd, India

2998 Azifast-500 Tablets Azithromycin 500mg POM Tablet Uncoated 114/045 IPCA Laboratories Ltd, India

Page 155 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 2999 Revelol xl 25 Tablets Metoprolol 25mg POM Tablet Uncoated 114/046 IPCA Laboratories Ltd, India

3000 Revelol xl 50 Tablets Metoprolol 50mg POM Tablet Uncoated 114/047 IPCA Laboratories Ltd, India

3001 Emnorm 500 Tablets Metformin 500mg POM Tablet Uncoated 114/048 IPCA Laboratories Ltd, India

3002 Emnorm 850 Tablets Metformin 850mg POM Tablet Uncoated 114/049 IPCA Laboratories Ltd, India

3003

Lisoretic -10 Tablets Hydrochlorothiazide

12.5mg + Lisinopril 10mg

POM Tablet Uncoated 114/050 IPCA Laboratories Ltd, India

3004

Lisoretic -20 Tablets Hydrochlorothiazide

12.5mg + Lisinopril20mg

POM Tablet Uncoated 114/051 IPCA Laboratories Ltd, India

3005 Piomed-15 Tablets Pioglitazone 15mg POM Tablet Uncoated 114/052 IPCA Laboratories Ltd, India

3006 Piomed-30 Tablets Pioglitazone 30mg POM Tablet Uncoated 114/053 IPCA Laboratories Ltd, India

3007 Presartan-25 Tablets Losartan 25mg POM Tablet Uncoated 114/054 IPCA Laboratories Ltd, India

3008 Presartan-50 Tablets Losartan 50mg POM Tablet Film coated 114/055 IPCA Laboratories Ltd, India

3009 Ramcor-1.25 Tablets Ramipril 1.25mg POM Tablet Uncoated 114/056 IPCA Laboratories Ltd, India

3010 Ramcor-2.5 Tablets Ramipril 2.5mg POM Tablet Uncoated 114/057 IPCA Laboratories Ltd, India

3011 Ramcor-5 Tablets Ramipril 5mg POM Tablet Uncoated 114/058 IPCA Laboratories Ltd, India

3012 Ramcor-10 Tablets Ramipril 10mg POM Tablet Uncoated 114/059 IPCA Laboratories Ltd, India

3013

Betamotil Injection Beta Arteether 150mg,

per 2ml

POM Solution for

Injection

114/060 IPCA Laboratories Ltd, India

3014

Cinkona Suspension Quinine 150mg, per 5ml POM Suspension for

Oral Use

114/061 IPCA Laboratories Ltd, India

3015

Arthemeter + Lumefanterine

Tablets

Artemether 20mg +

Lumefantrine 120mg

POM Tablet Uncoated 114/062 IPCA Laboratories Ltd, India

3016

Tenoric 50 Tablets Atenolol 50mg +

Chlortalidone 12.50mg

POM Tablet Uncoated 114/063 IPCA Laboratories Ltd, India

3017

Tenoric 100 Tablets Atenolol 100mg +

Chlortalidone 25mg

POM Tablet Uncoated 114/064 IPCA Laboratories Ltd, India

3018 Olex -7.5 Tablets Olanzepine 7.5mg POM Tablet Uncoated 114/065 IPCA Laboratories Ltd, India

3019 Zerodol-CR Tablets Aceclofenac 200mg POM Tablet Uncoated 114/066 IPCA Laboratories Ltd, India

3020 Glycinorm -80 Tablets Gliclazide 80mg POM Tablet Uncoated 114/067 IPCA Laboratories Ltd, India

3021

Presartan - H Tablets Lorsartan 50mg +

Hydrochlorothiazide

12.5mg

POM Tablet Uncoated 114/068 IPCA Laboratories Ltd, India

3022

Cotrimoxazole BP Tablets Trimethoprim 80mg +

Sulfamethoxazole

400mg

POM Tablet Uncoated 114/069 IPCA Laboratories Ltd, India

3023

Glyree - M 1 Tablets Glimepiride USP 1mg +

Metformin Hydrochloride

USP 500mg

POM Tablet Uncoated 114/071 IPCA Laboratories Ltd, India

Page 156 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3024

Glyree - M 2 Tablets Glimepiride USP 2mg +

Metformin Hydrochloride

USP 500mg

POM Tablet Uncoated 114/072 IPCA Laboratories Ltd, India

3025

Rapiclav 1g Tablets Amoxicillin trihydrate 875

mg + Clavulanate

Potassium 125mg

POM Tablet Uncoated 114/073 IPCA Laboratories Ltd, India

3026

Nutrifiber Resistant Maltodextrin

1.270g + Partially

hydrolyzed Guar Gum

1.110g + Inulin 1.320g +

Mannitol 0.800g

Powder for Oral

Suspension

114/074 IPCA Laboratories Ltd, India

3027

Larinate Injection Artesunate BP 60 mg POM Solution for

Injection

114/075 IPCA Laboratories Ltd, India

3028

iASAQ Tablets Artesunate 100mg +

Amodiaquine 270mg

POM Tablet Uncoated 114/076 IPCA Laboratories Ltd, India

3029

iSAQ 50/135 Tablets Artesunate 50mg +

Amodiaquine 135mg

POM Tablet Uncoated 114/077 IPCA Laboratories Ltd, India

3030

Pantonex -DR 20 Tablets Pantoprazole Sodium

Sesquihydrate BP 20mg

POM Tablet delayed

Release

114/078 IPCA Laboratories Ltd, India

3031

Pantonex -DR 40 Tablets Pantoprazole Sodium

Sesquihydrate BP 40mg

POM Tablet delayed

Release

114/079 IPCA Laboratories Ltd, India

3032

Zitram - SR 200 Tablets Tramadol Hydrochloride

Ph. Eur 200mg

POM Tablet sustained

release

114/080 IPCA Laboratories Ltd, India

3033

Cotrimoxazole Oral Suspension Trimethoprim BP 40mg +

Sulfamethoxazole BP

200mg

POM Suspension for

Oral Use

114/081 IPCA Laboratories Ltd, India

3034 Multicharge Capsules (Men) Combination P Capsule oral 114/082L IPCA Laboratories Ltd, India

3035

Multicharge Capsules Women Minerals + Natural

Extracts + Methionine

22mg + Glutamic Acid 20

mg + Lysin 10mg +

Cystein 2.5mg

P Capsule oral 114/083L IPCA Laboratories Ltd, India

3036

Multicharge Eye Capsules Eicosapantaenoic Acid

325mg +

Docosahexaenoic Acid

175mg + Lutein 5mg +

Zeaxanthin 1mg

P Capsule oral 114/084L IPCA Laboratories Ltd, India

3037 Multicharge Daily Capsules Combination P Capsule oral 114/085L IPCA Laboratories Ltd, India

Page 157 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3038

Multicharge Daily Heart Capsule combination of oils and

minerals

P Capsule oral 114/087 Ipca Laboratories Ltd, India

3039

Lumerax DT 20/120 Artemether 20mg +

Lumefantrine 120mg

POM Tablet Film coated 114/086 Ipca Laboratories Ltd, India

3040

Lumerax 80/480 tablets Arthemether 80mg +

Lumefantrine 480mg

POM Tablet Uncoated 114/088 Ipca Laboratories Ltd, India

3041

Beclasone CFC Free Metered

Doses Inhaler

Beclamethasone 50mcg POM Powder for

Inhalation

004/001 Ivax Pharma Ireland, Ireland

3042

Salmol CFC Free Metered Dose

Inhaler

Salbutamol 100mcg per

Metered Dose

POM Powder for

Inhalation

004/002 Ivax Pharma Ireland, Ireland

3043

Haycrom Aqueous Eye Drops Sodium Cromoglycate

2%

POM Eye Drops 004/003 Ivax Pharma Ireland, Ireland

3044

Warfarin Tablets Warfarin Sodium 100mcg POM Tablet Uncoated 004/004 Ivax Pharma Ireland, Ireland

3045 Ivytimol Eye Drops Timolol 5mg, per ml POM Eye Drops 189/001 Ivee Aqua EPZ Limited, Kenya

3046 Ivygentacin Eye/Ear Drops Gentamycin 3mg, per ml POM Ear/Eye Drops 189/002 Ivee Aqua EPZ Limited, Kenya

3047

Ivyphenicol Eye Drops Chloramphenicol 5mg,

per ml

POM Eye Drops 189/003 Ivee Aqua EPZ Limited, Kenya

3048

Ivyzoxam Eye/Ear Drops Ciprofloxacin 3mg, per ml POM Ear/Eye Drops 189/004 Ivee Aqua EPZ Limited, Kenya

3049 Ivynoraxine Eye/Ear Drops Norfloxacin 3mg, per ml POM Ear/Eye Drops 189/005 Ivee Aqua EPZ Limited, Kenya

3050

Ivydexone Eye Drops Dexamethasone 1mg,

per ml

POM Eye Drops 189/006 Ivee Aqua EPZ Limited, Kenya

3051

Ivysone Ophthalmic Solution Hydrocortisone 10mg,

per ml

POM Eye Drops 189/007 Ivee Aqua EPZ Limited, Kenya

3052

Ivysolone Opthlamic

Suspension

Prednisolone 10mg, per

ml

POM Eye Suspension 189/008 Ivee Aqua EPZ Limited, Kenya

3053

Ivydexnicol Eye Drops Dexamethasone 1mg+

Chloramphenicol 10mg,

per ml

POM Eye Drops 189/009 Ivee Aqua EPZ Limited, Kenya

3054

Ivydexgent Eye/Ear Drops Gentamycin 4mg +

Dexamethasone 3mg,

per ml

POM Ear/Eye Drops 189/010 Ivee Aqua EPZ Limited, Kenya

3055

Ivydexneocin Eye/Ear Drops Dexamethasone 3.5mg

+ Neomycin 1mg, per ml

POM Ear/Eye Drops 189/011 Ivee Aqua EPZ Limited, Kenya

3056 Ivytimol Eye Drops Timolol 0.5mg, per ml POM Eye Drops 189/012 Ivee Aqua EPZ Limited, Kenya

3057

Ivysine Eye Drops Tetrahydrozoline 0.5mg,

per ml

POM Eye Drops 189/013 Ivee Aqua EPZ Limited, Kenya

Page 158 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3058

Ivyzinc Eye Drops Zinc Sulphate 2.5mg, per

ml

POM Eye Drops 189/014 Ivee Aqua EPZ Limited, Kenya

3059

Ivyflur Eye Drops Flurbiprofen 0.3mg, per

ml

POM Eye Drops 189/015 Ivee Aqua EPZ Limited, Kenya

3060

Ivymoicell Eye Drops Hydroxypropylmethyl

Cellulose 7mg, per ml

POM Eye Drops 189/016 Ivee Aqua EPZ Limited, Kenya

3061 Ivyfrin Nasal Drops Ephedrine 10mg, per ml POM Nasal drops 189/017 Ivee Aqua EPZ Limited, Kenya

3062 Ivyfrin Nasal Drops Ephedrine 5mg, per ml POM Nasal drops 189/018 Ivee Aqua EPZ Limited, Kenya

3063

Ivynozvin A Nasal Drops Xylometazoline 1mg, per

ml

POM Nasal drops 189/019 Ivee Aqua EPZ Limited, Kenya

3064

Ivyfrin P Nasal Drops Xylometazoline 0.5mg,

per ml

POM Nasal drops 189/020 Ivee Aqua EPZ Limited, Kenya

3065

Ivyfchlornicol Ear Drops Drops Chloramphenicol 50mg,

per ml

POM Ear Drops 189/021 Ivee Aqua EPZ Limited, Kenya

3066

Ivybetasone Eye Drops Betamethasone 1mg, per

ml

POM Eye Drops 189/022 Ivee Aqua EPZ Limited, Kenya

3067

Ivybetaneocin Eye/Ear Drops Betamethasone 3.5mg +

Neomycin 1mg, per ml

POM Ear/Eye Drops 189/023 Ivee Aqua EPZ Limited, Kenya

3068 Ivyxolol Eye Drops Betaxolol 5mg, per ml POM Eye Drops 189/024 Ivee Aqua EPZ Limited, Kenya

3069

Water for Injection Sterile Water BP POM Solution for

Injection

189/025 Ivee Aqua EPZ Limited, Kenya

3070 Ivycarp Eye Drops Pilocarpine 20mg, per ml POM Eye Drops 189/026 Ivee Aqua EPZ Limited, Kenya

3071

Ivycrom Eye Drops Sodium Cromoglycate

20mg, per ml

POM Eye Drops 189/027 Ivee Aqua EPZ Limited, Kenya

3072

Trimetabol Oral Suspension Cyproheptadine

Acefyllinate 0.035mg + DI-

Carmitine Hydrochloride

7.00mg

P Solution for Oral

Use

324/001 J.Uriach Y Company, S.A

3073

Lusia - F Tablets Ethinyl Estradiol

0.0306mg + Norgesterel

0.30mg

POM Tablet Film coated 211/001 Jai Pharmacueticals Ltd

3074 Hyan Tablets Levonorgestrel 0.03mg POM Tablet Film coated 211/002 Jai Pharmacueticals Ltd

3075 Famyrel Tablets Norgestrel 0.075mg POM Tablet Film coated 211/003 Jai Pharmacueticals Ltd

3076

Oralcon Tablets Ethinyl Estradiol 0.03mg

+ Levonorgestrel 0.15mg

POM Tablet Film coated 211/004 Jai Pharmacueticals Ltd

3077 Pregnon Tablets Levonorgestrel 0.75mg POM Tablet Uncoated 211/005 Jai Pharmacueticals Ltd

Page 159 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3078

Oralcon-F Tablets Ethinyl Estradiol 0.15mg

+ Levonorgestrel 0.03mg

POM Tablet Uncoated 211/006 Jai Pharmacueticals Ltd

3079

Depo Progestin Injection Medroxyprogesterone

150mg, per ml

POM Solution for

Injection

211/007 Jai Pharmacueticals Ltd

3080

Daisy Tablets Desogestrel 0.15mg +

EthnylEstradiol 0.03mg

POM Tablet Uncoated 211/008 Jai Pharmacueticals Ltd

3081

Cypress Tablets Cyproterone Acetate 2.04

+ EthinylEstradiol

0.03675

POM Tablet Film coated 211/009 Jai Pharmacueticals Ltd

3082

Zinnia Tablets EthinylEstradiol 30mcg +

Levonogestrel 150mcg

POM Tablet Film coated 211/010 Jai Pharmacueticals Ltd

3083

Zinnia P Tablets EthinylEstradiol 30mcg +

Levonogestrel 150 mcg

POM Tablet Uncoated 211/011 Jai Pharmacueticals Ltd

3084

Famy Depo Injectable

Suspension

Medroxyprogesterone

Acetate 150mg, per ml

POM Suspension for

Injection

211/012 Jai Pharmacueticals Ltd

3085

Indoplant (Contraceptive

Implant)

Levonogestrel 75mg POM Implant 211/013 Jai Pharmacueticals Ltd

3086

Zinnia-F Tablets Levonorgestrel 150mcg +

EthinylEstradiol 30mcg

POM Tablet Film coated 211/014 Jai Pharmacueticals Ltd

3087 Revoke -72 Tablets Levonogestrel 0.75mg POM Tablet Film coated 211/015 Jai Pharmacueticals Ltd

3088

Caelyx Injection Doxorubicin

Hydrochloride 2mg, per

ml

POM Suspension for

Injection

071/006 Janssen Cilag Pharmaceuticals Limited

3089

Prezista 150 Tablets Darunavir Ethanolate

150mg

POM Tablet Film coated 071/008 Janssen Cilag Pharmaceuticals Limited

3090

Prezista 75 Tablets Darunavir Ethanolate

75mg

POM Tablet Film coated 071/009 Janssen Cilag Pharmaceuticals Limited

3091

Prezista 400 Tablets Darunavir Ethanolate 400

mg

POM Tablets oral 071/010 Janssen Cilag Pharmaceuticals Limited

3092

Prezista 100mg, per ml Oral

Suspension

Darunavir Ethanolate

100mg, per ml

POM Suspension for

Oral Use

071/011 Janssen Cilag Pharmaceuticals Limited

3093

Daktacort Cream 20g Hydrocortisone 2% w/w +

Miconazole 1% w/w

POM Cream Topical 009/007 Janssen-Cilag Pharmaceuticals Ltd

3094 Gyno-Daktarin Vaginal Cream Miconazole 2% w/w POM Cream Vaginal 009/008 Janssen-Cilag Pharmaceuticals Ltd

3095

Daktacort Oral Gel Hydrocortisone 2% w/w +

Miconazole 1% w/w

POM Gel Oral 009/010 Janssen-Cilag Pharmaceuticals Ltd

3096 Daktarin Cream 20g Miconazole 2% w/w POM Cream Topical 009/011 Janssen-Cilag Pharmaceuticals Ltd

Page 160 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 3097 Stugeron Tablets 25mg Cinnarizine 25mg POM Tablet Uncoated 009/012 Janssen-Cilag Pharmaceuticals Ltd

3098 Immodium Capsules 2mg Loperamide 2mg POM Tablet Uncoated 009/013 Janssen-Cilag Pharmaceuticals Ltd

3099 Gyno-Daktarin Vaginal Ovules Miconazole 1200mg POM Ovule Vaginal 071/003 Janssen-Cilag Pharmaceuticals Ltd

3100 Daktarin Dusting Powder 2% Miconazole 2% w/w POM Powder Topical 081/001 Janssen-Cilag Pharmaceuticals Ltd

3101 Intelence Tablets Etravirine 25mg POM Tablet Uncoated 364/001 Janssen-Cilag Pharmaceuticals Ltd

3102 Zenglobin Syrup Vitamins + Zinc P Syrup 266/001 Jenburt Pharmaceuticals Limited

3103 Zeglobin Capsules Vitamins + Zinc P Capsule oral 266/002 Jenburt Pharmaceuticals Limited

3104

Cartisafe Forte MSM Tablets Glucosamine Sulphate

750 mg + Elemental

calcium 250 mg +

Vitamin D3 125 IU +

Methylsulfonylmethane

200 mg

P Tablets oral 266/003 Jenburt Pharmaceuticals Limited

3105

Powergesic MR Tablets Chlorzoxazone 500 mg +

Paracetamol 325 mg +

Diclofenac Sodium 50

mg.

P Tablets oral 266/004 Jenburt Pharmaceuticals Limited

3106

Piritexyl – BR Tablets Terbutaline Sulphate 1.25

mg + Ambroxol

Hydrochloride 15 mg +

Guaiphenesin 50 mg +

Menthol 2.5 mg.

P Tablets oral 266/006 Jenburt Pharmaceuticals Limited

3107

Ojen-OZ Tablets Ofloxacin 200mg +

Ornidazole 500mg

POM Tablet Uncoated 266/007 Jenburt Pharmaceuticals Limited

3108

Luma Tablets Artemether 20mg +

Lumefantrine 120mg

POM Tablet Uncoated 266/008 Jenburt Pharmaceuticals Limited

3109

Powergesic Plus Gel Diclofenac 1%w/w +

Methyl Salicylate 5%w/w

+ Menthol 1.0%w/w

GS Gel Topical 266/009 Jenburt Pharmaceuticals Limited

3110

Nervijen -P Capsules Pregabalin 75mg +

Methylcobalamin

750mcg + Vitamin B6

1.50mg + Benfothiam

0.75mg

POM Capsule oral 266/010 Jenburt Pharmaceuticals Limited

3111

Trega Cream Econazole 10mg +

Triamcinolone Acetonide

1mg + Gentamicin 1mg

POM Cream Topical 266/011 Jenburt Pharmaceuticals Limited

Page 161 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3112

Spymal Tablets Pyrimethamine 25mg +

Suphadoxine 500mg

P Tablet Uncoated 022/001 JMB Pharmaceuticals Ltd, India

3113 Besix Tablets Pyridoxine 50mg POM Tablet Uncoated 022/002 JMB Pharmaceuticals Ltd, India

3114 Nystem Tablets Nystatin 100,000 IU POM Tablet Uncoated 022/003 JMB Pharmaceuticals Ltd, India

3115 Multi mix Tablets Vitamin A 2500 IU POM Tablet Uncoated 022/004 JMB Pharmaceuticals Ltd, India

3116 Metroz - 200 Tablets Metronidazole 200mg POM Tablet Uncoated 022/005 JMB Pharmaceuticals Ltd, India

3117 Loperid Capsules Loperamide 2mg POM Capsule oral 022/006 JMB Pharmaceuticals Ltd, India

3118

Kotrim Tablets Sulfamethoxazole 400mg

+ Trimethoprim 80mg

POM Tablet Uncoated 022/007 JMB Pharmaceuticals Ltd, India

3119 Frude Tablets Frusemide 40mg POM Tablet Uncoated 022/008 JMB Pharmaceuticals Ltd, India

3120 Flucoz-200 Tablets Fluconazole 200mg POM Tablet Uncoated 022/009 JMB Pharmaceuticals Ltd, India

3121 Fego Tablets Paracetamol 500mg GS Tablet Uncoated 022/010 JMB Pharmaceuticals Ltd, India

3122 DS - 100 Tablets Diclofenac 100mg P Tablet Uncoated 022/011 JMB Pharmaceuticals Ltd, India

3123 Beco Tablets B Complex P Tablet Uncoated 022/012 JMB Pharmaceuticals Ltd, India

3124 Pentra-50 Tablets Sildenafil 50mg POM Tablet Uncoated 022/013 JMB Pharmaceuticals Ltd, India

3125 Vitacy Tablets Ascorbic Acid 100mg GS Tablet Uncoated 022/014 JMB Pharmaceuticals Ltd, India

3126

C.M.T Tablets Aluminium Hydrochloride

120mg + Magnesium

Trisilicate 250mg

GS Tablet Uncoated 022/015 JMB Pharmaceuticals Ltd, India

3127 Ciprroz 500 Ciprofloxacin 500mg POM Tablet Uncoated 022/016 JMB Pharmaceuticals Ltd, India

3128 Indomin-25 Tablets Indomethacin 25mg P Tablet Uncoated 022/017 JMB Pharmaceuticals Ltd, India

3129

Brumol Capsules Paracetamol 325mg +

Ibuprofen 200mg +

Caffeine anhydrous 30mg

P Capsule oral 022/018 JMB Pharmaceuticals Ltd, India

3130 Erymin 250 Tablets Erythromycin 250mg POM Tablet Uncoated 022/019 JMB Pharmaceuticals Ltd, India

3131

Duomal Tablets Artemether 20mg +

Lumefantrine 120mg

POM Tablet Uncoated 022/020 JMB Pharmaceuticals Ltd, India

3132

Flugripp Tablets Paracetamol 500mg +

Caffeine 30mg +

Chlorpheniramine 2mg +

Phenylephrine 5mg

GS Tablet Uncoated 022/021 JMB Pharmaceuticals Ltd, India

3133 Vermox Tablets Mebendazole 100mg P Tablets 009/003 Johnson & Johnson (Pty) Limited

3134

Combantrin Tablets Pyrantel Pamoate 125mg P Tablet Uncoated 048/001 Johnson & Johnson (Pty) Limited

3135

Visine Original Eye Drops Tetrahydrozoline

Hydrochloride 0.05% w/v

P Eye Drops 050/001 Johnson & Johnson (Pty) Limited

Page 162 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3136

Benylin for Colds Tablets Pseudoephedrine 30mg

+ Ibuprofen 200mg

P Tablet Film coated 062/060 Johnson & Johnson (Pty) Limited

3137

Oraldine Mouth Wash Hexetidine 0.1g, per

100ml

GS Solution for Oral

Use

082/006 Johnson & Johnson (Pty) Limited

3138

Chaberlain's Cough Remedy

Regular Syrup

Guaiphenesin 50 mg, per

5 ml

P Syrup 082/007 Johnson & Johnson (Pty) Limited

3139

Chaberlain's Cough Remedy

PepperMint Syrup

Guainphenesin 50 mg,

per 5 ml + Peppermint

P Syrup 082/008 Johnson & Johnson (Pty) Limited

3140

Anusol Suppositories Bismuth Subgallate

22.5mg + Bismuth Oxide

8.75mg + Zinc Oxide

107.5mg

P Suppository 082/026 Johnson & Johnson (Pty) Limited

3141

Cool Mint Listerine Mouth Wash Alcohol 95% 4,58 ml +

Thymol 12,78 ml

GS Solution for Oral

Use

082/031 Johnson & Johnson (Pty) Limited

3142

Anusol Ointment Bismuth

Subgallate22.5mg +

Bismuth Oxide 8.75mg +

Zinc Oxide 107.5mg

P Ointment topical 082/032 Johnson & Johnson (Pty) Limited

3143

Listerine Antiseptic MouthWash Thymol 12,781 mg +

Alcohol 95% 5 +

Peppermint, per 20ml

GS Solution for Oral

Use

082/034 Johnson & Johnson (Pty) Limited

3144

Benylin Wet Cough methol

Syrup

Guaifenesin 100mg, per

5ml

P Syrup 082/039 Johnson & Johnson (Pty) Limited

3145

Benylin DMD Decongestant

Syrup

Dextromethorphan

HydroBromide 15 mg +

Pseudoephedrine

Hydrochloride 30 mg/5ml

P Syrup 082/046 Johnson & Johnson (Pty) Limited

3146

Benylin Dry Cough Syrup Dextromethorphan 15mg,

per 5ml

P Syrup 082/047 Johnson & Johnson (Pty) Limited

3147

Benylin 4 Flu Syrup Diphenhydramine

Hydrochloride 25mg+

Paracetamol 1000mg +

Pseudoephedrine

Hydrochloride 45mg

P Syrup 082/048 Johnson & Johnson (Pty) Limited

Page 163 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3148

Benylin with Codeine Syrup Diphenhydramine

Hydrochloride 14mg +

Codeine Phosphate

5.7mg + Levomenthol

1.1mg, per 5 ml.

P Syrup 082/049 Johnson & Johnson (Pty) Limited

3149

Benylin Original Cough Syrup Diphenyhydramine

Hydrochloride 12.5mg +

Ammoniun Chloride

125mg

P Syrup 082/050 Johnson & Johnson (Pty) Limited

3150

Benylin Chest Cough Syrup Guaifenesin 100mg +

Levomenthol 1.1 mg

P Syrup 082/051 Johnson & Johnson (Pty) Limited

3151

Benylin Paediatric Diphenhydramine 7mg,

per 5ml

P Syrup 082/052 Johnson & Johnson (Pty) Limited

3152

Tartar control Listerine

Antiseptic MouthWash

Alcohol 95% 4,54 ml

+Thymol 12,78 mg + Zinc

Chloride 18,0 mg, per

20ml

GS Solution for Oral

Use

082/053 Johnson & Johnson (Pty) Limited

3153

Fresburst Listerine MouthWash Alcohol 95% 4,540 ml +

Thymol 12,780 mg +

Menthol + Eucalyptus,

per 20ml

GS Solution for Oral

Use

082/054 Johnson & Johnson (Pty) Limited

3154

Benylin Children Wet Cough Guaifenesin 200 mg, per

5ml

P Syrup 082/055 Johnson & Johnson (Pty) Limited

3155

Benylin Adult Wet Cough Syrup Guaiphenesin 200mg +

Sodium Benzoate 200mg

P Syrup 082/056 Johnson & Johnson (Pty) Limited

3156

Sinutab Sinus Allergy

Congestion and Pain

Paracetamol 500mg +

Phenylephrine 2mg +

Chlorpheniramine +

Psuedoephedrine 30mg

P Tablet Uncoated 082/057 Johnson & Johnson (Pty) Limited

3157

Sinutab Nasal Drop Spray Xylometazoline 1mg +

Benzalkonium chloride

0.02%

POM Nasal drops 082/058 Johnson & Johnson (Pty) Limited

3158

Teeth and Gum Listerine Mouth

Wash

Thymol 12,780mg +

Alcohol 4,540ml +

Sodium Flouride 4,420mg

P Solution for Oral

Use

082/059 Johnson & Johnson (Pty) Limited

3159

Benylin Daytime Flu Tablets Pseudoephedrine 30mg

+ Ibuprofen 200mg

P Tablet 082/060 Johnson & Johnson (Pty) Limited

Page 164 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3160

Woods PepperMint Cough

Syrup for Children

Combination GSL Syrup 153/001 Kalbe International Ltd, South Africa

3161

Woods PepperMint Cough

Syrup

Combination GSL Syrup 153/002 Kalbe International Ltd, South Africa

3162 Karbazole Tablets Carbimazole 5mg POM Tablet Uncoated 098/001 Kamal International Ltd, India

3163 Kamlodipine Tablets Amlodipine 5mg POM Tablet Uncoated 098/002 Kamal International Ltd, India

3164

For-flu Tablets Paracetamol +

Chlopheniramine +

Caffeine

P Tablet Uncoated 098/004 Kamal International Ltd, India

3165

Kamcold Tablets Paracetamol +

Phenylephrine +

Chlorpheniramine +

Caffeine

P Tablet Uncoated 098/005 Kamal International Ltd, India

3166 Power-apetite Tablets Cyproheptadine 4mg P Tablet Uncoated 098/006 Kamal International Ltd, India

3167 Kaonil Tablets Glibenclamide 5mg POM Tablet Uncoated 098/007 Kamal International Ltd, India

3168

Mixiderm Cream Miconazole + Neomycin

+ Beclomethasone

POM Cream Topical 098/008 Kamal International Ltd, India

3169 Spironolactone 50mg Tablets Spironolactone 50mg POM Tablet Uncoated 098/009 Kamal International Ltd, India

3170 Kafen 100 Tablets Diclofenac 100mg P Tablet Uncoated 098/010 Kamal International Ltd, India

3171 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 098/011 Kamal International Ltd, India

3172 Kamtrax Tablets Levamisole 40mg P Tablet Uncoated 098/012 Kamal International Ltd, India

3173

Sure Cream Iodochlorhydroxyqunolon

e + Gentamycin +

Bethamethasone +

Tolnafate

POM Cream Topical 098/013 Kamal International Ltd, India

3174 Klopera Tablets Loperamide 2mg POM Tablet Uncoated 098/014 Kamal International Ltd, India

3175 Kamtopril Tablets Captopril 25mg POM Tablet Uncoated 098/015 Kamal International Ltd, India

3176 Kaydigo Tablets Digoxin 0.25mg POM Tablet Uncoated 098/016 Kamal International Ltd, India

3177 Klax Tablets Bisacodyl 5mg POM Tablet Uncoated 098/017 Kamal International Ltd, India

3178

Obrocid Suspension Pyrantel Pamoate

250mg, per 5ml

P Suspension for

Oral Use

098/018 Kamal International Ltd, India

3179

Ferrous Sulphate & Folic Acid

Tablets

Ferrous Sulphate 200mg

+ Folic Acid 0.25mg

P Tablet Uncoated 098/019 Kamal International Ltd, India

3180 Knor Tablets Norethistrerone 5mg POM Tablet Uncoated 098/020 Kamal International Ltd, India

3181 Kamipramine Tablets Imipramine 25mg POM Tablet Uncoated 098/021 Kamal International Ltd, India

3182 Kantibac Tablets Nitrofurantoin 100mg POM Tablet Uncoated 098/023 Kamal International Ltd, India

3183 Kamvit-6 Tablets Pyridoxine 50mg POM Tablet Uncoated 098/024 Kamal International Ltd, India

3184 Kasipro 25mg Tablets Spironolactone 25mg POM Tablet Uncoated 098/025 Kamal International Ltd, India

3185 Kamfru Tablets Frusemide 40mg POM Tablet Uncoated 098/026 Kamal International Ltd, India

Page 165 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3186

Oral Rehydration Salts Sodium Chloride 3.5g +

Sodium Citrate 1.5g +

Potassium Chloride

2.9g+ Glucose 20g

POM Powder for Oral

Solution

098/027 Kamal International Ltd, India

3187 Kamvir Tablets Aciclovir 200mg POM Tablet Uncoated 098/028 Kamal International Ltd, India

3188 Kampred Tablets Prednisolone 5mg POM Tablet Uncoated 098/029 Kamal International Ltd, India

3189 Kamcard Tablets Propranolol 40mg POM Tablet Uncoated 098/030 Kamal International Ltd, India

3190 Karbapin Tablets Carbamazepine 200mg POM Tablet Uncoated 098/031 Kamal International Ltd, India

3191 7 Hours 50mg Tablets Sildenafil 50mg POM Tablet Uncoated 098/032 Kamal International Ltd, India

3192 7 Hours 50mg Oral Gel Sildenafil 50mg POM Gel Oral 098/033 Kamal International Ltd, India

3193 Boro Pearl Cream Herbal Extracts P Cream Topical 219/001 Kamdhenu Agro-Chem Industrires, India

3194 Foot heal Cream Herbal Extracts P Cream Topical 219/002HM Kamdhenu Agro-Chem Industrires, India

3195 Pain off Cream Herbal Extracts P Cream Topical 219/003 Kamdhenu Agro-Chem Industrires, India

3196 Granny's formula Gel Herbal Extracts P Gel Topical 219/004HM Kamdhenu Agro-Chem Industrires, India

3197

Benzyl Penicillin Injection 1MU Benzyl Penicillin 1 MU POM Powder for

Injection

255/001 Karnataka Antibiotics &Pharmaceuticals

Ltd, India

3198

Benzyl Penicillin Injection 5MU Benzyl Penicillin 5 MU POM Powder for

Injection

255/002 Karnataka Antibiotics &Pharmaceuticals

Ltd, India

3199

Ampicillin & Cloxacillin Injection Cloxacillin 250mg +

Ampicillin 250mg

POM Powder for

Injection

255/003 Karnataka Antibiotics &Pharmaceuticals

Ltd, India

3200

Cloxacillin Injection Cloxacillin 500mg POM Powder for

Injection

255/004 Karnataka Antibiotics &Pharmaceuticals

Ltd, India

3201

Ampicillin 500 Injection Ampicillin 500mg POM Powder for

Injection

255/005 Karnataka Antibiotics &Pharmaceuticals

Ltd, India

3202

Cefotaxime 1g Injection Cefotaxime 1 gram POM Powder for

Injection

255/006 Karnataka Antibiotics &Pharmaceuticals

Ltd, India

3203

Cefotaxime 500mg Injection Cefotaxime 500mg POM Powder for

Injection

255/007 Karnataka Antibiotics &Pharmaceuticals

Ltd, India

3204

Cefotaxime 250mg Injection Cefotaxime 250mg, per

5ml

POM Powder for

Injection

255/008 Karnataka Antibiotics &Pharmaceuticals

Ltd, India

3205

Procaine Penicillin Injection Procaine Benzyl Penicillin

3 MU

POM Powder for

Injection

255/009 Karnataka Antibiotics &Pharmaceuticals

Ltd, India

3206

Benzathine Penicillin Injection

5MU

Benzathine Penicillin 5

MU

POM Powder for

Injection

255/010 Karnataka Antibiotics &Pharmaceuticals

Ltd, India

3207

Gentamycin Sulphate Injection Gentamycin 40mg, per ml POM Solution for

Injection

255/011 Karnataka Antibiotics &Pharmaceuticals

Ltd, India

3208

Ampicillin 1000 Injection Ampicillin 1000mg POM Powder for

Injection

255/012 Karnataka Antibiotics &Pharmaceuticals

Ltd, India

3209 Propranolol Tablets Propranolol 40mg POM Tablet Uncoated 007/001 Kausikh Therapeutics (P) Ltd, India

Page 166 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 3210 Chlorpheniramine Tablets Chlorpheniramine 4mg P Tablet Uncoated 007/002 Kausikh Therapeutics (P) Ltd, India

3211 Cimetidine Tablets Cimetidine 200mg POM Tablet Uncoated 007/003 Kausikh Therapeutics (P) Ltd, India

3212 Folic Acid Tablets Folic Acid 5mg P Tablet Uncoated 007/004 Kausikh Therapeutics (P) Ltd, India

3213 Tetracycline Capsules Tetracycline 250mg POM Capsule oral 007/005 Kausikh Therapeutics (P) Ltd, India

3214 Furosemide Tablets Furosemide 40mg POM Tablet Uncoated 007/006 Kausikh Therapeutics (P) Ltd, India

3215 Methyldopa Tablets Methyldopa 250mg POM Tablet Film coated 007/007 Kausikh Therapeutics (P) Ltd, India

3216 Nifedipine Tablets Nifedipine 20mg POM Tablet Uncoated 007/008 Kausikh Therapeutics (P) Ltd, India

3217

Ferrous Sulphate + Folic Acid

Tablets

Ferrous Sulphate + Folic

Acid

P Tablets oral 007/009 Kausikh Therapeutics (P) Ltd, India

3218 Aminophylline Tablets Aminophylline 100mg POM Tablet Uncoated 007/010 Kausikh Therapeutics (P) Ltd, India

3219 Ketoconazole Tablets Ketoconazole 200mg POM Tablet Uncoated 007/011 Kausikh Therapeutics (P) Ltd, India

3220

Penicillin V Tablets Phenoxymethyl Penicillin

V 250mg

POM Tablet Uncoated 007/012 Kausikh Therapeutics (P) Ltd, India

3221 Cloxacillin Capsules Cloxacillin 250mg POM Capsule oral 007/013 Kausikh Therapeutics (P) Ltd, India

3222 Ampicillin Capsules Ampicillin 250mg POM Capsule oral 007/014 Kausikh Therapeutics (P) Ltd, India

3223 Pyridoxine 50mg Tablets Pyridoxine 50mg P Tablet Uncoated 007/015 Kausikh Therapeutics (P) Ltd, India

3224 Omeprazole Capsules Omeprazole 20mg POM Capsule oral 007/016 Kausikh Therapeutics (P) Ltd, India

3225

Ampicillin and Cloxacillin

Capsules

Cloxacillin 250mg +

Ampicillin 250mg

POM Capsule oral 007/017 Kausikh Therapeutics (P) Ltd, India

3226 Hypocare-5 Tablets Amlodipine 5mg POM Tablet Uncoated 007/018 Kausikh Therapeutics (P) Ltd, India

3227 Ayocare Tablets Amlodipine 10mg POM Tablet Uncoated 007/019 Kausikh Therapeutics (P) Ltd, India

3228 Luxopril-20 Tablets Enalapril 20mg POM Tablet Uncoated 007/020 Kausikh Therapeutics (P) Ltd, India

3229 Luxcee 500 Tablets Ascorbic Acid 500mg GS Tablet Uncoated 007/021 Kausikh Therapeutics (P) Ltd, India

3230 Albendazole Tablets Albendazole 400mg POM Tablet Uncoated 007/022 Kausikh Therapeutics (P) Ltd, India

3231 Capril Tablets Captopril 25mg POM Tablet Uncoated 007/023 Kausikh Therapeutics (P) Ltd, India

3232 Domidome Tablets Domperidone 10mg POM Tablet Uncoated 007/024 Kausikh Therapeutics (P) Ltd, India

3233 Erythromycin Tablets Erythromycin 250mg POM Tablet Uncoated 007/025 Kausikh Therapeutics (P) Ltd, India

3234 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 007/026 Kausikh Therapeutics (P) Ltd, India

3235 Acyclvir Tablets Acyclovir 200mg POM Tablet Uncoated 007/027 Kausikh Therapeutics (P) Ltd, India

3236 Acyclovir Tablets Aciclovir 400mg POM Tablet Uncoated 007/028 Kausikh Therapeutics (P) Ltd, India

3237 Carbamazepine Tablets Carbamazepine 200mg POM Tablet Uncoated 007/029 Kausikh Therapeutics (P) Ltd, India

3238

Emthex 50 Injection Methotrexate 25mg, per

ml

POM Powder for

Injection

267/001 Khandelwal Laboratories Pvt.Ltd, India

3239

Oncomide 500 Injection Cyclophosphamide

500mg

POM Powder for

Injection

267/002 Khandelwal Laboratories Pvt.Ltd, India

3240

Platinex 50 Injection Cisplatin 1mg, per ml POM Powder for

Injection

267/003 Khandelwal Laboratories Pvt.Ltd, India

3241

Womastin Injection Carboplatin 150mg, per

15ml

POM Powder for

Injection

267/004 Khandelwal Laboratories Pvt.Ltd, India

Page 167 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3242

Urafil 50 Injection Fluorouracil 500mg, per

10ml

POM Powder for

Injection

267/005 Khandelwal Laboratories Pvt.Ltd, India

3243 Mamofen 10 Tablets Tamoxifen 10mg POM Tablet Uncoated 267/006 Khandelwal Laboratories Pvt.Ltd, India

3244 Mamofen 20 Tablets Tamoxifen 20mg POM Tablet Uncoated 267/007 Khandelwal Laboratories Pvt.Ltd, India

3245 Zophost Tablets Alendronate 10mg POM Tablet Uncoated 267/008 Khandelwal Laboratories Pvt.Ltd, India

3246

Anafortan Tablets Paracetamol + Camylofin P Tablet Film coated 267/009 Khandelwal Laboratories Pvt.Ltd, India

3247 Converten 5 Tablets Enalapril 5mg POM Tablet Uncoated 267/010 Khandelwal Laboratories Pvt.Ltd, India

3248 Allerfast 120 Tablets Fexofenadine 120mg POM Tablet Film coated 267/011 Khandelwal Laboratories Pvt.Ltd, India

3249 Prenoxid 100 Tablets Prednisolone 100mg POM Tablet Film coated 267/012 Khandelwal Laboratories Pvt.Ltd, India

3250

ROIVT Multivitamin

Effervescent Tablets

Ascorbic Acid 67.787mg

+ Vitamin E 33mg +

Nicotinamide 19mg +

Calcium D 7mg +

Pantothen 2.533mg

GS Tablet Effervescent 392/001 Kilitch Drugs ( India) Limited

3251

ROIVT Vitamin C 1000mg

Effervescent Tablets

Ascorbic Acid BP

1000mg

GS Tablet Effervescent 392/002 Kilitch Drugs ( India) Limited

3252

ROIVT Ginseng Plus

Effervescent Tablets

Taurine 250mg +

Guarana extract 30mg +

Ginseng root extract

15mg + Caffeine 15mg

GS Tablet Effervescent 392/003 Kilitch Drugs ( India) Limited

3253

ONECEF SB 1.5gm Injection

Ceftriazone Sodium USP

1gm + Sulbactam

Sodium 500mg

POMPowder for

Injection

392/004

Kilitch Drugs ( India) Limited

32549-Vit Infusion Multivitamin infusion

POM Solution for

Infusion

392/005Kilitch Drugs ( India) Limited

3255Metronidazole 200mg Tablets Metronidazole 200mg

POMTablet Uncoated

421/001Kingphar Company Zambia Limited, Zambia

3256

Oral Rehydration Salts, 21g,

Powder

Sodium Chloride BP 2.6g

+ Potassium Chloride BP

1.5g + Trisodium Citrate

Dihydrate BP 2.9g +

Glucose Anhydrate BP

13.5g

GS

Powder for solution

421/002

Kingphar Company Zambia Limited, Zambia

3257 Difisal SR Tablets Diclofenac 100mg P Tablet Film coated 250/001 Kopran Limited, India

3258

Ciproquin Tablets Ciprofloxacin USP

500mg

POM Tablet Uncoated 250/002 Kopran Limited, India

3259 Amyn Capsules Amoxicillin 250mg POM Capsule oral 250/003 Kopran Limited, India

Page 168 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3260

Ampicloxa Dry Suspension Cloxacillin 250mg +

Ampicillin 250mg

POM Suspension for

Oral Use

250/004 Kopran Limited, India

3261 Paralget Tablets Paracetamol 500mg GS Tablet Uncoated 250/005 Kopran Limited, India

3262

Eryko Oral Suspension Erythromycin 125mg, per

5ml

POM Suspension for

Oral Use

250/006 Kopran Limited, India

3263 Az-1 Capsules Azithromycin 250mg POM Capsule oral 250/007 Kopran Limited, India

3264 Lokit Capsules Omeprazole 20mg POM Capsule oral 250/008 Kopran Limited, India

3265 Difisal Tablets Diclofenac 50mg P Tablet Uncoated 250/009 Kopran Limited, India

3266 Ciproquin 250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 250/010 Kopran Limited, India

3267 Bren-200 Tablets Ibuprofen 200mg P Tablet Film coated 250/011 Kopran Limited, India

3268 Kometro 200 Tablets Metronidazole 200mg POM Tablet Uncoated 250/012 Kopran Limited, India

3269 Rintid 150 Tablets Ranitidine 150mg POM Tablet Uncoated 250/013 Kopran Limited, India

3270 Quinolox 400 Tablets Norfloxacin 400mg POM Tablet Uncoated 250/014 Kopran Limited, India

3271

Trim 480 Tablets Trimethoprim 80mg +

Sulphamethoxozole

400mg

POM Tablet Uncoated 250/015 Kopran Limited, India

3272

Ampic Dry Syrup Ampicillin 125mg, per

5ml

POM Syrup 250/016 Kopran Limited, India

3273 Ampik Capsules Ampicillin 250mg POM Capsule oral 250/017 Kopran Limited, India

3274 Bren-400 Tablets Ibuprofen 400mg P Tablet Uncoated 250/018 Kopran Limited, India

3275

Trim Suspension Sulphamethoxazole

200mg + Trimethoprim

40mg, per 5ml

POM Suspension for

Oral Use

250/019 Kopran Limited, India

3276 Eryko 250 Tablets Erythromycin 250mg POM Tablet Film coated 250/020 Kopran Limited, India

3277

Amyn Syrup Amoxicillin 125mg, per

5ml

POM Granules for Oral

Solution

250/021 Kopran Limited, India

3278 Nubend 400 Tablets Albendazole 400mg POM Tablet Uncoated 250/023 Kopran Limited, India

3279 Klodip-5 Tablets Amlodipine 5mg POM Tablet Uncoated 250/024 Kopran Limited, India

3280 Zimat Tablets Cetirizine 10mg POM Tablet Uncoated 250/025 Kopran Limited, India

3281 Felexin 500 Capsules Cephalexin 500mg POM Capsule oral 250/026 Kopran Limited, India

3282

Cloxin Oral Solution Cloxacillin Sodium eq. to

125mg, per 5ml

POM Granules for Oral

Solution

250/027 Kopran Limited, India

3283

Pulmin Inhaler Salbutamol BP 100mcg POM Powder for

Inhalation

250/028 Kopran Limited, India

3284

AZ-1 500 Tablets Azithromycin Dihydrate

500mg

POM Tablet Film coated 250/029 Kopran Limited, India

3285

Mepran - 500 IV Injection Meropenem Trihydrate

500mg

POM Powder for

Injection

250/030 Kopran Limited, India

Page 169 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3286

Mepran - 1000 IV Injection Meropenem Trihydrate

1000mg

POM Powder for

Injection

250/031 Kopran Limited, India

3287

Appeton A to Z Kids' Vitamin C

Pastilles

Vitamin C 0.28g GS Capsule oral 450/001L Kotra Pharma (M) Sdn. Bhd. Malaysia

3288

Artemeter Injection Artemether 80mg, per ml POM Solution for

Injection

135/001 Kunming Pharmaceutical Corp. (KPC),

China

3289

Artemether 40mg Tablets Artemether 40mg POM Tablet Uncoated 135/002 Kunming Pharmaceutical Corp. (KPC),

China

3290

Artemether 50mg Tablets Artemether 50mg POM Tablet Uncoated 135/003 Kunming Pharmaceutical Corp. (KPC),

China

3291

Gentamedine Injection Gentamycin 80,000iu, per

2ml

POM Solution for

Injection

135/004 Kunming Pharmaceutical Corp. (KPC),

China

3292

Vitamedine Injection Vitamin K POM Solution for

Injection

135/005 Kunming Pharmaceutical Corp. (KPC),

China

3293

Arco Tablets Artemisinine 250mg +

Naphthoquine 100mg

POM Tablet Film coated 135/006 Kunming Pharmaceutical Corp. (KPC),

China

3294

Skineal Cream 15g (Ketoconazole 10mg +

Clobetasol Propionate

0.25mg + Neomycin 5000

iu), per 1g

POM Cream Topical 135/007 Kunming Pharmaceutical Corp. (KPC),

China

3295

Rapid Relief Hot Gel Menthol 5.91% +

Eucalyptus 1.97% +

Methyl Salicylate 12.8%

+ Terpentine oil 1.47%

P Gel Topical 207/001 L`amar Natural Products Pvt Ltd,India

3296 Rapid relief cold Gel 30g Menthol 2% P Gel Topical 207/002 L`amar Natural Products Pvt Ltd,India

3297

Glutahenz Powder L-Glutamine 10g w/w P Powder for Oral

Solution

444/004L La Renon Healthcare Pvt. Ltd.

3298

Enzispor Capsules Probiotic blend of

Bacillus clausii spores 2

Billion CFU/ Capsule

P Capsule oral 444/005L La Renon Healthcare Pvt. Ltd.

3299

Kchek Oral Powder Calcium polystyrene

sulfonate BP 25g

P Powder for feed 444/006L La Renon Healthcare Pvt. Ltd.

3300

Sobisis 500mg Tablets Sodium Bicarbonate USP

500mg

P Tablet Uncoated 444/002L La Renon Healthcare Pvt. Ltd.

3301

Sobisis Forte Tablets Sodium Bicarbonate

Tablets USP 1000 mg

P Tablet Film coated 444/003L La Renon Healthcare Pvt. Ltd.

Page 170 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3302

Cudo Forte Capsules Probiotic blend of

Streptococcus

thermophilies+Lactobacil

us 90 Billion CFU/

Capsule

P Capsule oral 444/001L La Renon Healthcare Pvt. Ltd.

3303 Levigress 250 Tablets Levetiracetam 250mg POM Tablet Uncoated 444/007 La Renon Healthcare Pvt. Ltd.

3304 Levigress 500 Tablets Levetiracetam 500mg POM Tablet Uncoated 444/008 La Renon Healthcare Pvt. Ltd.

3305

Anaesthetic F.D Injection Lignocaine 2 % +

Epinephrine 1:100,000

POM Solution for

Injection

026/001 Laboratories ZEYCO S.A

3306 Burnazine Cream 15g Silver Sulphadiazine 1% POM Cream Topical 309/001 Laboratory & Allied Limited, India

3307 Hycorum Cream 15g Hydrocortisone 1%w/w POM Cream Topical 309/002 Laboratory & Allied Limited, India

3308

Neogracin Dusting Powder 10g Neomycin Sulphate 5mg

+ Bacitracin2.5mg +

Gramicidin D 0.5mg

P Powder for Topical

use

309/003 Laboratory & Allied Limited, India

3309

Gono Injection Specitinomycin

Hydrochloride 2.0g

POM Powder for

Injection

309/004 Laboratory & Allied Limited, India

3310

Homagon Capsules Chlorpheniramine

maleate 4mg +

Paracetamol 350mg +

Caffeine anhydrous

30mg +

Pseudoephedrine 3mg

GS Tablet Uncoated 309/005 Laboratory & Allied Limited, India

3311

Lastmol Salbutamol Sulphate

2mg, per 5ml

P Syrup 309/006 Laboratory & Allied Limited, India

3312

Kemoxyl 250 Capsules Amoxicillin Trihydrate

250mg

POM Capsule oral 309/007 Laboratory & Allied Limited, India

3313 Phenobarbiton 30 Tablets Phenobarbitone 30mg POM Capsule oral 309/008 Laboratory & Allied Limited, India

3314 Labesten Vaginal Tablets Nystatin 100,000 IU POM Tablet Uncoated 309/009 Laboratory & Allied Limited, India

3315

Lecotrim 480 Tablets Trimethoprim 80mg +

Sulphamethoxazole

400mg

POM Tablet Uncoated 309/010 Laboratory & Allied Limited, India

3316

Axylin Capsules Ampicillin 250mg +

Cloxacillin 250mg

POM Capsule oral 309/011 Laboratory & Allied Limited, India

3317

Ferrolic LF Tablets Ferrous sulfate + Folic

Acid

P Tablet Film coated 309/014 Laboratory & Allied Limited, India

3318

Labesten Cream Chlotrimazole USP

1%w/w

P Cream Topical 309/016 Laboratory & Allied Limited, India

3319

Rheumac Gel Diclofenac Diethylamine

1% w/v

P Gel Topical 309/015 Laboratory & Allied Limited, India

Page 171 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 3320 Hydopa Tablets Methydopa 250mg POM Tablet Film coated 309/012 Laboratory & Allied Limited, India

3321

Labstatin Suspension Nystatin 100,000 IU POM Suspension for

Oral Use

309/017 Laboratory & Allied Limited, India

3322

Laepen V Tablets Phenoxymethylpenicillin

250mg

POM Tablet Uncoated 309/018 Laboratory & Allied Limited, India

3323 Kloxy 250 Caspsules Cloxacillin 250mg POM Capsule oral 309/013 Laboratory & Allied Limited, India

3324 Coloncare Capsules Probiotics + Prebiotics P Capsule oral 424/009L Lactonova Nutripharm Private Limited

3325

Dermikelp shampoo Ecklonia maxima 31.5

mg, per g

GS Shampoo 301/001L Lamicare SA (PTY) Limited

3326

Dermikelp topical Cream Ecklonia maxima 375

mg, per g

GS Cream Topical 301/002L Lamicare SA (PTY) Limited

3327

Moxileb Dry Syrup Amoxycillin 125mg, per

5ml

POM Granules for Oral

Use

149/001 Leben Laboratories (Pvt) Limited, India

3328 Cipium Tablets Chlorpheniramine 4mg P Tablet Uncoated 149/002 Leben Laboratories (Pvt) Limited, India

3329 Regurg 10mg Tablets Metoclopramide 10mg POM Tablet Uncoated 149/003 Leben Laboratories (Pvt) Limited, India

3330 Moxileb 250mg Capsules Amoxycillin 250mg POM Capsule oral 149/004 Leben Laboratories (Pvt) Limited, India

3331 Nalidixic Acid Tablets Nalidixic Acid 500mg POM Tablet Uncoated 149/005 Leben Laboratories (Pvt) Limited, India

3332 Trifluoperazine Tablets Trifluoperazine 5mg POM Tablet Film coated 149/006 Leben Laboratories (Pvt) Limited, India

3333 Amphen Capsules Chloramphenicol 250mg POM Capsule Oral 149/007 Leben Laboratories (Pvt) Limited, India

3334 Alclox Capsules Cloxacillin 250mg POM Capsule oral 149/008 Leben Laboratories (Pvt) Limited, India

3335 Metroleb - 200 Tablets Metronidazole 200mg POM Tablets Oral 149/009 Leben Laboratories (Pvt) Limited, India

3336 Griseben 125mg Tablets Griseofulvin 125mg POM Tablet Uncoated 149/010 Leben Laboratories (Pvt) Limited, India

3337 Propranolol 40mg Tablets Propranolol 40mg POM Tablet Uncoated 149/011 Leben Laboratories (Pvt) Limited, India

3338 Ateleb 100mg Tablets Atenolol 100mg POM Tablet Uncoated 149/012 Leben Laboratories (Pvt) Limited, India

3339 Ateleb 50mg Tablets Atenolol 50mg POM Tablet Uncoated 149/013 Leben Laboratories (Pvt) Limited, India

3340 Silveleb 1% Cream Silver Suphadiazine 1% P Cream Topical 149/014 Leben Laboratories (Pvt) Limited, India

3341

Scabcur lotion Lindane 1% P Lotion for Topical

Use

149/015 Leben Laboratories (Pvt) Limited, India

3342 Benzyl Benzoate application Benzyl benzoate P Emulsion 149/016 Leben Laboratories (Pvt) Limited, India

3343 Tetret-250mg Capsules Tetracycline 250mg POM Capsule oral 149/017 Leben Laboratories (Pvt) Limited, India

3344 Indul 25mg Capsules Indomethacin 25mg P Capsule oral 149/018 Leben Laboratories (Pvt) Limited, India

3345 Ciproleb 500 Tablets Ciprofloxacin 500mg POM Tablet Film coated 149/019 Leben Laboratories (Pvt) Limited, India

3346 Ibut 200mg Tablets Ibuprofen 200mg P Tablet Film coated 149/020 Leben Laboratories (Pvt) Limited, India

3347 Promethazine 25mg Tablets Promethazine 25mg P Tablet Uncoated 149/021 Leben Laboratories (Pvt) Limited, India

3348

Zylo-P Topical Solution Povidone iodine 10%w/w P Solution for Topical

Use

149/022 Leben Laboratories (Pvt) Limited, India

3349 Foliben 5mg Tablets Folic Acid 5mg POM Tablet Uncoated 149/023 Leben Laboratories (Pvt) Limited, India

3350

QSM Suspension Quinine 150mg POM Suspension for

Oral Use

149/024 Leben Laboratories (Pvt) Limited, India

3351 Kelvin 500mg Tablets Paracetamol 500mg GS Tablet Uncoated 149/025 Leben Laboratories (Pvt) Limited, India

Page 172 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 3352 Adiflam Tablets Diclofenac 50mg POM Tablets Oral 149/026 Leben Laboratories (Pvt) Limited, India

3353

L-Trim Tablets Sulfamethoxazole 400mg

+ Trimethoprim 80mg

POM Tablets Oral 149/027 Leben Laboratories (Pvt) Limited, India

3354 Lebasma Syrup Salbutamol 2mg, per 5ml POM Syrup 149/028 Leben Laboratories (Pvt) Limited, India

3355 Lebasma-4 Tablets Salbutamol 4mg POM Tablet Uncoated 149/029 Leben Laboratories (Pvt) Limited, India

3356

Promethazine Syrup Promethazine 5mg, per

5ml

P Syrup 149/030 Leben Laboratories (Pvt) Limited, India

3357

Beclomin Ointment Beclomethasone

Dipropionate 0.025% +

Miconazole Nitrate BP

2% + Neomycin BP 0.55

POM Ointment topical 149/031 Leben Laboratories (Pvt) Limited, India

3358

L-Trim Suspension Sulfamethoxazole 200mg

+ Trimethoprim 40mg

POM Suspension for

Oral Use

149/032 Leben Laboratories (Pvt) Limited, India

3359 Chlorpromazine Tablets Chlorpromazine 100mg POM Tablet Film coated 149/033 Leben Laboratories (Pvt) Limited, India

3360 Doxyleb Capsule Doxycycline 100mg POM Capsule oral 149/034 Leben Laboratories (Pvt) Limited, India

3361 Lampy-250 Capsules Ampicillin 250mg POM Capsule oral 149/035 Leben Laboratories (Pvt) Limited, India

3362 Adiflam Gel Diclofenac 1 % w/w P Gel Topical 149/036 Leben Laboratories (Pvt) Limited, India

3363

Cipium Syrup Chlorpheniramine 2mg,

per ml

P Syrup 149/037 Leben Laboratories (Pvt) Limited, India

3364

Cebay-Trx-1000 Injection Ceftriaxone 1000mg POM Powder for

Injection

149/038 Leben Laboratories (Pvt) Limited, India

3365

Cefaxil-1000 Injection Cefotaxime 1000mg POM Powder for

Injection

149/039 Leben Laboratories (Pvt) Limited, India

3366 Prohibin Capsules Omeprazole 20mg POM Capsule oral 149/040 Leben Laboratories (Pvt) Limited, India

3367

Kelvin Syrup Paracetamol 120mg, per

5ml

GS Syrup 149/041 Leben Laboratories (Pvt) Limited, India

3368

Antagit-DS Gel Aluminium hydroxide

400mg + Magnesium

Hydroxide 400mg +

Simethicone 50mg/5ml

P Gel Oral 149/042 Leben Laboratories (Pvt) Limited, India

3369

Alclox Suspension Cloxacillin 125mg, per

5ml

POM Powder for Oral

Suspension

149/043 Leben Laboratories (Pvt) Limited, India

3370

Adiflam Injection Diclofenac 50mg, per 3ml POM Solution for

Injection

149/044 Leben Laboratories (Pvt) Limited, India

3371 Cortileb Cream Hydrocortisone 1%w/w POM Cream Topical 149/045 Leben Laboratories (Pvt) Limited, India

Page 173 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3372

Elcuf Syrup Chlorpheramine 2.5mg +

Ammonium Chloride

125mg + Sodium Citrate

55mg, per 5ml

P Syrup 149/046 Leben Laboratories (Pvt) Limited, India

3373

Enderm G.M Cream Clobetasol 0.05% +

Miconazole 2% +

Gentamicin 0.1%

POM Cream Topical 149/047 Leben Laboratories (Pvt) Limited, India

3374

Nystaleb Suspension Nystatin 100,000 iu, per

5ml

POM Suspension for

Oral Use

149/048 Leben Laboratories (Pvt) Limited, India

3375

Libitus Plus Syrup Guanefenesin 50mg +

Bromhexine 4mg +

Terbutaline Sulphate

1.25mg

POM Syrup 149/049 Leben Laboratories (Pvt) Limited, India

3376

Pyraleb Suspension Pyrantel Pamoate

125mg, per 5ml

P Suspension for

Oral Use

149/050 Leben Laboratories (Pvt) Limited, India

3377 Zylo-P Ointment Povidone Iodine 5% P Ointment topical 149/051 Leben Laboratories (Pvt) Limited, India

3378

Pyraleb Tablets Pyrantel Pamoate 125mg P Tablet Uncoated 149/052 Leben Laboratories (Pvt) Limited, India

3379 Cexil 125 Syrup Cefadroxil 125mg/5ml POM Syrup 149/054 Leben Laboratories (Pvt) Limited, India

3380 Hykophos Syrup Multivitamins GS Syrup 149/055 Leben Laboratories (Pvt) Limited, India

3381 Cexil 500mg Tablets Cefadroxil 500mg POM Tablet Uncoated 149/056 Leben Laboratories (Pvt) Limited, India

3382 Chlorpromazine 25mg Tablets Chlorpromazine 25mg POM Tablet Film coated 149/057 Leben Laboratories (Pvt) Limited, India

