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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as stated)
Product
Classification
1 BRU07100001P Augmentin Injection 1.2g Co-Amoxiclav 1000/200 - Amoxicillin 1g as
sodium salt, clavulanic acid 200mg as
potassium salt
SmithKline Beecham PLC, Worthing, West
Sussex, UK
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
2 BRU07100002P Augmentin Injection 600mg Co-Amoxiclav 500/100 - Amoxicillin 500mg
as sodium salt, clavulanic acid 100mg as
potassium salt
SmithKline Beecham PLC, Worthing, West
Sussex, UK
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
3 BRU08010001P Pharmaniaga Aciclovir Tablet
200mg
Aciclovir 200mg Pharmaniaga Manufacturing Berhad
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
4 BRU08010002P Pharmaniaga Ketoconazole
Tablet 200mg
Ketoconazole 200mg Pharmaniaga Manufacturing Berhad
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
5 BRU08010003P Pharmaniaga Clarithromycin
Tablet 250mg
Clarithromycin 250mg Pharmaniaga Manufacturing Berhad
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
6 BRU08010004P Pharmaniaga Fluconazole 150mg
Capsules
Fluconazole 150mg Pharmaniaga Manufacturing Berhad
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
7 BRU08010005P Pharmaniaga Ciprofloxacin Tablet
500mg
Ciprofloxacin 500mg Pharmaniaga Manufacturing Berhad
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
8 BRU08010009P Meronem Injection 1g Meropenem (as trihydrate) 1g AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
9 BRU08020010P Meronem Injection 500mg Meropenem (as trihydrate) 500mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
10 BRU08020011P Bactroban Cream Mupirocin 2% SmithKline Beecham, Philippines Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
11 BRU08020012P Pharmaniaga Cephalexin Capsule
500mg
Cephalexin 500mg Pharmaniaga Manufacturing Berhad
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
12 BRU08020013P Pharmaniaga Metronidazole
Tablet 200mg
Metronidazole 200mg Pharmaniaga Manufacturing Berhad
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
13 BRU08020016P Anikef Sterile 750mg Cefuroxime 750mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
14 BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
15 BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
BDMCA/RMP/1116 Page 1 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
16 BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
17 BRU08020020P Diprivan 10mg/ml (1%) Emulsion
for Injeciton or Infusion (20ml
Ampoule)
Propofol 10mg/ml (1%) Corden Pharma S.P.A Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
18 BRU08020021P Retrovir Capsule 100mg Zidovudine 100mg SmithKline Beecham Plc, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
19 BRU08020022P Bactroban Ointment Mupirocin 2% GlaxoSmithKline Philippines Inc,
Philippines
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
20 BRU08030023P Augmentin Tablet 625mg Amoxycillin 500mg (as trihydrate);
Clavulanic acid 125mg (as Potassium
Clavulanate)
SmithKline Beecham Plc, Worthing, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
21 BRU08030024P Augmentin Syrup 228mg/5ml Amoxycillin 200mg/5ml (as trihydrate);
Clavulanic acid 28.5mg/5ml (as Potassium
Clavulanate)
SmithKline Beecham Plc, Worthing, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
22 BRU08030025P Augmentin Syrup 457mg/5ml Amoxycillin 400mg/5ml (as trihydrate);
Clavulanic acid 57mg/5ml (as Potassium
Clavulanate)
SmithKline Beecham Plc, Worthing, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
23 BRU08030026P Augmentin Tablet 1g Amoxycillin 875mg (as trihydrate);
Clavulanic acid 125mg (as Potassium
Clavulanate)
SmithKline Beecham Plc, Worthing, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
24 BRU08030027P Foban Cream Fusidic acid 2% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
25 BRU08030030P Garasent 80mg Injection Gentamicin 40mg/ml (as Sulphate) Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 06 October 2015 till 05
October 2020
POM
26 BRU08030031P Retrovir 1% IV Infusion Zidovudine 1% Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
27 BRU08030032P Genta Eye Drop 0.3%w/v Gentamicin (as Sulphate) Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
28 BRU08030034P Zinacef Injection 750mg Cefuroxime (as sodium) GlaxoSmithKline Manufacturing SPA, Italy. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
29 BRU08030035P Zinacef Injection 1.5g Cefuroxime (as sodium) GlaxoSmithKline Manufacturing SPA, Italy. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
30 BRU08030036P Zinnat Tablet 125mg Cefuroxime (as axetil) Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
31 BRU08030037P Zinnat Tablet 250mg Cefuroxime (as axetil) Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 2 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
32 BRU08040039P Solulexin Granules 125mg/5ml Cefalexin Monohydrate equivalent to
Cefalexin 125mg/5ml
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
33 BRU08040040P Retrovir Syrup Zidovudine 50mg/5ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
34 BRU08040041PS1 &
BRU08040041PS2
Zeffix Tablet Lamivudine 100mg Glaxo Wellcome Operations UK Ltd, UK
(S1); GlaxoSmithKline Pharmaceuticals
S.A., Poland (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
35 BRU08040042P Combivir Tablet Lamivudine 100mg, Zidovudine 300mg GlaxoSmithKline Pharmaceuticals S.A.,
Poland
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
36 BRU08040043P Zoraxin Syrup Aciclovir 200mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
37 BRU08040046P Genta-Bet Eye Drops Gentamicin (as Sulphate) 0.3%,
Betamethasone Disodium Phosphate 0.1%
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
38 BRU08040047P Bicafar Sterile 2g (vial) Cefoperazone (as Sodium) 2g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
39 BRU08040049P Diflucan IV Infusion 2mg/ml
(50ml)
Fluconazole 2mg/ml Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
40 BRU08040050P Sulperazone IM/IV 1g Sulbactam (as Sodium) 500mg;
Cefoperazone (as Sodium) 500mg
Haupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
41 BRU08040051P Beagenta Cream 0.1% Gentamicin (as Sulphate BP) 0.1%w/w Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
42 BRU08040052P Becarin Cream 2% Miconazole Nitrate 2% Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
GSL
43 BRU08050053P Pharmaniaga Aciclovir Tablet
400mg
Aciclovir 400mg Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
44 BRU08050054P Pharmaniaga Cephalexin Capsule
250mg
Cephalexin (as Anhydrous) Cephalexin
250mg
Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
45 BRU08050058P Ketozotan Tablet 200mg Ketoconazole 200mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
46 BRU08050060P Unocef Injection 500mg (Vial) Ceftriaxone (as Sodium) 500mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
BDMCA/RMP/1116 Page 3 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
47 BRU08050061P Unocef Injection 1000mg (Vial) Ceftriaxone (as Sodium) 1000mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
48 BRU08050063P Solulexin Capsule 250mg Cephalexin Monohydrate 262.95mg
equivalent to Cephalexin 250mg
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
49 BRU08050064P Solulexin Capsule 500mg Cephalexin (as Monohydrate) 500mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
50 BRU08050065P Beavate-N Cream Betamethasone-17-valerate equivalent to
Betamethasone 0.1%w/w; Neomycin
Sulphate 0.5%w/w
Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
51 BRU08050066P Beagenta Eye/ Ear Drops Gentamicin Sulphate equivalent to
Gentamicin 0.3%w/w
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
52 BRU08050067P Uphalexin Granules 125 Cephalexin Monohydrate 138mg/5ml
equivalent to Cephalexin 125mg/5ml
Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
53 BRU08050068P Krisovin Tablet 500 Griseofulvin BP 500mg (micronised) Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
54 BRU08050069P Plaquenil Tablet Hydroxychloroquine Sulphate 200mg Sanofi-Aventis, S.A., Riells l Viabrea, Spain Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
55 BRU08050070P Betacin Eye Ear Drop Neomycin Sulphate 0.5% w/v;
Betamethasone Sodium Phosphate
0.1%w/v
Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 06 October 2015 till 05
October 2020
POM
56 BRU08050071P Foban Ointment Sodium Fusidate BP 2% w/v Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
57 BRU08050072P Fobancort Cream Fusidic acid 2%w/w; Betamethasone
Dipropionate 0.064%w/w equivalent to
Betamethasone 0.05%w/w
Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
58 BRU08050073P Dezor Cream Ketoconazole 2%w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
59 BRU08050074P Dezor Shampoo Ketoconazole 2%w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
60 BRU08060075P Genta-Dex Eye Drops Gentamicin 0.3% w/v; Dexamethsone
Phosphate 0.1%w/v
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
BDMCA/RMP/1116 Page 4 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
61 BRU08060077P Aecoras Ointment Econazole Nitrate 10mg; Triamcinolone
Acetonide 1mg
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
62 BRU08060078P Beapen VK Granules 125mg Phenoxymethypenicillin 125mg/5ml Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
63 BRU08060079P Enoxin Tablet 500mg Ciprofloxacin 500mg Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
64 BRU08060080P Beta Eye/ Ear Drops Betamethasone Sodium Phosphate 0.1% Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
65 BRU08060081P Betagen Eye/ Ear Drops Gentamicin 0.3% w/v; Dexamethsone
Phosphate 0.1%w/v
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
66 BRU08060082P Muprin Ointment Mupirocin 2.0%w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
67 BRU08060084P Eryson Granules 400 Erythromycin ethylsuccinate equiv. to
eryhtromycin 400mg/5ml
Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
68 BRU08060085P Neomycin Cream 0.5% Neomycin sulphate 0.5%w/w Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
69 BRU08060086P Foban Hydro Cream Fusidic acid 2%; Hydrocortisone 1% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
70 BRU08060087P Foban Hydro Ointment Sodium Fusidate 2%; Hydrocortisone 1% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
71 BRU08060088P Arava Tablet 10mg Leflunomide 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
72 BRU08060089P Arava Tablet 20mg Leflunomide 20mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
73 BRU08070090P Zinnat Suspension 125mg/5ml Cefuroxime Axetil equivalent to
Cefuroxime 250mg
Glaxo Wellcome Bernard Castle, United
Kingdom
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
74 BRU08070091P Metronol 0.5%w/v Injection Metronidazole 0.5% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 06 October 2015 till 05
October 2020
POM
75 BRU08070094P Ecocort Cream Econazole Nitrate 1% w/w; Triamcinolone
Acetonide 0.1% w/w
Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
76 BRU08070095P Beprogent Ointment Betamethasone 0.05%; Gentamicin 0.1% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 5 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
77 BRU08070096P Betamox Capsule 250mg Amoxicillin Trihydrate equivalent to
Amoxicillin 250mg
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
78 BRU08070097P Aprovel Tablet 300mg Irbesartan 300mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
79 BRU08070099P Atacand Tablet 8mg Candesartan Cilexetil 8mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
80 BRU08070100P Atacand Tablet 16mg Candesartan Cilexetil 16mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
81 BRU08070101P Zovirax Suspension 200mg/5ml Acyclovir 200mg/5ml GlaxoSmithKline GmbH & Co Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
82 BRU08070102P Fortum® Injection 500mg Ceftazidime (as Pentahydrate) 500mg GlaxoSmithKline Manufacturing SPA, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
83 BRU08070103P Fortum® Injection 1g Ceftazidime (as Pentahydrate) 1g GlaxoSmithKline Manufacturing SPA, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
84 BRU08080104P Beavate Cream 0.1% Betamethasone -17- valerate equiv. to
Betamethasone 0.1%
Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
85 BRU08080106P Candazole Cream Clotrimazole 1.0% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
GSL
86 BRU08080107P Gentamicin Cream Gentamicin (as Sulphate) 0.1% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
87 BRU08080108P Beprogent Cream Betamethasone (as dipropionate) 0.05%,
Gentamicin (as sulphate 0.1%)
Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
88 BRU08080109P Unasyn Tablet 375mg Sultamicillin (as tosilate) 375mg (Ampicillin
250mg & Sulbactam 125mg)
Pfizer Global Supply Japan Inc, Japan Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
89 BRU08080110P Zovirax Dispersable Tablet 200mg Aciclovir 200mg Glaxo Wellcome, S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
90 BRU08080111P Valtrex® 500mg Tablet Valciclovir (as HCl) 500mg Glaxo Wellcome SA, Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
91 BRU08080112P Fortum® Injection 2g Ceftazidime (as pentahydrate) 2g GlaxoSmithKline Manufacturing SPA, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
92 BRU08080113P Uphalexin Capsule 250 Cephalexin (as monohydrate) 250mg Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
93 BRU08080114P Uphalexin Capsule 500 Cephalexin (as monohydrate) 500mg Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
94 BRU08080115P Vaxcel Cefuroxime 750mg
Injection
Cefuroxime (as sodium) 750mg Kotra Pharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
95 BRU08080116P Vaxcel Ceftriaxone 1g Injection Ceftriaxone (as sodium) 1g Kotra Pharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 6 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
96 BRU08080117P Axcel Fusi-Corte Cream Fusidic acid 2%, Betamethasone (as 17-
valerate) 0.1%
Kotra Pharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
97 BRU08090118P Verorab Injection Inactivated rabies virus (Wistar strain
RABIES PM/WI 38-1503-3M) produced on
VERO cell line, inactivated and purifed
Sanofi Pasteur, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
98 BRU08090119P Decocort Cream Miconazole Nitrate 2%w/w;
Hydrocortisone 1% w/w
Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
99 BRU08090120P Fobancort Ointment Sodium Fusidate 2%w/w; Betamethasone
0.05%w/w (as Dipropionate 0.064%)
Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
100 BRU08090121P Candacort Cream Clotrimazole 1.0% w/w; Hydrocortisone
1.0%w/w
Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
101 BRU08090122P Hepsera Tablet 10mg Adefovir dipivoxil 10mg GlaxosmithKline (Tianjin) Co.Ltd, China Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
102 BRU08090124P Ciprobay® 200 Infusion Solution Ciprofloxacin (as lactate) 200mg Bayer Pharma AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
103 BRU08090125P Vaxcel Ceftazidime 2g Ceftazidime (as pentahydrate) 2g Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
104 BRU08090126P Axcel Fusidic Cream Fusidic acid 2% w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
105 BRU08090127P Axcel Fusidic Ointment Sodium Fusidate 2%w/w Kotra Pharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
106 BRU08090128P Vaxcel Ceftazidime 1g Ceftazidime (as pentahydrate) 1g Kotra Pharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
107 BRU08090129P Axcel Miconazole Cream Miconazole Nitrate 2% w/w Kotra Pharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
GSL
108 BRU08090130P Ciprobay 100 Infusion Solution x
50ml
Ciprofloxacin (as lactate) 100mg Bayer Pharma AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
P
109 BRU08090132P Aroxin Capsule 250mg Amoxicillin (as trihydrate) 250mg Agila Specialties Private Limited, India;
Medreich Limited Unit-1, Bangalore, India
G & H Trading Company 06 October 2015 till 05
October 2020
POM
110 BRU08090133NPS1;
BRU08090133NPS2
Dhamol Suspension 250mg/5ml Paracetamol 250mg/5ml Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
P GSL (60ml)
111 BRU08100134P Decozol Cream Miconazole Nitrate 2%w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
GSL
112 BRU08100135P Betamox Capsule 500mg BRU08090127P Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
113 BRU08100136P Zovirax Dispersable Tablet 800mg Aciclovir 800mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
114 BRU08100137P Neo Deca Eye/Ear Drop Neomycin Sulphate 0.5%; Dexamethasone
Sodium Phosphate 0.1% w/w
CCM Pharmaceutical Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 7 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
115 BRU08100138P Uphalexin Granules 250 Cephalexin (as Monohydrate) 250mg Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
116 BRU08100139P Ciprobay® 500 Tablet Ciprofloxacin (as HCl monohydrate) 500mg Bayer Pharma AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
117 BRU08100140P Avelox Infusion Solution
0.4g/250ml
Moxifloxacin (as Hydrochloride) 400mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
118 BRU08100141P Avelox 400mg Tablet Moxifloxacin (as Hydrochloride) 400mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
119 BRU08100142P Candazole Lotion Clotrimazole 1%w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
GSL
120 BRU08100143P Allopurinol 100mg Tablet Allopurinol 100mg Drug Houses of Australia Pte Ltd G & H Trading Company 06 October 2015 till 05
October 2020
POM
121 BRU08100144PS1;
BRU08100144PS2
Bifen Suspension 100mg/5ml Ibuprofen BP 100mg/5ml Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
P
122 BRU08100145NP Dhamol Tablet 500mg Paracetamol BP 500mg Drug House of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
P (1000's)
123 BRU08100146NP Silfazine Cream Silver Sulfadiazine 1%w/w Sunward Pharmaceutical Sdn Bhd
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
P
124 BRU08100147P Difenac 50 Tablet Diclofenac Sodium BP 50mg Drug House of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
125 BRU08100148P Erythro Ethyl Granules Erythromycin (as ethyl succinate)
200mg/5ml
Drug Houses of Australia Pte. Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
126 BRU08110150P Avaxim 160U Suspension for
Injection in a prefilled Syringe
Inactivated Hepatitis A Virus (GBM strain)
160u/0.5ml
Sanofi Pasteur France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
127 BRU08110151P Aprovel 150mg Tablet Irbesartan 150mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
128 BRU08110152P Zovirax IV for Infusion 250mg Aciclovir 250mg GlaxoSmithKline Manufacturing SPA Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
129 BRU08110153P Axcel Aciclovir Cream 5%w/w Aciclovir 5%w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
130 BRU08110154P Axcel Eryhthromycin ES Tablet
400mg
Erythromycin (as ethyl succinate) 400mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
131 BRU08110155P Axcel Cephalexin-500 Capsule Cephalexin (as monohydrate) 500mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
132 BRU08110156P Axcel Eryhthromycin ES-200
Suspension
Erythromycin (as Ethylsuccinate)
200mg/5ml
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
133 BRU08110157P Soden Tablet 275mg Naproxen Sodium BP 275mg Drug House of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
134 BRU08110158NP Dhamol Suspension 120mg/5ml Paracetamol BP 120mg/5ml Drug House of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
GSL (100mL)
135 BRU08110159P Miconazole Cream 2.0%w/w Miconazole Nitrate 2.0%w/w Sunward Pharmaceutical Sdn Bhd
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
GSL
BDMCA/RMP/1116 Page 8 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
136 BRU08110160P Malarone Tablet Atovaquone 250mg, Proguanil HCl 100mg GlaxoSmithKline Inc Canada Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
137 BRU08110162P Cordarone Tablet 200mg Amiodarone HCl 200mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
138 BRU08110163P CoAprovel 150/12.5mg Film-
coated Tablet
Irbesartan 150mg, Hydrochlorothiazide
12.5mg
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
139 BRU08110164P Dhaperazine Tablet 5mg Prochlorperazine (as maleate) 5mg Drug House of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
140 BRU08110165P Betasone Cream 0.1%w/w Betamethasone (as 17-valerate) 0.1%w/w Drug Houses of Australia Pte Ltd G & H Trading Company 06 October 2015 till 05
October 2020
POM
141 BRU08120166P Ciprobay 250 Tablet Ciprofloxacin (as HCl monohydrate) 250mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
142 BRU08120167P Axcel Cephalexin 250mg Caspule Cephalexin (as Monohydrate) 250mg Kotra Pharma (M) Sdn Bhd Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
143 BRU08120168P Axcel Cephalexin 125mg
Suspension
Cephalexin (as Monohydrate) 125mg Kotra Pharma (M) Sdn Bhd Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
144 BRU08120169P Cloxacillin Capsule 250 Cloxacillin (as Sodium) 250mg Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
145 BRU08120172P Betamox Tablet 125 Amoxicillin (as trihydrate) 125mg Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
146 BRU08120173P Ventolin Respirator Solution Salbutamol (as sulphate) 0.5%w/v Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
147 BRU08120174P Dhacopan Syrup 5mg/5ml Hyoscine (as butylbromide) BP 5mg/5ml Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
148 BRU08120175P Phenexpect Syrup Per 5ml - Diphenhydramine (as HCl)
12.5mg, Ammonium Chloride 135mg
Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
149 BRU08120176P Dhabesol Cream 0.05% Clobetasol (as propionate) 0.05% w/v Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
150 BRU08120177P Beprosalic Lotion Betamethasone (as dipropionate) 0.05%,
Salicylic acid 2.0%
Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
151 BRU08120178PS1;
BRU08120178PS2
Zenmolin Syrup 2mg/5ml Salbutamol (as sulphate) BP 2mg/5ml Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
POM
152 BRU08120179P Dhasedyl Syrup Per 5ml - Promethazine (as HCl) 3.85mg,
Epherdrine (as HCl) 6.0mg, Codeine (as
phosphate) 9.0mg
Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
153 BRU08120180P Zithromax Film-coated Tablet
250mg
Azithromycin (as dihydrate) 250mg Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
154 BRU09010181P Unasyn 0.75mg IM/IV Ampicillin (as sodium) 500mg; Sulbactam
(as sodium) 250mg
Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
155 BRU09010182P Unasyn 3.0g IM/IV Ampicillin (as sodium) 2000mg; Sulbactam
(as sodium) 1000mg
Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 9 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
156 BRU09010183P Vaxcel Ceftriaxone-500mg
Injection
Ceftriaxone (as sodium) 500mg Kotra Pharma (M) Sdn Bhd Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
157 BRU09010184PS1;
BRU09010184PS2
Aroxin granules 125mg/5ml Amoxicillin (as trihydrate) 125mg/5ml Drug Houses of Australia Pte Ltd,
Singapore (S1); Medreich Limited Unit-1,
India (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
POM
158 BRU09010185P Pacofen Tablet Paracetamol 500mg; Codeine Phosphate
8mg; Caffeine anhydrous 30mg
Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
159 BRU09010186P Plavix Tablet 75mg Clopidogrel (as Hydrogen Sulphate) 75mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
160 BRU09010187P Symbicort Turbuhaler
160/4.5mcg dose
Budenoside 160mcg; Formoterol fumarate
dihydrate 4.5mcg
AstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
161 BRU09010188P CoAprovel 300/12.5mg film-
coated tablet
Irbesartan 300mg; Hydrochlorothiazide
12.5mg
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
162 BRU09010189PS1;
BRU09010189PS2
Vasican Syrup 4mg/5ml Bromhexine HCl BP 4mg/5ml Drug House of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta
Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
POM
163 BRU09010190P Cardium 30 tablet Diltiazem HCl 30mg Drug House of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
164 BRU09010191PS1 &
BRU09010191PS2
Coversyl 8mg tablet Perindopril tert-butylamine 8mg Les Laboratoires Servier Industrie, France
(S1) & Kotra Pharma (M) Sdn. Bhd,
Malaysia (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
165 BRU09010192P Dhacopan Tablet Hyoscine (as butylbromide) BP 10mg Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
166 BRU09010194P Pulmicort turbuhaler
100mcg/dose
Budenoside 100mcg AstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
167 BRU09010195P Lantus for Optipen 100iu/ml Insulin glargine 100iu/ml Sanofi Aventis Deutschland, Germany Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
168 BRU09020196P Zovirax Cream 5% Aciclovir 5%w/w Glaxo Wellcome Opertions, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
169 BRU09020197P Zovirax Eye Ointment 3% Aciclovir 3%w/w Jubilant HollisterStier General
Partnership, Canada
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
170 BRU09020198P Adenocor Injection 6mg/2ml Adenosine 6mg/2ml Famar Health Care Services Madrid S.A.U.,
Madrid, Spain
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
171 BRU09020201NPS1,
BRU09020201NPS2
Dhamol Suspension 500mg/5ml Paracetamol BP 500mg/5ml Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
P
172 BRU09020205PS1 &
BRU09020205PS2
Fedac Syrup Pseudoephedrine 30mg/5ml; Triprolidine
1.25mg/5ml
Drug House of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta
Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 10 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
173 BRU09020206P Bricanyl Turbuhaler 0.5mg/dose Terbutaline Sulphate 0.5mg/dose AstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
174 BRU09020207P Beprosalic Ointment Betamethasone (as Dipropionate 0.064%)
0.05% & Salicylic acid 3% w/w
HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05
October 2020
POM
175 BRU09020208P Beprogel Topical Solution Betamethasone (as Dipropionate 0.064%)
0.05% w/w
HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05
October 2020
POM
176 BRU09020209P Cloderm Scalp Application Clobetasol (as dipropionate) 0.05% w/v HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05
October 2020
POM
177 BRU09020210P Declovir Cream Acyclovir 5.0% w/w HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05
October 2020
POM
178 BRU09020211P Lantus 100units/ml for Optiset Insulin Glargine (HOE 901) 100units/ml Sanofi-Aventis Deutschland GmbH,
Germany
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
179 BRU09020212P Glucobay 50 Tablet Acarbose 50mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
180 BRU09030213P 3TC Tablet 150mg Lamivudine 150mg Glaxo Wellcome Operaions, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
181 BRU09030214P 3TC Oral Solution 10mg/ml Lamivudine 10mg/ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
182 BRU09030215P Dhatrin Tablet Sulphamethoxazole BP 400mg;
Trimethoprim BP 80mg
Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
183 BRU09030216P Cordarone Injection 150mg/3ml Amiodarone 150mg/3ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
184 BRU09030217PS1 &
BRU09030217PS2
Vastarel MR 35mg Tablet Trimetazidine HCl 35mg Les Laboratoires Servier Industrie, France
(S1); Kotra Pharma (M) Sdn. Bhd, Malaysia
(S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
185 BRU09030218P0.5gS &
BRU09030218P0.5gA
Tetavax Suspension for Injection
(Single dose 0.5ml)
Purified Tetanus Toxoid Sanofi Pasteur, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
186 BRU09030219P Cataflam 1.5% Oral Drops
Suspension
Diclofenac Sodium 15mg/ml Novartis Farma SpA, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 11 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
187 BRU09030220P Vaxigrip Influenza Vaccine Strain composition for Influenza Vaccine
complies with the WHO recommendations
and EU Recommendations for the
Northern Hemisphere 2015/2016 year
influenza season.
Active substance(s):
Split influenza virus, inactivated containing
antigens equivalent to the following strains
per one 0.5ml dose:
• A/California/7/2009 (H1N1)pdm09-like
strain (A/California/7/2009, NYMC X-179A)
• A/Switzerland/9715293/2013 (H3N2)-like
strain (A/South Australia/55/2014, IVR-
175)
• B/Phuket/3073/2013
Sanofi Pasteur, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
188 BRU09030221P Lignocaine HCl BP Injection 1%
(5ml)
Lidocaine HCl (Lignocaine HCl) 1%
(50mg/5ml)
Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
189 BRU09030222P Crestor 5mg Tablet Rosuvastatin Calcium 5mg IPR Pharmaceuticals Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
190 BRU09030223P Crestor 20mg Tablet Rosuvastatin Calcium 20mg IPR Pharmaceuticals Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
191 BRU09030224P Beprosone Ointment Betamethasone (as Dipropionate 0.064%)
0.05% w/w
HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 12 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
192 BRU09030225P Beprosone Cream Betamethasone (as Dipropionate 0.064%)
0.05% w/w
HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05
October 2020
POM
193 BRU09030226P Benosone-N Cream Betamethasone (as Valerate 0.12%) 0.1%
w/w; Neomycin Sulphate 0.5%w/w
HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05
October 2020
POM
194 BRU09030227P Pocin H Ear Drop Neomycin Sulphate B.P. 3,400 i.u.;
Polymyxin B Sulphate B.P.10,000 i.u;
Hydrocortisone B.P.10mg
Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
195 BRU09030228P U-Closone Cream Clobetasone butyrate 0.05%w/w HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05
October 2020
POM
196 BRU09040229P Unasyn Powder for Oral
Suspension 250mg/5ml
Sultamicillin (as tosilate) 250mg Pfizer Global Supply Japan, Inc., Japan Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
197 BRU09040230P Axcel Cefuroxime-250 Capsule Cefuroxime (as axetil) 250mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
198 BRU09040231P Knowful Capsule 400mg Piracetam 400mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
199 BRU09040232P0.5gV &
BRU09040232P0.5gS
Stamaril Vaccine Live attenuated Yellow Fever Virus 17 D-
204 strain (per 0.5ml - Not less than 1000
LD50 units of the virus)
Sanofi Pasteur, Campus Merieux & Sanofi
Pasteur, Parc Insutrial d'Incarville, France
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
200 BRU09040233P Voltaren Suppository 25mg Diclofenac (as Sodium) 25mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
201 BRU09040234P Tidact Capsule 150mg Clindamycin (as hydrochloride) 150mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
202 BRU09040235P Voltaren 75mg/3ml solution for
injection
Diclofenac Sodium 75mg/3ml Novartis Pharma Stein, ag, Switzerland;
Lek Pharmaceuticals d.d, Slovenia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
203 BRU09040236P Vaxigrip Paediatric Injection Split influenza virus*, inactivated
containing antigens equivalent to the
following strains per one 0.25ml dose:
A/California/7/2009 (H1N1)pdm09-derived
strain used NYMC X-179A 7.5mcg HA**;
A/Texas/50/2012(H3N2)-derived strain
used NYMC X-223A 7.5mcg HA**;
B/Massachusetts/02/2012 15mcg HA**
Note - * Propagated in fertilized hens’ egg
from healthy chicken flocks
** haemagglutinin
Sanofi Pasteur, Campus Merieux & Sanofi
Pasteur, Parc Insutrial d'Incarville, France
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
204 BRU09040237P Depo-Medrol Sterile Aqueous
Suspension 40mg/ml (5ml)
Methylprednisolone Acetate 200mg/5ml Pfizer Manufacturing Belgium NV,
Belgium
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 13 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
205 BRU09040238P Typhim Vi Vaccine (20 doses) Per 0.5ml - Purified Vi Capsular
Polysaccharide of Salmonella typhi (Ty2
strain)
Sanofi Pasteur, Campus Merieux & Sanofi
Pasteur, Parc Insutrial d'Incarville, France
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
206 BRU09040239P Bupivacaine Hydrochloride BP
0.5% w/v injection
Bupivacaine hydrochloride BP 0.5%w/v Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
207 BRU09040240P Rhinathiol Capsule 375mg Carbocisteine 375mg Sanofi-aventis Egypt s.a.e., Egypt Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
208 BRU09040241P Celebrex Capsule 200mg Celecoxib 200mg Pfizer Pharmaceutical LLC, Vega Baja
Puerto Rico
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
209 BRU09040242P Voltaren® SR Tablet 100mg Diclofenac sodium 100mg Novartis Farma SPA, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
210 BRU09040243P T3 Mycin Gel Clindamycin (as phosphate) 1.0% HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05
October 2020
POM
211 BRU09040244P Cloderm Cream Clobetasone (as butyrate) 0.05%w/w HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05
October 2020
POM
212 BRU09040245P Bisacodyl Suppositroies Bisacodyl (micronised) 10mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 06 October 2015 till 05
October 2020
P
213 BRU09040246P U-Closone Ointment Clobetasol (as propionate) 0.05%w/w HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
214 BRU09040247P Nexium® IV 40mg Esomeprazole (as sodium) 40mg AstraZeneca AB, Sweden G & H Trading Company 06 October 2015 till 05
October 2020
POM
215 BRU09050248NPS1;
BRU09050248NPS2
Dhactulose Syrup Lactulose 67%w/w Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 06 October 2015 till 05
October 2020
GSL (200mL) &
P(1L)
216 BRU09050249P Vastarel 20mg Tablet Trimetazidine dihydrochloride 20mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
217 BRU09050250P Coversyl Plus Tablet Perindopril tert-butylamine 4mg,
Indapamide 1.25mg
Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
218 BRU09050251P Methyldopa Tablet 250mg Methyldopa (as anhydrous) 250mg Drug House of Australia (Asia) Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
219 BRU09050252P Glucobay Tablet 100mg Acarbose 100mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
220 BRU09050253P Benosone-N Ointment Betamethasone (as valerate 0.12% w/w)
0.01%, Neomycin Sulphate 0.50%w/w
HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
221 BRU09050254P Benosone Ointment Betamethasone 0.01% w/w HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
222 BRU09050255P Mycosone Cream Miconazole nitrate 2% w/w,
Hydrocortisone ( as acetate1.12%) 1% w/w
Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
223 BRU09050256P H-Cort Ointment Hydrocortisone 1% w/w HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
224 BRU09050257P T3 Mycin Lotion Clindamycin (as phosphate) 1.0% w/v HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 14 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
225 BRU09050258P Lobesol Cream Clobetasol (as propionate) 0.05%w/w Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
226 BRU09060259P Vaxcel Cefuroxime 1.5g Injection Cefuroxime (as sodium) 1.5g Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05
October 2020
POM
227 BRU09060260P Tetavax Suspension for Injection Tetanus toxoid 40i.u/0.5ml dose Sanofi Pasteur, Lyon, Pasteur Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
228 BRU09060262P Betamox Tablet 250mg Amoxicillin (as trihydrate) 250mg Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
229 BRU09060263P Voltaren 50mg Tablets Diclofenac Sodium 50mg Novartis Pharma SPA, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
230 BRU09060264P Voltaren 12.5mg Suppositories Diclofenac Sodium 12.5mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
231 BRU09060265P Voltaren 50mg Suppositories Diclofenac Sodium 50mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
232 BRU09060266P Benosone Cream Betamethasone (as valerate) 0.1%w/w HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
233 BRU09060267NP Uphamol 250 Syrup Paracetamol 250mg/5ml Upha Pharmaceutical Mfg (M) Sdn Bhd Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
GSL (60mL)
234 BRU09060268P Betamethasone Cream Betamethasone (as valerate) 0.1%w/w Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
235 BRU09060269P Zorax Cream Aciclovir 5%w/w Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
236 BRU09060270P Nexium mups 20mg Esomeprazole (as magnesium trihydrate)
20mg
AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
237 BRU09060271P Ebutol-100 Tablet Ethambutol HCl 100mg Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
238 BRU09060272P Neurontin Capsule 300mg Gabapentin 300mg Pfizer Pharmaceuticals LLC, Vega Baja
Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
239 BRU09060274P Relenza® Rotadisks 5mg Zanamivir 5mg GlaxoSmithKline Australia Pty Ltd,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
240 BRU09070275P Unasyn IM/IV 1.5g Sulbactam (as sodium 546.4mg) 500mg &
Ampicillin (as sodium 1084.6mg) 1000mg
Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
241 BRU09070277P Avaxim 80u Paediatric Inactivated Hepatitis A virus (GBM strain)
80u per 0.5ml
Sanofi Pasteur, Lyon, Pasteur Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
242 BRU09070278P Fedac Tablet Pseudoephedrine HCl 60mg; Triprolidine
HCl 2.5mg
Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
243 BRU09070279P Salazopyrin® EN-Tabs Sulfasalazine 500mg Kemwell AB, Bjorkgatan 30, SE-751 82
Uppsala, Sweden.
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
244 BRU09070280P Zyloric® 100mg Tablet Allopurinol 100mg GlaxoSmithKline Australia Pty Ltd.,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 15 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
245 BRU09070281P Orrepaste 0.1%w/w Triamcinolone Acetate 0.1%w/w HOE Pharmaceuticals Sdn Bhd, Malaysia. G & H Trading Company 06 October 2015 till 05
October 2020
POM
246 BRU09070282P Hydrocortisone Cream 1% w/w Hydrocortisone acetate 1%w/w Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
247 BRU09070283P XanaxTM 0.25mg Tablet Alprazolam 0.25mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
248 BRU09070284P Nexium mups 40mg Esomeprazole (as magnesium trihydrate)
40mg
AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
249 BRU09070286P XanaxTM 0.5mg Tablet Alprazolam 0.5mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
250 BRU09070287P Zolterol S/R Tablet 100mg Diclofenac Sodium 100mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
251 BRU09070288P Diane-35 Tablet Cyproterone acetate 2mg; Ethinylestradiol
0.035mg
Bayer Weimar GmbH und Co. KG,
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
252 BRU09070289P Amaryl 3mg Tablet Glimepiride Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
253 BRU09070290P Diamicron Tablet 80mg Gliclazide 80mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
254 BRU09070291NP Dulcolax Suppository 10mg Bisacodyl 10mg Istituto De Angeli S.r.l., Italy Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
255 BRU09070292P Clotrimazole Cream 1% w/w Clotrimazole 1% w/w Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
GSL
256 BRU09070293P Mucosolvon® 30mg Tablet Ambroxol hydrochloride 30mg PT Boehringer Ingelheim Indonesia,
Bogor, Indonesia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
257 BRU09080294P Euvax B Vaccine, Recombinant Purified Hepatitis B surface antigen
(HBsAg) 200µg/10ml
LG Life Science Ltd, Korea Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
258 BRU09080295P Pulmicort® Turbuhaler®
200mcg/dose
Budesonide (micronised) Ph Eur
200mcg/dose
AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
259 BRU09080296P Epilim Intravenous 400mg/ vial Sodium Valproate 400mg Gruppo Lepetit S.R.L. Italy Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
260 BRU09080297P Tritace® 5mg Tablet Ramipril 5mg Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
261 BRU09080298P Ebutol-400 Tablet Ethambutol HCl 400mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
262 BRU09080299P Beafemic Suspension 50mg/5ml Mefenamic acid 50mg/5mL Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
263 BRU09080300PS1 &
BRU09080300PS2
Diamicron MR Tablet 30mg Gliclazide 30mg Les Laboratoires Servier Industrie, France
(S1) & Kotra Pharma (M) Sdn. Bhd,
Malaysia (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
264 BRU09080301P Deltasolone Tablet 5mg Prednisolone 5mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
265 BRU09080302P Sunprox-275 Tablet Naproxen Sodium 275mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
266 BRU09080303P Spiriva® 18mcg Tiotropium 18mcg (as Bromide
Monohydrate 22.5mcg)
Boehringer Ingelheim Pharma GmbH &
Co. KG, Germany
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 16 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
267 BRU09080304P Prednisolone 1mg Tablet Prednisolone 1mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
268 BRU09080305NP Poro Suppository 250mg Paracetamol 250mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United Sdn Bhd 06 October 2015 till 05
October 2020
GSL P (10 x 10's)
269 BRU09080307P Buscopan Tablet 10mg Hyoscine-N-butylbromide Delpharm Reims S.A.S,France Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
270 BRU09080308P Atrovent N 20µg/ puff Metered
Dose Inhaler
Ipratropium bromide anyhdrous 20mcg (as
monohydrate 21mcg)
Boehringer Ingelheim Pharma GmbH &
Co. KG, Germany
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
271 BRU09080309P Fenagesic Capsule 250mg Mefenamic acid 250mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
272 BRU09080311P Carinox Capsule Pseudoephedrine sulphate 120mg;
Loratadine 5mg
Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
273 BRU09090312P Euvax B Vaccine, Recombinant
(100µg/5ml)
Purified Hepatitis B surface antigen
(HBsAg) 100µg/5ml
LG Life Science Ltd, Korea Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
274 BRU09090313P Typhim Vi Single Dose Purified Vi Capsular polysaccharides of
Salmonella typhi (Ty2 strain) 25µg/0.5ml
Sanofi Pasteur, Campus Merieux, France
& Sanofi Pasteur, Parc industrial
d'Incarville, France
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
275 BRU09090314P Crestor 10mg Tablet Rosuvastatin Calcium 10mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
276 BRU09090315P Amaryl 2mg Tablet Glimepride 2mg Sanofi-aventis S.p.A, Italy Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
277 BRU09090316P Lamisil® 250mg Tablet Terbinafine HCl 250mg Novartis Pharmaceuticals UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
278 BRU09090317P Voltaren® SR 75 Tablet Diclofenac Sodium 75mg Novartis Farma S.p.A, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
279 BRU09090318P Cataflam® 50 Tablet Diclofenac Potassium 50mg Novartis Urunleri, Istanbul Turkey Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
280 BRU09090320P Zyrtec-D Tablet Cetirizine Dihydrochloride 5mg;
Pseudoephedrine HCl 120mg
UCB Farchim SA, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
281 BRU09090321P Mono-Tildiem SR 200mg Capsule Diltiazem HCl 200mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
282 BRU09090322P Actilyse® Treatment-Set Recombinant Human Tissue-type
Plasminogen Activator (alteplase) 50mg
Boehringer Ingelheim Pharma GmbH &
Co. KG, Germany
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
283 BRU09090324P Trenlin SR Tablet 400mg Pentoxifylline 400mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
284 BRU09090325NP Paratab Tablet 500mg Paracetamol 500mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
P (100x10's)
285 BRU09090326P Micardis 40mg Tablet Telmisartan 40mg Boehringer Ingelheim Pharma GmbH &
Co. KG, Germany
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
286 BRU09090327P Metalyse Injection 10,000units Tenecteplase 10,000units (50mg) Boehringer Ingelheim Pharma GmbH &
Co. KG, Germany
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
287 BRU09090328NP Hemo RidTM Tablet Miconised Diosmin 450mg; Micronised
Hesperidine 50mg
Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
GSL
288 BRU09090329P Exforge Tablet 5mg/80mg Amlodipine 5mg (as besylate 6.94mg);
Valsartan 80mg
Novartis Farmaceutica SA , Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 17 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
289 BRU09100330P Imovax Polio Vaccine Inactivated Polio Virus: Type 1
(40DU/0.5mL), Type 2 (80DU/0.5mL), Type
3 32DU/0.5mL)
Sanofi Pasteur, Lyon, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
290 BRU09100331P Cloderm Ointment Clobetasol (as propionate) 0.05%w/w HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
291 BRU09100332P H-Cort Cream Hydrocortisone 1%w/w HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
292 BRU09100334P Prelone Syrup 3mg/5ml Prednisolone Sunward Pharmaceutical Sdn Bhd,
Malaysia.
G & H Trading Company 06 October 2015 till 05
October 2020
POM
293 BRU09100335P Ventolin Nebules 2.5mg/2.5ml Salbutamol Sulphate 2.5mg/2.5ml GlaxoSmithKline Australia Pty Ltd,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
294 BRU09100336NP Sunquadin Lozenges Dequalinium Chloride Sunward Pharmaceutical Sdn Bhd,
Malaysia.
G & H Trading Company 06 October 2015 till 05
October 2020
POM
295 BRU09100337P Zoloft Tablet 50mg Sertraline (as hydrochloride) 50mg Pfizer Australia Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
296 BRU09100338NP Uphamol 250 Suspension (Fruity) Paracetamol 250mg/5mL Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
GSL (60mL and
100mL)
297 BRU09100339P XanaxTM 1mg Tablet Alprazolam 1mg Sanico NV Industriezone, Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
298 BRU09100340P Pontalon Capsule Mefenamic acid 250mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
299 BRU09100342NP Maalox Plus Tablet Aluminium hydroxide dried gel 200mg,
Magnesium hydroxide 200mg, Simethicone
26.25mg (correspond to 25mg of
polydiemthylsiloxane)
Sanofi-Aventis S.p.A., Italy Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
GSL
300 BRU09100343P Neurontin 600mg Tablet Gabapentin Pfizer Pharmaceutical LLC, Puerto Rico,
USA
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
301 BRU09100345P LipitorTM 40mg Tablet Atorvastatin (as Calcium 43.38mg-
crystalline) 40mg
Pfizer pharmaceuticals LLC, vega baja
Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
302 BRU09100346NP Suniton Tablet Paracetamol 450mg, Orphenadrine Citrate
35mg
Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
303 BRU09100347P SCMC Plus Syrup 250mg/5mL S-carboxy-methylcysteine 250mg/5mL
(Carbocisteine)
Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
304 BRU09100348NP Glyprin Dispersible Tablet Aspirin 100mg, Glycine 45mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
305 BRU09100349P Actonel® 35mg Tablet Risedronate sodium 35mg (equivalent to
32.5mg risedronic acid)
Norwich Pharmaceuticals Inc., USA G & H Trading Company 06 October 2015 till 05
October 2020
POM
306 BRU09110350P Lantus® Solostar® 100units/ml Insulin Glargine (HOE 901) Sanofi-Aventis Deutschland GmbH,
Germany
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 18 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
307 BRU09110353P Tenoretic Tablet Atenolol 100mg; Chlorthalidone 25mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
308 BRU09110354P LipitorTM 10mg Tablet Atorvastatin (as calcium 10.85mg -
crystalline) 10mg
Pfizer pharmaceutical LLC, vega baja
Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
309 BRU09110355P RotarixTM Vaccine 1 reconstituted dose (1ml) contains live
attenuated human rotavirus RIX4414 strain
not less than 106.0
CCID50
GlaxoSmithKline Biologicals SA, Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
310 BRU09110357P Atrovent Unit Dose Vial (UDV)
250mcg/2ml
Ipratropium bromide anhydrous 250mcg
(as monohydrate 261mcg)
Laboratoire Unither, France Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
311 BRU09110358P Micardis Plus 40mg/12.5mg
Tablet
Telmisartan 40mg; Hydrochlorothiazide
12.5mg
Boehringer Ingelheim Pharma GmbH,
Germany
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
312 BRU09110359P Allavin Expectorant Diphenhydramine HCl 14mg/5ml;
Ammonium Chloride 135mg/5ml
Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
313 BRU09110361NP Uphamol 500 Tablet Paracetamol 500mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
P (100 x 10's)
314 BRU09110362P Carin Tablet 10mg Loratadine 10mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
P
315 BRU09110363P Rhinathiol 2% for Children Syrup Carbocisteine 100mg/5ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
316 BRU09120365P Tienam IV Injection 500mg Imipenem (as monohydrate) 500mg &
Cilastatin Sodium 500mg
Merck Sharp & Dohme Corp, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
317 BRU09120366PS1 &
BRU09120366PS2
Opvero (Oral trivalent
poliomyelitis vaccine)
Each 0.1mL (2 drops) contains: Type1
poliomyelitis virus (LS-c2ab strain) ≥ 106.0
CCID50; Type2 poliomyelitis virus
(p712,Ch,2ab strain) ≥ 105.0 CCID50; Type3
poliomyelitis virus (Leon 12a1b strain) ≥
105.8 CCID50;
Sanofi Pasteur, Campus Merieux, France
(S1); Sanofi Pasteur, Parc industrial
d'Incarville, France (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
318 BRU09120367P Dilantin 100mg Capsule Phenytoin Sodium Pfizer Australia Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
319 BRU09120368P Modalim 100mg Tablet Ciprofibrate 100mg Sanofi Winthrop Limited, UK Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
320 BRU09120369P Oral Aid Lotion Lignocaine HCl 2.5%; Triamcinolone
Acetonide 0.1%; Chlorhexidine HCl 0.5%
Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
321 BRU09120370P Primperan 10mg/2ml Injection Metoclopramide HCl 10mg/2ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
322 BRU09120371P Tritace 10mg Tablet Ramipril 10mg Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
323 BRU09120372P Mono-Tildiem SR 300mg Diltiazem HCl 300mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 19 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
324 BRU09120373P Micardis® 80mg Tablet Telmisartan 80mg Boehringer Ingelheim Pharma GmbH,
Germany
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
325 BRU09120374P Micardis Plus 80mg/12.5mg
Tablet
Telmisartan 80mg; Hydrochlorothiazide
12.5mg
Boehringer Ingelheim Pharma GmbH,
Germany
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
326 BRU09120375P Natrilix® SR Tablet Indapamide 1.5mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
327 BRU09120376NP Poro Suppository 125mg Paracetamol 125mg Y.S.P Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 06 October 2015 till 05
October 2020
GSL (1 x 5's); P(10
x 10's)