3383 Haloperidol Tablets Haloperidol 1.5mg POM Tablet Uncoated 149/058 Leben Laboratories (Pvt) Limited, India

3384

Chelferron Liquid Haematinic preparation P Solution for Oral

Use

149/059 Leben Laboratories (Pvt) Limited, India

3385 Greseben 500 Tablets Griseofulvin 500mg POM Tablets oral 149/060 Leben Laboratories (Pvt) Limited, India

3386 Q.S.M Tablets Quinine 300mg POM Tablet Uncoated 149/061 Leben Laboratories (Pvt) Limited, India

3387

Cebay - Trx 250 Injection Ceftriaxone 250mg POM Powder for

Injection

149/062 Leben Laboratories (Pvt) Limited, India

3388 Lebasma 2 Tablets Salbutamol 2mg POM Tablet Uncoated 149/063 Leben Laboratories (Pvt) Limited, India

3389

Cebay 100 Dry Powder Cefixime 100mg, per 5ml POM Powder for Oral

Suspension

149/064 Leben Laboratories (Pvt) Limited, India

3390 Praziquantel Tablets Praziquantel 600mg POM Tablet Uncoated 149/065 Leben Laboratories (Pvt) Limited, India

3391 Amileb-25 Tablets Amitriptyline 25mg POM Tablet Uncoated 149/066 Leben Laboratories (Pvt) Limited, India

3392 Betaleb Ointment Betamethasone 0.10% POM Ointment topical 149/067 Leben Laboratories (Pvt) Limited, India

3393

Kelvin-P Syrup Paracetamol 125mg +

Promethazine 6.25mg,

per 5ml

P Syrup 149/068 Leben Laboratories (Pvt) Limited, India

Page 174 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3394

Adiflam Compound Tablets Paracetamol 500mg +

Diclofenac 50mg

P Tablet Uncoated 149/069 Leben Laboratories (Pvt) Limited, India

3395

Adiflam Plus Tablets Paracetamol 500mg +

Ibuprofen 400mg

P Tablet Uncoated 149/070 Leben Laboratories (Pvt) Limited, India

3396 Ciproleb 250 Tablets Ciprofloxacin 250mg POM Tablet Film coated 149/071 Leben Laboratories (Pvt) Limited, India

3397

Lamizol O Suspension Ofloxacin 50mg +

Ornidazole 125mg, per

5ml

POM Suspension for

Oral Use

149/073 Leben Laboratories (Pvt) Limited, India

3398

Lamizol O Tablets Ofloxacin 200mg +

Ornidazole 500mg

POM Tablet Uncoated 149/074 Leben Laboratories (Pvt) Limited, India

3399

Ferrous Sulphate Tablets Ferrous Sulphate 200mg P Tablet Enteric

Coated

149/075 Leben Laboratories (Pvt) Limited, India

3400 Multivitamins Tablets Multivitamins GS Tablet Film coated 149/076 Leben Laboratories (Pvt) Limited, India

3401

Sinurhon Tablets Paracetamol 500mg +

Phenylephrine 5mg +

Chlorpheniramine 2mg +

Caffeine 30mg

P Tablet Uncoated 149/077 Leben Laboratories (Pvt) Limited, India

3402

Adiflam -SR Tablets Diclofenac Sodium

100mg

P Tablet Uncoated 149/078 Leben Laboratories (Pvt) Limited, India

3403

Fricold Suspension (Paracetamol BP 250mg

+ Chlorpheniramine

Maleate BP 2.0mg +

Phenylephrin 5.0mg), per

5ml

GS Suspension for

Oral Use

149/079 Leben Laboratories (Pvt) Limited, India

3404

Kaldol Suspension Paracetamol 120mg, per

5ml

GS Suspension for

Oral Use

149/080 Leben Laboratories (Pvt) Limited, India

3405

Moxileb CV 228.5 Dry Syrup (Amoxicillin 200mg +

Clavulanic Acid 28.5mg),

per 5ml

POM Syrup 149/081 Leben Laboratories (Pvt) Limited, India

3406

Libitus Cough Syrup (Dextromethorphan

HydroBromide BP

10.0mg + Phenylephrine

Hydrochloride 5.0mg +

Chlorpheniramine

Maleate 2.0mg), per 5ml

POM Syrup 149/082 Leben Laboratories (Pvt) Limited, India

3407

Rihaee Tablets Aceclofenac BP 100mg +

Paracetamol BP 500mg

P Tablet Film coated 149/083 Leben Laboratories (Pvt) Limited, India

Page 175 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3408

Colicspam Oral Drops (Dicyclomine

Hydrochloride 10mg +

Simethicone 40mg), per

5ml

POM Solution for Oral

Use

149/084 Leben Laboratories (Pvt) Limited, India

3409

Colicspam Oral Suspension (Dicyclomine

Hydrochloride 10mg +

Simethicone 40mg), per

5ml

POM Suspension for

Oral Use

149/085 Leben Laboratories (Pvt) Limited, India

3410

Adiflam Plus Suspension Ibuprofen BP 100mg +

Paracetamol BP 125mg

P Suspension for

Oral Use

149/086 Leben Laboratories (Pvt) Limited, India

3411

Libitus LS Syrup Levosalbutamol Sulphate

1 mg + Ambroxol

Hydrochloride BP 30mg +

Guafenisin BP 50mg

POM Syrup 149/087 Leben Laboratories (Pvt) Limited, India

3412 Alwo 400 Tablets Albendazole 400mg POM Tablet Chewable 149/088 Leben Laboratories (Pvt) Limited, India

3413

Azileb 200 Suspension Azithromycin 200mg POM Suspension for

Oral Use

149/089 Leben Laboratories (Pvt) Limited, India

3414 Azileb 500 Tablets Azithromycin 500mg POM Tablets Oral 149/090 Leben Laboratories (Pvt) Limited, India

3415

Betaleb Cream Betamethasone Valerate

0.1%w/w

POM Cream Topical 149/091 Leben Laboratories (Pvt) Limited, India

3416

Enderm Cream Clobetasol Propionate

USP 0.05%w/w

POM Cream Topical 149/092 Leben Laboratories (Pvt) Limited, India

3417

Sinurho Suspension Chlorpheniramine 1mg +

Phenylephrine 5mg +

Paracetamol 125mg

POM Suspension for

Oral Use

228/069 Leben Laboratories (Pvt) Limited, India

3418

Beclomin Lotion Beclomethasone

Dipropionate BP 0.025%

+ Miconazole Nitrate BP

2%

POM Lotion for Topical

Use

228/070 Leben Laboratories (Pvt) Limited, India

3419

HCT Tablets Hydrochlorothiazide

25mg

POM Tablet Uncoated 228/071 Leben Laboratories (Pvt) Limited, India

3420

IbuPlus Tablets Ibuprofen 400mg +

Paracetamol 325mg

P Tablet Uncoated 228/072 Leben Laboratories (Pvt) Limited, India

3421

Cypine Tablets Cyproheptadine

Hydrochloride BP 4mg

POM Tablet Enteric

Coated

228/073 Leben Laboratories (Pvt) Limited, India

3422 Lib-Mox 250 Capsules Amoxicillin 250mg POM Capsule oral 284/001 Liberal Pharmaceuticals Limited, India

3423

Lib-Mox Suspension Amoxicillin 125mg, per

5ml

POM Suspension for

Oral Use

284/002 Liberal Pharmaceuticals Limited, India

Page 176 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 3424 Lib-Dox-100 Capsules Doxycycline 100mg POM Capsule oral 284/003 Liberal Pharmaceuticals Limited, India

3425 Lib-Tetra Capsules Tetracycline 250mg POM Capsule oral 284/004 Liberal Pharmaceuticals Limited, India

3426 Lib-Indo-25 Capsules Indomethacin 25mg P Capsule oral 284/005 Liberal Pharmaceuticals Limited, India

3427

D'Tuss Ginger Lozenges

Pudina (Mentha viridis)

5.75mg + Karpura

(Cinnamomum camphora

Nees ) 0.18mg (Multiple)

GS

Lozenges

409/001L

Lifeon Labs Pvt Ltd

3428

D'Tuss Honey & Lemon

Lozenges

Pudina (Mentha viridis)

5.75mg + Karpura

(Cinnamomum camphora

Nees ) 0.18mg (Multiple)

GS

Lozenges

409/002L

Lifeon Labs Pvt Ltd

3429

D’Tuss Menthol Lozenges

Pudina (mentha viridis)

7mg + Taila Parni

(Eucalyptus globus)

3.3mg

GS

Lozenges

409/003L

Lifeon Labs Pvt Ltd

3430

D'Tuss Orange Lozenges

Pudina (Mentha viridis)

5.75mg + Karpura

(Cinnamomum camphora

Nees ) 0.18mg (Multiple)

GS

Lozenges

409/004L

Lifeon Labs Pvt Ltd

3431

Chloramphenicol Injection Chloramphehicol 1g POM Powder for

Injection

228/001 Lincoln Pharmaceuticals Ltd, India

3432

Lincosone Cream 15g Neomycin 0.5% +

Clotrimazole 1% +

Beclometasone 0.025%

POM Cream Topical 228/002 Lincoln Pharmaceuticals Ltd, India

3433 Te-De-V Tablets Clotrimazole 100mg POM Tablet Vaginal 228/003 Lincoln Pharmaceuticals Ltd, India

3434

Vivian Gel Diclofenac 1.16% +

Linseed Oil 3% + Methy

Salicylate 10% + Menthol

5%

P Gel Topical 228/004 Lincoln Pharmaceuticals Ltd, India

3435 Neovag Ointment 30g Nystatin 100,000iu POM Ointment topical 228/005 Lincoln Pharmaceuticals Ltd, India

3436

Deexa Eye Drops Dexamethasone 0.1%

w/v

POM Eye Drops 228/006 Lincoln Pharmaceuticals Ltd, India

3437

Deexa-N Eye Drops Dexamethasone 0.1 %

w/v + Neomycin 0.5 %

w/v

POM Eye Drops 228/007 Lincoln Pharmaceuticals Ltd, India

3438 Omlink-20 Capsules Omeprazole 20mg POM Capsule oral 228/008 Lincoln Pharmaceuticals Ltd, India

Page 177 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 3439 Daolin-5 Tablets Glibenclamide 5mg POM Tablet Uncoated 228/009 Lincoln Pharmaceuticals Ltd, India

3440 Malarid-200 Tablets Amodiaquine 200mg POM Tablet Uncoated 228/010 Lincoln Pharmaceuticals Ltd, India

3441

Rifalin Tablets Rifampicin 150mg +

Isoniazid 100mg

POM Tablet Uncoated 228/011 Lincoln Pharmaceuticals Ltd, India

3442 Konazol Cream Ketoconazole 2% w/w POM Cream Topical 228/012 Lincoln Pharmaceuticals Ltd, India

3443

Cotrimoxazole Oral Suspension Trimethoprim 40mg +

Sulphamethoxazole

200mg, per 5ml

POM Suspension for

Oral Use

228/013 Lincoln Pharmaceuticals Ltd, India

3444

Compound Magnesium

Triscilicate Tablets

Aluminium Hydrochloride

120mg + Magnesium

Trisilicate 250mg

GS Tablet Uncoated 228/014 Lincoln Pharmaceuticals Ltd, India

3445 Carbamazepine Tablets Carbamazepine 200mg POM Tablet Uncoated 228/015 Lincoln Pharmaceuticals Ltd, India

3446 Frusemide Tablets Furosemide 40mg POM Tablet Uncoated 228/016 Lincoln Pharmaceuticals Ltd, India

3447

Metronidazole Suspension Metronidazole Benzoate

200mg, per 5mls

POM Suspension for

Oral Use

228/017 Lincoln Pharmaceuticals Ltd, India

3448

Ampicillin Sodium Injection Ampicillin Sodium 500mg POM Powder for

Injection

228/018 Lincoln Pharmaceuticals Ltd, India

3449 Salbutamol Tablets Salbutamol 4mg POM Tablet Uncoated 228/019 Lincoln Pharmaceuticals Ltd, India

3450

Benzyl Penicillin Injection 5MU Benzyl Penicillin 5 Mega POM Powder for

Injection

228/020 Lincoln Pharmaceuticals Ltd, India

3451 Licambutol Tablets Ethambutol 800mg POM Tablet Uncoated 228/021 Lincoln Pharmaceuticals Ltd, India

3452

Perilin Injection Metoclopramide 5mg, per

ml

POM Solution for

Injection

228/022 Lincoln Pharmaceuticals Ltd, India

3453 Ranilink 150 Tablets Ranitidine 150mg POM Tablet Uncoated 228/023 Lincoln Pharmaceuticals Ltd, India

3454

Vitamin B Complex Injection Vitamin B Complex POM Solution for

Injection

228/024 Lincoln Pharmaceuticals Ltd, India

3455 Teterous-250 Capsules Tetracycline 250mg POM Capsule oral 228/025 Lincoln Pharmaceuticals Ltd, India

3456 Folic Acid Tablets Folic Acid 5mg P Tablet Uncoated 228/026 Lincoln Pharmaceuticals Ltd, India

3457

Penizin Tablets Benzathine Penicillin

2.4MU

POM Tablet Uncoated 228/027 Lincoln Pharmaceuticals Ltd, India

3458

Bet Cream 15g Betamethasone Valerate

0.1%

POM Cream Topical 228/028 Lincoln Pharmaceuticals Ltd, India

3459

Clotrilin MouthWash Clotrimazole 1% POM Solution for Oral

Use

228/029 Lincoln Pharmaceuticals Ltd, India

3460 Dermofulvin Tablets Griseofulvin 125mg POM Tablet Uncoated 228/031 Lincoln Pharmaceuticals Ltd, India

3461

Hydrocortisone Sodium Injection Hydrocortisone Sodium

Succinate 100mg

POM Powder for

Injection

228/032 Lincoln Pharmaceuticals Ltd, India

3462

Nystatin Oral Suspension Nystatin 100,000 IU, per

ml

POM Suspension for

Oral Use

228/033 Lincoln Pharmaceuticals Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 3463 Neovag vaginal Tablets Nystatin 100,000 IU POM Tablet Vaginal 228/034 Lincoln Pharmaceuticals Ltd, India

3464 Perfloxacin Tablets Perfloxacin 400mg POM Tablet Uncoated 228/035 Lincoln Pharmaceuticals Ltd, India

3465

Povidone iodine Ointment Povidone Iodine 5.0%w/w GS Ointment topical 228/036 Lincoln Pharmaceuticals Ltd, India

3466 Pyrazinamide Tablets Pyrazanamide 500mg POM Tablet Uncoated 228/037 Lincoln Pharmaceuticals Ltd, India

3467

Silvo Cream Silver Sulfadiazine USP

1%w/w + Chlorhexadine

Gluconate 2%w/w

P Cream Topical 228/038 Lincoln Pharmaceuticals Ltd, India

3468

Diclofenac Sodium Injection Diclofenac Sodium 75mg,

per 3ml

POM Solution for

Injection

228/039 Lincoln Pharmaceuticals Ltd, India

3469 Micolin Cream 15g Miconazole 2% POM Cream Topical 228/040 Lincoln Pharmaceuticals Ltd, India

3470 L-genta Drops Gentamycin 0.3%w/v POM Ear/Eye Drops 228/041 Lincoln Pharmaceuticals Ltd, India

3471

Allphenicol Eye Drops Chloramphenicol

0.5%w/v

POM Ear/Eye Drops 228/042 Lincoln Pharmaceuticals Ltd, India

3472

Bet.N Cream Betamethasone Valeate

0.05% w/w + Neomycin

Sulphate 0.5%w/w

POM Cream Topical 228/043 Lincoln Pharmaceuticals Ltd, India

3473 Doxycycline Capsules Doxycycline 100mg POM Capsule oral 228/044 Lincoln Pharmaceuticals Ltd, India

3474 Clotrimazole Cream Clotrimazole 1%w/w POM Cream Topical 228/045 Lincoln Pharmaceuticals Ltd, India

3475

Fortified procaine pencillin

Injection 2.4MU

Fortified Procaine

Penicillin 4MU

POM Powder for

Injection

228/046 Lincoln Pharmaceuticals Ltd, India

3476 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 228/047 Lincoln Pharmaceuticals Ltd, India

3477

Lignocaine Injection Lignocaine 2% POM Solution for

Injection

228/048 Lincoln Pharmaceuticals Ltd, India

3478

Ibun Tablets Ibuprofen 400mg +

Paracetamol 500mg

P Tablet Uncoated 228/049 Lincoln Pharmaceuticals Ltd, India

3479 Aminophylline Tablets Aminophylline 100mg POM Tablet Uncoated 228/050 Lincoln Pharmaceuticals Ltd, India

3480

Losa 50 Tablets Losartan Potassium USP

50mg

POM Tablet Uncoated 228/051 Lincoln Pharmaceuticals Ltd, India

3481

Strom Injection Tramadol Hydrochloride

100mg, per 2ml

POM Solution for

Injection

228/052 Lincoln Pharmaceuticals Ltd, India

3482

Soludine -M Ointment Povidone Iodine USP

5%w/w + Metronidazole

BP 1%w/w

P Ointment topical 228/053 Lincoln Pharmaceuticals Ltd, India

3483

Dermolin GM Cream Clobetasone Propionate

0.05% + Gentamicin

Sulphate 2.00% +

Miconazo 0.10%

POM Cream Topical 228/054 Lincoln Pharmaceuticals Ltd, India

Page 179 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3484

Flucomol Anticold Capsules Paracetamol 500mg +

Phenylephrine 10mg +

Dextromethorphan 15mg

+ Chlorpheniramine 2mg

POM Capsule oral 228/055 Lincoln Pharmaceuticals Ltd, India

3485

Flucomol Anticold Suspension (Paracetamol 250mg +

Phenylephrine 5mg +

Dextromethorphan 10mg

+ Chlorpheniramine

2mg)/5ml

POM Suspension for

Oral Use

228/056 Lincoln Pharmaceuticals Ltd, India

3486

Glymet -1 Tablets Glimepiride 1mg +

(extended release)

Metformin Hydrochloride

500mg

POM Tablet Uncoated 228/057 Lincoln Pharmaceuticals Ltd, India

3487

Glymet -2 Tablets Glimepiride 2mg +

(extended release)

Metformin Hydrochloride

500mg

POM Tablet Uncoated 228/058 Lincoln Pharmaceuticals Ltd, India

3488

Trioxon-O 200mg Cefixime Trihydrate USP

eq. Cefixime 200mg

POM Tablet Uncoated 228/059 Lincoln Pharmaceuticals Ltd, India

3489

Trioxon-O Oral Suspension Cefixime Trihydrate USP

eq. Cefixime 50mg, per

5ml

POM Suspension for

Oral Use

228/060 Lincoln Pharmaceuticals Ltd, India

3490

Trioxon-O 100mg Cefixime Trihydrate USP

eq. Cefixime 100mg

POM Tablet Uncoated 228/061 Lincoln Pharmaceuticals Ltd, India

3491 L-Pill Tablets Misoprostal 200mcg POM Tablet Uncoated 228/062 Lincoln Pharmaceuticals Ltd, India

3492

Pentalink 40mg Tablets Pantoprazole Sodium

Sesquihydrate BP 40mg

POM Tablet Uncoated 228/063 Lincoln Pharmaceuticals Ltd, India

3493

Ofloque -OZ Suspension Ofloxacin BP 50mg +

Ornidazole 125mg, per

5ml

POM Suspension for

Oral Use

228/064 Lincoln Pharmaceuticals Ltd, India

3494

PA 12 Tablets Paracetamol BP 300mg

(as immediate release) +

Paracetamol BP 700mg

(as sustained release)

P Tablet Modified

Release

228/065 Lincoln Pharmaceuticals Ltd, India

Page 180 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3495

Ciprovital + Tablets Cyproheptadine

Hydrochloride 2mg +

Thiamine Hydrochloride

1.2mg + Pyridoxine

Hydrochloride BP 1.2mg

+ Nicotinamide

Hydrochloride BP 1.2mg

P Tablet Uncoated 228/066 Lincoln Pharmaceuticals Ltd, India

3496

Ciprovital + Syrup (Cyproheptadine

Hydrochloride 2mg +

Thiamine Hydrochloride

1.2mg + Pyridoxine

Hydrochloride BP 1.2mg

+ Nicotinamide

Hydrochloride BP 1.2mg),

per 5ml

P Syrup 228/067 Lincoln Pharmaceuticals Ltd, India

3497

Losa-H Tablets Losartan Potassium USP

50mg +

Hydrochlorothiazide BP

12.5mg

POM Tablet Uncoated 228/068 Lincoln Pharmaceuticals Ltd, India

3498

L-kelfin Tablets Sulphadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 228/069 Lincoln Pharmaceuticals Ltd, India

3499

Gluzojoint-F Capsules Glucosamine

Hydrochloride 750mg

P Capsule oral 365/001 LOK WAL DEVELOPMENT LTD. HONG

KONG

3500

Glugogone Capsules Bitter Melon Extract

496.5mg

P Capsule oral 365/002 LOK WAL DEVELOPMENT LTD. HONG

KONG

3501

Refined Yunzhi Essence

Capsules

Yunzhi Essence 300 mg P Capsule oral 365/005L LOK WAL DEVELOPMENT LTD. HONG

KONG

3502

Ginseng coffee (4 in 1) Ginseng Extract 0.2mg +

Coffee 2mg

P Powder for Oral

Solution

382/003 LOK WAL DEVELOPMENT LTD. HONG

KONG

3503

Cerebrain Tablets Gingko leaves Extract

30mg

P Tablet Uncoated 382/004 LOK WAL DEVELOPMENT LTD. HONG

KONG

3504 Tonac -10mg Tablets Atorvastatin 10mg POM Tablet Film coated 281/001 Lupin laboratories Limited, India

3505 Ceff pead Tablets Cephalexin 125mg POM Tablet Uncoated 281/002 Lupin laboratories Limited, India

3506 Tonac-20mg Tablets Atorvastatin 20mg POM Tablet Uncoated 281/003 Lupin laboratories Limited, India

3507

Ceff Dry Syrup Cefalexin 125mg, per 5ml POM Suspension for

Oral Use

281/004 Lupin laboratories Limited, India

3508

Novapime 0.5g Injection Cefepime Hydrochloride

USP 500mg

POM Solution for

Injection

281/005 Lupin laboratories Limited, India

Page 181 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3509

Novapime 1g Injection Cefepime Hydrochloride

USP 1000mg

POM Solution for

Injection

281/006 Lupin laboratories Limited, India

3510

Salbair Solution Salbutamol 100mcg POM Solution for

Inhalation

281/012 Lupin laboratories Limited, India

3511

Salbair-1 Solution Salbutamol 100mcg +

Ipratropium 20mcg

POM Solution for

Inhalation

281/013 Lupin laboratories Limited, India

3512

Salbair-B Salbutamol 100mcg +

Beclomethasone 50mcg

POM Solution for

Inhalation

281/014 Lupin laboratories Limited, India

3513

Hepp Forte Syrup Folic Acid 0.5mg +

Elemental Iron 50mg,

per 15ml

P Syrup 281/015 Lupin laboratories Limited, India

3514 Cetil -250 Tablets Ceforoxime 250mg POM Tablet Uncoated 281/016 Lupin laboratories Limited, India

3515 Cetil -500 Tablets Ceforoxime 500mg POM Tablet Uncoated 281/017 Lupin laboratories Limited, India

3516

Odicef Injection Ceftriaxone 1g POM Powder for

Injection

281/018 Lupin laboratories Limited, India

3517 Ceff-250 Capsules Cephalexin 250mg POM Capsule oral 281/019 Lupin laboratories Limited, India

3518

Novapime Injection Cefepime 1000mg POM Solution for

Injection

281/020 Lupin laboratories Limited, India

3519 Ceff 500 Capsules Cephalexin 500mg POM Capsule oral 281/021 Lupin laboratories Limited, India

3520

Esiflo 125 Inhaler Salmeterol 25mcg +

Fluticasone 125mcg

POM Powder for

Inhalation

281/022 Lupin laboratories Limited, India

3521

Esiflo 250 Inhaler Salmeterol 25mcg +

Fluticasone 250mcg

POM Powder for

Inhalation

281/023 Lupin laboratories Limited, India

3522 Odoxil Tablets Cefadroxil 500mg POM Tablet Uncoated 281/024 Lupin laboratories Limited, India

3523

Odoxil Oral Suspension Cefradoxil 125mg/5mg POM Suspension for

Oral Use

281/025 Lupin laboratories Limited, India

3524

Akurit-3 Tablets Rifampicin 150mg +

Isoniazid 75mg +

Ethambutol 275mg

POM Tablet Uncoated 281/028 Lupin laboratories Limited, India

3525

Akurit Kids Rifampicin 60mg +

Isoniazid 30mg

POM Tablet Uncoated 281/029 Lupin laboratories Limited, India

3526

Akurit - Z Kids Tablets Rifampicin 60mg +

Isoniazid 30mg +

Pyrazinamide 150mg

POM Tablet Uncoated 281/030 Lupin laboratories Limited, India

3527

Akurit-4 Tablets Rifampicin 150mg +

Isoniazid 75mg +

Pyrazinamide 400mg +

Ethambutol 275mg

POM Tablet Uncoated 281/031 Lupin laboratories Limited, India

3528 Ethambutol Tablets Ethambutol 400mg POM Tablet Uncoated 281/032 Lupin laboratories Limited, India

Page 182 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 3529 Ethide Tablets Ethionamide 250mg POM Tablet Uncoated 281/033 Lupin laboratories Limited, India

3530

Desogestrel and Ethinyl

Estradiol Tablets USP

0.15mg/0.03mg

Desogestrel 0.15mg +

Ethinyl Estradiol 0.03mg

POM Tablet Film coated 281/034 Lupin laboratories Limited, India

3531

Lyforan Injection Cefotaxime 1g POM Powder for

Injection

163/001 Lyka Labs limited, India

3532 Fas-3 Kit Tablets Azithromycin 2.15g POM Tablet Uncoated 163/002 Lyka Labs limited, India

3533 Lyproquin Tablets Ciprofloxacin 250mg POM Tablet Uncoated 163/003 Lyka Labs limited, India

3534

Lyramycin Injection Gentamycin 40mg, per ml POM Solution for

Injection

163/004 Lyka Labs limited, India

3535 Imidil Vaginal Tablets Clotrimazole 100mg POM Tablet Uncoated 163/005 Lyka Labs limited, India

3536 Lamoxy Capsules Amoxicillin 250mg POM Capsule oral 163/006 Lyka Labs limited, India

3537

Lycortin-s-Injection Hydrocortisone 1000mg POM Powder for

Injection

163/007 Lyka Labs limited, India

3538

Basin 500 Capsules Cloxacillin 250mg +

Ampicillin 250mg

POM Capsule oral 163/008 Lyka Labs limited, India

3539 Anquin 400 Tablets Norfloxacin 400mg POM Tablet Film coated 163/009 Lyka Labs limited, India

3540

Ampicillin Injection Ampicillin 1g POM Powder for

Injection

163/010 Lyka Labs limited, India

3541 Sepexin-250 Capsules Cephalexin BP 250mg POM Capsule oral 163/011 Lyka Labs limited, India

3542

Lamoxyl Syrup Amoxicillin Trihydrate BP

125mg, per 5ml

POM Suspension for

Oral Use

163/012 Lyka Labs limited, India

3543

Lamoxy Syrup Amoxicillin Trihydrate BP

250mg

POM Powder for Oral

Solution

163/013 Lyka Labs limited, India

3544

Lyfaxone Injection Ceftriaxone USP 1g POM Powder for

Injection

163/014 Lyka Labs limited, India

3545

Lyseptol Tablets Sulphamethoxazole

400mg + Trimethoprim

80mg

POM Tablet Uncoated 163/015 Lyka Labs limited, India

3546 Lanol 500 Tablets Paracetamol BP 500mg GS Tablet Uncoated 163/016 Lyka Labs limited, India

3547

Imidil Vaginal Tablets Clotrimazole USP 200mg POM Tablet Vaginal 163/017 Lyka Labs limited, India

3548

Sulfadar Tablets Sulfadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 163/018 Lyka Labs limited, India

3549 Klox 250 Capsules Cloxacillin BP 250mg POM Capsule oral 163/019 Lyka Labs limited, India

3550

Lyproquin Tablets Ciprofloxacin USP

500mg

POM Tablet Uncoated 163/020 Lyka Labs limited, India

3551

Lydic Tablets Diclofenac Sodium BP

25mg

P Tablet Uncoated 163/021 Lyka Labs limited, India

Page 183 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3552

Ampicillin 250 Capsules Ampicillin Trihydrate BP

250mg

POM Capsule oral 206/001 Maan Pharmaceuticals Limited, India

3553

Amoxicillin 250 Capsules Amoxicillin Trihydrate BP

250mg

POM Capsule oral 206/002 Maan Pharmaceuticals Limited, India

3554

Primacort 100 Injection Hydrocortisone 100mg,

per 10ml

POM Powder for

Injection

192/001 Macleods Pharmaceuticals Limited, India

3555

Kanamac 1000 Injection Kanamycin 1000mg, per

10ml

POM Powder for

Injection

192/002 Macleods Pharmaceuticals Limited, India

3556

Macox Plus 100 Tablets Isoniazid 50mg +

Rifampicin 250mg

POM Tablet Uncoated 192/003 Macleods Pharmaceuticals Limited, India

3557 Anti-thyrox Tablets Carbimazole 5mg POM Tablet Uncoated 192/004 Macleods Pharmaceuticals Limited, India

3558 Amlodipine Tablets Amlodipine 5mg POM Tablet Uncoated 192/005 Macleods Pharmaceuticals Limited, India

3559 Ecox 400 Tablets Ethambutol 400mg POM Tablet Uncoated 192/006 Macleods Pharmaceuticals Limited, India

3560 Macrozide 500 Tablets Pyrazinamide 500mg POM Tablet Uncoated 192/007 Macleods Pharmaceuticals Limited, India

3561 Azicure 250 Tablets Azithromycin 250mg POM Tablet Uncoated 192/008 Macleods Pharmaceuticals Limited, India

3562 Azicure 500 Tablets Azithromycin 500mg POM Tablet Uncoated 192/009 Macleods Pharmaceuticals Limited, India

3563

Azicure 200/5ml Oral

Suspension

Azithromycin 200mg, per

5ml

POM Suspension for

Oral Use

192/010 Macleods Pharmaceuticals Limited, India

3564

Chloramphenicol Sodium

Injection

Chlorampehicol 1g POM Powder for

Injection

192/011 Macleods Pharmaceuticals Limited, India

3565 Econex 400 Tablets Ethambutol + Isoniazid POM Tablet Uncoated 192/012 Macleods Pharmaceuticals Limited, India

3566

Forecox-Trac Tablets Rifampicin + Isoniazid +

Pyrazinamide +

Ethambutol

POM Tablet Uncoated 192/013 Macleods Pharmaceuticals Limited, India

3567

Levomac 500 I.V infusion Levofloxacin 500mg POM Solution for

infusion

192/014 Macleods Pharmaceuticals Limited, India

3568 Levovac 250 Tablets Levofloxacin 250mg POM Tablet Uncoated 192/015 Macleods Pharmaceuticals Limited, India

3569 Levovac 500 Tablets Levofloxacin 500mg POM Tablet Uncoated 192/016 Macleods Pharmaceuticals Limited, India

3570

Kapocin Injection Capreomycin 1g POM Powder for

Injection

192/017 Macleods Pharmaceuticals Limited, India

3571 Coxerin Tablets Cycloserine 250mg POM Tablet Uncoated 192/018 Macleods Pharmaceuticals Limited, India

3572

Macripril – 10 Tablets (Enalapril

maleate USP 10mg)

Enalapril 10mg POM Tablets Oral 192/019 Macleods Pharmaceuticals Limited, India

3573

Tenomac 50 Tablets (Atenolol

BP 50mg)

Atenolol 50mg POM Tablets Oral 192/020 Macleods Pharmaceuticals Limited, India

3574

Haloperidol Tablets (Haloperidol

BP 5mg)

Haloperidol 5mg POM Tablets Oral 192/021 Macleods Pharmaceuticals Limited, India

3575

Rifampicin and Isoniazid Tablets Isoniazid150mg +

Rifampicin 225mg

POM Tablet Film coated 192/023 Macleods Pharmaceuticals Limited, India

Page 184 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3576

Forecox Tablets Rifampicin 150mg +

Isoniazid 75mg +

Pyrazinamide 400mg +

Ethambutol 275mg

POM Tablet Uncoated 192/024 Macleods Pharmaceuticals Limited, India

3577 Nevirapine Tablets Nevirapine 200mg POM Tablet Uncoated 192/025 Macleods Pharmaceuticals Limited, India

3578

Cotrimoxazole Tablets Sulphamethoxazole +

Trimethoprim 480mg

POM Tablet Uncoated 192/026 Macleods Pharmaceuticals Limited, India

3579 Lamivudine Tablets Lamivudine 150mg POM Tablet Film coated 192/027 Macleods Pharmaceuticals Limited, India

3580

Lamivudine/Zidovudine Tablets Lamivudine 150mg +

Zidovudine 300mg

POM Tablet Uncoated 192/028 Macleods Pharmaceuticals Limited, India

3581 Isoniazid Tablets Isoniazid 100mg POM Tablet Film coated 192/029 Macleods Pharmaceuticals Limited, India

3582 Isoniazid Tablets Isoniazid 300mg POM Tablet Film coated 192/030 Macleods Pharmaceuticals Limited, India

3583 Nifedipine BP 10mg Tablets Nifedipine 10mg POM Tablet Uncoated 192/031 Macleods Pharmaceuticals Limited, India

3584 Macrozide Tablets Pyrazinamide 400mg POM Tablet Uncoated 192/032 Macleods Pharmaceuticals Limited, India

3585 Torvast 20mg Tablets Artovastatin 20mg POM Tablet Uncoated 192/033 Macleods Pharmaceuticals Limited, India

3586

Cefolac 200 Tablets Cefixime Trihydrate

200mg

POM Tablet Uncoated 192/034 Macleods Pharmaceuticals Limited, India

3587 Ziidovudine 300mg Tablets Zidovudine 300mg POM Tablet Uncoated 192/035 Macleods Pharmaceuticals Limited, India

3588 Efavirenz 600mg Tablets Efavirenz 600mg POM Tablet Uncoated 192/036 Macleods Pharmaceuticals Limited, India

3589

Emtricitabine 200mg + Tenofovir

DF 300mg Tablets

Emtricitabine 200mg +

Tenofovir DF 300mg

Tablets

POM Tablet Film coated 192/037 Macleods Pharmaceuticals Limited, India

3590

Rifampicin 60mg + Isoniazid

30mg

Rifampicin 60mg +

Isoniazid 30mg

Dispersible tablets

POM Tablet Dispersible 192/038 Macleods Pharmaceuticals Limited, India

3591

Rifampicin 60mg + Isoniazid

30mg + Pyrazinamide 150mg

Dispersible tabl

Rifampicin 60mg +

Isoniazid 30mg +

Pyrazinamide 150mg

Dispersible tablet

POM Tablet Dispersible 192/039 Macleods Pharmaceuticals Limited, India

3592

Lamivudine 300mg & Tenofovir

300mg Tablets

Lamivudine 300mg +

Tenofovir 300mg tablets

POM Tablet Uncoated 192/040 Macleods Pharmaceuticals Limited, India

3593

Lamivudine 150mg+Zidovudine

300mg + Nevirapine 200mg

Tablets

Lamivudine 150mg+

Zidovudine 300mg +

Nevirapine 200mg tablets

POM Tablet Uncoated 192/041 Macleods Pharmaceuticals Limited, India

3594

Tenofovir 300mg Tablets Tenofovir Disoproxil

Fumarate 300mg

POM Tablet Uncoated 192/042 Macleods Pharmaceuticals Limited, India

Page 185 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3595

Emtricitabine 200mg + Tenofovir

DF 300mg + Efavirenz 600mg

Tablets

Emtricitabine I.H 200mg

+ Tenofivir Diisoproxil

I.H 300mg + Efavirenz

600mg

POM Tablet Uncoated 192/043 Macleods Pharmaceuticals Limited, India

3596

Lumitar Tablets Artemether 20mg +

Lumefantrine 120mg

POM Tablet Uncoated 192/044 Macleods Pharmaceuticals Limited, India

3597 Ethomid 250 Tablets Ethionamide 250mg POM Tablet Film coated 192/045 Macleods Pharmaceuticals Limited, India

3598

Pas Sodium Granules Para Aminosalicylate

Sodium 600mg, per g

POM Powder for Oral

Suspension

192/046 Macleods Pharmaceuticals Limited, India

3599

Moximac Tablets Moxifloxacin

Hydrochloride Tablets

400 mg

POM Tablet Film coated 192/047 Macleods Pharmaceuticals Limited, India

3600

Ethambutol 100 Dispersible

Tablets

Ethambutol

Hydrochloride 100mg

POM Tablet Film coated 192/050 Macleods Pharmaceuticals Limited, India

3601

Streptomycin sulphate for

injection

Streptomycin sulphate

BP 1000mg

POM Powder for

Injection

192/051 Macleods Pharmaceuticals Limited, India

3602 Maxadol Tablets Paracetamol 500mg GS Tablet Uncoated 167/012 Mac's Pharmaceuticals Limited, Kenya

3603

Cofrid Tablets Extract Glycyrhh BP

35mg + Menthol BP

10mg + Aniseed BP

0.001ml + Peppermint oil

BP 0.001ml + Tincture of

Capsicum BPC 0.020ml

+ Pini pumil oil BPC

0.001ml + Eucalyptus BP

0.02ml

GS Tablet Uncoated 167/013 Mac's Pharmaceuticals Limited, Kenya

3604

Orthoboon Sachets

Collagen Peptides 10g +

Glucosamine Sulphate

1500mg + Potassium

Chloride 35mg

GS

Powder for Oral

Solution

325/030L

Mankind Pharma Limited

3605

Uniortho - 500 Tablets

Univestin (a blend of

extracts of Scutellaria

baicalensis) 500mg

P

Tablet Uncoated

325/031L

Mankind Pharma Limited

3606

Uniortho - 250 Tablets

Univestin (a blend of

extracts of Scutellaria

baicalensis) 250mg

P

Tablet Uncoated

325/032L

Mankind Pharma Limited

Page 186 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3607

Reheptin Tablets

Metadoxine 500mg +

Silymarin 140mg + L-

Ornithine150mg + L-

Aspartate 3mg + Pyridox

1.5mg

P

Tablet Uncoated

325/033L

Mankind Pharma Limited

3608Texakind Injection

Tranexamic Acid BP

500mg

POM Solution for

Injection

325/034Mankind Pharma Limited

3609

Manforce Condoms Strawberry

FlavourMale Latex Condom

GS Latex Products 325/035LMankind Pharma Limited

3610

Manforce Condoms Mango

FlavourMale Latex Condom

GS Latex Products 325/036LMankind Pharma Limited

3611

Manforce Condoms Black

Grapes FlavourMale Latex Condom

GS Latex Products 325/037LMankind Pharma Limited

3612

Manforce Condoms Black

Chocolate FlavourMale Latex Condom

GS Latex Products 325/038LMankind Pharma Limited

3613

Vomikind Oral Solution Ondansentron

Hydrochloride 4mg/5ml

POM Solution for Oral

Use

325/039 MANKIND PHARMA LIMITED

3614

Pantakind 40 Tablets Pantoprazole Sodium

40mg

POM Tablet Film coated 325/001 Mankind Pharma Ltd, India

3615 Manforce 50 Tablets Sildenafil Citrate 50mg POM Tablet Film coated 325/002 Mankind Pharma Ltd, India

3616 Manforce 100 Tablets Sildenafil Citrate 100mg POM Tablet Film coated 325/003 Mankind Pharma Ltd, India

3617

Losakind-50 Tablets Losartan Potassium

50mg

POM Tablet Uncoated 325/004 Mankind Pharma Ltd, India

3618

Losakind 25 Tablets Losartan Potassium

25mg

POM Tablet Uncoated 325/005 Mankind Pharma Ltd, India

3619 Glimestar 4 Tablets Glimepiride 4mg POM Tablet Film coated 325/006 Mankind Pharma Ltd, India

3620 Glimestar 3 Tablets Glimepiride 3mg POM Tablet Film coated 325/007 Mankind Pharma Ltd, India

3621 Glimestar 2 Tablets Glimepiride 2mg POM Tablet Film coated 325/008 Mankind Pharma Ltd, India

3622 Glimestar 1 Tablets Glimepiride 1mg POM Tablet Film coated 325/009 Mankind Pharma Ltd, India

3623

Moxikind - CV 625 Tablets Amoxicillin Trihydrate BP

500mg + Clavulanate

Potassium BP 125mg

POM Tablet Film coated 325/010 Mankind Pharma Ltd, India

3624

Moxikind - CV Suspension Amoxicillin Trihydrate BP

200mg + Potassium

Clavulanate BP 28.50mg

POM Suspension for

Oral Use

325/011 Mankind Pharma Ltd, India

3625

Moxikind - CV 375 Tablets Amoxicillin Trihydrate BP

250mg + Clavulanate

Potassium BP 125mg

POM Tablet Uncoated 325/012 Mankind Pharma Ltd, India

3626 Rabekind -20 tablet Rabeprazole 20mg POM Tablet Uncoated 325/013 Mankind Pharma Ltd, India

Page 187 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3627

Vomikind Injection Ondasetron

Hydrochloride USP 2mg

POM Solution for

Injection

325/014 Mankind Pharma Ltd, India

3628 Deoregdina Tablets Levonorgestrel 1.5mg POM Tablet Uncoated 325/015 Mankind Pharma Ltd, India

3629 Ominext -20 Capsules Omeprazole BP 20mg POM Capsule oral 325/016 Mankind Pharma Ltd, India

3630

Nuforce G Cream Betamethasone

Dipropionate BP 0.643mg

+ Clotrimazole BP 10mg

+ Gentamycin 1mg

POM Cream Topical 325/017 Mankind Pharma Ltd, India

3631

Losakind - H Tablets Losartan Potassium USP

50mg +

Hydrochlorothiazide USP

25mg

POM Tablet Uncoated 325/018 Mankind Pharma Ltd, India

3632

Cefakind 500 Tablets Cefuroxime Axetil

500mg

POM Tablet Uncoated 325/019 Mankind Pharma Ltd, India

3633

Cefakind 250 Tablets Cefuroxime Axetil

250mg

POM Tablet Uncoated 325/020 Mankind Pharma Ltd, India

3634

Terbinaforce - 250 Tablets Terbinafine

Hydrochloride USP

250mg

POM Tablet Uncoated 325/021 Mankind Pharma Ltd, India

3635

Clopikind - 75 Tablets Clopidogrel Bisulphate

USP 75mg

POM Tablet Film coated 325/022 Mankind Pharma Ltd, India

3636

Ceftatime SB 1.5 Injection Ceftriaxone USP 1000mg

+ Sulbactum Sodium

USP 500mg

POM Powder for

Injection

325/023 Mankind Pharma Ltd, India

3637

Ceftatime -1000 Injection Ceftriaxone USP 1000mg POM Powder for

Injection

325/024 Mankind Pharma Ltd, India

3638

Levostand 500 Tablets Levofloxacin

Hemihydrate 500mg

POM Tablet Uncoated 325/025 Mankind Pharma Ltd, India

3639

Zadiways - 500 Tablets Azithromycin

Dihydrochloride 500mg

POM Tablet Uncoated 325/026 Mankind Pharma Ltd, India

3640

Zadiways - 250 Tablets Azithromycin

Dihydrochloride 250mg

POM Tablet Uncoated 325/027 Mankind Pharma Ltd, India

3641

Ubinex-LC Tablets L-Carnitine L-Tatrate

735mg + Ubidecarenone

30mg

Pharmacy

Medicine

Tablet Film coated 325/028L Mankind Pharma Ltd, India

3642

Ovagrace Sachets Myo-inositol 2000mg +

Folic Acid 0.3mg +

Vitamin D3 8mg

Pharmacy

Medicine

Powder for Oral

Solution

325/029L Mankind Pharma Ltd, India

Page 188 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3643

TOTACEF 1000 Powder for

injection

Cefepime hydrochloride

USP eq. to Cefepime

1000mg

POM Powder for

Injection

325/040 Mankind Pharma Ltd, India

3644

Candican liquid Infusion Fluconazole 200mg, per

100ml

POM Solution for

infusion

186/002 Marck Biosciences Ltd, India

3645

Mannitol Intravenous Solution Mannitol 20g, per 100ml POM Solution for

infusion

186/004 Marck Biosciences Ltd, India

3646

Sterilised Water BP Sterlised Water POM Solution for

Injection

186/005 Marck Biosciences Ltd, India

3647 Paracetin Eye Drops Chloramphenicol 0.5% POM Eye Drops 186/009 Marck Biosciences Ltd, India

3648

Septimar Tablets Sulphamethoxazole

400mg + Trimethoprim

80mg

POM Tablet Uncoated 148/001 Mars Life Sciences Ltd, India

3649 Marquinite Tablets Quinine 300mg POM Tablet Film coated 148/002 Mars Life Sciences Ltd, India

3650 O-mar Capsules Omeprazole 20mg POM Capsule oral 148/003 Mars Life Sciences Ltd, India

3651 Moxmar Capsules Amoxicillin 250mg POM Capsule oral 148/004 Mars Life Sciences Ltd, India

3652 Marthrocin Tablets Erythromycin 250mg POM Tablet Uncoated 148/005 Mars Life Sciences Ltd, India

3653 Candimar Cream Clotrimazole 1% POM Cream Topical 148/006 Mars Life Sciences Ltd, India

3654 Flumar 200 Capsules Fluconazole 200mg POM Capsule oral 148/007 Mars Life Sciences Ltd, India

3655

Marzid Injection Certazidine 1g POM Powder for

Injection

148/008 Mars Life Sciences Ltd, India

3656

Resflo Granules Saccharomyces Boulardii

250mg

POM Powder for Oral

Suspension

148/009 Mars Life Sciences Ltd, India

3657 Instakleen Hand Gel Ethyl Alcohol 96% GS Gel Topical 148/010 Mars Life Sciences Ltd, India

3658

Mardip GC Cream Clotrimazole 10mg +

Gentamycin 1mg +

Betamethasone 0.65mg

POM Cream Topical 148/011 Mars Life Sciences Ltd, India

3659 Marixime-100 Tablets Cefixime 100mg POM Tablet Uncoated 148/012 Mars Life Sciences Ltd, India

3660 Haemar-z Capsules Haematinic Preparation P Capsule oral 148/013 Mars Life Sciences Ltd, India

3661

Marixime-200 Tablets Cefixime Trihydrate USP

200mg

POM Tablet Film coated 148/014 Mars Life Sciences Ltd, India

3662

Marvoran-50 Tablets Diclofenac Sodium BP

50mg

P Tablet Enteric

Coated

148/015 Mars Life Sciences Ltd, India

3663

Atropine Injection Atropine Sulphate

600mcg

POM Solution for

Injection

422/007 Matindale Pharma

3664

Ephedrine 30mg Injection Ephedrine Hdyrochloride

30mg

POM Solution for

Injection

422/008 Matindale Pharma

3665

Fentanyl citrate Injection,

50mg/ml

Fentanyl Citrate 50mg/ml,

5ml

POM Solution for

Injection

422/004 Matindale Pharma Ltd

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3666

Fentanyl citrate Injection Fentanyl Citrate 50mg/ml,

10ml

POM Solution for

Injection

422/005 Matindale Pharma Ltd

3667

Morphine Sulphate Injection Morphine Sulphate 10mg POM Solution for

Injection

422/006 Matindale Pharma Ltd

3668 Miconaz Cream Miconazole 2%w/v POM Cream Topical 277/001 Medical Union Pharmaceuticals Ltd, Egypt

3669 Miconaz Vaginal Ovules Miconazole 400mg POM Ovule Vaginal 277/003 Medical Union Pharmaceuticals Ltd, Egypt

3670 Miconaz Oral Gel Miconazole 2%w/v POM Gel Oral 277/004 Medical Union Pharmaceuticals Ltd, Egypt

3671

Miconaz-H Emugel Hydrocortisone 10mg +

Miconazole 20mg

POM Gel Topical 277/005 Medical Union Pharmaceuticals Ltd, Egypt

3672

Vagyl Powder Borax 13.75mg +

Sodium Chloride 8mg

P Powder for Topical

use

277/006 Medical Union Pharmaceuticals Ltd, Egypt

3673

Sediproct Cream Hydrocortisone 0.5% +

Cinchocaine 0.5%

POM Cream Topical 277/007 Medical Union Pharmaceuticals Ltd, Egypt

3674

Biovit 12 Depot Injection Folic Acid 1mg +

Pyridoxine 20mg +

Hydroxocobalamin 1mg

POM Solution for

Injection

277/008 Medical Union Pharmaceuticals Ltd, Egypt

3675

Phytovit MM Injection Phytomenadione 10mg,

per ml

POM Solution for

Injection

277/009 Medical Union Pharmaceuticals Ltd, Egypt

3676 Zinc Olive Cream Zinc Oxide BP 10% GS Cream Topical 277/011 Medical Union Pharmaceuticals Ltd, Egypt

3677

Fantem Tablets Artemether 20mg +

Lumefantrine 120mg

POM Tablet Uncoated 058/001 Medinomics Healthcare Pvt Ltd, India

3678 Nevirapine Tablets Nevirapine 200mg POM Tablet Uncoated 142/001 Meditab Specialities (Pvt) Ltd, India

3679 Indinavir 400 Capsules Indinavir 400mg POM Capsule oral 142/002 Meditab Specialities (Pvt) Ltd, India

3680 Stavudine30 Capsules Stavudine 30mg POM Capsule oral 142/003 Meditab Specialities (Pvt) Ltd, India

3681 Stavudine 40 Capsules Stavudine 40mg POM Capsule oral 142/004 Meditab Specialities (Pvt) Ltd, India

3682

Medivir- L Tablets Lamivudine 300mg +

Zidovudine 150mg

POM Tablet Film coated 142/005 Meditab Specialities (Pvt) Ltd, India

3683 Zidovudine Capsules Zidovudine 100mg POM Capsule oral 142/006 Meditab Specialities (Pvt) Ltd, India

3684 Efavirenz Capsules Efavirenz 200mg POM Capsule oral 142/007 Meditab Specialities (Pvt) Ltd, India

3685

LSN-30 Tablets Lamivudine 150mg +

Stavudine 30mg +

Nevirapine 200mg

POM Tablet Uncoated 142/008 Meditab Specialities (Pvt) Ltd, India

3686

Medilam S 30 Tablets Lamivudine 150mg +

Stavudine 30mg

POM Tablet Uncoated 142/009 Meditab Specialities (Pvt) Ltd, India

3687

Medivir LN Tablets Lamivudine 150mg +

Nevirapine 200mg

POM Tablet Uncoated 142/010 Meditab Specialities (Pvt) Ltd, India

3688

Medilan S-40 Tablets Lamivudine 150mg +

Stavudine 40mg

POM Tablet Uncoated 142/011 Meditab Specialities (Pvt) Ltd, India

Page 190 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3689

LSN- 40 Tablets Lamivudine 150mg +

Nevirapine 200mg +

Stavudine 40mg

POM Tablet Uncoated 142/012 Meditab Specialities (Pvt) Ltd, India

3690 Zidovudine Tablets Zidovudine 300mg POM Tablet Film coated 142/013 Meditab Specialities (Pvt) Ltd, India

3691 Codeine Phosphate Tablets Codeine 30mg POM Tablet Uncoated 048/002 Mediwin Pharmaceuticals , India

3692

Ciprogun TZ Tablets Ciprofloxacin 600mg +

Tindazole 500mg

POM Tablet Uncoated 048/003 Mediwin Pharmaceuticals , India

3693

Medizox Tablets Paracetamol 325mg +

Diclofenac 50mg +

Chlorzoxane 250mg

P Tablet Uncoated 048/004 Mediwin Pharmaceuticals , India

3694 Celexin 250mg Capsules Cefalexin 250mg POM Tablet Uncoated 048/005 Mediwin Pharmaceuticals , India

3695 Lomexel Tablets Lomefloxacin 400mg POM Tablet Uncoated 106/001 Medley Pharmaceuticals Limited, India

3696 Helmintol Tablets Mebendazole 100mg P Tablet Uncoated 106/002 Medley Pharmaceuticals Limited, India

3697

Axane Gel Methyl Salicylate 50mg +

Camphors 25mg +

Menthol 25mg +

Capsaicin 0.25mg, per 1g

GS Gel Topical 106/003 Medley Pharmaceuticals Limited, India

3698

R B tone Capsules Ferrous Gluconate

259mg + Folic Acid 5mg

+ Dibasic Calcium

Ohosph. 100mg + Zinc

Sulp. 33mg + Vit B12

2.5mcg

POM Capsule oral 106/004 Medley Pharmaceuticals Limited, India

3699

Prosup Syrup B Complex + Protein +

Vitamin

POM Syrup 106/005 Medley Pharmaceuticals Limited, India

3700 Encardil 2.5 Tablets Enalapril 2.5mg POM Tablet Uncoated 106/006 Medley Pharmaceuticals Limited, India

3701 Encardil 5 Tablets Enalapril 5mg POM Tablet Uncoated 106/007 Medley Pharmaceuticals Limited, India

3702 Encardil 10 Tablets Enalapril 10mg POM Tablet Uncoated 106/008 Medley Pharmaceuticals Limited, India

3703 Encardil 20 Tablets Enalapril 20mg POM Tablet Uncoated 106/009 Medley Pharmaceuticals Limited, India

3704 Astem Tablets Astemizole 10mg POM Tablet Uncoated 106/010 Medley Pharmaceuticals Limited, India

3705 Gromin Syrup Minerals + Multivitamins P Syrup 106/011 Medley Pharmaceuticals Limited, India

3706

Xymex Syrup Riboflavin + Thiamine +

Fungal + Pepsin

P Syrup 106/012 Medley Pharmaceuticals Limited, India

3707

Geramed Injection Gentamicin 80mg, per

2ml

POM Solution for

Injection

106/015 Medley Pharmaceuticals Limited, India

3708

Deximed Injection Dexamethasone 4mg POM Powder for

Injection

106/016 Medley Pharmaceuticals Limited, India

3709 Moxmed-250 Capsules Amoxicillin 250mg POM Capsule oral 106/018 Medley Pharmaceuticals Limited, India

Page 191 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 3710 Ultigra-180 Tablets Fexofenadine 180mg POM Tablet Uncoated 106/019 Medley Pharmaceuticals Limited, India

3711 Oncet 10 Tablets Cetirizine 10mg POM Tablet Uncoated 106/020 Medley Pharmaceuticals Limited, India

3712

Helmintol Suspension Mebendazole 100mg, per

5ml

P Suspension for

Oral Use

106/021 Medley Pharmaceuticals Limited, India

3713 Zoxil 500 Tablets Cefadroxil 500mg POM Tablet Uncoated 106/022 Medley Pharmaceuticals Limited, India

3714 Zoxil dt Tablets Cefadroxil 250mg POM Tablet Uncoated 106/023 Medley Pharmaceuticals Limited, India

3715 Spocelin 250 Capsules Cephalexin 250mg POM Capsule oral 106/024 Medley Pharmaceuticals Limited, India

3716 Ofoxin 200 Tablets Ofloxacin 200mg POM Tablet Uncoated 106/025 Medley Pharmaceuticals Limited, India

3717 Primodil 5 Tablets Amlodipine 5mg POM Tablet Uncoated 106/026 Medley Pharmaceuticals Limited, India

3718 Lansoprazole Capsules Lansoprazole 30mg POM Capsule oral 106/027 Medley Pharmaceuticals Limited, India

3719 Rofexib 25 Tablets Rofecoxib 25mg POM Tablet Uncoated 106/028 Medley Pharmaceuticals Limited, India

3720 Cefo L-200 Tablets Cefixime 200mg POM Tablet Uncoated 106/029 Medley Pharmaceuticals Limited, India

3721 Cefo L-100 Tablets Cefixime 100mg POM Tablet Uncoated 106/030 Medley Pharmaceuticals Limited, India

3722 Pantaz Tablets Pantoprazole 40mg POM Tablet Uncoated 106/031 Medley Pharmaceuticals Limited, India

3723

Ceftriaxone Injection Ceftriaxone 1g POM Powder for

Injection

106/032 Medley Pharmaceuticals Limited, India

3724 Primodil 10 Tablets Amlodipine 10mg POM Tablet Uncoated 106/033 Medley Pharmaceuticals Limited, India

3725 Ofloxin 400 Tablets Ofloxacin 400mg POM Tablet Uncoated 106/034 Medley Pharmaceuticals Limited, India

3726 Ultigra 120 Tablets Fexofenadine 120mg POM Tablet Uncoated 106/035 Medley Pharmaceuticals Limited, India

3727 Ecoflox -500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 106/036 Medley Pharmaceuticals Limited, India

3728 Ecoflox-250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 106/037 Medley Pharmaceuticals Limited, India

3729 Decifen SR Tablets Diclofenac 100mg P Tablet Film coated 106/038 Medley Pharmaceuticals Limited, India

3730 Floxilet 300 Tablets Norfloxacin 400mg POM Tablet Uncoated 106/039 Medley Pharmaceuticals Limited, India

3731 Spocelin 500 Capsules Cephalexin 500mg POM Capsule oral 106/040 Medley Pharmaceuticals Limited, India

3732 Rofexib 12.5 Tablets Rofecoxib 12.5mg POM Tablet Uncoated 106/041 Medley Pharmaceuticals Limited, India

3733 Vasortan-50 Tablets Losartan 50mg POM Tablet Uncoated 106/042 Medley Pharmaceuticals Limited, India

3734 Glucozid Tablets Gliclazide 80mg POM Tablet Uncoated 106/043 Medley Pharmaceuticals Limited, India

3735

Zoxil 125 Rediuse Suspension Cefadroxil 125mg, per

5ml

POM Suspension for

Oral Use

106/044 Medley Pharmaceuticals Limited, India

3736

GTN Spray Glyceryltrinitrate 0.4mg,

per Metered Dose

POM Solution for

Inhalation

106/045 Medley Pharmaceuticals Limited, India

3737

Spasmonorm Tablets Paracetamol +

Dicyclomine

P Tablet Uncoated 106/046 Medley Pharmaceuticals Limited, India

3738

Gromin Drops Minerals + Multivitamins P Solution for Oral

Use

106/047 Medley Pharmaceuticals Limited, India

3739

Motinorm Syrup Domperidone 5mg, per

5ml

POM Syrup 106/048 Medley Pharmaceuticals Limited, India

3740 Motinorm Tablets Domperidone 10mg POM Tablet Uncoated 106/049 Medley Pharmaceuticals Limited, India

3741

Motinorm Drops Domperidone 10mg, per

5ml

POM Solution for Oral

Use

106/050 Medley Pharmaceuticals Limited, India

Page 192 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3742

Trisoliv Syrup Kalmegh + Citric Acid +

Tricholine Citrate 500mg

P Syrup 106/051 Medley Pharmaceuticals Limited, India

3743 Poraz-20 Capsules Omeprazole 20mg POM Capsule oral 106/052 Medley Pharmaceuticals Limited, India

3744 Atorin 10 Tablets Atorvastatin 10mg POM Tablet Film coated 106/053 Medley Pharmaceuticals Limited, India

3745 BP Norm 50 Tablets Atenolol 50mg POM Tablet Uncoated 106/054 Medley Pharmaceuticals Limited, India

3746

New Tuxiril Syrup Dextromethorphan 10mg

+ Phenylephrine 5mg +

Menthol 5mg

P Syrup 106/055 Medley Pharmaceuticals Limited, India

3747 R.B.Tone Syrup Haematinic Preparation P Syrup 106/056 Medley Pharmaceuticals Limited, India

3748

Coldrid Day and Night Tablets Paracetamol 500mg+

Chlorpheniramine 2mg+

Phenylephrine 5mg+

Caffeine 15mg

P Tablet Uncoated 106/057 Medley Pharmaceuticals Limited, India

3749 Atorin 50 Tablets Atorvastatin 50mg POM Tablet Uncoated 106/058 Medley Pharmaceuticals Limited, India

3750

Glucozid m Tablets Metformin 500mg +

Gliclazide 80mg

POM Tablet Uncoated 106/059 Medley Pharmaceuticals Limited, India

3751

Primodil AT Tablets Amlodipine 7.11mg +

Atenolol 50mg

POM Tablet Uncoated 106/060 Medley Pharmaceuticals Limited, India

3752

Acenac-P Tablets Paracetamol 325mg +

Aceclofenac 100mg

P Tablet Uncoated 106/061 Medley Pharmaceuticals Limited, India

3753 Ceurox 500 Tablets Cefuroxime 500mg POM Tablet Uncoated 106/062 Medley Pharmaceuticals Limited, India

3754

Xymex Drops Pepsin 10mg + Papain

6mg + Sodium Citrate

40mg + Weak Ginger

Tincture 0.024ml + Citric

8mg

P Solution for Oral

Use

106/063 Medley Pharmaceuticals Limited, India

3755

Cefo-L Dry Syrup Cefixime Trihydrate

50mg + Lactic Acid

Bacillus 6000 million

spore/g

POM Suspension for

Oral Use

106/064 Medley Pharmaceuticals Limited, India

3756

Vazortan-H Tablets Losartan Potassium

50mg +

Hydrochlorothiazide

12.5mg

POM Tablet Uncoated 106/065 Medley Pharmaceuticals Limited, India

3757

Dompan- OD Tablets Domperidone 30mg +

Pantoprazole 47.360mg

POM Tablet Uncoated 106/066 Medley Pharmaceuticals Limited, India

Page 193 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3758

Coldrid Syrup Cetirizine Dihydrochloride

2.5mg + Phenylephrine

Hydrochloride 5mg +

Paracetamol 125mg

P Syrup 106/067 Medley Pharmaceuticals Limited, India

3759

Supiclox Injection Ampicillin + Cloxacillin POM Powder for

Injection

106/095 Medley Pharmaceuticals Limited, India

3760

SunDe Choleclaciferol 60,000IU P Granules for Oral

Use

106/096L Medley Pharmaceuticals Limited, India

3761

Emcycline 250 Capsules Tetracycline Capsules

BP 250

POM Capsule oral 272/001 Medopharm,India

3762 Doxicon Capsules 100mg Doxycycline 100mg POM Capsule oral 272/002 Medopharm,India

3763

Sulphadoxine + Pyrimethamine

USP Tablets

Sulphadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 272/003 Medopharm,India

3764

M-Dopa Tablets Methyldopa Tablets BP

250mg

POM Tablets oral 272/004 Medopharm,India

3765 Nalidixic acid Nalidixic Acid 500mg POM Tablet Uncoated 272/007 Medopharm,India

3766 Amitriptyline Tablets Amitriptyline 25mg POM Tablet Uncoated 272/008 Medopharm,India

3767 Amoxicillin BP Capsules Amoxicillin 250mg POM Capsule oral 272/009 Medopharm,India

3768 Cimetidine Tablets Cimetidine 200mg POM Tablet Uncoated 272/010 Medopharm,India

3769

Co-trimoxazole Tablets Trimethoprim 80 +

Sulfamethoxazole 400mg

POM Tablet Uncoated 272/011 Medopharm,India

3770 Cyproheptadine Tablets Cyproheptadine 4mg P Tablet Uncoated 272/012 Medopharm,India

3771 Diclofenac Tablets Diclofenac 100mg P Tablet Uncoated 272/013 Medopharm,India

3772 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 272/014 Medopharm,India

3773 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 272/015 Medopharm,India

3774 Norfloxacin Tablets Norfloxacin 400mg POM Tablet Uncoated 272/016 Medopharm,India

3775 Nitrofurantoin Tablets Nitrofurantoin 100mg POM Tablet Uncoated 272/017 Medopharm,India

3776 Ranitidine Tablets Ranitidine 150mg POM Tablet Uncoated 272/018 Medopharm,India

3777

Amoxicillin Suspension Amoxicillin 125mg, per

5ml

POM Suspension for

Oral Use

272/019 Medopharm,India

3778 Ethionamide Tablets Ethionamide 250mg POM Tablet Uncoated 272/020 Medopharm,India

3779 Ofloxacin Tablets Ofloxacin 200mg POM Tablet Uncoated 272/021 Medopharm,India

3780 Medomol Tablets Paracetamol 500mg GS Tablet Uncoated 272/022 Medopharm,India

3781

Cedomox 228.5 Suspension Clavulanate 28.5mg +

Amoxicillin 200mg

POM Suspension for

Oral Use

272/023 Medopharm,India

3782

Cledomox 375 Tablets Clavulanate 250mg +

Amoxicillin 125mg

POM Tablet Uncoated 272/024 Medopharm,India

Page 194 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3783

Phenoxymethyl Penicillin

Tablets

Phenoxymethyl Penicillin

250mg

POM Tablet Uncoated 272/026 Medopharm,India

3784 Nat B Capsules Multivitamins & Minerals P Capsule oral 355/001 Mega Lifescience PLC

3785

Osteomin Tablets Glucosamine Sulphate

2Kcl USP 667mg eq to

Glucosamine Sulphate

500mg + Chondroitin

Sulphate USP 400mg

P Tablets uncoated 355/002 Mega Lifescience PLC

3786 Enat 400 SoftGel Capsules Vitamin E 400 I.U P Capsule oral 385/001 Mega Lifescience PLC

3787

Zeman SX Capsules Magnesium 83.52mg+

Zinc 5.58mg + Vitamin

B6 1.935mg

P Capsule oral 385/002 Mega Lifescience PLC

3788 Gogaz Capsules Simethicone 200mg P Capsule oral 385/003 Mega Lifescience PLC

3789 Livolin Forte Capsules Vitamins & Minerals P Capsule oral 385/004L Mega Lifescience PLC

3790

Calcivita Supplement for

Children

Calcium Supplement +

Vitamins

P Capsule oral 385/005L Mega Lifescience PLC

3791

Ginsomin Capsules Ginseng Extract 50mg+

Multivitamins & Minerals

P Capsule oral 385/006L Mega Lifescience PLC

3792

Maxcal Tablets CaCO3 600mg + Vit D3

200 IU+ Culpric

Gluconate 40mg + Mg

O2m 7.5mg+ MnO2 1mg

+ NaTetraborate 1.8mg +

Z 0.25mg

P Tablets uncoated 385/009L Mega Lifescience PLC

3793

Ginsomin Eve Capsules Evening Primrose Oil

50mg + Ginseng Extract

50mg+ Multivitamins

P Capsule oral 385/010L Mega Lifescience PLC

3794 Vitacap Softgel Capsules Multivitamin & Minerals P Capsule oral 385/011L Mega Lifescience PLC

3795

Prenatal Softgel Capsules Multivitamin & Minerals Pharmacy

Medicine

Capsule oral 385/012L Mega Lifescience PLC

3796 GOFEN 400 Capsules Ibuprofen USP 400mg P Capsule oral 385/013 Mega Lifescience PLC

3797

IICare capsules Bilberry extract 25mg +

Lutein suspension15mg

+Providing Lut

P Tablet Uncoated 385/014L Mega Lifescience PLC

3798 Meldol Tablets 500mg Paracetamol 500mg GS Tablet Uncoated 008/001 Melcome Pharmaceuticals Limited Zambia

3799

Meldol Syrup (Paracetamol

120mg, per 5ml)

Paracetamol 120mg, per

5ml

GS Solution for Oral

Use

008/003 Melcome Pharmaceuticals Limited Zambia

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3800

Melcotrim Suspension Oral

Suspension.