328 BRU09120377P Vascor 40mg Film-coated Tablet Simvastatin 40mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
329 BRU09120379P Covastin Film-coated Tablet 10mg Simvastatin 10mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
330 BRU09120381P Co-Diovan 80/12.5 Film-coated
Tablets
Valsartan 80mg; Hydrochlorothiazide
12.5mg
Novartis Farma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
331 BRU09120382P Rhinathiol® Promethazine syrup Carbocisteine 100mg/5ml; Promethazine
HCl 2.5mg/5ml
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
332 BRU09120383P Methotrexate Injection BP
1000mg/10ml
Methotrexate 1000mg/10ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
333 BRU10010384P Zyloric 300mg Tablet Allopurinol 300mg GlaxoSmithKline Australia Pty Ltd.
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
334 BRU10010385PS1 &
BRU10010385PS2
Coversyl 4mg Tablet Perindopril tert-butylamine 4mg Les Laboratoires Servier Industrie, France
(S1) & Kotra Pharma (M) Sdn Bhd.,
Malaysia
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
335 BRU10010386P Atrovent Unit Dose Vial
0.5mg/2ml
Ipratropium bromide (as monohydrate)
500mcg/2ml
Laboratoires Unither, Amiens cedex,
France
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
336 BRU10010387P Aspirin EC Tablet 100mg Acetylsalicylic acid 100mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
337 BRU10010388P Exforge Tablet 5mg/160mg Amlodipine 5mg (as besylate 6.94mg);
Valsartan 160mg
Novartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
338 BRU10010389P Taxotere 80mg/2ml Vial Docetaxel anhydrous (as trihydrate) 80mg Sanofi-Aventis Deutschland GmbH,
Germany
MediPharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
339 BRU10010390NPS1,
BRU10010390NPS2 &
BRU10010390NPS3
Dulcolax 5mg Tablet Bisacodyl 5mg Boehringer Ingelheim Korea (S1);
Boehringer Ingelheim France (S2);
Delpharm Reims S.A.S., France (S3)
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
340 BRU10010391P Diovan 80mg Tablet Valsartan 80mg Novartis Farma S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
341 BRU10010392P Co-Diovan 160/25 Film-coated
Tablets
Valsartan 160mg; Hydrochlorothiazide
25mg
Novartis Farma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
342 BRU10010395P Isoket Spray Isosrobide Dinitrate 1.25mg per actuation Schwarz Pharma Ltd, Ireland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
343 BRU10010396P Beafemic Capsule 250mg Mefenamic acid 250mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
344 BRU10010397P Metformin Tablet 500mg Metformin HCl 500mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 20 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
345 BRU10010399P Seretide Accuhaler 50/500 Salmeterol 50mcg (as Xinafoate),
Fluticasone propionate 500mcg
GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
346 BRU10010401P VentolinTM Tablet 4mg Salbutamol 4mg (as Sulphate 4.8mg) Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
347 BRU10020402P Solu-Medrol Sterile Powder
500mg
Methyprednisolone (as Sodium succinate)
500mg
Pfizer Manufacturing Belgium N.V.,
Belgium
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
348 BRU10020404P Imdex 60mg CR Tablet Isosorbide-5-Mononitrate 60mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
349 BRU10020405P Vascor Tablet 20mg Simvastatin Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
350 BRU10020406P Combivent Unit Dose Vial 500mcg Per 2.5ml - Ipratropium bromide (as
monohydrate 522mcg) 500mcg;
Salbutamol 2.5mg (as sulphate 3.013mg)
Laboratorie UNITHER , France Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
351 BRU10020408P Guadex Linctus Per 5ml - Dextromethorphan
Hydrobromide 15mg; Guaifenesin 100mg
Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05
October 2020
POM
352 BRU10020409P Diovan® 160mg Tablet Valsartan 160mg Novartis Farma S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
353 BRU10020410P Etoposide 100mg/5ml Injection Etoposide 100mg/5ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
354 BRU10020411P Decondine Syrup Per 5ml - Triprolidine HCl 1.25mg;
Pseudoephedrine HCl 30mg
Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
355 BRU10020412P Seretide Accuhaler 50/100 Salmeterol 50mcg (as Xinafoate),
Fluticasone propionate 100mcg
GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
356 BRU10020413P Optizoline eye drops Tetrahydrozoline HCl 0.05%w/w Xepa-Soul Pattinson (Malaysia) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
357 BRU10020414P Sunadine Syrup Loratadine 5mg/5ml Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
P
358 BRU10020415P Adalat LA 30 Tablet Nifedipine 30mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
359 BRU10020416P Lipitor 20mg Tablet Atorvastatin (Calcium) 20mg Pfizer Pharmaceutical LLC, Puerto Rico Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
360 BRU10020417P Isosorbide Dinitrate Tablet 10mg Isosorbide Dinitrate BP 10mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
POM
361 BRU10020418P Nitroderm TTS® 5 (5mg/24hr) Glyceryl Trinitrate/ nitroglycerin 25mg Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
362 BRU10020419P Adalat® LA 20 Tablet Nifedipine 20mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
363 BRU10020421P Xatral XL Tablet 10mg Alfuzosin HCl 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
364 BRU10030423P Rhinathiol 5% Adult Expectorant
Syrup
Carbocisteine 5g/100ml Unither Liquid Manufacturing, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
P
BDMCA/RMP/1116 Page 21 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
365 BRU10030425NP Dulcolax Suppository 5mg Bisacodyl 5mg Instituto De Angeli S.R.L., Italy Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
366 BRU10030426P Aromasin 25mg Tablet Exemestane 25mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
367 BRU10030427P Omesec Capsule 20mg Omeprazole 20mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
K-Seri Pharma Sdn Bhd 06 October 2015 till 05
October 2020
POM
368 BRU10030428P Adalat LA 60 Tablet Nifedipine 60mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
369 BRU10030429P Polarax 2mg Tablet Dexchlorpheniramine maleate 2mg Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
370 BRU10030430P Pharmorubicin CS 50mg/25ml Epirubicin HCl 50mg/2ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
371 BRU10030432P Cisplatin Injection 50mg/50ml Cisplatin USP 50mg/50ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
372 BRU10030433P Terramycin Ophthalmic Ointment Per g - Oxytetracycline 5mg; Polymyxin B
10,000units
PT Pfizer (Indonesia), Indonesia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
373 BRU10030435P Adriamycin CS Injection
50mg/25ml
Doxorubicin HCl 50mg/25ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
374 BRU10030436NP Maalox® Plus Suspension Per 5ml - Aluminium hydroxide 225mg;
Magnesium hydroxide 200mg; Simethicone
USP 25mg
Sanofi Aventis S.p.A., Italy Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
GSL
375 BRU10030437P Seretide Evohaler 50 Salmeterol Xinafoate (micronised) 25mcg;
Fluticasone Propionate (micronised) 50mcg
Glaxo Wellcome Production, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
376 BRU10030438P Miacalcic® Ampoules 100IU Calcitonin salmon, synthetic 100IU Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
377 BRU10030439P Prozine Syrup 5mg/5ml Promethazine HCl Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
378 BRU10030440P Olmetec Tablet 20mg Olmesartan Medoxomil 20mg Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
379 BRU10040441P Diflucan Capsule 150mg Fluconazole 150mg Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
380 BRU10040442P Diflucan Capsule 100mg Fluconazole 100mg Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
381 BRU10040443P Diflucan Capsule 50mg Fluconazole 50mg Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
382 BRU10040445P Seretide Accuhaler 50/250 Salmeterol (as Xinafoate) 50mcg;
Fluticasone Propionate 250mcg
GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
383 BRU10040447P Ventolin Tablet 2mg Salbutamol (as sulphate) 2mg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
384 BRU10040448P Zyrtec® Film-coated Tablet 10mg Cetrizine HCl 10mg UCB Farchim S.A., Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
385 BRU10040450P Seretide 125 Evohaler Salmeterol (as Xinafoate, micronised)
25mcg; Fluticasone Propionate 125mcg
Glaxo Wellcome Production, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 22 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
386 BRU10040452P Nitroderm TTS® 10 Glyceral trinitrate/ nitroglycerin 50mg
(10mg/24hr)
Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
387 BRU10040453P Temodal Capsule 20mg Temozolomide 20mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
388 BRU10040454NP ColimixTM Syrup Per 5ml - Simethicone (activated
dimethicone) 50mg; dicylcomine HCl 5mg
Xepa-Soul Pattinson (Malaysia) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
GSL
389 BRU10040455P Xepanicol® Eye Drops 0.5% Chloramphenicol 0.5% Xepa-Soul Pattinson (Malaysia) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
390 BRU10040457P Co-Diovan 160/12.5mg Tablets Valsartan HCl 160mg; Hydrochlorothiazide
12.5mg
Novartis Pharma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
391 BRU10040458P Zyrtec® Oral Drops 10mg/ml Cetrizine diHCl 10mg/ml Aesica Pharmaceuticals S.r.L., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
392 BRU10040459P Atenolol 50mg Tablet Atenolol 50mg Sunward Pharmaceutical Pte Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
393 BRU10040460P Bromhexine Tablet 8mg Bromhexine HCl 8mg Sunward Pharmaceutical Pte Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
394 BRU10040461P Cytarabine® Injection 1000mg in
10ml
Cytarabine 1000mg/10ml Pfizer (Perth) Pty, Ltd., Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
395 BRU10040462P Exelon Oral Solution 2mg/ml Rivastigmine 2mg/ml (as hydrogen
tartrate)
Novartis Pharma S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
396 BRU10050463P Nebido 1000mg/4ml, Solution for
Injection
Testosterone undecanoate 250mg(equiv.
to testosterone 157.9mg)
Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
397 BRU10050464NP Mucosolvon Liquid 30mg/5ml Ambroxol Hydrochloride 30mg/5ml Boehringer Ingelheim, France Hongkiat Trading & Company 06 October 2015 till 05
October 2020
P
398 BRU10050466NP Uphamol Suspension 250
(Orange)
Paracetamol 250mg/5ml Upha Pharmaceuticals Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2010 till 05
October 2015 (PL extended
to 26 March 2017)
GSL (60mL); P
(3.8L)
399 BRU10050467P Taxotere® 20mg/0.5ml
Concentrate and solvent for
solution for Infusion
Docetaxel 20mg/0.5ml (as trihydrate) Sanofi-Aventis Deutschland GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
400 BRU10050468P Remicade Powder for
Concentrate for Solution for
Infusion 100mg/vial
Infliximab (cA2 IgG) 100mg/vial Patheon Italia S.p.A, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
401 BRU10050470P Pristinex Cream 2% w/w Ketoconazole 2%w/w Xepa-Soul Pattinson (Malaysia) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
402 BRU10050471P Zyvox Infusion Bag 600mg/300ml Linezolid 600mg/300ml Fresenius Kabi Norge As, Norway Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
403 BRU10050472P Panadeine Tablet Codeine Phosphate 8mg, Paracetamol
500mg
Sanofi India Limited, India Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
404 BRU10050473P Cervagem Pessary 1mg Gemeprost 1mg Ono Pharmaceutical Co Ltd, Japan Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
405 BRU10050474P Provinace Tablet 4mg Perindopril erbumine 4mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 23 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
406 BRU10050475P Zyrtec® Oral Solution 1mg/ml Cetrizine diHCl 1mg/ml (0.1%) Aesica Pharmaceuticals S.r.L., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
407 BRU10050476P Dalacin C Capsule 150mg Clindamycin (as hydrochloride) 150mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
408 BRU10050477P Clozaril® Tablet 100mg Clozapine 100mg Novartis Saglik Gida ve Tarim Urunleri
San. Ve Tic.A.S., Istanbul, Turkey
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
409 BRU10050478P Telfast® 180mg Tablet Fexofenadine HCl 180mg PT Aventis Pharma, Indonesia Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
410 BRU10050479P Cozaar 100mg film-coated tablet Losartan Potassium 100mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
411 BRU10050480P Dalacin T Topical Solution 1% Clindamycin (as phosphate) 10mg/Ml Zoetis P&U LLC, Kalamazoo, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
412 BRU10060484P Miacalcic 50IU Ampoules Salmon calcitonin, synthetic 50IU/1ml Novartis Pharma Stein AG, Switzerland. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
413 BRU10060485P Allersin-F Tablet 4mg Chlorpheniramine maleate 4mg Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
P
414 BRU10060486P Daonil Tablet 5mg Glibenclamide 5mg PT Aventis Pharma, Indonesia Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
415 BRU10060487P Asmol Syrup Salbutamol 2mg/5ml (as Sulphate 2.4mg) Sunward Pharmaceutical Sdn. Bhd.,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
416 BRU10060488P Lescol capsule 40mg Fluvastatin (as the sodium salt) 40mg Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
417 BRU10060489P Lescol XL Tablet 80mg Fluvastatin (as the sodium salt) 80mg Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
418 BRU10060490P Lescol capsule 20mg Fluvastatin (as the sodium salt) 20mg Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
419 BRU10060491P Diatrol Tablet 2mg Loperamide HCl 2mg Sunward Pharmaceutical Sdn. Bhd.,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
420 BRU10060492P Clozaril® 25mg Tablet Clozapine 25mg Novartis Saglik Gida ve Tarim Urunleri
San. Ve Tic.A.S., Istanbul, Turkey
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
421 BRU10060493P Olmetec 10mg Tablet Olmesartan medoxomil 10mg Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
422 BRU10060494P Norvasc Tablet 5mg Amlodipine Besylate 5mg Pfizer Australia Pty. Ltd., NSW Australia. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
423 BRU10060495P Epilim 200mg/5ml Syrup Sodium Valproate 200mg Unither Liquid Manufacturing, France. Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
424 BRU10060496P Stilnox 10mg film-coated tablet Zolpidem tartrate 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
425 BRU10060497P Hyosun syrup Hyoscine-N-Butylbromide (Scopolamine
Butylbromide) 5mg/5ml
Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
426 BRU10060498P Nalol Tablet 40mg Propranalol HCl 40mg Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 24 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
427 BRU10060499P Exelon capsule 1.5mg Rivastigmine 1.5mg (as hydrogen tartrate
2.4mg)
Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
428 BRU10060500P Syntocinon 10IU solution for
injection
Synthetic Oxytocin 10IU/ml Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
429 BRU10060501P Exelon capsule 6mg Rivastigmine 6mg (as hydrogen tartrate
9.6mg)
Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
430 BRU10060502P Zyvox film-coated tablet 600mg Linezolid 600mg Pfizer Pharmaceuticals LLC, Puerto Rico,
United States
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
431 BRU10060504P Sifrol tablet 0.125mg Pramipexole 0.088mg (eqv. to Pramipexole
dihydrochloride monohydrate 0.125mg)
Boehringer Ingelheim Pharma GmbH &
Co. Germany
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
432 BRU10060505P Myfortic Gastro-Resistant tablet
180mg
Mycophenolic Acid 180mg (as Sodium Salt
192.4mg)
Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
433 BRU10070506P Phensedyl Dry Cough Linctus Per 5ml - Promethazine HCl 3.6mg;
Pholcodine 4mg; Ephedrine HCl 7.2mg
Sanofi-Aventis Pakistan Limited, Pakistan Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
434 BRU10070507P Miacalcic® Nasal Spray 200IU Salmon calcitonin, synthetic 200IU Delpharm Huningue S.A.S., Switzerland. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
435 BRU10070508P Norvasc Tablet 10mg Amlodipine Besylate 10mg Pfizer Australia Pty. Ltd., NSW Australia. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
436 BRU10070509P Pseudorine Tablet 60mg Pseudoephedrine HCl 60mg Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
P
437 BRU10070510P Laxodyl Tablet 5mg Bisacodyl 5mg Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
GSL (6's) & P (60's)
438 BRU10070511P Decondine Tablet Tripolidine HCl 2.5mg; Pseudoephedrine
HCl 60mg
Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
439 BRU10070512P Metoclopramide Tablet 10mg Metoclopramide HCl 10mg Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2015 till 05
October 2020
POM
440 BRU10070513P Desferal 500mg Desferrioxamine Methane Sulphonate Novartis Pharma Stein AG, Switzerland;
Wasserburger Arzneimittelwerk GmbH,
Wasserburg
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
441 BRU10070514P Anafranil® 25mg Tablet Clomipramine HCl 25mg Novartis Farma SpA., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
442 BRU10070515P Zaricort Cream Miconazole Nitrate 2%w/w;
Hydrocortisone 1%w/w
Xepa-Soul Pattinson (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
443 BRU10070516P Singulair® Tablet 10mg Montelukast (as sodium) 10mg Merck Sharp & Dohme Ltd., United
Kingdom
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
444 BRU10070517P Singulair® Chewable Tablet 5mg Montelukast (as sodium) 5mg Merck Sharp & Dohme Ltd., United
Kingdom
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
445 BRU10070518P Lanoxin Injection 0.5mg/2ml Digoxin 0.5mg/2ml GlaxoSmithKline Manufacturing SpA., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
446 BRU10070519P Zithromax IV 500mg Azithromycin (as dehydrate) 500mg Pharmacia & Upjohn Company,
Kalamazoo, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 25 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
447 BRU10070520P Exelon® 4.5mg Capsule Rivastigmine 4.5mg (as Rivastigmine
hydrogen tartrate 7.2mg)
Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
448 BRU10070521P Epilim Chrono 500mg Scored Film-
coated Tablet
Sodium valproate 500mg (Sodium
valproate 333mg & Valproic acid 145mg)
Sanofi Winthrop Industries, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
449 BRU10070522P Ritalin® Modified Release Capsule
30mg
Methylphenidate HCl 30mg Recro Gainsville LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
450 BRU10080523P Exforge 10/160mg FC Tablet Amlodipine 10mg (as besylate); Valsartan
160mg
Novartis Farmaceutica SA, Barbera del
Valles, (Barcelona) Spain
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
451 BRU10080524P Zometa Concentrate for Solution
for Infusion 4mg/5ml
Zoledronic Acid (anhydrous) 4mg
corresponding to zoledronic acid
monohydrate 4.264mg
Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
452 BRU10080528P Imovane 7.5mg Tablet Zopiclone 7.5mg Aventis International France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
453 BRU10080529P Nasacort Aqueous Nasal Spary Triamcinolone Acetonide 55mcg/actuation Aventis Pharma UK Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
454 BRU10080530P Ritalin 10mg Tablet Methylphenidate Hydrochloride 10mg Novartis Pharmaceuticals SA Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
455 BRU10080531P Proctosedyl Suppositories Chinchocaine 5mg; Framycetin sulphate
10mg; Hydrocortisone 5mg; Aesculin 10mg
PT Aventis Pharma, Indonesia Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
456 BRU10080532P Prostin VR Paediatric® Sterile
Solution 500mcg
Alprostadil 500mcg/ml Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
457 BRU10080533P Lioresal 10mg Tablet Baclofen 10mg Novartis Farma SPA Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
458 BRU10080534PS1;
BRU10080534PS2
Fosamax 70mg Tablet Alendronate sodium 91.37 (as trihydrate)
equivalent to alendronic acid 70mg
Merck Sharp & Dohme (Italia) SpA, Italy
(S1); Aesica Pharmaceuticals GmbH,
Germany (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
459 BRU10080535PS1;
BRU10080535PS2
Telfast-D Extended Release
Tablet
Fexofenadine hydrochloride 60mg ;
Pseudoephedrine HCl 120mg
Sanofi-Aventis US LLC USA (S1); Sanofi
Winthrop Industrie, France (S2)
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
460 BRU10080536P Claforan 1.0g Injection Cefotaxime 1g (as Sodium 1.048g) Patheon UK Ltd, England, UK Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
461 BRU10080538P Immucyst ® BCG
Immnuotherapeutic 81mg/vial
Bacillus Calmette-Guerin 81mg Sanofi Pasteur Limited, Toronto, Ontario,
Canada
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
462 BRU10090539P Singulair Tablet 4mg Montelukast 4mg (as sodium 4.16mg) Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
463 BRU10090540P Cozaar Tablet 50mg Losartan Potassium 50mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
464 BRU10090541P Lanoxin Paediatric/ Geriatric Elixir Digoxin 0.05mg/mL Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/1116 Page 26 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
465 BRU10090542PS1;
BRU10090542PS2
Singulair Oral Granules 4mg Montelukast Sodium (free acid equivalent)
4mg
Merck Sharp & Dohme Corp. USA (S1);
DSM Pharmaceuticals, Inc., USA
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
466 BRU10090543P Frisium® 10mg Tablet Clobazam 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
467 BRU10090544P Vytorin Tablet 10mg/20mg Ezetimibe 10mg: Simvastatin 20mg Merck Sharp & Dohme (Italia) SpA, Italy &
MSD International GmbH (Singapore
Branch), Singapore
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
468 BRU10090545P Zocor 10mg Tablet Simvastatin 10mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
469 BRU10090546P Zocor 40mg Tablet Simvastatin 40mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
470 BRU10090547P Bonefos 800mg Tablet Disodium Clodronate Tetrahydrate 1000mg
equivalent to Disodium Clodronate
(anhydrous) 800mg
Bayer Oy, Finland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
471 BRU10090548P Suprefact® 1mg/ml Injection
Solution
Buserelin 1.00mg/ml (as acetate 1.05mg) Aventis-Pharma Deutshland GmbH,
Germany
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
472 BRU10090549P Livial 2.5mg Tablet Tibolone 2.5mg N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
473 BRU10090550P Ritalin LA 20mg Capsules Methylphenidate Hydrochloride 20mg Recro Gainsville LLC, USA. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
474 BRU10090551P Zoladex LA Depot Injection
10.8mg
Goserelin Acetate equivalent to Goserelin
10.8mg
AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
475 BRU10090552P Harnal OCAS 400mcg Film-coated
tablet
Tamsulosin (as hydrochloride 400mcg)
367mcg
Astellas Pharma Europe BV, The
Netherlands
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
476 BRU10090553P ActifedTM Expectorant (100ml) Triprolidine hydrochloride 1.25mg/5mL;
Pseudoephedrine hydrochloride
30mg/5mL; Guaiphenesin 100mg/5mL
Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
P
477 BRU10090554P Proscar® Tablets 5mg Finasteride 5mg MSD International GmbH (Puerto Rico
Branch) LLC., Puerto Rico, USA.
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
478 BRU10090555PS1;
BRU10090555PS2
Elomet Cream 0.1% Mometasone Furoate 0.1% Schering-Plough Labo N.V., Belgium (S1);
PT. Merck Sharp Dohme Pharma Tbk,
Indonesia (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
479 BRU10100556P Myfortic Gastro-Resistant tablet
360mg
Mycophenolic (as sodium) acid 360mg Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
480 BRU10100557P Intron A* 30 million IU Solution
for Injection, Multidose Pen
Interferon Alfa-2b 30 million IU Schering-Plough (Brinny) Co., Ireland Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
481 BRU10100559P Exelon® Capsule 3mg Rivastigmine (as hydrogen tartrate) 3mg Novartis Farmaceutica S.A. Spain Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
482 BRU10100560P Arcoxia 60mg Film-coated tablet Etoricoxib 60mg Frosst Iberica S.A., Spain Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
BDMCA/RMP/1116 Page 27 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
483 BRU10100561P Proctosedyl Ointment Cinchocaine hydrochloride 0.5%;
Framycetin sulphate 1.0%; Hydrocortisone
0.5%; Aesculin 1.0%
Patheon UK Ltd., England Medipharm Sdn Bhd 28 October 2015 till 27
October 2020
POM
484 BRU10100562P Exelon® Patch 10 Rivastigmine Base 18mg / 10cm2
(9.5mg/24h)
LTS Lohmann Theraphie-System AG,
Germany
Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
485 BRU10100563P Exelon® Patch 5 Rivastigmine base 9mg/5cm2 (4.6mg/24
hours)
LTS Lohmann Theraphie-System AG,
Germany
Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
486 BRU10100564P ATGAM® Sterile Solution
50mg/mL (5mL amp)
Lymphocyte immune globulin, anti-
thymocyte globulin (equine) 250mg/5mL
Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
487 BRU10100565P Ezetrol 10mg Tablet Ezetimibe 10mg 1) MSD International GmbH (Puerto Rico
Branch) LLC, Puerto Rico; 2) MSD
International GmbH (Singapore Branch),
Singapore
Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
488 BRU10100566P Arcoxia 120mg Tablet Etoricoxib 120mg Frosst Iberica S.A., Spain Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
489 BRU10100567P Sun-Glizide Tablet 80mg Gliclazide 80mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Traidng Company 28 October 2015 till 27
October 2020
POM
490 BRU10100568P Zithromax Powder For Oral
Suspension 200mg/5ml
Azithromycin (as dihydrate) 200mg/5ml Haupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
491 BRU10100569P Fosamax Plus 70/2800mcg
Tablets
Alendronic (as sodium 91.37) acid 70mg &
(Vitamin D3 100,000 IU/g) Cholecalciferol
2800mcg
MSD Frosst Iberica, Spain Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
492 BRU10100571P Arimidex 1mg tablet Anastrozole 1mg AstraZeneca Pharmaceuticals USA Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
493 BRU10100572P Casprin Enteric
Microencapsulated Capsule
100mg
Aspirin 100mg Y.S.P. Industries (M) Sdn Bhd, Malaysia. Asterix United (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
494 BRU10100573P Pontalon Tablet 500mg Mefenamic Acid 500mg Y.S.P. Industries (M) Sdn Bhd, Malaysia. Asterix United (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
495 BRU10100576P Albutein® Solution for Infusion
25%
Albumin (Human) 25% Grifols Biologicals Inc., USA Hongkiat Trading & Company 28 October 2015 till 27
October 2020
POM
496 BRU10100577P RebetolTM 200mg Capsule Ribavirin 200mg MSD International GmbH (Puerto Rico
Branch) LLC., Puerto Rico, USA.
Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
497 BRU10100578P Axol Liquid 3mg/ml Ambroxol Hydrochloride 3mg/ml Y.S.P. Industries (M) Sdn Bhd, Malaysia. Asterix United (B) Sdn Bhd 28 October 2015 till 27
October 2020
P (100ml) & POM
(4L)
498 BRU10100579PS1 &
BRU10100579PS1
Vytorin™ Tablets 10mg/10mg Ezetimibe 10mg; Simvastatin 10mg Merck Sharp & Dohme (Italia) S.p.A.,
Italy (S1); MSD International GmbH
(Singapore Branch), Singapore (S2)
Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27
October 2020
POM
499 BRU10110580P Intron A* 18million IU Solution
for Injection, Multidose Pen
Interferon Alfa-2b 18 million IU Schering-Plough (Brinny) Co., Ireland Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
500 BRU10110581PS1;
BRU10110581PS2JanuviaTM Tablet 50mg Sitagliptin (as phosphate) 50mg Merck Sharp & Dohme (Italia) S.p.A.,
Pavia, Italy (S1); Merck Sharp & Dohme
Ltd, England (S2)
Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
BDMCA/RMP/1116 Page 28 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
501 BRU10110582P Arcoxia® 90mg Tablet Etrocoxib 90mg Frosst Iberica S.A., Spain Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
502 BRU10110584P Zocor 20mg Film-coated Tablet Simvastatin 20mg Merck Sharp & Dohme Ltd.,
Northumberland, UK
Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
503 BRU10110585P Sifrol® Tablet 1mg Pramipexole dihydrochloride monohydrate
1mg (equivalent to 0.7mg pramipexole)
Boehringer Ingelheim Pharma GmbH &
Co. KG, Germany
Hongkiat Trading & Company 24 November 2015 till 23
November 2020
POM
504 BRU10110587P Metoclopramide Syrup 5mg/5ml Metoclopramide hydrochloride 5mg/5ml Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Traidng Company 24 November 2015 till 23
November 2020
POM
505 BRU10110588NP Suntacid Tablet Aluminium Hydroxide 250mg, Magnesium
Trisilicate 250mg, Simethicone 30mg
Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Traidng Company 24 November 2015 till 23
November 2020
GSL
506 BRU10110590P Zoladex Depot 3.6mg/dose Goserelin (as acetate) 3.6mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
507 BRU10110591P Voren Enteric Coated Tablet
25mg
Diclofenac Sodium 25mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
508 BRU10110592P Oroxine Tablet 50mcg Levothyroxine Sodium 55.63mcg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
509 BRU10110593P Voren Enteric Coated Tablet
50mg
Diclofenac Sodium 50mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
510 BRU10110595P Zantac™ Injection 25mg/ml Ranitidine hydrochloride 25mg/ml GlaxoSmithKline Manufacturing S.p.A.,
Italy
Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
511 BRU10110596P Beconase™ Aqueous Nasal Spray Beclomethasone Dipropionate (as
monohydrate)
Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
512 BRU10110597P Campto 40mg/2ml Injection Irinotecan hydrochloride trihydrate
40mg/2ml
Pfizer (Perth) Pty Ltd., Australia Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23
November 2020
POM
513 BRU10120599PS1;
BRU10120599PS2 JanuviaTM Tablet 25mg Sitagliptin (as phosphate) 25mg Merck Sharp & Dohme (Italia) S.p.A.,
Pavia, Italy (S1); Merck Sharp & Dohme
Ltd, England
Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
514 BRU10120600P Ritalin® LA Modified Release
Capsule 40mg
Methylphenidate hydrochloride 40mg Recro Gainsville LLC, USA Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
515 BRU10120602P Orgalutron Solution for Injection
0.25mg/0.5ml
Ganirelix acetate 0.25mg/0.5ml Vetter Pharma-Fertigung GmbH & Co. KG,
Germany
Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
516 BRU10120604P Afrin Nasal Spray 0.05% Oxymetazoline Hydrochloride 0.05% PT. Merck Sharp Dohme Pharma Tbk,
Indonesia
Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
P
517 BRU10120605P Clarityne Tablet 10mg Loratadine 10mg PT. Merck Sharp Dohme Pharma Tbk,
Indonesia
Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
P
518 BRU10120606P Frotin Pessaries Metronidazole 250mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
519 BRU10120607P Allopurinol Tablet 300mg Allopurinol 300mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
520 BRU10120608P Methergin Tablet 0.125mg Methylergometrine maleate 0.125mg Novartis Pharma Produktions GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
521 BRU10120609P Vesicare Tablet 10mg Solifenacin Succinate 10mg Astellas Pharma Europe B.V., The
Netherlands
Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
BDMCA/RMP/1116 Page 29 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
522 BRU10120611P Voren Suppositories 12.5mg Diclofenac Sodium 12.5mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
523 BRU10120612P Flixonase Aqueous Nasal Spray
0.05%
Fluticasone propionate (micronised) 50mcg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
524 BRU10120613PS1;
BRU10120613PS2
Esmeron® Injection 50mg/5ml
(10mg/ml)
Rocuronium Bromide 50mg/5ml N.V. Organon, The Netherlands; Hameln
Pharmaceuticals GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
525 BRU10120614P Clomid Tablet 50mg Clomifene Citrate 50mg Patheon France S.A., France Medipharm Sdn Bhd 29 December 2015 till 28
December 2020
POM
526 BRU10120615P FlixotideTM EvohalerTM 125mcg Fluticasone propionate 125mcg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
527 BRU10120616P Levitra® film-coated Tablet 5mg Vardenafil 5mg (as monohydrochloride
trihydrate)
Bayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
528 BRU10120617P IRESSATM Tablet 250mg Gefitinib 250mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28
December 2020
POM
529 BRU11010619PS1;
BRU11010619PS2 Januvia
TM Tablet 100mg Sitagliptin (as phosphate) 100mg Merck Sharp & Dohme (Italia) S.p.A.,
Pavia, Italy (S1); Merck Sharp & Dohme
Ltd, England
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
530 BRU11010621P Femara® 2.5mg Tablet Letrozole 2.5mg Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
531 BRU11010623P Allopurinol Tablet 100mg Allopurinol 100mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
532 BRU11010624P Elomet Ointment 0.1% PT. Merck Sharp Dohme Pharma Tbk,
Indonesia
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
533 BRU11010625 Implanon® 68mg Implant Etonogestrel (Micronised) [Org3236] 68mg N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
534 BRU11010626NP Poro Tablet 500mg Paracetamol 500mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 January 2016 till 25
January 2021
P (10 x 10's), P
(100x10's &
3,000's)535 BRU11010627P Tegretol CR 200 Tablet Carbamazapine 200mg Novartis Farma S.p.A., Torree Annunziata,
Italy
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
536 BRU11010628P Oxy-Nase Paediatric Nasal Spray
0.025%
Oxymetazoline HCl 0.025% HOE Pharmaceuticals Sdn Bhd, Malaysia G&H Trading Company 26 January 2016 till 25
January 2021
P
537 BRU11010629P TrandateTM
Tablets 100mg Labetalol hyrdochloride 100mg Glaxo Wellcome GmbH & Co., Germany Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
538 BRU11010631P Tegretol® CR 400 Tablet Carbamazapine 400mg Novartis Farma S.p.A., Torree Annunziata,
Italy
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
539 BRU11010632P Comtan® Tablet 200mg Entacapone 200mg Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
540 BRU11010633P DF118 Tablet Dihydrocodeine GlaxoSmithKline South Africa (Pty) Ltd.,
South Africa
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
541 BRU11010635P Zantac SyrupTM 150mg/10ml Ranitidine (as hydrochloride) 150mg/10ml Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
542 BRU11010636NP Bisacodyl Suppositories Bisacodyl 5mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
BDMCA/RMP/1116 Page 30 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
543 BRU11010637P EngerixTM-B Adult Dose Vaccine
20mcg/ml
Purified Hepatitis B Surface Antigen
(HBsAg) 20mcg/ml
GlaxoSmithKline Biologicals SA, Rixensart
Belgium; GlaxoSmithKline Biologicals S.A.,
Wavre Belgium
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
544 BRU11010638P HavrixTM720 Junior Vaccine Inactivated Hepatitis A virus antigen (HAV),
HM175 strain 720 EL.U
GlaxoSmithKline Biologicals SA, Rixensart
Belgium; GlaxoSmithKline Biologicals S.A.,
Wavre Belgium
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
545 BRU11010639P HiberixTM Vaccine Purified polyribosyl-ribitol-phosphate
capsular polyaccharide (PRP) of
Haemophilus influenza type b (Hib) 10µg
covalently bound to 20-40µg tetanus
toxoid
GlaxoSmithKline Biologicals SA, Belgium;
GlaxoSmithKline Biologicals S.A., Saint-
Amand-Les-Eaux
France
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
546 BRU11010640P Microgynon® 30 Tablet Levonorgestrel 0.15mg, Ethinylestradiol
0.03mg
Bayer Weimar GmbH und Co., KG,
Germany
Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
547 BRU11010641P Ami-hydrotride Tablet Amiloride hydrochloride 5mg &
Hydrochlorthiazide 50mg
Upha Pharmaceutical Mfg (M) Sdn Bhd.,
Malaysia
Hongkiat Trading & Company 26 January 2011 till 25
January 2016 (PL extended
to 26 March 2017)
POM
548 BRU11010642P Virless Tablets 200mg Acyclovir 200mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 January 2016 till 25
January 2021
POM
549 BRU11020643P Dalacin C 300mg Capsule Clindamycin (as Hydrochloride) 300mg Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
550 BRU11020644P Tegretol® 200mg Tablet Carbamazepine 200mg Novartis Pharma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
551 BRU11020645P OroxineTM Tablet 100mcg Levothyroxine (as sodium) anhydrous
100mcg
Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
552 BRU11020646P ActifedTM Syrup Triprolidine Hydrochloride BP 1.25mg/5ml;
Pseudoephedrine hydrochloride BP
30mg/5ml
Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
P (60ml & 100ml)
553 BRU11020647P Tegretol® 2% Syrup Carbamazepine 100mg/5ml Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
554 BRU11020648P Glivec® 100mg Film-coated Tablet Imatinib (as mesylate) 100mg Novartis Pharma Produktions GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
555 BRU11020649P Sandostatin® Ampoules
0.05mg/ml
Octreotide (as acetate) 0.05mg/ml Novartis Pharma Stein AG., Switzerland Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
556 BRU11020650P Levitra® film-coated Tablet 20mg Vardenafil (as monochloride trihydrate)
20mg
Bayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
557 BRU11020652P Urosin® Film-coated Tablet 50mg Atenolol 50mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
558 BRU11020653P Ibuprofen Film-coated Tablet
400mg
Ibuprofen 400mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 February 2016 till 23
February 2021
P
559 BRU11020654P Promethazine Syrup 5mg/5ml Promethazine HCl 5mg/5ml Drug House of Australia Pte Ltd.,
Singapore
G & H Trading Company 24 February 2016 till 23
February 2021
POM
BDMCA/RMP/1116 Page 31 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
560 BRU11020655P Voren Gel Diclofenac Sodium 10mg/g (as Diclofenac
Acid Diethylamine)
Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 February 2016 till 23
February 2021
GSL
561 BRU11020656P Atacor 20mg Film-coated Tablets Atorvastatin (as Calcium) 20mg Actavis hf., Iceland K-Seri Pharma Sdn Bhd 24 February 2016 till 23
February 2021
POM
562 BRU11020657P Dermosol Cream Clobetasol (as propionate) 0.5%w/w Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 February 2016 till 23
February 2021
POM
563 BRU11020658P Zendhin 150 Tablet Ranitidine (as hydrochloride) 150mg Drug House of Australia (Asia) Pte Ltd.,
Singapore
G & H Trading Company 24 February 2016 till 23
February 2021
POM
564 BRU11030659PS1 &
BRU11030659PS2
Vytorin Tablet 10mg/40mg Ezetimibe 10mg, Simvastatin 40mg MSD International gmbH (Singapore
Branch), Singapore (S1); Merck Sharp &
Dohme (Italia) S.p.A., Italy (S2)
Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
565 BRU11030660P Oxy-nase® Nasal Spray 0.05% Oxymetazoline HCl 0.05% HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 26 March 2016 till 25 March
2021
P
566 BRU11030661P Primperan® 10mg Suppositories Metoclopramide 10mg Unither Liquid Manufacturing, France. Medipharm Sdn Bhd 26 March 2016 till 25 March
2021
POM
567 BRU11030662P Fucon Film Coated Tablet 10mg Hysocine-n-butylbromide 10mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
568 BRU11030663P Betamethasone Tablet 0.5mg Betamethasone 0.5mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
569 BRU11030664P Trivastal® Retard 50 Tablet Piribedil 50mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
570 BRU11030667P Clarinase Syrup 5mg/5ml Per 5ml: Loratadine 5mg, Pseudoephedrine
Sulphate 60mg
Sanofi Aventis Argentina S.A., Argentina Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
P
571 BRU11030668P Vivaxim Suspension and Solution
for Suspension for Injection
Inactivated Hepatitis A Virus, GBM strain
160 antigen units
Sanofi Pasteur, Parc industriel d'Incarville,
France
Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
572 BRU11030669PS1;
BRU11030669PS2
Caelyx 2mg/ml Concentrate for
Infusion
Doxorubicin HCl 2mg/ml Alza Corporation, USA (S1);
GlaxoSmithKline Manufacturing S.P.A.,
Italy (S2)
Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
573 BRU11030670P Alkeran Tablet 2mg Melphalan 2mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
574 BRU11030671P Hyzaar Forte Tablet 100/25mg Losartan potassium 100mg,
Hydrochlorothiazide 25mg
Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
575 BRU11030672P Avodart Soft Capsules 0.5mg Dutasteride 0.5mg GlaxoSmithKline Pharmaceuticals S.A.,
Poland
Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
576 BRU11030673P Topistin® Solution for IV Infusion
200mg/100ml
Ciprofloxacin (as lactate) 200mg/100ml Elpen Pharmaceutical Co., Inc., Greece. G & H Trading Company 26 March 2016 till 25 March
2021
POM
BDMCA/RMP/1116 Page 32 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
577 BRU11030674P Arixtra Injection 2.5mg/0.5ml Fondporinux sodium 2.5mg/0.5ml Glaxo Wellcome Production, France Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March
2021
POM
578 BRU11040675P Puregon® 600iu/0.72ml Solution
for Injection
Recombinant follicle-stimulating hormone
(FSH) (follitrophin beta) [Org 32489]
600iu/0.72ml
Vetter Pharma-Fertigung GmbH & Co. KG.,
Mooswiesen, Revensburg, Germany and
Vetter Pharma-Fertigung GmbH & Co. KG.,
Schutzenstrasse, Ravensburg, Germany
Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
579 BRU11040676PS1;
BRU11040676PS2
Tazocin EF 4.5g Piperacillin (asmonohydrate) 4g;
Tazobactam (as sodium) 0.5g
Wyeth Lederle S.r.I, Catania, Italy (S1);
Pfizer Biotech Corporation,
Hsinchu Plant, Taiwan-Republic of China
(S2)
Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
580 BRU11040677P Vaxigrip Suspension for Injection Split influenza virus*, inactivated
containing antigens equivalent to the
following strains per one 0.5ml dose:
A/California/7/2009 (H1N1)pdm09-derived
strain used NYMC X-179A) 15mcg HA**;
A/Texas/50/2012(H3N2)-derived strain
used NYMC X-223A 15mcg HA**;
B/Massachusetts/2/2012-derived strain
used NYMC BX-51B 15mcg HA**
Note - * Propagated in fertilized hens’ egg
from healthy chicken flocks
** haemagglutinin
Sanofi Pasteur, Lyon, France Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
581 BRU11040678P Euvax B Adult Vaccine
Recombinant
Purified HBs-Ag 20mcg LG Life Science Ltd., Korea Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
582 BRU11040679P TrandateTM Injection 5mg/ml x
5ml
Labetalol HCl 25mg/5ml Hsinchu Plant of UBI Pharma Inc., Taiwan Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
583 BRU11040680P Puregon® 50IU/0.5ml Solution for
Injection
Follitrophin Beta (recombinant follicale-
stimulating hormone (FSH) 50IU/0.5ml
N.V.Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
584 BRU11040681P Oxy-Nase Nasal Drops 0.05% Oxymetazolin Hydrochloride 0.05%w/v HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 30 April 2016 till 29 April
2021
P
585 BRU11040682P Sunolut Tablet 5mg Norethisterone 5mg Sunward Pharmaceutical Pte Ltd.,
Singapore
G & H Trading Company 30 April 2016 till 29 April
2021
POM
586 BRU11040683P Sandostatin® LAR® Injection
10mg
Octreotide 10mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
587 BRU11040684P Vfend TM Film-Coated Tablets
200mg
Voriconazole 200mg Pfizer Italia S.R.L, Italy Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
588 BRU11040685P Voren Suppositories 25mg Diclofenac Sodium 25mg Y.S.P Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
BDMCA/RMP/1116 Page 33 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
589 BRU11040687P Multaq 400mg Film-coated Tablet Dronedarone 400mg (equiv. Dronedarone
HCl 426mg)
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 30 April 2016 till 29 April
2021
POM
590 BRU11040688P Stablon Coated Tablet 12.5mg Tianeptine (as sodium) 12.5mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
591 BRU11040689P Shinoxol Tablet 30mg Ambroxol HCl 30mg Y.S.P Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
592 BRU11040690P EngerixTM
-B Paediatric Vaccine
10mcg/0.5ml
Purified HBs-Ag 10mcg GlaxoSmithKline Biologicals SA., Rixensart
Belgium; GlaxoSmithKline Biologicals S.A.,
Wavre
Belgium
Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
593 BRU11040691P Elosone Cream Mometasone Furoate 0.1%w/w HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 30 April 2016 till 29 April
2021
POM
594 BRU11040693P Cinna Tablet 25mg Cinnarizine 25mg Y.S.P Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
595 BRU11040694P Stalevo® 100/25/200mg Film-
coated Tablet
Levodopa 100mg; Carbidopa 25mg;
Entacapone 200mg
Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
596 BRU11040695P RevoladeTM
Film-coated Tablet
25mg
Eltrombopag 25mg [as free acid] (as
olamine)
Glaxo Operations UK Ltd (trading as Glaxo
Wellcome Operations), UK
Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
597 BRU11040696P Coversyl® Film-coated Tablet
10mg
Perindopril arginine 20mg (equiv to
perindopril 6.790mg)
Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
598 BRU11040697P Atorvastatin Winthrop® 20mg
Film-coated Tablet
Atorvastatin 20mg (as calcium 20.68mg) Zentiva k.s., Prague, Czech Republic Medipharm Sdn Bhd 30 April 2016 till 29 April
2021
POM
599 BRU11040698P SeroxatTM CR Tablet 12.5mg Paroxetine 12.5mg (as Paroxetine HCl
hemihydrate)
GlaxoSmithKline Inc., Ontario, Canada Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April
2021
POM
600 BRU11050699P Avamys® Nasal Spray Fluticasone furoate (micronised) 27.5µg
/spray
Glaxo Operations UK Ltd, United Kingdom Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
601 BRU11050700P Tetraxim Vaccine Purified diphteria toxoid ≥ 30IU; purified
tetanus toxoid ≥ 40IU; Bordetella pertusis
antigens: Adsorbed purified pertusis toxoid
25µg, Adsorbed purified filamentous
haemagglutinin 25µg ; Inactivated
poliomyelitis virus: Type 1 40 D units, Type
2 8 Dunits, Type 3 32 Dunits.