Sulphamethoxazole

100mg + Trimethoprim

20mg

POM Suspension for

Oral Use

008/004 Melcome Pharmaceuticals Limited Zambia

3801

Painrid Capsules Paracetamol BP 50mg +

Caffiene 30mg

GS Capsule Oral 008/002 Melcome Pharmaceuticals Ltd, Zambia

3802

Euthyrox 25 Levothyroxine Sodium

25mcg

POM Tablet Uncoated 363/007 Merck (Pty) Ltd

3803

Euthyrox 50 Levothyroxine Sodium

50mcg

POM Tablet Uncoated 363/008 Merck (Pty) Ltd

3804

Euthyrox 100 Levothyroxine Sodium

100mcg

POM Tablet Uncoated 363/009 Merck (Pty) Ltd

3805

Glucovance 500/5 film coated

tablets

Metformin hydrochloride

BP 500mg +

Glibenclamide BP 5mg

POM Tablet Film coated 363/014 Merck (Pty) Ltd

3806

Betanil GM Cream Gentamycin 0.1% +

Miconazole 2% +

Betamethasone 0.05%

POM Cream Topical 181/001 Merck Limited, India

3807

Betanil Cream Betamethasone

0.05%w/w

POM Cream Topical 181/002 Merck Limited, India

3808

Betanil N Cream Betamethasone 0.05% +

Neomycin Sulphate 0.5%

POM Cream Topical 181/003 Merck Limited, India

3809 Diclofenac Diethylamine Cream Diclofenac 1% P Gel Topical 181/004 Merck Limited, India

3810 Nasivion Adult Nasal Drops Oxymetazoline 0.05% P Nasal drops 181/005 Merck Limited, India

3811

Navison Paediatric Nasal Drops Oxymetazoline 0.025% P Nasal drops 181/006 Merck Limited, India

3812

Evion 200 Capsules D-Alpha-Tocopherol

200mg

POM Capsule oral 181/007 Merck Limited, India

3813

Evion 400 Capsules D-Alpha-Tocopherol

400mg

POM Capsule oral 181/008 Merck Limited, India

3814 Evion Cream Vitamin E 1.0%w/w POM Cream Topical 181/009 Merck Limited, India

3815

Neurobion Forte Tablets Thiamine Mononitrate 10

mg + Riboflavin 10 mg +

Pyridoxine Hydrochloride

3 mg + Cyanocobalamin

15 mcg + Nicotinamide

45 mg + Calcium

Pantothenate 50 mg

P Tablet Uncoated 181/010 Merck Limited, India

Page 196 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3816

Neurobion Forte Injection Mecobalamin 1000 mcg

+ Pyridoxine

Hydrochloride 100 mg +

Niacinamide 100 mg, per

2 ml

P Solution for

Injection

181/011 Merck Limited, India

3817

Polybion Syrup Vit B Complex and

Minerals

P Syrup 181/012 Merck Limited, India

3818

Polybion Tablets Vit B Complex and

Minerals

P Tablet Uncoated 181/013 Merck Limited, India

3819

Glucophage 1000 Tablets Metformin Hydrochloride

BP 1000mg

POM Tablet Film coated 363/001 Merck Limited, India

3820

Glucophage 850 Tablets Metformin Hydrochloride

BP 850mg

POM Tablet Film coated 363/002 Merck Limited, India

3821

Glucophage 500 Tablets Metformin Hydrochloride

BP 500mg

POM Tablet Film coated 363/003 Merck Limited, India

3822

Ziak 2.5/6.25 Tablets Bisoprolol Fumarate

2.5mg +

Hydrochlorothiazide

6.25mg

POM Tablet Uncoated 363/004 Merck Limited, India

3823

Ziak 5/6.25 Tablets Bisoprolol Fumarate 5mg

+ Hydrochlorothiazide

6.25mg

POM Tablet Uncoated 363/005 Merck Limited, India

3824

Ziak 10/6.25 Tablets Bisoprolol Fumarate

2.5mg +

Hydrochlorothiazide

6.25mg

POM Tablet Uncoated 363/006 Merck Limited, India

3825 Crixivan 400mg Capsules Indinavir 400mg POM Capsule oral 105/002 Merck Sharp and Dohme

3826 Stocrin 200mg Tablets Ritonavir 200mg POM Tablet Uncoated 105/003 Merck Sharp and Dohme

3827 Stocrin 600mg Tablets Ritonavir 600mg POM Tablet Uncoated 105/004 Merck Sharp and Dohme

3828 Stocrin 50mg Tablets Ritonavir 50mg POM Tablet Uncoated 105/005 Merck Sharp and Dohme

3829

Atripla Tablets Efavirenz 600mg +

Emtricitabine 200mg +

Tenofovir 300mg

POM Tablet Uncoated 105/007 Merck Sharpe & Dohme (Pty) Ltd,France

3830

Gardasil Vaccine Human Papillomavirus 9-

valent Vaccine,

Recombinant

POM Suspension for

Injection

105/008 Merck Sharpe & Dohme (Pty) Ltd,France

3831 Isentress Tablets Raltegravir 400mg POM Tablet Film coated 105/009 Merck Sharpe & Dohme (Pty) Ltd,France

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3832

Implanon Implant Etonogestrel 68mg, per

Implant

POM Implant 105/019 Merck Sharpe & Dohme (Pty) Ltd,France

3833

Janumet 50/850 Tablets Sitagliptin 50mg +

Metformin Hydrochloride

850mg

POM Tablet Enteric

Coated

105/020 Merck Sharpe & Dohme (Pty) Ltd,France

3834

Janumet 50/1000 Tablets Sitagliptin 50mg +

Metformin Hdrochloride

1000mg

POM Tablet Enteric

Coated

105/021 Merck Sharpe & Dohme (Pty) Ltd,France

3835 Implanon NXT Implant Etonogestrel 68mg POM Implant 105/022 Merck Sharpe & Dohme (Pty) Ltd,France

3836 Januvia 25mg Tablets Sitagliptin 25mg POM Tablet Film coated 105/023 Merck Sharpe & Dohme (Pty) Ltd,France

3837 Januvia 50mg Tablets Sitagliptin 50mg POM Tablet Film coated 105/024 Merck Sharpe & Dohme (Pty) Ltd,France

3838 Januvia 100mg Tablets Sitagliptin 100mg POM Tablet Film coated 105/025 Merck Sharpe & Dohme (Pty) Ltd,France

3839

Glucovance 500/2.5 film coated

tablets

Metformin hydrochloride

BP 500mg +

Glibenclamide BP 2.5mg

POM Tablet Film coated 363/015 Merck Sharpe & Dohme (Pty) Ltd,France

3840

Rol Cold Tablets Paracetamol 500mg +

Phenylepherine 5mg +

Caffeine 15mg +

Chlorpheniramine 2mg

P Tablet Uncoated 294/001 Merit Organics Limited

3841

Congestyl Tablets Paracetamol 500mg +

Phenylephrine 5mg +

Chlorpheniramine 4mg

P Tablet Uncoated 019/001 Meyer Organics Pvt Ltd, India

3842

Fiberex Powder Ispaghula Husk 3.75 gm,

per 4.8g

GS Powder for Oral

Suspension

019/002 Meyer Organics Pvt Ltd, India

3843

Gericare Capsules Magnesium Hydroxide

40mg + Vitamins +

Minerals)

P Capsule oral 019/003 Meyer Organics Pvt Ltd, India

3844

Kidcare Plus Syrup Multivitamins + Lysine

40mg + Minerals

GS Syrup 019/004 Meyer Organics Pvt Ltd, India

3845

Lactulin liquid Concentrate Lactulose 10g +

Riboflavin 0.6mg

P Solution for Oral

Use

019/005 Meyer Organics Pvt Ltd, India

3846

Mim Capsules Magnesium Hydroxide

72mg + Vitamins +

Minerals

GS Capsule oral 019/006 Meyer Organics Pvt Ltd, India

3847

Mim Organic Tonic Minerals + Multivitamins P Solution for Oral

Use

019/007 Meyer Organics Pvt Ltd, India

3848 Motionil Capsules Loperamide 2mg POM Capsule oral 019/008 Meyer Organics Pvt Ltd, India

3849 Wingora Tablets Sildenafil 50mg POM Tablet Uncoated 019/009 Meyer Organics Pvt Ltd, India

3850 Lomez Capsules Omeprazole 20mg POM Capsule oral 019/010 Meyer Organics Pvt Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3851

Aloesilk Cream Vitamin A 1000IU + Aloe

Vera Extracts

P Cream Topical 019/011 Meyer Organics Pvt Ltd, India

3852

Babygesic Drops Paracetamol 100mg, per

ml

GS Solution for Oral

Use

019/012 Meyer Organics Pvt Ltd, India

3853

Candifem Vaginal Tablets Miconazole 100mg +

Ornidazole 500mg

POM Tablet Vaginal 019/013 Meyer Organics Pvt Ltd, India

3854

Congestyl Syrup Paracetamol 125mg +

Phenylephrine 2.5mg +

Chlorpheniramine 1.5mg

+ Menthol 1mg, per 5ml

P Syrup 019/014 Meyer Organics Pvt Ltd, India

3855 Ugesic Tablets Piroxicam 20mg POM Capsule oral 019/015 Meyer Organics Pvt Ltd, India

3856

Colicaid Drops Simethicone 40mg + Dill

Oil 0.005ml + Fennel Oil

0.0007ml, per ml

P Solution for Oral

Use

019/016 Meyer Organics Pvt Ltd, India

3857

Fevril Suspension Paracetamol 125 mg +

Promethazine 2.5mg, per

5ml

P Suspension for

Oral Use

019/017 Meyer Organics Pvt Ltd, India

3858

Fairyl Cream (Vitamin E 1% + Vitamin

A 1000IU + Zinc oxide

4%), per g

P Cream Topical 019/018 Meyer Organics Pvt Ltd, India

3859

Zedcal Tablets Calcium Carbonate

250mg + Zinc Sulphate

7.5mg + Calciferol

0.25mg

P Tablet Uncoated 019/019 Meyer Organics Pvt Ltd, India

3860 Coldcare Tablets Multivitamins + Minerals GS Tablet Uncoated 019/020 Meyer Organics Pvt Ltd, India

3861

Gastracid liquid Calcium Carbonate

400mg + Magnesium

Hydroxide 120mg +

Magnesium Trisilicate

50mg + Simethicone

83mg

P Suspension for

Oral Use

019/021 Meyer Organics Pvt Ltd, India

3862 Oligocare Capsules Multivitamins GS Capsule oral 019/022 Meyer Organics Pvt Ltd, India

3863 Ovacare Capsules Multivitamins GS Capsule oral 019/023 Meyer Organics Pvt Ltd, India

3864 Ultimale Capsules Herbal Extracts P Capsule oral 019/024 Meyer Organics Pvt Ltd, India

3865

Zithrocare-250 Tablets Azithromycin Dihydrate

250mg

POM Tablet Uncoated 019/025 Meyer Organics PVT LTd, India

3866

Zithrocare-500 Tablets Azithromycin Dihydrate

500mg

POM Tablet Uncoated 019/026 Meyer Organics PVT LTd, India

Page 199 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3867

Uvex- 500 Tablets Levofloxacin

Hemihydrate 500mg

POM Tablet Uncoated 019/027 Meyer Organics PVT LTd, India

3868

Uvex- 750 Tablets Levofloxacin

Hemihydrate 750mg

POM Tablet Uncoated 019/028 Meyer Organics PVT LTd, India

3869

Cofaid Liquid Solution Herbal Extracts POM Solution for Oral

Use

019/HM001 Meyer Organics Pvt Ltd, India

3870

Ornilox Tablets Ornidazole 500mg +

Ofloxacin 200mg

POM Tablet Uncoated 315/001 Micro labs Limited, India

3871

Levobact 750 Tablets Levofloxacin

Hemihydrate 750mg

POM Tablet Uncoated 315/003 Micro labs Limited, India

3872

Clariwin 500 Tablets Clarithromycin USP

500mg

POM Tablet Uncoated 315/004 Micro labs Limited, India

3873

Bactoclave 562.5 Tablets Amoxicillin Trihydrate BP

500mg + Potassium

Clavulanate 62.5mg

POM Tablet Uncoated 315/005 Micro labs Limited, India

3874

Bactoclave 112.5 Dry Syrup Amoxicillin Trihydrate BP

100mg + Potassium

Clavulanate 12.5mg

POM Powder for Oral

Suspension

315/006 Micro labs Limited, India

3875

Bactoclave 1000 Tablets Amoxicillin Trihydrate

875mg + Clavulanate

Potassium 125mg

POM Tablet Film coated 315/007 Micro labs Limited, India

3876 Arbitel 80 Tablets Telmisartan USP 80mg POM Tablet Uncoated 315/008 Micro labs Limited, India

3877

Nebilong Tablets Nebivolol Hydrochloride

5mg

POM Tablet Uncoated 315/009 Micro labs Limited, India

3878

Nebilong - H Tablets Nebivolol Hydrochloride

5mg +

Hydrochlorothiazide

12.5mg

POM Tablet Uncoated 315/010 Micro labs Limited, India

3879

Alendro Tablets Alendronate Sodium USP

70mg

POM Tablet Uncoated 315/011 Micro labs Limited, India

3880

Micropime Injection Cefeprime Hydrochloride

USP 1g

POM Powder for

Injection

315/012 Micro labs Limited, India

3881 Prednisolone Tablets Prednisolone 5mg POM Tablet Uncoated 315/013 Micro labs Limited, India

3882

Cotrimoxazole Tablets Trimethoprim BP 80mg +

Sulphamethoxazole BP

400mg

POM Tablet Uncoated 315/014 Micro labs Limited, India

3883

Nebilong -AM Tablets Nebivolol Hydrochloride

5mg + Amlodipine

Besylate 5mg

POM Tablet Uncoated 315/015 Micro labs Limited, India

Page 200 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3884

Amlozaar Tablets losartan Potassium 50mg

+ Amilodipine Besilate

5mg

POM Tablet Uncoated 315/016 Micro labs Limited, India

3885

Amlozaar -H Tablets losartan Potassium 50mg

+ Amilodipine Besilate

5mg +

Hydrochlorothiazide

12.5mg

POM Tablet Uncoated 315/017 Micro labs Limited, India

3886

Doxycycline Hyclate USP

Tablets

Doxcycline Hyclate USP

100mg

POM Tablet Uncoated 315/018 Micro labs Limited, India

3887

Doxycycline Capsules BP Doxcycline Hyclate BP

100mg

POM Capsule oral 315/019 Micro labs Limited, India

3888

Nugrel A Plus Tablets Clopidogrel Bisulfate

USP 75mg + Aspirin BP

100mg

POM Tablet Film coated 315/020 Micro labs Limited, India

3889 Mebux 80 Tablets Febuxostat 80mg POM Tablet Uncoated 315/021 Micro labs Limited, India

3890 Mebux 40 Tablets Febuxostat 40mg POM Tablet Uncoated 315/022 Micro labs Limited, India

3891

Gramocef-O-100 Dry Syrup Cefixime Trihydrate USP

100mg, per 5ml

POM Powder for Oral

Suspension

315/023 Micro labs Limited, India

3892

Gramocef-O-200 Capsules Cefixime Trihydrate USP

200mg

POM Capsule oral 315/024 Micro labs Limited, India

3893

Dolosip-Z Tablets Paracetamol BP 500mg +

Phenylephrine HCl BP 5

mg + Caffeine BP 25mg

P Tablet Film coated 315/025 Micro labs Limited, India

3894

Clariwin ER Tablets Clarithromycin USP

500mg

POM Tablet Film coated 315/026 Micro labs Limited, India

3895

Arbitel-AV Tablets Telmisartan 40 mg +

Atorvastatin 10mg

Tablets

POM Tablet Uncoated 315/027 Micro labs Limited, India

3896 Arbitel Tablets Telmisartan USP 40mg POM Tablet Uncoated 315/028 Micro labs Limited, India

3897

Ethionamide 250 Tablets Ethionamide USP 250mg POM Tablet Uncoated 315/029 Micro labs Limited, India

3898

Bonair HFA Inhaler Salbutamol 100mcg POM Powder for

Inhalation

297/001 Midas- Care Pharmaceuticals Pvt Limited

3899

X-Cite Spray (Lidocaine USP) Lidocaine Hydrochloride

1.5mg

POM Spray for Topical

Use

279/009 Midas- Care Pharmaceuticals Pvt Limited,

India

3900

Besone 250 HFA Inhaler Beclomethasone

Dipropionate 250mcg

POM Solution for

Inhalation

297/002 Midas- Care Pharmaceuticals Pvt Limited,

India

Page 201 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3901

Mistdress Spray Lidocaine Hydrochloride

1.0%w/w + Cetrimide

1.0%w/w

POM Spray for Topical

Use

297/003 Midas- Care Pharmaceuticals Pvt Limited,

India

3902

Flusal 50 HFA Inhaler Salmeterol Xinafoate

25mcg + Fluticasone

Propionate 50mcg

POM Solution for

Inhalation

297/004 Midas- Care Pharmaceuticals Pvt Limited,

India

3903

Flusal 125 HFA Inhaler Salmeterol Xinafoate

25mcg + Fluticasone

Propionate 125mcg

POM Solution for

Inhalation

297/005 Midas- Care Pharmaceuticals Pvt Limited,

India

3904

Flusal 250 HFA Inhaler Salmeterol Xinafoate

25mcg + Fluticasone

Propionate 250mcg

POM Solution for

Inhalation

297/006 Midas- Care Pharmaceuticals Pvt Limited,

India

3905

Coolex Spray Lidocaine Hydrochloride

3.0%w/v +

Benzethonium Chloride

0.2%w/v

POM Spray for Topical

Use

297/007 Midas- Care Pharmaceuticals Pvt Limited,

India

3906

Vinodine Spray Povidone Iodine 5.0%w/v P Solution for Topical

Use

297/008 Midas- Care Pharmaceuticals Pvt Limited,

India

3907

Relispray -Ayurvedic Pain Relief

Spray

Herbal Preparation GS Spray for Topical

Use

297/010 Midas- Care Pharmaceuticals Pvt Limited,

India

3908

Antim Tablets Pyrimthamine25mg +

Sulfadoxine 500mg

POM Tablet Uncoated 170/001 Mihika Pharmaceuticalds Ltd, India

3909

Effecip-500 Tablets Ciprofloxacin USP

500mg

POM Tablet Uncoated 170/002 Mihika Pharmaceuticalds Ltd, India

3910 Acyclex 200mg Tablets Acyclovir 200mg POM Tablet Uncoated 170/003 Mihika Pharmaceuticalds Ltd, India

3911 Dermiral 200 Tablets Ketoconazole 200mg POM Tablet Uncoated 170/004 Mihika Pharmaceuticalds Ltd, India

3912 Zolmed 150 Tablets Fluconazole 150mg POM Tablet Uncoated 170/005 Mihika Pharmaceuticalds Ltd, India

3913 Actiflam 200 Tablets Ibuprofen BP 200mg P Tablet Uncoated 170/006 Mihika Pharmaceuticalds Ltd, India

3914

Endorm-100 Tablets Mebendazole USP

100mg

P Tablet Uncoated 170/007 Mihika Pharmaceuticalds Ltd, India

3915 Mihizole 200 Tablets Metronidazole 200mg POM Tablet Uncoated 170/008 Mihika Pharmaceuticalds Ltd, India

3916

Cloxasafe 250 Capsules Cloxacillin Sodium BP

250mg

POM Capsule oral 170/009 Mihika Pharmaceuticalds Ltd, India

3917

Novoxi Oral Suspension Amoxicillin 125mg, per

5ml

POM Suspension for

Oral Use

170/010 Mihika Pharmaceuticalds Ltd, India

3918 Ompalen 20mg Capsules Omeprazole 20mg POM Capsule oral 170/012 Mihika Pharmaceuticalds Ltd, India

3919

Spasmorid-10mg Tablets Hyoscine Butylbromide

10mg

P Tablet Film coated 170/013 Mihika Pharmaceuticalds Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3920

Voltika 50 Tablets Diclofenac Sodium 50mg P Tablet Enteric

Coated

170/014 Mihika Pharmaceuticalds Ltd, India

3921 Histergan 25 Tablets Promethazine 25mg P Tablet Film coated 170/016 Mihika Pharmaceuticalds Ltd, India

3922

Mihizole Oral Suspension Metronidazole Benzoate

BP 125mg, per 5ml

POM Suspension for

Oral Use

170/017 Mihika Pharmaceuticalds Ltd, India

3923

Mahitrim Suspension Sulfamethoxazole 200mg

+ Trimethoprim 40mg,

per 5ml

POM Suspension for

Oral Use

170/018 Mihika Pharmaceuticalds Ltd, India

3924

Betrim Tablets Sulfamethoxazole 400mg

+ Trimethoprim 80mg

POM Tablet Uncoated 280/004 Milan Laboratories Pvt Ltd, India

3925 Milzor Tablets Paracetamol 500mg GS Tablet Uncoated 280/005 Milan Laboratories Pvt Ltd, India

3926

ML-Cotri Suspension Sulfamethoxazole 200mg

+ Trimethoprim 40mg,

per 5ml

POM Suspension for

Oral Use

280/006 Milan Laboratories Pvt Ltd, India

3927

ML-Metro Suspension Metronidazole 125mg,

per 5ml

POM Suspension for

Oral Use

280/007 Milan Laboratories Pvt Ltd, India

3928 Streptol Cough lozenges Menthol + Eucalyptus Oil GS Lozenges 280/008 Milan Laboratories Pvt Ltd, India

3929 Milmaleate Tablets Chlorpheniramine 4mg P Tablet Uncoated 280/009 Milan Laboratories Pvt Ltd, India

3930 Furosimide Tablets Furosemide 40mg POM Tablet Uncoated 280/010 Milan Laboratories Pvt Ltd, India

3931 Clonex Cream Clotrimazole 1%w/w POM Cream Topical 280/011 Milan Laboratories Pvt Ltd, India

3932

Miloxy Oral Suspension Amoxicillin 125mg, per

5ml

POM Powder for Oral

Suspension

280/012 Milan Laboratories Pvt Ltd, India

3933

Milpol Syrup Paracetamol 120mg, per

5ml

GS Syrup 280/013 Milan Laboratories Pvt Ltd, India

3934 ML - Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 280/014 Milan Laboratories Pvt Ltd, India

3935

Phenoxymethyl Penicillin Oral

Suspension

Phenoxymethyl Penicillin

Potassium 125mg, per

5ml

POM Powder for Oral

Suspension

280/015 Milan Laboratories Pvt Ltd, India

3936 Diclofenac Sodium Tablets Diclofenac 50mg P Tablet Uncoated 280/016 Milan Laboratories Pvt Ltd, India

3937 Diclofenac Gel Diclofenac 1%w/w P Gel Topical 280/017 Milan Laboratories Pvt Ltd, India

3938

Milclox Capsules Ampicillin 250mg +

Cloxacillin 250mg

POM Capsule oral 280/018 Milan Laboratories Pvt Ltd, India

3939

Phenoxymethyl Penicillin

Potassium Tablets

Phenoxymethyl Penicillin

250mg

POM Tablet Uncoated 280/019 Milan Laboratories Pvt Ltd, India

3940 Heptovit Softgel Capsules Herbal Phytomedicine GS Capsule oral 373/001 Millenium Herbal Care Ltd

3941

Amoxicillin Oral Suspension Amoxiclllin 125mg, per

5ml

POM Suspension for

Oral Use

144/045 Mission Pharma A/S, Denmark

3942 Amoxicillin Capsules Amoxicillin 250mg POM Capsule oral 144/046 Mission Pharma A/S, Denmark

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3943

Oral Rehydration Salts Sodium Chloride 2.6g +

Potassium Chloride 1.5g

+ Sodium Citrate 2.9g +

Anhydrous Glucose

13.5g

GS Powder for Oral

Solution

144/047 Mission Pharma A/S, Denmark

3944

Nystatin Pessaries BP

100,000IU

Nystatin 100,000IU POM Tablet Vaginal 144/048 Mission Pharma A/S, Denmark

3945

Paracetamol Tablets BP 500mg Paracetamol 500mg P Tablet Uncoated 144/049 Mission Pharma A/S, Denmark

3946 Amoxicillin Tablets USP 250mg Amoxicillin 250mg POM Tablet Uncoated 144/050 Mission Pharma A/S, Denmark

3947 Salbutamol Tablets BP 4mg Salbutamol 4mg POM Tablet Uncoated 144/051 Mission Pharma A/S, Denmark

3948 Amoxicillin Tablets USP 250mg Amoxicillin 250mg POM Tablet Uncoated 144/052 Mission Pharma A/S, Denmark

3949

Triclovera Injection Medroxyprogesterone

150mg, per ml (1ml)

POM Solution for

Injection

144/053 Mission Pharma A/S, Denmark

3950 Nystatin Vaginal Inserts Nystatin USP 100,000IU POM Tablet Vaginal 144/055 Mission Pharma A/S, Denmark

3951

Dextrose 50 Injection Dextrose USP 50% POM Solution for

Injection

144/056 Mission Pharma A/S, Denmark

3952

Benzylpenicilline 1M Benzyl penicillin 1MIU POM Powder for

Injection

144/057 Mission Pharma A/S, Denmark

3953

Sterilised Water For Injection Water for Injections 5ml POM Solution for

Injection

144/058 Mission Pharma A/S, Denmark

3954

Sterilised Water For Injection Water for Injections 10ml POM Solution for

Injection

144/059 Mission Pharma A/S, Denmark

3955

Nystatin Oral Suspension Nystatin 100 000 IU POM Suspension for

Oral Use

144/063 Mission Pharma A/S, Denmark

3956 Metronidazole 200 Tablets Metronidazole 200mg POM Tablet Uncoated 144/064 Mission Pharma A/S, Denmark

3957

Salbutamol 4 Tablets Salbutamol Sulfate BP

4mg

POM Tablet Uncoated 144/065 Mission Pharma A/S, Denmark

3958Metronidazole Tablets Metronidazole BP 200mg

POMTablet Film coated

144/066Mission Pharma A/S, Denmark

3959 Male Latex Condoms Male Latex Condoms GS Latex Products 144/066L Mission Pharma A/S, Denmark

3960Chlopheniramine Tablets

Chlopheniramine Maleate

4 mg

PTablet Uncoated

144/067Mission Pharma A/S, Denmark

3961 Male Latex Condoms Male Latex Condoms GS Latex Products 144/067L Mission Pharma A/S, Denmark

3962Quinine 300mg

Quinine Sulphate BP

300mg

POMTablet Film coated

144/068Mission Pharma A/S, Denmark

3963Salbutamol Tablets BP 4 mg

Salbutamol Tablets BP 4

mg

POMTablet Uncoated

144/069Mission Pharma A/S, Denmark

Page 204 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3964Erythromycin Stearate Tablets

Erythromycin Stearate

BP 250 mg

POMTablet Film coated

144/070Mission Pharma A/S, Denmark

3965

Tetracycline Hydrochloride

Ophthalmic Ointment

Tetracycline

Hydrochloride USP 1%

POMOintment topical

144/071Mission Pharma A/S, Denmark

3966

Phenoxymethylpenicillin Tablets

BP

Phenoxymethylpenicillin

BP 250mg

POMTablet Uncoated

144/072Mission Pharma A/S, Denmark

3967

Quinine Sulphate Tablets BP

300mg

Quinine Sulphate BP

300mg

POMTablet Film coated

144/073Mission Pharma A/S, Denmark

3968

Ceftriaxone Powder For

Injection

Ceftriaxone Sodium

250mg

POM Powder for

Injection

144/074Mission Pharma A/S, Denmark

3969Sterilised Water for Injection

Water for Injection POM Solution for

infusion

144/075Mission Pharma A/S, Denmark

3970

Pethidine 50 Injection Pethidine 50mg/ml POM Solution for

Injection

422/001 Mission Pharma A/S, Denmark

3971

Pethidine 100 Injection Pethidine 100mg/ml) POM Solution for

Injection

422/002 Mission Pharma A/S, Denmark

3972

Glycopyrronium Bromide

Injection

Glycopyrronium bromide

200mcg/ml

POM Solution for

Injection

422/003 Mission Pharma A/S, Denmark

3973

Co-trimoxazole Oral Suspension Sulphamethoxazole

200mg + Trimethoprim

40mg

POM Suspension for

Oral Use

144/002 Missionpharma A/S, Denmark

3974

Co-trimoxazole Tablets Sulphamethoxazole

400mg + Trimethoprim

80mg

POM Tablet Uncoated 144/003 Missionpharma A/S, Denmark

3975

Ampicillin Oral Suspension Ampicillin 250mg, per

5ml

POM Powder for Oral

Suspension

144/004 Missionpharma A/S, Denmark

3976

Amoxicillin Oral Suspension Amoxicillin 250mg, per

5ml

POM Powder for Oral

Suspension

144/005 Missionpharma A/S, Denmark

3977 Metronidazole Tablets Metronidazole 250mg POM Tablet Uncoated 144/006 Missionpharma A/S, Denmark

3978 Paracetamol Tablets 1000's Paracetamol 500mg GS Tablet Uncoated 144/007 Missionpharma A/S, Denmark

3979 Ibuprofen Tablets Ibuprofen 200mg P Tablet Uncoated 144/008 Missionpharma A/S, Denmark

3980 Diclofenac Tablets Diclofenac 50mg P Tablet Uncoated 144/009 Missionpharma A/S, Denmark

3981

Sulfadoxine + Pyrimethamine

Tablets

Sulfadoxine 400mg +

Pyrimethamine 25mg

P Tablet Uncoated 144/010 Missionpharma A/S, Denmark

3982

Nystatin Oral Suspension Nystatin 100,000IU POM Suspension for

Oral Use

144/011 Missionpharma A/S, Denmark

3983

Aspirin Tablets Acetyl Salicylic Acid

300mg

P Tablet Uncoated 144/012 Missionpharma A/S, Denmark

3984 Amoxicillin Capsules Amoxicillin 250mg POM Tablet Uncoated 144/013 Missionpharma A/S, Denmark

Page 205 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

3985

Benzathine Benzylpenicillin

Injection 2.4MU

Benzathine

Benzylpenicillin 2.4MU

POM Solution for

Injection

144/014 Missionpharma A/S, Denmark

3986

Benzylpenicillin Injection 1MU Benzyl penicillin 1MU POM Solution for

Injection

144/015 Missionpharma A/S, Denmark

3987

Benzylpenicillin Injection 5MU Benzyl penicillin 5MU POM Solution for

Injection

144/016 Missionpharma A/S, Denmark

3988

Diazepam Injection 5m, per ml Diazepam 5mg, per ml POM Solution for

Injection

144/017 Missionpharma A/S, Denmark

3989

Lidocaine Hydrochloride

Injection

Lidocaine 100mg, per ml POM Solution for

Injection

144/018 Missionpharma A/S, Denmark

3990 Mebendazole 100mg Tablets Mebendazole 100mg P Tablet Uncoated 144/019 Missionpharma A/S, Denmark

3991

Methyllergonovine Injection

0.2mg, per ml

Methylergonovine 0.2mg,

per ml

POM Solution for

Injection

144/020 Missionpharma A/S, Denmark

3992 Nitrofurantoin 50mg Tablets Nitrofurantoin 50mg P Tablet Uncoated 144/021 Missionpharma A/S, Denmark

3993 Paracetamol 500mg Tablets Paracetamol 500mg GS Tablet Uncoated 144/022 Missionpharma A/S, Denmark

3994 Chlorpheniramine 4mg Tablets Chlorpheniramine 4mg P Tablet Uncoated 144/023 Missionpharma A/S, Denmark

3995 Clotrimazole 1% Cream Clotrimazole 1%w/w POM Tablet Uncoated 144/024 Missionpharma A/S, Denmark

3996

Erythromycin Stearate 250mg

Tablets

Erythromycin 250mg POM Tablet Uncoated 144/025 Missionpharma A/S, Denmark

3997 Ferrous Sulphate 50mg Tablets Ferrous Sulphate 50mg P Tablet Uncoated 144/026 Missionpharma A/S, Denmark

3998 Folic Acid 5mg Tablets Folic Acid 5mg P Tablet Uncoated 144/027 Missionpharma A/S, Denmark

3999

Hydrocortisone Acetate

Ointment 1%

Hydrocortisone 1% POM Ointment topical 144/028 Missionpharma A/S, Denmark

4000

Compound Magnesium

Trisilicate Tablets

Dried Aluminium

Hydroxide 120mg +

Magnesium Trisilicate

250mg

GS Tablet Uncoated 144/029 Missionpharma A/S, Denmark

4001 Salbutamol 2mg Tablets Salbutamol 2mg POM Tablet Uncoated 144/030 Missionpharma A/S, Denmark

4002

Procain Penicillin Injection Procain Penicillin 3MU POM Solution for

Injection

144/031 Missionpharma A/S, Denmark

4003 Salbutamol Tablets Salbutamol 4mg POM Tablet Uncoated 144/032 Missionpharma A/S, Denmark

4004

Phenoxymethylpenicillin Tablets Phenoxymethyl Penicillin

V 250mg

POM Tablet Uncoated 144/033 Missionpharma A/S, Denmark

4005

Nystatin Oral Suspension Nystatin 100 IU, per 5ml POM Suspension for

Oral Use

144/034 Missionpharma A/S, Denmark

4006 Doxycycline Tablets Doxycycline 100mg POM Tablet Uncoated 144/035 Missionpharma A/S, Denmark

4007 Multivitamin Tablets Multivitamins GS Tablet Uncoated 144/036 Missionpharma A/S, Denmark

4008

Water for Injections Sterile Water for

Injections 10ml

POM Solution for

Injection

144/037 Missionpharma A/S, Denmark

Page 206 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 4009 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 144/038 Missionpharma A/S, Denmark

4010 Aciclovir Tablets Aciclovir BP 400mg POM Tablet Uncoated 144/039 Missionpharma A/S, Denmark

4011

Benzylpenicillin Injection Benzyl Penicillin Sodium

BP 5MIU

POM Powder for

Injection

144/040 Missionpharma A/S, Denmark

4012

Erythromycin Tablets Erythromycin Stearate

BP 250mg

POM Tablet Uncoated 144/041 Missionpharma A/S, Denmark

4013

Erythromycin Suspension Erythromycin Ethyl

Succinate USP 125mg,

per 5ml

POM Suspension for

Oral Use

144/042 Missionpharma A/S, Denmark

4014 Fluconazole Tablets Fluconazole USP 200mg POM Tablet Uncoated 144/043 Missionpharma A/S, Denmark

4015

Gentamicin Injection Gentamicin BP 40ml, per

2ml

POM Solution for

Injection

144/044 Missionpharma A/S, Denmark

4016 Multivitamin Tablets Multivitamin P Tablet Film coated 144/054 Missionpharma A/S, Denmark

4017 Lofin 500 Tablets Metformin 500mg POM Tablet Uncoated 062/001 MJ Biopharm Pvt Limited

4018

Biosulin N Injection Insulin Isophane 100IU,

per 10ml

POM Solution for

Injection

062/002 MJ Biopharm Pvt Limited

4019

Biosulin R Injection Insulin Soluble 100IU, per

10ml

POM Solution for

Injection

062/003 MJ Biopharm Pvt Limited

4020

Biosulin 30/70 Injection Insulin Solube EP 30% +

Insulin Isophane EP 70%

POM Solution for

Injection

062/004 MJ Biopharm Pvt Limited

4021 Glibex 5 Tablets Glibenclamide 5mg POM Tablet Uncoated 062/005 MJ Biopharm Pvt Limited

4022 Indomethacin 25 Capsules Indomethacin 25mg P Capsule oral 062/006 MJ Biopharm Pvt Limited

4023 Allerdin Syrup Loratadine 5mg P Syrup 310/001 MMC Healthcare Limited, India

4024

Cofsy Syrup Ambroxol BP 15mg +

Salbutamol Sulphate BP

1mg + Guiaphenesin BP

+ 50mg + Menth 1mg

P Syrup 310/002 MMC Healthcare Limited, India

4025 Glimetab -2 Tablets Glimepiride USP 2mg POM Tablet Uncoated 310/003 MMC Healthcare Limited, India

4026 Glimetab -1 Tablets Glimepiride USP 1mg POM Tablet Uncoated 310/004 MMC Healthcare Limited, India

4027

Amlowin -10 Tablets Amlodipine Besylate USP

10mg

POM Tablet Uncoated 310/005 MMC Healthcare Limited, India

4028

Easoril -40 Capsules Esomeprazole

Magnesium USP 40mg

POM Capsule oral 310/006 MMC Healthcare Limited, India

4029 Moringa Miracle Capsules Moringa Oleifera 300mg P Capsule oral 352/001L Moringa Initialtive Limited, Zambia

4030

Atorem 10 Tablets Artovastatin Calcium

10mg

POM Tablet Uncoated 311/001 MSN Laboratories Ltd, India

4031

Atorem 20 Tablets Artovastatin Calcium

20mg

POM Tablet Uncoated 311/002 MSN Laboratories Ltd, India

Page 207 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4032

LDNIL 10 Tablets Rosuvastatin Calcium

10mg

POM Tablet Uncoated 311/003 MSN Laboratories Ltd, India

4033

LDNIL 20 Tablets Rosuvastatin Calcium

20mg

POM Tablet Uncoated 311/004 MSN Laboratories Ltd, India

4034

Breathezy CW 5 Tablets Montelukast Sodium 5mg POM Tablet Uncoated 311/005 MSN Laboratories Ltd, India

4035 Plasep Tablets Clopidogrel 75mg POM Tablet Film coated 311/006 MSN Laboratories Ltd, India

4036

Esem 5 Tablets S-Amlodipine Besylate

5mg

POM Tablet Uncoated 311/007 MSN Laboratories Ltd, India

4037

Esem 2.5mg Tablets S-Amlodipine Besilate

2.5mg

POM Tablet Uncoated 311/008 MSN Laboratories Ltd, India

4038

Safelevo 750 Tablets Levofloxacin

Hemihydrate 750mg

POM Tablet Film coated 311/009 MSN Laboratories Ltd, India

4039 Safetelmi 40 Tablets Telmisartan 40mg POM Tablet Film Coated 311/010 MSN Laboratories Ltd, India

4040 Safetelmi 80 Tablets Telmisartan 80mg POM Tablet Film coated 311/011 MSN Laboratories Ltd, India

4041 Silmet 50 Tablets Sildenafil Citrate 50mg POM Tablet Uncoated 311/012 MSN Laboratories Ltd, India

4042 Silmet 100 Tablets Sildenafil Citrate 100mg POM Tablet Uncoated 311/013 MSN Laboratories Ltd, India

4043

Breatheay 4 Tablets Montelukast Sodium 4mg POM Tablet Uncoated 311/014 MSN Laboratories Ltd, India

4044 Silotrif 8 Capsules Silodosin 8mg POM Capsule oral 311/015 MSN Laboratories Ltd, India

4045 Cosamide 50 Tablets Lacosamide I.H 50mg POM Tablet Uncoated 311/016 MSN Laboratories Ltd, India

4046 Cosamide 100 Tablets Lacosamide I.H 100mg POM Tablet Uncoated 311/017 MSN Laboratories Ltd, India

4047 Cosamide 150 Tablets Lacosamide I.H 150mg POM Tablet Uncoated 311/018 MSN Laboratories Ltd, India

4048 Cosamide 200 Tablets Lacosamide I.H 200mg POM Tablet Uncoated 311/019 MSN Laboratories Ltd, India

4049

Safelevo 500 Tablets Levofloxacin

Hemihydrate 500mg

POM Tablet Uncoated 311/020 MSN Laboratories Ltd, India

4050 Nebiem 2.5 Tablets Nebivolol 2.5mg POM Tablet Uncoated 311/021 MSN Laboratories Ltd, India

4051 Nebiem 5 Tablets Nebivolol 5mg POM Tablet Uncoated 311/022 MSN Laboratories Ltd, India

4052 Nebiem 10 Tablets Nebivolol 10mg POM Tablet Uncoated 311/023 MSN Laboratories Ltd, India

4053 Nebiem 20 Tablets Nebivolol 20mg POM Tablet Uncoated 311/024 MSN Laboratories Ltd, India

4054

ILET B2 Extended Release

Tablets

Glimepiride 2mg +

Metformin Hydrochloride

500mg

POMCaplet Sustained

Release

311/025

MSN Laboratories Ltd, India

4055

ILET B1 Extended Release

Tablets

Glimepiride 1mg +

Metformin Hydrochloride

500mg

POMTablet Extended

Release

311/026

MSN Laboratories Ltd, India

4056Febuday 80 Tablets Febuxostat 80mg

POM Tablet sustained

release

311/027MSN Laboratories Ltd, India

4057 Febuday 40 Tablets Febuxostat 40mg POM Tablet Uncoated 311/028 MSN Laboratories Ltd, India

Page 208 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 4058 Breatheazy 10 Tablets Montelukast 10mg POM Tablet Uncoated 311/029 MSN Laboratories Ltd, India

4059

Ramgic 50 Injection Tramadol hydrochloride

50mg

POM Solution for

Injection

311/031 MSN Laboratories Ltd, India

4060

Lopinavir and Ritonivir Tablets Ritonavir 200mg +

Lopinavir 50mg

POM Tablet Uncoated 014/001 Mylan Laboratories Ltd, India

4061

Tenofivir Disoproxil Fumurate /

Lamivudine Tablets

Tenofovir 300mg +

Lamivudine 300mg

POM Tablet Uncoated 014/002 Mylan Laboratories Ltd, India

4062

Tenofovir Disoproxil Fumurate

Tablets

Tenofovir 300mg POM Tablet Uncoated 014/003 Mylan Laboratories Ltd, India

4063 Abacavir Sulphate Tablets Abacavir 300mg POM Tablet Uncoated 014/004 Mylan Laboratories Ltd, India

4064

Tenofovir Disoproxil Fumurate +

Emtricitabine Tablets

Tenofovir 300mg +

Emtricitabine 200mg

POM Tablet Uncoated 014/005 Mylan Laboratories Ltd, India

4065 Lamivudine Tablets Lamivudine 150mg POM Tablet Uncoated 014/006 Mylan Laboratories Ltd, India

4066 Efavirenz Tablets Efavirenz 600mg POM Tablet Uncoated 014/007 Mylan Laboratories Ltd, India

4067

Lamivudine + Nevirapine +

Zidovudine Tablets

Lamivudine 150mg +

Nevirapine 200mg +

Zidovudine 300mg

POM Tablet Uncoated 014/019 Mylan Laboratories Ltd, India

4068

Lamivudine + Zidovudine

Tablets

Lamivudine 150mg +

Zidovudine 300mg

POM Tablet Uncoated 014/021 Mylan Laboratories Ltd, India

4069 Nevirapine 200mg Tablets Nevirapine 200mg POM Tablet Uncoated 014/022 Mylan Laboratories Ltd, India

4070 Nevirapine 300mg Tablets Nevirapine 300mg POM Tablet Uncoated 014/023 Mylan Laboratories Ltd, India

4071

Tenofovir disoproxil fumerate/

Efavirenz/ Emitricitabine FDC

Tablets

Tenofovir Disoproxil

Fumarate 300mg +

Emtricitabine 200mg +

Efavirenz 600mg

POM Tablet Uncoated 014/024 Mylan Laboratories Ltd, India

4072

Abacavir sulphate/ Lamivudine/

Zidovudine Tablets

Abacavir 60mg +

Lamivudine 30mg +

Zidovudine 60mg

POM Tablet Film coated 014/025 Mylan Laboratories Ltd, India

4073 Abacavir Tablets Abacavir 60mg POM Tablet Film coated 014/026 Mylan Laboratories Ltd, India

4074

Lamivudine/ Zidovudine Tablets Lamivudine 30mg+

Zidovudine 60mg

POM Tablet Film coated 014/027 Mylan Laboratories Ltd, India

4075

Lopinavir/ Ritonavir Tablets Lopinavir 100 + Ritonavir

25mg

POM Tablet Film coated 014/028 Mylan Laboratories Ltd, India

4076

Lamivudine/ Nevirapine/

Zidovudine Tablets

Lamivudine 30mg +

Nevirapine 50mg +

Zidovudine 60mg

POM Tablet Uncoated 014/029 Mylan Laboratories Ltd, India

Page 209 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4077

Tenofovir disoproxil fumarate/

Lamivudine/ Efavirenz Tablets

Tenofovir Disproxil

Fumarate 300mg +

Lamivudine 300mg +

Efavirenz 600mg

POM Tablet Uncoated 014/030 Mylan Laboratories Ltd, India

4078 Efavirenz Tablets Efavirenz 100mg POM Tablet Film coated 014/031 Mylan Laboratories Ltd, India

4079 Efavirenz Tablets Efavirenz 200mg POM Tablet Film coated 014/032 Mylan Laboratories Ltd, India

4080

Abacavir Sulphate/Lamivudine

Tablets

Abacavir 60mg +

Lamivudine 30mg

POM Tablet Film coated 014/033 Mylan Laboratories Ltd, India

4081 Ritonivir Tablets Ritonavir 100mg POM Tablet Film coated 014/034 Mylan Laboratories Ltd, India

4082 Atazanavir Sulphate Tablets Atazanavir 300mg POM Capsule oral 014/035 Mylan Laboratories Ltd, India

4083

Anzavir-R Tablets Atazanavir 300mg +

Ritonivir 100mg

POM Tablet Film coated 014/036 Mylan Laboratories Ltd, India

4084

Oseltamivir Phosphate

Capsules USP

Oseltamivir 30mg POM Capsule oral 014/037 Mylan Laboratories Ltd, India

4085

Oseltamivir Phosphate

Capsules USP

Oseltamivir 45mg POM Capsule oral 014/038 Mylan Laboratories Ltd, India

4086

Oseltamivir Phosphate

Capsules USP

Oseltamivir 75mg POM Capsule oral 014/039 Mylan Laboratories Ltd, India

4087

Komefan 280 Tablet Artemether 40mg +

Lumefantrine 240mg

POM Tablet Uncoated 014/040 Mylan Laboratories Ltd, India

4088

Komefan 140 Tablet Artemether 20mg +

Lumefantrine 120mg

POM Tablet Uncoated 014/041 Mylan Laboratories Ltd, India

4089

Lamivudine 30 + Zidovudine 60

Tablets

Lamivudine 30mg +

Zidovudine 60mg

POM Tablet Film coated 014/042 Mylan Laboratories Ltd, India

4090

Kefloxa 500 Tablets Cefuroxime Axetil USP

500mg

POM Tablet Film coated 014/043 Mylan Laboratories Ltd, India

4091

Kefloxa 250 Tablets Cefuroxime Axetil USP

250mg

POM Tablet Film coated 014/044 Mylan Laboratories Ltd, India

4092

Te4lkast 4 Tablets Montelukast Sodium BP

4mg

POM Tablet Uncoated 014/045 Mylan Laboratories Ltd, India

4093

Te4lkast 5 Tablets Montelukast Sodium BP

5mg

POM Tablet Uncoated 014/046 Mylan Laboratories Ltd, India

4094

Telkast 10 Tablets Montelukast Sodium BP

10mg

POM Tablet Uncoated 014/047 Mylan Laboratories Ltd, India

4095 Zomacid 20 Omeprazole 20mg POM Capsule oral 014/052 Mylan Laboratories Ltd, India

4096 Zomacid 40 Capsules Omeprazole 40mg POM Capsule oral 014/053 Mylan Laboratories Ltd, India

4097

Hertraz 150 Infusion Trastuzumab 150mg POM Solution for

infusion

014/054 Mylan Laboratories Ltd, India

Page 210 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4098

Hertraz 440 Infusion Trastuzumab 440mg POM Solution for

infusion

014/055 Mylan Laboratories Ltd, India

4099

Vancomycin Hydrochloride 500

Injection

Vancomycin

Hydrochloride 500mg

POM Solution for

Injection

014/056 Mylan Laboratories Ltd, India

4100

Avonza Tablets Tenofovir Disoproxil

Fumarate 300mg +

Lamivudine 300mg +

Efavirenz 400mg

POM Tablet Film coated 014/057 Mylan Laboratories Ltd, India

4101

Vaclovir 500 Film Coated

Tablets

Valacyclovir 500mg POM Tablet Uncoated 014/058 Mylan Laboratories Ltd, India

4102 Protionamide Tablets 250mg Protionamide 250mg

POM Tablet Film coated 014/059 Mylan Laboratories Ltd, India

4103

Carboplatin Mylan Injection Carboplatin 10mg, per

ml, 45ml

POM Solution for

Injection

014/060 Mylan Laboratories Ltd, India

4104

Carboplatin Mylan Injection Carboplatin 10mg, per

ml, 15ml

POM Solution for

Injection

014/061 Mylan Laboratories Ltd, India

4105

Azithromycin Injection Azithromycin

Monohydrate USP

500mg

Prescription Only

Medicine

Powder for

Injection

406/001 Mylan Laboratories Ltd, India

4106 Mydekla 60 Tablets Daclatasvir 60mg POM Tablet Film coated 014/061 Mylan Laboratories Ltd, India

4107 Mydekla 30 Tablets Daclatasvir 30mg POM Tablet Film coated 014/062 Mylan Laboratories Ltd, India

4108

Myzomib Injection Bortezomib 3.5mg POM Solution for

Injection

014/063 Mylan Laboratories Ltd, India

4109 Glandin E2 Vaginal Gel Dinoprostone 2mg POM Gel Vaginal 070/001 Nabiqasim Industries Ltd, Pakistan

4110 Glandin E2 Vaginal Tablets Dinoprostone 2mg POM Tablet Vaginal 070/002 Nabiqasim Industries Ltd, Pakistan

4111

Kleen Enama Sodium Biphosphate

19.2g + Sodium

Phosphate 7.2g

POM Solution for

infusion

070/003 Nabiqasim Industries Ltd, Pakistan

4112

Colospas Fibro Sachets Mebeverine

Hydrochloride 135mg +

Ispaghula Husks 3.5mg

GS Granules for Oral

Use

070/004 Nabiqasim Industries Ltd, Pakistan

4113

Detoxicol Syrup Lactulose + Lactose +

Galactose

P Syrup 070/005 Nabiqasim Industries Ltd, Pakistan

4114

Irpo FA Tablets Hydroxide Polymaltose

Complex 0.35mg + Folic

Acid 0.403mg

P Tablet Uncoated 070/006 Nabiqasim Industries Ltd, Pakistan

4115

Acefyl Cough Syrup Acefilline Pipetazine

45mg +

Diphenhydramine 8mg

P Syrup 070/007 Nabiqasim Industries Ltd, Pakistan

Page 211 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4116

Irpo FA Syrup Hydroxide Polymaltose

Complex 50mg + Folic

Acid 0.35mg

P Syrup 070/008 Nabiqasim Industries Ltd, Pakistan

4117

Clarithro Tablets Clarithromycin USP

500mg

POM Tablet Film coated 070/009 Nabiqasim Industries Ltd, Pakistan

4118 Capro 6.25 Tablets Carvedilol BP 6.25mg POM Tablet Uncoated 070/010 Nabiqasim Industries Ltd, Pakistan

4119 Capro 25mg Tablets Carvedilol BP 25mg POM Tablets oral 070/011 Nabiqasim Industries Ltd, Pakistan

4120 Capro 12.5 Tablets Carvedilol BP 12.5mg POM Tablet Uncoated 070/012 Nabiqasim Industries Ltd, Pakistan

4121

Zynq Syrup Zinc Sulphate 20mg, per

5ml

GSL Solution for Oral

Use

070/013 Nabiqasim Industries Ltd, Pakistan

4122

Multical plus Sachets 10's Calcium Pantothenate BP

15mg

P Powder for Oral

Solution

070/014L Nabiqasim Industries Ltd, Pakistan

4123

Multical 1000 Sachets 10's Calcium Lactate

Gluconate BP 1000mg

P Powder for Oral

Suspension

070/015L Nabiqasim Industries Ltd, Pakistan

4124 Cefabact 500 Capsules 20's Cefacroxil 500mg USP POM Capsule oral 070/016 Nabiqasim Industries Ltd, Pakistan

4125

Cefabact 125 /5ml Syrup 60ml Cefadroxil 125mg, per

5ml

POM Suspension for

Oral Use

070/017 Nabiqasim Industries Ltd, Pakistan

4126

Ciprodex Tablets Ciprofloxacin

Hydrochloride 500mg

POM Tablet Film coated 210/001 Nabros Pharma Limited, India

4127 Nifedipine Capsules Nifedipine 20mg POM Capsule oral 210/002 Nabros Pharma Limited, India

4128

Flucoldex Tablets Chlorpheniramine

Maleate 2mg +

Phenylephrine HCl 5mg +

Paracetamol 500mg

P Tablet Uncoated 210/003 Nabros Pharma Limited, India

4129

Carboplatin Injection Carboplatin 150mg, per

15ml

POM Solution for

Injection

086/001MT Naprod Life Sciences Pvt Limited, India

4130

Daunorubicin Hcl Injection Daunorubicin 20mg POM Solution for

Injection

086/002MT Naprod Life Sciences Pvt Limited, India

4131

Doxorubicin Hcl Injection Doxorubicin 50mg POM Powder for

Injection

086/003MT Naprod Life Sciences Pvt Limited, India

4132

Etoposide Injection Etoposide 100mg, per

5ml

POM Powder for

Injection

086/004MT Naprod Life Sciences Pvt Limited, India

4133

Ifosfamide for Injection Ifosfamide 1g POM Powder for

Injection

086/005MT Naprod Life Sciences Pvt Limited, India

4134

Leucovorin Calcium Injection Leucovorin 50mg, per

5ml

POM Solution for

Injection

086/006MT Naprod Life Sciences Pvt Limited, India

4135

Vinorelbine Injection Vinorelbine 5mg, per 5ml POM Solution for

Injection

086/007 Naprod Life Sciences Pvt Limited, India

Page 212 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4136

Dactinomycin for Injection Dactinomycin 0.5mg POM Solution for

Injection

086/008MT Naprod Life Sciences Pvt Limited, India

4137

Capacetabine USP 500mg

TabletsCapacetabine 500mg

POM Tablet Film coated 086/009MT Naprod Life Sciences Pvt Limited, India

4138Fluouracil BP Injection Fluorouracil 500mg

POM Powder for

Injection

086/010MT Naprod Life Sciences Pvt Limited, India

4139Cisplatin BP 50mg/5ml Cisplatin 50mg, per 5ml

POM Solution for

Injection

086/011MT Naprod Life Sciences Pvt Limited, India

4140Dacarbazine for Injection USP Dacarbazine 200mg

POM Solution for

Injection

086/012MT Naprod Life Sciences Pvt Limited, India

4141

Bleomycin for Injection USP

15UnitsBleomycin 15Units

POM Powder for

Injection

086/013 Naprod Life Sciences Pvt Limited, India

4142Necpime- 1G Injection Cefepime 1g

POM Powder for

Injection

306/001 Nectar Lifesciences Limited

4143Nectram- 1G Injection Ceftriaxone 1g

POM Powder for

Injection

306/002 Nectar Lifesciences Limited

4144Cefuaxit Dry Syrup

Cefuroxime Axetil USP

125mg, per 5ml

POM Powder for Oral

Suspension

306/003 Nectar Lifesciences Limited

4145Cefuaxit 250 Tablets

Cefuroxime Axetil USP

250mg

POM Tablet Uncoated 306/004 Nectar Lifesciences Limited

4146

Fixinect 200 Tablets

Cefixime Trihydrate USP

Eq Anhydrous Cefixime

200mg

POM Tablet Uncoated 306/005 Nectar Lifesciences Limited

4147Mycol Injection

Amphotericin B USP

50mg

POM Solution for

Injection

182/001 Neon Antibiotics Pvt Ltd, India

4148

Alpha Lipid Lifeline Powder

Dextrose 42.22%w/w +

Skim Milk Powder

25.59%w/w + Calcium

Phosphate 10.5%w/w +

Colostrum Powder

GS Powder for Oral

Solution

344/001L New Image International Ltd, New zealand

4149 Fluconazole Capsules Fluconazole 200mg POM Jar 226/001 Nibin Pharmaceuticals Ltd, India

4150Sterile Polygeline Solution Polygeline 25g

POM Solution for

infusion

103/001 Nicholas Piramal India Limited

4151Halothane Calibrated Solution Halothane 250mg

POM Solution for

Inhalation

103/002 Nicholas Piramal India Limited

4152Metronidazole Injection

Metronidazole 500mg,

per 100ml

POM Solution for

Injection

103/003 Nicholas Piramal India Limited

4153Ciprofloxacin Injection

Ciprofloxacin 200mg, per

100ml

POM Solution for

Injection

103/004 Nicholas Piramal India Limited

Page 213 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4154Glucose IV Infusion 500ml Dextrose 5%

POM Solution for

infusion

036/001 Nirlife Healthcare (Former Core Healthcare

Ltd), India

4155Glucose IV Infusion 1000ml Dextrose 5%

POM Solution for

infusion

036/002 Nirlife Healthcare (Former Core Healthcare

Ltd), India

4156Glucose IV Infusion 10D 1000ml Dextrose 10%

POM Solution for

infusion

036/003 Nirlife Healthcare (Former Core Healthcare

Ltd), India

4157Glucose IV Infusion 10D 500ml Dextrose 10%

POM Solution for

infusion

036/004 Nirlife Healthcare (Former Core Healthcare

Ltd), India

4158

Sodium Chloride & Glucose

DNS 500ml

Dextrose 5% + Sodium

Chloride 0.9%

POM Solution for

infusion

036/005 Nirlife Healthcare (Former Core Healthcare

Ltd), India

4159

Sodium Chloride & Glucose

DNS 1000ml

Dextrose 5% + Sodium

Chloride 0.9%

POM Solution for

infusion

036/006 Nirlife Healthcare (Former Core Healthcare

Ltd), India

4160Sodium Chloride Infusion 500ml Sodium Chloride 0.9%

POM Solution for

infusion

036/007 Nirlife Healthcare (Former Core Healthcare

Ltd), India

4161

Sodium Chloride Infusion

1000mlSodium Chloride 0.9%

POM Solution for

infusion

036/008 Nirlife Healthcare (Former Core Healthcare

Ltd), India

4162Ciprofloxacin Injection Ciprofloxacin 0.2%

POM Solution for

infusion

036/009 Nirlife Healthcare (Former Core Healthcare

Ltd), India

4163Water For Injection 5ml Water For Inj. USP

POM Solution for

infusion

036/010 Nirlife Healthcare (Former Core Healthcare

Ltd), India

4164Water For Injection 10ml Water For Inj. USP

POM Solution for

infusion

036/011 Nirlife Healthcare (Former Core Healthcare

Ltd), India

4165Mannitol IV Infusion 100ml Mannitol 20%

POM Solution for

infusion

036/012 Nirlife Healthcare (Former Core Healthcare

Ltd), India

4166Mannitol IV Infusion 250ml Mannitol 20%

POM Solution for

Injection

036/013 Nirlife Healthcare (Former Core Healthcare

Ltd), India

4167

Compound Sodium Lactate

500ml

Sodium Chloride 6.0g,

per L+ Sodium Lactate

3.20g, per L + Potassium

Chloride 0.40g, per L +

Calcium Chloride 0.27g,

per L

POM Solution for

Injection

036/014 Nirlife Healthcare (Former Core Healthcare

Ltd), India

4168

Compound Sodium Lactate

1000ml

Sodium Chloride 6.0g,

per L + Sodium Lactate

3.20g, per L+ Potassium

Chloride 0.4g, per L +

Calcium Chloride 0.27g,

per L

POM Solution for

Injection

036/015 Nirlife Healthcare (Former Core Healthcare

Ltd), India

Page 214 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4169Metronidazole Injection Metronidazole 200mg

POM Solution for

Injection

036/016 Nirlife Healthcare (Former Core Healthcare

Ltd), India

4170Benzylpenicillin Injection 5MU

Benzyl Penicillin 5Mega

I.U.