Sanofi Pasteur, Campus Merieux, France;
Sanofi Pasteur, Parc industriel d'Incarville,
France
Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
602 BRU11050701P Depo-Provera Vial 150mg/3ml Medroxyprogesterone acetate 150mg Pfizer Manufacturing Belgium N.V.,
Belgium
Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
603 BRU11050702P Benzhexol Tablet 2mg Benzhexol HCl 2mg Sunward Pharmaceutical Pte Ltd.,
Singapore
G & H Trading Company 25 May 2016 till 24 May
2021
POM
604 BRU11050703P Levitra Film-coated Tablets 10mg Vardenafil (as monohydrochloride
trihydrate) 10mg
Bayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
BDMCA/RMP/1116 Page 34 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
605 BRU11050704P Ventolin Solution for Intravenous
Infusion 5mg/5ml
Salbutamol (as sulphate) 5mg/5ml GlaxoSmithKline Pharmaceutical S.p.A.,
Italy
Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
606 BRU11050705NP Upha B6 10 Tablet Pyridoxine HCl 10mg Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 25 May 2011 till 24 May
2016 (PL extended to 26
March 2017)
P (5 x 50's)
607 BRU11050706P Zofran Injection Flexi-Amp
Ampoules
Ondansetron HCl Dihydrate 8mg/4ml GlaxoSmithKline Australia Pty Ltd.m
Australia
Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
608 BRU11050707P Caverject 20mcg Powder and
solvent for injection
Alprostadil 20µg Pfizer Manufacturing Belgium N.V.,
Belgium
Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
609 BRU11050708NP Essentiale Forte N Capsule Phospholipids fatty mass 392mg
(equivalent to 300mg phospholipids from
soya beans containing 76% of (3-sn-
phosphatidyl) choline)
A. Nattermann & Cie. GmbH., Germany Medipharm Sdn Bhd 25 May 2016 till 24 May
2021
GSL (50's)
610 BRU11050710P Coveram Tablets 5mg/5mg Perindopril arginine 5mg (equiv. to
perindopril 3.395mg); Amlodipine 5mg (as
besilate 6.935mg)
Servier (Ireland) Industries Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
611 BRU11050712P Tracrium Injection 25mg/2.5ml Atracurium besylate 25mg/2.5ml GlaxoSmithKline Manufactuirng S.p.A.,
Italy
Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May
2021
POM
612 BRU11060714P Zantac 150mg Tablet Ranitidine 150mg (as HCl 168mg) GlaxoSmithKline (Tianjin) Co. Ltd., PR
China
Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
613 BRU11060715P Oxy-Nase Paediatric Nasal Drop
0.025%w/v
Oxymetazoline HCl 0.025% HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 02 July 2016 till 01 July 2021 POM
614 BRU11060716P Vfend 50mg film-coated Tablet Voriconazole 50mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
615 BRU11060717P Protaxos 2g Strontium Ranelate 2632mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
616 BRU11060718P MyleranTM Tablets 2mg Busulphan 2mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
617 BRU11060719P Amlodipine Winthrop Tablet 5mg Amlodipine (as besilate) Unichem Laboratories Limited, Goa, India Medipharm Sdn Bhd 02 July 2016 till 01 July 2021 POM
618 BRU11060720P Virless Tablet 800mg Acyclovir 800mg Y.S.P. Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
619 BRU11060721P Atorvastatin Winthrop® 40mg
Tablet
Atorvastatin 40mg (as Calcium 41.36mg) Zentiva k.s., Czech Republic Medipharm Sdn Bhd 02 July 2016 till 01 July 2021 POM
620 BRU11060722P Propecia 1mg Tablet Finasteride 1mg Merck Sharp & Dohme, Puerto Rico, USA Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
621 BRU11060723P Seroquel XR Extended-Release
Tablets 50mg
Quetiapine 50mg (as fumarate 57.560mg) AstraZeneca Pharmaeuticals LP, USA Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM
622 BRU11070724P Vesicare® 5mg Tablet Solifenacin Succinate 5mg Astella Pharma Europe B.V., The
Netherlands
Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
BDMCA/RMP/1116 Page 35 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
623 BRU11070727P SW Bena-Expectorant Per 5ml: Diphenhydramine HCl 10mg,
Ammonium Chloride 102mg, Sodium
Citrate 46mg
Sunward Pharmaceutical Pte Ltd.,
Singapore
G&H Trading Company 27 July 2016 till 26 July 2021 POM
624 BRU11070729P Priorix TM Composition of Priorix™ per dose (0.5ml):
Live attenuated measles virus (Schwarz
strain) ≥103.0
CCID50, Live attenuated
mumps virus (RIT4385 strain) ≥103.7 CCID50,
Live attenuated rubella virus (Wistar RA
27/3 strain) ≥103.0 CCID50
GlaxoSmithKline Biologicals s.a., Belgium;
FIDIA Farmaceutici S.p.a., Italy
Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
625 BRU11070730P Mirena® Intrauterine System
20mcg/24hr
Levonorgestrel 52mg Bayer Oy, Finland Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
626 BRU11070731P Amlodipine Winthrop® 10mg
Tablet
Amlodipine 10mg (as besilate) Unichem Laboratories Limited, Goa, India Medipharm Sdn Bhd 27 July 2016 till 26 July 2021 POM
627 BRU11070732PS1;
BRU11070732PS2
Zoral 400 Tablet 400mg Acyclovir USP 400mg Drug House of Australia Pte Ltd.,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indoensia (S2)
G & H Trading Company 27 July 2016 till 26 July 2021 POM
628 BRU11070733P ZofranTM Injection 4mg/2ml Ondansetron 4mg/5ml (as HCl dihydrate) GlaxoSmithKline Australia Pty Ltd.,
Australia
Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
629 BRU11070734P Syntometrine® Injection 5IU/ml
Ampoule
Oxytocin 5IU/ml Novartis Pharma Steing AG., Switzerland Medipharm Sdn Bhd 27 July 2016 till 26 July 2021 POM
630 BRU11070735P Elosone Ointment 0.1%w/w Mometasone furoate 0.1% w/w HOE Pharmaceuticals Sdn Bhd., Malaysia G & H Trading Company 27 July 2016 till 26 July 2021 POM
631 BRU11070736P Coveram 5/10mg Tablet Perindopril arginine 5mg (equiv. to
3.395mg perindopril) and amlodipine 10mg
(as besilate 13.870mg)
Servier (Ireland) Industries Ltd, Ireland Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
632 BRU11070737P ZofranTM
Tablets 8mg Ondansetron 8mg (as HCl dihydrate) Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
633 BRU11070738PS1;
BRU11070738PS2
Diamicron® MR 60mg Tablet Gliclazide 60mg Les Laboratoires Servier Industrie, France
(S1); Kotra Pharma (M) Sdn. Bhd, Malaysia
(S2)
Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
634 BRU11070739P Fedac DM Linctus Per 5ml: Triprolidine HCl 12.5mg,
Pesudoephedrine HCl 30mg,
Dextrometorphan HBr 10mg
Drug House of Australia Pte Ltd.,
Singapore
G & H Trading Company 27 July 2016 till 26 July 2021 POM
635 BRU11070740P Tracrium Injection 50mg/5ml Atracurium Besylate 50mg/5ml GlaxoSmithKline Manufacturing S.p.A.,
Parma, Italy
Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
636 BRU11070741P Coralan® Tablet 2.5mg Ivabradine 7.5mg (as HCl 8.085mg) Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM
637 BRU11080742P Aclasta 5mg/10ml Solution for
Infusion
Zolendranic acid (anhydrous) 5mg (as
zolendranic acid monohydrate 5.33mg)
Novartis Pharma Stein AG., Switzerland Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
638 BRU11080743P Lanoxin Tablet 250mcg Digoxin 250mcg GlaxoSmithKline Australia Pty Ltd.,
Australia
Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
BDMCA/RMP/1116 Page 36 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
639 BRU11080744P Lanoxin PG Tablet 0.0625mg Digoxin 0.0625mg GlaxoSmithKline Australia Pty Ltd.,
Australia
Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
640 BRU11080745P Glivec® 400mg Film-coated Tablet Imatinib (as mesylate) 400mg Novartis Pharma Stein AG., Switzerland Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
641 BRU11080746P Stalevo 50/12.5/200mg film-
coated tablet
Levodopa 50mg, Carbidopa 12.5mg,
Entacapone 200mg
Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
642 BRU11080747PS1,
BRU11080747PS2,
BRU11080747PS3
Pentaxim Vaccine Composition of final container per dose
(0.5ml): TETRAXIM - Purified diphteria
toxoid ≥ 30 I.U; Purified tetanus toxoid ≥40
I.U; Adsorbed purified pertusis toxoid
25µg; Inactivated poliomyeltis virus type1
40 DU, type 2 8DU, type 3 32 DU; Act-HIB -
Polysaccharide of Haemophilus influenza
type b conjugated to tetanus protein 10µg
Sanofi Pasteur, Campus Merieux, Marcy
I'Etoile, France (S1); Sanofi Pasteur, Parc
Industriel d'Incarville, France (S2); Sanofi
Pasteur, Gruppo Lepeptit, Angani, Italy
(S3)
Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
643 BRU11080748P Campto 100mg/5ml Injection Irinotecan hydrochloride trihydrate Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
644 BRU11080749P Econazine Cream Econazole nitrate 1% w/w, Triamcinolone
actonide 0.1% w/w
Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
645 BRU11080750P Frotin Film Coated 200mg Tablet Metronidazole 200mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
646 BRU11080751P Urosin Film Coated Tablet 100mg Atenolol 100mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
647 BRU11080752P TwinrixTM Vaccine Hepatitis A virus antigen 720 ELISA units; r-
DNA hepatitis B virus surface antigen
(HBsAg)* 20µg *Thiomersal-free
HBsAg purified bulk
GlaxoSmithKline Biologicals SA, Belgium Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
648 BRU11080753P Fukole Capsule 150mg Fluconazole 150mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
649 BRU11080754P CoAprovel Tablet 300/25mg Irbesartan 300mg, Hydrochlorothiazide
25mg
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 25 August 2016 till 24 August
2021
POM
650 BRU11080755P SeroxatTM CR Tablet 25mg Paroxetine 25mg(as Paroxetine
hydrochloride hemihydrate)
GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
651 BRU11080757P Orphenadol® Tablet Orphenadrine Citrate 50mg, Paracetamol
325mg
Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
652 BRU11080758P Loramide Capsule 2mg Loperamide HCl 2mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
653 BRU11080759P VOREN Suppositories 50mg Diclofenac Sodium 50mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
654 BRU11080760P Decan Tablet 0.75mg Dexamethasone 0.75mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August
2021
POM
655 BRU11090762P Properazine Tablet 5mg Prochlorperazine maleate 5mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 27 September 2016 till 26
September 2021
POM
BDMCA/RMP/1116 Page 37 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
656 BRU11090763P Infanrix HexaTM Composition of reconstiitiuted DTPa-HBV-
IPV+Hib Vaccine per dose (0.5ml):
Diphteria toxoid min. 30 I.U; Tetanus
toxoid min. 40 I.U; Pertusis toxoid (PT)
25µg; Filamentous haemagglutinin (FHA),
adsorbed 25µg; Pertactin, adsorbed 8µg; r-
DNA Hepatitis B surface antigen (HBsAg
purified) 10µg; Inactivated poliomyeltis
virus type I 40 DU, Inactivated poliomyeltis
virus type II 8DU, Inactivated poliomyeltis
virus type III 32 DU;Conjugate of
Haemophilus influenza type b capsular
polysaccharide (PRP) and tetanus toxoid
10µg PRP and ~25µg T
GlaxoSmithKline Biologicals SA, Rixensart
Belgium; GlaxoSmithKline Biologicals S.A.,
Saint-Amand-Les-Eaux
France; GlaxoSmithKline Biologicals S.A.,
Wavre
Belgium;
Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
657 BRU11090764P Eloxatin 5mg/ml Concentrate for
Solution for Infusion (10ml)
Oxaliplatin 50mg/10ml Sanofi-Aventis Deutschland GmbH,
Germany
Medipharm Sdn Bhd 27 September 2016 till 26
September 2021
POM
658 BRU11090765P Eloxatin 5mg/ml Concentrate for
Solution for Infusion (20ml)
Oxaliplatin 100mg/20ml Sanofi-Aventis Deutschland GmbH,
Germany
Medipharm Sdn Bhd 27 September 2016 till 26
September 2021
POM
659 BRU11090766P InfanrixTM
-IPV Vaccine Composition per dose (0.5ml): Diphteria
toxoid (DT), adsorbed min. 30 I.U; Tetanus
toxoid (TT), adsorbed min. 40 I.U; Pertusis
toxoid (PT), adsorbed 25µg; Filamentous
haemagglutinin (FHA), adsorbed 25µg;
Pertactin, adsorbed 8µg; Inactivated
poliomyeltis virus type I 40 DU, Inactivated
poliomyeltis virus type II 8DU, Inactivated
poliomyeltis virus type III 32 DU
GlaxoSmithKline Biologicals SA, Belgium Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
660 BRU11090767P Sandimmun Neoral® Oral
Solution 100mg/ml
Ciclosporin A 100mg/ml Novartis Pharma S.A.S., France Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
661 BRU11090768P Hyzaar® Tablet 50/12.5mg Losartan Potassium 50mg,
Hydrochlorothiazide 12.5mg
Merck Sharp & Dohme, Northumberland,
UK
Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
662 BRU11090769P Hyzaar® Plus Tablet 100/12.5mg Losartan Potassium 100mg,
Hydrochlorothiazide 12.5mg
Merck Sharp & Dohme, Northumberland,
UK
Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
663 BRU11090770P Flebogamma 5% DIF Solution for
Infusion (100mL)
Human Normal Immunoglobulin 50mg/ml Instituo Grifols S.A., Barcelona, Spain Hongkiat Trading & Company 27 September 2016 till 26
September 2021
POM
BDMCA/RMP/1116 Page 38 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
664 BRU11090771P Seroquel XR Tablets 200mg Quetiapine (as fumarate) 200mg AstraZeneca Pharmaeuticals LP, USA Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
665 BRU11090772P Diabetamin Film-coated Tablet
500mg
Metformin HCl 500mg Hovid Bhd, Perak, Malaysia G & H Trading Company 27 September 2016 till 26
September 2021
POM
666 BRU11090773P Tidact Gel 1% Clindamycin 10mg/g (as phosphate
11.9mg/g)
Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
667 BRU11090774P Daunoblastina Injection 20mg Daunoribicin Hydrochloride 20mg Actavis S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
668 BRU11090775P Fucon Capsule 10mg Hyoscine-N-butylbromide 10mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
669 BRU11090776P Virless Cream Acyclovir 50mg/g Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 27 September 2016 till 26
September 2021
POM
670 BRU11090777P Solian® 100mg Scored Tablet Amisulpiride 100mg Sanofi Winthrop Industrie, France MediPharm Sdn Bhd 27 September 2016 till 26
September 2021
POM
671 BRU11090778P Hovasc Tablet 5mg Amlodipine 5mg (as besilate 6.90mg) Hovid Bhd, Malaysia G & H Trading Company 27 September 2016 till 26
September 2021
POM
672 BRU11100779P Pariet® Tablet 20mg Sodium Rabeprazole 20mg Bushu Pharmaceuticals Ltd, Japan. , Japan MediPharm Sdn Bhd 31 October 2016 till 30
October 2021
POM
673 BRU11100780P Pariet® Tablet 10mg Sodium Rabeprazole 10mg Bushu Pharmaceuticals Ltd, Japan. , Japan MediPharm Sdn Bhd 31 October 2016 till 30
October 2021
POM
674 BRU11100781P Puregon® 100IU/0.5ml Solution
for Injection
Follitropin beta (recombinant follicle-
stimulating hormone - FSH) 100IU/0.5ml
N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
675 BRU11100782P Gardasil Vaccine HPV Type 6 L1 protein 20mcg/0.5ml; HPV
Type 11 L1 protein 40mcg/0.5ml; HPV Type
16 L1 protein 40mcg/0.5ml; HPV Type 18 L1
protein 20mcg/0.5ml
Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
676 BRU11100783P TypherixTM Vi Polysccharide
Typhoid Vaccine 25mcg/0.5ml
Vi Polysaccaharide of Salmonella Typhi GlaxoSmithKline Biologicals SA, Rixensart
Belgium; GlaxoSmithKline Biologicals S.A.,
Wavre Belgium; Sächsisches Serumwerk
Dresden
Branch of SmithKline Beecham Pharma
GmbH & Co. K.G., Dresden
Germany; GlaxoSmithKline Biologicals,
Saint Amand Les Eaux France
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
677 BRU11100784P Sandostatin® ampoules 0.1mg/ml Octreotide (as acetate) 0.1mg/ml Novartis Pharma Stein A.G., Switzerland Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
678 BRU11100785P Atorvastatin Winthrop® 10mg
film-coated Tablets
Atorvastatin 10mg (as calsium 10.34mg) Zentiva k.s., Czech Republic MediPharm Sdn Bhd 31 October 2016 till 30
October 2021
POM
679 BRU11100786P Stalevo® 150/37.5/200mg Film-
coated Tablet
Levodopa 150mg; Carbidopa 37.5mg;
Entacapone 200mg
Orion Corporation Fermion, Finland Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
BDMCA/RMP/1116 Page 39 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
680 BRU11100787P Coveram Tablet 10mg/5mg Perindopril arginine 10mg (eqv. To
Perindopril 6.790mg); Amlodipine 5mg (as
besilate 6.935mg)
Servier (Ireland) Industries Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
681 BRU11100788P Coversyl® Fim-coated Tablet 5mg Perindopril arginine 5mg (eqv. Perindopril
3.395mg)
Les Laboratoires Servier Industrie, Gidy,
France
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
682 BRU11100789P Myonal 50mg Tablet Eperisone Hydrochloride 50mg Eisai Co., Ltd, Saitama Prefecture, Japan MediPharm Sdn Bhd 31 October 2016 till 30
October 2021
POM
683 BRU11100790P VarilrixTM Live attenuated varicella virus (OKA strain) GlaxoSmithKline Biologicals SA, Rixensart,
Belgium (Manufacturer of finished
product); GlaxoSmithKline Biologicals SA,
Rixensart, Belgium (Manufacturing site for
Water for Injection (WFI) diluents in
syringe and ampoule); Delpharm Tours,
Chambray-lès-Tours, France
(Manufacturing site for Water for
Injection (WFI) diluents in ampoules);
GlaxoSmithKline Biologicals S.A., Wavre,
Belgium
& GlaxoSmithKline Biologicals, Saint-
Amand-Les-Eaux, France & Centre de
Recherche et de Nouvelles Applications
(CRNA) SA, Belgium (Manufacturing site
for final packaging operations)
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
684 BRU11100791P Coveram Tablet 10mg/10mg Perindopril arginine 10mg (eqv. To
Perindopril 6.790mg); Amlodipine 10mg (as
besilate 13.870mg)
Servier (Ireland) Industries Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
685 BRU11100792P Voker Film Coated Tablet 20mg Famotidine 20mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
686 BRU11100793P Solian® 400mg Scored Tablet Amisulpride 400mg Sanofi Winthrop Industrie, France MediPharm Sdn Bhd 31 October 2016 till 30
October 2021
POM
687 BRU11100794P Clarityn-D 12HR EXTENDED
RELEASE TABLET 5mg/120mg
Loratadine 5mg, Pseudoephedrine
sulphate 120mg
Schering Plough Labo N.V., Belgium Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
688 BRU11100795P Euthyrox® Tablet 25mcg Levothyroxine sodium 25mcg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
689 BRU11100796P Concor® 2.5mg Tablet Bisoprolol hemifumarate 2.5mg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
690 BRU11110797P OnglyzaTM
Tablet 2.5mg Saxagliptin 2.5mg (as HCl anhydrous
2.79mg)
Bristol-Myers Squibb Company, Indiana,
USA
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
691 BRU11110798P OnglyzaTM Tablet 5mg Saxagliptin 5mg (as HCl anhydrous 5.58mg) Bristol-Myers Squibb Company, Indiana,
USA
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
BDMCA/RMP/1116 Page 40 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
692 BRU11110799P Sandostatin® LAR® Injection
20mg
Octreotide (as acetate) 20mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
693 BRU11110800P Sandostatin® LAR® Injection
30mg
Octreotide (as acetate) 30mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
694 BRU11110802P GardasilTM Vaccine (Syringe) Per 0.5ml dose - HPV Type 6 L1 protein
20mcg; HPV Type 11 L1 protein 40mcg;
HPV Type 16 L1 protein 40mcg; HPV Type
18 L1 protein 20mcg
Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
695 BRU11110803P Nexavar® 200mg Film-coated
Tablets
Sorafenib Tosylate 200mg Bayer Pharma AG., Leverkusen, Germany;
Bayer Healthcare Manufacturing S.r.l.,
Italy
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
696 BRU11110804P PEG Intron CLEARCLICK for
Injection 150mcg/0.5ml
Recombinant interferon alfa-2b 150mcg
(pegylated to monoethoxy polyethylene
glycol)
MSD International GmbH (Singapore
Branch), Singapore Singapore
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
697 BRU11110805P PEG Intron CLEARCLICK for
Injection 120mcg/0.5ml
Recombinant interferon alfa-2b 120mcg
(pegylated to monoethoxy polyethylene
glycol)
Schering-Plough Ltd., Singapore Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
698 BRU11110806P PEG Intron CLEARCLICK for
Injection 100mcg/0.5ml
Recombinant interferon alfa-2b 100mcg
(pegylated to monoethoxy polyethylene
glycol)
MSD International GmbH (Singapore
Branch), Singapore Singapore
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
699 BRU11110807P PEG Intron CLEARCLICK for
Injection 80mcg/0.5ml
Recombinant interferon alfa-2b 80mcg
(pegylated to monoethoxy polyethylene
glycol)
MSD International GmbH (Singapore
Branch), Singapore Singapore
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
700 BRU11110808P PEG Intron CLEARCLICK for
Injection 50mcg/0.5ml
Recombinant interferon alfa-2b 50mcg
(pegylated to monoethoxy polyethylene
glycol)
MSD International GmbH (Singapore
Branch), Singapore Singapore
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
701 BRU11110809P Dalacin CTM Sterile Solution
150mg/ml x 2ml ampoule
Clindamycin Phosphate 300mg Pfizer Manufacturing Belgium N.V., Puurs,
Belgium
Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
702 BRU11110811P Aricept® Tablet 5mg Donepezil HCl 5mg (equiv. to Donepezil
free base 4.56mg)
Eisai Taiwan Inc., Tainan Hsien, Taiwan MediPharm Sdn Bhd 24 November 2011 till 23
November 2016
POM
703 BRU11110812P Euthyrox® Tablet 100mcg Levothyroxine sodium 100mcg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
704 BRU11110813P Ketipinor Film-coated Tablet
200mg
Quetiapine 200mg (as fumarate 230.36mg) Orion Corporation, Espoo, Finland Hongkiat Trading & Company 24 November 2011 till 23
November 2016 (PL
extended to 26 March 2017)
POM
705 BRU11110814P Prednisolone Tablet 5mg Prednisolone 5mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 November 2016 till 23
November 2021
POM
706 BRU11110815P Granocyte® 34 Injection Lenograstim (rHug-CSF) 33.6 million IU
(equiv. to 263 mcg)/ vial
Sanofi Winthrop Industrie, France MediPharm Sdn Bhd 24 November 2016 till 23
November 2021
POM
707 BRU11120816P Euvax B Pediatric Vaccine
Recombinant (10mcg/0.5ml)
Purified HBs-Ag 10mcg/0.5ml LG Life Science Ltd., Korea Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
BDMCA/RMP/1116 Page 41 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
708 BRU11120817P Puregon® 300IU/0.36 ml Solution
for Injection
Recombinant follicle-stimulating hormone
(FSH) (follitrophin beta) [Org 32489]
600iu/0.72ml
Vetter Pharm-Fertigung GmbH & Co. KG.,
Schutzenstrasse, Ravensburg, Germany:
Vetter Pharm-Fertigung GmbH & Co. KG.,
Mooswiesen, Ravensburg, Germany;
Vetter Pharma-Fertigung GmbH & Co.