POM Powder for

Injection

033/001 North China Pharmaceutical Group

International Corporation,

4171Benzylpenicillin Injection 1MU

Benzyl Penicillin 1Mega

I.U

POM Powder for

Injection

033/002 North China Pharmaceutical Group

International Corporation,

4172Amoxicillin Capsules

Amoxicillin Trihydrate

250mg

POM Capsule oral 033/003 North China Pharmaceutical Group

International Corporation,

4173Paracetamol Tablets Paracetamol 500mg

GS Tablet Uncoated 033/004 North China Pharmaceutical Group

International Corporation,

4174

Co-trimoxazole Tablets

Sulphamethoxazole

400mg + Trimethoprim

80mg

POM Tablet Uncoated 033/005 North China Pharmaceutical Group

International Corporation,

4175Prednisolone Tablets Prednisolone 5mg

POM Tablet Uncoated 033/006 North China Pharmaceutical Group

International Corporation,

4176Captotril Tablets Captopril 25mg

POM Tablet Uncoated 033/007 North China Pharmaceutical Group

International Corporation,

4177Carbocisteine Syrup

Carbocisteine 250mg, per

5ml

POM Syrup 033/008 North China Pharmaceutical Group

International Corporation,

4178NCPC Carbocisterine Syrup

Carbocisteine 100mg, per

5ml

POM Syrup 033/009 North China Pharmaceutical Group

International Corporation,

4179

Multi-Cal-Vita

Calciumgluconate 100mg

+ Calcium 60mg +

Hydrogen 20mg

Phosphate 100mg+

Calcium Glycero 30mg

P Tablet Uncoated 033/010 North China Pharmaceutical Group

International Corporation,

4180Ibuprofen Tablets Ibuprofen 200mg

P Tablet Uncoated 033/011 North China Pharmaceutical Group

International Corporation,

4181Ceftriaxone Injection Ceftriaxone 1g

POM Powder for

Injection

033/012 North China Pharmaceutical Group

International Corporation,

4182Diclofenac Tablets Diclofenac 50mg

P Tablet Uncoated 033/013 North China Pharmaceutical Group

International Corporation,

4183Diclofenac Injection Diclofenac 75mg, per 3ml

POM Solution for

Injection

033/014 North China Pharmaceutical Group

International Corporation,

4184Streptomycin Injection Streptomycin 1g

POM Powder for

Injection

033/015 North China Pharmaceutical Group

International Corporation,

4185Tetracycline Capsules Tetracycline 250mg

POM Capsule oral 033/016 North China Pharmaceutical Group

International Corporation,

Page 215 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4186Vitamin C Tablets Ascorbic Acid 250mg

GS Tablet Uncoated 033/017 North China Pharmaceutical Group

International Corporation,

4187Gentamicin Injection

Gentamicin 80mg, per

2ml

POM Solution for

Injection

033/018 North China Pharmaceutical Group

International Corporation,

4188Chlorpheniramine Tablets Chlorpheniramine 4mg

P Tablet Uncoated 033/019 North China Pharmaceutical Group

International Corporation,

4189Metronidazole Tablets Metronidazole 250mg

POM Tablet Uncoated 033/020 North China Pharmaceutical Group

International Corporation,

4190Ibupamol Capsules

Paracetamol 200mg +

Ibuprofen 325mg

P Capsule oral 033/021 North China Pharmaceutical Group

International Corporation,

4191Cefalexin For Oral Suspension Cefalexin 125mg, per 5ml

POM Powder for Oral

Suspension

033/022 North China Pharmaceutical Group

International Corporation,

4192Cephalexin BP 500mg Capsules Cephalexin 500mg

POM Capsule oral 033/023 North China Pharmaceutical Group

International Corporation,

4193

Cefuroxime Axetil For Oral

Suspension

Cefuroxime 125mg, per

5ml

POM Powder for Oral

Suspension

033/024 North China Pharmaceutical Group

International Corporation,

4194

Cefuroxime Axetil 250mg

TabletsCefuroxime 250mg

POM Tablet Uncoated 033/025 North China Pharmaceutical Group

International Corporation,

4195

Benzathine Benzlypenicillin For

Injection

Benzathine

Benzlypenicillin 2.4Mega

POM Powder for

Injection

033/026 North China Pharmaceutical Group

International Corporation,

4196Aminophylline 250mg Injection

Aminophylline 250mg,

per 10ml

POM Solution for

Injection

033/027 North China Pharmaceutical Group

International Corporation,

4197Fluconazole Injection Fluconazole 2mg, per ml

POM Solution for

Injection

033/029 North China Pharmaceutical Group

International Corporation,

4198Salbutamol Tablets Sabultamol 2mg

POM Tablet Uncoated 033/030 North China Pharmaceutical Group

International Corporation,

4199Chloramphenicol Capsules Chloramphehicol 250mg

POM Capsule oral 033/031 North China Pharmaceutical Group

International Corporation,

4200Furosemide Injection BP

Furosemide 20mg, per

2ml

POM Solution for

Injection

033/032 North China Pharmaceutical Group

International Corporation,

4201

Cefotaxime Sodium BP 1gram

InjectionCefotaxime 1gram

POM Powder for

Injection

033/033 North China Pharmaceutical Group

International Corporation,

4202

Hyocine Butylbromide 20mg BP

Injection

Hyocine Butylbromide

20mg

POM Solution for

Injection

033/034 North China Pharmaceutical Group

International Corporation,

4203

Kanamycin Sulphate Injection

BPKanamycin 1.0g

POM Powder for

Injection

033/035 North China Pharmaceutical Group

International Corporation,

4204

Carbamezapine Tablets 200mg

BPCarbamezapine 200mg

POM Tablet Uncoated 033/036 North China Pharmaceutical Group

International Corporation,

Page 216 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4205Trihexyphenidyl Tablets BP 5mg Trihexyphenidyl 5mg

POM Tablet Uncoated 033/037 North China Pharmaceutical Group

International Corporation,

4206Methyldopa Tablets BP 250mg Methyldopa 250mg

POM Tablet Uncoated 033/038 North China Pharmaceutical Group

International Corporation,

4207

Sterile Water for Injection BP

10mls

Sterile Water for

Injections

POM Solution for

infusion

033/039 North China Pharmaceutical Group

International Corporation,

4208Vitamin B Complex Injection Vitamin B

POM Solution for

Injection

033/040 North China Pharmaceutical Group

International Corporation,

4209Aciclovir Tablets Aciclovir 400mg

POM Tablet Uncoated 033/041 North China Pharmaceutical Group

International Corporation,

4210

Hydrocortisone Sodium

Succinate for InjectionHydrocortisone 100mg

POM Powder for

Injection

033/042 North China Pharmaceutical Group

International Corporation,

4211Magnesium Sulphate Injection

Magnesium Sulphate

500mg, per ml

POM Solution for

Injection

033/043 North China Pharmaceutical Group

International Corporation,

4212Amoxicillin Oral Suspension

Amoxicilin Trihydrate

125mg, per 5ml

POM Suspension for

Oral Use

033/044 North China Pharmaceutical Group

International Corporation,

4213

Chloramphenical Powder for

Oral Suspension

Chloramphenicol

Palmitate 125mg/5ml

POM Powder for Oral

Suspension

033/045 North China Pharmaceutical Group

International Corporation,

4214

Phenoxymethylpenicillin Powder

For Oral Suspension 125mg/5ml

Phenoxymethyl Penicillin

Potassium 125mg, per

5ml

POM Powder for Oral

Suspension

033/046 North China Pharmaceutical Group

International Corporation,

4215Aminophylline Tablets Aminophylline 100mg

POM Tablet Uncoated 033/047 North China Pharmaceutical Group

International Corporation,

4216Aspirin Tablets Aspirin 300mg

P Tablet Uncoated 033/048 North China Pharmaceutical Group

International Corporation,

4217Ciprofloxacin Tablets

Ciprofloxacin

Hydrochloride 500mg

POM Tablet Uncoated 033/049 North China Pharmaceutical Group

International Corporation,

4218Pyridoxine Tablets

Pyridoxine Hydrochloride

50mg

POM Tablet Uncoated 033/050 North China Pharmaceutical Group

International Corporation,

4219Phenoxymethylpenicillin Tablets

Phenoxymethyl Penicillin

Potassium 250mg

POM Tablet Uncoated 033/051 North China Pharmaceutical Group

International Corporation,

4220Ranitidine tablets Ranitidine 150mg

POM Tablet Uncoated 033/052 North China Pharmaceutical Group

International Corporation,

4221Water for injection Water for Injection

POM Solution for

Injection

033/053 North China Pharmaceutical Group

International Corporation,

4222

Fortified Procaine Penicillin

injectionProcaine Penicillin 4MU

POM Powder for

Injection

033/054 North China Pharmaceutical Group

International Corporation,

Page 217 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4223

Co-trimoxazole Oral Suspension

Sulfamethoxazole 200mg

+ Trimethoprim 40mg ,

per 5ml

POM Suspension for

Oral Use

033/055 North China Pharmaceutical Group

International Corporation,

4224

Vitamin B Complex Tablets

Vitamin B1+ Vitamin B2 +

Vitamin B6 +

Nicotinamide 5 + Calcium

D-Pantothenate BP +

Vitamin B 12 + Folic Acid

BP

P Tablet Uncoated 033/056 North China Pharmaceutical Group

International Corporation,

4225Oxytocin 10IU Injection Oxytocin 10 IU

POM Solution for

Injection

033/057 North China Pharmaceutical Group

International Corporation,

4226Chloramphenicol Eye Drops Chloramphehicol 1%

POM Eye Drops 033/058 North China Pharmaceutical Group

International Corporation,

4227Cloxacillin Capsules Cloxacillin 250mg

POM Capsule oral 033/059 North China Pharmaceutical Group

International Corporation,

4228Diclofenac Tablets

Diclofenac Sodium

100mg

P Tablet Uncoated 033/060 North China Pharmaceutical Group

International Corporation,

4229Indomethacin Capsule Indomethacin 25mg

P Capsule oral 033/061 North China Pharmaceutical Group

International Corporation,

4230Nystatin Oral Suspension

Nystatin 100,000IU, per

ml

POM Suspension for

Oral Use

033/062 North China Pharmaceutical Group

International Corporation,

4231Piroxicam Capsules Piroxicam 20mg

P Capsule oral 033/063 North China Pharmaceutical Group

International Corporation,

4232

Actifed Expectorant Syrup

Triprolidine 1.25mg+

Pseudoephedrine 30mg

+ Guaiphenesin 100mg

P Syrup 025/002 Norvatis Consumer Health International,

Switzerland

4233

Antigesic Tablets

Paracetamol +

Propylptenazone +

Caffeine

P Tablet Uncoated 025/005 Norvatis Consumer Health International,

Switzerland

4234

Linctifed Expectorant Forte

Syrup

Tripolidine +

Pseudoephedrine +

Guaiphenisin + Codeine

P Syrup 025/015 Norvatis Consumer Health International,

Switzerland

4235Calpol Suspension

Paracetamol 120mg, per

5ml

GS Suspension for

Oral Use

025/018 Norvatis Consumer Health International,

Switzerland

4236Sudafed Syrup

Pseudoephedrine 30mg,

per 5ml

P Syrup 025/031 Norvatis Consumer Health International,

Switzerland

4237

Sudagesic Tablets

Triprolidine +

Pseudoephedrine +

Paracetamol

P Tablet Uncoated 025/033 Norvatis Consumer Health International,

Switzerland

Page 218 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4238Galvus Met 50 Tablets Vildagliptin 50mg

POM Tablet Film coated 121/041 Norvatis Consumer Health International,

Switzerland

4239Coartem 80/480 Tablet

Artemether 80mg +

Lumefantrine 480mg

POM Tablet Uncoated 121/047 Norvatis Consumer Health International,

Switzerland

4240Otrivin Gel Xylometazoline 1%w/w

P Gel Topical 242/001 Norvatis Consumer Health International,

Switzerland

4241Fenistil Drops

Dimethendene 1mg, per

ml

P Syrup 242/002 Norvatis Consumer Health International,

Switzerland

4242Slow Iron & Folic Acid Tablets

Ferrous Sulphate 160mg

+ Folic Acid 0.4mg

P Tablet Film coated 242/005 Norvatis Consumer Health International,

Switzerland

4243

Pulmex Baby Ointment

Rosemary Oil 5% +

Eucalyptus Oil 5% +

Synthetic Perivian

Balisam 6%

P Ointment topical 242/007 Norvatis Consumer Health International,

Switzerland

4244Travegyl Ampoules Clemastine 1.0mg, per ml

POM Solution for

Injection

242/009 Norvatis Consumer Health International,

Switzerland

4245Travegyl Syrup Clemastine 0.1mg, per ml

POM Syrup 242/010 Norvatis Consumer Health International,

Switzerland

4246Travegyl 1mg Syrup Clemastine 1mg

POM Syrup 242/011 Norvatis Consumer Health International,

Switzerland

4247Voltaren Emulgel Diclofenac 1%

P Gel Topical 242/015 Norvatis Consumer Health International,

Switzerland

4248Calcium Sandoz Tablets Calcium 500mg

P Tablet Uncoated 242/016 Norvatis Consumer Health International,

Switzerland

4249

Calcium Sandoz + Vitamin C

Tablets

Calcium 260mg +

Ascorbic Acid 1000mg

P Tablet Uncoated 242/017 Norvatis Consumer Health International,

Switzerland

4250

Co-Diovan Tablets

Valsartan 160mg +

Hydrochlorothiazide

25mg

POM Tablet Film coated 242/018 Norvatis Consumer Health International,

Switzerland

4251

Galvus Met 50/500 Tablets Vildagliptin 50mg +

Metformin Ph. Eur.

500mg

POM Tablet Film coated 242/021 Norvatis Consumer Health International,

Switzerland

4252

Galvus Met 50/500 Tablets Vildagliptin 50mg +

Metformin Ph. Eur.

850mg

POM Tablet Film coated 242/022 Norvatis Consumer Health International,

Switzerland

4253

Galvus Met 50/1000 Tablets Vildagliptin 50mg +

Metformin Ph. Eur.

1000mg

POM Tablet Film coated 242/023 Norvatis Consumer Health International,

Switzerland

4254 Voltaren 75mg Tablets Diclofenac 75mg p Tablet Uncoated 0359/05 Novartis Pharma Services Inc, Kenya

Page 219 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4255Exforge Tablets

Valsartan 160mg +

Amlodpine 5mg

POM Tablet Film coated 120/041 Novartis Pharma Services Inc, Kenya

4256Exforge Tablets

Valsartan 80mg +

Amlodipine 5mg

POM Tablet Film coated 120/042 Novartis Pharma Services Inc, Kenya

4257Exforge Tablets

Valsartan 160mg +

Amlodipine 10mg

POM Tablet Film coated 120/043 Novartis Pharma Services Inc, Kenya

4258Sebivo Tablets Telbivudine 600mg

POM Tablet Film coated 120/045 Novartis Pharma Services Inc, Kenya

4259 Sirdakud Tablets Tizinidine 4mg POM Tablet Uncoated 120/046 Novartis Pharma Services Inc, Kenya

4260Coartem Tablets

Artemether 20mg +

Lumefantrine 120mg

POM Tablet Uncoated 121/001 Novartis Pharma Services Inc, Kenya

4261 Voltaren D 50mg Tablets Diclofenac 50mg P Tablet Uncoated 121/002 Novartis Pharma Services Inc, Kenya

4262 Cataflam Drops Diclofenac 15mg, per ml P Oral drops 121/003 Novartis Pharma Services Inc, Kenya

4263 Elidel Cream Pimecrolimus 1%w/w POM Cream Topical 121/004 Novartis Pharma Services Inc, Kenya

4264 Voltaren SR 75mg Tablets Diclofenac 75mg P Tablet Uncoated 121/005 Novartis Pharma Services Inc, Kenya

4265 Lescol XL Tablets Fluvastatin 80mg POM Tablet Uncoated 121/006 Novartis Pharma Services Inc, Kenya

4266

Co-Diovan 80/12.5mg Tablets

Hydrochlorothiazide

12.5mg + Valsartan

80mg

POM Tablet Uncoated 121/007 Novartis Pharma Services Inc, Kenya

4267 Cataflam 50mg Tablets Diclofenac 50mg P Tablet Film coated 121/008 Novartis Pharma Services Inc, Kenya

4268 Lamisil Tablets Terbinafine 250mg POM Tablet Uncoated 121/009 Novartis Pharma Services Inc, Kenya

4269 Tegretol Syrup Carbamazepine 2%w/w POM Syrup 121/010 Novartis Pharma Services Inc, Kenya

4270 Tofranil Tablets Imipramine 25mg POM Tablet Uncoated 121/011 Novartis Pharma Services Inc, Kenya

4271 Voltaren 50 Suppositories Diclofenac 50mg P Suppository 121/012 Novartis Pharma Services Inc, Kenya

4272 Voltaren 100 Suppositories Diclofenac 100mg P Suppository 121/013 Novartis Pharma Services Inc, Kenya

4273Voltaren Injection Diclofenac 75mg, per 3ml

POM Solution for

Injection

121/014 Novartis Pharma Services Inc, Kenya

4274 Anafranil Tablets Clomipramine 25mg POM Tablet Uncoated 121/015 Novartis Pharma Services Inc, Kenya

4275 Diovan 80mg Tablets Valsartan 80mg POM Tablet Uncoated 121/016 Novartis Pharma Services Inc, Kenya

4276 Diovan 160mg Tablets Valsartan 160mg POM Tablet Uncoated 121/017 Novartis Pharma Services Inc, Kenya

4277

Co-Diovan 160/12.5mg Tablets

Hydrochlorothiazide

12.5mg + Valsartan

160mg

POM Tablet Uncoated 121/018 Novartis Pharma Services Inc, Kenya

4278 Voltfast 50mg Tablets Diclofenac 50mg P Tablet Uncoated 121/019 Novartis Pharma Services Inc, Kenya

4279 Voltaren 12.5 Suppositories Diclofenac 12.5mg P Suppository 121/020 Novartis Pharma Services Inc, Kenya

4280 Tegretol CR Tablets Carbamazepine 400mg POM Tablet Uncoated 121/021 Novartis Pharma Services Inc, Kenya

4281 Tegretol Tablets Carbamazepine 200mg POM Tablet Uncoated 121/022 Novartis Pharma Services Inc, Kenya

4282Slow K Tablets

Potassium Chloride

600mg

POM Tablet Film coated 121/023 Novartis Pharma Services Inc, Kenya

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4283

Sandomigran Coated Tablet

0.5mgPizotifen Malate 0.5mg

POM Tablet film coated 121/025 Novartis Pharma Services Inc, Kenya

4284Viskaldix Tablet 5/10mg

Pindolol 10 Mg +

Clopamide 5mg

POM Tablet uncoated 121/026 Novartis Pharma Services Inc, Kenya

4285Zaditen Tablet 1mg

Ketotifen Hydrogen

Fumarate 1mg

POM Tablet uncoated 121/028 Novartis Pharma Services Inc, Kenya

4286Zaditen Syrup 1mg/5ml

Ketotifen Hydrogen

Fumarate 1 Mg, per 5ml

POM Syrup 121/029 Novartis Pharma Services Inc, Kenya

4287

Syntocinon Solution For

Injection 5IU/mlOxtocin 5IU

POM Solution for

Injection

121/031 Novartis Pharma Services Inc, Kenya

4288 Parlodel Tablet 2.5mg Bromocriptine 2.5mg POM Tablet uncoated 121/032 Novartis Pharma Services Inc, Kenya

4289

Syntocinon Solution For

Injection 10IU/mlOxtocin 10IU

POM Solution for

Injection

121/035 Novartis Pharma Services Inc, Kenya

4290Coartem Dispersible Tablets

Artemether 20mg +

Lumefantrine 120mg

POM Tablet Dispersible 121/036 Novartis Pharma Services Inc, Kenya

4291

Co-Diovan 320/12.5mg Tablets

Hydrochlorothiazide

12.5mg + Valsartan

320mg

POM Tablet Uncoated 121/037 Novartis Pharma Services Inc, Kenya

4292 Rasilez 150mg Tablets Aliskren 150mg POM Tablet Film coated 121/038 Novartis Pharma Services Inc, Kenya

4293 Rasilez 300mg Tablets Aliskiren 300mg POM Tablet Film coated 121/039 Novartis Pharma Services Inc, Kenya

4294 Flotac Capsules Diclofenac 75mg P Capsule oral 121/040 Novartis Pharma Services Inc, Kenya

4295

Voltaren Modified Release

Tablet 100mg

Diclofenac Sodium

100mg

P modified release

tablet

121/044 Novartis Pharma Services Inc, Kenya

4296Sirdalud 4 Tablets

Tizanidine Hydrochloride

4mg

POM Tablet Film coated 121/046 Novartis Pharma Services Inc, Kenya

4297Insulin Actrapid HM Injection Insulin 100 IU, per ml

POM Suspension for

Injection

040/009 Novo Nordisk (Pty) Ltd, South Africa

4298Insulin Actrapid Penfil Injection Insulin 100 IU, per ml

POM Suspension for

Injection

040/010 Novo Nordisk (Pty) Ltd, South Africa

4299Insulin Protaphane Injection Insulin 100 IU, per ml

POM Suspension for

Injection

040/011 Novo Nordisk (Pty) Ltd, South Africa

4300

Insulin Protaphane HM Penfil

InjectionInsulin 100 IU, per ml

POM Suspension for

Injection

040/012 Novo Nordisk (Pty) Ltd, South Africa

4301Insulin Actraphane HM injection Insulin 100 IU, per ml

POM Suspension for

Injection

040/013 Novo Nordisk (Pty) Ltd, South Africa

4302Insulin Actraphane HM Penfil Insulin 100 IU, per ml

POM Suspension for

Injection

040/014 Novo Nordisk (Pty) Ltd, South Africa

4303Insulin Monotard HM Injection Insulin Zinc 40IU, per ml

POM Suspension for

Injection

040/015 Novo Nordisk (Pty) Ltd, South Africa

Page 221 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4304Novo Rapid Injection

Insulin Aspart 100IU, per

ml

POM Solution for

Injection

040/016 Novo Nordisk (Pty) Ltd, South Africa

4305Levemir Injection

Insulin Detemir 100IU,

per ml

POM Solution for

Injection

040/017 Novo Nordisk (Pty) Ltd, South Africa

4306

Novo Mix 30 Injection

30% Soluble Insulin

Aspart And 70% Insulin

Aspart Crystallised with

Protamine

POM Solution for

Injection

040/018 Novo Nordisk (Pty) Ltd, South Africa

4307Cotrix 480 Tablet Cotrimoxazole BP 480mg

POM Tablets 390/001 NRB Pharma Zambia Limited

4308 Pyridox 25 Tablets Pyridoxine 25mg POM Tablets 390/002 NRB Pharma Zambia Limited

4309 Ison 100 Tablets Isoniazid 100mg POM Tablets 390/003 NRB Pharma Zambia Limited

4310 Ison 300 Tablets Isoniazid 300mg POM Tablets 390/004 NRB Pharma Zambia Limited

4311 Trim 200 Tablets Trimethoprim 200mg POM Tablets 390/005 NRB Pharma Zambia Limited

4312 Azibact 250 Tablets Azithromycin 250mg POM Tablets 390/006 NRB Pharma Zambia Limited

4313 Clomcet 50 Tablets Clomiphene 50mg POM Tablets 390/007 NRB Pharma Zambia Limited

4314 Quinin 300 Tablet Quinine Sulphate 300mg POM Tablets 390/008 NRB Pharma Zambia Limited

4315 Metro 200 Tablets Metronidazole 200mg POM Tablets 390/009 NRB Pharma Zambia Limited

4316Eryfast 250 Tablets

Erythromycin Stearate

BP 250mg

POM Tablet oral 390/010 NRB Pharma Zambia Limited

4317

MAGTRI-AL Chewable Tablets

Magnesium Trisilicate BP

250 mg + Dried

Aluminium Hydroxide BP

120mg

P Tablet Chewable 390/011 NRB Pharma Zambia Limited

4318CHORPHEN 4 Tablets

Chlorpheniramine

Maleate BP 4mg

P Tablet Uncoated 390/012 NRB Pharma Zambia Limited

4319 SALMOL 4 Tablets Salbutamol BP 4mg POM Tablet Uncoated 390/013 NRB Pharma Zambia Limited

4320

Viprox® Powder

GSH COMPLEX®:

Whey Protein Isolate +

Triozyme®: Sprouted

P Powder for Oral

Solution

377/001L Nutraxis International

4321Nutrilite Sachets Multivitamins + Minerals

P Granules for Oral

Suspension

375/001L Nutrilite Access Business Group

4322 Acfree Gel Adapalene 0.1%w/w P Gel Topical 287/001 Ochoa Laboratories Ltd, India

4323 Ultican 50 Tablets Fluconazole 50mg POM Tablet Uncoated 287/002 Ochoa Laboratories Ltd, India

4324 Ultican 150 Tablets Fluconazole 150mg POM Tablet Uncoated 287/003 Ochoa Laboratories Ltd, India

4325 Ultican 200 Tablets Fluconazole 200mg POM Tablet Uncoated 287/004 Ochoa Laboratories Ltd, India

4326Terbofin Cream

Terbinafine

Hydrochloride 1%w/w

POM Cream Topical 287/005 Ochoa Laboratories Ltd, India

Page 222 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4327Terbofin Tablets

Terbinafine

Hydrochloride 250mg

POM Tablet Uncoated 287/006 Ochoa Laboratories Ltd, India

4328

Exevate G Cream

Betamethasone

Dipropionate BP 0.05% +

Gentamycin Sulphate

0.1%

POM Cream Topical 287/007 Ochoa Laboratories Ltd, India

4329

Xtraderm Cream

Betamethasone 0.05% +

Gentamycin sulphate

0.1%+ Clotrimazole 1.0%

POM Cream Topical 287/008 Ochoa Laboratories Ltd, India

4330 Topibact Ointment Mupirocin 2% POM Ointment topical 287/009 Ochoa Laboratories Ltd, India

4331Doloact Injection

Diclofenac Sodium 25mg,

per ml

POM Solution for

Injection

287/011 Ochoa Laboratories Ltd, India

4332Bivir 300/150mg Tablets

Lamivudine 150mg +

Zidovudine 300mg

POM Tablet Film coated 141/001 Okasa Pharma Limited, India

4333

Maxivir 30 Tablets

Lamivudine 150mg +

Nevirapine 200mg +

Stavudine 30mg

POM Tablet Uncoated 141/002 Okasa Pharma Limited, India

4334

Maxivir 40 Tablets

Lamivudine 150 +

Nevirapine 200mg +

Stavudine 40mg

POM Tablet Uncoated 141/003 Okasa Pharma Limited, India

4335Okavir Oral Solution

Lamivudine 50mg, per

5ml

POM Solution for Oral

Use

141/005 Okasa Pharma Limited, India

4336 Okamune Tablets Nevirapine 200mg POM Tablet Uncoated 141/006 Okasa Pharma Limited, India

4337Oka-Ceftriaxone Injection Ceftriaxone 1g

POM Powder for

Injection

141/007 Okasa Pharma Limited, India

4338 Efiva 200 Capsules Efavirenz 200mg POM Capsule oral 141/008 Okasa Pharma Limited, India

4339Oka-Vincristine Injection Vincristine 1mg, per ml

POM Powder for

Injection

141/009 Okasa Pharma Limited, India

4340 Efiva 600 Tablets Efavirenz 600mg POM Tablet Uncoated 141/010 Okasa Pharma Limited, India

4341Cefurox 500 Tablets Cefuroxime 500mg

POM Tablet Enteric

Coated

141/012 Okasa Pharma Limited, India

4342 Oka-Azithromycin Tablets Azithromycin 250mg POM Tablet Uncoated 141/013 Okasa Pharma Limited, India

4343 Okavir S 30 Tablets Stavudine 30mg POM Tablet Uncoated 141/014 Okasa Pharma Limited, India

4344Artheleria Oral Suspension

Artemether 15mg, per

5ml

POM Suspension for

Oral Use

141/016 Okasa Pharma Limited, India

4345 Ibuprofen Tablets Ibuprofen 200mg P Tablet Film coated 141/017 Okasa Pharma Limited, India

Page 223 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4346

Viscodril Expectorant Syrup

Ammonium Chloride BP

138mg +

Diphenylhydramine

Hydrochloride BP 14mg

P Syrup 258/001 Oman Pharmaceutical Products Co. LLC,

Oman

4347Opizole Cream Clotrmazole USP 1%w/w

POM Cream Topical 258/002 Oman Pharmaceutical Products Co. LLC,

Oman

4348Clofast Gel

Diclofenac Diethylamine

BP 1%w/w

P Gel Topical 258/003 Oman Pharmaceutical Products Co. LLC,

Oman

4349Dimet 650 Tablets

Metformin Hydrochloride

BP 650mg

POM Tablet Uncoated 258/004 Oman Pharmaceutical Products Co. LLC,

Oman

4350Dimet 500 Tablets

Metformin Hydrochloride

BP 500mg

POM Tablet Uncoated 258/005 Oman Pharmaceutical Products Co. LLC,

Oman

4351

Medicoril-E Syrup

Sodium Citrate 55mg +

Chlorpheniramine 2.5mg

+ Ammonium Chloride

125mg

P Syrup 258/006 Oman Pharmaceutical Products Co. LLC,

Oman

4352Atormin 50 Tablets Atenolol BP 50mg

POM Tablet Uncoated 258/007 Oman Pharmaceutical Products Co. LLC,

Oman

4353Atormin 100 Tablets Atenolol BP 100mg

POM Tablet Uncoated 258/008 Oman Pharmaceutical Products Co. LLC,

Oman

4354Pmol Syrup

Paracetamol BP 120mg,

per 5ml

GS Syrup 258/009 Oman Pharmaceutical Products Co. LLC,

Oman

4355Pmol Caplets Paracetamol BP 500mg

GS Capsule oral 258/010 Oman Pharmaceutical Products Co. LLC,

Oman

4356 OraQuick - HIV Self-Test Kit HIV Self-Test Kit P HDPE Strips 412/001 OraSure Technologies

4357 Cefacure Capsules Cephalexin USP 250mg POM Capsule oral 185/001 Orchid Healthcare Limited, India

4358 Cefacure Capsules Cephalexin USP 500mg POM Capsule oral 185/002 Orchid Healthcare Limited, India

4359Cefogram Injection

Ceftriaxone Sodium

250mg

POM Powder for

Injection

185/003 Orchid Healthcare Limited, India

4360Cefogram Injection

Ceftriaxone Sodium

1000mg

POM Powder for

Injection

185/004 Orchid Healthcare Limited, India

4361Orzid Injection Ceftazidine 500mg

POM Powder for

Injection

185/005 Orchid Healthcare Limited, India

4362Orzid Injection Ceftazidine 1000mg

POM Powder for

Injection

185/006 Orchid Healthcare Limited, India

4363Tax-O -BID Injection

Cefotaxime Sodium

1000mg

POM Powder for

Injection

185/007 Orchid Healthcare Limited, India

4364Tax-O-BID Injection

Cefotaxime Sodium

500mg

POM Powder for

Injection

185/008 Orchid Healthcare Limited, India

Page 224 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4365Tax-O-BID Injection

Cefotaxime Sodium

250mg

POM Powder for

Injection

185/009 Orchid Healthcare Limited, India

4366Spizef 250 Tablets

Cefuroxime Axetil I.H.

250mg

POM Tablet Uncoated 185/010 Orchid Healthcare Limited, India

4367Spizef 500 Tablets

Cefuroxime Axetil I.H.

500mg

POM Tablet Uncoated 185/011 Orchid Healthcare Limited, India

4368 Ulti-Mate 50 Sildenafil Tablets Sildenafil Citrate I. 50mg POM Tablet Uncoated 185/012 Orchid Healthcare Limited, India

4369Ulti-Mate 100 Sildenafil Tablets

Sildenafil Citrate I.

100mg

POM Tablet Uncoated 185/013 Orchid Healthcare Limited, India

4370Orpime Injection

Cefepime Hydrochloride

1g

POM Powder for

Injection

185/014 Orchid Healthcare Limited, India

4371 Orfix Capsules Cefixime Soduim 200mg POM Capsule oral 185/015 Orchid Healthcare Limited, India

4372 Manorest Tablets Alprazolam 0.5mg POM Tablet Uncoated 185/016 Orchid Healthcare Limited, India

4373Cepotil 200 Tablets

Cefpodoxime Proxetil

USP 200mg

POM Tablet Uncoated 185/017 Orchid Healthcare Limited, India

4374Cepotil 100 Tablets

Cefpodoxime Proxetil

USP 100mg

POM Tablet Uncoated 185/018 Orchid Healthcare Limited, India

4375E-Pril -10 Tablets

Enalapril Maleate USP

10mg

POM Tablet Uncoated 185/019 Orchid Healthcare Limited, India

4376Epril 5 Tablets

Enalapril Maleate USP

5mg

POM Tablet Uncoated 185/020 Orchid Healthcare Limited, India

4377 Monorest Tablets Alprazolam USP 0.25mg POM Tablet Uncoated 185/021 Orchid Healthcare Limited, India

4378Ciprox Injection

Ciprofloxacin USP

200mg, per 100ml

POM Solution for

Injection

194/009 Otsuka Pharmaceuticals India Pvt Ltd

4379Metris Injection

Metronidazole USP 5mg,

per ml

POM Solution for

Injection

194/013 Otsuka Pharmaceuticals India Pvt Ltd

4380Dextrose Intravenous Infusion Glucose 50g/L

POM Solution for

infusion

194/015 Otsuka Pharmaceuticals India Pvt Ltd

4381Sodium Chloride And Glucose

Sodium Chloride 0.9w/v +

Glucose 5%w/v

POM Solution for

infusion

194/016 Otsuka Pharmaceuticals India Pvt Ltd

4382Sodium Chloride Injection Sodium Chloride 0.9%

POM Solution for

infusion

194/017 Otsuka Pharmaceuticals India Pvt Ltd

4383Compound Sodium Lactate Ringer's Lactate

POM Solution for

infusion

194/018 Otsuka Pharmaceuticals India Pvt Ltd

4384Gentamycin Sulphate Injection

Gentamycin 80mg, per

2ml

POM Solution for

Injection

213/001 Ouyi Pharma Co.Ltd, China

4385Palsar Tablets

Losartan Potassium USP

50mg

POM Tablet Uncoated 138/001 Palash Pharma

Page 225 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4386

Sitcom Cream Euphorbia prostrata dry

extract ethanolic 80%

w/w

P Cream Topical 439/001 Panacea Biotech Limited

4387

Sitcom Tablets Euphorbia prostrata dry

extract

P Tablet Film coated 439/002 Panacea Biotech Limited

4388Diflucan 200mg Tablets Fluconazole 200mg

POM Tablet Uncoated 120/001 Pfizer Global Pharmaceuticals Ltd, South

Africa

4389Zithromax Tablets Azithromycin 500mg

POM Tablet Uncoated 120/002 Pfizer Global Pharmaceuticals Ltd, South

Africa

4390Viagra Tablets Sildenafil 50mg

POM Tablet Uncoated 120/003 Pfizer Global Pharmaceuticals Ltd, South

Africa

4391Viagra Tablets Sildenafil 25mg

POM Tablet Uncoated 120/004 Pfizer Global Pharmaceuticals Ltd, South

Africa

4392Liptor Tablets Atorvastatin 10mg

POM Tablet Uncoated 120/005 Pfizer Global Pharmaceuticals Ltd, South

Africa

4393Liptor Tablets Atorvastatin 20mg

POM Tablet Uncoated 120/006 Pfizer Global Pharmaceuticals Ltd, South

Africa

4394Diflucan 150mg Tablets Fluconazole 150mg

POM Tablet Uncoated 120/007 Pfizer Global Pharmaceuticals Ltd, South

Africa

4395Feldene Tablets Piroxcam 20mg

POM Tablet Uncoated 120/008 Pfizer Global Pharmaceuticals Ltd, South

Africa

4396Diflucan 50mg Tablets Fluconazole 50mg

POM Tablet Uncoated 120/009 Pfizer Global Pharmaceuticals Ltd, South

Africa

4397Fasigyn Tablets Tinidazole 150mg

POM Tablet Uncoated 120/010 Pfizer Global Pharmaceuticals Ltd, South

Africa

4398Xalatan Eye Drops Latanoprost 0.005%

POM Eye Drops 120/011 Pfizer Global Pharmaceuticals Ltd, South

Africa

4399Depo Provera Injection

Medroxyprogesterone

Acetate 150mg, per ml

POM Suspension for

Injection

120/012 Pfizer Global Pharmaceuticals Ltd, South

Africa

4400Norvasc Tablets Amlodipine 5mg

POM Tablet Uncoated 120/013 Pfizer Global Pharmaceuticals Ltd, South

Africa

4401

Terra-Cotril Eye/Ear Drops

10 Mg Oxytetracycline+ 5

Mg Hydrocortisone

Acetate +10000 Units

Polymyxin B Sulphate,

per ml

POM Ear/Eye Drops 120/014 Pfizer Global Pharmaceuticals Ltd, South

Africa

4402Feldene Injection Piroxcam 20mg, per ml

POM Solution for

Injection

120/015 Pfizer Global Pharmaceuticals Ltd, South

Africa

Page 226 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4403Prostine E 2 Vaginal Tablets Dinoprostone HSE 3mg

POM Tablet Uncoated 120/017 Pfizer Global Pharmaceuticals Ltd, South

Africa

4404Feldene Capsules Piroxcam 10mg

POM Capsule oral 120/018 Pfizer Global Pharmaceuticals Ltd, South

Africa

4405Trobicin Injection Specitinomycin 3mg

POM Solution for

Injection

120/021 Pfizer Global Pharmaceuticals Ltd, South

Africa

4406Depo Medrol Injection

Methylprednisolone

40mg, per ml

POM Solution for

Injection

120/022 Pfizer Global Pharmaceuticals Ltd, South

Africa

4407Dalacin C 150mg Capsules Clindamycin 150mg

POM Capsule oral 120/023 Pfizer Global Pharmaceuticals Ltd, South

Africa

4408Accupril Tablets Quinapril 5mg

POM Tablet Uncoated 120/024 Pfizer Global Pharmaceuticals Ltd, South

Africa

4409Accupril Tablets Quinapril 10mg

POM Tablet Uncoated 120/025 Pfizer Global Pharmaceuticals Ltd, South

Africa

4410

Accupretic Tablets

Hydrochlothiazide

12.5mg + Quinapril

10mg

POM Tablet Uncoated 120/026 Pfizer Global Pharmaceuticals Ltd, South

Africa

4411Ponstan Capsules Mefenamic Acid 250mg

P Capsule oral 120/027 Pfizer Global Pharmaceuticals Ltd, South

Africa

4412Ponstan Suspension

Mefenamic Acid 50mg,

per 5ml

P Suspension for

Oral Use

120/028 Pfizer Global Pharmaceuticals Ltd, South

Africa

4413Feldene Topical Gel Piroxcam 0.5%

POM Gel Topical 120/029 Pfizer Global Pharmaceuticals Ltd, South

Africa

4414Zithromax Suspension

Azithromycin 200mg, per

5ml

POM Suspension for

Oral Use

120/030 Pfizer Global Pharmaceuticals Ltd, South

Africa

4415Sayana Injection

Medroxyprogesterone

104mg, per 0.65ml

POM Solution for

Injection

120/031 Pfizer Global Pharmaceuticals Ltd, South

Africa

4416Mycobutin Capsules Rifabutin 150mg

POM Capsule oral 120/032 Pfizer Global Pharmaceuticals Ltd, South

Africa

4417Dalacin C Capsules Clindamycin 150mg

POM Capsule oral 198/008 Pfizer Global Pharmaceuticals Ltd, South

Africa

4418 Cytotec Tablets Misoprostol 200mcg POM Tablet Uncoated 120/037 Pfizer Global Pharmaceuticals Ltd,Nigeria

4419ASPAVOR 10 Tablets

Atorvastalin Calcium

Trihydrate 10mg

POM Tablet Uncoated 357/001 Pfizer Global Pharmaceuticals Ltd,Nigeria

4420ASPAVOR 20 Tablets

Atorvastalin Calcium

Trihydrate 20mg

POM Tablet Uncoated 357/002 Pfizer Global Pharmaceuticals Ltd,Nigeria

4421ASPAVOR 40 Tablets

Atorvastalin Calcium

Trihydrate 40mg

POM Tablet Uncoated 357/003 Pfizer Global Pharmaceuticals Ltd,Nigeria

Page 227 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4422

Sayana Press® Pre-Filled

Single-Use Suspension For

Injection System

Medroxyprogesterone

Acetate 104mg, per

0.65ml

Prescription Only

Medicine

Suspension for

Injection

120/038 Pfizer Laboratories Limited, Kenya

4423

Cardura XL tablets Doxazosin mesyltate 4mg POM Tablet Modified

Release

120/039 Pfizer Laboratories Limited, Kenya

4424

Cadura XL tablets Doxazosin mesyltate 8mg POM Tablet Modified

Release

120/040 Pfizer Laboratories Limited, Kenya

4425 Tetracycline Capsules Tetracycline 250mg POM Capsule oral 131/008 Pharco Limited,Zambia

4426

Normavir Tablets

Lamivudine 150mg +

Stavudine 30mg +

Nevirapine 300mg

POM Tablet Uncoated 132/002 Pharco Limited,Zambia

4427 Cimetidine Tablets Cimetidine 100mg POM Tablet Uncoated 132/003 Pharco Limited,Zambia

4428Chlorpheniramine Tablets

Chlorpheniramine

Maleate 4mg

P Tablet Uncoated 132/004 Pharco Limited,Zambia

4429

Co-Trimoxazole TabletsSulfamethoxazole 400mg

+ Trimethoprim 80mg

POM Tablet Uncoated 132/005 Pharco Limited,Zambia

4430 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 132/006 Pharco Limited,Zambia

4431 Folic Acid Tablets Folic Acid 5mg P Tablet Uncoated 132/007 Pharco Limited,Zambia

4432 Pyrazinamide Tablets Pyrazinamide 500mg POM Tablet Uncoated 132/009 Pharco Limited,Zambia

4433 Paracetamol Tablets Paracetamol 100mg GS Tablet Uncoated 132/010 Pharco Limited,Zambia

4434 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 132/011 Pharco Limited,Zambia

4435

Sulphadoxine/Pyrimethamine

Tablets

Pyrimethamine 25mg +

Sulphadoxine 500mg

POM Tablet Uncoated 132/012 Pharco Limited,Zambia

4436 Carbamazepine Tablets Carbamazepine 200mg POM Tablet Uncoated 132/013 Pharco Limited,Zambia

4437Metoclopramide Tablets

Metoclopramide BP

10mg

POM Tablet Uncoated 132/014 Pharco Limited,Zambia

4438 Quinine Sulphate Tablets Quinine Sulphate 300mg POM Tablet Uncoated 132/015 Pharco Limited,Zambia

4439 Zarin Sino II Implant Levenorgestrel 75mg POM Transdermal Rod 081/001 Pharm Access Africa Ltd, Kenya

4440Dynafloc 500 Tablets Ciprofloxacin 500mg

POM Tablet Uncoated 051/001 Pharma Dynamics (Pty) Limited, South

Africa

4441

Efferflu C Effervesent Tablets

Paracetamol 500mg +

Vitamin C 250mg +

Chlorpheniramine 2mg

P Tablet Dispersible 051/002 Pharma Dynamics (Pty) Limited, South

Africa

4442Pollentymes S Syrup Loratadine 5mg, per 5mls

P Syrup 051/003 Pharma Dynamics (Pty) Limited, South

Africa

4443Texa Syrup Cetirizine 1mg, per ml

P Syrup 051/004 Pharma Dynamics (Pty) Limited, South

Africa

Page 228 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4444Texa 10mg Tablets Cetirizine 10mg

P Tablet Uncoated 051/005 Pharma Dynamics (Pty) Limited, South

Africa

4445Enap 5mg Tablets Enalapril 5mg

POM Tablet Film coated 051/006 Pharma Dynamics (Pty) Limited, South

Africa

4446Enap 10 Tablets Enalapril 10mg

POM Tablet Film coated 051/007 Pharma Dynamics (Pty) Limited, South

Africa

4447Enap 20 Tablets Enalapril 20mg

POM Tablet Film coated 051/008 Pharma Dynamics (Pty) Limited, South

Africa

4448Pollentyme Tablets Loratadine 10mg

P Tablet Film coated 051/009 Pharma Dynamics (Pty) Limited, South

Africa

4449

Oradoc Gargle & Mouth Wash

Tea Tree Oil 200mg +

Eucalyptol 18mg +

Thymol 13mg

GS Solution for Oral

Use

051/010 Pharma Dynamics (Pty) Limited, South

Africa

4450

Enap - Co Tablets

Enalapril 20mg +

Hydrochlorothiazide

12.5mg

POM Tablet Film coated 051/011 Pharma Dynamics (Pty) Limited, South

Africa

4451Pearinda 4 Tablets Perindopril 4mg

POM Tablet Uncoated 051/012 Pharma Dynamics (Pty) Limited, South

Africa

4452Pearinda 8 Tablets Perindopril 8mg

POM Tablet Uncoated 051/013 Pharma Dynamics (Pty) Limited, South

Africa

4453Carvetrend 6.25mg Tablets Carvedilol 6.25mg

POM Tablet Uncoated 051/014 Pharma Dynamics (Pty) Limited, South

Africa

4454Carvetrend 12.5mg Tablets Carvedilol 12.5mg

POM Tablet Uncoated 051/015 Pharma Dynamics (Pty) Limited,South

Africa

4455

Efferflu C IB

Vitamin C 1000.0mg +

Echinacea Purpurea

50mg + Zinc Lactate

Trihydrate 22.71mg

POM Tablet uncoated 051/016 Pharma Dynamics (Pty) Limited,South

Africa

4456Depogest Injection

Medroxyprogesteron

USP 150mg

POM Solution for

Injection

247/001 Pharmacarechem International Ltd, England

4457Cloxacillin Dry Syrup

Cloxacillin 125mg, per

5ml

POM Syrup 247/002 Pharmacarechem International Ltd, England

4458Amoxicillin Dry Syrup

Amoxicillin 125mg, per

5ml

POM Suspension for

Oral Use

247/003 Pharmacarechem International Ltd, England

4459Erythromycin Oral Suspension

Erythromycin BP 125mg,

per 5ml

POM Suspension for

Oral Use

247/004 Pharmacarechem International Ltd, England

4460Ampicillin Dry Syrup

Ampicillin 125mg, per

5ml

POM Syrup 247/005 Pharmacarechem International Ltd, England

Page 229 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4461

Phenoxymethyl Penicillin

Suspension

Phenoxymethyl Penicillin

USP 125mg, per 5ml

POM Suspension for

Oral Use

247/006 Pharmacarechem International Ltd, England

4462Solu Medrol Injection Methylprednisolone 40mg

POM Solution for

Injection

198/001 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4463Medrol Tablets Methylprednisolone 4mg

POM Tablet Uncoated 198/002 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4464Halcion Tablets Triazolam 0.25mg

POM Tablet Uncoated 198/003 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4465Xalatan Eye Drops Latanoprost 50mg

POM Eye Drops 198/005 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4466Provera Tablets

Medroxyprogesterone

5mg

POM Tablet Uncoated 198/006 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4467Dalacin C Injection Clindamycin 150mg

POM Solution for

Injection

198/007 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4468Dalacin C Syrup

Clindamycin 75mg, per

5ml

POM Solution for Oral

Use

198/009 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4469Caverject Powder for Injection Alprostadil 20mcg

POM Powder for

Injection

198/010 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4470

Neo Medrol Acne Lotion

Sulfur 50mg +

Methyprednisolone

2.5mg + Neomycin 2.5mg

+ Aluminium

Chlorohydrate 100mg

POM Lotion for Topical

Use

198/011 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4471Solu Cortef Injection

Hydrocortisone Sodium

Succinate 100mg

POM Powder for

Injection

198/012 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4472Unicarp M Capsules Multivitamins

P Capsules Oral 198/013 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4473Togamycin Injection Specitinomycin 2g

POM Powder for

Injection

198/015 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4474Depo Provera Injection

Medroxyprogesterone

150mg

POM Suspension for

Injection

198/016 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4475Lomanor 10 Tablets

Amlodipine Besylate

10mg

POM Tablet Uncoated 357/004 Pharmacia South Africa (Pty) Ltd

4476Lomanor 5 Tablets Amlodipine Besylate 5mg

POM Tablet Uncoated 357/005 Pharmacia South Africa (Pty) Ltd

4477Accumax 10mg Tablets

Quinapril Hydrochloride

10mg

POM Tablet Enteric

Coated

357/006 Pharmacia South Africa (Pty) Ltd

4478Accumax 20mg Tablets

Quinapril Hydrochloride

20mg

POM Tablet Film coated 357/007 Pharmacia South Africa (Pty) Ltd

Page 230 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4479

Accumax Co 10/12.5mg Tablets

Quinapril Hydrochloride

10mg +

Hydrochlorothiazide

12.5mg

POM Tablet Film coated 357/008 Pharmacia South Africa (Pty) Ltd

4480

Accumax Co 20/12.5mg Tablets

Quinapril Hydrochloride

20mg +

Hydrochlorothiazide

12.5mg

POM Tablet Film coated 370/013L Pharmacia South Africa (Pty) Ltd

4481 Closcript Vaginal Cream Clotrimazole 1% POM Cream Topical 017/001 Pharmanova (Pty) Ltd, Zimbabwe

4482 Closcript Topical Cream Clotrimazole 1% POM Cream Topical 017/002 Pharmanova (Pty) Ltd, Zimbabwe

4483Goldgesic Syrup

Paracetamol + Codeine +

Meprobamate

P Syrup 017/003 Pharmanova (Pty) Ltd, Zimbabwe

4484 Grays Eye Drops Tetrahydrozoline 0.05% POM Eye Drops 017/004 Pharmanova (Pty) Ltd, Zimbabwe

4485Goldgesic Tablets

Paracetamol + Codeine +

Meprobamate

P Tablet Uncoated 017/005 Pharmanova (Pty) Ltd, Zimbabwe

4486 Pain-Eeze Tabs Aspirin + Caffeine P Tablets oral 017/006 Pharmanova (Pty) Ltd, Zimbabwe

4487Grays Cough Syrup

Grays Pine Tar & Honey

Cough Syrup

P Syrup 017/007 Pharmanova (Pty) Ltd, Zimbabwe

4488 Novadol Tablets Paracetamol 500mg GS Tablet Uncoated 017/009 Pharmanova (Pty) Ltd, Zimbabwe

4489 Novadol Syrup Paracetamol 120mg GS Syrup 017/010 Pharmanova (Pty) Ltd, Zimbabwe

4490

Novatrim Suspension

Sulphamethoxazole

200mg + Trimethoprim

40mg, per 5ml

POM Suspension for

Oral Use

017/011 Pharmanova (Z) Ltd, Lusaka, Zambia

4491Adult Cafemol Tablets

Aspirin 500mg + Caffeine

15mg

GS Tablet Uncoated 077/001 Pharmanova (Z) Ltd, Lusaka, Zambia

4492 Child Cafemol Tablets Aspirin 80mg GS Tablet Uncoated 077/002 Pharmanova (Z) Ltd, Lusaka, Zambia

4493 Panado Tablets Paracetamol 500mg GS Tablet Uncoated 077/003 Pharmanova (Z) Ltd, Lusaka, Zambia

4494Novaderm Dusting Powder Clotrimazole 1%w/w

P Powder for Topical

use

077/006 Pharmanova (Z) Ltd, Lusaka, Zambia

4495

Phipps Gripe Water

Sodium Bicarbonate

50mg, Sodium Citrate

2.5mg, Sucrose 120mg,

Spearmint Oil 0.14mg,

0.1mg/50ml

GS Solution for Oral

Use

077/007 Pharmanova (Z) Ltd, Lusaka, Zambia

4496Novatrim Tablets

Trimethoprim 80mg +

Sulphadoxine 400mg

POM Tablet Uncoated 077/008 Pharmanova (Z) Ltd, Lusaka, Zambia

4497Novidar Tablets

Pyrimethamine 25mg +

Sulphadoxine 500mg

P Tablet Uncoated 077/009 Pharmanova (Z) Ltd, Lusaka, Zambia

Page 231 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4498Panado Syrup

Paracetamol 125mg, per

5ml

P Syrup 077/010 Pharmanova (Z) Ltd, Lusaka, Zambia

4499Drews Liver Salt

Magnesium + Sodium

Bicarbonate 3.165gm

GS Powder for Oral

Solution

077/011 Pharmanova (Z) Ltd, Lusaka, Zambia

4500

Padax 1.65g (Piperazine

Citrate)Piperazine Citrate 1.65g

POM Powder 077/012 Pharmanova (Z) Ltd, Lusaka, Zambia

4501 Metronidazole 200mg Tabs Metronidazole 200mg POM Tablets oral 077/013 Pharmanova (Z) Ltd, Lusaka, Zambia

4502Co-trimoxazole Tablets

Trimethoprim 80mg +

Sulphadoxine 400mg

POM Tablet Uncoated 077/014 Pharmanova (Z) Ltd, Lusaka, Zambia

4503 Novafen 200mg Capsules Ibuprofen 200mg P Capsules oral 077/015 Pharmanova (Z) Ltd, Lusaka, Zambia

4504 Tetracycline 250mg Caps Tetracyline 250mg POM Capsules oral 077/016 Pharmanova (Z) Ltd, Lusaka, Zambia

4505

Novalyn Cough Syrup

Diphenyhydramine

Hydrochloride 14mg +

Ammonium Chloride

138mg + Sodium Citrate

57.3mg + Menthol 2g, per

5ml

P Syrup 077/017 Pharmanova (Z) Ltd, Lusaka, Zambia

4506Aspirin Tablets

Acetyl Salicylic Acid

300mg

P Tablet Uncoated 077/018 Pharmanova (Z) Ltd, Lusaka, Zambia

4507

Novalyte ORS

Sodium Chloride 2.6g +

Sodium Citrate2.9g +

Potassium Chloride1.5g

+ Anhydrous Glucose

13.5g

GS Powder for Oral

Solution

077/019 Pharmanova (Z) Ltd, Lusaka, Zambia

4508

Novidar Plus Tablets

Sulfadoxine 500mg +

Pyrimethamine 25mg +

Artesunate 100mg

POM Tablet Uncoated 077/020 Pharmanova (Z) Ltd, Lusaka, Zambia

4509Novachlor Syrup

Chlorpheniramine 2mg,

per 5ml

P Syrup 077/021 Pharmanova (Z) Ltd, Lusaka, Zambia

4510

Nocold Capsules

Paracetamol 400mg +

Caffeine 30mg +

Chlorpheniramine 4mg +

Pseudoephedrine 30mg

P Capsules oral 077/022 Pharmanova (Z) Ltd, Lusaka, Zambia

4511 Child Panado Tablets Paracetamol 100mg GS Tablet Uncoated 077/023 Pharmanova (Z) Ltd, Lusaka, Zambia

4512Panado Plus Tablets

Ibuprofen 200mg +

Paracetamol325mg

P Tablet Uncoated 077/024 Pharmanova (Z) Ltd, Lusaka, Zambia

4513 Novazinc Tablets Zinc Sulfate 20mg GS Tablet Uncoated 077/025 Pharmanova (Z) Ltd, Lusaka, Zambia

4514Kit Yamoyo the Flexi Pack Kit

ORS + Zinc Sulphate

200mg + 1 Hand Soap

GS Kit 077/026 Pharmanova (Z) Ltd, Lusaka, Zambia

Page 232 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4515Yamoyo Screw Top Kit

ORS + Zinc Sulphate

200mg + 1 Hand Soap

GS kit 077/027 Pharmanova (Z) Ltd, Lusaka, Zambia

4516Yamoyo GRZ Co-Pack

ORS + Zinc Sulphate

200mg

GS Kit 077/028 Pharmanova (Z) Ltd, Lusaka, Zambia

4517 Aspirin Tablets 300mg Aspirin 300mg P Tablet Uncoated 257/001 Pharmanova Limited, Malawi

4518Phipps Milk Of Magnesia

Magnesium Hydroxide

400mg, per 5ml

GS Suspension for

Oral Use

257/002 Pharmanova Limited, Malawi

4519 Panadol Tablets For Children Paracetamol 100mg GS Tablet Uncoated 257/003 Pharmanova Limited, Malawi

4520

Stearns Pine Tar

Salicylic Acid 0.014% +

Ammonium Chloride

1.15% + Hexysuranal

0.1% + Alcohol 1.6%

GS Syrup 257/019 Pharmanova Limited, Malawi

4521Micro Betamethasone Injection

Betamethasone 4mg, per

ml

POM Solution for

Injection

034/001 Pharma-Q Holdings (Pty) Ltd, South Africa

4522

Micro Bupivacaine Spinal with

Dextrose Injection

Bupivacaine + Dextrose

20mg, per 4ml

POM Solution for

Injection

034/002 Pharma-Q Holdings (Pty) Ltd, South Africa

4523Micro Dopamine Injection

Dopamine Hydrochloride

200mg, per 5ml

POM Solution for

Injection

034/003 Pharma-Q Holdings (Pty) Ltd, South Africa

4524

Pharma Q Bupivacaine Injection

50mg/10ml Injection

Bupivacaine

Hydrochloride 50mg, per

10ml

POM Solution for

Injection

034/004 Pharma-Q Holdings (Pty) Ltd, South Africa

4525

Pharma -Q Gentamicin

80mg/2ml Injection

Gentamycin Sulphate

80mg, per 2ml

POM Solution for

Injection

034/005 Pharma-Q Holdings (Pty) Ltd, South Africa

4526

Pharma-Q Metoclopramide

Injection

Metoclopramide

Hydrochloride 10mg

POM Solution for

Injection

034/006 Pharma-Q Holdings (Pty) Ltd, South Africa

4527

Pharma-Q Hyocine

Butylbromide Injection

20mg/2ml

Hyocine Butylbromide

20mg

POM Solution for

Injection

034/007 Pharma-Q Holdings (Pty) Ltd, South Africa

4528

Pharma-Q Clindamycin Injection

600mg/4ml

Clindamycin Phosphate

600mg, per 4ml

POM Solution for

Injection

034/008 Pharma-Q Holdings (Pty) Ltd, South Africa

4529Pharma-Q Adrenalin Injection

Adrenaline Hydrochloride

1mg

POM Solution for

Injection

034/009 Pharma-Q Holdings (Pty) Ltd, South Africa

4530Pharma-Q Pethidine Injection

Pethidine Hydrochloride

100mg

POM Solution for

Injection

034/010 Pharma-Q Holdings (Pty) Ltd, South Africa

4531Pharma-Q Diclofenac Injection

Diclofenac Sodium 75mg,

per 3ml

POM Solution for

Injection

034/011 Pharma-Q Holdings (Pty) Ltd, South Africa

4532

Pharma-Q Dexamethasone

Phosphate Injection

Dexamethasone Sodium

Phosphate 4.0mg

POM Solution for

Injection

034/012 Pharma-Q Holdings (Pty) Ltd, South Africa

4533 Larvin Tablets Clopidogrel 75mg POM Tablet Film coated 320/001 Pharmex SA

Page 233 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4534

Butafusin Cream

Fusidic Acid 2%w/w +

Betamethasone Valerate

0.1%

POM Cream Topical 320/002 Pharmex SA

4535 Cipocal Cream Calcipotriol 0.005% POM Cream Topical 320/003 Pharmex SA

4536

Phardinol Eye Drop Solution

Dorzalamide

Hydrochloride 2.0% +

Timolol Maleate 0.5%

POM Eye Drops 320/004 Pharmex SA

4537Cipocal Ointment

Calcipotriol (Anhydrous),

0.005%

GS Ointment topical 320/005 Pharmex SA

4538Qina Drops Herbal Extracts

P Solution for Oral

Use

078/001HM Phend Pharmaceuticals Pty Ltd, China

4539

Propovan Injection, 20ml

AmpoulePropofol 1%

POM Suspension for

Injection

103/005 Piramal Healthcare Limited, India

4540

Actifresh Lozenges - Regular

Mentha Piperata 1.89mg

+ Eucalyptus Globules

0.65mg

GS Lozenges 037/001 Plethico Pharmaceuticals Limited, India

4541

Travisil Cold Rub

Camphor + Turpentine +

Menthol + Eucalyptus Oil

+ Thymol + Nutmeg

GS Ointment topical 037/002 Plethico Pharmaceuticals Limited, India

4542

Therasil Sore Throat Formula

Lozenges

Amylmetacresol 0.6mg +

2,4 Dichlorobenzyl

Alcohol 1.2mg

GS Lozenges 037/003 Plethico Pharmaceuticals Limited, India

4543Artemal M Injection Artemether 80mg, per ml

POM Solution for

Injection

037/004 Plethico Pharmaceuticals Limited, India

4544Falquin 600 Injection Quinine 600mg, per 2ml

POM Solution for

Injection

037/005 Plethico Pharmaceuticals Limited, India

4545

Timizol Tablets

Trimethoprim 80mg +

Sulphamethoxazole

400mg

POM Tablet Uncoated 037/006 Plethico Pharmaceuticals Limited, India

4546 Taxocef -O 200 Tablets Cefixime 200mg POM Tablet Uncoated 037/007 Plethico Pharmaceuticals Limited, India

4547

Travisil Herbal Cough Lemon

Flavoured LozengesHerbal Extract

GS Lozenges 037/008 Plethico Pharmaceuticals Limited, India

4548

Travisil Herbal Cough Mint

Flavour LozengesHerbal Extract

GS Lozenges 037/009 Plethico Pharmaceuticals Limited, India

4549 Travisil Herbal Cough Syrup Herbal Extract GS Syrup 037/010 Plethico Pharmaceuticals Limited, India

4550

Fastorik Tablets

Paracetamol 500mg +

Phenylephrine 5mg +

Chlorpheniramine 4mg +

Caffeine 30mg

P Tablet Uncoated 037/011 Plethico Pharmaceuticals Limited, India

Page 234 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 4551 Cloptaz Tablets Clopidogrel 75mg POM Tablet Film coated 037/012 Plethico Pharmaceuticals Limited, India

4552

Coolz Suspension

Aluminium Hydroxide

300mg + Magnesium

Trisilicate 50mg +

Magnesium Hydroxide

25mg + Simethicone

25mg

POM Suspension for

Oral Use

037/013 Plethico Pharmaceuticals Limited, India

4553Forcepime 1g Injection

Cefepime Hydrochloride

1g

POM Powder for

Injection

037/014 Plethico Pharmaceuticals Limited, India

4554Maxi 75 Injection

Diclofenac Sodium 75mg,

per 3ml

POM Solution for

Injection

037/015 Plethico Pharmaceuticals Limited, India

4555Terbact Cream

Terbinafine

Hydrochloride 1%w/w

POM Cream Topical 037/016 Plethico Pharmaceuticals Limited, India

4556Q-Med Adrenaline Injection Adrenaline

POM Solution for

Injection

183/001 Preterius Patents CC, South Africa

4557 Alphacillin 250 Capsules Ampicillin 250mg POM Capsule oral 265/001 Prime Pharmaceuticals Ltd, India

4558 Acyzon Tablets Acyclovir 200mg POM Tablet Uncoated 265/002 Prime Pharmaceuticals Ltd, India

4559Ketoniz Tablets

Ketaconazole USP

200mg

POM Tablet Uncoated 265/004 Prime Pharmaceuticals Ltd, India

4560Clotflush Injection Heparin 100IU

POM Solution for

Injection

246/001 Prisma Pharmaceuticals Ltd, UK

4561Priskacin 250 Injection Amikacin 250mg

POM Powder for

Injection

246/002 Prisma Pharmaceuticals Ltd, UK

4562 Purecal Tablets Calcium 1250mg POM Tablet Uncoated 246/003 Prisma Pharmaceuticals Ltd, UK

4563Priskacin 500 Injection Amikacin 500mg

POM Powder for

Injection

246/004 Prisma Pharmaceuticals Ltd, UK

4564Synolube Injection

Sodium Hyaluronate

20mg

POM Solution for

Injection

246/005 Prisma Pharmaceuticals Ltd, UK

4565Odicef 1000 Injection Ceftriaxone 1000mg

POM Powder for

Injection

246/009 Prisma Pharmaceuticals Ltd, UK

4566Odicef 50 Injection Ceftriaxone 50mg

POM Powder for

Injection

246/010 Prisma Pharmaceuticals Ltd, UK

4567Odicef 250 Injection Ceftriaxone 250mg

POM Powder for

Injection

246/011 Prisma Pharmaceuticals Ltd, UK

4568

Clavex Injection

Amoxicillin 1000mg +

Clavulanate Potassium

200mg

POM Powder for

Injection

246/014 Prisma Pharmaceuticals Ltd, UK

4569LMW Enox Injection

Enoxaparin 80mg, per

0.8ml

POM Solution for

Injection

246/016 Prisma Pharmaceuticals Ltd, UK

Page 235 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4570LMW Enox Injection

Enoxaparin 40mg, per

0.4ml

POM Solution for

Injection

246/017 Prisma Pharmaceuticals Ltd, UK

4571LMW Enox Injection

Enoxaparin 60mg, per

0.6ml

POM Solution for

Injection

246/018 Prisma Pharmaceuticals Ltd, UK

4572 Kefurox 250 Mg Tablets Cefuroxime 250mg POM Tablet Film coated 246/019 Prisma Pharmaceuticals Ltd, UK

4573 Kefurox 500mg Tablets Cefuroxime 500mg POM Tablet Film coated 246/020 Prisma Pharmaceuticals Ltd, UK

4574

EAZZ UP + Pain Relief Cream Methyl Salicylate +

Peppermint Oil + Sallaki

oil + Bakuchi

P Cream Topical 435/002L PSA Chemicals and Pharmaceuticals Pvt

Ltd

4575

KIDOGRIP Gripe Water Sodium bicarbonate BP

1% w/v

P Solution for Oral

Use

435/003L PSA Chemicals and Pharmaceuticals Pvt

Ltd

4576 Amoxsan® 250 DT Amoxicillin Trihydrate POM Tablet Dispersible 631/001 PT CAPRIFARMINDO LABORATORIES

4577

Co-Trimoxazole Tablets

Sulphamethoxazole BP

400mg + Trimethoprim

BP 80mg

POM Tablet Uncoated 162/001 Pure pharma Limited, India

4578 Feefen Tablet Ibuprofen BP 200mg P Tablet Uncoated 162/002 Pure pharma Limited, India

4579

Sulphadoxine + Pyrimethamine

Tablets

Sulfadoxine 500mg +

Pyrimethamine 25mg +

Artesunate 100mg

POM Tablet Uncoated 162/004 Pure pharma Limited, India

4580 Praziquantel Tablets Praziquantel BP 600mg POM Tablet Uncoated 162/006 Pure pharma Limited, India

4581Peevaran Tablets Diclofenac Sodium 50mg

P Tablet Uncoated 162/008 Pure pharma Limited, India

4582 Peemox Capsules Amoxicillin 250mg POM Capsule oral 162/009 Pure pharma Limited, India

4583 Indomethacin Capsules Indomethacin 25mg P Capsule oral 162/010 Pure pharma Limited, India

4584 Cloxacillin Capsules Cloxacillin 250mg POM Capsule oral 162/011 Pure pharma Limited, India

4585

Betamethasone Dipropionate

Cream

Betamethasone

0.05%w/w

POM Cream Topical 064/001 R K Sharma, India

4586 Acyclovir Tablets 200mg BP Acyclovir 200mg POM Tablet Uncoated 064/002 R K Sharma, India

4587 Ketoconazole Cream 2% Ketoconazole 2%w/w POM Cream Topical 064/004 R K Sharma, India

4588 Miconazole Cream 2% Miconazole 2%w/w POM Cream Topical 064/005 R K Sharma, India

4589 Acyclovir Cream 5% BP Acyclovir 5%w/w POM Cream Topical 064/006 R K Sharma, India

4590Adosine Dr 250 Capsules

Didanosine Delayed

Release USP 250mg

POM Capsule Delayed

Release

112/133 Ranbaxy Laboratories Ltd, India

4591Adosine Dr 400 Capsules

Didanosine Delayed

Release USP 400mg

POM Capsule Delayed

Release

112/134 Ranbaxy Laboratories Ltd, India

4592Cefpi 1000 Injection

Cefpirome Sulphate

1000mg

POM Powder for

Injection

112/135 Ranbaxy Laboratories Ltd, India

4593Cefpi 500 Injection

Cefpirome Sulphate

500mg

POM Powder for

Injection

112/136 Ranbaxy Laboratories Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4594Vesizen 5 Tablets

Solifenacin Succinate

5mg

POM Tablet Film coated 112/137 Ranbaxy Laboratories Ltd, India

4595Vesizen 10 Tablets

Solifenacin Succinate

10mg

POM Tablet Film coated 112/138 Ranbaxy Laboratories Ltd, India

4596Staxom Tablets

Moxifloxacin

Hydrochloride 400mg

POM Tablet Film coated 112/139 Ranbaxy Laboratories Ltd, India

4597

Zytee Mouth Wash

Clove Oil 1% + Mentha

Arvensis 1% + Menthol

1% + Chamomile Oil

0.15% + Sodium

Benzoate 2% + Alcohol

95%

POM Solution for Oral

Use

029/001 Raptakos -Brett Company Ltd, India

4598Igol Granules Ispaghula Husk 0.66g

GS Powder for Oral

Suspension

029/002 Raptakos -Brett Company Ltd, India

4599 Subsyde CR100mg Capsules Diclofenac 100mg POM Tablet Uncoated 029/003 Raptakos -Brett Company Ltd, India

4600 Sucon RB Capsules Vitamins + Minerals GS Capsule oral 029/004 Raptakos -Brett Company Ltd, India

4601Sucon RB Suspension Vitamins + Minerals

GS Suspension for

Oral Use

029/005 Raptakos -Brett Company Ltd, India

4602 Duralyn-CR Tablets Theophylline 200mg POM Tablet Uncoated 029/006 Raptakos -Brett Company Ltd, India

4603 Duralyn - CR 400 Capsules Theophylline 400mg POM Capsule oral 029/007 Raptakos -Brett Company Ltd, India

4604 Neogadine Elixir Vitamins + Minerals GS Elixir 029/008 Raptakos -Brett Company Ltd, India

4605

Zytee RB Gel

Choline Salicylate 9%w/v

+ Benzokonium Chloride

0.002%w/v

GS Gel Topical 029/009 Raptakos -Brett Company Ltd, India

4606

Catoxymag-N Suspension

Dried Aluminium

Hydroxide 200mg +

Magnesium Trisilicate

200mg + Magnesium

Hydroxide 100mg +

Sodium Alginate 100mg

+ Simethicone 25mg, per

5ml

P Suspension for

Oral Use

029/010 Raptakos -Brett Company Ltd, India

4607 Durasal 4mg Tablets Salbutamol 4mg POM Tablet Uncoated 029/011 Raptakos -Brett Company Ltd, India

4608

Norash Cream

Dimethicone 20%w/w +

Zinc Oxide 7.5%w/w +

Calamine 1.5%w/w +

Cetrimide + 1.125%w/w

GS Cream Topical 029/012 Raptakos -Brett Company Ltd, India

4609Takol CR 100mg Capsules

Tramadol Hydrochloride

100mg

POM Capsule Sustained

Release

029/013 Raptakos -Brett Company Ltd, India

Page 237 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4610

Neopeptine Capsules

Alpha Amylase 100mg +

Papain 100mg +

Simethicone 30mg

P Capsule oral 029/014 Raptakos -Brett Company Ltd, India

4611Neopeptine Liquid

Alpha Amylase 100mg +

Papain 50mg

P Solution for Oral

Use

029/015 Raptakos -Brett Company Ltd, India

4612Neopeptine Drops

Alpha Amylase 20mg +

Papain 10mg

P Solution for Oral

Use

029/016 Raptakos -Brett Company Ltd, India

4613

Zevac Syrup

Zinc Acetate USP as

Dihydrate eq. to

Elemental Zinc 20mg

POM Syrup 029/017 Raptakos -Brett Company Ltd, India

4614Dettol Antiseptic Liquid

Chloroxylenol 4.8g, per

100ml

GS Solution for

sterilisation

133/008 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4615

Strepsils Eucalyptus Menthol

Lozenges

Amylmetacresol 0.6mg +

2,4 Dichlorobenzyl

Alcohol 1.2 Mg +

Lignocaine 10.0mg

GS Lozenges 133/009 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4616

Strepsils Orange With Vitamin C

Lozenges

Amylmetacresol 0.6mg +

2.4 Dichlorobenzyl

Alcohol 1.2mg + Vitamin

C 100mg

GS Lozenges 133/010 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4617

Strepsils Original Lozenges

Amylmetacresol 0.6mg +

2,4 Dichlorobenzyl

Alcohol 1.2mg,

GS Lozenges 133/011 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4618

Strepsils Cool Mint Lozenges

Amylmetacresol 0.6mg +

2,4 Dichlorobenzyl

Alcohol 1.2mg

GS Lozenges 133/012 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4619Nurofen Cold & Flu Tablets

Ibuprofen 200mg +

Pseudoephedrine 30mg

P Tablet Uncoated 133/013 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4620Nurofen Tablets Ibuprofen 200mg

P Tablet Uncoated 133/014 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4621

Mycota Cream 25gZinc Undecenoate 5.0g +

Undecenoic Acid 1.25g

GS Cream Topical 133/015 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4622Transact 12 Hour Patches Flurbiprofen 40mg

P Transdermal patch 133/016 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4623Senokot Tablets Sennoside B 7.5mg

P Tablet Film coated 133/017 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4624

Strepsils Plus, Anaesthetic

lozenges

Amylmetacresol 0.6mg +

2.4 Dichlorobenzyl 1.2mg

+ Lignocaine 10.0mg

P Lozenges 133/018 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4625

Strepsils Intensive lozenges

(Honey & Lemon)Flurbiprofen 8.75mg

P Lozenges 133/019 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4626Strepsils Intensive Lozenges

Flurbiprofen Sodium

8.75mg

P Lozenges 133/020 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4627

Nurofen For Children Strawberry

Suspension

Ibuprofen 2% w/v

(100mg, per 5ml)

P Solution for Oral

Use

133/021 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4628

Nurofen For Children Sugar

Free SyrupIbuprofen 100mg, per 5ml

P Syrup 133/022 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4629

Nurofen 400 Period Pain

TabletsIbuprofen 400mg

P Tablet Film coated 133/023 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4630

Gaviscon Double Action Liquid

Sodium Alginate 500mg

+ Sodium Bicarbonate

213mg + Calcium

Carbonate 325mg

GS Suspension for

Oral Use

133/024 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4631

Gaviscon Double Action Tablet

Sodium Alginate 250mg

+ Sodium Bicarbonate

106.05mg + Calcium

Carbonate 187.50mg

GS Tablet Uncoated 133/025 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4632

Nurofen Maximum Strength 684

CapletsIbuprofen Lysin 684mg

P Tablet Film coated 133/026 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4633

Nurofen Tension Headache 342

CapletsIbuprofen Lysin 342mg

P Tablet Film coated 133/027 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4634

Nurofen Express 400 Liquid

CapsulesIbuprofen 400mg

P Capsule, Soft 133/028 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4635

Gaviscon Double Action Liquid

Sachets

Sodium Alginate 500mg

+ Sodium Bicarbonate

213mg + Calcium

Carbonate 325mg

GS Suspension for

Oral Use

133/029 Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4636

E45 Cream White Paraffin 14.5g

+Light Paraffin 12.6g +

Anhydrous Lanol

GS 133/035L Reckitt Benckiser Pharmaceutical (Pty) Ltd,

SA

4637Disprin 300mg Tablets Aspirin 300mg

GS Tablets Uncoated 133/001 Reckitt Benkiser Pharmaceuticals S.A.(Pty)

Ltd, South Africa

4638Disprin 500mg Tablets Aspirin 500mg

GS Tablets Uncoated 133/002 Reckitt Benkiser Pharmaceuticals S.A.(Pty)

Ltd, South Africa

Page 239 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4639Mycota Powder

Zinc Undecenoate 20%

w/w

GS Powder Topical 133/003 Reckitt Benkiser Pharmaceuticals S.A.(Pty)

Ltd, South Africa

4640

Gaviscon Tablets

Alginic Acid 500 +

Sodium Bicarbonate

213mg + Calcium

Carbonate 325.0mg

GS Suspension for

Oral Use

133/004 Reckitt Benkiser Pharmaceuticals S.A.(Pty)

Ltd, South Africa

4641

Gaviscon Original Aniceed

Sodium Algnite 500mg +

Sodium Hydrogen

Carbonate 213mg +

Calcium Carbonate

325mg

GS Suspension for

Oral Use

133/005 Reckitt Benkiser Pharmaceuticals S.A.(Pty)

Ltd, South Africa

4642

Gaviscon Peppermint Liquid

Sodium Algnite 500mg +

Sodium Hydrogen

Carbonate 213mg +

Calcium Carbonate

325mg

GS Suspension for

Oral Use

133/006 Reckitt Benkiser Pharmaceuticals S.A.(Pty)

Ltd, South Africa

4643

Bonjela Clear Gel

Centalkonium Chloride

0.010% w/w + Choline

Salicylate 8.714 % w/w

GS Gel Topical 133/007 Reckitt Benkiser Pharmaceuticals S.A.(Pty)

Ltd, South Africa

4644

Delased Chesty Syrup

Diphenhydramine

Hydrochloride BP 14mg +

Ammonium Chloride BP

135mg + Sodium Citrate

BP 57mg + Menthol

1.1mg, per 5ml.

P Syrup 205/001 Regal Pharmaceuticals Limited,Kenya

4645

Delased Dry Syrup

Menthol 2mg + Sodium

Citrate 57mg +

Dextrometherphan 6.5mg

+ Diphenhydramine

14mg

P Syrup 205/002 Regal Pharmaceuticals Limited,Kenya

4646

Coldcap Syrup

Chlorpheniramine

Maleate BP 2mg +

Pseudoephedrine

Hydrochloride BP 10mg +

Paracetamol BP 120mg,

per 5ml.

P Syrup 205/003 Regal Pharmaceuticals Limited,Kenya

Page 240 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4647

Delased Peadiatric Syrup

Diphenhydramine

Hydrochloride BP 7mg +

Sodium Citrate BP

28.5mg + Menthol BP

0.55mg, per 5ml.

P Syrup 205/004 Regal Pharmaceuticals Limited,Kenya

4648

Coldcap Capsules

Phenylephrine 30mg +

Caffeine 30mg +

Paracetamol 100mg +

Chlorpheniramine 4mg

P Capsule oral 205/005 Regal Pharmaceuticals Limited,Kenya

4649Whitfield Ointment

Salicylic Acid 30mg +

Benzoic Acid 60mg

P Ointment topical 205/006 Regal Pharmaceuticals Limited,Kenya

4650 Rinavit Syrup Multivitamins GS Syrup 205/007 Regal Pharmaceuticals Limited,Kenya

4651Ibumex Suspension Ibuprofen 100mg, per 5ml

P Suspension for

Oral Use

205/008 Regal Pharmaceuticals Limited,Kenya

4652Rinalin Syrup

Chlorpheniramine

2mg/5ml

P Syrup 205/009 Regal Pharmaceuticals Limited,Kenya

4653 Megayl - 200 Tablets Metronidazole 200mg POM Tablet Uncoated 205/010 Regal Pharmaceuticals Limited,Kenya

4654Cetamol Syrup

Paracetamol 120mg, per

5ml

GS Syrup 205/011 Regal Pharmaceuticals Limited,Kenya

4655 Salbutamol Syrup Salbutamol 2mg, per 5ml POM Syrup 205/012 Regal Pharmaceuticals Limited,Kenya

4656

Compound Magnesium Tablets

Aluminium Hydrochloride

125mg + Magnesium

Trisilicate 250mg

GS Tablet Uncoated 205/013 Regal Pharmaceuticals Limited,Kenya

4657

Ruben Cream

White Soft Paraffin +

Methyl Salicylate +

Capsicum Oleoresin

P Cream Topical 205/014 Regal Pharmaceuticals Limited,Kenya

4658 Cetanol Tablets Paracetamol 500mg GS Tablet Uncoated 205/015 Regal Pharmaceuticals Limited,Kenya

4659

Trimex Mucolytic Syrup

Salbutamol 2mg +

Bromhexine 4mg +

Guanfenesin 100mg

P Syrup 205/016 Regal Pharmaceuticals Limited,Kenya

4660 Ibumex Tablets Ibuprofen 200mg P Tablet Uncoated 205/017 Regal Pharmaceuticals Limited,Kenya

4661 Intamine Cream Mepyramine 20mg P Cream Topical 205/018 Regal Pharmaceuticals Limited,Kenya

4662

Magnomint Suspension

Aluminium Hydrochloride

250mg + Magnesium

Trisilicate 250mg

GS Suspension for

Oral Use

205/019 Regal Pharmaceuticals Limited,Kenya

4663

Intaplex Tablets

Nicotinamide 15mg +

Riboflavin 1mg +

Thiamine Hydrochloride

1mg

P Tablet Film coated 205/020 Regal Pharmaceuticals Limited,Kenya

Page 241 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4664Unixil Oral Suspension

Amoxicilin Trihydrate Bp

125mg, per 5ml

POM Powder for Oral

Suspension

205/021 Regal Pharmaceuticals Limited,Kenya

4665

TrastuRel 150 Injection Trastuzumab 150mg POM Solution for

infusion

451/001 Reliance Life Sciences Pvt Ltd

4666

TrastuRel 440 Injection Trastuzumab 440mg POM Solution for

Injection

451/002 Reliance Life Sciences Pvt Ltd

4667 Cilox Tablets Ofloxacin 200mg POM Tablet Film coated 209/001 Remedica Ltd, Cyprus

4668 Alfoxan 250 Capsules Mefenamic Acid 250mg P Capsule oral 209/002 Remedica Ltd, Cyprus

4669 Cyclovax 200 Tablets Acylovir 200mg POM Tablet Film coated 209/003 Remedica Ltd, Cyprus

4670 Ibuprofen Tablets Ibuprofen 200mg P Tablet Film coated 209/004 Remedica Ltd, Cyprus

4671 Korandil 10 Tablets Enalapril 10mg POM Tablet Uncoated 209/005 Remedica Ltd, Cyprus

4672 Nifelat Sr Tablets Nifedipine 20mg POM Tablet Film coated 209/006 Remedica Ltd, Cyprus

4673 Nifelat 10 Tablets Nifedipine 10mg POM Tablet Film coated 209/007 Remedica Ltd, Cyprus

4674 Ova-Mit 50 Tablets Clomifene 50mg POM Tablet Film coated 209/008 Remedica Ltd, Cyprus

4675 Remethan 25 Tablets Diclofenac 25mg P Tablet Film coated 209/009 Remedica Ltd, Cyprus

4676 Roxitan 10 Capsules Piroxicam 10mg POM Capsule oral 209/010 Remedica Ltd, Cyprus

4677 Zindolin 250 Tablets Ciprofloxacin 250mg POM Tablet Film coated 209/011 Remedica Ltd, Cyprus

4678Calcium + Vitamin D Tablets

Calcium 1200mg +

Vitamin D 3600IU

P Tablet Uncoated 367/001L Robinson Pharma, INC

4679 Garlic Oil Soft Gels Garlic Oil 5000mg P Capsule oral 367/002L Robinson Pharma, INC

4680Multi-Enzyme Complete Tablets

Calcium 110mg + Multi-

Enzyme Blend 430mg

P Tablet Uncoated 367/003L Robinson Pharma, INC

4681 Co-Enzyme Q10 Softgels Co-Enzyme Q10 50mg P Capsule oral 367/004L Robinson Pharma, INC

4682 Women Once A Day Tablets Multivitamins & Minerals P Tablet Uncoated 367/005L Robinson Pharma, INC

4683

Acetyl L - Carnitine Tablets

Calcium Carbinate

150mg + Alpha Lipoic

Acid 200mg + Acetyl L

Carnitine 500mg

P Tablet Uncoated 367/006L Robinson Pharma, INC

4684Green Tea Extract Softgels

Green Tea Extract

320mg

P Capsule oral 367/007L Robinson Pharma, INC

4685

Liquid Absorbable Calcium

Softgels

Vitamin D 200iu +

Calcium Carbonate

1000mg

P Capsule oral 367/008L Robinson Pharma, INC

4686 Beta Carotene Softgels Vitamin A 25000IU P Capsule oral 367/009L Robinson Pharma, INC

4687 Men Daily Tablets Multivitamins & Minerals P Tablet Uncoated 367/010L Robinson Pharma, INC

4688 Saw Palmetto 450 Capsules Saw Palmetto 450mg P Capsule oral 367/011L Robinson Pharma, INC

4689 Super B Complex Capsules Vitamin B Complex P Capsule oral 367/012L Robinson Pharma, INC

4690 Aloe Vera 25 Softgels Aloe Vera 25mg P Capsule oral 367/013L Robinson Pharma, INC

Page 242 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4691

Glucosamine Sulphate 1000

Capsules

Glucosamine Sulphate

1000mg

P Capsule oral 367/014L Robinson Pharma, INC

4692 Melatonin 5 Tablets Melatonin 5mg P Tablet Uncoated 367/015L Robinson Pharma, INC

4693 Vitamin D 2000IU Softgel Vitamin D 2000IU P Capsule oral 367/016L Robinson Pharma, INC

4694Resveratrol Complex Capsules

Resveratrol Complex

260mg

P Capsule oral 367/017L Robinson Pharma, INC

4695Rubuphine 10 Injection

Nelbuphine

Hydrochloride 10mg

POM Solution for

Injection

359/001 RUSAN PHARMA LIMITED

4696Rubuphine 20 Injection

Nelbuphine

Hydrochloride 20mg

POM Solution for

Injection

359/002 RUSAN PHARMA LIMITED

4697BP -Care Tablets

Telmisartan 20mg +

Amlodipine 2.5mg

POM Tablet Uncoated 354/001 S3K Private Limited, India

4698BP-Care Tablets

Telmisartan 40mg +

Amlodipine 5mg

POM Tablet Uncoated 354/002 S3K Private Limited, India

4699

GM - Pride Tablets

Glimepiride 2mg +

Metformin Hydrochloride

500mg

POM Tablet Film coated 354/003 S3K Private Limited, India

4700Safecoat Aspirin 75mg Tablets Aspirin 75mg

POM Tablet Enteric

Coated

354/004 S3K Private Limited, India

4701 Moxypen Capsules Amoxicillin BP 250mg POM Capsule oral 032/001 SADM Pharmaceuticals Ltd, Malawi

4702 Puromylon Tablets Nalidixic Acid 500mg POM Tablet Uncoated 032/002 SADM Pharmaceuticals Ltd, Malawi

4703 Trichozole Tablets Metronidazole 200mg POM Tablet Uncoated 032/003 SADM Pharmaceuticals Ltd, Malawi

4704Len VK Tablets

Phenoxymethyl Penicillin

BP 250mg

POM Tablet Uncoated 032/004 SADM Pharmaceuticals Ltd, Malawi

4705

Doxycline CapsulesDoxycycline

Hydrochloride BP 100mg

POM Capsule oral 032/005 SADM Pharmaceuticals Ltd, Malawi

4706Quinine Tablets Quinine Sulphate 300mg

POM Tablet Enteric

Coated

032/006 SADM Pharmaceuticals Ltd, Malawi

4707 Pertecillin Capsules Ampicillin 250mg POM Tablet Uncoated 032/007 SADM Pharmaceuticals Ltd, Malawi

4708

Trimaprim Tablets

Sulphamethoxazole

400mg + Trimethoprim

80mg

POM Tablet Uncoated 249/001 Saga Laboratories, India

4709 Flamcid Capsules Indomethacin BP 25mg P Capsule oral 249/002 Saga Laboratories, India

4710Safexin 500mg Capsules

Cephalexin Anhydrous

BP 500mg

POM Capsule oral 249/003 Saga Laboratories, India

4711Q-Bact Tablets

Ciprofloxacin USP

500mg

POM Tablet Uncoated 249/004 Saga Laboratories, India

4712 Rufen 200 Tablets Ibuprofen 200mg P Tablet Uncoated 249/005 Saga Laboratories, India

Page 243 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4713Rythrocine Tablets

Erythromycin Estolate BP

250mg

POM Tablet Uncoated 249/006 Saga Laboratories, India

4714 Omecid Capsules Omeprazole 20mg POM Capsule oral 249/007 Saga Laboratories, India

4715 Finapril Tablets Enalapril Maleate 20mg POM Tablet Uncoated 249/008 Saga Laboratories, India

4716 Finapril Tablets Enalapril 10mg POM Tablet Uncoated 249/009 Saga Laboratories, India

4717 Finapril Tablets Enalapril 5mg POM Tablet Uncoated 249/010 Saga Laboratories, India

4718Hexantel Tablets Pyrantel Pamoate 125mg

POM Tablet Uncoated 249/011 Saga Laboratories, India

4719 Eze DT Tablets Cetirizine 10mg POM Tablet Uncoated 249/012 Saga Laboratories, India

4720 Antipress 100 Tablets Atenolol 100mg POM Tablet Uncoated 249/013 Saga Laboratories, India

4721 Antipress 50 Tablets Atenolol 50mg POM Tablet Uncoated 249/014 Saga Laboratories, India

4722 Nifetab 10 Tablets Nifedipine 10mg POM Tablet Uncoated 249/015 Saga Laboratories, India

4723Nifetab 20 Tablets Nifedipine 20mg

POM Tablet extended

release

249/016 Saga Laboratories, India

4724 Vitarich Tablets Multivitamins + Minerals POM Tablet Uncoated 249/017 Saga Laboratories, India

4725 Allerban Tablets Loratadine 10mg POM Tablet Uncoated 249/018 Saga Laboratories, India

4726 Pyranim Tablets Nimesulide 100mg POM Tablet Uncoated 249/019 Saga Laboratories, India

4727 Piroximicam Tablets Piroxicam 20mg POM Tablet Uncoated 249/020 Saga Laboratories, India

4728

Diarid Suspension

Metronidazole 100mg +

Norfloxacin 100mg, per

5ml

POM Suspension for

Oral Use

249/021 Saga Laboratories, India

4729ACE Selenium Tablets

Vitamin A,C,E With

Selenium

P Tablet Uncoated 249/022 Saga Laboratories, India

4730

Diarest Suspension

Metronidazole 100mg +

Furazolidone 30mg, per

5ml

POM Suspension for

Oral Use

249/023 Saga Laboratories, India

4731

Airmax -Plus Syrup

Ambroxol 15mg +

Salbutamol Sulphate 1mg

+ Guaphenesin 50mg +

Menthol 1mg

POM Syrup 249/024 Saga Laboratories, India

4732Abvit Drops Multivitamins

GS Solution for Oral

Use

249/025 Saga Laboratories, India

4733

Lamoryl Suspension

Paracetamol 125mg +

Phenylephrine 2.5mg +

Chlopheniramine Maleate

1mg, per 5ml

P Suspension for

Oral Use

249/026 Saga Laboratories, India

4734

Iburex Capsules

Caffeine 30mg +

Paracetamol 325mg +

Ibuprofen 200mg

P Capsule oral 249/027 Saga Laboratories, India

Page 244 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4735Hexantel Suspension Pyrantel Pamoate 250mg

POM Suspension for

Oral Use

249/028 Saga Laboratories, India

4736Lotenz Tablets

Lorsartan Potassium

50mg

POM Tablet Uncoated 249/029 Saga Laboratories, India

4737

Lotenz-H

Lorsartan Potassium

50mg +

Hydrochlorothiazide

12.5mg

POM Tablet Uncoated 249/030 Saga Laboratories, India

4738Sefixi Injection Ceftriaxone 1g

POM Powder for

Injection

401/001 Sakar Health Care Pvt India

4739Samero Meropenem 1g

POM Powder for

Injection

401/002 Sakar Health Care Pvt India

4740Silpen -1000 Injection

Impenem 500mg +

Cilastatin 500mg

POM Powder for

Injection

401/003 Sakar Health Care Pvt India

4741

Malacur Tablets

Dihydroartemisinin 40mg

+ Piperaquine Phosphate

320mg

POM Tablet Uncoated 350/001 Salvat, SA

4742

Malacur Powder For Oral

Suspension

Dihydroartemisinin 90mg

+ Piperaquine Phosphate

720mg, per 60ml

POM Powder for Oral

Suspension

350/002 Salvat, SA

4743Clindahexal 150 Capsules

Clindamycin

Hydrochloride 150mg

POM Capsule oral 039/033 Sandoz (SA) Limited

4744

Rifampicin BP150mg / Isoniazid

BP 75mg

Rifampicin 150mg +

Isoniazid 75mg

POM Tablet Uncoated 308/001 Sandoz Private Limited,India

4745

Rimstar -4-FDC Tablets

Rifampicin + Isoniazide +

Pyrazinamide +

Ethambutol

Hydrochloride

POM Tablet Uncoated 308/002 Sandoz Private Limited,India

4746ACC 200 Effevescent Tablets n- Acetylcysteine 200mg

p Tablet Effervescent 039/001 Sandoz Pvt Limited, S.A

4747ACC 600 Effervescent Tablets n- Acetylcysteine 600mg

P Tablet Effervescent 039/002 Sandoz Pvt Limited, S.A

4748Clatax 0.5g Injection Cefotaxime 0.5g

POM Powder for

Injection

039/003 Sandoz Pvt Limited, S.A

4749Clatax 1.0g Injection Cefotaxime 1.0g

POM Powder for

Injection

039/004 Sandoz Pvt Limited, S.A

4750Kefzol 500 Powder for Injection Cefazolin 500mg

POM Powder for

Injection

039/005 Sandoz Pvt Limited, S.A

Page 245 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4751Kefzol 1g Powder for Injection Cefazolin 1g

POM Powder for

Injection

039/006 Sandoz Pvt Limited, S.A

4752Lopedium Effevescent Tablets Loperamide 2mg

POM Tablet Effervescent 039/007 Sandoz Pvt Limited, S.A

4753

Sandoz Co Amoxyclav 0.6g

/20ml Injection

Amoxycillin 500mg +

Clavulanate 100mg

POM Powder for

Injection

039/008 Sandoz Pvt Limited, S.A

4754

Sandoz Co Amoxyclav

1.2g/20ml Injection

Amoxycillin 1000mg +

Clavulanate 200mg

POM Powder for

Injection

039/009 Sandoz Pvt Limited, S.A

4755

Sandoz Co Amoxyclav 625mg

Tablets

Amoxicillin 500mg +

Clavulanate 125mg

POM Tablet Film coated 039/011 Sandoz Pvt Limited, S.A

4756

Sandoz Co Amoxuclav 1000

Tablets

Amoxycillin 875mg +

Clavulanate 125mg

POM Tablet Film coated 039/012 Sandoz Pvt Limited, S.A

4757

Sandoz Co Amoxyclav BD

Suspension

Amoxycillin 400mg +

Clavulanate 57mg

POM Powder for Oral

Suspension

039/013 Sandoz Pvt Limited, S.A

4758

Sandoz Co Amoxyclav S

Suspension

Amoxycillin 125mg +

Clavulanate 31.25mg

POM Powder for Oral

Suspension

039/014 Sandoz Pvt Limited, S.A

4759

Sandoz Co- Amoxyclav SF

Suspension

Amoxycillin 250mg +

Clavulanate 62.5mg, per

5ml

POM Powder for Oral

Suspension

039/015 Sandoz Pvt Limited, S.A

4760

Sandoz Carbamezapine CR 200

TabletsCarbamezapine 200mg

POM Tablet delayed

Release

039/016 Sandoz Pvt Limited, S.A

4761

Sandoz Carbamezapine CR

400mg TabletsCarbamezapine 400mg

POM Tablet delayed

Release

039/017 Sandoz Pvt Limited, S.A

4762 Tramhexal Capsules Tramadol 50mg POM Capsule oral 039/018 Sandoz Pvt Limited, S.A

4763Tramhexal 100mg/2ml Injections Tramadol 100mg per 2ml

POM Solution for

Injection

039/019 Sandoz Pvt Limited, S.A

4764 Sandoz Atorvastatin 10 Tablets Atorvastalin 10mg POM Tablet Uncoated 039/020 Sandoz Pvt Limited, S.A

4765 Sandoz Atorvastatin 20 Tablets Atorvastalin 20mg POM Tablet Uncoated 039/021 Sandoz Pvt Limited, S.A

4766 Sandoz Atorvastatin 40 Tablets Atorvastalin 40mg POM Tablet Uncoated 039/022 Sandoz Pvt Limited, S.A

4767 Sandoz Atorvastatin 80 Tablets Atorvastalin 80mg POM Tablet Uncoated 039/023 Sandoz Pvt Limited, S.A

4768Hexal - MPA 10 Tablets

Medroxyprogesterone

10mg

POM Tablet Uncoated 039/026 Sandoz Pvt Limited, S.A

4769Hexal - MPA 5 Tablets

Medroxyprogesterone

5mg

POM Tablet Uncoated 039/027 Sandoz Pvt Limited, S.A

4770 Terbane 250mg Tablets Terbinafine 250mg POM Tablet Uncoated 039/028 Sandoz Pvt Limited, S.A

4771 Terbane 10mg Cream Terbinafine 10mg POM Cream Topical 039/029 Sandoz Pvt Limited, S.A

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4772

Los -Arb Comp 100 Tablets

Lorsartan Potassium

100mg +

Hydrochlorothiazide

25mg

POM Tablet Uncoated 039/031 Sandoz Pvt Limited, S.A

4773

Los -Arb Comp 50 Tablets

Lorsartan Potassium

50mg +

Hydrochlorothiazide

12.5mg

POM Tablet Uncoated 039/032 Sandoz Pvt Limited, S.A

4774

Capectabine Sandoz 500 Film

Coated TabletsCapacetabine 500mg

POM Tablet Film coated 039/034 Sandoz Pvt Limited, S.A

4775

Capectabine Sandoz 150 Film

Coated TabletsCapacetabine 150mg

POM Tablet Film coated 039/035 Sandoz Pvt Limited, S.A

4776Epipro 300 CR Tablets Sodium Valproate 300mg

POM Tablet Modified

Release

039/036 Sandoz Pvt Limited, S.A

4777Epipro 500 CR Tablets Sodium Valproate 500mg

POM Tablet Modified

Release

039/037 Sandoz Pvt Limited, S.A

4778

Gentamycin 80mg per 2ml

Injection

Gentamycin Suliphate

80mg per 2ml

POM Solution for

Injection

039/038 Sandoz Pvt Limited, S.A

4779 Hexal - Lisinopril 5 Tablets Lisinopril Dihydrate 5mg POM Tablet Uncoated 039/039 Sandoz Pvt Limited, S.A

4780Hexal - Lisinopril 10 Tabletrs Lisinopril Dihydrate 10mg

POM Tablet Uncoated 039/040 Sandoz Pvt Limited, S.A

4781Hexal - Lisinopril 20 Tablets Lisinopril Dihydrate 20mg

POM Tablet Uncoated 039/041 Sandoz Pvt Limited, S.A

4782 HR-Enalapril Maleate 5 Tablets Enalapril Maleate 5mg POM Tablet Uncoated 039/042 Sandoz Pvt Limited, S.A

4783HR-Enalapril Maleate 10 Tablets Enalapril Maleate 10mg

POM Tablet Uncoated 039/043 Sandoz Pvt Limited, S.A

4784HR-Enalapril Maleate 20 Tablets Enalapril Maleate 20mg

POM Tablet Uncoated 039/044 Sandoz Pvt Limited, S.A

4785 Pixicam 20 Tablets Piroxicam 20mg P Tablet Uncoated 039/045 Sandoz Pvt Limited, S.A

4786Vancocin CP 1g Injection

Vancomycin

Hydrochloride 1g

POM Powder for

Injection

039/046 Sandoz Pvt Limited, S.A

4787Vancocin CP 500 Injection

Vancomycin

Hydrochloride 500mg

POM Powder for

Injection

039/047 Sandoz Pvt Limited, S.A

4788 Zomevak 80 Tablets Valsartan 80mg POM Tablet Uncoated 039/048 Sandoz Pvt Limited, S.A

4789 Zomevak 160 Tablets Valsartan 160mg POM Tablet Uncoated 039/049 Sandoz Pvt Limited, S.A

4790

Sandoz Levofloxacin 500

Tablets

Levofloxacin

Hemihydrate 500mg

POM Tablet Film coated 039/050 Sandoz Pvt Limited, S.A

4791

Sandoz Isosorbide Dinitrate 30

Tablets

Isorsorbide Dinitrate

30mg

POM Tablet Uncoated 039/051 Sandoz Pvt Limited, S.A

Page 247 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4792

Cetirizine HEXAL -1 SyrupCetirizine Dihydrochloride

10mg per 5ml

P Solution for Oral

Use

039/052 Sandoz Pvt Limited, S.A

4793Cetirizine Hexal 10 Tablets

Cetirizine Hydrochloride

10mg

P Solution for Oral

Use

039/053 Sandoz Pvt Limited, S.A

4794Dantron 4mg Injection

Ondansetron

Hydrochloride 4mg

POM Solution for

Injection

039/054 Sandoz Pvt Limited, S.A

4795

Dantron 8mg Injection

Ondansetron

Hydrochloride Dihydrate

8mg

POM Solution for

infusion

039/055 Sandoz Pvt Limited, S.A

4796

Dantron 4mg Tablets

Ondansetron

Hydrochloride Dihydrate

4mg

POM Tablet Uncoated 039/056 Sandoz Pvt Limited, S.A

4797

Doxorubicin Hexal 10mg/5ml

Infusion

Doxorubicin

Hydrochloride 10mg, per

5ml

POM Solution for

infusion

039/057 Sandoz Pvt Limited, S.A

4798

Sandoz Isorsobide Dinitrate 5

Sublingual TabletIsorsobide Dinitrate 5 Mg

POM Tablet Sublingual 039/058 Sandoz Pvt Limited, S.A

4799

Sandoz Isorsobide Dinitrate 30

Tablet

Isorsobide Dinitrate 30

Mg

POM Tablet Uncoated 039/059 Sandoz Pvt Limited, S.A

4800

Doxorubicin Hexal 50mg, per

25ml Infusion

Doxorubicin

Hydrochloride 50mg, per

25ml

POM Solution for

infusion

039/060 Sandoz Pvt Limited, S.A

4801 Lorano Tablets Loratadine 10mg P Tablet Uncoated 039/061 Sandoz Pvt Limited, S.A

4802Clenil AQ Nasal Spray

Beclomethasone

Dipropionate 50mcg

POM Solution for

Inhalation

039/062 Sandoz Pvt Limited, S.A

4803Clomihexal Tablets Clomiphene Citrate 50mg

POM Tablet Uncoated 039/063 Sandoz Pvt Limited, S.A

4804 Oxiceb 100 Mg Capsules Celecoxib 100mg POM Capsules oral 039/084 Sandoz Pvt Limited, S.A

4805 Oxiceb 200 Mg Capsules Celecoxib 200mg POM Capsules oral 039/085 Sandoz Pvt Limited, S.A

4806

Airflusal Forspiro

Salmeterol Xinafoate

50µg + Fluticasone

Propionate 250µg

POM Inhaler 039/086 Sandoz Pvt Limited, S.A

4807

Airflusal Forspiro

Salmeterol Xinafoate

50mcg + Fluticasone

Propionate 500mcg

POM Inhaler 039/087 Sandoz Pvt Limited, S.A

4808

Salbutamol Sandoz 100 µg, per

Dose Pressurised Inhalation

Salbutamol 100 µg, per

Dose

POM Inhaler 039/088 Sandoz Pvt Limited, S.A

Page 248 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4809

Mometasone Sandoz 50

Mometasone Furoate

Monohydrate 50mg, per 1

Dose

POM Inhaler 039/089 Sandoz Pvt Limited, S.A

4810

Metformin 1000 Film Coated

Tablets

Metformin Hydrochloride

1000mg

POM Tablet Film coated 039/090 Sandoz Pvt Limited, S.A

4811

Metformin 500 Film Coated

Tablets

Metformin Hydrochloride

500mg

POM Tablet Film coated 039/091 Sandoz Pvt Limited, S.A

4812

Anastrozole Sandoz 1mg

TabletsAnastrozole 1mg

POM Tablet Film coated 039/092 Sandoz Pvt Limited, S.A

4813 Fenahex 20 mg Tamoxifen Citrate 20 mg POM Tablet Uncoated 039/093 Sandoz Pvt Limited, S.A

4814 Simvastatin 20 mg Simvastatin 20 mg POM Tablet Film coated 039/094 Sandoz Pvt Limited, S.A

4815 Simvastatin 40 mg Simvastatin 40 mg POM Tablet Film coated 039/095 Sandoz Pvt Limited, S.A

4816Ospamox 1000 Tablets

Amoxicillin Trihydrate

1000mg

POM Tablet Uncoated 039/096 Sandoz Pvt Limited, S.A

4817 Ospamox 500 Tablets Amoxicillin 500mg POM Tablet Uncoated 039/097 Sandoz Pvt Limited, S.A

4818Voriconazole Sandoz 50 Tablets Voriconazole 50mg

POM Tablet Uncoated 039/098 Sandoz Pvt Limited, S.A

4819 Nexmezol 20 Esomeprazole 20mg POM Tablet Uncoated 039/099 Sandoz Pvt Limited, S.A

4820 Nexmezol 40 Esomeprazole 40mg POM Tablet Uncoated 039/100 Sandoz Pvt Limited, S.A

4821 Deslatyne 5 Tablets Desloratidine 5mg POM Tablet Uncoated 039/101 Sandoz Pvt Limited, S.A

4822 Furose 40 Tablets Frusemide 40mg POM Tabet Uncoated 039/102 Sandoz Pvt Limited, S.A

4823Topraflux 40 IVI Injection

Pantoprazole Sodium

Sesquihydrate BP 40mg

POM Solution for

Injection

039/103 Sandoz Pvt Limited, S.A

4824 Amlodipine 5 mg Amlodipine 5 mg POM Tablet Uncoated 039/104 Sandoz Pvt Limited, S.A

4825 Amlodipine 10 mg Amlodipine 10 mg POM Tablet Uncoated 039/105 Sandoz Pvt Limited, S.A

4826

Sandaz Azithromycin 500

TabletsAzithromycin 500mg

POMTablet Uncoated

039/106Sandoz Pvt Limited, S.A

4827Azithromycin 200 Sandoz Syrup Azithromycin 200mg

POM Solution for Oral

Use

039/107Sandoz Pvt Limited, S.A

4828

Voriconazole Sandoz 200

TabletsVoriconazole 200mg

POM Tablet Film Coated 039/108Sandoz Pvt Limited, S.A

4829

Sandoz Co Amoxyclav 375

Tablets

Amoxycillin 250mg +

Clavulanate 125mg

POM Tablet Film coated 039/010 Sandoz Pvt Limited, South Africa

4830 Bisohexal 10 Tablets Bisoprolol 10mg POM Tablet Uncoated 039/024 Sandoz Pvt Limited, South Africa

4831 Bisohexal 5 Tablets Bisoprolol 5mg POM Tablet Uncoated 039/025 Sandoz Pvt Limited, South Africa

4832Sintrine 5 Chewable Tablets

Montelukast Sodium BP

5mg

POM Tablet Chewable 039/064 Sandoz Pvt Limited, South Africa

4833Sintrine 10 Chewable Tablets

Montelukast Sodium BP

10mg

POM Tablet Chewable 039/065 Sandoz Pvt Limited, South Africa

Page 249 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4834

Dantron 8 Tablets

Ondansetron

Hydrochloride Dihydrate

8mg

POM Tablet Uncoated 039/066 Sandoz Pvt Limited, South Africa

4835Hexaide 25mg Tablets

Hydrochlorothiazide

25mg

POM Tablet Film coated 039/067 Sandoz Pvt Limited, South Africa

4836 Coughspan Dried Ivy Leaves 0.9g P Syrup 039/068 Sandoz Pvt Limited, South Africa

4837Curitaz 4,5 Infusion Powder

Piperacilline 4g +

Tozobactam 0.5g

POM Powder for

Injection

039/069 Sandoz Pvt Limited, South Africa

4838Linex Capsules

Bifidobacterium Animalis

Sub Spp. 280mg

P Capsule oral 039/070 Sandoz Pvt Limited, South Africa

4839Linex Baby Sachets

Bifidobacterium Animalis

Sub Spp. 100mg

P Granules for

Suspension

039/071 Sandoz Pvt Limited, South Africa

4840

Gemcitabine Ebewe Injection

Gemcitabine

Hydrochloride 10mg, per

ml

POM Solution for

Injection

039/076 Sandoz Pvt Limited, South Africa

4841 Probitor 40 Capsules Omeprazole 40mg POM Capsule oral 039/077 Sandoz Pvt Limited, South Africa

4842

Sandoz - Isosorbide Dinitrate 5

Sublingual TabletsIsorsorbide Dinitrate 5mg

POM Tablet Sublingual 039/078 Sandoz Pvt Limited, South Africa

4843

Sandoz Isosorbide dinitrate 10

tablets

Isorsorbide Dinitrate

10mg

POM Tablet Uncoated 039/079 Sandoz Pvt Limited, South Africa

4844Sandoz Levofloxacin 250 tablets

Levofloxacin

Hemihydrate 250mg

POM Tablet Film coated 039/080 Sandoz Pvt Limited, South Africa

4845 Bromaze 6 tablets Bromazepam 6mg POM Tablet Uncoated 039/081 Sandoz Pvt Limited, South Africa

4846

Bacitracin Zinc + Neomycin

Sulphate

Bacitracin Zinc 5000IU +

Neomycin Sulphate

250mg

POM Powder for Topical

use

039/082 Sandoz Pvt Limited, South Africa

4847Dozalgic C Sachets

Paracetamol 500mg +

Ascorbic Acid 300mg

P Powder for Oral

Solution

039/083 Sandoz Pvt Limited, South Africa

4848

Retarpen 0.6 Injection Benzathine

BenzylPenicillin

600,000IU

POM Powder for

Injection

039/118 Sandoz Pvt Limited, South Africa

4849

Retarpen 2.4 Injection Benzathine

Benzylpenicillin Ph. Eur.

2,400,000 IU

POM Powder for

Injection

039/120 Sandoz Pvt Limited, South Africa

4850

Retarpen 1.2 Injection Benzathine

BenzylPenicillin

1,200,000IU

POM Powder for

Injection

039/119 Sandoz Pvt Limited, South Africa

4851 Phenergan 10mg Tablets Promethazine 10mg P Tablets 175/001 Sanofi Aventis Pharma Limited

4852 Phenergan 25 Tablets Promethazine 25mg P Tablet Film coated 175/002 Sanofi Aventis Pharma Limited

Page 250 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4853Phenergan Elixir

Promethazine 5mg, per

5ml

P Elixir 175/003 Sanofi Aventis Pharma Limited

4854 Tritace 5 Tablets Ramipril 5mg POM Tablet Uncoated 175/004 Sanofi Aventis Pharma Limited

4855 Tritace 2.5 Tablets Ramipril 2.5mg POM Tablet Uncoated 175/005 Sanofi Aventis Pharma Limited

4856 Largactil 100mg Tablets Chlorpromazine 100mg POM Tablet Uncoated 175/006 Sanofi Aventis Pharma Limited

4857Largactil Injection

Chlorpromazine 50mg,

per 2ml

POM Solution for

Injection

175/007 Sanofi Aventis Pharma Limited

4858 Largactil 25 Tablets Chlorpromazine 25mg POM Tablet Film coated 175/008 Sanofi Aventis Pharma Limited

4859Stemetil Injection

Prochlorperazine

Mesylate 12.5mg, per ml

POM Solution for

Injection

175/009 Sanofi Aventis Pharma Limited

4860Stemitil 5 Tablets

Prochloperazine

Mesylate BP 5mg

POM Tablet Uncoated 175/010 Sanofi Aventis Pharma Limited

4861 Flagyl Suppository Metronidazole 1g POM Suppository 175/011 Sanofi Aventis Pharma Limited

4862 Flagyl 400 Tablets Metronidazole 400mg POM Tablet Uncoated 175/012 Sanofi Aventis Pharma Limited

4863 Flagyl 200 Tablets Metronidazole 200mg POM Tablet Uncoated 175/013 Sanofi Aventis Pharma Limited

4864 Amaryl 4 Tablets Glimepiride 4mg POM Tablet Uncoated 175/014 Sanofi Aventis Pharma Limited

4865 Amaryl 2 Tablets Glimepiride 2mg POM Tablet Uncoated 175/015 Sanofi Aventis Pharma Limited

4866 Amaryl 1 Tablets Glimepiride 1mg POM Tablet Uncoated 175/016 Sanofi Aventis Pharma Limited

4867Flagyl Injection

Metronidazole 500mg,

per 100ml

POM Solution for

Injection

175/017 Sanofi Aventis Pharma Limited

4868Clexane 20 Injection

Enoxaparin 20mg, per

0.2ml

POM Solution for

Injection

175/018 Sanofi Aventis Pharma Limited

4869Clexane 60 Injection

Enoxaparin 60mg, per

0.6ml

POM Solution for

Injection

175/019 Sanofi Aventis Pharma Limited

4870Clexane 40 Injection

Enoxaparin 40mg, per

0.4ml

POM Solution for

Injection

175/020 Sanofi Aventis Pharma Limited

4871Clexane 80 Injection

Enoxaparin 80mg, per

0.8ml

POM Solution for

Injection

175/021 Sanofi Aventis Pharma Limited

4872

Amaryl-M 1mg/250mg Tablets

Glimepiride 1mg +

Metformin Hydrochloride

250mg

POM Tablet Uncoated 175/022 Sanofi Aventis Pharma Limited

4873

Amaryl-M 2mg/500mg Tablets

Glimepiride 2mg +

Metformin Hydrochloride

500mg

POM Tablet Uncoated 175/023 Sanofi Aventis Pharma Limited

4874 Xatral 10mg Tablets Alfuzosin 10mg POM Tablet Uncoated 175/024 Sanofi Aventis Pharma Limited

4875 Xatral 2.5mg Tablets Alfuzosin 2.5mg POM Tablet Uncoated 175/025 Sanofi Aventis Pharma Limited

4876 Daonil Tablets Glibenclamide 5mg POM Tablet Uncoated 175/026 Sanofi Aventis Pharma Limited

4877

Artesunate 25mg/Amodiaquine

67.5mg Tablets

Artesunate 25mg +

Amodiaquine 67.5mg

POM Tablet Uncoated 175/027 Sanofi Aventis Pharma Limited

Page 251 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4878

Coarsucam 25mg/67.5mg

Tablets

Artesunate 25mg +

Amodiaquine 67.5mg

POM Tablet Uncoated 175/028 Sanofi Aventis Pharma Limited

4879

Artesunate

50mg/Amodiaquine135mg

Tablets

Artesunate 50mg +

Amodiaquine 135mg

POM Tablet Uncoated 175/029 Sanofi Aventis Pharma Limited

4880

Coarsucam 50mg/135mg

Tablets

Artesunate 50mg +

Amodiaquine 135mg

POM Tablet Uncoated 175/030 Sanofi Aventis Pharma Limited

4881

Coarsucam 100mg/270 Mg

Tablets

Artesunate 100mg +

Amodiaquine 270mg

POM Tablet Uncoated 175/031 Sanofi Aventis Pharma Limited

4882

Artesunate 100/270

Amodiaquine Tablets

Artesunate 100mg +

Amodiaquine 270mg

POM Tablet Uncoated 175/032 Sanofi Aventis Pharma Limited

4883 Tritace 10mg Capsules Ramipril 10mg POM Tablet Uncoated 175/033 Sanofi Aventis Pharma Limited

4884Epilim CR 500 Tablets Sodium Valproate 500mg

POM Tablet Modified

Release

175/034 Sanofi Aventis Pharma Limited

4885Epilim CR 300 Tablets Sodium Valproate 300mg

POM Tablet Modified

Release

175/035 Sanofi Aventis Pharma Limited

4886

Imovax Polio Vaccine

In Activated Polio Virus

Type 1 ( Mahoney) 40

Units + Type 2(Mef-1) 8

Units + Type 3 (Saukett)

32 Units

POM Suspension for

Injection

175/036 Sanofi Aventis Pharma Limited

4887Shancol Vaccine

Vibrio Cholerae Straines

(Oral Cholera Vaccine)

POM Powder for

Injection

175/037 Sanofi Aventis Pharma Limited

4888 Fluconazole 150 Tablets Fluconazole 150mg POM Tablets 175/038 Sanofi Aventis Pharma Limited

4889Taxotere Injection

Docetaxel BP 20mg, per

ml

POM Powder for

Injection

175/039 Sanofi Aventis Pharma Limited

4890

Taxotere RTU 80mg/4ml

InjectionDocetaxel 80mg, per 4ml

POM Solution for

infusion

175/040 Sanofi Aventis Pharma Limited

4891

Allstar Reusable Insulin Delivery

DeviceMedical Device

P Medical Device 175/041L Sanofi Aventis Pharma Limited

4892 Calbio 200 Nasal Spray Calcitonin 200IU POM Spray , Eye Use 313/001 SAVA Medica Limited, India

4893Azi Bio 500 Tablets

Azithromycin Dihydrate

500mg

POM Tablet Uncoated 313/002 SAVA Medica Limited, India

4894Azi Bio Suspension

Azithromycin 200mg, per

5ml

POM Suspension for

Oral Use

313/003 SAVA Medica Limited, India

4895Biomist NS 0.1 Nasal Spray

Xylometazoline

Hydrochloride 0.1%

POM Spray For Nasal

Use

313/004 SAVA Medica Limited, India

4896Biomist NS 0.05 Nasal Spray

Xylometazoline

Hydrochloride 0.05%

POM Spray For Nasal

Use

313/005 SAVA Medica Limited, India

Page 252 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4897Flutiair 0.05 Nasal Spray

Fluticasone Propionate

0.05%

POM Spray For Nasal

Use

313/006 SAVA Medica Limited, India

4898

Flutiair -S 250 Powder for

Inhalation

Salmeterol 50mcg +

Fluticasone250mcg

POM Powder for

Inhalation

313/007 SAVA Medica Limited, India

4899 Rozatin - 10 Tablets Rosuvastatin 10mg POM Tablet Uncoated 313/008 SAVA Medica Limited, India

4900 Rozatin -20 Tablets Rosuvastatin 20mg POM Tablet Uncoated 313/009 SAVA Medica Limited, India

4901 Esaktive 40 Tablets Esomeprazole 40mg POM Tablet Uncoated 313/010 SAVA Medica Limited, India

4902Momenap Ns 0.05 Nasal Spray

Mometasone Furoate

0.05%

POM Spray For Nasal

Use

313/011 SAVA Medica Limited, India

4903 Nystanova Pessaries Nystatin 100,000 I.U. POM Tablet Vaginal 035/003 Scanpharm A/S, Denmark

4904Viminova Drops

Multivitamin Mineral

Drops

GS Solution for Oral

Use

035/013 Scanpharm A/S, Denmark

4905Spasmonova Injection Hyoscine Butyl Bromide

POM Solution for

Injection

035/021 Scanpharm A/S, Denmark

4906Ergonova Injection Ergometrine Injection

POM Solution for

Injection

035/028 Scanpharm A/S, Denmark

4907Oxy Ergonova Injection Ergotocin Maleate

POM Solution for

Injection

035/029 Scanpharm A/S, Denmark

4908Mezonova Suspension Trichozol Syrup

POM Suspension for

Oral Use

035/033 Scanpharm A/S, Denmark

4909 Neo-Polynova Ear/Eye Drops Combination POM Ear/Eye Drops 035/034 Scanpharm A/S, Denmark

4910 Gyno-Nova Pesseries Clotrimazole 100mg POM Tablet Vaginal 035/043 Scanpharm A/S, Denmark

4911Pregnatal Tablets

Vitamins + Minerals +

Amino Acids

POM Tablet Uncoated 035/042 Scanpharm A/S, Denmark

4912Dexanova Injection

Dexamethasone Sodium

Phosphate 5mg, per ml

POM Solution for

Injection

035/044 Scanpharm A/S, Denmark

4913Oxytocin Injection Oxytocin 10mg

POM Solution for

Injection

035/045 Scanpharm A/S, Denmark

4914 Cloronova Ear Drops Chlororamphenical 1% POM Ear Drops 035/047 Scanpharm A/S, Denmark

4915 Cloronova Eye Drops Chlororamphenical 1% POM Eye Drops 035/048 Scanpharm A/S, Denmark

4916 Viminova Tablets Multivitamins GS Tablet Uncoated 035/049 Scanpharm A/S, Denmark

4917 Viminova Syrup Multivitamins P Syrup 035/051 Scanpharm A/S, Denmark

4918 Vitalinova Tonic Multivitamins P Syrup 035/052 Scanpharm A/S, Denmark

4919 Claritine Tablets Loratidine 10mg POM Tablet Uncoated 042/002 Schering-Plough Labo N.V, Belgium

4920 Elocom Cream Mometasone 0.1% POM Cream Topical 042/003 Schering-Plough Labo N.V, Belgium

4921Elocom Lotion Mometasone 0.1%

POM Lotion for Topical

Use

042/004 Schering-Plough Labo N.V, Belgium

4922 Elocom Ointment Mometasone 0.1% POM Ointment topical 042/005 Schering-Plough Labo N.V, Belgium

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4923Peg-Intron 50mcg Injection

Peg-Inteferon Alfa-2b

50mcg

POM Suspension for

Injection

042/006 Schering-Plough Labo N.V, Belgium

4924Peg-Intron 80mcg Injection

Peg-Inteferon Alfa-2b

80mcg

POM Suspension for

Injection

042/007 Schering-Plough Labo N.V, Belgium

4925Peg-Intron 100mcg Injection

Peg-Inteferon Alfa-2b

100mcg

POM Suspension for

Injection

042/008 Schering-Plough Labo N.V, Belgium

4926Peg-Intron 120mcg Injection

Peg-Inteferon Alfa-2b

120mcg

POM Suspension for

Injection

042/009 Schering-Plough Labo N.V, Belgium

4927Peg-Intron 150mcg Injection

Peg-Inteferon Alfa-2b

150mcg

POM Suspension for

Injection

042/010 Schering-Plough Labo N.V, Belgium

4928Ramicade Injection Infliximab 100mg

POM Powder for

Injection

042/011 Schering-Plough Labo N.V, Belgium

4929Intron A Solution 18 IU

Interferon Alfa 2b

18M.I.U

POM Solution for

Injection

042/012 Schering-Plough Labo N.V, Belgium

4930Intron A Solution 25 IU

Interferon Alfa 2b

25M.I.U

POM Solution for

Injection

042/013 Schering-Plough Labo N.V, Belgium

4931Caelyx Injection Doxorubicin 2mg, per ml

POM Suspension for

Injection

042/015 Schering-Plough Labo N.V, Belgium

4932Nasonex Aqueous Nasal Spray Mometasone

POM Spray For Nasal

Use

042/016 Schering-Plough Labo N.V, Belgium

4933 Temodal 5mg Capsules Temozolomide 5mg POM Capsule oral 042/017 Schering-Plough Labo N.V, Belgium

4934 Temodal 20mg Capsules Temozolomide 20mg POM Capsule oral 042/018 Schering-Plough Labo N.V, Belgium

4935 Temodal100mg Capsules Temozolomide 100mg POM Capsule oral 042/019 Schering-Plough Labo N.V, Belgium

4936 Temodal 250 Mg Capsules Temozolomide 250mg POM Capsule oral 042/020 Schering-Plough Labo N.V, Belgium

4937Aerius Syrup

Des-Loratadine 0.5mg,

per ml

POM Syrup 042/021 Schering-Plough Labo N.V, Belgium

4938 Aerius Tablets Des-Loratadine 5mg POM Tablet Uncoated 042/022 Schering-Plough Labo N.V, Belgium

4939

Diprofos Injection

Betamethasone

Dipropionate

5mg+Betamethasone

Sodium Sulphate 2.5mg

POM Injection 042/023 Schering-Plough Labo N.V, Belgium

4940

Celestamine Tablets

Betamethasone 0.25mg

+ Dexchlorpheniramine

2mg

POM Tablet Uncoated 042/024 Schering-Plough Labo N.V, Belgium

4941Esmeron Injection

Rocuronium 10mg, per

ml

POM Solution for

Injection

042/025 Schering-Plough Labo N.V, Belgium

Page 254 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4942

Octenisept Solution

Ocetinidine

Dihydrochloride 0.1%w/v

+ Phenoxy Ethanol

2.0%w/v

P Solution for Oral

Use

321/001L Schulke & Mayr GBMH, Germany

4943

Lignospan Special Injection

Lidocaine Hydrochloride

2% + 1:80,000

Adrenaline Tartrate

POM Solution for

Injection

319/001 Septodont, France

4944

SII Polyvalent Anti -Snake

Venom Injection

Polyvalent Anti Snake

Serum

POM Solution for

Injection

035/002 Serum Institute of India

4945Sicriptin Tablets

Bromocriptine Mesylate

2.5mg

POM Tablet Uncoated 053/001 Serum Institute of India

4946

Hepatitis B Vaccine (rDNA)

InjectionHepatitis B Vaccine

POM Suspension for

Injection

053/003 Serum Institute of India

4947

S11 Rabivax- Liquid (Rabies

Vaccine USP)

Rabies Vaccine, Human

I.P. (Liquid)

POM Suspension for

Injection

053/004 Serum Institute of India

4948

Measles Vaccine, Live,

Attenuated (Freeze Dried)

Injection

1000 CCID50 Of Live

Measles Virus Particles,

per 0.5ml

POM Suspension for

Injection

053/005 Serum Institute of India

4949

Rubella Vaccine/Mumps

Vaccine/Measles Vaccine,

Live,Atten.(Freeze Dried

Rubella Vaccine 1000

Ccid50 + Mumps 5000

Ccid50 + Measles 1000

Ccid50, Per 0.5ml

POM Suspension for

Injection

053/006 Serum Institute of India

4950

Vincristine Sulphate BP

(Lyophilised) InjectionVincristine 1mg, per Vial

POM Powder for

Injection

053/007 Serum Institute of India

4951Cisplatin BP Injection Cisplatin 1mg, per ml

POM Powder for

Injection

053/008 Serum Institute of India

4952Tetanus Antitoxin BP Injection Tetanus Antitoxin

POM Suspension for

Injection

053/009 Serum Institute of India

4953

Tetanus Toxoid Vaccine

adsorbed InjectionTetanus Toxoid 1500IU

POM Suspension for

Injection

053/010 Serum Institute of India

4954

Diptheria-Tetanus-Pertusis

Vaccine adsorbed Injection

Diptheria 30IU + Tetanus

40IU + Pertusis 4IU

POM Suspension for

Injection

053/011 Serum Institute of India

4955

Measles and Rubella Vacine

Live

Measles And Rubella

Vaccine Live

POM Lyophilised Powder

for Injection

053/012 Serum Institute of India

4956

Seven Seas Orange Syrup +

Cod Liver OilCod Liver Oil + Vitamins

GS Syrup 154/001 Seven Seas Ltd, England

Page 255 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4957

Seven Seas One A Day Pure

Cod Liver Oil + Vitamin

Capsules

Cod Liver Oil + Vitamins

GS Capsule oral 154/003 Seven Seas Ltd, England

4958

Seven Seas Cherry Flavoured

Cod Liver LiquidCod Liver Oil + Vitamins

GS Syrup 154/004 Seven Seas Ltd, England

4959

Seven Seas One A Day Cod

Liver Oil + Evening Primrose

Capsules

Cod Liver Oil + Evening

Primerose

GS Capsule oral 154/007 Seven Seas Ltd, England

4960

Seven Seas One A Day

Odourless Garlic Pearls

Capsules

Garlic Oil 6mg

GS Capsule oral 154/008 Seven Seas Ltd, England

4961

Seven Seas One A Day Cod

Liver Oil + Glusamine Capsules

Cod Liver Oil +

Glusamine 1500mg

GS Capsule oral 154/011 Seven Seas Ltd, England

4962

Seven Seas Multivitamins +

Minerals CapsulesMinerals + Multivitamins

P Capsule oral 154/013 Seven Seas Ltd, England

4963 Minadex Tonic Vitamins + Minerals GS Syrup 154/019 Seven Seas Ltd, England

4964 Diproson Cream Betamethasone 0.05% POM Cream Topical 057/034 Shalina Healthcare Limited, UAE

4965

Alcozyme Xp Syrup

Cetirizine 5mg +

Bromhexine 4mg +

Ammonium Chloride

125mg

P Syrup 075/001 Shalina Healthcare Limited, UAE

4966

Shaltoux Syrup

Salbutamol 2mg +

Bromhexine 4mg +

Guaiphenesin 100mg +

Menthol 1mg

POM Syrup 075/002 Shalina Healthcare Limited, UAE

4967 Ketazol Shampoo Ketoconazole 2%w/w POM Shampoo 075/003 Shalina Healthcare Limited, UAE

4968

Polygel Suspension

Dimethicone 50mg +

Magnesium Hydroxide

250mg + Dried

Aluminium Hydroxide

250mg

P Suspension for

Oral Use

075/004 Shalina Healthcare Limited, UAE

4969

Polygel Mango Suspension

Dimethicone 50mg +

Magnesium Hydroxide

250mg + Dried

Aluminium Hydroxide

250mg

P Syrup 075/005 Shalina Healthcare Limited, UAE

Page 256 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4970

Polygel Mint Suspension

Dimethicone 50mg +

Magnesium Hydroxide

250mg + Dried

Aluminium Hydroxide

250mg

P Suspension for

Oral Use

075/006 Shalina Healthcare Limited, UAE

4971 Floxan 250mg Tablets Ofloxacin 250mg POM Tablet Uncoated 075/007 Shalina Healthcare Limited, UAE

4972 Floxan 500mg Tablets Ofloxacin 500mg POM Tablet Uncoated 075/008 Shalina Healthcare Limited, UAE

4973

Shaltrim Suspension

Sulphamethoxazole

40mg + Trimethoprim

200mg

POM Suspension for

Oral Use

075/009 Shalina Healthcare Limited, UAE

4974Leopard Baume

Methyl Salicylate 7%w/w

+ Menthol 7%w/w

GS Ointment topical 075/010 Shalina Healthcare Limited, UAE

4975 Gogynax Cream Clotrimazole 2% POM Cream Topical 075/011 Shalina Healthcare Limited, UAE

4976

Zanzicap Capsules

Aspirin 300mg +

Paracetamol 300mg +

Caffeine 30mg

GS Capsule oral 075/012 Shalina Healthcare Limited, UAE

4977

Monalisa Cream

Allantoin 1.0% +

Hydroquinone 2% +

Vitamin E 0.3%w/w

P Cream Topical 075/013 Shalina Healthcare Limited, UAE

4978Flazine Cream

Silver Sulphadiazine

1.0%

P Cream Topical 075/014 Shalina Healthcare Limited, UAE

4979Metazol Suspension

Metronidazole 125mg,

per 5ml

POM Suspension for

Oral Use

075/015 Shalina Healthcare Limited, UAE

4980 Rufenac-50 Tablets Diclofenac 50mg P Tablet Film coated 075/016 Shalina Healthcare Limited, UAE

4981 Shalvit Syrup Multivitamin GS Syrup 075/017 Shalina Healthcare Limited, UAE

4982Rufedol Tablets

Paracetamol 500mg +

Diclofenac 50mg

P Tablet Uncoated 075/018 Shalina Healthcare Limited, UAE

4983

Germol Solution

Chloroxylenol 4.8%

Terpineol + 9% Ethanol

13.1%

GS Solution for Topical

Use

075/019 Shalina Healthcare Limited, UAE

4984 Rufenac Gel Diclofenac 1.16% P Gel Topical 075/020 Shalina Healthcare Limited, UAE

4985 Magnavit Capsules Minerals + Multivitamins P Capsule oral 075/021 Shalina Healthcare Limited, UAE

4986 Amlox-5 Tablets Amlodipine 5mg POM Tablet Uncoated 075/022 Shalina Healthcare Limited, UAE

4987 Amlox-10 Tablets Amlodipine 10mg POM Tablet Uncoated 075/023 Shalina Healthcare Limited, UAE

4988 Ketazol Cream Ketoconazole 2%w/w POM Cream Topical 075/024 Shalina Healthcare Limited, UAE

Page 257 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

4989

Epiderm Cream

Betamethasone 0.643mg

+ Gentamycin 1mg +

Tolnaftate 10mg +

Iodochlorohydroxyquinolo

ne 10mg

POM Cream Topical 075/025 Shalina Healthcare Limited, UAE

4990

Marfol Syrup

Ferric Ammonium 250mg

+ Folic Acid 0.5mg +

Cyanocobalamin 5mcg,

per 5ml

P Syrup 075/026 Shalina Healthcare Limited, UAE

4991Efishal 200 Capsules Alpha Tocopherol 200mg

P Capsule oral 075/027 Shalina Healthcare Limited, UAE

4992

Epiderm Lotion

Betamethasone 0.643mg

+ Gentamycin 1mg +

Tolnaftate 10mg +

Iodochlorohydroxyquinolo

ne 10mg

POM Lotion for Topical

Use

075/028 Shalina Healthcare Limited, UAE

4993 Betasol Cream Clobetasol 0.05%w/w POM Cream Topical 075/029 Shalina Healthcare Limited, UAE

4994Gliben M Tablets

Glibenclamide 5mg +

Metformin 500mg

POM Tablet Uncoated 075/030 Shalina Healthcare Limited, UAE

4995

Ibucap Tablets

Ibuprofen 200mg +

Paracetamol 325mg +

Caffeine 30mg

P Tablet Uncoated 075/032 Shalina Healthcare Limited, UAE

4996Betasol Solution Clobetasol 0.05%w/v

POM Solution for Topical

Use

075/033 Shalina Healthcare Limited, UAE

4997

Neocin Ointment

Polymyxin B 5000 IU +

Bacitracin Zinc 400 IU +

Neomycin 3400 IU/g

POM Ointment topical 075/035 Shalina Healthcare Limited, UAE

4998

Hemoforce Syrup

Haemoglobin 2.095gm +

Ferric Ammonium Nitrate

125mg +

Cynanocobalamin 7.5mg

+ Folic Acid 0.51gm

P Syrup 075/036 Shalina Healthcare Limited, UAE

4999

Germol Soap

Triclosan 1.0% +

Triclocarban 0.40% +

Glycerine 0.5%

GS Solid Soap 075/037 Shalina Healthcare Limited, UAE

Page 258 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5000

Sulfatrim Forte Tablets

Trimethoprim 160mg +

Sulphamethoxazole

800mg

POM Tablet Uncoated 075/038 Shalina Healthcare Limited, UAE

5001Cal - D Tablets

Calcium 500mg + Vitamin

D3 250mg

P Tablet Uncoated 075/040 Shalina Healthcare Limited, UAE

5002 Kifaru 50 Tablets Sildenafil Citrate 50mg POM Tablet Uncoated 075/041 Shalina Healthcare Limited, UAE

5003

Polygel Tablets

Aluminium Hydroxide

300mg + Magnesium

Hydroxide 25mg +

Simethicone 25mg

P Tablet Uncoated 075/042 Shalina Healthcare Limited, UAE

5004 Loprade Tablets Loperamide 2mg P Tablet Uncoated 075/043 Shalina Healthcare Limited, UAE

5005Clarinez Nasal Drops (Paed) Xylometazoline 0.05%w/v

POM Nasal drops 075/044 Shalina Healthcare Limited, UAE

5006 Clarinez Nasal Drops (Adult) Xylometazoline 0.1%w/v POM Nasal drops 075/045 Shalina Healthcare Limited, UAE

5007 Tanzol Tablets Albendazole 400mg POM Tablet Uncoated 075/046 Shalina Healthcare Limited, UAE

5008

Sulfatrim TabletsSulfamethoxazole 400mg

+ Trimethoprim 80mg

POM Tablet Uncoated 075/047 Shalina Healthcare Limited, UAE

5009 Wormex -100 Tablets Mebendazole 100mg POM Tablet Uncoated 075/048 Shalina Healthcare Limited, UAE

5010 Super Apeti Tablets Cyproheptadine 4mg POM Tablet Uncoated 075/049 Shalina Healthcare Limited, UAE

5011 Shalcip Tablets Ciprofloxacin 500mg POM Tablet Uncoated 075/050 Shalina Healthcare Limited, UAE

5012 Tinizol 500 Tablets Tinidazole 500mg POM Tablet Uncoated 075/051 Shalina Healthcare Limited, UAE

5013Amidol Syrup

Paracetamol 120mg, per

5mls

GS Solution for Oral

Use

075/052 Shalina Healthcare Limited, UAE

5014

Shaltoux XPS Syrup

Diphenhydramine

Hydrochlorothiazide BP

14.00mg + Ammonium

Chloride BP 135.0mg

P Syrup 075/053 Shalina Healthcare Limited, UAE

5015 Amidol Tablets Paracetamol 500mg POM Tablet Uncoated 075/054 Shalina Healthcare Limited, UAE

5016

Leopard Vapour Rub

Menthol 2.82% +

Camphor 5.25% +

Thymol 0.1% +

Turpentine 5.57% +

Eucalypt 1.49% + 0.54%

GS Ointment topical 075/055 Shalina Healthcare Limited, UAE

5017Shalcip Injection Ciprofloxacin 0.2%

POM Solution for

infusion

075/056 Shalina Healthcare Limited, UAE

5018

Cevite Tablets

Ascorbic Acid 200mg +

Sodium Ascorbate

300mg

P Tablet Chewable 075/057 Shalina Healthcare Limited, UAE

Page 259 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5019Omeshal -D Capsules