KG, Eisenbahnstrasse, Langenargen,
Germany and Vetter Pharma-Fertigung
GmbH & Co. KG, Holbeinstrassee,
Ravensburg Germany
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
709 BRU11120818P Clarityn Syrup Loratadine 1mg/ml PT. Merck Sharp Dohme Pharma Tbk,
Indonesia
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
P
710 BRU11120819P SynflorixTM Vaccine 1 dose (0.5ml) contains: Pneumococcal
polysaccharide serotype 11,2
- 1mcg,
Pneumococcal polysaccharide serotype 41,2
- 3mcg, Pneumococcal polysaccharide
serotype 51,2 - 1mcg, Pneumococcal
polysaccharide serotype 6B1,2
- 1mcg,
Pneumococcal polysaccharide serotype
7F1,2 - 1mcg, Pneumococcal polysaccharide
serotype 9V1,2
- 1mcg, Pneumococcal
polysaccharide serotype 141,2 - 1mcg,
Pneumococcal polysaccharide
serotype18C1,3 - 3mcg, Pneumococcal
polysaccharide serotype 19F1,4 - 3mcg,
Pneumococcal polysaccharide serotype
23F1,2 - 1mcg
GlaxoSmithKline Biologicals SA, Rixensart
Belgium; Glaxo SmithKline Biologicals SA,
Saint-Amand-Les-Eaux
France
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
711 BRU11120820P VentolinTM EvohalerTM Salbutamol (as sulphate 120.5mcg) 100mcg Glaxo Wellcome S.A., Burgos, Spain Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
712 BRU11120821P MencevaxTM ACWY Vaccine (1
Dose)
Per 0.5ml : Meningococcal purified
polysaccharides of: Serogroup A - 50mcg,
Serogroup C - 50mcg Serogroup W135 -
50mcg Serogroup W135 - 50mcg Serogroup
Y - 50mcg
GlaxoSmithKline Biologicals SA, Rixensart
Belgium
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
713 BRU11120822P RevoladeTM Film-coated Tablets
50mg
Eltrombopag olamine (eq. to Eltrombopag
50mg as Eltrombopag free acid)
Glaxo Operations UK Ltd (trading as Glaxo
Wellcome Operations) United Kingdom
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
BDMCA/RMP/1116 Page 42 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
714 BRU11120823P Coversyl® Plus 5mg Perindopril arginine 5mg (as besilate
3.395mg); Indapamide 1.25mg
Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
715 BRU11120824P Yasmin® Film-coated Tablets Drospirenone 3mg, Ethinylestradiol 0.03mg Bayer Weimar GmbH und Co. KG
(WEIMAR PLANT), Germany
Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
716 BRU11120826NP Arcalion® 200mg Tablet Sulbutiamine 200mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21
December 2021
GSL
717 BRU11120827P Methycobal Injection 500mcg/ml Mecobalamin 500mcg Bushu Pharmaceuticals Ltd, Japan MediPharm Sdn Bhd 22 December 2016 till 21
December 2021
POM
718 BRU11120828P Flebogamma® 5% DIF Solution for
Infusion (200ml)
Human Normal Immunoglobulin
10g/200mL (50mg/ml)
Instituto Grifols, S.A., Spain Hongkiat Trading 22 December 2016 till 21
December 2021
POM
719 BRU11120829NP Shintamet film coated Tablet Cimetidine 400mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 22 December 2011 till 21
December 2016
POM
720 BRU11120830P Dermafin cream 1% Terbinafine Hydrochloride 1%w/w Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 22 December 2016 till 21
December 2021
GSL
721 BRU11120831P Pontalon Tablet 250mg Mefenamic Acid 250mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
722 BRU11120832P Clopivid Tablet 75mg Clopidogrel 75mg (as hydrogen sulphate
97.90mg)
Hovid Bhd, Malaysia G & H Trading Company 22 December 2016 till 21
December 2021
POM
723 BRU11120833P Shincort Injection “Yung Shin”
10mg/ml
Triamcinolone Acetonide 50mg/5ml Yung Shin Pharmaceutical Ind. Co. Ltd.,
Taiwan ROC
Asterix United (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
724 BRU11120834P Hovasc Tablet 10mg Amlodipine 10mg (as Besylate 13.8mg) Hovid Bhd, Malaysia G & H Trading Company 22 December 2016 till 21
December 2021
POM
725 BRU11120835P Indomen Capsule 25mg Indomethacin 25mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 22 December 2016 till 21
December 2021
POM
726 BRU11120836P Clomiphene Tablet 50mg Clomiphene citrate 50mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 22 December 2011 till 21
December 2016
POM
727 BRU11120837P Primacor® 10mg/10ml Injection Milrinone 10mg/10ml (as lactate) Sanofi Winhtrop Industrie, France MediPharm Sdn Bhd 22 December 2016 till 21
December 2021
POM
728 BRU11120838NP Champs D-Worms 6 Chewable
Tablet (Chocolate)
Albendazole 200mg Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 22 December 2011 till 21
December 2016 (PL
extended to 26 March 2017)
GSL (2's)
729 BRU11120839P Epilim® 200 Enteric Coated
Tablets
Sodium Valproate 200mg Sanofi-Synthelabo Ltd., United Kingdom MediPharm Sdn Bhd 22 December 2016 till 21
December 2021
POM
BDMCA/RMP/1116 Page 43 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
730 BRU12010840P InfanrixTM-IPV+Hib Vaccine (DTPa-
IPV+Hib)
1 dose (0.5ml) contains: Diphteria toxoid
(DT) Min 30 I.U.; Tetanus toxoid (TT) Min
40 I.U.; Pertussis toxoid (PT) Min 25mcg;
Filamentous haemagglutinin (FHA) 25mcg;
Pertactin (69Kda Outer membrance
protein) 8mcg; Inactivated Polio Virus Type
1 (Mahoney seed) 40DU; Inactivated Polio
Virus Type 2 (MEF-1 seed) 8DU; Inactivated
Polio Virus Type 3 (Saukett seed) 32DU;
Conjugate of purified capsular
polysaccharide (10mcg) of Haemophilus
influenza type b covalently bound to
approximately 30mcg to 50 mcg tetanus
toxoid
GlaxoSmithKline Biologicals SA, Rixensart
Belgium; GlaxoSmithkline Biologicals S.A.,
France
Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
731 BRU12010841P Cardura XLTM tablet 4mg Doxazosin Mesylate 4mg Pfizer Pharmaceuticals LLC, Puerto Rico,
USA
Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
732 BRU12010842P Valdoxan® 25mg film-coated
tablet
Agomelatine 25mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
733 BRU12010843P Zofran Tablet 4mg Ondansetron (as Hydrochloride Dihydrate)
4mg
Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
734 BRU12010844P Flebogamma® 5% DIF Solution for
Infusion (50ml)
Human Normal Immunoglobulin
2.5g/50mL (50mg/ml)
Instituto Grifols, S.A., Spain Hongkiat Trading & Co 01 February 2017 till 31
January 2022
POM
735 BRU12010845P Coralan® Tablet 5mg Ivabradine 5mg eq. to 5.39mg ivabradine
hydrochloride
Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
736 BRU12010846P Seroquel XR tablets 300mg Quetiapine (as fumarate) 300mg Astrazeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
737 BRU12010847P Seroquel XR tablets 400mg Quetiapine (as fumarate) 400mg Astrazeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
738 BRU12010848P Chemix tablet Trimethoprim 80mg, Sulfamethoxazole
400mg
Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 01 February 2012 till 31
January 2017
POM
739 BRU12010849P Sofradex ear/eye drops Dexamethasone (as sodium
metasulphobenzoate) 0.05%w/v,
Framycetin sulphate 0.5% w/v, Gramicidin
0.005% w/v
Patheon UK, UK MediPharm Sdn Bhd 01 February 2017 till 31
January 2022
POM
740 BRU12010850P Enapril tablet 10mg Enalapril maleate 10mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 01 February 2012 till 31
January 2017
POM
741 BRU12010851NP Princi-B Fort® tablet Thiamin mononitrate 250mg, Pyridoxine
hydrochloride 250mg & Cyanocobalamin
1mg
Olic (Thailand) Ltd, Thailand MediPharm Sdn Bhd 01 February 2017 till 31
January 2022
P
742 BRU12010852P Antifungal Cream 2% Miconazole Nitrate 20mg/g (2% w/w) Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 01 February 2012 till 31
January 2017
GSL
BDMCA/RMP/1116 Page 44 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
743 BRU12010853P Concor® 5mg tablet Bisoprolol hemifumarate 5mg Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
744 BRU12010854P Ketipinor film-coated tablet
100mg
Quetiapine (as fumarate 115.13mg) 100mg Orion Corporation, Finland Hongkiat Trading & Co 01 February 2012 till 31
January 2017 (PL extended
to 26 March 2017)
POM
745 BRU12010855P Euthyrox® Tablet 50mg Levothyroxine sodium 50mcg Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31
January 2022
POM
746 BRU12010856NP Panadol Suspension 250mg/5ml Paracetamol 250mg/5ml Smithkline Beecham, Philippines Kingston Beverage & Creamery
Sdn Bhd
01 February 2012 till 31
January 2017
GSL (60ml/120ml)
747 BRU12010857P Targocid® Injection 200mg Teicoplanin 200mg/3ml (200mg/vial) Gruppo Lepetit S.r.I., Italy MediPharm Sdn Bhd 01 February 2017 till 31
January 2022
POM
748 BRU12020858P Sebivo™ Tablet 600mg Telbivudine 600mg Novartis Pharma Stein AG., Switzerland Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28
February 2022
POM
749 BRU12020859P Esonide Nasal Spray
100mcg/dose
Budesonide 2mg/ml equivalent to
100mcg/dose
Kleva S.A., Greece G & H Trading Company 29 February 2012 till 28
February 2017
POM
750 BRU12020860P Yucomy Tablet 200mg Ketoconazole 200mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 29 February 2012 till 28
February 2017
POM
751 BRU12020861P Thyrozol® 20mg Film-coated
Tablets
Thiamazole 20mg Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28
February 2022
POM
752 BRU12020862P Ketipinor Film-coated Tablet
25mg
Quetiapine (as fumarate 28.78mg) 25mg Orion Corporation, Finland Hongkiat Trading & Co 29 February 2012 till 28
February 2017 (PL extended
to 26 March 2017)
POM
753 BRU12020863P Taxotere 20mg/1ml concentrate
for solution for infusion
Docetaxel (as trihydrate) 20mg/ml Sanofi-Aventis Deutschland GmbH,
Germany
MediPharm Sdn Bhd 29 February 2012 till 28
February 2017
POM
754 BRU12020864P Zanidip® Tablet 10mg Lercanidipine Hydrochloride 10mg (eq. to
9.4mg Lercanidipine)
Recordati Industria Chimica &
Farmaceutica S.p.A, Italy
Hongkiat Trading & Co 29 February 2012 till 28
February 2017 (PL extended
to 26 March 2017)
POM
755 BRU12020865PS1 &
BRU12020865PS2
Nifedipine LA Tablet 30mg Nifedipine 30mg Valpharma International S.p.A, Italy (S1);
Valpharma S.A, Italy (S2)
G & H Trading Company 29 February 2012 till 28
February 2017
POM
756 BRU12020866P Apidra® Solostar® 100units/ml,
Solution for Injection in a Pre-
filled Pen
Insulin Glulisine 100units/ml Sanofi-Aventis Deutschland GmbH,
Germany
MediPharm Sdn Bhd 1 March 2017 till 28
February 2022
POM
757 BRU12020867P Zavedos CS Injection vials Idarubicin hydrochloride 1mg/ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28
February 2022
POM
758 BRU12020868P Betnovate™ Cream Betamethasone 0.1%w/w (as
Betamethasone 17-Valerate BP 0.122%
w/w)
Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28
February 2022
POM
759 BRU12020869P Dermovate™ Cream Clobetasol (as propionate) 0.05% w/w Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28
February 2022
POM
760 BRU12020870P Lyrica™ 150mg Capsules Pregabalin 150mg Pfizer Manufacturing Deutshland GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28
February 2022
POM
BDMCA/RMP/1116 Page 45 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
761 BRU12030871NP Panadol® Menstrual Caplet Paracetamol 500mg & Pamabrom 25mg Sterling Drug (Malaya) Sdn Bhd., Malaysia Kingston Beverage & Creamery
Sdn Bhd
30 March 2012 till 29 March
2017
P (12 x 10's)
762 BRU12030872NP Panadol® Pain Relief Patch Glycol Salicylate 1.5%w/w, L-Menthol 1.0%
w/w, DL-Camphor 0.5%w/w, DL-A-
Tocopherol Acetate 0.3%w/w
Teh Seng Pharmaceutical Mfg Co., Ltd.,
Taiwan, ROC
Kingston Beverage & Creamery
Sdn Bhd
30 March 2012 till 29 March
2017
GSL
763 BRU12030873P LacipilTM Tablet 4mg Lacipidine 4mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March
2022
POM
764 BRU12030874P BrilintaTM 90mg F/C Tablet Ticagrelor 90mg AstraZeneca AB., Sweden Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March
2022
POM
765 BRU12030875P DetrusitolTM
SR Capsule 4mg Tolterodine L-Tartrate 4mg (equivalent to
Tolterodine 2.74mg)
Catalent Pharma Solutions LLC, USA Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March
2022
POM
766 BRU12030876NP Ellgy Corns & Warts Treatment
Solution
Salicylic acid 17%w/v HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 30 March 2017 till 29 March
2022
P
767 BRU12030877P Puregon® 900IU/1.08ml Solution
for Injection
Follitropin Beta (Recombinant follicle-
stimulating hormone FSH) [Org 32489]
Vetter Pharma-Fertigung GmbH & Co. KG.,
Schutzenstrasse, Ravensburg, Germany;
Vetter Pharma-Fertigung GmbH & Co. KG.,
Mooswiesn2, Ravensburg, Germany;
Vetter Pharma-Fertigung GmbH & Co. KG.,
Eisenbahnstrasse, Langenargen,
Germany; Vetter Pharma-Fertigung GmbH
& Co. KG., Holbeinstrasse, Ravensburg,
Germany
Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March
2022
POM
768 BRU12030879P Methotrexate Injection BP 50mg
in 2ml
Methotrexate 50mg/2ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March
2022
POM
769 BRU12030880NP Aqua Cream Emulsifying Wax 8% w/w, White Soft
Paraffin 12%w/w, Liquid Paraffin 8%w/w
Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 30 March 2012 till 29 March
2017
GSL
770 BRU12030881P CelebrexTM 400mg Capsule Celecoxib 400mg Pfizer Pharmaceuticals LLC., vega Baja
Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March
2022
POM
771 BRU12030882P Cancidas Powder for Injection
50mg/vial
Caspofungin (as acetate) 50mg/vial Laboratoires Merck Sharp & Dohme
Chibret, France
Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March
2022
POM
772 BRU12030883P Axcel Dextrozine Syrup Dextromethorphan Hydrobromide
15mg/5ml; Promethazine HCl 3.6mg/5ml
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 March 2017 till 29 March
2022
POM
773 BRU12040884P Dilantin Steri Vials 250mg in 5ml Phenytoin Sodium 250mg/5ml Actavis Italy S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April
2022
POM
774 BRU12040885P Jevtana® 60mg Concentrate and
Solvent for Solution for Infusion
Cabazitaxel 60mg/1.5ml Sanofi-Aventis Deutschland GmbH,
Germany
Medipharm Sdn Bhd 30 April 2012 till 29 April
2017
POM
775 BRU12040886P HycamtinTM Hard Capsule 1mg Topotecan 1mg (as hydrochloride) GlaxoSmithKline Manufacturing S.p.A.,
Parma, Italy
Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April
2022
POM
776 BRU12040887NP Panadol Suspension 120mg/5ml Paracetamol 120mg/5ml SmithKline Beecham, Cainta Rizal,
Philippines
Kingston Beverage & Creamey
Sdn Bhd
30 April 2012 till 29 April
2017
GSL (60ml
& 120ml)
BDMCA/RMP/1116 Page 46 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
777 BRU12040888P Cancidas Powder for Injection
70mg/vial
Paracetamol 120mg/5ml Laboratoires Merck Sharp & Dohme
Chibret, France
Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April
2022
POM
778 BRU12040889PS1 &
BRU12040889PS2
Nasonex Aqueous Nasal Spray
0.05%
Mometasone furorate monohydrate,
micronized 0.05%
Schering-Plough Labo N.V., Belgium (S1) &
MSD International GmbH (Singapore
Branch), Singapore (S2)
Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April
2022
POM
779 BRU12040890PS1 &
BRU12040890PS2
Cerazette® Tablet 75mcg Desogestrel 75mcg N.V.Organon, The Netherlands (S1) &
Organon Ireland Limited, Ireland (S2)
Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April
2022
POM
780 BRU12040891P Axcel Diprodin Elixir Diphenhydramine HCl 12.5mg/5ml;
Ephedrine HCl 6mg/5ml
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 April 2017 till 29 April
2022
POM
781 BRU12040892NP Axcel Paracetamol-120 Syrup
(Cherry)
Paracetamol 120mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 April 2017 till 29 April
2022
GSL (60ml &
100ml)
782 BRU12040893P Axcel Clobetasol 0.05% Cream Clobetasol propionate 0.05%w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 April 2017 till 29 April
2022
POM
783 BRU12040894P Axcel Tridine Syrup Triprolidine HCl 1.25mg/5ml;
Pseudoephedrine HCl 30mg/5ml
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 April 2017 till 29 April
2022
POM
784 BRU12040895P Axcel Lignocaine Sterile Gel
2%w/w
Lignocaine HCl (Equiv. to anhydrous HCl)
2g/100g
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 April 2017 till 29 April
2022
POM
785 BRU12040896P Niquitin 21mg Transdermal Patch Nicotine 114mg (delivers 21mg/24 hours) ALZA Corporation, California, USA Zuellig Pharma (B) Sdn Bhd 30 April 2012 till 29 April
2017
P
786 BRU12050897P VfendTM IV 200mg Voriconazole 200mg Pharmacia & Upjohn Company, USA
(Repacker - Pfizer PGM, France)
Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May
2022
POM
787 BRU12050898P Lamictal Dispersible Tablet 5mg Lamotrigine 5mg GlaxoSmithKline Pharmaceuticals SA.,
Poznan, Poland (Repacker -
GlaxoSmithKline Australia Pty Ltd.,
ViCtoria, Australia)
Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May
2022
POM
788 BRU12050899P HycamtinTM Hard Capsule 0.25mg Topotecan 0.25mg (as hydrochloride) GlaxoSmithKline Manufacturing S.p.A.,
Parma, Italy
Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May
2022
POM
789 BRU12050900P AeriusTM Syrup 0.5mg/ml Desloratadine 0.5mg/ml Schering-Plough Labo N.V., Belgium Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May
2022
POM
790 BRU12050901NP Flamazine Cream 1% w/w Silver Sulfadiazine 1.0%w/w Recipharm Parets S.L., Barcelona, Spain Mc Quipp Technisell Marketing
Sdn Bhd
24 May 2017 till 23 May
2022
P
791 BRU12050902P AeriusTM Tablets 5mg Desloratadine 5mg Schering-Plough Labo N.V., Belgium Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May
2022
POM
792 BRU12050903NP Panadol® ActiFast Caplets Paracetamol 500mg GlaxoSmithKline Dungravan Ltd, Ireland
(Repacker - Sterling Drug (Malaya) Sdn
Bhd., Malaysia
Kingston Beverage & Creamery
Sdn Bhd
24 May 2012 till 23 May
2017
P ( 48's; 80's (8
tabs per blister)
per box)
793 BRU12050904P Vaxcel Heparin Sodium Injection
5000 IU/ml x 5ml
Heparin Sodium (Bovine mucosa)
25,000/5ml
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 24 May 2017 till 23 May
2022
POM
794 BRU12050905P Pregnyl® 5000IU Powder and
Solvent for Injection
Heparin Sodium (Bovine mucosa)
25,000/5ml
Merck & Co. Inc., USA Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May
2022
POM
795 BRU12050906P Niquitin 7mg Transdermal Patch Nicotine 36mg/cm2 (delivers 7mg/24
hours)
ALZA Corporation, California, USA Zuellig Pharma (B) Sdn Bhd 24 May 2012 till 23 May
2017
P
BDMCA/RMP/1116 Page 47 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
796 BRU12050907NP Eye Mo Moist Eye Lubricant (Eye
Drops)
Hydroxypropyl Methycellulose 0.3%w/v GlaxoSmithKline (Tianjin) Co Ltd., China Kingston Beverage & Creamery
Sdn Bhd
24 May 2012 till 23 May
2017
GSL
797 BRU12060908P Methycobal Tablets 500mcg Mecobalamin JP 0.5mg Bushu Pharmaceuticals Ltd, Japan Medipharm Sdn Bhd 30 June 2012 till 29 June
2017
POM
798 BRU12060909P LyricaTM 75mg Capsules Pregabalin 75mg Pfizer Manufacturing Deutschland GmbH,
Freiburg, Germany
Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June
2022
POM
799 BRU12060910NP Panadol® Soluble Tablet 500mg Paracetamol 500mg GlaxoSmithKline Australia Pty Ltd,
Ermington, NSW, Australia
Kingston Beverage & Creamery
Sdn Bhd
30 June 2012 till 29 June
2017
GSL (20's)
& P (144's)
800 BRU12060911NP Panadol For Children Tablets
120mg
Paracetamol 120mg Sterling Drug (Malaya) Sdn Bhd., Selangor,
Malaysia
Kingston Beverage & Creamery
Sdn Bhd
30 June 2012 till 29 June
2017
P (24's & 144's)
801 BRU12060912P Canesten GYN 1 Day Therapy
Vaginal Tablet 0.5g
Clotrimazole 500mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June
2022
POM
802 BRU12060913P Casodex Tablet 50mg Bicalutamide 50mg Corden Pharma GmbH, Plankstadt,
Germany
Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June
2022
POM
803 BRU12060914NP ENO Mint Fruit Salt Sodium Bicarbonate Coarse 1.483g
(34.49%w/w); Sodium Bicarbonate Fine
0.495g (11.51%w/w); Citric Acid Anhydrous
1.860g (43.26%w/w); Sodium Carbonate
Anhydrous 0.43g (10.0%w/w)
Sterling Drug (Malaya) Sdn Bhd., Selangor,
Malaysia
Kingston Beverage & Creamery
Sdn Bhd
30 June 2012 till 29 June
2017
GSL (48's)
804 BRU12060915P Drapolene Cream Cetrimide 0.2%w/w; Benzalkonium
Chloride Solution 0.02%w/w (equiv. to
Benzalkonium Chloride 0.01%w/w)
GlaxoSmithKline Pharmacuetical SA,
Poznan, Poland
Kingston Beverage & Creamery
Sdn Bhd
30 June 2012 till 29 June
2017
GSL (55g)
805 BRU12060916P Rhewlin Gel 1%w/w Diclofenac Diethylamine equiv. to
Diclofenac Sodium 1%w/w
Beacons Pharmaceutical Pte Ltd,
Singapore
Hongkiat Trading & Company 30 June 2012 till 29 June
2017
GSL
806 BRU12060917P Efexor® XR 37.5mg Capsule Venlafaxine Hydrochloride 37.5mg Pfizer Ireland Pharmacueticals, Kildare,
Republic of Ireland
Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June
2022
POM
807 BRU12070918P Beclomet Nasal Aqua
50mcg/dose Nasal Spray
Beclomethasone dipropionate 50mcg/dose Orion Corporation, Kuopio, Finland Hongkiat Trading & Company 30 July 2012 till 29 July 2017 POM
808 BRU12070919P Panadol CF Cold and Flu Caplets Paracetamol 500mg; Pseudoephedrine HCl
30mg; Chlorpheniramine 2mg
Sterling Drug (Malaya) Sdn Bhd., Selangor,
Malaysia
Zuellig Pharma (B) Sdn Bhd 30 July 2012 till 29 July 2017 P (10's)
809 BRU12070920NP Panadol® Biconvex Film-coated
Tablet 500mg
Paracetamol 500mg Sterling Drug (Malaya) Sdn Bhd., Selangor,