Omeprazole 20mg +

Domperidone 10mg

POM Capsule sublingual 075/058 Shalina Healthcare Limited, UAE

5020 Omeshal Capsules Omeprazole 20mg POM Capsule oral 075/059 Shalina Healthcare Limited, UAE

5021

Amido Cold & Flu Tablets

Chlorpheniramine 2mg +

Paracetamol 500mg +

Phenylephrine 5mg +

Caffeine 30mg

GS Tablet Uncoated 075/060 Shalina Healthcare Limited, UAE

5022

Amidol Cold And Flu Syrup

Chlorpheniramine1mg +

Paracetamol 125mg +

Phenylephrine 2.5mg

GS Syrup 075/061 Shalina Healthcare Limited, UAE

5023Cevite Effervescent Tablets Ascorbic Acid 1000mg

GS Tablet Effervescent 075/062 Shalina Healthcare Limited, UAE

5024

Hemoforce Plus Syrup

Ferric Ammonium Citrate

160mg + Folic Acid

0.5mg + Cynocobalamin

7.5mg

P Suspension for

Injection

075/063 Shalina Healthcare Limited, UAE

5025Leopard Nasal Inhaler

Mentha Piperata 42.5% +

Cinnamon 40.0%

GS Nasal Inhaler 075/064 Shalina Healthcare Limited, UAE

5026

Super Apeti Plus Syrup

Cyproheptadine

Hydrochloride 2mg +

Multivitamins

P Syrup 075/065 Shalina Healthcare Limited, UAE

5027Wormex Suspension Mebendazole 100mg

P Suspension for

Oral Use

075/066 Shalina Healthcare Limited, UAE

5028

Ibucap Forte Capsules

Ibuprofen 400mg +

Paracetamol 325mg +

Cafeine 30mg

P Capsule oral 075/067 Shalina Healthcare Limited, UAE

5029

Zanitin Duo 1.2g Powder For

Injection

Amoxycillin Trihydrate

1000mg + Clavulanate

Potassium 200mg

POM Powder for

Injection

075/068 Shalina Healthcare Limited, UAE

5030Shalcip TZ Tablets

Ciprofloxacin 500mg +

Tindazole 600mg

POM Tablet Uncoated 075/069 Shalina Healthcare Limited, UAE

5031Metazol Infusion 100mls Metronidazole 0.5w/v

POM Solution for

infusion

075/070 Shalina Healthcare Limited, UAE

5032Cevite Syrup

Ascorbic Acid 50mg, per

5ml

P Syrup 075/071 Shalina Healthcare Limited, UAE

5033

Rufezone Plus Tablets

Diclofenac Potassium

50mg + Paracetamol

500mg + Chlorzoxazone

250mg

P Tablet Uncoated 075/072 Shalina Healthcare Limited, UAE

Page 260 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5034

Germol Cream

Chloroxylenol 0.3%w/v +

Triclosan 0.3%w/v +

Edetic acid (as

Potassium) 0.2%w/v

GS Cream Topical 075/073 Shalina Healthcare Limited, UAE

5035Maladox Tablets

Sulphadoxine 500mg +

Pyrimethamine 25mg

POM Tablet Uncoated 075/074 Shalina Healthcare Limited, UAE

5036

Gogynax Clotrimazole Vaginal

InsertsClotrimazole 100mg

POM Tablet Uncoated 075/075 Shalina Healthcare Limited, UAE

5037

Shaltoux Natural Cough

Lozenges

Glycyrrhiza glabra 20mg

+ Terminalia belerica

5mg + Zingibar Officinalis

5mg

GS Lozenges 075/076 Shalina Healthcare Limited, UAE

5038Tanzol Suspension

Albendazole 400mg, per

10ml

P Suspension for

Oral Use

075/077 Shalina Healthcare Limited, UAE

5039Shal' Artem Dry Syrup

Artemether 180mg +

Lumefantrine 1080mg

POM Powder for Oral

Suspension

075/078 Shalina Healthcare Limited, UAE

5040Canderm Powder Clotrimazole USP 1%w/w

POM Powder for Topical

use

075/079 Shalina Healthcare Limited, UAE

5041

ZANITIN DUO 1000 Tablets

Amoxycillin 875mg +

Clavulanate Potassium

125mg

POM Tablet Film coated 075/080 Shalina Healthcare Limited, UAE

5042

ZANITIN DUO 562.5 Tablets

Amoxycillin 500mg +

Clavulanate Potassium

62.5mg

POM Tablet Film coated 075/081 Shalina Healthcare Limited, UAE

5043

ZANITIN DUO 457 Oral

Suspension

Amoxycillin 400mg +

Clavulanate Potassium

57mg

POM Powder for Oral

Suspension

075/082 Shalina Healthcare Limited, UAE

5044Ceftriaxone Injection Ceftriaxone 1g

POM Powder for

Injection

075/083 Shalina Healthcare Limited, UAE

5045 Magnavit Tonic Syrup Multivitamins & Minerals P Syrup 075/084 Shalina Healthcare Limited, UAE

5046Shalzin Tablets

Azithromycin Dihydrate

USP 500mg

POM Tablet Uncoated 075/085 Shalina Healthcare Limited, UAE

5047Shalzin Suspension

Azithromycin Dihydrate

USP 100mg, per 5ml

POM Suspension for

Oral Use

075/086 Shalina Healthcare Limited, UAE

5048 Kifaru 100 Tablets Sildenafil Citrate 100mg POM Tablet Film coated 075/087 Shalina Healthcare Limited, UAE

5049 Gentamycin Ear/Eye Drops Gentamycin 0.3%w/v POM Ear/Eye Drops 075/088 Shalina Healthcare Limited, UAE

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5050

Seloral Oral Rehydration Salt

Sodium Chloride +

Potassium Chloride +

Sodium Citrate +

Dextrose

GS Powder for Oral

Suspension

075/089 Shalina Healthcare Limited, UAE

5051

Polyfast Granules

Citric Acid 2.18g +

Sodium Bicarbonate

2.32g

P Granules for Oral

Use

075/090 Shalina Healthcare Limited, UAE

5052

Epiderm Light Cream

Vitamin B3 I.H 9.31mg +

Vitamin C I.H 23.28mg +

Vitamin E I.H 2.33mg

GS Cream Topical 075/091L Shalina Healthcare Limited, UAE

5053

Epiderm Light Lotion

Vitamin B3 I.H 9.25mg +

Vitamin C I.H 23.14mg +

Vitamin E I.H 2.31mg

GS Lotion for Topical

Use

075/092L Shalina Healthcare Limited, UAE

5054Shal Artem Tablets

Artemether 80mg +

Lumefantrine 480mg

POM Tablet Uncoated 075/093 Shalina Healthcare Limited, UAE

5055Shal Artem Tablets

Artemether 20mg +

Lumefantrine 120mg

POM Tablet Uncoated 075/094 Shalina Healthcare Limited, UAE

5056Amoxy 500 Capsules

Amoxicillin Trihydrate

500mg

POM Tablet Uncoated 075/095 Shalina Healthcare Limited, UAE

5057Amoxy 250 Capsules

Amoxicillin Trihydrate

250mg

POM Tablet Uncoated 075/096 Shalina Healthcare Limited, UAE

5058Ampicillin 1000 Injection Ampicillin Sodium BP 1g

POM Powder for

Injection

075/097 Shalina Healthcare Limited, UAE

5059Ampicillin 500 Injection

Ampicillin Sodium BP

500mg

POM Powder for

Injection

075/098 Shalina Healthcare Limited, UAE

5060

Fortified Benzylpenicillin

Injection

Procaine Benzyl Penicillin

BP 4M.I.U

POM Powder for

Injection

075/099 Shalina Healthcare Limited, UAE

5061

Benzathine Benzylpenicllin 2.4

Injection

Benzathine Benzyl

Penicillin 2,400,000 IU

POM Powder for

Injection

075/100 Shalina Healthcare Limited, UAE

5062Benzylpenillin 5 Injection

Benzyl Penicillin

5,000,000 IU

POM Powder for

Injection

075/101 Shalina Healthcare Limited, UAE

5063

Phenoxymethyl Penicillin 250

Tablets

Phenoxymethyl Penicillin

Potassium 250mg

POM Tablet Uncoated 075/102 Shalina Healthcare Limited, UAE

5064Gentamycin 40 Injection Gentamycin 40mg, per ml

POM Solution for

Injection

075/103 Shalina Healthcare Limited, UAE

Page 262 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5065

Hemoforce Plus Syrup

Sodium Feredetate 11mg

+ Folic Acid 0.5mg +

Cyanocobalamin 5mcg +

Zinc Sulphate 3.33mg +

20mg

P Syrup 075/104 Shalina Healthcare Limited, UAE

5066

Lamivude/Zidovudine tablets Lamuvidine 150mg +

Zidovudine 300mg Tablet

POM Tablet Film coated 442/001 Shangai Denaso Biopharmaceuticals Ltd

5067 Efavirenz 600 Tablets Efavirenz 600mg POM Tablet Film coated 442/002 Shangai Denaso Biopharmaceuticals Ltd

5068Aloe Soft Gel Capsules Aloe Vera 500mg

P Capsule oral 323/001L Shanghai Eternal Biotechnology Co.

Limited, China

5069

Broken Ganoderma Lucidium

Spore Softgel Capsules

Ganoderma Lucidium

500mg

P Capsule oral 323/002L Shanghai Eternal Biotechnology Co.

Limited, China

5070Fish Oils Softgel Capsules Fish Oil 1000mg

P Capsule oral 323/003L Shanghai Eternal Biotechnology Co.

Limited, China

5071Lecithin Soft Capsules Soyabean Lecithin 22.3%

P Capsule oral 323/004L Shanghai Eternal Biotechnology Co.

Limited, China

5072

Natural Vitamin E Soft Gel

CapsulesVitamin E 500mg

P Capsule oral 323/005L Shanghai Eternal Biotechnology Co.

Limited, China

5073Propolis Softgel Capsules Propolis Extracts 55%

P Capsule oral 323/006L Shanghai Eternal Biotechnology Co.

Limited, China

5074Soy Isoflavones Capsules

Soy Bean Extracts

67.06%

P Capsule oral 323/007L Shanghai Eternal Biotechnology Co.

Limited, China

5075Spirulina Soft Gel Capsules Spirulina 150mg

P Capsule oral 323/008L Shanghai Eternal Biotechnology Co.

Limited, China

5076Kanamycin Injection Kanamycin 1000mg

POM Powder for

Injection

269/001 Shanghai Pharmateq Company Ltd, China

5077Calcium Gluconate Injection

Calcium Gluconate

10%w/v

POM Solution for

Injection

269/002 Shanghai Pharmateq Company Ltd, China

5078Promethazine Injection

Promethazine 50mg, per

2ml

POM Solution for

Injection

269/003 Shanghai Pharmateq Company Ltd, China

5079Diclofenac Sodium Injection Diclofenac 75mg, per 3ml

POM Solution for

Injection

269/004 Shanghai Pharmateq Company Ltd, China

5080Atropine Injection Atropine 0.6mg, per ml

POM Solution for

Injection

269/005 Shanghai Pharmateq Company Ltd, China

5081Furosemide Injection

Furosemide 20mg, per

2ml

POM Solution for

Injection

269/006 Shanghai Pharmateq Company Ltd, China

Page 263 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5082

Dexamethasone Sodium

Injection

Dexamethasone 4mg,

per ml

POM Solution for

Injection

269/007 Shanghai Pharmateq Company Ltd, China

5083Adrenaline Injection Adrenaline 1mg, per ml

POM Solution for

Injection

269/008 Shanghai Pharmateq Company Ltd, China

5084Oxytocin Injection Oxytocin 10IU/Ml

POM Solution for

Injection

269/010 Shanghai Pharmateq Company Ltd, China

5085Menadione Injection

Phytomenadione 10mg,

per ml

POM Solution for

Injection

269/011 Shanghai Pharmateq Company Ltd, China

5086

Quinine Dihydrochloride

InjectionQuinine 600mg, per 2ml

POM Solution for

Injection

269/012 Shanghai Pharmateq Company Ltd, China

5087Hydrocortisone Injection Hydrocortisone 100mg

POM Powder for

Injection

269/013 Shanghai Pharmateq Company Ltd, China

5088Zwagra Tablets Sildenafil 50mg

POM Tablet Uncoated 066/001 Shaphaco Pharmaceutical Industries ,

Yemen

5089Saheal Tablets Tadalafil 20mg

POM Tablet Uncoated 066/002 Shaphaco Pharmaceutical Industries ,

Yemen

5090 Koflyn Syrup Herbal Extracts P Syrup 134/001 Shelys Pharmaceuticals Limited, Tanzania

5091 Diclofenac Sodium Tablets Diclofenac 50mg P Tablet Uncoated 134/003 Shelys Pharmaceuticals Limited, Tanzania

5092Chloramphenicol Suspension

Chloramphenicol 125mg,

per 5ml

POM Suspension for

Oral Use

134/004 Shelys Pharmaceuticals Limited, Tanzania

5093Shelys Gripe Water Bicarbonate

GS Solution for Oral

Use

134/005 Shelys Pharmaceuticals Limited, Tanzania

5094 Ibuprofen 200 Tablets Ibuprofen 200mg P Tablet Uncoated 134/006 Shelys Pharmaceuticals Limited, Tanzania

5095Amolin Suspension

Amoxicillin 125mg, per

5ml

POM Granules for Oral

Suspension

134/007 Shelys Pharmaceuticals Limited, Tanzania

5096Sheladol Suspension

Paracetamol 120mg, per

5ml

GS Suspension for

Oral Use

134/008 Shelys Pharmaceuticals Limited, Tanzania

5097 Ampishel Capsules Ampicillin 250mg POM Capsule oral 134/009 Shelys Pharmaceuticals Limited, Tanzania

5098 Hemovit Capsules Haematic Preparation P Capsule oral 134/010 Shelys Pharmaceuticals Limited, Tanzania

5099 Hemovit Syrup Haematic Preparation P Syrup 134/011 Shelys Pharmaceuticals Limited, Tanzania

5100Aspirin Tablets

Acetyl Salicylic Acid

300mg

P Tablet Uncoated 134/012 Shelys Pharmaceuticals Limited, Tanzania

5101 Histin Tablets Chlorpheniramine 4mg P Tablet Uncoated 134/013 Shelys Pharmaceuticals Limited, Tanzania

5102

Shetrim Tablets

Sulphamethoxazole

400mg + Trimethoprim

80mg

POM Tablet Uncoated 134/015 Shelys Pharmaceuticals Limited, Tanzania

5103 Mebendazole Tablets Mebendazole 200mg P Tablet Uncoated 134/016 Shelys Pharmaceuticals Limited, Tanzania

5104Alben Suspension

Albendazole 200mg, per

10ml

POM Suspension 134/017 Shelys Pharmaceuticals Limited, Tanzania

Page 264 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 5105 Shelgyl 200 Tablets Metronidazole 200mg POM Tablet Uncoated 134/018 Shelys Pharmaceuticals Limited, Tanzania

5106 Chloramphenicol Capsules Chloramphenicol 250mg POM Capsule oral 134/020 Shelys Pharmaceuticals Limited, Tanzania

5107 Ascorbic Acid Tablets Ascorbic Acid 100mg GS Tablet Uncoated 134/021 Shelys Pharmaceuticals Limited, Tanzania

5108Bactol Solution Chloroxylenol 4.8%w/w

GS Solution for Topical

Use

134/022 Shelys Pharmaceuticals Limited, Tanzania

5109 Folic Acid Tablets Folic Acid 5mg P Tablet Uncoated 134/023 Shelys Pharmaceuticals Limited, Tanzania

5110Sulphadar Tablets

Pyrimethamine 500mg +

Sulphadoxine 25mg

P Tablet Uncoated 134/024 Shelys Pharmaceuticals Limited, Tanzania

5111 Erythromycin Tablets Erythromycin 250mg POM Tablet Uncoated 134/025 Shelys Pharmaceuticals Limited, Tanzania

5112

Mucolyn Asthalin Syrup

Salbutamol 2mg +

Bromhexine 4mg, per

5ml

POM Syrup 134/026 Shelys Pharmaceuticals Limited, Tanzania

5113 Asthalin Syrup Salbutamol 2mg, per 5ml POM Syrup 134/028 Shelys Pharmaceuticals Limited, Tanzania

5114

Shetrim Per 5ml

Sulfamethoxazole BP

200mg + Trimethoprim

BP 40mg

POM Syrup 134/029 Shelys Pharmaceuticals Limited, Tanzania

5115 Cloxashel Capsules Cloxacillin 250mg POM Capsule oral 134/030 Shelys Pharmaceuticals Limited, Tanzania

5116 Vitamin B Complex Tablets Vitamin B Complex P Tablet Uncoated 134/031 Shelys Pharmaceuticals Limited, Tanzania

5117 Amolin Capsules Amoxicillin 250mg POM Capsule oral 134/032 Shelys Pharmaceuticals Limited, Tanzania

5118

Cloxam Dry Syrup

Cloxacillin 125mg +

Ampicillin 125mg, per

5ml

POM Suspension for

Oral Use

134/034 Shelys Pharmaceuticals Limited, Tanzania

5119 Megavit Syrup Multivitamins GS Syrup 134/035 Shelys Pharmaceuticals Limited, Tanzania

5120Hyosine Butyl Bromide Tablets

Hyoscine Butyl Bromide

10mg

POM Tablet Uncoated 134/036 Shelys Pharmaceuticals Limited, Tanzania

5121

Mucolyn Paediatric Syrup

Ammonium Chloride BP

50mg +

Pseudoephedrine

Hydrochloride 10mg +

Chlorpheniramine

Maleate BP 2mg +

Dextromethorphan

Hydrobromide BP 5mg,

per 5ml

P Syrup 134/037 Shelys Pharmaceuticals Limited, Tanzania

5122 Feritone Syrup Haematic Preparation P Syrup 134/038 Shelys Pharmaceuticals Limited, Tanzania

5123 Praziquantel 600mg Tablets Praziquantel 600mg POM Tablet Film coated 134/039 Shelys Pharmaceuticals Limited, Tanzania

5124Bromoxil Capsules

Bromhexine 8mg +

Amoxicillin 250mg

POM Capsule oral 134/040 Shelys Pharmaceuticals Limited, Tanzania

Page 265 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5125Bromoxil Syrup 100ml

Bromhexine 4mg +

Amoxicillin 125mg

POM Syrup 134/041 Shelys Pharmaceuticals Limited, Tanzania

5126Sulphadar Tablets

Pyrimethamine 25mg +

Sulphadoxine 500mg

P Tablet Uncoated 134/042 Shelys Pharmaceuticals Limited, Tanzania

5127 Sheladol Tablets Paracetamol 500mg GS Tablet Uncoated 134/044 Shelys Pharmaceuticals Limited, Tanzania

5128Shelgyl Oral Suspension

Metronidazole 200mg,

per 5ml

POM Suspension for

Oral Use

134/045 Shelys Pharmaceuticals Limited, Tanzania

5129

Mucolyn Syrup

Ammonium Chloride

50mg + Bromhexine 4mg

+ Chlorpheniramine 2mg.

P Syrup 134/046 Shelys Pharmaceuticals Limited, Tanzania

5130 Ampishel Syrup Ampicillin 125mg POM Syrup 134/048 Shelys Pharmaceuticals Limited, Tanzania

5131Erthromycin Dry Syrup Erythromycin 125mg

POM Powder for Oral

Suspension

134/049 Shelys Pharmaceuticals Limited, Tanzania

5132Diclopar 550mg Tablets

Paracetamol 500mg +

Diclofenac 50mg

P Tablet Uncoated 134/050 Shelys Pharmaceuticals Limited, Tanzania

5133Amodar Suspension

Amodiaquine 50mg, per

5ml

POM Suspension 134/051 Shelys Pharmaceuticals Limited, Tanzania

5134 Cipron Tablets Ciprofloxacin 500mg POM Tablet oral 134/052 Shelys Pharmaceuticals Limited, Tanzania

5135

Coldril Syrup

Chlorpheniramine 1mg +

Paracetamol 120mg +

Pseudoephedrine 10mg

P Syrup 134/053 Shelys Pharmaceuticals Limited, Tanzania

5136

Malafin Tablets

Pyrimethamine 25mg +

Sulphamethoxypyrazine

500mg

P Tablet Uncoated 134/054 Shelys Pharmaceuticals Limited, Tanzania

5137 Malather Tablets Artesunate BP 100mg POM Tablet Uncoated 134/055 Shelys Pharmaceuticals Limited, Tanzania

5138

Coldril Capsules

Paracetamol BP 500mg +

Pseudoephedrine

Hydrochloride BP 30mg +

Chlorpheniramine

Maleate BP 2mg

POM Capsule oral 134/056 Shelys Pharmaceuticals Limited, Tanzania

5139 Amodar Tablets Amodiaquine 260mg POM Tablet Uncoated 134/057 Shelys Pharmaceuticals Limited, Tanzania

5140

Gastocid Suspension

Simethicone 25mg +

Aluminium Hydroxide

220mg + Magnesium

Hydroxide 195mg

P Suspension for

Oral Use

134/058 Shelys Pharmaceuticals Limited, Tanzania

5141

Gastrocid Chewable Tablets

Dried Aluminium

Hydroxide + Magnesium

Trisilicate 395mg

GS Tablet Chewable 134/059 Shelys Pharmaceuticals Limited, Tanzania

Page 266 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 5142 Flucozal 150 Tablets Fluconazole 150mg POM Tablet Uncoated 134/060 Shelys Pharmaceuticals Limited, Tanzania

5143 Flucozal 200 Tablets Fluconazole 200mg POM Tablet Uncoated 134/062 Shelys Pharmaceuticals Limited, Tanzania

5144Maladar Adult Kit Tablets

Amodiaquine 200mg +

Artesunate 50mg

POM Tablet Uncoated 134/063 Shelys Pharmaceuticals Limited, Tanzania

5145Maladar Pead Kit Tablets

Amodiaquine 100mg +

Artesunate 50mg

POM Tablet Uncoated 134/064 Shelys Pharmaceuticals Limited, Tanzania

5146

Save Oral Rehydration Salt

Sodium Chloride +

Sodium Citrate +

Potassium Chloride +

Glucose

GS Powder for Oral

Solution

134/065 Shelys Pharmaceuticals Limited, Tanzania

5147 Ped Zinc Tablets Zinc Sulphate 20mg GS Tablet Uncoated 134/066 Shelys Pharmaceuticals Limited, Tanzania

5148 Acefen Tablets Aceclofenac 100mg P Tablet Uncoated 134/067 Shelys Pharmaceuticals Limited, Tanzania

5149 Levoz Tablets Levofloxacin 500mg POM Tablet Uncoated 134/068 Shelys Pharmaceuticals Limited, Tanzania

5150 Njoi Tablets Sildenafil 50mg POM Tablet Uncoated 134/069 Shelys Pharmaceuticals Limited, Tanzania

5151 Quinalin Syrup Quinine 100g/5ml POM Syrup 134/070 Shelys Pharmaceuticals Limited, Tanzania

5152Diclopar-Ultra Tablets

Paracetamol 500mg +

Diclofenac 50mg

P Tablet Uncoated 134/071 Shelys Pharmaceuticals Limited, Tanzania

5153 Azuma - 250 Tablets Azithromycin 250mg POM Tablet Uncoated 134/072 Shelys Pharmaceuticals Limited, Tanzania

5154 Azuma - 500 Tablets Azithromycin 500mg POM Tablet Film coated 134/073 Shelys Pharmaceuticals Limited, Tanzania

5155Azuma Suspension Azithromycin 200mg

POM Suspension for

Oral Use

134/074 Shelys Pharmaceuticals Limited, Tanzania

5156 Sheltrizine Tablets Cetrizine 10mg P Tablet Uncoated 134/075 Shelys Pharmaceuticals Limited, Tanzania

5157

Burnox Cream

Silver Sulfadiazine

1.0%w/w +

Chlorhexidine 0.2%w/w

P Cream Topical 134/076 Shelys Pharmaceuticals Limited, Tanzania

5158

Dermacin Cream

Clobetasone 0.05%w/w

+ Gentamicin Sulphate

0.1%w/w + Miconazole

10.0%w/w

POM Cream Topical 134/077 Shelys Pharmaceuticals Limited, Tanzania

5159Orazinc Kit

ORS + Zinc Sulphate

20mg

P Powder for oral

solution

134/078 Shelys Pharmaceuticals Limited, Tanzania

5160

Diclopar Activa Gel

Diclofenac

Diethylalamine

1.16%w/w + Methyl

Salycilate 10.00%w/w +

Racementhol 5.00%w/w

P Gel Topical 134/079 Shelys Pharmaceuticals Limited, Tanzania

5161Micosil Cream

Miconazole Nitrate BP

1%w/w

POM Cream Topical 134/080 Shelys Pharmaceuticals Limited, Tanzania

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5162

Benzathine Penicillin 2.4MU

InjectionBenzathine Penicillin 2.4g

POM Powder for

Injection

212/001 Shijiazhvang Pharma Group, Zhonghuo

Pharmaceutical Co., Ltd,

5163Ampicillin Sodium Injection Ampicillin 1.0g

POM Powder for

Injection

212/002 Shijiazhvang Pharma Group, Zhonghuo

Pharmaceutical Co., Ltd,

5164

Ceftriaxone Sodium Injection Cefriaxone 1.0g POM Powder for

Injection

212/003 Shijiazhvang Pharma Group, Zhonghuo

Pharmaceutical Co., Ltd,

5165

Benzathine Penicillin 2.4MU

Injection

Benzathine Penicillin

2.4MU

POM Powder for

Injection

212/006 Shijiazhvang Pharma Group, Zhonghuo

Pharmaceutical Co., Ltd,

5166

Cefotaxime Sodium 1g For

InjectionCefotaxime Sodium 1g

POM Powder for

Injection

212/007 Shijiazhvang Pharma Group, Zhonghuo

Pharmaceutical Co., Ltd,

5167Cichlor Eye Drops

Chloramphenicol

0.5%w/v

POM Eye Drops 143/003 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5168Vitamin B Complex Injection Vitamin B Complex

POM Solution for

Injection

143/004 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5169Sangel Tablets

Aluminium Hydroxide +

Magnesium Trisilicate

P Tablet Uncoated 143/005 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5170Multivitamins Tablets Multivitamins

GS Tablet Uncoated 143/006 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5171Maxinfen Tablets

Sulphadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 143/007 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5172Ciphenicol 250 Capsules Chloramphenicol 250mg

POM Capsule oral 143/008 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5173Apetito Tablets Cyproheptadine 4mg

P Tablet Uncoated 143/009 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5174

Bumol Capsules

Paracetamol 325mg +

Ibuprofen 200mg +

Caffeine 25mg

P Capsule oral 143/010 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5175Deworm Tablets Mebendazole 100mg

P Tablet Uncoated 143/011 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5176Lignocaine Injection Lignocaine 2%w/w

POM Solution for

Injection

143/012 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5177Cimol Tablets Paracetamol 500mg

GS Tablet Uncoated 143/013 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5178Chaptone Extra Tablets Multivitamins

GS Tablet Uncoated 143/014 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5179Ceagra Tablets Sildenafil 50mg

POM Tablet Uncoated 143/015 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5180Chapsulf Ointment Precipitated Sulphur 10%

P Ointment topical 143/016 Shreechem Pharmaceuticals (Pvt) Ltd,

India

Page 268 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5181Cindo-25 Capsules Indomethacin 25mg

P Capsule oral 143/017 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5182Cibufen-200 Tablets Ibuprofen 200mg

P Tablet Uncoated 143/018 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5183Chapvit Tablets Multivitamins

GS Tablet Uncoated 143/019 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5184

Clearcold Tablets

Chlorpheniramine BP

2mg + Paracetamol BP

500mg + Caffeine

(Anhydrous) BP 30mg

P Tablet Uncoated 143/020 Shreechem Pharmaceuticals (Pvt) Ltd,

India

5185 Misotac Tablets Misoprostol 0.2mg POM Tablet Uncoated 107/001 Sigma Pharmaceuticals Ltd, Egypt

5186

Eurartesim 320/40 Tablets

Piperaquine

Tetraphosphate 320mg +

Dihydroartemesinin 40mg

POM Tablet Film coated 351/001 SIGMA-TAU INDUSTRIE

FARMACEUTICHE RIUNITE S.P.A

5187

Eurartesim 160/20 Tablets

Piperaquine

Tetraphosphate 160mg +

Dihydroartemesinin 20mg

POM Tablet Film coated 351/002 SIGMA-TAU INDUSTRIE

FARMACEUTICHE RIUNITE S.P.A

5188 Frusemide Tablets Frusemide 40mg POM Tablet Uncoated 151/051 SK Age Exports, India

5189 Amoxykant 250 Capsules Amoxicillin 250mg POM Capsule oral 162/005 SK Age Exports, India

5190 Metronol Tablets Metronidazole 200mg POM Tablet Uncoated 162/007 SK Age Exports, India

5191 Melquin 250 Tablets Erythromycin 250mg POM Tablet Uncoated 161/003 SKant Healthcare Ltd, India

5192Malacure Tablets

Pyrimethamine 25mg +

Sulphadoxine 500mg

P Tablet Uncoated 161/004 SKant Healthcare Ltd, India

5193 Amoxykant Capsules Amoxycillin 250mg POM Capsule oral 161/005 SKant Healthcare Ltd, India

5194

Promethazine Hydrochloride

Injection

Promethazine 25mg, per

2ml

POM Solution for

Injection

161/006 SKant Healthcare Ltd, India

5195Gentamycin Injection Gentamycin 40mg, per ml

POM Solution for

Injection

161/007 SKant Healthcare Ltd, India

5196Metronikant Suspension

Metronidazole 125mg,

per 5ml

POM Suspension for

Oral Use

161/009 SKant Healthcare Ltd, India

5197

Cotrikant Oral Suspension

Sulphamethoxazole

200mg + Trimethoprim

40mg

POM Suspension for

Oral Use

161/010 SKant Healthcare Ltd, India

5198 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 161/011 SKant Healthcare Ltd, India

5199 Salbukant 4 Tablets Salbutamol 4mg POM Tablet Uncoated 161/013 SKant Healthcare Ltd, India

Page 269 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5200

Cotrikant Tablets

Sulphamethoxazole

400mg + Trimethoprim

80mg

POM Tablet Uncoated 161/014 SKant Healthcare Ltd, India

5201 Ampikant Capsules Ampicillin 250mg POM Capsule oral 161/015 SKant Healthcare Ltd, India

5202 Ibukant Tablets Ibuprofen 200mg BP P Tablet Uncoated 161/016 SKant Healthcare Ltd, India

5203Erythrokant Suspension

Erythromycin 125mg, per

5ml

POM Suspension 161/017 SKant Healthcare Ltd, India

5204 Doxykant Capsules Doxycycline 250mg POM Capsule oral 161/018 SKant Healthcare Ltd, India

5205

Phenoxymethyl Penicillin

Tablets

Phenoxymethyl Penicillin

V 250mg

POM Tablet Uncoated 161/019 SKant Healthcare Ltd, India

5206 Cloxikant Capsules Cloxacillin 250mg POM Capsule oral 161/020 SKant Healthcare Ltd, India

5207

Tetrakant CapsulesTetracycline

Hydrochloride BP 250mg

POM Capsule oral 161/021 SKant Healthcare Ltd, India

5208Apicloxkant Capsules

Cloxacillin 250mg +

Ampicillin 250mg

POM Capsule oral 161/022 SKant Healthcare Ltd, India

5209Aspikant Tablets

Acetyl Salicylic Acid

300mg

P Tablet Uncoated 161/023 SKant Healthcare Ltd, India

5210 Metrokant Tablets Metronidazole 200mg POM Tablet Uncoated 161/024 SKant Healthcare Ltd, India

5211Magtrikant Tablets

Aluminium Hydrochloride

+ Magnesium Trisilicate

GS Tablet Uncoated 161/025 SKant Healthcare Ltd, India

5212 CPkant Tablets Chlorpheniramine 2mg P Tablet Uncoated 161/026 SKant Healthcare Ltd, India

5213 Salbukant Syrup Salbutamol 2mg, per 5ml POM Syrup 161/027 SKant Healthcare Ltd, India

5214Parakant Syrup

Paracetamol 120mg, per

5ml

GS Syrup 161/028 SKant Healthcare Ltd, India

5215Amoxykant Syrup

Amoxicillin 125mg, per

5ml

POM Syrup 161/029 SKant Healthcare Ltd, India

5216Procaine Penicillin Injection Procain Penicillin 4MU

POM Powder for

Injection

161/030 SKant Healthcare Ltd, India

5217 Diclokant Tablets Diclofenac 100mg P Tablet Uncoated 161/031 SKant Healthcare Ltd, India

5218 Cimetidine 200 Tablets Cimetidine 200mg POM Tablet Uncoated 161/032 SKant Healthcare Ltd, India

5219 Cimetidine 400 Tablets Cimetidine 400mg POM Tablet Uncoated 161/033 SKant Healthcare Ltd, India

5220

Oral Rehydration Salts

Sodium Chloride +

Sodium Citrate +

Potassium Chloride +

Glucose

GS Powder for Oral

Solution

161/034 SKant Healthcare Ltd, India

5221Apiclockant Capsules

Cloxacillin 250mg +

Ampicillin 250mg

POM Capsule oral 161/036 SKant Healthcare Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5222Ferrous+ Folic Acid Tablets

Ferrous Sulphate + Folic

Acid

P Tablet Uncoated 161/037 SKant Healthcare Ltd, India

5223 Nalikant Tablets Nalidixic Acid 500mg POM Tablet Uncoated 161/038 SKant Healthcare Ltd, India

5224 Aminophyline Tablets Aminophylline 100mg POM Tablet Uncoated 161/039 SKant Healthcare Ltd, India

5225 Prazikant Tablets Praziquantel 600mg POM Tablet Uncoated 161/040 SKant Healthcare Ltd, India

5226 Mebekant Tablets Mebendazole 100mg P Tablet Uncoated 161/041 SKant Healthcare Ltd, India

5227Ampicillin Injection Ampicillin 1000mg

POM Powder for

Injection

161/042 SKant Healthcare Ltd, India

5228 Ciprokant 250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 161/043 SKant Healthcare Ltd, India

5229 Meldol Tablets Paracetamol 500mg GS Tablet Uncoated 161/044 SKant Healthcare Ltd, India

5230 Painrid Capsules Paracetamol + Caffeine GS Capsule oral 161/045 SKant Healthcare Ltd, India

5231Coldnil Tablets

Paracetamol + Caffeine +

Chlorpheniramine

P Tablet Uncoated 161/046 SKant Healthcare Ltd, India

5232

Melcid Tablets

Dried Aluminium

Hydroxide + Magnesium

Trisilicate

GS Tablet Uncoated 161/047 SKant Healthcare Ltd, India

5233 Melkoff Tablets Combination P Tablet Uncoated 161/048 SKant Healthcare Ltd, India

5234 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 161/049 SKant Healthcare Ltd, India

5235

Hematonic

Ferric Ammonium Citrate

204mg +

Cyanocobalamine

0.100mg + Pyridoxine

Hydrochloride 0.600mg +

Folic Acid 1.800mg +

Zinc Sulphate

Monohydrate 1.455mg,

per 5ml

P Syrup 161/050 SKant Healthcare Ltd, India

5236 Good Night Syrup Combination P Syrup 161/052 SKant Healthcare Ltd, India

5237 Propranolol Tablets Propranolol 40mg POM Tablet Uncoated 161/053 SKant Healthcare Ltd, India

5238 Methyldopa Tablets Methyldopa 250mg POM Tablet Uncoated 161/054 SKant Healthcare Ltd, India

5239 Pyrazinamide Tablets Pyrazinamide 500mg POM Tablet Uncoated 161/055 SKant Healthcare Ltd, India

5240 Erythrokant Tablets Erythromycin 250mg POM Tablet Uncoated 161/056 SKant Healthcare Ltd, India

5241 Folicant 5 Tablets Folic Acid 5mg P Tablet Uncoated 161/057 SKant Healthcare Ltd, India

5242 Tetrakant 250 Capsules Tetracycline 250mg POM Capsule oral 161/058 SKant Healthcare Ltd, India

5243 Ibuprofen Tablets Ibuprofen 200mg P Tablet Film coated 161/059 SKant Healthcare Ltd, India

5244 Quinine Sulphate Tablets BP Quinine Sulphate 300mg POM Tablet Film coated 161/060 SKant Healthcare Ltd, India

5245

Arthemether + Lumefantrine

Tablets

Artemether 20mg +

Lumefantrine 120mg

POM Tablet Uncoated 161/061 SKant Healthcare Ltd, India

Page 271 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5246

Nystatin Vaginal Insert USP

1000IUNystatin USP 100 000IU

POM Tablet Vaginal 161/062 SKant Healthcare Ltd, India

5247Silverkant Cream

Silver Sulfadiazine USP

1%w/w

POM Cream topical 161/063 SKant Healthcare Ltd, India

5248

Hematonic Syrup

Ferric Ammonium Citrate

204mg +

Cyanocobalamine

0.100mg + Pyridoxine Hcl

0.600mg + Folic Acid

1.800mg + Zinc Sulphate

Monohydrate 1.455mg,

per 5ml

POM Syrup 161/064 SKant Healthcare Ltd, India

5249

Go Gel

Diclofenac

Dimethylamine 1.16%

w/w + Oleum Lini 1%w/w

+ Menthol BP 5%w/w +

Mathyl Salicylate 10% +

Capsaicin USP

0.025%w/w

P Gel Topical 161/065 SKant Healthcare Ltd, India

5250

Safe Plan Family Planning Pills

Ethinylestradiol 0.03mg +

Levonorgestrel 0.15mg +

Ferrous Fumurate 75mg

POM Tablet Uncoated 125/001 Soceity For Family Health Ltd, Zambia

5251My Choice Injection

Medroxyprogesterone

150mg, per ml

POM Solution for

Injection

125/002 Society for Family Health Ltd, Zambia

5252

Mychoice Microgynon Ed Fe

Tablets

Ethinyl Estradiol 0.03mg

+ Levonorgestrel 0.15mg

+ Ferrous Fumurate

75mg

POM Tablet Uncoated 125/003 Society for Family Health Ltd, Zambia

5253

Mychoice Intra Uterine

Contraceptive DeviceCopper-T Cu 380 A

N/A Intra Uterine 125/004 Society for Family Health Ltd, Zambia

5254 Mychoice Woman Condom Latex Products GS Latex Products 125/005L Society for Family Health Ltd, Zambia

5255 Mychoice Diaphragm Latex Products GS Latex Products 125/006L Society for Family Health Ltd, Zambia

5256 Mychoice Lubricant Lubricant GS Gel Topical 125/007L Society for Family Health Ltd, Zambia

5257 Trust Studed Condom Male Latex Condom GS Latex Products 125/008L Society for Family Health Ltd, Zambia

5258 Trust Smooth Condom Male Latex Condom GS Latex Products 125/009L Society for Family Health Ltd, Zambia

5259 Cloxispa Capsules Cloxacillin 250mg POM Capsule oral 231/001 Sparsh Biotech Pvt Ltd, India

5260 Spamcil Capsules Ampicillin 250mg POM Capsule oral 231/002 Sparsh Biotech Pvt Ltd, India

5261 Spmox Capsules Amoxicillin 250mg POM Capsule oral 231/003 Sparsh Biotech Pvt Ltd, India

Page 272 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5262Speniv Tablets

Phenoxymethyl Penicillin

V 250mg

POM Tablet Uncoated 231/004 Sparsh Biotech Pvt Ltd, India

5263Speniv Oral Suspension

Phenoxymethyl Penicillin

V 125mg, per 5ml

POM Powder for Oral

Suspension

231/005 Sparsh Biotech Pvt Ltd, India

5264Spamox Capsules

Ampicillin 250mg +

Cloxacillin 250mg

POM Capsule oral 231/006 Sparsh Biotech Pvt Ltd, India

5265 Spamox Dispersible Tablets Amoxicillin 250mg POM Tablet Dispersible 231/007 Sparsh Biotech Pvt Ltd, India

5266 Hibiscrub Topical Solution Chlorhexidine 4.0%w/v GS Solution Topical 023/005 SSL International, England

5267 Hibitane 5% Concentrate Chlorhexidine 5% GS Solution Topical 023/006 SSL International, England

5268Hibiscet Hospital Concentration Chlorhexidine 40%

GS Solution Topical 023/016 SSL International, England

5269Esoz 40 Tablets Esomeprazole 40mg

POM Tablet Uncoated 039/030 Stada Vietnam Joint Venture Co. Ltd,

Vietnam

5270Stalclox Capsules

Ampicillin 250mg +

Cloxacillin 250mg

POM Capsule oral 016/001 Stallion Laboratories Limited, India

5271 Cedril-250 Tablets Cefadroxil 250mg POM Tablet Uncoated 016/002 Stallion Laboratories Limited, India

5272Endulax Powder

Ispaghula Husk 3.5g

100% w/w

P Powder for Oral

Suspension

016/003 Stallion Laboratories Limited, India

5273 Ole-400 Tablets Ofloxacin 400mg POM Tablet Uncoated 016/004 Stallion Laboratories Limited, India

5274 Ciptid-500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 016/005 Stallion Laboratories Limited, India

5275Stalfin Tablets

Sulphadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 016/006 Stallion Laboratories Limited, India

5276P-Cam 20 Caspules Piroxicam 20mg

POM Capsule Sustained

Release

016/007 Stallion Laboratories Limited, India

5277 Endulx Garlic Tablets Ispaghula Husk 300mg P Tablet Uncoated 016/008 Stallion Laboratories Limited, India

5278 Quinlin-300 Tablets Quinine 300mg POM Tablet Uncoated 016/009 Stallion Laboratories Limited, India

5279 Endulax Karela Capsules Ispaghula Husk 400mg P Capsule oral 016/010 Stallion Laboratories Limited, India

5280Alvenax Drench 1000ml

Albendazole 23mg, per

ml

P Suspension for

Oral Use

122/711 Star Laboratories Pvt Ltd, Pakistan

5281Teragen Aerosol Spray

Oxytetracycline 40mg +

Gentian Violet 4mg

P Spray for Topical

Use

122/712 Star Laboratories Pvt Ltd, Pakistan

5282Tylomac Injection 100ml Tylosin 200mg, per ml

POM Solution for

Injection

122/713 Star Laboratories Pvt Ltd, Pakistan

5283Amino Vital Injection 100mls Multivitamin

POM Solution for

Injection

122/714 Star Laboratories Pvt Ltd, Pakistan

5284

Drez Ointment

Povidone Iodine

5.0%w/w + Metronidazole

1.0%w/w

P Ointment topical 208/002 Stedman Pharmaceuticals (Pvt) Litd, India

Page 273 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5285

Drez Powder

Povidone Iodine 5.0%w/w

+ Metronidazole

1.0%w/w

P Powder for Topical

Solution

208/003 Stedman Pharmaceuticals (Pvt) Litd, India

5286

Drez Solution

Povidone Iodine

5.0%w/w + Metronidazole

1.0%w/w

P Solution for Topical

Use

208/004 Stedman Pharmaceuticals (Pvt) Litd, India

5287

Contus Plus Paediatric

Suspension

Chlorpheniramine 1mg +

Phenylephrine 5mg +

Paracetamol 160mg

P Suspension for

Oral Use

208/005 Stedman Pharmaceuticals (Pvt) Litd, India

5288

Contus Paediatric linctus

Chlorpheniramine 1mg +

Phenylephrine 5mg +

Dextromethophen 10mg

P Solution for Oral

Use

208/006 Stedman Pharmaceuticals (Pvt) Litd, India

5289Drez-V Gel

Miconazole 1%w/w +

Metronidazole 100mg

POM Gel Vaginal 208/007 Stedman Pharmaceuticals (Pvt) Litd, India

5290

Contus-650 Tablets

Chlorpheniramine 2mg +

Paracetamol 650mg +

Phenylephrine 5mg

P Tablet Uncoated 208/008 Stedman Pharmaceuticals (Pvt) Litd, India

5291 STEDNAC Tablets Aceclofenac 100mg P Tablet Uncoated 208/009 Stedman Pharmaceuticals (Pvt) Litd, India

5292DREZ Gargle

Iodinated Povidone

2%w/v

P Solution for Oral

Use

208/010 Stedman Pharmaceuticals (Pvt) Litd, India

5293

Tenofovir Disproxil Fumarate

300mg Tablet

Tenofovir Disproxil

Fumarate 300mg

POM Tablet Uncoated 090/030 Strides Arcolab Ltd, India

5294

Lamivudine + Zidovudine

Tablets

Lamivudine 150mg +

Zidovudine 300mg

POM Tablet Uncoated 090/001 Strides Shasun

5295 Stavudine Capsules Stavudine 30mg POM Capsule oral 090/002 Strides Shasun

5296 Efavirenz Tablets Efavirenz 600mg POM Tablet Uncoated 090/003 Strides Shasun

5297

Stavudine + Lamivudine +

Nevirapine Tablets

Stavudine 30mg +

Lamivudine 150mg +

Nevirapine 200mg

POM Tablet Uncoated 090/004 Strides Shasun

5298Stavudine + Lamivudine Tablets

Stavudine 30mg +

Lamivudine 150mg

POM Tablet Uncoated 090/005 Strides Shasun

5299Abacavir Sulphate Tablets Abacavir Sulphate 300mg

POM Tablet Uncoated 090/006 Strides Shasun

5300 Lamivudine Tablets Lamivudine USP 300mg POM Tablet Uncoated 090/007 Strides Shasun

5301 Pyrazinamide Tablets Pyrazinamide 400mg POM Tablet Uncoated 090/008 Strides Shasun

5302Rifampicin & Isoniazid Tablets

Rifampicin 60mg +

Isoniazid 30mg

POM Tablet Dispersible 090/009 Strides Shasun

5303Simclox -500 Capsules

Ampicillin 250mg +

Cloxacillin 250mg

POM Capsule oral 090/010 Strides Shasun

Page 274 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5304Hyosim Tablets

Hyoscine Butylbromide

10mg

POM Tablet Film coated 090/013 Strides Shasun

5305 Griseosim - 500 Tablets Griseofulvin 500mg POM Tablet Uncoated 090/014 Strides Shasun

5306 Mebrone -100 Tablets Mebendazole 100mg P Tablet Uncoated 090/015 Strides Shasun

5307 Nalidixic Acid Tablets Nalidixic Acid 500mg P Tablet Uncoated 090/016 Strides Shasun

5308 Cefalexin - 500 Capsules Cefalexin 500mg POM Capsule oral 090/017 Strides Shasun

5309Celltriaxone Injection

Ceftriaxone Sodium USP

1g

POM Powder for

Injection

090/018 Strides Shasun

5310

Vitafer Forte Syrup

Ferric Ammonium Citrate

USP 200mg (Equivalent

To Elemental Iron 41mg)

Folic Acid BP 1.5mg +

Vitamin B12 BP 50mcg,

per 5ml)

P Syrup 090/019 Strides Shasun

5311 Lorhist Tablets Loratadine USP 10mg POM Tablet Uncoated 090/020 Strides Shasun

5312 Melonax 15 Tablets Meloxicam 15mg BP POM Tablet Film coated 090/021 Strides Shasun

5313 Camvit -Plus Capsules Multivitamins & Minerals P Capsule oral 090/022 Strides Shasun

5314 Efavirenz Tablets Efavirenz 200mg POM Tablet Uncoated 090/023 Strides Shasun

5315

Amoxicillin Dry Powder For

Syrup 125mg/5mlAmoxicillin 125mg

POM powder for syrup 286/001 Strides Shasun

5316 Indomethacin Capsules 25mg Indomethacin 25mg P Capsule oral 286/004 Strides Shasun

5317 Apirone 250mg Capsules Ampicillin 250mg POM Capsule oral 286/005 Strides Shasun

5318 Cloxacillin 250mg Capsules Cloxacillin 250mg POM Capsule oral 286/006 Strides Shasun

5319 Tetracycline 250mg Capsules Tetracycline 250mg POM Capsule oral 286/008 Strides Shasun

5320 Vitamin C Tablets Ascorbic Acid P Tablet 286/009 Strides Shasun

5321

Cloxacillin Dry Powder For

Syrup 125mg/5mlCloxacillin 125mg

POM powder for syrup 286/010 Strides Shasun

5322

Co-trimoxazole Dry Powder For

Syrup 240mg/5ml

Sulfamethoxazole 200mg

+ Trimethoprim 40mg

POM powder for syrup 286/013 Strides Shasun

5323Medabon Tablets

Mifepristone 200mg +

Misoprostol 200mcg

POM Tablet Uncoated 083/001 Sun Pharmaceticals Limited

5324 Sporidex 500 Capsules Cephalexin 500mg POM Capsule oral 112/001 Sun Pharmaceutical Industries Limited

5325 Sporidex Capsules Cephalexin 250mg POM Capsule oral 112/002 Sun Pharmaceutical Industries Limited

5326 Simvor 10 Tablets Simvastatin 10mg POM Tablet Film coated 112/003 Sun Pharmaceutical Industries Limited

5327 Simvor 20 Tablets Simvastatin 20mg POM Tablet Film coated 112/004 Sun Pharmaceutical Industries Limited

5328Effical Tablets

Vitamin B3 + Calcium

Carbonate

P Tablet Film coated 112/005 Sun Pharmaceutical Industries Limited

Page 275 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5329

Enhancin Injection

Amoxicillin 1000mg +

Clavulanate Potassium

200mg

POM Solution for

Injection

112/007 Sun Pharmaceutical Industries Limited

5330 Canova-50 Tablets Sildenafil 50mg POM Tablet Uncoated 112/009 Sun Pharmaceutical Industries Limited

5331 Fluroric 50 Capsules Fluconazole 50mg POM Capsule oral 112/012 Sun Pharmaceutical Industries Limited

5332 Fluroric 150 Capsules Fluconazole 150mg POM Capsule oral 112/013 Sun Pharmaceutical Industries Limited

5333Silverex Cream

Chlorhexidine + Silver

Sulfadiazine

P Cream Topical 112/016 Sun Pharmaceutical Industries Limited

5334

Volini Gel

Race Menthol + Methyl

Salicylate + Diclofenac +

Linse

P Gel Topical 112/018 Sun Pharmaceutical Industries Limited

5335 Storvas 20mg Tablets Atorvastatin 20mg POM Tablet Film coated 112/023 Sun Pharmaceutical Industries Limited

5336 Storvas 10mg Tablets Atorvastatin 10mg POM Tablet Film coated 112/024 Sun Pharmaceutical Industries Limited

5337 Ranophage 500mg Tablets Metformin 500mg POM Tablet Uncoated 112/025 Sun Pharmaceutical Industries Limited

5338

Enhancin 1000 Tablets

Amoxicillin 875mg +

Clavulanate Potassium

125mg

POM Tablet Film coated 112/026 Sun Pharmaceutical Industries Limited

5339 Amlovas Tablets Amlodipine 10mg POM Tablet Uncoated 112/027 Sun Pharmaceutical Industries Limited

5340Ceroxim 125mg/5ml Suspension

Cefuroxime 125mg, per

5ml

POM Suspension for

Oral Use

112/028 Sun Pharmaceutical Industries Limited

5341Ceroxim 250mg/5ml Suspension

Cefuroxime 250mg, per

5ml

POM Suspension for

Oral Use

112/029 Sun Pharmaceutical Industries Limited

5342 Flucoric 100mg Capsules Fluconazole 100mg POM Capsule oral 112/030 Sun Pharmaceutical Industries Limited

5343 Klabax Tablets Clarithromycin 250mg POM Tablet Film coated 112/031 Sun Pharmaceutical Industries Limited

5344 Klabax 500 Tablets Clarithromycin 500mg POM Tablet Film coated 112/032 Sun Pharmaceutical Industries Limited

5345 Flucoric Capsules Fluconazole 200mg POM Capsule oral 112/033 Sun Pharmaceutical Industries Limited

5346

Ranmoxy 125 Suspension

125mgAmoxicillin 125mg

POM Suspension for

Oral Use

112/035 Sun Pharmaceutical Industries Limited

5347 Cifran OD Tablets Ciprofloxacin 1g POM Tablet Uncoated 112/036 Sun Pharmaceutical Industries Limited

5348 Cifran OD Tablets Ciprofloxacin 500mg POM Tablet Uncoated 112/037 Sun Pharmaceutical Industries Limited

5349Oframax 250 Injection Ceftriaxone 250mg

POM Powder for

Injection

112/040 Sun Pharmaceutical Industries Limited

5350Oframax Injection Ceftriaxone 1000mg

POM Powder for

Injection

112/041 Sun Pharmaceutical Industries Limited

5351

Ranferon - 12 Capsules

Ferrous Fumarate 305mg

+ Ascorbic Acid 75mg +

Cyanocobalamine 5mcg

+ Foilc Acid 0.75mg

P Capsule oral 112/042 Sun Pharmaceutical Industries Limited

Page 276 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5352Loxof Infusion Levofloxacin 5mg, per ml