Malaysia
Kingston Beverage & Creamery
Sdn Bhd
30 July 2012 till 29 July 2017 P (50's, 3 x 10's &
15 x 10's)810 BRU12070921NP ENO Ginger Fruit Salt Sodium Bicarbonate Coarse 1.462g
(34.002%w/w); Sodium Bicarbonate Fine
0.487g (11.316%w/w); Citric Acid
Anhydrous 1.834g (42.640%w/w); Sodium
Carbonate Anhydrous 0.425g (9.892%w/w)
Sterling Drug (Malaya) Sdn Bhd., Selangor,
Malaysia
Kingston Beverage & Creamery
Sdn Bhd
30 July 2012 till 29 July 2017 GSL
BDMCA/RMP/1116 Page 48 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
811 BRU12070922NP ENO Fruit Salt Sodium Bicarbonate Coarse 1.489g
(34.63%w/w); Sodium Bicarbonate Fine
0.496 (11.54%w/w); Citric Acid Anhydrous
1.873g (43.58%w/w); Sodium Carbonate
Anhydrous 0.43g (10.00%w/w)
Sterling Drug (Malaya) Sdn Bhd., Selangor,
Malaysia
Kingston Beverage & Creamery
Sdn Bhd
30 July 2012 till 29 July 2017 GSL
812 BRU12070923P Coversyl Plus 10mg/2.5mg Tablet Perindopril arginine 10mg (equiv. to
6.79mg perindopril); Indapamide 2.5mg
Servier (Ireland) Industries Ltd, Ireland Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM
813 BRU12070924P RotarixTM
oral Suspension Human rotavirus RIX4414 strain, not less
than 106.0 CCID50
GlaxoSmithKline Biological SA, Belgium Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM
814 BRU12070925P CutivateTM Cream Fluticasone propionate (micronised)
0.05%w/w
Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM
815 BRU12070926NP Bepanthen® Ointment Dexpanthenol 5%w/w GP Genzech Produktions GmbH, Germany Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 GSL
816 BRU12070927P Axcel Hydrocortisone Cream Hydrocortisone (micronised) 1% w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 July 2017 till 29 July 2022 POM
817 BRU12070928P Sevoflurane Inhalation
Anaesthetic Liquid 100%
Sevoflurane 100% (1ml/ml) Baxter Healthcare Corporation, Puerto
Rico, USA
Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM
818 BRU12080929P Niquitin 14mg Transdermal Patch Nicotine 78mg (14mg/24hrs) Alza Corporation, California, USA Zuellig Pharma (B) Sdn Bhd 29 August 2012 till 28 August
2017
P
819 BRU12080930NP Dequadin® Lozenges (Citrus
Flavour)
Dequalinium Chloride 0.25mg Sterling Drug (Malaya) Sdn Bhd., Selangor,
Malaysia
Kingston Beverage & Creamery
Sdn Bhd
29 August 2012 till 28 August
2017
GSL (6x4's & 24's)
820 BRU12080931P Rilutek Tablets 50mg Riluzole 50mg Sanofi Winthrop Industrie, Cedex, France Medipharm Sdn Bhd 29 August 2012 till 28 August
2017
POM
821 BRU12080932P Efexor XR 75mg Capsule Venlafaxine (as HCl) 75mg Pfizer Ireland Pharmaceuticals, Kildare,
Republic of Ireland
Zuellig Pharma (B) Sdn Bhd 29 August 2017 till 28 August
2022
POM
822 BRU12090933P Xarelto® Film-coated Tablet 10mg Rivaroxaban 10mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 27 September 2012 till 26
September 2017
POM
823 BRU12090934P Nif-Ten Capsule Atenolol 50mh; Nifedipine 20mg Corden Pharma GmbH, Plankstadt,
Germany
Zuellig Pharma (B) Sdn Bhd 27 September 2012 till 26
September 2017
POM
824 BRU12090937P Telfast 6mg/ml Oral Suspension Fexofenadine Hydrochloride 6mg/ml Sanofi-Aventis Farmceutica Ltd, Vila
Areiao Suzano-SP-Brasil
Medipharm Sdn Bhd 27 September 2012 till 26
September 2017
POM
825 BRU12090938P Glucophage® XR 750mg Extended
Release Tablet
Metformin HCl 750mg Merck KGaA, Germany; Merck Sante SAS,
Semoy, France
Zuellig Pharma (B) Sdn Bhd 27 September 2017 till 26
September 2022
POM
826 BRU12090939P Glucophage® Tablet 500mg Metformin HCl 500mg Merck Sante SAS, Semoy, France Zuellig Pharma (B) Sdn Bhd 27 September 2017 till 26
September 2022
POM
827 BRU12100940NP Dermoplex Calamine Cream Calamine (Fine) 4.00%; Zinc Oxide 3.00%
w/w
Upha Pharmaceutical Mfg (M) Sdn Bhd Hongkiat Trading & Company 31 October 2012 till 30
October 2017
GSL
828 BRU12100941P FragminTM Solution for Injection
5,000IU (anti-Xa)/0.2ml
Dalteparin Sodium 5,000IU (anti-Xa)/0.2ml Vetter Pharma-Fertigung GmbH & Co.,
Germany
Zuellig Pharma (B) Sdn Bhd 31 October 2012 till 30
October 2017
POM
BDMCA/RMP/1116 Page 49 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
829 BRU12100942P Prostin E2TM Vaginal Tablet 3mg Dinoprostone 3mg Sanico N.V., Turnhout, Belgium Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30
October 2022
POM
830 BRU12100943NP Dianeal Low Calcium (2.5mEq/L)
Peritoneal Dialysis Solution with
2.5% Dextrose
Dextrose 2.5g; Sodium Chloride 538mg;
Sodium Lactate 448mg; Calcium Chloride
dihydrate 18.3mg; Magnesium Chloride
Hexhydrate 5.08mg
Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 31 October 2012 till 30
October 2017
POM
831 BRU12100944NP Potassium Chloride Tablet 600mg
(Slow release)
Potassium Chloride 600mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 31 October 2012 till 30
October 2017
POM
832 BRU12100945NP Anucare Suppositories Zinc Oxide 300mg; Balsam Peru 50mg;
Benzyl Benzoate 33mg
Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 31 October 2012 till 30
October 2017
GSL
833 BRU12100946P Salbu-Air CFC Free Inhaler Salbutamol Sulphate (micronised) 100mcg
per actuation
Laboratorio Aldo-Union S.A., Barcelona G & H Trading Company 31 October 2012 till 30
October 2017
POM
834 BRU12100947P Illiadin Nasal Decongestant
Solution 0.01%
Oxymetazoline Hydrochloride 0.01% Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 31 October 2012 till 30
October 2017
P
835 BRU12100948P Renvela (Sevelamer Carbonate)
Tablet 800mg
Sevelamer Carbonate 800mg Genzyme Ireland Limited, Ireland Medipharm Sdn Bhd 31 October 2012 till 30
October 2017
POM
836 BRU12100949P Lyrica Capsules 50mg Pregabalin 50mg Pfizer Manufacturing Deutschland GmbH,
Freiburg, Germany
Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30
October 2022
POM
837 BRU12100950P QvarTM 100 Inhaler Beclomethasone dipropionate 100mcg per
inhalation
3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30
October 2021
POM
838 BRU12100951P Prograf Capsule 0.5mg Tacrolimus 0.5mg Astellas Ireland Ltd, Ireland Zuellig Pharma (B) Sdn Bhd 31 October 2012 till 30
October 2017
POM
839 BRU12110952P Panadol C Tablet Paracetamol 500mg; Pseudoephedrine
Hydrochloride 30mg
Sterling Drug (Malaya) Sdn Bhd, Malaysia Zuellig Pharma (B) Sdn Bhd 27 November 2012 till 26
November 2017
P
840 BRU12110953P FragminTM
Solution for Injection
2,500IU (anti-Xa)/0.2ml, Single
dose syringe
Dalteparin Sodium 2,500IU (anti-Xa)/0.2ml Vetter Pharma-Fertigung GmbH & Co.,
Germany
Zuellig Pharma (B) Sdn Bhd 27 November 2012 till 26
November 2017
POM
841 BRU12110954P Efexor XR 150mg Capsule Venlafaxine (as Hydrochloride) 150mg Pfizer Ireland Pharmaceuticals, Kildare,
Republic of Ireland
Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26
November 2022
POM
842 BRU12110955P Eprex® 4000 Prefilled Syringe
4000IU/0.4ml
Epoetin alfa 4,000IU/0.4ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2012 till 26
November 2017
POM
843 BRU121109561P Topamax® 50 Tablets Topiramate 50mg Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2012 till 26
November 2017
POM
844 BRU12110956NP Vitamin C 100mg Tablet Ascorbic Acid 100mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 27 November 2012 till 26
November 2017
GSL
845 BRU12110957PS1;
BRU12110957PS2
Actrapid® 100IU/ml Solution for
Injection
Insulin Human (rDNA) 100iu/ml Novo Nordisk A/S, Denmark (S1); Novo
Nordisk Production SAS, France (S2)
Medipharm Sdn Bhd 27 November 2017 till 26
November 2022
POM
846 BRU12110958P Tretino Cream 0.05% Tretionoin (Retinoic acid) 0.5mg/g Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 27 November 2012 till 26
November 2017
POM
847 BRU12110959P Eprex® 2000 Prefilled Syringe
2000IU/0.5ml
Epoetin alfa 2,000IU/0.5ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2012 till 26
November 2017
POM
BDMCA/RMP/1116 Page 50 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
848 BRU12110960NP Daflon 500mg Tablet Diosmin 450mg; Hesperidin 50mg Les Laboratories Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 27 November 2012 till 26
November 2017
GSL
849 BRU12110962P Tenol-100 Atenolol 100mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 27 November 2012 till 26
November 2017
POM
850 BRU12110963NP Polysilic III Suspension Per 5ml contains Dried Aluminium
Hydroxide Gel 400mg; Magnesium
Trisilicate light 400mg; Simethicone 30mg
Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 27 November 2012 till 26
November 2017
GSL (200ml); GSL
(3.8L)
851 BRU12110964P Exjade 125mg Dispersible Tablets Deferasirox 125mg Novartis Pharmas Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26
November 2022
POM
852 BRU12110965P Exjade 500mg Dispersible Tablets Deferasirox 500mg Novartis Pharmas Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26
November 2022
POM
853 BRU12110966NP Dhamotil Tablets Diphenoxylate HCl BP 2.5mg; Atropine
Sulphate 0.025mg
Drug Houses of Australia Pte Ltd.,
Singapore
G & H Trading Company 27 November 2012 till 26
November 2017
POM
854 BRU12120967P CervarixTM Vaccine (Prefilled
Syringe)
1 dose (0.5ml) contains: Human
Papillomavirus type 16 L1 protein 20mcg;
Human Papillomavirus type 18 L1 protein
20mcg; 3-O-desacyl-4'-monophosphoryl
lipid A (MPL) 50mcg; adsorbed on
aluminium hydroxide, hydrated (Al(OH)3)
0.5mcg Al3+
GlaxoSmithKine Biologicals S.A., Rixensart,
Belgium
Zuellig Pharma (B) Sdn Bhd 27 December 2012 till 26
December 2017
POM
855 BRU12120968NP Dianeal Low Calcium (2.5mEq/L)
Peritoneal Dialysis Sodium with
4.25% Dextrose
Per 100ml contains Calcium Chloride
18.3mg; Dextrose hydrous 4.25g;
Magnesium Chloride 5.08mg; Sodium
Chloride 538mg; Sdoium Lactate 448mg
Baxter Healthcare SA, Singapore Zuellig Pharma (B) Sdn Bhd 27 December 2012 till 26
December 2017
POM
856 BRU12120969NP ENO Orange Each 4.3g contains Citric Acid Anhydrous
1.851g; Sodium Bicarbonate Coarse 1.478g;
Sodium Bicarbonate Fine 0.492; Sodium
Carbonate Anhydrous 0.43g
Sterling Drug (Malaya) Sdn Bhd., Malaysia Kingston Beverage & Creamery
Sdn Bhd
27 December 2012 till 26
December 2017
GSL
857 BRU12120970P Clementin Film Coated Tablet
625mg
Amoxicillin (as Trihydrate) 500mg;
Clavulanic Acid (as Potassium Salt) 125mg
Yung Shin Pharmaceutical Ind. Co. Ltd.,
Taichung, Taiwan
Asterix United (B) Sdn Bhd 27 December 2012 till 26
December 2017
POM
858 BRU12120971P Survanta® Beractant Intratracheal
Suspension
Beractant (as phospholipids) 25mg/ml AbbVie Inc., USA Zuellig Pharma (B) Sdn Bhd 27 December 2012 till 26
December 2017
POM
859 BRU12120972P Humira Solution for Injection
40mg/0.8ml
Adalimumab 40mg/0.8ml Vetter-Pharma-Fertigung GmbH & Co.,
KG, Ravensburg, Germany
Zuellig Pharma (B) Sdn Bhd 27 December 2012 till 26
December 2017
POM
860 BRU12120973P ZyrprexaTM
Tablet 10mg Olanzapine 10mg Lily del Caribe Inc, Puerto Rico, USA & Lilly
S.A., Madrid, Spain
Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
861 BRU12120974P SutentTM Hard Capsules 12.5mg Sunitinib 12.5mg (as Malate) Pfizer Italia S.r.l., Ascoli Piceno, Italy Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
BDMCA/RMP/1116 Page 51 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
862 BRU12120975P Stelara Solution for Injection in
pre-filled syringe 45mg/0.5ml
Ustekinumab 45mg/0.5ml Baxter Pharmaceutical Solutions LLC,
Blommington, United States
Zuellig Pharma (B) Sdn Bhd 27 December 2012 till 26
December 2017
POM
863 BRU12120976P Viagra 50mg Tablet Sildenafil 50mg (as Citrate) Pfizer PGM Amboise, France Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
864 BRU12120977P Viagra 100mg Tablet Sildenafil 100mg (as Citrate) Pfizer PGM Amboise, France Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
865 BRU12120978P Aerrane (Isoflurane USP)
Inhalation Liquid
Isoflurane USP 100% Baxter Healthcare Corporation, Puerto
Rico, USA
Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26
December 2022
POM
866 BRU12120979P Kogenate FS for Injection
250IU/vial
Antihaemophilic Factor (recombinant)
sucrose formulated 250IU
Bayer Healthcare LLC., United States Zuellig Pharma (B) Sdn Bhd 27 December 2012 till 26
December 2017
POM
867 BRU12120980P Potcit Mixture Per 5ml contains Potassium Citrate 1g;
Citric acid anhydrous 200mg
Beacons Pharmaceutical Pte Ltd.,
Singapore
Hongkiat Trading & Company 27 December 2012 till 26
December 2017
POM
868 BRU12120981P Garbose Tablet 100mg Acarbose 100mg Y.S.P Industries (M) Sdn Bhd., Selangor
Darul Ehsan, Malaysia
Asterix United (B) Sdn Bhd 27 December 2012 till 26
December 2017
POM
869 BRU13010982P KombiglyzeTM XR Tablet
5/1000mg
Saxagliptin HCl 5mg (as anhydrous
5.58mg); Metformin Hydrochloride
1000mg
Bristol Myers Squibb Company USA Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25
January 2018
POM
870 BRU13010983P KombiglyzeTM XR Tablet 5/500mg Saxagliptin HCl 5mg (as anhydrous
5.58mg); Metformin Hydrochloride 500mg
Bristol Myers Squibb Company USA Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25
January 2018
POM
871 BRU13010984P KombiglyzeTM XR Tablet
2.5/1000mg
Saxagliptin HCl 2.5mg (as anhydrous
2.79mg); Metformin Hydrochloride
1000mg
Bristol Myers Squibb Company USA Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25
January 2018
POM
872 BRU13010985P Zanidip® 20mg Tablet Lercanidipine HCl 20mg Recordati Industria Chimica &
Farmaceutica S.p.A., Milan, Italy
Hongkiat Trading & Co 26 January 2013 till 25
January 2018
POM
873 BRU13010986NP Eye Mo Eye Drops Boric acid 12.98mg/ml (1.298% w/v);
Sodium Borate (equivalent to) 2.04mg/ml
(0.204%w/v)
GlaxoSmithKline (Tianjin) Co. Ltd., China Kingston Beverage & Creamery
Sdn Bhd
26 January 2013 till 25
January 2018
GSL
874 BRU13010987P Pontalon Tablet 500mg Mefenamic Acid 500mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 26 January 2013 till 25
January 2018
POM
875 BRU13010988P Co-Trimexazole Suspension Per 5ml - Sulphamethoxazole BP 200mg;
Trimethoprim 40mg
Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & CO 26 January 2013 till 25
January 2018
POM
876 BRU13010989P Opticrom® Eye Drops 2% w/v Sodium Cromoglycate BP 2% w/v Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 26 January 2013 till 25
January 2018
P
877 BRU13010990NP Panamol Paed. Suspension
120mg/5ml
Paracetamol 120mg/5ml Beacons Pharmaceuticals Pte ltd,
Singapore
Hongkiat Trading & Co 26 January 2013 till 25
January 2018
P (3.8L)
878 BRU13010991P Humulin 30/70 Injection 100iu/ml
(vial)
Human Insulin 100IU/ml (recombinant) -
30% Soluble insulin & 70% Isophane Insulin
Eli Lilly and Co., USA Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25
January 2023
POM
879 BRU13010993P FML® Liquifilm Sterile Opthalmic
Solution 0.1%
Fluorometholone 0.1%w/v Allergan Pharmaceuticals Ireland, Ireland Medipharm Sdn Bhd 26 January 2013 till 25
January 2018
POM
880 BRU13010994NP Lacri-Lube S.O.P. Lubricants Eye
Ointment
Liquid Paraffin (Mineral Oil) 42.5%w/w;
Soft White Paraffin (White Petrolatum)
56.8% w/w
Allergan Sales LLC, United States Medipharm Sdn Bhd 26 January 2013 till 25
January 2018
GSL
BDMCA/RMP/1116 Page 52 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
881 BRU13010995P Daivonex® Ointment Calcipotriol 50mcg/g (0.005% w/w) LEO Laboratories Ltd (LEO Pharma),
Ireland
Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25
January 2018
POM
882 BRU13010996P Seretide Evohaler 25/125mcg Per actuation - Fluticasone propionate
125mcg; Salmetarol 25mcg (as xinafoate)
Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25
January 2018
POM
883 BRU13010997P Glucophage® Tablet 850mg Metformin HCl 850mg (~Metformin
662.9mg)
Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25
January 2018
POM
884 BRU13010998P Revlimid® Capsules 5mg Lenalidomide 5mg Penn Pharmaceutical Services Limited, UK
& Celgene International Sarl, Switzerland
Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25
January 2018
POM
885 BRU13010999NP Infusol® NS Sodium Chloride 0.9% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 January 2013 till 25
January 2018
GSL
886 BRU13011000P Inpanol Tablets 10mg Propranolol BP 10mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 26 January 2013 till 25
January 2018
POM
887 BRU13011001P Ciloxan Eyedrops Per ml - Ciprofloxacin HCl 3mg (as
Ciprofloxacin HCl monohydrate 3.5%)
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 26 January 2013 till 25
January 2018
POM
888 BRU13011002P One-Alpha® Capsule 1mcg Alfacalcidol 1mcg (1α-Hydroxy-vitamin D3) Leo Pharmaceutical Products Ltd., A/S
(Leo Pharma), Denmark
Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25
January 2018
POM
889 BRU13011003P Nimotop Infusion Solution 0.02% Nimodipine 0.01g/50ml Bayer Schering Pharma AG, Leverkeusen,
Germany
Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25
January 2018
POM
890 BRU13011004P Gemzar 200mg Powder for
Solution for Infusion
Gemcitabine 200mg (as HCl) Eli Lilly and Company, Indiana, USA Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25
January 2018
POM
891 BRU13011005P ZyprexaTM 5mg Tablet Olanzapine 5mg Lilly del Caribe Inc., Puerto Rico, USA &
Lilly, S.A., Spain
Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25
January 2023
POM
892 BRU13021006P Canesten GYN Vaginal Tablet
100mg - 3 day therapy
Clotrimazole 100mg Bayer Consumer AG, Basel, Switzerland Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25
February 2018
POM
893 BRU13021008P Prevenar 13 Suspension for
Injection
Per 0.5ml - Pneumococcal Polysaccharide
Serotype 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A,
19F, 23F - 2.2mcg; Pneumococcal
Polysaccharide Serotype 6B - 4.4mcg
Pfizer Ireland Pharmaceuticals, Dublin,
Ireland
Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25
February 2018
POM
894 BRU13021009P Hemabate Sterile Solution
250mcg/ml
Carboprost (as tromethamine) 250mcg/ml Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25
February 2018
POM
895 BRU13021010PS1;
BRU13021010PS2
Humulin® 30/70 Injection
100iu/ml (catridge)
Human Insulin 100IU/ml (recombinant) -
30% Soluble insulin & 70% Isophane Insulin
Eli Lilly and Company, Indiana, USA (S1);
Eli Lily Italia S.p.A., Sesto Fiorentino,
(FI) Italy (S2)
Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25
February 2023
GSL
896 BRU13021011P Extraneal Peritoneal Dialysis
Solution 75g/L
Per 100ml: Icodextrin 7.5g; Sodium
Chloride 538mg; Sodium Lactate 448mg;
Calcium Chloride 25.7mg; Magnesium
Chloride 5.08mg
Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 26 February 2013 till 25
February 2018
POM
897 BRU13021012P Afinitor Tablet 10mg Everolimus 10mg Novartis Pharma Stein AG, Stein,
Switzerland
Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25
February 2018
POM
BDMCA/RMP/1116 Page 53 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
898 BRU13021013P Ketovid Cream 2% Ketoconazole 2.0% w/w Hovid Bhd, Perak, Malaysia G & H Trading Company 26 February 2013 till 25
February 2018
POM
899 BRU13021014P Progynova® Tablet 2mg Estradiol Valerate 2mg Delpharm Lille SAS, Lys Les Lannoy, Franc Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25
February 2018
POM
900 BRU13021015P Azopt Eye Drops, Suspension Brinzolamide 10mg/ml (1.0%w/w) S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 26 February 2013 till 25
February 2018
POM
901 BRU13021016P Rhewlin SR Tablet Diclofenac Sodium 100mg Beacons Pharmaceutical Pte Ltd,
Singapore
Hongkiat Trading & Co 26 February 2013 till 25
February 2018
POM
902 BRU13021017P Hydrogen Peroxide Solution 6% Hydrogen Peroxide 6% w/v (equivalent to
20 volumes of oxygen)
Xepa-Soul Pattinson (Malaysia) Sdn Bhd,
Malaysia
Hongkiat Trading & Co 26 February 2013 till 25
February 2018
P
903 BRU13021018P Inpanol Tablets 40mg Propranolol BP 40mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 26 February 2013 till 25
February 2018
POM
904 BRU13021019P Stilamin 3000 for Injection
3mg/ampoule
Somatostatin (as acetate) 3mg Merck Serono SA, Aubonne, Switzerland G&H Trading Company 26 February 2013 till 25
February 2018
POM
905 BRU13021020P Loradine Syrup 1mg/ml Loratadine 1mg/ml Y.S.P Industries (M) Sdn Bhd, Selangor
Darul Ehsan, Malaysia
Asterix United (B) Sdn Bhd 26 February 2013 till 25
February 2018
P
906 BRU13021021P Decozol Oral Gel 2% w/w Miconazole 2% w/w HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 26 February 2013 till 25
February 2018
GSL
907 BRU13021022P Rasitol Injection 20mg/2ml Furosemide 20mg/2ml Yung Shin Pharmaceutical Ind. Co. Ltd.,
Taiwan, ROC
Asterix United (B) Sdn Bhd 26 February 2013 till 25
February 2018
POM
908 BRU13021023P Fusate-250 Tablet Sodium fusidate 250mg Noripharma Sdn Bhd, Selangor Darul
Ehsan, Malaysia
K-Seri Pharma Sdn Bhd 26 February 2013 till 25
February 2018
POM
909 BRU13021024P Premarin Vaginal Cream Conjugated Oestrogen (CE) 0.625mg/g Pfizer Canada Inc., Canada Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25
February 2018
POM
910 BRU13021025NP Dhalgesic Rub 15% w/w Methyl salicylate 15% w/w; Menthol 5%