POM Solution for

infusion

112/046 Sun Pharmaceutical Industries Limited

5353 Avostav 30 Capsules Stavudine 30mg POM Capsule oral 112/047 Sun Pharmaceutical Industries Limited

5354 Loxf-250 Tablets Levofloxacin 250mg POM Tablet Film coated 112/049 Sun Pharmaceutical Industries Limited

5355 Loxof 500 Tablets Levofloxacin 500mg POM Tablet Film coated 112/050 Sun Pharmaceutical Industries Limited

5356

Rancotrim Suspension

Sulphamethoxazole

200mg + Trimethoprim

40mg, per 5ml

POM Suspension for

Oral Use

112/051 Sun Pharmaceutical Industries Limited

5357 Copril Capsules Ramipril 5mg POM Capsule oral 112/054 Sun Pharmaceutical Industries Limited

5358 Amlovas Tablets Amlodipine 5mg POM Tablet Uncoated 112/055 Sun Pharmaceutical Industries Limited

5359Bacqure 50 Injection

Cilastatin 500mg +

Imipenem 500mg

POM Solution for

Injection

112/056 Sun Pharmaceutical Industries Limited

5360 Contiflo 0.4 Capsules Tamsulosin 0.4mg POM Capsule oral 112/057 Sun Pharmaceutical Industries Limited

5361 Avolam Tablets Lamivudine 150mg POM Tablet Uncoated 112/058 Sun Pharmaceutical Industries Limited

5362Avocomb Tablets

Lamivudine 150mg +

Zidovudine 300mg

POM Tablet Uncoated 112/059 Sun Pharmaceutical Industries Limited

5363

Avocomb-N Tablets

Lamivudine 150mg +

Nevirapine 200mg +

Zidovudine 300mg

POM Tablet Uncoated 112/060 Sun Pharmaceutical Industries Limited

5364 Abac 300 Tablets Abacavir 300mg POM Tablet Uncoated 112/061 Sun Pharmaceutical Industries Limited

5365 Aviro-Z Tablets Zidovudine 300mg POM Tablet Uncoated 112/062 Sun Pharmaceutical Industries Limited

5366 Nevipan Tablets Nevirapine 200mg POM Tablet Uncoated 112/063 Sun Pharmaceutical Industries Limited

5367 Histac EVT 150 Tablets Ranitidine 150mg POM Tablet Uncoated 112/068 Sun Pharmaceutical Industries Limited

5368

Enhancin 375 Tablets

Amoxicillin 250mg +

Clavulanate Potassium

125mg

POM Tablet Uncoated 112/069 Sun Pharmaceutical Industries Limited

5369

Enhancin 625 Tablets

Amoxicillin 500mg +

Clavulanate Potassium

125mg

POM Tablet Uncoated 112/070 Sun Pharmaceutical Industries Limited

5370Sporidex Suspension

Cephalexin 125mg, per

5ml

POM Suspension for

Oral Use

112/071 Sun Pharmaceutical Industries Limited

5371

Triviro 30 --LNS Tablets

Stavudine 30mg +

Nevirapine 200mg +

Lamivudine 150mg

POM Tablet Uncoated 112/073 Sun Pharmaceutical Industries Limited

5372

Triviro 40 -LNS Tablets

Stavudine 40mg +

Nevirapine 200mg +

Lamivudine 150mg

POM Tablet Uncoated 112/074 Sun Pharmaceutical Industries Limited

5373

Coviro-LS 30 Compliance Pack

Tablets

Lamivudine 150mg +

Stavudine 30mg

POM Tablet Uncoated 112/075 Sun Pharmaceutical Industries Limited

Page 277 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5374

Coviro-LS 40 Compliance Pack

Tablets

Lamivudine 150mg +

Stavudine 40mg

POM Tablet Uncoated 112/076 Sun Pharmaceutical Industries Limited

5375

Abac-LZ Tablets

Abacavir 300mg +

Lamivudine 150mg +

Zidovudine 300mg

POM Tablet Uncoated 112/077 Sun Pharmaceutical Industries Limited

5376 Avirodin Capsules Indinavir 400mg POM Capsule oral 112/078 Sun Pharmaceutical Industries Limited

5377 Aviranz 600 Tablets Efavirenz 600mg POM Tablet Uncoated 112/079 Sun Pharmaceutical Industries Limited

5378 Aviranz 200 Tablets Efavirenz 200mg POM Tablet Uncoated 112/080 Sun Pharmaceutical Industries Limited

5379

Chericoff Syrup

Chlorpheniramine 2mg +

Dextrometherphan 10mg

+ Phenylephrine 5mg,

per 5ml

P Syrup 112/081 Sun Pharmaceutical Industries Limited

5380Cifran C.T Tablets

Ciprofloxacin 500mg +

Tinidazole 600mg

POM Tablet Uncoated 112/082 Sun Pharmaceutical Industries Limited

5381 Riconia Liquid Multivitamins GS Syrup 112/083 Sun Pharmaceutical Industries Limited

5382 Sebifin Tablets Terbinafine 250mg POM Tablet Uncoated 112/084 Sun Pharmaceutical Industries Limited

5383 Riconia Tablets Multivitamins GS Tablet Uncoated 112/085 Sun Pharmaceutical Industries Limited

5384 Monsin Ointment Mupirocin 2.0%w/w POM Ointment topical 112/086 Sun Pharmaceutical Industries Limited

5385Cepodem Suspension

Cefpodoxime 40mg, per

5ml

POM Suspension for

Oral Use

112/087 Sun Pharmaceutical Industries Limited

5386 Cepodem 200mg Tablets Cefpodoxime 200mg POM Tablet Uncoated 112/088 Sun Pharmaceutical Industries Limited

5387 Ranophage 1000mg Tablets Metformin 1000mg POM Tablet Uncoated 112/089 Sun Pharmaceutical Industries Limited

5388 Cepodem 100mg Tablets Cefpodoxime 100mg POM Tablet Uncoated 112/090 Sun Pharmaceutical Industries Limited

5389Brustan Tablets

Paracetamol 375mg +

Ibuprofen 200mg

P Tablet Film coated 112/091 Sun Pharmaceutical Industries Limited

5390Brustan Suspension

Paracetamol 125mg +

Ibuprofen 100mg

P Suspension for

Oral Use

112/092 Sun Pharmaceutical Industries Limited

5391 Corpril 2.5 Tablets Ramipril 2.5mg POM Tablet Uncoated 112/093 Sun Pharmaceutical Industries Limited

5392 Corpril 10 Tablets Ramipril 10mg POM Tablet Uncoated 112/094 Sun Pharmaceutical Industries Limited

5393

Avocomb-E Compliance Pack

Tablets

Lamivudine 150mg +

Zidovudine 300mg +

Efavirenz 600mg

POM Tablet Uncoated 112/095 Sun Pharmaceutical Industries Limited

5394

Coviro-E 30 Compliance Pack

Tablets

Stavudine 30mg +

Lamivudine 150mg +

Efavirenz 600mg

POM Tablet Uncoated 112/096 Sun Pharmaceutical Industries Limited

5395

Triviro LNS Kid Dispersible

Tablets

Stavudine 10mg +

Lamivudine 40mg +

Nevirapine 70mg

POM Tablet Dispersible 112/098 Sun Pharmaceutical Industries Limited

Page 278 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5396

Triviro LNS Kid Dispersible

Tablets

Stavudine 5mg +

Lamivudine 20mg +

Nevirapine 35mg

POM Tablet Dispersible 112/099 Sun Pharmaceutical Industries Limited

5397 Ranferon-12 Syrup Haematinic Preparation P Syrup 112/100 Sun Pharmaceutical Industries Limited

5398

Enhancin Suspension

Amoxicillin 125mg +

Clavulanic Acid 31.25mg,

per 5ml

POM Suspension for

Oral Use

112/101 Sun Pharmaceutical Industries Limited

5399 Lovir Cream Acyclovir 5% POM Cream Topical 112/102 Sun Pharmaceutical Industries Limited

5400 Klabax Suspension -12 Clarithromycin 125mg POM Suspension 112/103 Sun Pharmaceutical Industries Limited

5401Revital Capsules

Ginseng + Multivitamin +

Mineral

GS Capsule 112/104 Sun Pharmaceutical Industries Limited

5402Mucasone Ointment

Fluticasone 0.05mg +

Mupirocin 20mg

POM Ointment topical 112/105 Sun Pharmaceutical Industries Limited

5403 Relenost Tablets Alendronate 70mg POM Tablet Uncoated 112/106 Sun Pharmaceutical Industries Limited

5404 Raciper Tablets Esomeprazole 20mg POM Tablet Uncoated 112/107 Sun Pharmaceutical Industries Limited

5405 Amosec Tablets Secnidazole 1000mg POM Tablet Uncoated 112/108 Sun Pharmaceutical Industries Limited

5406 Rodera Tablets Desloratadine 5mg POM Tablet Uncoated 112/109 Sun Pharmaceutical Industries Limited

5407 Staval 80 Tablets Valsartan 80mg POM Tablet Uncoated 112/110 Sun Pharmaceutical Industries Limited

5408 Starval 16 Tablets Valsartan 160mg POM Tablet Uncoated 112/111 Sun Pharmaceutical Industries Limited

5409

Starval HCT 80 + 12.5 Tablets

Valsartan 80mg +

Hydrochlorothiazide

12.5mg

POM Tablet Uncoated 112/112 Sun Pharmaceutical Industries Limited

5410

Starval HCT 160/25 Tablets

Valsartan 160mg +

Hydrochlorothiazide

25mg

POM Tablet Uncoated 112/113 Sun Pharmaceutical Industries Limited

5411 Raciper 40 Tablets Esomeprazole 40mg POM Tablet Uncoated 112/114 Sun Pharmaceutical Industries Limited

5412 Romilast 10 Tablets Montelukast 10mg POM Tablet Uncoated 112/115 Sun Pharmaceutical Industries Limited

5413 Ceruvin Tablets Clopidogrel 75mg POM Tablet Uncoated 112/116 Sun Pharmaceutical Industries Limited

5414Brustan Gel

Ibuprofen 5% +

Levomenthol 3%

P Gel Topical 112/117 Sun Pharmaceutical Industries Limited

5415 Rosuvas 10 Tablets Rosuvastatin 10mg POM Tablet Uncoated 112/118 Sun Pharmaceutical Industries Limited

5416 Rosuvas 20 Tablets Rosuvastatin 20mg POM Tablet Uncoated 112/119 Sun Pharmaceutical Industries Limited

5417 Alyvir Tablets Valacyclovir 500mg POM Tablet Uncoated 112/120 Sun Pharmaceutical Industries Limited

5418Ranophage G1 Tablets

Glimepiride 1mg +

Metformin 500mg

POM Tablet Film coated 112/121 Sun Pharmaceutical Industries Limited

5419Ranophage G2 Tablets

Glimepiride 2mg +

Metformin 500mg

POM Tablet Film coated 112/122 Sun Pharmaceutical Industries Limited

5420Bestinem 1000mg Injection Meropenem 1000mg

POM Powder for

Injection

112/123 Sun Pharmaceutical Industries Limited

Page 279 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5421Cilentra Tablets

Escitalopram Oxalate

10mg

POM Tablet Uncoated 112/124 Sun Pharmaceutical Industries Limited

5422Cilentra Tablets

Escitalopram Oxalate

20mg

POM Tablet Uncoated 112/125 Sun Pharmaceutical Industries Limited

5423 Adosine 100 Tablets Didanosine 100mg POM Tablet Dispersible 112/126 Sun Pharmaceutical Industries Limited

5424 Adosine 50 Tablets Didanosine 50mg POM Tablet Dispersible 112/127 Sun Pharmaceutical Industries Limited

5425 Adosine 25 Tablets Didanosine 25mg POM Tablet Dispersible 112/128 Sun Pharmaceutical Industries Limited

5426Olvance 20 Tablets

Olmesartan Medoxomil

20mg

POM Tablet Film coated 112/129 Sun Pharmaceutical Industries Limited

5427Olvance 40 Tablets

Olmesartan Medoxomil

40mg

POM Tablet Film coated 112/130 Sun Pharmaceutical Industries Limited

5428

Olvance HCT 20 Tablets

Olmesartan Medoxomil

20mg +

Hydrochlorothiazide

12.5mg

POM Tablet Film coated 112/131 Sun Pharmaceutical Industries Limited

5429

Olvance HCT 40 Tablets

Olmesartan Medoxomil

40mg +

Hydrochlorothiazide

12.5mg

POM Tablet Film coated 112/132 Sun Pharmaceutical Industries Limited

5430 Suntel 40 Tablets Telmisartan 40mg POM Tablet Film coated 446/002 Sunberg Lifescience Ltd

5431

Clintrim SB Vaginal

Suppositories

Clotrimazole 100mg +

Clindamycin 100mg

POM Vaginal

suppositories

446/001 Sunberg Lifescience Ltd

5432Sterile Water For Injection Water For Injection

POM Solution for

Injection

262/001 Sunny Impex Private Ltd, India

5433

Oral Rehydrate Salts

Sodium Chloride +

Sodium Citrate +

Potassium Chloride +

Dextrose

GS Powder for Oral

Solution

262/002 Sunny Impex Private Ltd, India

5434Water For Injection Water For Injection

POM Solution for

Injection

056/001 Svizera Europe BV, The Netherlands

5435

Rifampicin + Isoniazid +

Pyrazinamide + Ethambutol

FDC Tablets

Rifampicin 150mg +

Isoniazid 75mg +

Pyrazinamide 400mg +

Ethambutol 275mg

POM Tablet Uncoated 056/002 Svizera Europe BV, The Netherlands

5436

Streptomycin Sulphate Powder

For InjectionStreptomycin 1.0 Grams

POM Powder for

Injection

056/003 Svizera Europe BV, The Netherlands

5437Synerpen Injection

Sulbactam 125mg +

Ampicillin 250mg

POM Solution for

Injection

131/002 T3A Pharma Group, Egypt

Page 280 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5438Synerpen T3A Injection

Sulbactam 250mg +

Ampicillin 500mg

POM Solution for

Injection

131/003 T3A Pharma Group, Egypt

5439Synerpen T3A Injection

Sulbactam 500mg +

Ampicillin 1000mg

POM Solution for

Injection

131/004 T3A Pharma Group, Egypt

5440Cefotax T3A Injection Cefotaxime 250mg

POM Solution for

Injection

131/005 T3A Pharma Group, Egypt

5441Bacticid Injection

Gentamicin 80mg, per

2ml

POM Solution for

Injection

238/001 Tablets (India) Ltd, India

5442 Ambrolite Syrup Ambroxol 30mg, per 5ml POM Syrup 238/002 Tablets (India) Ltd, India

5443Omnicort Injection

Dexamethasone Sodium

Phosphate 4mg, per ml

POM Solution for

Injection

238/003 Tablets (India) Ltd, India

5444

Ferup Syrup

Ferrous Glycine Sulphate

220mg + Thiamine

Hydrochloride BP 0.25mg

+ Cynocobalamin BP +

Folic Acid 0.5mg

P Syrup 238/004 Tablets (India) Ltd, India

5445Tilprome Injection Promethazine 25mg

POM Solution for

Injection

238/005 Tablets (India) Ltd, India

5446 Ednisol Tablets Prednisolone 5mg POM Tablet Uncoated 238/006 Tablets (India) Ltd, India

5447 Tocosules 400 Capsules Vitamin E 400mg POM Capsule 238/007 Tablets (India) Ltd, India

5448Astymin-3-200 Ml Injection Amino Acids

P Powder for

Injection

238/008 Tablets (India) Ltd, India

5449 Tilzole Tablets Mebendazole 100mg P Tablet Uncoated 238/009 Tablets (India) Ltd, India

5450 Neutrosec Syrup Vitamins + Minerals P Syrup 238/010 Tablets (India) Ltd, India

5451Cifrotil Injection

Ciprofloxacin 200mg, per

100ml

POM Solution for

infusion

238/011 Tablets (India) Ltd, India

5452 Statasmin-4 Tablets Salbutamol 4mg POM Tablet Uncoated 238/012 Tablets (India) Ltd, India

5453 Fevastin Tablets Paracetamol 500mg GS Tablet Uncoated 238/013 Tablets (India) Ltd, India

5454Astymin Syrup

Amino Acids And

Vitamins

P Syrup 238/014 Tablets (India) Ltd, India

5455Tilstigmin Injection

Neostigmine 0.5mg, per

ml

P Solution for

injection

238/015 Tablets (India) Ltd, India

5456 Astymin Forte Capsules Amino Acids + Minerals P Capsule oral 238/017 Tablets (India) Ltd, India

5457 Tilprome Tablets Promethazine 25mg P Tablet Uncoated 238/018 Tablets (India) Ltd, India

5458 Tilvit Syrup Multivitamins GS Syrup 238/019 Tablets (India) Ltd, India

5459Astyfer Liquid Haematic Preparation

P Solution for Oral

Use

238/020 Tablets (India) Ltd, India

5460 Antoxyl Forte Capsules Vitamins + Minerals P Capsule oral 238/021 Tablets (India) Ltd, India

Page 281 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5461Movactive Capsules

Glucosamine 500mg +

Magnesium 2mg

P Capsule oral 238/022 Tablets (India) Ltd, India

5462 Profundin Tablets Ibuprofen 200mg P Tablet Uncoated 238/023 Tablets (India) Ltd, India

5463 Amedosix Tablets Furosemide 40mg POM Tablet Uncoated 238/024 Tablets (India) Ltd, India

5464 Trichogyl - 200 Tablets Metronidazole 200mg POM Tablet Uncoated 238/025 Tablets (India) Ltd, India

5465Estyplex-5 Injection Vitamin B Complex

POM Solution for

Injection

238/026 Tablets (India) Ltd, India

5466 Promethazine Tablets Promethazine 10mg P Tablet Uncoated 238/027 Tablets (India) Ltd, India

5467Trichogyl I.V. Injection Metronidazole 500mg

POM Solution for

infusion

238/028 Tablets (India) Ltd, India

5468Amedosix -10 Injection Furosemide 10mg

POM Solution for

Injection

238/029 Tablets (India) Ltd, India

5469Astyfer Capsules

Folic Acid + Iron + Vit B

Complex + Amino Acids

P Capsule oral 238/030 Tablets (India) Ltd, India

5470 Cifrotil Tablets Ciprofloxacin 500mg POM Tablet Uncoated 238/031 Tablets (India) Ltd, India

5471 Tilvitone Tablets Vitamin B Complex P Tablet Uncoated 238/032 Tablets (India) Ltd, India

5472Zoleshot

Fluconazole 200mg, per

ml

POM Solution for

infusion

238/033 Tablets (India) Ltd, India

5473 Omega 3 Capsules Minerals + Vitamins GS Capsules Oral 008/000HM Tasly(S.A) Pty Ltd, South Africa

5474

Tasly Nano Iron + Vitamin C

Tablets

Iron 11mg + Ascorbic

Acid 100mg

GS Tablets 008/001 Tasly(S.A) Pty Ltd, South Africa

5475

Miss Bee Propolis & Glossy

Ganordema Capsules

Propolis Beeglue CP

125mg + Spora

Gonaderma CP 125mg

GS Capsules oral 008/001HM Tasly(S.A) Pty Ltd, South Africa

5476 Tasly Sea Oil Capsules Cold Liver Oil 313mg GS Capsule oral 008/002HM Tasly(S.A) Pty Ltd, South Africa

5477 Kasly Cordyceps Capsules

Quinese Cordceps

Powder

GSL capsules 008/003HM Tasly(S.A) Pty Ltd, South Africa

5478Tasly Phyto Soy Tablets

White Peony Root

Extract, Soy Isoflavones

GSL Tablets 008/004HM Tasly(S.A) Pty Ltd, South Africa

5479 Ginseng RH Capsules Radix Ginseng Powder GSL capsules 008/005 HM Tasly(S.A) Pty Ltd, South Africa

5480Tasly Danshen Tea Herbal Extracts 1500mg

GS Granules for Oral

Use

008/006HM Tasly(S.A) Pty Ltd, South Africa

5481

Tasly Miss Bee Royal Jelly

CapsulesRoyal Jelly 500mg

GS Capsule oral 008/007HM Tasly(S.A) Pty Ltd, South Africa

5482

Tasly Miss Bee Propolis Soft

GelBee Propolis 400mg

GS Capsule oral 008/008HM Tasly(S.A) Pty Ltd, South Africa

5483Tasly Miss Bee Camellia Bee

Camellia Pollen 500mg +

Green Tea 100mg

GS Capsule oral 008/009HM Tasly(S.A) Pty Ltd, South Africa

5484 Tasly AL Capsules Herbal Extracts 400mg GS Capsule oral 008/010HM Tasly(S.A) Pty Ltd, South Africa

Page 282 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 5485 Tasly Propolis Syrup Bee Propolis GS Syrup 008/011HM Tasly(S.A) Pty Ltd, South Africa

5486

Tasly Miss Bee Propolis +

Water Pollen CapsuleBee Propolis 500mg

GS Capsule oral 008/012HM Tasly(S.A) Pty Ltd, South Africa

5487 Tasly Kings Capsules Herbal Extracts 300mg GS Capsule oral 008/013HM Tasly(S.A) Pty Ltd, South Africa

5488

Tasly Bitter Melon Powder

Capsules

Bitter Melon Extract

500mg

GS Capsule oral 008/014HM Tasly(S.A) Pty Ltd, South Africa

5489 Tasly Amical Capsules Amino Acids P Capsule oral 008/015 Tasly(S.A) Pty Ltd, South Africa

5490 Tasly Glucare Capsules Herbal Extracts 500mg GS Capsule oral 008/015HM Tasly(S.A) Pty Ltd, South Africa

5491 Tasly Milk Calcium Tablets Milk Calcium + Vitamins P Tablet Uncoated 008/016 Tasly(S.A) Pty Ltd, South Africa

5492

Tasly Nano Tammy Relief

PowderHerbal Extracts

GS Powder for Oral

Use

008/016HM Tasly(S.A) Pty Ltd, South Africa

5493 Tasly Colim Forte Tablets B Complex P Tablet Uncoated 008/017 Tasly(S.A) Pty Ltd, South Africa

5494Tasly Cerebralcare Granules Herbal Extracts

GS Granules for Oral

Use

008/017HM Tasly(S.A) Pty Ltd, South Africa

5495 Tasly Cen Forte Tablets Vitamins + Minerals P Tablet Uncoated 008/018 Tasly(S.A) Pty Ltd, South Africa

5496 Tasly Citrus Sour Tablets Herbal Extracts GS Tablet Uncoated 008/019 Tasly(S.A) Pty Ltd, South Africa

5497 Tasly I- Cleansing Capsules Herbal Extracts GS Capsule oral 008/019HM Tasly(S.A) Pty Ltd, South Africa

5498 Tasly Red Yeast Tablets Red Yeast Rice Extract GS Tablet Uncoated 008/020 Tasly(S.A) Pty Ltd, South Africa

5499Adrenalline Injection Adrenalline 1mg, per ml

POM Solution for

Injection

147/001 Tejay Pharmaceuticals Limited

5500Atropine Injection Atropine 0.6mg, per ml

POM Solution for

Injection

147/002 Tejay Pharmaceuticals Limited

5501Amonophylline Injection

Amonophylline 25mg, per

ml

POM Solution for

Injection

147/003 Tejay Pharmaceuticals Limited

5502Chlorpromazine Injection

Chlorpromazine 25mg,

per ml

POM Solution for

Injection

147/004 Tejay Pharmaceuticals Limited

5503Diazepam Injection Diazepam 5mg, per ml

POM Solution for

Injection

147/005 Tejay Pharmaceuticals Limited

5504Furosemide Injection Furosemide 10mg, per ml

POM Solution for

Injection

147/006 Tejay Pharmaceuticals Limited

5505Gentamycin Injection Gentamycin Injection

POM Solution for

Injection

147/007 Tejay Pharmaceuticals Limited

5506Pethidine Injection Pethidine 40mg, per ml

POM Solution for

Injection

147/008 Tejay Pharmaceuticals Limited

5507Quinine Injection Quinine 300mg, per ml

POM Solution for

Injection

147/009 Tejay Pharmaceuticals Limited

5508Chloramphenicol Drops Chlorampehicol BP 0.5%

POM Eye Drops 147/010 Tejay Pharmaceuticals Limited

5509 Betamethasone Drops Betamethasone 0.1% POM Eye Drops 147/011 Tejay Pharmaceuticals Limited

Page 283 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5510Betamethasone Plus Drops

Neomycin +

Betamethasone 0.45%

POM Eye Drops 147/012 Tejay Pharmaceuticals Limited

5511 Ciprofloxacin Eye/Ear Drops Ciprofloxacin 0.3% POM Eye Drops 147/013 Tejay Pharmaceuticals Limited

5512Analgin Injection

Analgin I.P 500mg, per

ml

POM Solution for

Injection

147/014 Tejay Pharmaceuticals Limited

5513

Dexamethasone+ Neoomycin

Eye/Ear Drops

Neomycin Sulphate +

Dexamethasone

Phosphate

POM Ear/Eye Drops 147/015 Tejay Pharmaceuticals Limited

5514

Promethazine Injection

Promethazine

Hydrochloride 25mg, per

ml

POM Solution for

Injection

147/016 Tejay Pharmaceuticals Limited

5515Gentamycin Eye/Ear Drops

Gentamycin Sulphate

0.3%

POM Ear/Eye Drops 147/018 Tejay Pharmaceuticals Limited

5516Lignocaine 2% Injection

Lignocaine

Dihydrochloride 2.0%

POM Solution for

Injection

147/020 Tejay Pharmaceuticals Limited

5517Hydralazine Injection Hydralazine 20mg, per ml

POM Solution for

Injection

147/021 Tejay Pharmaceuticals Limited

5518Dexamethasone Injection

Dexamethasone

Phosphate 0.1%w/v

POM Solution for

Injection

147/022 Tejay Pharmaceuticals Limited

5519Diclofenac Sodium Injection Diclofenac Sodium 25mg

POM Solution for

Injection

147/023 Tejay Pharmaceuticals Limited

5520

Metoclopromide Injection

Metoclopromide

Hydrochloride USP 5mg,

per ml

POM Solution for

Injection

147/024 Tejay Pharmaceuticals Limited

5521Hyoscine Butylbromide Injection

Hyocine Butylbromide

20mg, per ml

POM Solution for

Injection

147/025 Tejay Pharmaceuticals Limited

5522Potassium Chloride Injection

Potassium Chloride

Injection 150mg, per ml

POM Solution for

Injection

147/026 Tejay Pharmaceuticals Limited

5523Calcium Gluconate Injection Calcium Gluconate 15mg

POM Solution for

Injection

147/027 Tejay Pharmaceuticals Limited

5524 Pilocarpine Nitrate Eye Drops Pilocarpine Nitrate 15mg POM Eye Drops 147/028 Tejay Pharmaceuticals Limited

5525

Sodium Cromoglycate Eye

Drops

Sodium Cromoglycate

2%

P Eye Drops 147/029 Tejay Pharmaceuticals Limited

5526 Xylomethazoline Nasal Drops Xylomethazoline 0.1% P Nasal drops 147/030 Tejay Pharmaceuticals Limited

5527 Timolol Eye Drops Timolol 0.5% POM Eye Drops 147/031 Tejay Pharmaceuticals Limited

5528Sodium Bicarbonate Injection

Sodium Bicarbonate

8.4%

POM Solution for

Injection

147/032 Tejay Pharmaceuticals Limited

5529Magnesium Sulphate Injection Magnesium Sulphate

POM Solution for

Injection

147/033 Tejay Pharmaceuticals Limited

Page 284 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 5530 Atropin Sulphate Eye Drops Atropin Sulphate 1% POM Eye Drops 147/034 Tejay Pharmaceuticals Limited

5531Morphine Sulphate Injection Morphine Sulphate

POM Solution for

Injection

147/035 Tejay Pharmaceuticals Limited

5532

Asmarid Syrup

Adhatoda vasica 0.68gm

+ Piper longum 0.14gm +

Vitis vinifera 0.14gm +

Terminalia chebula

73.24mg + Woodfordia

fruti- cosa 1.14gm +

Glycyrhiza glabra 6.78mg

+ Ficas infectoria 6.78mg

+ Acorns calamus

6.78mg + Trikatu ( Piper

longum + Piper nigrum +

Zingiber officinalis

P Syrup 147/036 Tejay Pharmaceuticals Limited

5533

Histinil SyrupChlopheniramine Maleate

BP 2mg, per 5ml

P Syrup 147/037 Tejay Pharmaceuticals Limited

5534 Panridol Syrup P Syrup 147/038 Tejay Pharmaceuticals Limited

5535Promethazine Syrup

Promethazine 5mg, per

5ml

P Syrup 147/039 Tejay Pharmaceuticals Limited

5536

Guaiphen Cough Syrup

Paracetamol +

Chlopheniramine +

Guaiphenesin

P Syrup 147/040 Tejay Pharmaceuticals Limited

5537

Co-Trimoxazole Suspension

Sulphamethoxazole +

Trimethoprim 240mg, per

5ml

POM Suspension for

Oral Use

147/041 Tejay Pharmaceuticals Limited

5538 Diclofenac Eye Drops Diclofenac 1.1% POM Eye Drops 147/042 Tejay Pharmaceuticals Limited

5539Arti Tear

Hydroxypropyl Methyl

Cellulose

P Eye Drops 147/043 Tejay Pharmaceuticals Limited

5540Betagenta Eye/Ear Drops

Betamethasone 0.1% +

Gentamycin 0.3%

POM Eye Drops 147/044 Tejay Pharmaceuticals Limited

5541Dexagenta Eye/Ear Drops

Betamethasone 0.1% +

Gentamycin 0.3%

POM Ear/Eye Drops 147/045 Tejay Pharmaceuticals Limited

5542Chlordex Eye/Ear Drops

Dexamethasone 0.1%+

Chloramphenicol 0.5%

POM Ear/Eye Drops 147/046 Tejay Pharmaceuticals Limited

5543 Tvision Eye Drops Lignocaine 0.02% POM Eye Drops 147/047 Tejay Pharmaceuticals Limited

Page 285 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5544Menadione Bisufite Injection

Phytomenadione 10mg,

per ml

POM Solution for

Injection

147/048 Tejay Pharmaceuticals Limited

5545

Histinil with Codiene

Diphenylhydramine

Hydrochloride 10mg +

Codeine Phosphate

10mg + Ammonium

Chloride 125mg

P Syrup 147/049 Tejay Pharmaceuticals Limited

5546

Mentholatum Deep Rub

Terpentine + Eucalyptus

+ Menthol + Methyl

Salicylate

P Cream Topical 003/004 The Mentholatum company Ltd, UK

5547Mentholatum Balm

Camphor + Menthol +

Methyl Salicylate

GS Ointment topical 003/006 The Mentholatum company Ltd, UK

5548Sepgard Gel

Centbucridine +

Feracrylum 1%

P Gel Topical 171/001 Themis Medicare Ltd, India

5549 Simvastol 10mg Tablets Simvastatin 10mg POM Tablet Uncoated 171/002 Themis Medicare Ltd, India

5550 Simvastol 20mg Tablets Simvastatin 20mg POM Tablet Uncoated 171/003 Themis Medicare Ltd, India

5551Hemolok Solution Feracrylum 1%w/v

P Solution for Topical

Use

171/004 Themis Medicare Ltd, India

5552E Mal Injection

Artemether 150mg, per

2ml

POM Solution for

Injection

171/005 Themis Medicare Ltd, India

5553

Theoxone Plus 1500 Injection Ceftriaxone sodium

1000mg + Sulbactum

sodium 500mg

POM Powder for

Injection

454/001 Theon Pharmaceuticals Limited

55547-Forces Capsules Herbal Extracts 115mg

GS Capsule oral 069/001 Tianjin Tianshi Biological Engineering Co.

Ltd, China

5555Casper Capsules Herbal Extracts

GS Capsule oral 069/002 Tianjin Tianshi Biological Engineering Co.

Ltd, China

5556Mega-Mind 1120mg Capsules Herbal Extracts 1120mg

GS Capsule oral 069/003 Tianjin Tianshi Biological Engineering Co.

Ltd, China

5557Vega Power 710mg Capsules Herbal Extracts 710mg

GS Capsule oral 069/004 Tianjin Tianshi Biological Engineering Co.

Ltd, China

5558

CZF-Iron 55.3mg Capsules

Ferrous Sulphate

16.33mg + Zinc Sulfate

15mg + Vitamin C 24mg

P Capsule oral 069/005 Tianjin Tianshi Biological Engineering Co.

Ltd, China

5559Dia Gins Soft Gel Capsules Ginseng Extract 100mg

P Capsule oral 069/006 Tianjin Tianshi Biological Engineering Co.

Ltd, China

5560Toma Soft Gelatin Capsules

Garlic Oil 0.66mg +

Biloba Extract 120mg

GS Capsule oral 069/007 Tianjin Tianshi Biological Engineering Co.

Ltd, China

Page 286 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5561King Royal 600mg Capsules

Royal Jelly 600mg +

Puama Extract 30mg

GS Capsule oral 069/008 Tianjin Tianshi Biological Engineering Co.

Ltd, China

5562

Ever Youth Capsules

Royal Jelly 200mg +

Damiana Extract 200mg

+ Evening Primrose

Extract 250mg

P Capsule oral 069/009 Tianjin Tianshi Biological Engineering Co.

Ltd, China

5563 Antidep Tablets Imipramine 25mg POM Tablet Uncoated 089/061 Torrent Pharmaceuticals Limited, India

5564

Nexpro -40 Tablets

Esomeprazole

Magnesium Trihydrate

40mg

POM Tablet Enteric

Coated

089/062 Torrent Pharmaceuticals Limited, India

5565

Nexpro -20 Tablets

Esomeprazole

Magnesium Trihydrate

20mg

POM Tablet Enteric

Coated

089/063 Torrent Pharmaceuticals Limited, India

5566 Listril-10 Tablets Lisinopril 10mg POM Tablet Uncoated 082/022 Torrent Exports Limited, India

5567 Rantin-150 Tablets Ranitidine 150mg POM Tablet Uncoated 089/003 Torrent Exports Limited, India

5568 Quintor-500 Tablets Ciprofloxacin 500mg POM Tablet Film coated 089/007 Torrent Exports Limited, India

5569 Herpex-200 Tablets Acyclovir 200mg POM Tablet Uncoated 089/008 Torrent Exports Limited, India

5570 Herpex Cream Aciclovir 5%w/w POM Cream Topical 089/009 Torrent Exports Limited, India

5571Calcigard Retard Tablets Nifedipine 20mg

POM Tablet extended

release

089/010 Torrent Exports Limited, India

5572 Tozaar - 50 Tablets Losartan 50mg POM Tablet Film coated 089/011 Torrent Exports Limited, India

5573 Domstal Tablets Domperidone 10mg POM Tablet Uncoated 089/012 Torrent Exports Limited, India

5574Domstal Suspension

Domperidone 1mg, per

ml

POM Suspension for

Oral Use

089/013 Torrent Exports Limited, India

5575Ranitin Injection Ranitidine 25mg

POM Solution for

Injection

089/014 Torrent Exports Limited, India

5576 Toroxx -MT-50 Tablets Rofecoxib 50mg POM Tablet Uncoated 089/016 Torrent Exports Limited, India

5577Deplatt Tablets

Mannitol USP +

Clopidogrel I.H

POM Tablet Film coated 089/017 Torrent Exports Limited, India

5578 Uroflox -400 Tablets Norfloxacin 400mg POM Tablet Uncoated 089/018 Torrent Exports Limited, India

5579 Betacard-100 Tablets Atenolol 100mg POM Tablet Uncoated 089/019 Torrent Exports Limited, India

5580 Syscan-100 Caspules Fluconazole 100mg POM Capsule oral 089/020 Torrent Exports Limited, India

5581 Omizac Capsules Omeprazole 20mg POM Capsule oral 089/021 Torrent Exports Limited, India

5582 Syscan- 200 Capsules Fluconazole 200mg POM Capsule oral 089/023 Torrent Exports Limited, India

5583

Tocofer-200 Soft Gelatin

CapsulesVitamin E 200mg

POM Capsule oral 089/024 Torrent Exports Limited, India

5584 Tocofer-400 Capsules Vitamin E 400mg POM Capsule oral 089/025 Torrent Exports Limited, India

5585 Batacard-50 Tablets Atenolol 50mg POM Tablet Uncoated 089/026 Torrent Exports Limited, India

5586 Syscan-150 Capsules Fluconazole 150mg POM Capsule oral 089/027 Torrent Exports Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 5587 Calcigard-10 Capsules Nifedipine 10mg POM Capsule oral 089/028 Torrent Exports Limited, India

5588 Lopamide Tablets Loperamide 2mg POM Tablet Uncoated 089/029 Torrent Exports Limited, India

5589Ive Metro Injection

Metronidazole 5mg, per

ml

POM Solution for

Infusion

089/030 Torrent Exports Limited, India

5590 Tormoxine 250 Capsules Amoxicillin 250mg POM Capsule oral 089/031 Torrent Exports Limited, India

5591 Listril-5 Tablets Lisinopril 5mg POM Tablet Uncoated 089/032 Torrent Exports Limited, India

5592 Fegem 100 Tablets Ferric Hydroxide 450mg P Tablet Uncoated 089/033 Torrent Exports Limited, India

5593 Herpex 800 DT Tablets Acyclovir 800mg POM Tablet Uncoated 089/035 Torrent Exports Limited, India

5594 Modlip 10 Tablets Atorvastatin 10mg POM Tablet Film coated 089/036 Torrent Exports Limited, India

5595Domstal O Capsules

Omeprazole 10mg +

Domperidone 10mg

POM Capsule oral 089/037 Torrent Exports Limited, India

5596 Modlip 20 Tablets Atorvastatin 20mg POM Tablet Film coated 089/038 Torrent Exports Limited, India

5597 Lamitor 100 Tablets Lamotrigine 100mg POM Tablet Uncoated 089/039 Torrent Exports Limited, India

5598 Nebicard -5 Tablets Nebivolol 5mg POM Tablet Uncoated 089/040 Torrent Exports Limited, India

5599 Velos-20 Tablets Rabeprazole 20mg POM Tablet Uncoated 089/041 Torrent Exports Limited, India

5600 Velos-Tablets Rabeprazole 10mg POM Tablet Uncoated 089/042 Torrent Exports Limited, India

5601Valparin 200 Tablets Sodium Valproate 200mg

POM Tablet Uncoated 089/043 Torrent Exports Limited, India

5602 Tide-10 Tablets Torasemide 10mg POM Tablet Uncoated 089/044 Torrent Exports Limited, India

5603 Lefra 20 Tablets Leflunomide 20mg POM Tablet Uncoated 089/045 Torrent Exports Limited, India

5604 Karvil-6.25 Tablets Carvedilol 6.25mg POM Tablet Uncoated 089/046 Torrent Exports Limited, India

5605 Esam-2.5 Tablets Amlodipine 2.5mg POM Tablet Uncoated 089/047 Torrent Exports Limited, India

5606 Azulix 2 Tablets Glimepiride 2mg POM Tablet Uncoated 089/048 Torrent Exports Limited, India

5607 Topril Capsules Ramipril 5mg POM Capsule oral 089/049 Torrent Exports Limited, India

5608 Serenata-50 Tablets Sertraline 50mg POM Tablet Uncoated 089/050 Torrent Exports Limited, India

5609 Valzaar 80 Tablets Valsartan 80mg POM Tablet Uncoated 089/051 Torrent Exports Limited, India

5610 Valzaar 160 Tablets Valsartan 160mg POM Tablet Uncoated 089/052 Torrent Exports Limited, India

5611

Tozaar-H 62.5mg TabletsHydrochlorothiazide

12.5mg + Losartan 50mg

POM Tablet Uncoated 089/053 Torrent Exports Limited, India

5612 Tozaar-100mg Tablets Losartan 125mg POM Tablet Uncoated 089/054 Torrent Exports Limited, India

5613Nexpro IV Injection Esomeprazole 40mg

POM Powder for

Injection

089/055 Torrent Exports Limited, India

5614Tozaar-Plus DS 125mg Tablets

Hydrochlorothiazide

25mg + Losartan 100mg

POM Tablet Uncoated 089/056 Torrent Exports Limited, India

5615Torocef - 1 Injection Ceftriaxone 1000mg

POM Powder for

Injection

089/057 Torrent Exports Limited, India

5616Quintor Infusion Ciprofloxacin 200mg

POM Solution for

infusion

089/058 Torrent Exports Limited, India

Page 288 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5617Syscan -100ml I.V Infusion Fluconazole 200mg

POM Solution for

infusion

089/059 Torrent Exports Limited, India

5618 Funginoc Cream Ketoconazole 2%w/w POM Cream Topical 089/060 Torrent Exports Limited, India

5619Asthator 5 Tablets

Montelukast Sodium IH

5mg

POM Tablet Uncoated 089/064 Torrent Exports Limited, India

5620Asthator 10 Tablets

Montelukast Sodium IH

10mg

POM Tablet Uncoated 089/065 Torrent Exports Limited, India

5621Asthator 4 Tablets

Montelukast Sodium BP

4mg

POM Tablet Uncoated 089/066 Torrent Exports Limited, India

5622Olmecor Tablets

Olmesartan Medoxomil

Hydrochloride 40mg

POM Tablet Uncoated 089/068 Torrent Exports Limited, India

5623

Alfutor ER TabletsAlfuzosine Hydrochloride

USP 10mg

POM Tablet Uncoated 089/069 Torrent Exports Limited, India

5624

Boom Force Toilet Cleaner Cetyl Dimethyl

Ammonium Chloride 2.0

%w/w

GS Liquid Soap 430/004L Trade Kings Group Ltd, Zambia

5625

Boom Force Multipurpose Liquid

Detergent - Pine Fresh

PCMX-Chloroxylenol

1.0% w/w

GS Liquid Soap 430/006L Trade Kings Group Ltd, Zambia

5626

Romeo Hygienix Instant Hand

Sanitizer Gel

Ethanol 60%w/w GS Liquid soap 430/012L Trade Kings Group Ltd, Zambia

5627

Romeo+ Hygienix -Liquid Soap

With Active Silver Sulphate and

formulate

Silver Sulfate 0.3%w/w GS Liquid soap 430/014L Trade Kings Group Ltd, Zambia

5628

Boom Force 'Multipurpose'

Thick Bleach

Sodium Hypochloride 3.0

%w/w

GS Liquid Soap 430/005L Trade Kings Group Ltd, Zambia

5629

Boom Sparkle Plus Dishwash

Liquid Orange

Chloroxylenol 0.01 %w/w GS Liquid detergent 430/008L Trade Kings Group Ltd, Zambia

5630

Yebo Medicated Health Soap Para-Chloro-Meta-

Xylenol

0.04635%w/v+Cresylic

Acid 0.8552%w/

GS Solid Soap 430/009L Trade Kings Group Ltd, Zambia

5631

Xtra No.1 Soap PCMX/Cresylic Acid

98%w/w

GS Soap 430/011L Trade Kings Group Ltd, Zambia

5632

Romeo+ Hygienix Soap with

Active Silver Technology

Silver Sulfate 0.3%w/w GS Soap 430/013L Trade Kings Group Ltd, Zambia

5633

Boom Shine Plus Tile Cleaner

Lavender Blossom

Silver Sulfate 2.0% w/w GS Liquid Soap 430/007L Trade Kings Group Ltd, Zambia

Page 289 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5634

Pure Plus Water Purification

Solution

Sodium Hypochloride 0.5-

0.6% w/w

GS Solution for Topical

Use

430/010L Trade Kings Group Ltd, Zambia

5635

Acetyl Salicylic Acid 300mg

Tablets

Acetycylsalicylic Acid BP

300mg

GS Tablet Uncoated 110/002 Troge Medical GMBH, Germany

5636 Amoxicillin 250 Capsules Amoxicilin 250mg POM Capsule oral 110/003 Troge Medical GMBH, Germany

5637 Trio-Vital Tablets Multivitamin GS Tablet Uncoated 110/003 Troge Medical GMBH, Germany

5638Amoxicillin Suspension

Amoxicilin 125mg, per

5ml

POM Powder for Oral

Suspension

110/004 Troge Medical GMBH, Germany

5639 Tetracycline 250mg Capsules Tetracycline 250mg POM Capsule oral 110/005 Troge Medical GMBH, Germany

5640

Tetracycline Ophthalmic

Ointment

Tetracycline

Hydrochloride 1%w/v

POM Eye Ointment 110/006 Troge Medical GMBH, Germany

5641Ampicillin Injection Ampicillin 500mg

POM Powder for

Injection

110/008 Troge Medical GMBH, Germany

5642Ampicillin Oral Suspension Ampicillin 125mg, per ml

POM Suspension for

Oral Use

110/009 Troge Medical GMBH, Germany

5643Streptomycin Injection Streptomycin Sulphate 1g

POM Powder for

Injection

110/010 Troge Medical GMBH, Germany

5644Vitamin B Complex Injection Vitamin B Complex

POM Solution for

Injection

110/011 Troge Medical GMBH, Germany

5645

Crystalline Benzylpenicillin

InjectionBenzyl Penicillin 1Mega

POM Solution for

Injection

110/012 Troge Medical GMBH, Germany

5646 Indomethacin 25mg Capsules Indomethacin 25mg POM Capsule oral 110/015 Troge Medical GMBH, Germany

5647 Metronidazole 200mg Tablets Metronidazole 200mg POM Tablet Uncoated 110/016 Troge Medical GMBH, Germany

5648

Phenoxymethyl Penicillin 250

Tablets

Phenoxymethyl Penicillin

250mg

POM Tablet Uncoated 110/018 Troge Medical GMBH, Germany

5649

Crystalline Benzyl Penicillin

InjectionBenzyl Penicillin 5mega

POM Solution for

Injection

110/019 Troge Medical GMBH, Germany

5650 Chloramphenicol Eye Ointment Chlorampenicol 1%w/w POM Eye Ointment 110/021 Troge Medical GMBH, Germany

5651

Fortified Procaine Penicillin

InjectionProcain Penicillin 4Mega

POM Powder for

Injection

110/022 Troge Medical GMBH, Germany

5652Gentamycin Injection

Gentamycin 80mg, per

2ml

POM Solution for

Injection

110/023 Troge Medical GMBH, Germany

5653 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 110/024 Troge Medical GMBH, Germany

5654

Chloramphenicol InjectionChlorampenicol Sodium

Succinate Injection BP 1g

POM Powder for

Injection

110/025 Troge Medical GMBH, Germany

5655

Co-trimoxazole Tablets

Trimethoprim 80mg +

Sulphamethoxazole

400mg

POM Tablet Uncoated 110/026 Troge Medical GMBH, Germany

Page 290 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5656Ampicillin/Cloxacillin Capsules

Ampicillin 250mg +

Cloxacillin 250mg

POM Capsule oral 110/027 Troge Medical GMBH, Germany

5657Erythromycin Tablets

Erythromycin Stearate

BP 250mg

POM Tablet Uncoated 110/029 Troge Medical GMBH, Germany

5658Dynapar AQ 3ml Injection Diclofenac 25mg, per ml

POM Solution for

Injection

196/001 Troikaa Pharmaceuticals Limited, India

5659

Hydrocortisone Sodium

Succinate InjectionHydrocortisone 100mg

POM Powder for

Injection

196/002 Troikaa Pharmaceuticals Limited, India

5660Gentamicin Sulphate Injection

Gentamicin 80mg, per

2ml

POM Solution for

Injection

196/004 Troikaa Pharmaceuticals Limited, India

5661Dynapar tablets

Diclofenac 50mg +

Paracetamol 500mg

P Tablets Uncoated 196/005 Troikaa Pharmaceuticals Limited, India

5662Ketamax-50 Injection

Ketamine Hydrochloride

50mg, per ml

POM Solution for

Injection

196/006 Troikaa Pharmaceuticals Limited, India

5663 Dynapar SR 100 Tablets Diclofenac 100mg POM Tablet Uncoated 196/007 Troikaa Pharmaceuticals Ltd, India

5664Dynapar AQ 1ml Injection Diclofenac 75mg

POM Solution for

Injection

196/008 Troikaa Pharmaceuticals Ltd, India

5665Isotroy 100 Liquid Isoflurane 1mg, per ml

POM Solution for

Inhalation

196/009 Troikaa Pharmaceuticals Ltd, India

5666Troypofol Injection Propofol 10mg, per ml

POM Powder for

Injection

196/010 Troikaa Pharmaceuticals Ltd, India

5667Troycurium Injection

Atracurium Besylate

10mg/ml

POM Solution for

Injection

196/011 Troikaa Pharmaceuticals Ltd, India

5668Xykaa Extend Tablets Paracetamol 650mg

GS Tablet extended

release

196/012 Troikaa Pharmaceuticals Ltd, India

5669Lesstrol -10 Tablets

Atorvastatin Calcium

10mg

POM Tablet Uncoated 196/013 Troikaa Pharmaceuticals Ltd, India

5670 Telmikaa - 40 Tablets Telmisartan 40mg POM Tablet Uncoated 196/014 Troikaa Pharmaceuticals Ltd, India

5671 Telmikka - 80 Tablets Telmisartan 80mg POM Tablet Uncoated 196/015 Troikaa Pharmaceuticals Ltd, India

5672 Feno TG Tablets Fenofibrate 160mg POM Tablet Uncoated 196/016 Troikaa Pharmaceuticals Ltd, India

5673

Telmikaa -H Tablets

Telmisartan 40mg +

Hydrochlorothiazide

12.50mg

POM Tablet Uncoated 196/017 Troikaa Pharmaceuticals Ltd, India

5674Zyltan 50 Tablets

Losartan Potassium

50mg

POM Tablet Uncoated 196/018 Troikaa Pharmaceuticals Ltd, India

5675 Xykaa Rapid Tablets Paracetamol 500mg GS Tablet Uncoated 196/019 Troikaa Pharmaceuticals Ltd, India

5676

Bupitroy 0.5% Injection

Bupivacaine

Hydrochloride 0.5mg

USP

POM Solution for

Injection

196/020 Troikaa Pharmaceuticals Ltd, India

Page 291 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5677Dynapar QPS Topical Solution

Diclofenac Diethyl Amine

46.40mg

P Solution for Topical

Use

196/021 Troikaa Pharmaceuticals Ltd, India

5678

Dynapar QPS Plus Topical

Soution

Diclofenac Diethyl Amine

23.20mg + Methyl

Salicylate 100.00mg +

Menthol 50mg

P Solution for Topical

Use

196/022 Troikaa Pharmaceuticals Ltd, India

5679Diltigesic Gel

Diltiazem Hydrochloride

2% w/w

POMGel Topical

196/023Troikaa Pharmaceuticals Ltd, India

5680 Ucetamol-500 Tablets Paracetamol 500mg GS Tablet Uncoated 193/001 Umedica Laboratories (Pvt Ltd, India

5681 Erythromycin 250mg Tablets Erythromycin 250mg POM Tablet Uncoated 193/002 Umedica Laboratories (Pvt Ltd, India

5682 Nifedipine Retard-20 Tablets Nifedipine 20mg POM Tablet Uncoated 193/003 Umedica Laboratories (Pvt Ltd, India

5683Ucetaxime-1000 Injection Cetaxime 1000mg

POM Powder for

Injection

193/004 Umedica Laboratories (Pvt Ltd, India

5684

Co-Trimoxazole 480mg Tablets

Sulphamethoxazole

400mg + Trimethoprim

80mg

POM Tablet Uncoated 193/005 Umedica Laboratories (Pvt Ltd, India

5685 Umoxil-250mg Capsules Amoxicillin 250mg POM Capsule Oral 193/006 Umedica Laboratories (Pvt Ltd, India

5686Benzyl Penicillin 5 M.U Injection Benzyl Penicillin 5M.U

POM Powder for

Injection

193/007 Umedica Laboratories (Pvt Ltd, India

5687

Co-Trimoxazole 240mg/5ml

Oral Suspension

Sulphamethoxazole

200mg + Trimethoprim

80mg

POM Suspension for

Oral Use

193/008 Umedica Laboratories (Pvt Ltd, India

5688

Umoxil-125mg/5ml Powder For

Oral Suspension

Amoxicillin 125mg, per

5ml

POM Powder for Oral

Suspension

193/009 Umedica Laboratories (Pvt Ltd, India

5689

Umeran 50 (Diclofenac 50mg

TabletsDiclofenac 50mg

P Tablet Oral 193/010 Umedica Laboratories (Pvt Ltd, India

5690 Kojex Tablets Liquorice 180mg GS Tablet Uncoated 193/013 Umedica Laboratories (Pvt Ltd, India

5691Umedica Blood Tonic Haematic Preparation

P Solution for Oral

Use

193/014 Umedica Laboratories (Pvt Ltd, India

5692 Uroxime 250 Tablets Cefuroxime 250mg POM Tablet Uncoated 193/015 Umedica Laboratories (Pvt Ltd, India

5693 Uroxime 500 Tablets Cefuroxime 500mg POM Tablet Uncoated 193/016 Umedica Laboratories (Pvt Ltd, India

5694Fast Releif Tablets

Paracetamol 100mg +

Aceclofenac 500mg

P Tablet Uncoated 193/017 Umedica Laboratories (Pvt Ltd, India

5695Malidar Tablets

Sulfadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 193/018 Umedica Laboratories (Pvt Ltd, India

5696 Fixdep -180 Tablets Fexofenadine 180mg POM Tablet Uncoated 193/019 Umedica Laboratories (Pvt Ltd, India

5697 Unimezol Tablets Metronidazole 200mg POM Tablet Uncoated 268/001 Unichem Laboratories Limited, India

5698 Zyncet Tablets Cetirizine 10mg POM Tablet Uncoated 268/002 Unichem Laboratories Limited, India

5699 Zyncet Syrup Cetirizine 5mg, per 5ml POM Syrup 268/003 Unichem Laboratories Limited, India

Page 292 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER 5700 Evaflox Tablets Ofloxacin 200mg POM Tablet Uncoated 268/004 Unichem Laboratories Limited, India

5701 Evaflox 400 Tablets Ofloxacin 400mg POM Tablet Uncoated 268/005 Unichem Laboratories Limited, India

5702 M-Cam 15 Tablets Meloxicam 15mg POM Tablet Uncoated 268/006 Unichem Laboratories Limited, India

5703 M-Cam 7.5 Tablets Meloxicam 7.5mg POM Tablet Uncoated 268/007 Unichem Laboratories Limited, India

5704Corvadil-A Tablets

Atenolol 50mg +

Amlodipine 5mg

POM Tablet Uncoated 268/008 Unichem Laboratories Limited, India

5705 Tagera Forte Tablets Secnidazole 1g POM Tablet Uncoated 268/009 Unichem Laboratories Limited, India

5706Sulbacin Injection

Ampicillin 500mg +

Sulbactam 250mg

POM Powder for

Injection

268/010 Unichem Laboratories Limited, India

5707Sulbacin 375 Tablets

Ampicillin 500mg +

Sulbactam 250mg

POM Tablet Uncoated 268/011 Unichem Laboratories Limited, India

5708 Domadol Capsules Tramadol 50mg POM Capsule oral 268/012 Unichem Laboratories Limited, India

5709Domadol Injection Tramadol 50mg

POM Solution for

Injection

268/013 Unichem Laboratories Limited, India

5710 Tg Tor Tablets Atorvastatin 10mg POM Tablet Uncoated 268/014 Unichem Laboratories Limited, India

5711 Corvadil 5 Tablets Amlodipine 5mg POM Tablet Uncoated 268/015 Unichem Laboratories Limited, India

5712 Losar-50 Tablets Losartan 50mg POM Tablet Uncoated 268/016 Unichem Laboratories Limited, India

5713Myclav 625 Tablets

Amoxicillin 500mg +

Clavulanate 125mg

POM Tablet Uncoated 268/018 Unichem Laboratories Limited, India

5714Domadol 100mg Injection Tramadol 100mg

POM Solution for

Injection

268/019 Unichem Laboratories Limited, India

5715

Unienzyme Cmps Tablet

Fungal Distate (1:8000)

20mg + Papain 30mg +

Simethicone 30mg + Act

75mg

P Tablet Chewable 268/020 Unichem Laboratories Limited, India

5716Corbis - 10 Tablets

Bisoprolol Fumerate

10mg

POM Tablet Uncoated 268/021 Unichem Laboratories Limited, India

5717Corbis-5 Tablets Bisoprolol Fumerate 5mg

POM Tablet Uncoated 268/022 Unichem Laboratories Limited, India

5718 Aroff Tablets Aceclofenac 100mg P Tablet Film coated 268/023 Unichem Laboratories Limited, India

5719

Myclav Powder 228.5

Suspension

Amoxicillin Trihydrate

200mg + Potassium

Clavulanate 28.5mg

POM Suspension 268/024 Unichem Laboratories Limited, India

5720

Myclav Powder 156.25

Suspension

Amoxicillin Trihydrate

125mg + Potassium

Clavulanate 28.5mg

POM Suspension 268/025 Unichem Laboratories Limited, India

5721Myclav 375 Tablets

Amoxicillin 250mg +

Clavulanate 125mg

POM Tablet Uncoated 286/017 Unichem Laboratories Limited, India

Page 293 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5722

Domadol Plus Tablets

Acetaminophen 325mg +

Tramadol Hydrocholoride

37.5mg

POM Tablet Film coated 288/026 Unichem Laboratories Limited, India

5723 Quetia 25 Tablets Quentiapine 25mg POM Tablet Uncoated 288/027 Unichem Laboratories Limited, India

5724 Quetia 100 Tablets Quentiapine 100mg POM Tablet Uncoated 288/028 Unichem Laboratories Limited, India

5725 Quetia 200 Tablets Quentiapine 200mg POM Tablet Uncoated 288/029 Unichem Laboratories Limited, India

5726 Quetia 300 Tablets Quentiapine 300mg POM Tablet Uncoated 288/030 Unichem Laboratories Limited, India

5727 Lenor 72 Tablets Levonorgestrel 0.75mg POM Tablet Uncoated 223/001 Unicure Remedies (Pvt) Limited, India

5728 Mepen 250 Tablets Mefenamic Acid 250mg P Tablet Uncoated 223/002 Unicure Remedies (Pvt) Limited, India

5729 NC Norm-P Tablets Norethisterone 5mg POM Tablet Uncoated 223/003 Unicure Remedies (Pvt) Limited, India

5730 Eros 10 Tablets Tadalafil 10mg POM Tablet Uncoated 223/004 Unicure Remedies (Pvt) Limited, India

5731 Lactone 25 Tablets Spironolactone 25mg POM Tablet Uncoated 223/005 Unicure Remedies (Pvt) Limited, India

5732 Flagon 50 Tablets Diclofenac 50mg P Tablet Uncoated 223/006 Unicure Remedies (Pvt) Limited, India

5733 Blue Diamond Tablets Sildenafil 50mg POM Tablet Uncoated 223/007 Unicure Remedies (Pvt) Limited, India

5734

Florina -28 TabletsEthinylestradiol 0.03mg +

Levonorgestrel 0.15mg

POM Tablet Film coated 223/008 Unicure Remedies (Pvt) Limited, India

5735 Eros 20 Tablets Tadalafil 20mg POM Tablet Uncoated 223/010 Unicure Remedies (Pvt) Limited, India

5736Goldman Tablets

Dapoxetine

Hydrochloride 60mg

POM Tablet Uncoated 223/011 Unicure Remedies (Pvt) Limited, India

5737

Vital-Z Powder

Anhydrous Glucose +

Sucrose + Ascorbic Acid

+ Zinc

P Powder for Oral

Solution

223/07 Unicure Remedies (Pvt) Limited, India

5738 Love condoms Male Latex Condoms GS Latex Products 410/001L Unidus Corporation

5739

Lifebuoy Deofresh Bar Soap

EHDP/ADPA/Etidronic

Acid 0.04% +

Tetrasodium EDTA

0.02%

GS Solid Soap 012/001 Unilever SEA Zambia Limited, Zambia

5740

Lifebuoy Total Red Bar Soap

EHDP + ADPA +

Etidronic Acid +

Tetrasodium EDTA

GS Solid Soap 012/002 Unilever SEA Zambia Limited, Zambia

5741

Geisha Germigaurd Soap

(Neem & Soothing Basil)

Extrapone 5 Plant

0.0003%w/w

GS Solid Soap 012/002HM Unilever SEA Zambia Limited, Zambia

5742

Lifebuoy Herbal Bar Soap

EHDP/ADPA/Etidronic

Acid 0.04% +

Tetrasodium EDTA

0.02%

GS Solid Soap 012/003 Unilever SEA Zambia Limited, Zambia

5743

Geisha Germigaurd Soap (Mint

& Green Tea)

Extrapone 5 Plant

0.0003%w/w

GS Solid Soap 012/003HM Unilever SEA Zambia Limited, Zambia

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5744

Lifebuoy Care Bar Soap

EHDP/ADPA/Etidronic

Acid 0.04% +

Tetrasodium EDTA

0.02%

GS Solid Soap 012/004 Unilever SEA Zambia Limited, Zambia

5745

Lifebouy Antibacterial

Handwash - Care

Trichlorocarbanilide

0.02% + DTPA-Na

0.125% + Glyceryl Mono

Laurate 0.05% + Tur

0.05%

GS Liquid soap 012/004L Unilever SEA Zambia Limited, Zambia

5746

Lifebouy Antibacterial

Handwash - Classic

Trichlorocarbanilide

0.02% + DTPA -Na

0.125% + Glyceryl Mono

Laurate 0.05% + Tur

0.05%

GS Liquid soap 012/005L Unilever SEA Zambia Limited, Zambia

5747

Lifebouy Antibacterial

Handwash - Fresh

Trichlorocarbanilide

0.02% + DTPA -Na

0.125% + Glyceryl Mono

Laurate 0.05% + Tur

0.05%

GS Liquid soap 012/006L Unilever SEA Zambia Limited, Zambia

5748

Lifebouy Antibacterial

Handwash-Nature

Trichlorocarbanilide

0.02% + DTPA -Na

0.125% + Glyceryl Mono

Laurate 0.05% + Tur

0.05%

GS Liquid soap 012/007L Unilever SEA Zambia Limited, Zambia

5749

Lifebouy Herbal Antibacterial

Soap

Trichlorocarbanilide

0.04% + Trichlorosan

0.02%

GS Solid soap 012/001HM Uniliver SEA Zambia Limited, Zambia

5750IC2 500 Injection Imipenem 500mg

POM Powder for

Injection

356/001 Unimark Ramedies Limited, India

5751Vencer 250 Injection

Meropenem Trihydrate

250mg

POM Powder for

Injection

356/002 Unimark Ramedies Limited, India

5752Vencer 1000 Injection

Meropenem Trihydrate

1000mg

POM Powder for

Injection

356/003 Unimark Ramedies Limited, India

5753Pedvite Forte Capsules Multivitamins

GS Capsule oral 072/011 Unique Pharmaceyticals Laboratories, India

5754Epirubitec 50 Injection

Epirubicin Hcl 50mg, per

50ml

POM Powder for

Injection

314/001MT United Biotec (P) Ltd, India

5755Oplatin 100 Injection

Oxaliplatin 100mg, per

50ml

POM Solution for

Injection

314/002MT United Biotec (P) Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5756Oncosid 100 Injection Etopside 100mg, per 5ml

POM Solution for

Injection

314/003MT United Biotec (P) Ltd, India

5757Uniblastin Injection

Vinblastine Sulphate

10mg, per 10ml

POM Solution for

Injection

314/004MT United Biotec (P) Ltd, India

5758Uniplatin 50 Injection Cisplatin 50mg, per 50ml

POM Solution for

Injection

314/005MT United Biotec (P) Ltd, India

5759Unifolin 15 Tablets

Leucovorin Calcium

15mg

POM Tablet Uncoated 314/006MT United Biotec (P) Ltd, India

5760 Citabin 500 Tablets Capacetabine 500mg POM Tablet Film coated 314/007MT United Biotec (P) Ltd, India

5761O-SET - 4mg Injection

Ondasetron

Hydrochloride USP 4mg

POM Solution for

Injection

314/008MT United Biotec (P) Ltd, India

5762O-SET - 8mg Injection

Ondasetron

Hydrochloride USP 8mg

POM Solution for

Injection

314/009MT United Biotec (P) Ltd, India

5763UNICARB 150 Injection Dacarbazine 150mg USP

POM Powder for

Injection

314/010MT United Biotec (P) Ltd, India

5764DACMED 150 Injection

Darcabazine 150mg, per

15ml

POM Solution for

Injection

314/011MT United Biotec (P) Ltd, India

5765

Clotrine B Cream

Clotrimazole 1%w/w +

Betamethasone

0.05%w/w

POM Cream Topical 283/001 Universal Corporation Ltd, Kenya

5766 Univir Cream Acyclovir 5%w/v POM Cream Topical 283/002 Universal Corporation Ltd, Kenya

5767 Univir 400 Tablets Aciclovir 400mg POM Tablet Uncoated 283/003 Universal Corporation Ltd, Kenya

5768 Strox Tablets Ciprofloxacin 500mg POM Tablet Uncoated 283/004 Universal Corporation Ltd, Kenya

5769

Unilyte Oral Powder

Sodium Chloride 3.5g +

Sodium Citrate 1.5g +

Potassium Chloride 2.5g

+ Glucose 20g

P Powder for Oral

Solution

283/005 Universal Corporation Ltd, Kenya

5770Nelzole Suspension Metronidazole 200mg

POM Suspension for

Oral Use

283/007 Universal Corporation Ltd, Kenya

5771

Universal Gripe Water

Sodium Bicarbonate

50mg + Dill Oil 2.15mg,

per 5ml

GS Solution for Oral

Use

283/008 Universal Corporation Ltd, Kenya

5772

Sulfran Paediatric Suspension

Sulphamethoxazole

200mg + Trimethoprim

40mg, per 5ml

POM Suspension for

Oral Use

283/009 Universal Corporation Ltd, Kenya

5773Unified Ointment

Benzoic Acid 80mg +

Salicylic Acid 30mg

P Ointment topical 283/010 Universal Corporation Ltd, Kenya

5774 Dinac Tablets Diclofenac 50mg P Tablet Uncoated 283/011 Universal Corporation Ltd, Kenya

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5775

Sulfran Tablets

Sulphamethoxazole

400mg + Trimethoprim

80mg

POM Tablet Uncoated 283/012 Universal Corporation Ltd, Kenya

5776 Ulzol Capsules Omeprazole 20mg POM Capsule oral 283/013 Universal Corporation Ltd, Kenya

5777 Acnesol Cream Tretinoin 0.05%w/v P Cream Topical 283/014 Universal Corporation Ltd, Kenya

5778 Dinac Gel Diclofenac 1%w/v P Gel Topical 283/015 Universal Corporation Ltd, Kenya

5779 Clobit Cream Clobetasol 0.05%w/v P Cream Topical 283/016 Universal Corporation Ltd, Kenya

5780 Clotrine Pessaries Clotrimazole 100mg P Tablet Vaginal 283/017 Universal Corporation Ltd, Kenya

5781 Clotrine Cream Clotrimazole 1%w/v P Cream Topical 283/018 Universal Corporation Ltd, Kenya

5782 Flutrox Capsules Fluconazole 200mg POM Capsule oral 283/019 Universal Corporation Ltd, Kenya

5783 Lockit Tablets Domperidone 10mg POM Tablet Uncoated 283/020 Universal Corporation Ltd, Kenya

5784Nelstat Oral Drops Nystatin 100000IU

P Solution for Oral

Use

283/021 Universal Corporation Ltd, Kenya

5785Unibazole Suspension

Albendazole 400mg, per

100ml

P Suspension for

Oral Use

283/022 Universal Corporation Ltd, Kenya

5786 Unibazole Tablets Albendazole 400mg P Tablet Uncoated 283/023 Universal Corporation Ltd, Kenya

5787 Unibet Cream Betamethasone 0.1%w/v P Cream Topical 283/024 Universal Corporation Ltd, Kenya

5788 Univir 200 Tablets Aciclovir 200mg POM Tablet Uncoated 283/025 Universal Corporation Ltd, Kenya

5789Neladol Extra Caplets

Paracetamol 500mg +

Caffeine 65mg

GS Caplets oral

Uncoated

283/026 Universal Corporation Ltd, Kenya

5790Co-Max Tablets

Artemether 120mg +

Lumefantrine 20mg

P Tablet Uncoated 283/027 Universal Corporation Ltd, Kenya

5791

Actcid Tablets

Aluminium Hydrochloride

120mg + Magnesium

Trisilicate 250mg

P Tablet Uncoated 283/029 Universal Corporation Ltd, Kenya

5792 Unigentyl Tablets Secnidazole 500mg POM Tablet Uncoated 283/030 Universal Corporation Ltd, Kenya

5793Rexedine Mouthwash Povidone Iodine 1%

GS Solution for Oral

Use

283/031 Universal Corporation Ltd, Kenya

5794 K-Nac 50 Tablets Diclofenac 50mg P Tablet Film coated 283/032 Universal Corporation Ltd, Kenya

5795

Sulfran DS CapletsSulfamethoxazole 800mg

+ Trimethoprim 160mg

POM Caplets oral

Uncoated

283/033 Universal Corporation Ltd, Kenya

5796 Erythro 250 Tablets Erythromycin 250mg POM Tablet Uncoated 283/034 Universal Corporation Ltd, Kenya

5797Neladol Suspension

Paracetamol 120mg, per

5ml

GS Suspension for

Oral Use

283/035 Universal Corporation Ltd, Kenya

5798 Lolip 20mg Tablets Atorvastatin 20mg POM Tablet Uncoated 283/036 Universal Corporation Ltd, Kenya

5799 Lolip 10mg Tablets Atorvastatin 10mg POM Tablet Uncoated 283/037 Universal Corporation Ltd, Kenya

5800 K-Nac 75 Tablets Diclofenac 75mg P Tablet Uncoated 283/038 Universal Corporation Ltd, Kenya

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5801Unibrol Oral Syrup

Aminosidine 125mg, per

5ml

POM Syrup 283/039 Universal Corporation Ltd, Kenya

5802 Unibrol Tablets Aminosidine 250mg POM Tablet Uncoated 283/040 Universal Corporation Ltd, Kenya

5803 Altrine Syrup Cetirizine 5mg, per 5ml P Syrup 283/041 Universal Corporation Ltd, Kenya

5804 Altrine Tablets Cetirizine 10mg P Tablet Uncoated 283/042 Universal Corporation Ltd, Kenya

5805 Throza 500 tablets Azithromycin 500mg POM Tablet Uncoated 283/043 Universal Corporation Ltd, Kenya

5806 Zeenk 20 tablets Zinc sulphate 20mg General Sale Tablet Dispersible 283/044 Universal Corporation Ltd, Kenya

5807

Zeerol Co-Pack for Diarrhoea

Treatment

Oral Rehydration Salts

Int. Ph 20.56g + Zinc

sulphate USP 20

General Sale Powder for Oral

Solution

283/045 Universal Corporation Ltd, Kenya

5808 HB Glow Capsules Haematic Preparation P Capsule oral 054/001 Universal Pharmaceuticals Ltd, India

5809HB Glow Liquid Haematic Preparation

P Solution for Oral

Use

054/002 Universal Pharmaceuticals Ltd, India

5810Unimin Liquid Minerals + Multivitamins

P Solution for Oral

Use

054/003 Universal Pharmaceuticals Ltd, India

5811 Unimin Capsules Minerals + Multivitamins P Capsule oral 054/004 Universal Pharmaceuticals Ltd, India

5812Mestil Liquid Salbutamol 1mg/5ml

POM Solution for Oral

Use

054/005 Universal Pharmaceuticals Ltd, India

5813

Mestil-S Liquid

Ambroxol 15mg +

Salbutamol 1mg +

Guaiphenesin 50mg

P Solution for Oral

Use

054/006 Universal Pharmaceuticals Ltd, India

5814Unimin G Liquid Minerals + Multivitamins

P Solution for Oral

Use

054/007 Universal Pharmaceuticals Ltd, India

5815

Mucorol-S Liquid

Ambroxol 30mg +

Salbutamol 1mg +

Guiaphenesin 50mg

P Solution for Oral

Use

054/008 Universal Pharmaceuticals Ltd, India

5816Apitup-P Liquid

Cyproheptadine 2mg, per

5ml

P Solution for Oral

Use

054/009 Universal Pharmaceuticals Ltd, India

5817Fradex Capsules

Ferrous Fumarate +

Multivitamins + Minerals

P Capsule oral 054/010 Universal Pharmaceuticals Ltd, India

5818 Softvit-E Capsules Vitamin E 200mg POM Capsule oral 054/011 Universal Pharmaceuticals Ltd, India

5819 Softvit-E Capsules Vitamin E 400mg POM Capsule oral 054/012 Universal Pharmaceuticals Ltd, India

5820

Trilac Capsules

Probiotic (Streptococcus

Faecalis + Clostridium

Butyricum + Bacillus

Mesentericus + Lactic

Acid Bacillus

(Lactobacillus

Sporogenes))

POM Capsule oral 054/013 Universal Pharmaceuticals Ltd, India

Page 298 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5821

Trilac Sachets

Probiotic (Streptococcus

Faecalis + Clostridium

Butyricum + Bacillus

Mesentericus + Lactic

Acid

Bacillus(Lactobacillus

Sporogenes))

POM Granules for Oral

Use

054/014 Universal Pharmaceuticals Ltd, India

5822Vovenil Injection Diclofenac Sodium 25mg

POM Solution for

Injection

374/001 Unosource Pharma Ltd. India

5823Akurose Injection

Elemental Iron 20mg, per

2ml

POM Solution for

Injection

374/002 Unosource Pharma Ltd. India

5824 Corfex 250 Capsules Cephalexin 250mg POM Capsule 374/003 Unosource Pharma Ltd. India

5825 Corfex 500 Capsules Cephalexin 500mg POM Capsule 374/004 Unosource Pharma Ltd. India

5826Prostar 100 Injection

Progesterone 100mg, per

2ml

POM Solution for

Injection

374/005 Unosource Pharma Ltd. India

5827Prostar 200 Injection

Progesterone 200mg, per

2ml

POM Solution for

Injection

374/006 Unosource Pharma Ltd. India

5828Thermodol Infusion Paracetamol 1%w/v

POM Solution for

infusion

374/007 Unosource Pharma Ltd. India

5829Unotation Injection

Tranexamic Acid 100mg

BP

POM Solution for

Injection

374/008 Unosource Pharma Ltd. India

5830Welquine Infusion Levofloxacin 0.5%w/v

POM Solution for

infusion

374/009 Unosource Pharma Ltd. India

5831Akumero 1000 Injection Meropenem 1000mg

POM Powder for injection 374/010 Unosource Pharma Ltd. India

5832Ceftrisone 1000 Injection

Ceftriaxone Sodium

1000mg

POM Solution for

Injection

374/011 Unosource Pharma Ltd. India

5833

Damphos Vaginal Suppositories

Clindamycin Phosphate

100mg USP +

Clotrimazole 100mg

POM Vaginal Suppostory 374/012 Unosource Pharma Ltd. India

5834Tradmin Injection

Tramadol Hydrochloride

50mg

POM Solution for

Injection

374/013 Unosource Pharma Ltd. India

5835

Tumbeno

Sodium bicarbonate -

Sarjikshara (Suddha)

2.6g + Citrus Medica

(Citric Acid) – Nimbu

Satva (Nimbukamlam)

1.90g

GS

Powder for Oral

Solution

374/014

Unosource Pharma Ltd. India

Page 299 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5836Oflotech Infusion Ofloxacin USP 200mg

POM Solution for

Infusion

374/015Unosource Pharma Ltd. India

5837

KOFCLEAN Syrup - Herbal

Cough Syrup

Adosa + Jesthimadh +

Pappli + Draksha + Tulsi

P Syrup 374/017 Unosource Pharma Ltd. India

5838

Ceftrisone-S Ceftriaxone USP

1000mg + Sulbactum

sodium USP 500mg

POM Solution for

Injection

374/018 Unosource Pharma Ltd. India

5839

Ultimate Condoms Banana

Scented

Latex Condom GS Protective barrier 438/001L USAID Discover-Health Project

5840

Ultimate Condoms Vanilla

Scented

Latex Condom GS Protective barrier 438/002L USAID Discover-Health Project

5841 Ultimate Condoms Smooth Latex Condoms GS Protective barrier 438/003L USAID Discover-Health Project

5842 Glynase XL-5 Tablets Glipizide 5mg POM Tablet Uncoated 282/001 USV Ltd, India

5843 Grovit Drops Multivitamin P Syrup 282/002 USV Ltd, India

5844Pioz-15 Tablets

Pioglitazone

Hydrochloride 15mg

POM Tablet Uncoated 282/003 USV Ltd, India

5845Ecorin-75 Tablets

Acetylsalicyclic Acid

75mg

POM Tablet Uncoated 282/004 USV Ltd, India

5846 Lipicard Capsules Fenofibrate 200mg POM Capsule oral 282/005 USV Ltd, India

5847Amoxen Suspension

Amoxicillin 125mg, per

5ml

POM Suspension for

Oral Use

230/002 Varichem Pharmaceuticals (Pvt) Ltd,

Zimbabwe

5848Amoxen Capsule Amoxicillin 250mg

POM Capsule oral 230/003 Varichem Pharmaceuticals (Pvt) Ltd,

Zimbabwe

5849

Cotrizole Tablets

Sulphamethoxazole

400mg + Trimethoprim

80mg

POM Tablet Uncoated 230/004 Varichem Pharmaceuticals (Pvt) Ltd,

Zimbabwe

5850Cloxacillin Capsules Cloxacillin 250mg

POM Capsule oral 230/005 Varichem Pharmaceuticals (Pvt) Ltd,

Zimbabwe

5851Varipan Tablets Paracetamol 500mg

GS Tablet Uncoated 230/006 Varichem Pharmaceuticals (Pvt) Ltd,

Zimbabwe

5852Varivar Tablets

Lamivudine 150mg +

Zidovudine 300mg

POM Tablet Film coated 230/007 Varichem Pharmaceuticals (Pvt) Ltd,

Zimbabwe

5853

STALANEV 30 Tablets

Stavudine 30mg +

Lamivudine 150mg +

Nevirapine 200mg

POM Tablet Uncoated 230/008 Varichem Pharmaceuticals (Pvt) Ltd,

Zimbabwe

Page 300 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5854

Hydrasalts Oral Rehydration

Salts

Glucose Anhydrous Ph.

Int 13.5g,+Glucose

75.0mmol/L + Sodium

Chloride Ph.Int 2.6g +

Sodium 75.0mmol/ L +

Trisodium Citrate

Dihydrate Ph.Int 2.9g+

Citrate 10.0mmol/L +

Potassium Chloride

Ph.Int 1.5g + Potassium

20.0mmol/L + Chloride

65.0mmol/L

P Powder for Oral

Solution

230/009 Varichem Pharmaceuticals (Pvt) Ltd,

Zimbabwe

5855

Micort Cream

Miconazole Nitrate 20mg

+ Hydrocortisone Acetate

10mg

POM Cream Topical 230/010 Varichem Pharmaceuticals (Pvt) Ltd,

Zimbabwe

5856

Neutracid Tablets

Aluminium Hydrochloride

120mg + Magnesium

Trisilicate 250mg

GS Tablet Uncoated 230/011 Varichem Pharmaceuticals (Pvt) Ltd,

Zimbabwe

5857Ibuprofen Oral Suspension Ibuprofen 100mg

GS Suspension for

Oral Use

230/012 Varichem Pharmaceuticals (Pvt) Ltd,

Zimbabwe

5858Erythromycin Tablets

Erythromycin Stearate

250mg

POM Tablet Uncoated 214/001 Venkant Pharma Limited, India

5859 Cephalexin Capsules Cephalexin 500mg POM Capsule oral 214/002 Venkant Pharma Limited, India

5860 Ibuprofen Tablets Ibuprofen 400mg P Tablet Film coated 214/003 Venkant Pharma Limited, India

5861 Diclofenac Tablets Diclofenac 50mg P Tablet Uncoated 214/004 Venkant Pharma Limited, India

5862 Amoxicillin Capsules Amoxicillin 250mg POM Capsule oral 214/005 Venkant Pharma Limited, India

5863 Omeprazole Capsules Omeprazole 20mg POM Capsule oral 214/006 Venkant Pharma Limited, India

5864 Indomethacin Capsules Indomethacin 25mg P Capsule oral 214/007 Venkant Pharma Limited, India

5865 Ampicillin Capsules Ampicillin 250mg POM Capsule oral 214/008 Venkant Pharma Limited, India

5866

Ronem 500 Injection Meropenem Trihydrate

500mg

POM Powder for

Injection

448/001 VENUS REMEDIES LTD

5867

Ronem 1000 Injection Meropenem Trihydrate

1000mg

POM Powder for

Injection

448/002 VENUS REMEDIES LTD

5868Mtx-vhb Injection

Methotrexate 50mg, per

ml

POM Powder for

Injection

084/001 VHB Medi Sciences

5869T- Bactum Injection

Cefoperazone USP 0.5g

+ Sulbactam 0.5g

POM Powder for

Injection

084/002 VHB Medi Sciences

5870Zonactam Injection

Ceftriazone USP 1g +

Tazobactam 125mg

POM Powder for

Injection

084/003 VHB Medi Sciences

Page 301 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5871Ce - Fine 1g Injection

Cefepime Hydrochloride

1g

POM Powder for

Injection

084/004 VHB Medi Sciences

5872Domaxin Rd 10mg Injection

Doxorubicin

Hydrochloride 10mg

POM Solution for

Injection

084/005 VHB Medi Sciences

5873

Peractam 4.5 G InjectionPiperacillin Sodium 4g +

Tazobactam Sodium 0.5g

POM Powder for

Injection

084/006 VHB Medi Sciences

5874Tetra 250 Capsules Tetracycline 250mg

POM Capsule oral 160/001 Vigor Laboratories 586-A Mody Estates,

India

5875Vardhmans Silver Cream Silver Sulfadiazine 1%

P Cream Topical 160/002 Vigor Laboratories 586-A Mody Estates,

India

5876

Vardex CreamBeclomethasone +

Gentamycin + Econazole

POM Cream Topical 160/003 Vigor Laboratories 586-A Mody Estates,

India

5877Betavard Cream Betamethasone 1%

POM Cream Topical 160/004 Vigor Laboratories 586-A Mody Estates,

India

5878Tetraskin Ointment Tetracycline 1%

POM Ointment topical 160/005 Vigor Laboratories 586-A Mody Estates,

India

5879

Vardman Strong Cream

Camphor + Eucalyptus

Oil + Turpentine Oil +

Methol + Methyl

Salicylate

GS Cream Topical 160/006 Vigor Laboratories 586-A Mody Estates,

India

5880Pen-V Oral Solution Suspension

Phenoxymethyl Penicillin

V 125mg, per 5ml

POM Suspension for

Oral Use

160/007 Vigor Laboratories 586-A Mody Estates,

India

5881Blimketas Tablets Levamisole 40mg

POM Tablet Uncoated 160/008 Vigor Laboratories 586-A Mody Estates,

India

5882Conjex Tablets Liquorice

GS Tablet Uncoated 160/009 Vigor Laboratories 586-A Mody Estates,

India

5883

Cotrim 480 Tablets

Sulphamethoxazole

400mg + Trimethoprim

80mg

POM Tablet Uncoated 160/010 Vigor Laboratories 586-A Mody Estates,

India

5884Doloprin Tablets Aspirin

POM Tablet Uncoated 160/011 Vigor Laboratories 586-A Mody Estates,

India

5885Go-Cough Tablets Liquorice 189.98mg

GS Tablet Uncoated 160/012 Vigor Laboratories 586-A Mody Estates,

India

5886Indo-25 Caspules Indomethacin 25mg

P Capsule oral 160/013 Vigor Laboratories 586-A Mody Estates,

India

Page 302 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5887

Jeri Stop Cold Tablets

Chlorpheniramine 2mg +

Caffeine 30mg +

Paracetamol 500mg

P Tablet Uncoated 160/014 Vigor Laboratories 586-A Mody Estates,

India

5888Mebenda-100 Tablets Mebendazole 100mg

P Tablet Uncoated 160/015 Vigor Laboratories 586-A Mody Estates,

India

5889Mekalfin Tablets

Sulfadoxine +

Pyrimethamine 525mg

P Tablet Uncoated 160/016 Vigor Laboratories 586-A Mody Estates,

India

5890Metro-200 Tablets Metronidazole 200mg

POM Tablet Uncoated 160/017 Vigor Laboratories 586-A Mody Estates,

India

5891MCT Tablets

Magnesium Trisilicate

200mg

P Tablet Uncoated 160/018 Vigor Laboratories 586-A Mody Estates,

India

5892

Parapain Capsules

Pseudoephedrine +

Chlorpheniramine +

Paracetamol 550mg

P Capsule oral 160/019 Vigor Laboratories 586-A Mody Estates,

India

5893Salbuta 2 Tablets Salbutamol 2mg

POM Tablet Uncoated 160/020 Vigor Laboratories 586-A Mody Estates,

India

5894Symaclox 500 Capsules

Cloxacillin Sodium

500mg

POM Capsule oral 160/021 Vigor Laboratories 586-A Mody Estates,

India

5895Analgin Tablets Dipyrone 500mg

POM Tablet Uncoated 160/022 Vigor Laboratories 586-A Mody Estates,

India

5896Pyramoate Suspension

Pyrantel Pamoate

125mg, per ml

P Suspension for

Oral Use

160/023 Vigor Laboratories 586-A Mody Estates,

India

5897Jonacan Cream Clotrimazole 1%w/v

POM Cream Topical 160/024 Vigor Laboratories 586-A Mody Estates,

India

5898Pyrantrin Tablets Pyrantel Pamoate 125mg

P Tablets 160/025 Vigor Laboratories 586-A Mody Estates,

India

5899Ibu-200 Tablets Ibuprofen 200mg

P Tablet Uncoated 160/027 Vigor Laboratories 586-A Mody Estates,

India

5900Lopamide Capsules

Loperamide

Hydrochloride2mg

POM Capsule oral 160/028 Vigor Laboratories 586-A Mody Estates,

India

5901Nystatin Vaginal Tablets Nystatin 100,000I.U.

POM Tablet Vaginal 160/029 Vigor Laboratories 586-A Mody Estates,

India

5902Stamache Tablets

Magnesium Carbonate +

Magnesium Hydroxide

GS Tablet Uncoated 160/030 Vigor Laboratories 586-A Mody Estates,

India

5903Kezoral Cream Ketoconazole 2%

POM Cream Topical 160/031 Vigor Laboratories 586-A Mody Estates,

India

5904Vardacort Cream Hydrocortisone 1%w/w

POM Cream Topical 160/032 Vigor Laboratories 586-A Mody Estates,

India

Page 303 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5905Vardacort Ointment Hydrocortisone 1%w/w

POM Ointment topical 160/033 Vigor Laboratories 586-A Mody Estates,

India

5906Vardamin Tablets

Metformin Hydrochloride

500mg

POM Tablet Uncoated 160/034 Vigor Laboratories 586-A Mody Estates,

India

5907Vardaplex Super Tablets B Complex

P Tablet Uncoated 160/035 Vigor Laboratories 586-A Mody Estates,

India

5908Vardaplex Forte Tablets B Complex

P Tablet Uncoated 160/036 Vigor Laboratories 586-A Mody Estates,

India

5909Diclofenac Gel Diclofenac 1%w/w

P Gel Topical 160/037 Vigor Laboratories 586-A Mody Estates,

India

5910Isoniazid Tablets Isoniazid 300mg

POM Tablet Uncoated 160/038 Vigor Laboratories 586-A Mody Estates,

India

5911Vard Blood Tonic Haematic Preparation

P Solution for Oral

Use

160/039 Vigor Laboratories 586-A Mody Estates,

India

5912Kofsil Lozenges Eucalyptus + Menthol

GS Lozenges 160/040 Vigor Laboratories 586-A Mody Estates,

India

5913

Safiphen Syrup

Chlorpheniramine USP

2mg + Ammonium

Chloride BP 100mg +

Guaifenesin BP 80mg +

Sodium Citrate BP 44mg

+ Terpine Hydrate 4mg +

Tolu Balsam 6mg, per

5ml

P Syrup 160/041 Vigor Laboratories 586-A Mody Estates,

India

5914Vardavit Syrup Multivitamins

GS Syrup 160/042 Vigor Laboratories 586-A Mody Estates,

India

5915

Benzathine Penicillin 2.4MU

Injection

Benzathine Penicillin

2.4MU

POM Powder for

Injection

160/043 Vigor Laboratories 586-A Mody Estates,

India

5916Dexamycin Eye/Ear Drops

Dexamethasone 5mg +

Neomycin 1mg, per ml

POM Ear/Eye Drops 160/044 Vigor Laboratories 586-A Mody Estates,

India

5917Mr. Power 500 Tablets

Aspirin 500 + Caffeine

30mg

GS Tablet Uncoated 160/045 Vigor Laboratories 586-A Mody Estates,

India

5918Benzyl Peniciliin 5MU Injection Benzyl Penicillin 5MU

POM Powder for

Injection

160/046 Vigor Laboratories 586-A Mody Estates,

India

5919Quinine Injection Quinine 300mg

POM Solution for

Injection

160/047 Vigor Laboratories 586-A Mody Estates,

India

5920Anti-Diar Suspension Light Kaolin + Pectin

GS Suspension for

Oral Use

160/048 Vigor Laboratories 586-A Mody Estates,

India

Page 304 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5921Ciprofin 250 Tablets Ciprofloxacin 250mg

POM Tablet Uncoated 160/049 Vigor Laboratories 586-A Mody Estates,

India

5922Ciprofin 500 Tablets Ciprofloxacin 500mg

POM Tablet Uncoated 160/050 Vigor Laboratories 586-A Mody Estates,

India

5923Syamoxil 500 Capsules Amoxicillin 500mg

POM Capsule oral 160/051 Vigor Laboratories 586-A Mody Estates,

India

5924Cimedine 200 Tablets Cimetidine 200mg

POM Tablet Uncoated 160/052 Vigor Laboratories 586-A Mody Estates,

India

5925Rifa 300 Capsules Rifampicin 300mg

POM Capsule oral 160/053 Vigor Laboratories 586-A Mody Estates,

India

5926Paladol Tablets Paracetamol 500mg

GS Tablet Uncoated 160/054 Vigor Laboratories 586-A Mody Estates,

India

5927Chlorphen Eye/Ear Drops

Chloramphenicol

0.5%w/v

POM Ear/Eye Drops 160/056 Vigor Laboratories 586-A Mody Estates,

India

5928Chlorpheniramine Suspension

Chlorpheniramine 2mg,

per 5ml

P Suspension 160/057 Vigor Laboratories 586-A Mody Estates,

India

5929Tetracycline Eye Drops Tetracycline 1%w/v

POM Eye Drops 160/058 Vigor Laboratories 586-A Mody Estates,

India

5930Betnovate Cream Betamethasone 1.0%w/v

P Cream Topical 160/059 Vigor Laboratories 586-A Mody Estates,

India

5931

Diarstop Tablets

Metronidazole BP 200mg

+ Furazolidone BP

100mg

POM Tablet Uncoated 160/060 Vigor Laboratories 586-A Mody Estates,

India

5932Cimedine 400 Tablets Cimetidine 400mg

POM Tablet Uncoated 160/061 Vigor Laboratories 586-A Mody Estates,

India

5933Wintogram 500 Tablets Nalidixic Acid 500mg

POM Tablet Uncoated 160/062 Vigor Laboratories 586-A Mody Estates,

India

5934Ferenol 500 Tablets Paracetamol 500mg

GS Tablet Uncoated 160/063 Vigor Laboratories 586-A Mody Estates,

India

5935Dawanol 500 Tablets Paracetamol BP 500mg

GS Tablet Uncoated 160/064 Vigor Laboratories 586-A Mody Estates,

India

5936Nystatin Oral Suspension

Nystatin 100,000 IU, per

ml

POM Suspension for

Oral Use

160/065 Vigor Laboratories 586-A Mody Estates,

India

5937Salbuta 4 Tablets Salbutamol 4mg

POM Tablet Uncoated 160/066 Vigor Laboratories 586-A Mody Estates,

India

5938Go Coff Cough syrup

Go Coff Cough Syrup

315.5mg, per 100ml

P Syrup 160/067 Vigor Laboratories 586-A Mody Estates,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5939

Vardhaman ORS Powder

Sodium Chloride BP 2.9g

+ Potassium Chloride BP

1.5g + Glucose

Anhydrous BP 20g +

Orange Flavour 0.05g

GS Powder for Oral

Solution

160/068 Vigor Laboratories 586-A Mody Estates,

India

5940Get-On Capsules Herbal Extracts

P Capsule oral 160/069 Vigor Laboratories 586-A Mody Estates,

India

5941Jeritone E Capsules Minerals + Multivitamins

P Capsule oral 160/070 Vigor Laboratories 586-A Mody Estates,

India

5942Powerfil 50 Tablets Sildenafil 50mg

POM Tablet Uncoated 160/071 Vigor Laboratories 586-A Mody Estates,

India

5943Vardavit Plus Tablets Multivitamins

GS Tablet Uncoated 160/072 Vigor Laboratories 586-A Mody Estates,

India

5944Supertone Syrup Multivitamin

GS Syrup 160/073 Vigor Laboratories 586-A Mody Estates,

India

5945

Instaclenz Hand Gel

Ethyl Alcohol 66.5%w/v

+ Isopropyl Alcohol

3.5%v/v

GS Gel Topical 068/001 Virchow Healthcare Ltd, India

5946

Vife-Z

Cabonyl Iron 50mg +

Zinc Sulphate

Monohydrate 61.8mg +

Folic Acid 0.5mg

P Capsule oral 068/002 Virchow Healthcare Ltd, India

5947 Viprax 200 Tablets Cefixime Tables 200mg POM Tablet Uncoated 068/003 Virchow Healthcare Ltd, India

5948 Viprax-Dt 100 Cefixime Tablets 100mg POM Tablet Uncoated 068/004 Virchow Healthcare Ltd, India

5949 Osteocare Tablets Minerals + Vitamins P Tablet Uncoated 236/001 Vitabiotics Limited, England

5950 Immunace Capsules Multivitamins GS Capsule oral 236/002 Vitabiotics Limited, England

5951 Perfectil Capsules Minerals + Vitamins P Capsule oral 236/003 Vitabiotics Limited, England

5952Ferroglobin B12 Syrup

Ferroglobin B12 Syrup

717.45mg

P Syrup 236/004 Vitabiotics Limited, England

Page 306 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5953

Omega H3 Capsules

Soya Bean Oil (from

Soya), Wheat-Germ Oil,

Vitamin C (Ascorbic

Acid), Methionine,

Magnesium Oxide, L-

Lysine HCl, Cod Liver Oil

(from Fish), Omega-3

Fish Oil (from Fish),

Ferrous Fumarate, Zinc

Sulphate, Lecithin

(contains Soya Bean Oil)

(from Soya), Hard

Vegetable Prep., Vitamin

E (as DL-Alpha

Tocopheryl Acetate

Prep.), Inositol, Para-

Aminobenzoic Acid,

Thiamin (Vitamin B1

Mononitrate), Niacin (as

Nicotinamide), Garlic

Concentrate (Grapeseed

Oil), Natural Mixed

Carotenoids

(Betacarotene, Alpha-

Carotene, Cryptoxanthin,

Zeaxanthin, Lutein,

[Carrier; Olive Oil]),

Pantothenic Acid (as

Calcium Salt), Vitamin

B12 (as Cyanocobalamin,

P Capsule oral 236/005 Vitabiotics Limited, England

5954 Wellwoman Capsules Minerals + Vitamins P Capsule oral 236/006 Vitabiotics Limited, England

5955 Wellman Capsules Minerals + Vitamins P Capsule oral 236/007 Vitabiotics Limited, England

5956 Visionace Capsules Minerals + Vitamins P Capsule oral 236/008 Vitabiotics Limited, England

5957 Cardioace Capsules Minerals + Vitamins P Capsule oral 236/009 Vitabiotics Limited, England

5958 Jointace Capsules Minerals + Vitamins P Capsule oral 236/010 Vitabiotics Limited, England

5959 Diabetone Capsules Minerals + Vitamins P Capsule oral 236/011 Vitabiotics Limited, England

5960 Feroglobin B12 Capsules Minerals + Vitamins P Capsule oral 236/012 Vitabiotics Limited, England

5961 Neurozan Capsules Minerals + Vitamins P Capsule oral 236/013 Vitabiotics Limited, England

5962 Jointace Omega -3 Capsules Multivitamins GS Capsule oral 236/014 Vitabiotics Limited, England

Page 307 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5963Liveril Capsules

Vitamins + Minerals +

Amino Acids

P Capsule oral 236/015 Vitabiotics Limited, England

5964

VITAHEALTH OMEGA 3 Pure

Fish Oils with Vitamin A & D

Capsules

Fish Oil 335mg + Omega

3 200mg + EPA 113mg

+ DHA 59mg + Vitamin

A 400mcg + Vitamin D

2mcg

P Capsule oral 453/001L Vitahealth Limited

5965

VITAHEALTH Jointcare Fortified

Capsules

Fish Oil 750mg + Omega

3 500mg + EPA 283mg +

DHA 142mg +

Glucosamine 250mg +

Vitamin C + 30mg +

Vitamin D 5mcg

P Capsule oral 453/002L Vitahealth Limited

5966 Vital Multime Capsules Multivitamins GS Capsule oral 191/001 Vital Health Foods (Pvt) Ltd, South Africa

5967 Vital Dolomite 200's Tablets Vitamin D3 + Dolomite P Tablet Film coated 191/002 Vital Health Foods (Pvt) Ltd, South Africa

5968 Multitime Potency Capsules Multivitamins GS Capsule oral 191/003 Vital Health Foods (Pvt) Ltd, South Africa

5969

Vitane's Nature Evening

Primrose Oil Softgels 1000mgPrimrose Oil 1000mg

GS Capsule oral 300/001 Vitane Pharmaceuticals Pvt Ltd, India

5970Probiotane Capsules Lactobacilli Culture 36mg

P Capsule oral 300/002 Vitane Pharmaceuticals Pvt Ltd, India

5971

Vitane's Nature Kids Plus

TabletsMultivitamins

GS Tablet Chewable 300/003 Vitane Pharmaceuticals Pvt Ltd, India

5972

Vitane's Nature Vitamin E 400iu

SoftgelsAlpha Tocopheryl 400IU

POM Capsule oral 300/004 Vitane Pharmaceuticals Pvt Ltd, India

5973Omegavyte Liquicaps Omega-3 Fish Oil 600mg

GS Capsule oral 300/005 Vitane Pharmaceuticals Pvt Ltd, India

5974 Igra 100 Oral Jelly Sildenafil Citrate100mg POM Tablet Film coated 395/001 VV Labs Pvt. Ltd

5975Vivamox Suspension

Amoxicillin Trihydrate

125mg, per 5ml

POM Powder for Oral

Suspension

243/001 VVS Pharmaceuticals and Chemicals (P)

Ltd,India

5976Vivamox Capsules

Amoxicillin Trihydrate

250mg

POM Capsule oral 243/002 VVS Pharmaceuticals and Chemicals (P)

Ltd,India

5977Vigrex D5 Tablets Sildenafil Citrate 100mg

POM Tablet Film coated 243/003 VVS Pharmaceuticals and Chemicals (P)

Ltd,India

5978Vecostatin Injection

Nystatin 500000 IU, per

5ml

POM Solution for

Injection

243/004 VVS Pharmaceuticals and Chemicals (P)

Ltd,India

5979Inal Gel Diclofenac Sodium 1mg

POM Gel Topical 243/005 VVS Pharmaceuticals and Chemicals (P)

Ltd,India

5980 Salbutamol Syrup Salbutamol 2mg, per 5ml POM Syrup 104/001 VYKing Pharmaceuticals Ltd, Lusaka

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5981

Kotrim Suspension

Trimethoprim 200mg +

Sulphamethoxazole

40mg

POM Suspension for

Oral Use

104/005 VYKing Pharmaceuticals Ltd, Lusaka

5982

Magnesium Trisilicate Mixture

Sodium Bicarbonate

500mg, per 5ml +

Magnesium Trisilicate

500mg, per 5ml + Light

Magnesium Oxide

500mg, per 5ml

GS Suspension for

Oral Use

104/006 VYKing Pharmaceuticals Ltd, Lusaka

5983Whitefield’s Ointment

Salicylic Acid 3% +

Benzoic Acid 6%

P Ointment topical 104/012 VYKing Pharmaceuticals Ltd, Lusaka

5984

Antacid Tablets

Peppermint Oil 0.003ml +

Dried Aluminium

Hydroxide 120mg +

Magnesium Trisilicate

250mg

GS Tablet Uncoated 104/018 VYKing Pharmaceuticals Ltd, Lusaka

5985

Kotrim Tablets

Trimethoprim 400mg +

Sulphamethoxazole

80mg

POM Tablet Uncoated 104/020 VYKing Pharmaceuticals Ltd, Lusaka

5986Aspirin Tablets

Acetyl Salicylic Acid

300mg

P Tablet Uncoated 104/030 VYKing Pharmaceuticals Ltd, Lusaka

5987 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 104/031 VYKing Pharmaceuticals Ltd, Lusaka

5988 Mebendazole Tablets Mebendazole 100mg P Tablet Uncoated 104/032 VYKing Pharmaceuticals Ltd, Lusaka

5989

Triphen 4 Flu Syrup

Diphenhydramine

12.5mg + Paracetamol

500mg +

Pseudoephedrine 22.5mg

P Syrup 104/034 VYKing Pharmaceuticals Ltd, Lusaka

5990 Pharmadol Tablets Paracetamol 100mg GS Tablet Uncoated 104/035 VYKing Pharmaceuticals Ltd, Lusaka

5991

DIOVOL Forte Oral Suspension Alumina 1.H. 300mg +

Magnesia l.H. 250mg

+Simethicone

l.P.40mq/5ml)

P Suspension for

Oral Use

443/001 Wallace Pharmaceuticals Ltd

Page 309 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

5992

Grilinctus Syrup

Dextromethophan

Hydrochloride 5mg, per

5ml + Chlorpheinramine

Maleate BP 2.5mg, per

5ml + Guainephensin BP

50mg, per 5ml +

Ammonium Chloride BP

6mg, per 5ml

P Syrup 220/001 Wardex Pharmaceuticals Pvt Ltd, India

5993

Grilintus BM Syrup

Brohexine Hydrochloride

8mg + Terbutaline

Sulphate 2.5mg

P Syrup 220/002 Wardex Pharmaceuticals Pvt Ltd, India

5994

Grilinctus BM Pediatric Syrup

Bromhexine

Hydrochloride 4mg +

Terbutaline Sulphate

1.5mg

P Syrup 220/003 Wardex Pharmaceuticals Pvt Ltd, India

5995

Dexorange Syrup

Ferric Ammonium Citrate

160mg/15ml +

Cyanocobalamin 7.5mg

P Syrup 220/004 Wardex Pharmaceuticals Pvt Ltd, India

5996

Forache Toothache Solution

Solvent Ether 1.5%v/v +

Menthol 1.25w/v +

Cajuput Oil 2.5%v/v+

Clove Oil 3.12%v/v +

Tolu Balsum 1.25%

POM Solution for Oral

Use

011/035 West-Coast Pharmaceutical Works, India

5997

Waxnil Ear Drops

Paradichlorobenzene

2%w/v + Benzocaine

2.7% w/v + Chlorobutol

5.0% w/v + Turpentine

2% w/v

P Solution for Topical

Use

011/037 West-Coast Pharmaceutical Works, India

5998Pedicol Drops

Dicyclomine 10mg +

Dimethicone 133.32mg

P Solution for Oral

Use

011/039 West-Coast Pharmaceutical Works, India

5999 Wescovita Tablets Multivitamin P Tablet Uncoated 011/044 West-Coast Pharmaceutical Works, India

6000 Wescotone Syrup Multivitamin GS Syrup 011/045 West-Coast Pharmaceutical Works, India

6001 Demson Tablets Dexamethasone 0.5mg POM Tablet Uncoated 011/050 West-Coast Pharmaceutical Works, India

6002

Folfes Plus TabletsFerrous Sulphate 200mg

+ Folic Acid 0.5mg

P Tablet Uncoated 011/059 West-Coast Pharmaceutical Works, India

6003Levazid Suspension

Levamisole 15mg +

Oxyclozanide 30mg

P Suspension 011/062 West-Coast Pharmaceutical Works, India

6004 Mebenda Tablets Mebendazole 100mg P Tablet Uncoated 011/063 West-Coast Pharmaceutical Works, India

Page 310 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

6005Leva-Vet Solution Levamisole 15mg

P Solution for Oral

Use

011/701 West-Coast Pharmaceutical Works, India

6006Welden-10 Tablet Piroxicam 10mg

POM Tablet Uncoated 011/001 West-Coast Pharmaceutical Works, India,

Lusaka

6007Welden-20 Tablets Piroxicam 20mg

POM Tablet Uncoated 011/002 West-Coast Pharmaceutical Works, India,

Lusaka

6008Profen 200 Tablets Ibuprofen 200mg

P Tablet Uncoated 011/003 West-Coast Pharmaceutical Works, India,

Lusaka

6009Profen 400 Tablets Ibuprofen 400mg

P Tablet Uncoated 011/004 West-Coast Pharmaceutical Works, India,

Lusaka

6010Samaol-2 Tablets Salbutamol 2mg

POM Tablet Uncoated 011/005 West-Coast Pharmaceutical Works, India,

Lusaka

6011Samaol-4 Tablets Salbutamol 4mg

POM Tablet Uncoated 011/006 West-Coast Pharmaceutical Works, India,

Lusaka

6012Ulcidin-200 Tablets Cimetidine 20mg

POM Tablet Uncoated 011/007 West-Coast Pharmaceutical Works, India,

Lusaka

6013Metamide Tablets Metoclopramide

POM Tablet Uncoated 011/008 West-Coast Pharmaceutical Works, India,

Lusaka

6014Tenil Tablets Atenolol 50mg

POM Tablet Uncoated 011/009 West-Coast Pharmaceutical Works, India,

Lusaka

6015Tenil 100 Tablets Atenolol 100mg

POM Tablet Uncoated 011/010 West-Coast Pharmaceutical Works, India,

Lusaka

6016Clofen 25 Tablets Diclofenac 25mg

P Tablet Uncoated 011/011 West-Coast Pharmaceutical Works, India,

Lusaka

6017Clofen 50 Tablets Diclofenac 50mg

P Tablet Uncoated 011/012 West-Coast Pharmaceutical Works, India,

Lusaka

6018Hexin Tablets

Bromhexine

Hydrochloride IP 8mg

P Tablet Uncoated 011/013 West-Coast Pharmaceutical Works, India,

Lusaka

6019Wescolax Tablets Bisacodyl 5mg

P Tablet Uncoated 011/014 West-Coast Pharmaceutical Works, India,

Lusaka

6020Prodin Tablets Cyproheptadine 4mg

P Tablet Uncoated 011/015 West-Coast Pharmaceutical Works, India,

Lusaka

6021Nefed-5 Tablets Nifedipine 5mg

POM Tablet Uncoated 011/016 West-Coast Pharmaceutical Works, India,

Lusaka

6022Nefed-10 Tablets Nifedipine 10mg

POM Tablet Uncoated 011/017 West-Coast Pharmaceutical Works, India,

Lusaka

6023Clomzol Tablets Clotrimazole 10mg

POM Lozenges 011/018 West-Coast Pharmaceutical Works, India,

Lusaka

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

6024Zepine Tablets Chlorpromazine 200mg

POM Tablet Uncoated 011/019 West-Coast Pharmaceutical Works, India,

Lusaka

6025Tizole 150 Tablets Tinidazole 150mg

POM Tablet Uncoated 011/020 West-Coast Pharmaceutical Works, India,

Lusaka

6026Tizole 300 Tablets Tinidazole 300mg

POM Tablet Uncoated 011/021 West-Coast Pharmaceutical Works, India,

Lusaka

6027Tizole 500 Tablets Tinidazole 500mg

POM Tablet Uncoated 011/022 West-Coast Pharmaceutical Works, India,

Lusaka

6028Glemide 2.5 Tablets Glibenclamide 2.5mg

POM Tablet Uncoated 011/023 West-Coast Pharmaceutical Works, India,

Lusaka

6029Glemide 5 Tablets Glibenclamide 5mg

POM Tablet Uncoated 011/024 West-Coast Pharmaceutical Works, India,

Lusaka

6030

Dawacid Suspension

Aluminium Hydrochloride

625mg + Magnesium

Trisilicate 312mg

GS Suspension for

Oral Use

011/025 West-Coast Pharmaceutical Works, India,

Lusaka

6031Wescogyl Oral Suspension

Metronidazole 200mg,

per 5ml

POM Suspension for

Oral Use

011/026 West-Coast Pharmaceutical Works, India,

Lusaka

6032Nytin Pessaries Nystatin 100,000IU

POM Tablet Vaginal 011/027 West-Coast Pharmaceutical Works, India,

Lusaka

6033

Allucid Tablets

Aluminium Hydrochloride

250mg + Magnesium

Trisilicate 120mg

GS Tablet Uncoated 011/028 West-Coast Pharmaceutical Works, India,

Lusaka

6034Wamargan Syrup

Promethazine 5mg, per

5ml

P Syrup 011/029 West-Coast Pharmaceutical Works, India,

Lusaka

6035Loptil Capsules

Loperamide

Hydrocholride 2mg

POM Capsule oral 011/030 West-Coast Pharmaceutical Works, India,

Lusaka

6036

Oralyt Powder

ORS (Sodium Chloride +

Sodium Citrate +

Potassium Chloride +

Glucose)

POM Powder for Oral

Solution

011/031 West-Coast Pharmaceutical Works, India,

Lusaka

6037

B-Covit Tablets

B Complex (Vit B1 1mg +

B2 1mg + Niacinamide

10mg)

P Tablet Uncoated 011/032 West-Coast Pharmaceutical Works, India,

Lusaka

6038Samol Syrup Salbutamol 2mg, per 5ml

POM Syrup 011/033 West-Coast Pharmaceutical Works, India,

Lusaka

6039

Bacrizole 480 TabletsSulfamethoxazole 400mg

+ Trimethoprim 80mg

POM Tablet Uncoated 011/034 West-Coast Pharmaceutical Works, India,

Lusaka

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

6040Kezol Cream Ketoconazole 2%w/w

POM Cream Topical 011/036 West-Coast Pharmaceutical Works, India,

Lusaka

6041

OTO-4 Ear Drops

Chloramphenicol 5%w/v

+ Beclomethasone

Dipropionate 0.025%w/v

+ Clotrim 1%w/v

POM Ear Drops 011/038 West-Coast Pharmaceutical Works, India,

Lusaka

6042Phenamine Tablets Chlopheniramine 4mg

P Tablet Uncoated 011/040 West-Coast Pharmaceutical Works, India,

Lusaka

6043Spasminal Tablets

Hyoscine Butylbromide

10mg

POM Tablet Uncoated 011/041 West-Coast Pharmaceutical Works, India,

Lusaka

6044Xylone Nasal Drops (Paed) Xylometazoline 0.05%w/v

P Nasal drops 011/042 West-Coast Pharmaceutical Works, India,

Lusaka

6045Xylone Nasal Drops (Adult) Xylometazoline 0.1%w/v

P Nasal drops 011/043 West-Coast Pharmaceutical Works, India,

Lusaka

6046Asbic-100 Tablets Ascorbic Acid 100mg

P Tablet Uncoated 011/046 West-Coast Pharmaceutical Works, India,

Lusaka

6047ASP-300 Tablets

Acetylsalicylic Acid

300mg

P Tablet Uncoated 011/047 West-Coast Pharmaceutical Works, India,

Lusaka

6048Etoin -100 Tablets Phenytoin 100mg

POM Tablet Uncoated 011/048 West-Coast Pharmaceutical Works, India,

Lusaka

6049Eril-10 Tablets Enalapril 10mg

POM Tablets oral 011/049 West-Coast Pharmaceutical Works, India,

Lusaka

6050CT-Suspension

Ciprofloxacin 250mg +

Tinidazole 300mg

POM Suspension for

Oral Use

011/051 West-Coast Pharmaceutical Works, India,

Lusaka

6051

Cofnil Syrup

Chlorpheniramine 2.5mg

+ Ammonium Chloride

125mg + Soduim Citrate

+125mg

P Syrup 011/052 West-Coast Pharmaceutical Works, India,

Lusaka

6052Cetri-10 Tablets Cetirizine 10mg

P Tablet Uncoated 011/053 West-Coast Pharmaceutical Works, India,

Lusaka

6053

Bactrizole Suspension

Trimethoprim 40mg +

Sulphamethoxazole

200mg

POM Suspension for

Oral Use

011/054 West-Coast Pharmaceutical Works, India,

Lusaka

6054

B-Folcin Tablets

Niacinamide 50mg +

Riboflavin 10mg + Folic

Acid 1.5mg

P Tablet Uncoated 011/055 West-Coast Pharmaceutical Works, India,

Lusaka

6055Azolevet Suspension Albendazole 25mg/Ml

P Suspension for

Oral Use

011/056 West-Coast Pharmaceutical Works, India,

Lusaka

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

6056

Forache Tablets

Acetaminophen 250mg +

Caffeine 30mg + Aspirin

300mg

GS Tablet Uncoated 011/058 West-Coast Pharmaceutical Works, India,

Lusaka

6057Fesate Tablets Ferrous Sulphate 200mg

P Tablet Uncoated 011/060 West-Coast Pharmaceutical Works, India,

Lusaka

6058Ferolax Syrup Haematinic

P Syrup 011/061 West-Coast Pharmaceutical Works, India,

Lusaka

6059

Diclomol Injection Diclofenac Sodium

25mg/ml

POM Solution for

Injection

452/001 Win-Medicare Pvt Ltd

6060

Urgendol Injection Tramadol Hydrochloride

50mg/ml

POM Solution for

Injection

452/002 Win-Medicare Pvt Ltd

6061Glucose Intravenous Infusion

Glucose Intravenous

Infusion B.P 5%w/v

POM Solution for

infusion

124/001 Wockhardt Limited, India

6062Glucose Intravenous Infusion

Glucose Intravenous

Infusion B.P 10%w/v

POM Solution for

infusion

124/002 Wockhardt Limited, India

6063

Compound Sodium Lactate

Injection

Sodium Chloride

0.6%w/v + Calcium

Chloride 0.027g w/v +

Potassium Chloride

0.04%w/v + Sodium

Lactate 0.24%w/v

POM Solution for

infusion

124/003 Wockhardt Limited, India

6064 Pelox-400 Tablets Perfloxacin 400mg POM Tablet Uncoated 124/004 Wockhardt Limited, India

6065Metronidazole Injection

Metronidazole 5mg, per

ml

POM Solution for

infusion

124/005 Wockhardt Limited, India

6066Wokadine Germicide Gargles Povidone Iodine 1%

GS Solution for Oral

Use

124/006 Wockhardt Limited, India

6067 Wokadine Vaginal Pesseries Povidone Iodine 200mg POM Tablet Vaginal 124/007 Wockhardt Limited, India

6068

Zedex Cough Syrup

Bromhexine 4mg +

Dextromethorphan 5mg +

Ammonium Chloride

50mg + Menthol 2.5mg,

per 100ml

POM Syrup 124/008 Wockhardt Limited, India

6069Soduim Chloride Injection Sodium Chloride 0.9%

POM Solution for

infusion

124/009 Wockhardt Limited, India

6070 Aziwork USP Capsules Azithromycin 250mg POM Capsule oral 124/010 Wockhardt Limited, India

6071

Bro-Zedex Cough Syrup

Terbutaline 1.25mg +

Bromhexine 4mg +

Guaifenesin 50mg +

Menthol 2.5mg, per 5ml

POM Syrup 124/011 Wockhardt Limited, India

Page 314 of 320

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

6072Aziwork Suspension

Azithromycin 100mg, per

5ml

POM Suspension for

Oral Use

124/012 Wockhardt Limited, India

6073

Proxyvon Capsules

Dextropropoxyphen

65mg + Paracetamol

400mg

POM Capsule oral 124/013 Wockhardt Limited, India

6074 Pelox-400 Tablets Perfloxacin 400mg POM Tablet Uncoated 124/014 Wockhardt Limited, India

6075Wokadine 10%w/w Ointment Povidone Iodine 10%w/w

GS Ointment topical 124/015 Wockhardt Limited, India

6076Powercef 125mg Injection Ceftriaxone 125mg

POM Powder for

Injection

124/016 Wockhardt Limited, India

6077Powercef 250 Injection Ceftriaxone 250mg

POM Powder for

Injection

124/017 Wockhardt Limited, India

6078Powercef 500mg Injection Ceftriaxone 500mg

POM Powder for

Injection

124/018 Wockhardt Limited, India

6079Powercef 1000mg Injection Ceftriaxone 1000mg

POM Powder for

Injection

124/019 Wockhardt Limited, India

6080 Sparx-200 Tablets Sparfloxacin 200mg POM Tablet Uncoated 124/020 Wockhardt Limited, India

6081

Wepox 2000 Injection

Recombinant Human

Erythropoietin 2000 IU,

per ml

POM Solution for

Injection

124/021 Wockhardt Limited, India

6082 Nadoxin Cream Nadifloxacin 1%w/v POM Cream Topical 124/022 Wockhardt Limited, India

6083Wosulin-R Injection Insulin EP 100 IU, per ml

POM Solution for

Injection

124/023 Wockhardt Limited, India

6084

Wosulin 30/70 Injection

Recombinant (R-DNA)

Human Insulin Biphasic

30% Regular/70%

Isophane

POM Solution for

Injection

124/024 Wockhardt Limited, India

6085

Wosulin N Injection 30%

Recombinant (R-DNA)

Human Insulin NPH -

Intermediate Acting

POM Solution for

Injection

124/025 Wockhardt Limited, India

6086Promethazine Injection

Promethazine 50mg, per

2ml

POM Solution for

Injection

028/001MT Wuhan Grand Pharmaceutical Group Co.

Ltd

6087Chlorpromazine Injection

Chlorpromazine 25mg,

per ml

POM Solution for

Injection

028/002MT Wuhan Grand Pharmaceutical Group Co.

Ltd

6088Metoclopromide Injection

Metoclopramide 10mg,

per 2ml

POM Solution for

Injection

028/003MT Wuhan Grand Pharmaceutical Group Co.

Ltd

6089Oxytocin Injection Oxytocin 10 IU

POM Solution for

Injection

033/027 Wuhan Grand Pharmaceutical Group Co.

Ltd

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

6090

Oral Rehydration Salts

Sodium Chloride 3.5g +

Potassium Chloride 1.5g

+ Sodium Citrate 2.9g +

Anhydrous Glucose 20g

GS Powder for Oral

Solution

033/028 Wuhan Grand Pharmaceutical Group Co.

Ltd

6091

Shangring Male Circumcision

Device With Removal Tool &

Band Aid

Shangring Male

Circumcision Device with

Removal Tool & Band

P Medical Device 386/001L Wuhu Snnda Medical Treatment Appliance

6092 Premarin Tablets Oestrogen 0.3mg POM Tablet Uncoated 116/005 Wyeth Laboratories (Pty) Limited, SA

6093

Advil CS Tablets

Ibuprofen 200mg +

Pseudoephedrine

Hydrochloride 30mg

P Tablet Uncoated 120/033 Wyeth Laboratories (Pty) Limited, SA

6094Anadin Tablets

Aspirin 400mg + Caffeine

22.7mg

GS Tablet Uncoated 120/034 Wyeth Laboratories (Pty) Limited, SA

6095

Preparation H Ointment

Yeast Cell Extract + 3g

Shark Liver Oil + 1g

Alcohol, per 100g

P Ointment topical 120/035 Wyeth Laboratories (Pty) Limited, SA

6096

Preparation H Suppositories

Petrolatum71.9% +

Mineral Oil 14% + Shark

Liver Oil 3% +

Phenylephedrine

Hydrochloride 0.25%

P Suppository 120/036 Wyeth Laboratories (Pty) Limited, SA

6097 Valizgy Eczema Cream Betamethasone 1% POM Cream Topical 216/001 Yash Pharmaceuticals Ltd

6098 Herpizyg Cream Acyclovir 5 % POM Cream Topical 216/002 Yash Pharmaceuticals Ltd

6099Butate Antifungal Cream

Clotrimazole 1%w/w +

Benzyl Alcohol 1%w/w

POM Cream Topical 216/003 Yash Pharmaceuticals Ltd

6100Dipvite Cream

Betamethasone

0.643mg/g

POM Cream Topical 216/004 Yash Pharmaceuticals Ltd

6101Naftol Topical Solution Tolnaftate 10mg

POM Solution for Topical

Use

216/005 Yash Pharmaceuticals Ltd

6102

Clodip Cream

Clotrimazole 10mg +

Betamethasone 0.643mg,

per g

POM Cream Topical 216/006 Yash Pharmaceuticals Ltd

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

6103

Fosure Cream

Betamethasone

Dipropionate 0.64mg +

Clotrimazole 10mg +

Gentamicin Base 1 mg +

Tolnaftate 10 Mg +

Iodochlorhydroxyquinolin

e 10mg

POM Cream Topical 216/007 Yash Pharmaceuticals Ltd

6104Epiklin Ointment

Salicylic Acid 30mg +

Betamethasone 0.64mg

POM Ointment topical 216/009 Yash Pharmaceuticals Ltd

6105Naftatin Cream

Nystatin 100,000 I.U +

Tolnaftate 10mg

POM Cream Topical 216/010 Yash Pharmaceuticals Ltd

6106 Yashiprostol - 200 Tablets Misoprostol 200mcg POM Tablet Uncoated 349/001 Yashika Pharmaceuticals Pvt Ltd

6107Oxytocin Injection USP 10 IU/Ml

Oxytocin USP 10IU, per

ml

POM Solution for

Injection

349/002 Yashika Pharmaceuticals Pvt Ltd

6108 Gummi King Vitamin C Gummi Ascorbic Acid 30mg P Gel Oral 411/001L Zanon USA Inc. d.b.a. Vitamec USA Inc

6109

Gummi King Multivitamin &

Mineral GummiMultivitamins & Minerals

PGel Oral

411/002LZanon USA Inc. d.b.a. Vitamec USA Inc

6110

Gummi King Calcium Plus

+Vitamin D Gummi

Calcium 50mg + Vitamin

D 0.00006mg

PGel Oral

411/003LZanon USA Inc. d.b.a. Vitamec USA Inc

6111

Gummi King Echinacea Plus

Vitamin C & Zinc Gummi

Echinacea 25mg +

Ascorbic Acid 15mg +

Zinc 2.5mg

P

Gel Oral

411/004L

Zanon USA Inc. d.b.a. Vitamec USA Inc

6112 Gummi King Vitamin D Gummi. Vitamin D 0.01mg P Gel Oral 411/005L Zanon USA Inc. d.b.a. Vitamec USA Inc

6113Siesta Tablets

Valeriana Officinalis Root

Extract 2g

GS Tablet Uncoated 052/001 Zifam Pinnacle Pty Ltd, Australia

6114Pinch Tablets

Chromium Picolinate

50mcg + Sucralose 8mg

GS Tablet Uncoated 052/001L Zifam Pinnacle Pty Ltd, Australia

6115Eposoft Gelatin Capsules

Gamma Linolenic Acid

100mg

GS Capsule oral 052/002 Zifam Pinnacle Pty Ltd, Australia

6116 Supravit Tablets Minerals + Multivitamins P Tablet Uncoated 052/003 Zifam Pinnacle Pty Ltd, Australia

6117Lobese Capsules

Phaseolus Vulgaris

Extract 500mg

P Capsule oral 052/004 Zifam Pinnacle Pty Ltd, Australia

6118 Vitacee Tablets Ascorbic Acid 500mg GS Tablet Uncoated 052/005 Zifam Pinnacle Pty Ltd, Australia

6119Vibran Tablets

D-Alpha-Tocopherol

82.6mg

POM Tablet Uncoated 052/006 Zifam Pinnacle Pty Ltd, Australia

6120Protec Caplets Multivitamins

GS Caplets oral

Uncoated

052/007 Zifam Pinnacle Pty Ltd, Australia

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

6121

Mega 3 Fish Oil Concentrate

Capsules

Eicosapentaenoic Acid

180mg +

Ocosahexaenoic Acid

120mg

P Capsule oral 052/008 Zifam Pinnacle Pty Ltd, Australia

6122 Vitakid Tablets Minerals + Multivitamins P Tablet Chewable 052/009 Zifam Pinnacle Pty Ltd, Australia

6123Ozical Tablets

Milk Calcium 600mg +

Vitamin D3 0.5mg

P Tablet Uncoated 052/010 Zifam Pinnacle Pty Ltd, Australia

6124

Immunor Capsules

Colostrum Powder

Bovine75mg+ Lactoferrin

Bovin 100mg

P Capsule oral 052/011 Zifam Pinnacle Pty Ltd, Australia

6125Zifam St Johns Wort Tablets

Hypericum Perforatum

1800mg

P Tablet Uncoated 052/012 Zifam Pinnacle Pty Ltd, Australia

6126Amino-XL Tablets

Amino Acids + Vitamins

& Minerals

P Tablet Uncoated 052/013 Zifam Pinnacle Pty Ltd, Australia

6127Vitrum Tablets Minerals + Multivitamins

P Caplets oral

Uncoated

052/014 Zifam Pinnacle Pty Ltd, Australia

6128

G-Trim Powder (Lime & Lemon

Flavour)Herbal Preparation

P Powder for Oral

Solution

052/015L Zifam Pinnacle Pty Ltd, Australia

6129

Mega 3 Chewable Softgels

Fish Oil Natural (Eq. To

Docosahexaenoic Acid

)750mg

P Capsule oral 052/016L Zifam Pinnacle Pty Ltd, Australia

6130 Natocare Softgels Fish Oil Natural 800mg P Capsule oral 052/017L Zifam Pinnacle Pty Ltd, Australia

6131

Tribull Tablets

Tribulus Terrestris 250mg

+ Avena Sativa Extract

10mg + Zinc Sulphate

40mg

P Tablet Uncoated 052/018L Zifam Pinnacle Pty Ltd, Australia

6132

Cee Lime N Lemon Chewable

TabletsVitamin C 500mg

GS Tablet Chewable 052/019L Zifam Pinnacle Pty Ltd, Australia

6133 Cee Orange Chewable Tablets Vitamin C 500mg GS Tablet Chewable 052/020L Zifam Pinnacle Pty Ltd, Australia

6134Menofem Capsules

Black Cohosh 200mg +

Red Clover 1g

P Capsule Hard

Gelatin

052/021L Zifam Pinnacle Pty Ltd, Australia

6135 Emuflam Cream Herbal Extracts GS Cream Topical 052/022L Zifam Pinnacle Pty Ltd, Australia

6136

Nuflam Capsules

Glucosamine Sulphate

667mg + Chondroitin

278mg

GS Capsule Hard

Gelatin

052/023L Zifam Pinnacle Pty Ltd, Australia

6137 Cee Pineapple Tablets Vitamin C 500mg GS Tablet Chewable 052/024L Zifam Pinnacle Pty Ltd, Australia

6138 Cee Strawberry Tablets Vitamin C 500mg GS Tablet Chewable 052/025L Zifam Pinnacle Pty Ltd, Australia

6139 Gaseze Softgels Combination P Capsule, soft 052/026L Zifam Pinnacle Pty Ltd, Australia

6140 Infant Coleze Softgels Combination P Capsule, soft 052/027L Zifam Pinnacle Pty Ltd, Australia

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

6141Urisol Sachets

Vaccinum Macrocarpon

360mg

P Powder for oral 052/028L Zifam Pinnacle Pty Ltd, Australia

6142

Ferosorb Capsules

Iron 24mg + Vitamin C

100mg + Vitamin B12

500mcg + Folic Acid

500mcg

P Capsule, Hard

gelatin

052/029L Zifam Pinnacle Pty Ltd, Australia

6143

OPTICA Capsules Lutein esters calculated

as Lutein 5.6mg +

Zeaxanthin 324mg + R,S-

Alpha Lipoic Acid 250mg

P Capsule oral 052/039L Zifam Pinnacle Pty Ltd, Australia

6144

NATOCARE PLUS DHA 125mg with

Multivitamins

P Capsule oral 052/040L Zifam Pinnacle Pty Ltd, Australia

6145

ZI LIV Capsules Silybum marianum 7.5g +

Taraxacum officiale

250mg + Schisandra

chinensis extract 125mg

+ Astragalus

membranaceus extract

100mg + Cynara

scolymus 1.5g +

Andrographis 500mg +

Curcuma longa 1.5g

Inositol 125mg + Choline

bitartrate 125mg +

Taurine 75mg + Ascorbic

acid 50mg

P Capsule oral 052/038L Zifam Pinnacle Pty Ltd, Australia

6146

CINRO Tablets Cinnamomum cassia

extract 1g + Chromium

Picolinate 50mcg +

Chronium Chloride

50mcg + total elemental

Chronium 200mcg +

Ascorbic Acid 75mg +

Biotin 5mg

P Tablet Film coated 052/041L Zifam Pinnacle Pty Ltd, Australia

6147Deltaprim Tablets

Pyrimethamine 3.125mg

+ Dapsone 25mg

P Tablet Uncoated 091/001 Zimbabwe Pharmaceuticals (Pvt) Limited,

Zimbabwe

6148Betaco Syrup

Dextromethorphan

Hydrobromide 15mg/5ml

P Syrup 091/002 Zimbabwe Pharmaceuticals (Pvt) Limited,

Zimbabwe

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ZAMBIA MEDICINES REGULATORY AUTHORITY

MEDICINES FOR HUMAN USE 2019 REGISTER

6149

Betafed Syrup

Dextromethorphan 15mg,

per 5ml +

Pseudoephedrine 30mg,

per 5ml

P Syrup 091/003 Zimbabwe Pharmaceuticals (Pvt) Limited,

Zimbabwe

6150Betamint Cough Syrup

Guaiphenesin 100mg,

per 5ml

P Syrup 091/004 Zimbabwe Pharmaceuticals (Pvt) Limited,

Zimbabwe

6151Betamol Syrup

Paracetamol 120mg, per

5ml

GS Syrup 091/005 Zimbabwe Pharmaceuticals (Pvt) Limited,

Zimbabwe

6152

Betapro Syrup

Triprolidine 1.375mg, per

5ml + Pseudoephedrine

30mg, per 5ml

P Syrup 091/006 Zimbabwe Pharmaceuticals (Pvt) Limited,

Zimbabwe

6153Deltaprim Paediatric Syrup

Dapsone 25mg +

Pyrimethamine 3.125mg

POM Syrup 091/007 Zimbabwe Pharmaceuticals (Pvt) Limited,

Zimbabwe

6154R-Loc 150 Tablets

Ranitidine Hydrochloride

150mg

POM Tablet Uncoated 139/001 Zydus Cadila Healthcare Ltd, India

6155 Tiniba 500 Tablets Tinidazole 500mg POM Tablet Uncoated 139/002 Zydus Cadila Healthcare Ltd, India

6156 Betanese 5 Tablets Glibenclamide 5mg POM Tablet Uncoated 139/003 Zydus Cadila Healthcare Ltd, India

6157 Amlodac-5 Tablets Amilodipine 5mg POM Tablet Uncoated 139/004 Zydus Cadila Healthcare Ltd, India

6158 Amilodac 10 Tablets Amilodipine 10mg POM Tablet Uncoated 139/005 Zydus Cadila Healthcare Ltd, India

6159 Piricam 10 Capsules Piroxicam 10mg POM Tablet Uncoated 139/006 Zydus Cadila Healthcare Ltd, India

6160 Piricam 20 Capsules Piroxicam 20mg POM Capsule oral 139/007 Zydus Cadila Healthcare Ltd, India

6161 Odace 5 Tablets Lisinopril Dihydrate 5mg POM Capsule oral 139/008 Zydus Cadila Healthcare Ltd, India

6162 Nilfast Suspension Nimesulide 50mg, per ml POM Tablet Uncoated 139/009 Zydus Cadila Healthcare Ltd, India

6163Cefotim 1000 Injection Cefotaxime 1000mg

POM Suspension for

Oral Use

139/010 Zydus Cadila Healthcare Ltd, India

6164Hipen Capsules Amoxicillin 250mg

POM Powder for

Injection

139/011 Zydus Cadila Healthcare Ltd, India

6165 Loridin Rapitas Tablets Loratadine 10mg POM Capsule oral 139/012 Zydus Cadila Healthcare Ltd, India

6166 Loridin Suspension Loratadine 5mg, per 5ml POM Tablet Uncoated 139/013 Zydus Cadila Healthcare Ltd, India

6167Norswell Tablets Ibuprofen 200mg

P Suspension for

Oral Use

139/014 Zydus Cadila Healthcare Ltd, India

6168Tramazac Injection

Tramadol Hydrochloride

50mg, per ml

POM Solution for

Injection

139/015 Zydus Cadila Healthcare Ltd, India

6169Tramazac Capsules

Tramadol Hydrochloride

50mg

P Tablet Uncoated 139/016 Zydus Cadila Healthcare Ltd, India

6170 Odace-10 Tablets Lisinopril 10mg POM Tablets Uncoated 139/017 Zydus Cadila Healthcare Ltd, India

Page 320 of 320