w/w; Camphor (racemic) 2% w/w
Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 26 February 2013 till 25
February 2018
GSL
911 BRU13021026P Kaletra Film-coated Tablet
200mg/50mg
Lopinavir 200mg; Ritonavir 50mg AbbVie Deutschland GmbH & Co. KG,
Germany
Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25
February 2018
POM
912 BRU13021027P Sustanon 250 Per 1ml - Testosterone decanoate 100mg;
Testosterone phenylpropionate 60mg;
Testosterone isocaproate 60mg;
Testosterone propionate 30mg [Equivalent
to Testosterone 176mg/ml]
Merck Sharp & Dohme, the Netherlands Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25
February 2018
POM
913 BRU13021028P Holoxan for Injection Ifosfamide 1g Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25
February 2018
POM
914 BRU13031029NP Panadol Extend Tablet Paracetamol 665mg GlaxoSmithKline Australia Pty Ltd,
Australia
Kingston Beverage & Creamery
Sdn Bhd
28 March 2013 till 27 March
2018
P (8 x 6's)
915 BRU13031030P Canesten Cream 1% w/w Clotrimazole 1% w/w Encube Ethicals Private Ltd, India Zuellig Pharma (B) Sdn Bhd 28 March 2013 till 27 March
2018
GSL
916 BRU13031032P Pantaprazole Winthrop 20mg
Tablet
Pantoprazole (as sodium sesquihydrate)
20mg
Sanofi-Aventis S.P.Z.O.O., Poland Medipharm Sdn Bhd 28 March 2013 till 27 March
2018
POM
BDMCA/RMP/1116 Page 54 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
917 BRU13031033PS1;
BRU13031033PS2
Metoclopramide Tablet 10mg Metoclopramide HCl BP (equivalent to
Metoclopramide HCl anhydrous 10mg)
Drug House of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 28 March 2013 till 27 March
2018
POM
918 BRU13031034P Loperamil Tablet 2mg Loperamide 2mg Drug House of Australia Pte Ltd,
Singapore
G & H Trading Company 28 March 2013 till 27 March
2018
POM
919 BRU13031035P Hydralazine Tablet 50mg Hydralazine HCl 50mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Co 28 March 2013 till 27 March
2018
POM
920 BRU13031036P Dhacort Cream 1%w/w Hydrocortisone acetate BP (micronised) 1%
w/w
Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 28 March 2013 till 27 March
2018
POM
921 BRU13031037P Tracidol Capsule 50mg Tramadol HCl 50mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 28 March 2013 till 27 March
2018
POM
922 BRU13031038P Solcoseryl Dental Adhesive Paste Per g - Solcoseryl CMC 2.125mg;
Polidocanol 10mg
Legacy Pharmaceuticals Switzreland
GmbH, Switzerland
Zuellig Pharma (B) Sdn Bhd 28 March 2013 till 27 March
2018
POM
923 BRU13031039NP Infusol® S3 Sodium Chloride 3% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 28 March 2013 till 27 March
2018
POM
924 BRU13031040P Indapamide SR Tablet 1.5mg Indapamide 1.5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 28 March 2013 till 27 March
2018
POM
925 BRU13031041P Dhatifen Syrup 1mg/5ml Ketotifen (as hydrogen fumarate) 1mg/5ml Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 28 March 2013 till 27 March
2018
POM
926 BRU13031042P Inox Capsule 100mg Itraconazole 100mg Hovid Bhd, Malaysia G & H Trading Company 28 March 2013 till 27 March
2018
POM
927 BRU13031043P Doxycap capsule 100mg Anhydrous Doxycycline 100mg Hovid Bhd, Malaysia G & H Trading Company 28 March 2013 till 27 March
2018
POM
928 BRU13031044P Zenmolin tablet 2mg Salbutamol (as sulphate) 2mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 28 March 2013 till 27 March
2018
POM
929 BRU13031045P Recormon Pre-filled Syringe
2000IU/0.3ml
Erythropoetin Beta 2,000iu/0.3ml Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 March 2013 till 27 March
2018
POM
930 BRU13031046P Leukeran Tablet 2mg Chlorambucil 2mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 March 2013 till 27 March
2018
POM
931 BRU13031047P Recormon Pre-filled Syringe
4000IU/0.3ml
Erythropoetin Beta 4,000iu/0.3ml Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 March 2013 till 27 March
2018
POM
932 BRU13031049P Saizen for Injection 3.33mg/vial Somatropin 3.33mg (10 IU) Merck Serono S.A., Switzerland G & H Trading Company 28 March 2013 till 27 March
2018
POM
933 BRU13031050P Isentress 400mg Tablet Raltegravir 400mg (as potassium 434.4mg) MSD Technology Singapore Pte Ltd.,
Singapore
Zuellig Pharma (B) Sdn Bhd 28 March 2013 till 27 March
2018
POM
934 BRU13041051P Taxotere 80mg/4ml Concentrate
for Solution for Infusion
Docetaxel trihydrate 80mg/4ml Sanofi-Aventis Deutschland GmbH,
Germany
Medipharm Sdn Bhd 30 April 2013 till 29 April
2018
POM
935 BRU13041052P Fosamax Plus Tablet
70mg/5600IU
Alendronic Acid 70mg (as Sodium
91.37mg); Colecalciferol 140mcg (5,600IU)
MSD Frosst Iberica, S.A., Madrid, Spain Zuellig Pharma (B) Sdn Bhd 30 April 2013 till 29 April
2018
POM
936 BRU13041053P Glucovance Tablet 500mg/2.5mg Metformin HCl 500mg, Glibenclamide
2.5mg
Merck Sante SAS, Semoy, France Zuellig Pharma (B) Sdn Bhd 30 April 2013 till 29 April
2018
POM
937 BRU13041054PS1 &
BRU13041054PS2
Rebif ® Pre-filled Syringe
22mcg/0.5ml
Interferon beta-1a 22mcg (6MIU) / 0.5ml Merck Serono S.p.A., Modugno, Italy (S1);
Merck Serono S.A., Aubonne, Switzerland
G & H Trading Company 30 April 2013 till 29 April
2018
POM
BDMCA/RMP/1116 Page 55 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
938 BRU13041055P Alpranax Tablet 0.5mg Alprazolam 0.5mg Y.S.P Industries (M) Sdn Bhd Malaysia K-Seri Pharma Sdn Bhd 30 April 2013 till 29 April
2018
POM
939 BRU13041056NP Liquid Paraffin Liquid Paraffin 100%w/w Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 April 2013 till 29 April
2018
GSL
940 BRU13041057P Fucithalmic® Eye Drops 1% Fusidic acid 10mg/g (1.0%w/w) LEO Laboratories Ltd, Dublin, Ireland Zuellig Pharma (B) Sdn Bhd 30 April 2013 till 29 April
2018
POM
941 BRU13041058P Pegasys Pre-filled Syringe
180mcg/0.5ml
Peginterferon alfa-2a 180mcg/0.5ml F Hoffman-La Roche Ltd, Switzerland;
Roche Diagnostic GmbH, Germany; F
Hoffman-La Roche Ltd, Betriebsstandort
Kaiseraugst (Parenterals), Switzerland
Hongkiat Trading & Co 30 April 2013 till 29 April
2018
POM
942 BRU13041059P Borymycin Capsule 50mg Minocycline HCl 50mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 April 2013 till 29 April
2018
POM
943 BRU13041060P Kytril Tablet 1mg Granisetron 1mg (as HCl) Roche S.p.A., Italy Hongkiat Trading & Co 30 April 2013 till 29 April
2018
POM
944 BRU13041061P Venofer® Solution for Injection
100mg/5ml
Iron (III) [as Iron (III)-hydroxide sucrose
complex] 100mg/5ml
IDT Biologika GmbH, Germany; BIPSO
GmbH, Germany
Hongkiat Trading & Co 30 April 2013 till 29 April
2018
POM
945 BRU13041062NP Calamine cream Calamine 4%w/w; Zinc Oxide 3% w/w Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 April 2013 till 29 April
2018
GSL
946 BRU13041063P Apuzin tablet 25mg Captopril 25mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 April 2013 till 29 April
2018
POM
947 BRU13041064P Lezpain film-coated tablet 135mg Mebeverine HCl 135mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 April 2013 till 29 April
2018
POM
948 BRU13041065P Copegus Tablet 200mg Ribavarin 200mg Hoffman-La Roche Inc., USA; Patheon Inc.,
Ontario, Canada
Hongkiat Trading & Co 30 April 2013 till 29 April
2018
POM
949 BRU13041066P Celexin 250 Film-coated Tablet Cephalexin 250mg (as monohydrate) Hovid Bhd, Malaysia K-Seri Pharma Sdn Bhd 30 April 2013 till 29 April
2018
POM
950 BRU13041067NP White Soft Paraffin White Soft Paraffin Sasaol Wax GmbH, Germany Hongkiat Trading & Co 30 April 2013 till 29 April
2018
GSL
951 BRU13041068NP Calamine Lotion 15% w/v Calamine 15%w/v Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 April 2013 till 29 April
2018
GSL
952 BRU13061069P Votrient™ Film-coated tablets
200mg
Pazopanib (as hydrochloride) 200mg Glaxo Operations UK Ltd, Hertfordshire,
UK
Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
953 BRU13061070PS1;
BRU13061070PS2;
BRU13061070PS3
NovoMix® 30 FlexPen®
Suspension for Injection 100 U/ml
1ml contains 100u of Soluble Insulin aspart
30% and Protamine-crystallised Insulin
aspart 70%
Novo Nordisk Producao Farmaceutica do
Brasil Ltda., Brazil (S1); Novo Nordisk A/S,
Bagsværd, Denmark (S2); Novo Nordisk
Production SAS, France (S3)
Medipharm Sdn Bhd 04 June 2013 till 03 June
2018
POM
954 BRU13061071P Duphaston Tablet 10mg Dydrogesterone 10mg Abbott Biologicals B.V., The Netherlands Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
BDMCA/RMP/1116 Page 56 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
955 BRU13061072NP Nutravit™ Syrup Per 5ml - Riboflavine 1.46mg; Calcium
Pantothenate 3.25mg; Ascorbic Acid
17.5mg; Vitamin A 4000iu; Vitamin D
400iu; Nicotinamide 10.00mg; Lysine HCl/
Monochloride 100.00mg; Thiamine HCl/
Vit. B1 2.00mg; Cynocobalamine/ Vit B12
1.5mcg; Pyridoxine HCl/Vit B6 2.00mg
Hovid Bhd, Malaysia G & H Trading Company 04 June 2013 till 03 June
2018
GSL
956 BRU13061073P Prednisolone Tablet 20mg Prednisolone 20mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 04 June 2013 till 03 June
2018
POM
957 BRU13061074P Kytril For Infusion 3mg/3ml Granisetron 3mg (as HCl 3.36mg) Cenexi SAS, France Hongkiat Trading & Co 04 June 2013 till 03 June
2018
POM
958 BRU13061075P Minison Tablet 1mg Prazosin 1mg (as HCl 1.095mg) Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
959 BRU13061076P Xeloda™ Tablets 500mg Capecatibine 500mg Productos Roche S.A. de C.V, Mexico Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
960 BRU13061077P Chloramphenicol Eye Ointment Chloramphenicol 10mg/g KRKA d.d., Slovenia K-Seri Pharma Sdn Bhd 04 June 2013 till 03 June
2018
POM
961 BRU13061078NP Zentel Tablet 200mg Albendazole 200mg Tianjin SKF Labs Ltd, Tianjin, China Kingston Beverage & Creamery
Sdn Bhd
04 June 2013 till 03 June
2018
GSL (2's)
962 BRU13061079NP Maltofer® Syrup Iron (III) [as Iron (III)-hydroxide-
polymaltose complex] 10mg/ml
Vifor S.A., Switzerland & Vifor
(International) Inc., Switzerland
Medipharm Sdn Bhd 04 June 2013 till 03 June
2018
GSL
963 BRU13061080P Noriday® Tablet Norethisterone 0.35mg Piramal Healthcare UK Limited, United
Kingdom
Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
964 BRU13061081P Keppra 250mg Film-coated Tablet Levetiracetam 250mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
965 BRU13061082P Keppra 500mg Film-coated Tablet Levetiracetam 500mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
966 BRU13061083PS1,
BRU13061083PS2,BRU13
061083PS3,
BRU13061083PS4
Avastin Concentrate For Solution
For Infusion 400mg/16ml
Bevacizumab 400mg/16ml Genentech Inc., USA (S1); F-Hoffman-La
Roche Ltd, Basel, Switzerland (S2); Roche
Diagnostics GmbH, Manheim, Germany
(S3); F Hoffmann-La Roche Ltd,
Kaiseraugst, Switzerland (S4)
Medicare 04 June 2013 till 03 June
2018
POM
967 BRU13061084P Xeloda Tablet 150mg Capecatibine 150mg Productos Roche S.A. de C.V, Mexico Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
968 BRU13061085P Uripax Film-coated Tablet 200mg Flavoxate HCl 200mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 04 June 2013 till 03 June
2018
POM
969 BRU13061086P Atorvas Tablets 10mg Atorvastatin (as calcium) 10mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 04 June 2013 till 03 June
2018
POM
970 BRU13061087P Elonva Solution for Injection
150mcg/0.5ml
Corifollitrophin alfa 150mcg/0.5ml Vetter Pharma-Fertigung GmbH & Co. KG,
Germany
Zuellig Pharma (B) Sdn Bhd 27 June 2013 till 26 June
2018
POM
BDMCA/RMP/1116 Page 57 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
971 BRU13061088P Maxitrol Eye Ointment Per g: Neomycin Sulfate 3,500 IU;
Polymyxin B Sulfate 6,000IU;
Dexamethasone 0.1%
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 27 June 2013 till 26 June
2018
POM
972 BRU13061089P Maxidex® Eye Ointment Dexamethasone 0.1% w/w S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 27 June 2013 till 26 June
2018
POM
973 BRU13061090NP Ciproxol (Ciprofloxacin) 0.2% w/v
Intravenous Infusion BP
Ciprofloxacin 0.2% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 June 2013 till 26 June
2018
POM
974 BRU13061091NP Infusol® W Intravenous Infusion
BP
Water for Injection BP Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 June 2013 till 26 June
2018
GSL
975 BRU13061092P Isoket Ampoule 10mg/10ml Isosorbide Dinitrate 10mg/10ml (0.1%) EVER Pharma Jena GmbH, Germany Zuellig Pharma (B) Sdn Bhd 27 June 2013 till 26 June
2018
POM
976 BRU13061093P Invoril tablets 10mg Enalapril maleate 10mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 27 June 2013 till 26 June
2018
POM
977 BRU13061094P Pharmaniaga Simvastatin tablet
10mg
Simvastatin 10mg Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 27 June 2013 till 26 June
2018
POM
978 BRU13061095P Vitamin B1 Tablet Thiamine HCl 10mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 27 June 2013 till 26 June
2018
POM
979 BRU13061096P Invoril tablets 20mg Enalapril maleate 20mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 27 June 2013 till 26 June
2018
POM
980 BRU13061097P Seldron Cleaning Lotion Selenium Sulphide USP 2.5% w/v ICM Pharma Pte Ltd, Singapore Mc Quipp Technisell Marketing
Sdn Bhd
27 June 2013 till 26 June
2018
p
981 BRU13071098NP Cortal for Children Tablet Acetaminophen (Paracetamol) 80mg Sterling Drug (Malaya) Sdn Bhd, Malaysia Kingston Beverage & Creamery
Sdn Bhd
30 July 2013 till 29 July 2018 P 12
x 12's (144's)
982 BRU13071099P Champix 1mg film-coated tablet Varenicline Tartrate 1mg Pfizer Manufacturing Deutschland GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM
983 BRU13071100P Iodosorb Ointment Cardexomar Iodine (eq. to Iodine 0.9%) Perstorp Speciality Chemicals, Sweden Mc Quipp Technisell Marketing
Sdn Bhd
30 July 2013 till 29 July 2018 POM
984 BRU13071101P Glucophage XR 500mg Extended
Release Tablet
Metformin HCl 500mg Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM
985 BRU13071102P Victrelis Capsule 200mg Boceprevir 200mg Schering-Plough (Singapore) Pte Ltd,
Singapore
Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM
986 BRU13071103P Axcel Cefaclor-250 Capsule Cefaclor (as monohydrate) 250mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 July 2013 till 29 July 2018 POM
987 BRU13071104P Gonal-F Powder and Solvent for
Solution for Injection 75IU
(5.5mcg)/ vial
Follitrophin Alfa 75 IU ( 5.5mcg) Merck Serono S.p.A., Bari (MSB), Italy;
Merck Serono S.A. (MSA), Swizerland
G & H Trading Company 30 July 2013 till 29 July 2018 POM
988 BRU13071105P Lignocaine Injection 2% x 5ml Lignocaine Hydrochloride 20mg/ml Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM
989 BRU13071106P Pred Mild® Sterile Ophthalmic
Suspension 0.12%
Prednisolone acetate 0.12% w/v Allergen Pharmaceuticals Ireland,
Wesport, Ireland
Medipharm Sdn Bhd 30 July 2013 till 29 July 2018 POM
990 BRU13071107P Tamiflu Capsules 75mg Oseltamivir 75mg Cenexi SAS, France; Catalent Germany
Schorndorf GmbH, Germany; Roche
S.p.A., Italy
Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM
BDMCA/RMP/1116 Page 58 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
991 BRU13071108P Revlimid® Capsules 25mg Lenalidomide 25mg Penn Pharmaceutical Services Limited, UK
& Celgene International Sarl, Switzerland
Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM
992 BRU13071109P Revlimid® Capsules 15mg Lenalidomide 15mg Penn Pharmaceutical Services Limited, UK
& Celgene International Sarl, Switzerland
Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM
993 BRU13071110P Solcoseryl Eye Gel Solcoseryl 120 Concentrate 8.3mg/g Legacy Pharmaceuticals Switzreland
GmbH, Switzerland
Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM
994 BRU13071111P Micosten-H Cream Miconazole Nitrate 2%; Hydrocortisone 1% Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd 30 July 2013 till 29 July 2018 POM
995 BRU13071112P Pharmaniaga Labetalol Tablet
100mg
Labetalol Hydrochloride 100mg Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 30 July 2013 till 29 July 2018 POM
996 BRU13071113P Hydralazine Tablet 10mg Hydralazine Hydrochloride 10mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 30 July 2013 till 29 July 2018 POM
997 BRU13071114P Sandimmun Neoral Capsule 25mg Ciclosporin A 25mg R.P. Scherer GmbH & Co. KG., Germany Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM
998 BRU13081115P Champix 0.5mg & 1mg Tablet Varenicline Tartrate 0.5mg & Varenicline
Tartrate 1mg
Pfizer Manufacturing Deutschland GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 27 August 2013 till 26 August
2018
POM
999 BRU13081116P Daktarin Oral Gel 2% Miconzaole 2% Janssen Pharmaceutical NV, Belgium Zuellig Pharma (B) Sdn Bhd 27 August 2013 till 26 August
2018
P
1000 BRU13081117P Dhasedyl DM Syrup Per 5ml - Dextromethorphan HBr 10mg;
Promethazine HCl 3.6mg/ Ephedrine HCl
6mg
Drug House of Australia (Asia) Pte Ltd,
Singapore
G & H Trading Company 27 August 2013 till 26 August
2018
POM
1001 BRU13081118P Daivonex® Cream Calcipotriol 50mcg/g (0.0005% w/w) LEO Laboratories Ltd (LEO Pharma),
Ireland
Zuellig Pharma (B) Sdn Bhd 27 August 2013 till 26 August
2018
POM
1002 BRU13081119PS1;
BRU13081119PS2
Zoral Cream Acyclovir USP 5% w/w Drug Houses of Australia Private Limited,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 27 August 2013 till 26 August
2018
POM
1003 BRU13081120P Enbrel® 25mg solution for
injection in pre-filled syringe
Etanercept 25mg/0.5ml Pfizer Ireland Pharmaceuticals, Ireland Zuellig Pharma (B) Sdn Bhd 27 August 2013 till 26 August
2018
POM
1004 BRU13081121P Xenical Capsule 120mg Orlistat 120mg Roche SpA, Italy Zuellig Pharma (B) Sdn Bhd 27 August 2013 till 26 August
2018
POM
1005 BRU13081122P Requip® Tablet 1mg Ropinirole (as Hydrochloride) 1mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 27 August 2013 till 26 August
2018
POM
1006 BRU13081123P Minazol Powder 2% Miconzaole Nitrate 2% w/w Biosis Pharmaceuticals Sdn Bhd., Malaysia K-Seri Pharma Sdn Bhd 27 August 2013 till 26 August
2018
P
1007 BRU13081124P Heparinol 5000IU/ml Heparin Sodium (bovine) 5,000IU/ml Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 August 2013 till 26 August
2018
POM
1008 BRU13081125P Pharmaniaga Pyrazinamide
Tablet 500mg
Pyrazinamide 500mg Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 27 August 2013 till 26 August
2018
POM
1009 BRU13081126P Sathrocin ES Tablet 400mg Erythromycin (as ethylsuccinate) 400mg Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 27 August 2013 till 26 August
2018
POM
1010 BRU13081127P Ketovid Shampoo 2% w/v Ketoconazole (micronised) 2% w/w Hovid Bhd, Malaysia G & H Trading Company 27 August 2013 till 26 August
2018
POM
BDMCA/RMP/1116 Page 59 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1011 BRU13081128P Maxitrol Eye Drops Per 1ml - Dexamethasone 0.1%; Neomycin
Sulphate 3,500IU; Polymyxin B Sulphate
6,000 IU
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 27 August 2013 till 26 August
2018
POM
1012 BRU13091129P VentolinTM Syrup 2mg/5ml (T) Salbutamol Sulphate (as sulphate)
5mg/5ml
SmithKlineBeecham, Rizal, Philippines Zuellig Pharma (B) Sdn Bhd 28 September 2013 till 27
September 2018
POM
1013 BRU13091130P Erbitux® 5mg/ml Solution for
Infusion
Cetuximab 5mg/ml Boehringer Ingelheim, Germany & Merck
KGaA, Germany (1 Artwork)
Zuellig Pharma (B) Sdn Bhd 28 September 2013 till 27
September 2018
POM
1014 BRU13091132NP Beafort Syrup Each 5ml contains: Thiamine HCl 5mg;
Riboflavin 2.5mg; Pyridoxine HCl 2mg;
Cyanocobalamin 5mcg; Nicotinamide
20mg; Calcium Panthothenate 1.5mg
Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 28 September 2013 till 27
September 2018
GSL
1015 BRU13091133P Clexane 4000/0.4ml Anti XA Pre-
filled Syringe
Enoxaprin sodium 4,000 anti-Xa IU/0.4ml
equivalent to 40mg/0.4ml
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 28 September 2013 till 27
September 2018
POM
1016 BRU13091134P Pantaprazole Winthrop 40mg
Tablet
Pantoprazole (as sodium Sesquihydate)
40mg
Sanofi-Aventis S.P.Z.O.O., Poland Medipharm Sdn Bhd 28 September 2013 till 27
September 2018
POM
1017 BRU13091135P Iodosorb Powder Cadexomer 99.1% w/w, with Iodine
0.9%w/w
Perstorp Speciality Chemicals AB, Sweden Mc Quipp Technisell Marketing
Sdn Bhd
28 September 2013 till 27
September 2018
P
1018 BRU13091136P Anlodin Tablet 10mg Amlodipine (as besylate) 10mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 28 September 2013 till 27
September 2018
POM
1019 BRU13091137P Effient Tablet 5mg Prasugrel HCl 5mg Eli Lilly & Co., USA Zuellig Pharma (B) Sdn Bhd 28 September 2013 till 27
September 2018
POM
1020 BRU13091138P Clexane 6000/0.6ml Anti-Xa IU
Pre-filled Syringe
Enoxaprin sodium 6,000 anti-Xa IU/0.6ml
equivalent to 60mg/0.6ml
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 28 September 2013 till 27
September 2018
POM
1021 BRU13091139P Simvastatin Winthrop 40mg
Tablet
Simvastatin 40mg Sanofi Aventis S.p.z.o.o, Poland Medipharm Sdn Bhd 28 September 2013 till 27
September 2018
POM
1022 BRU13091140P Camazol Tablet 5mg Carbimazole 5mg Xepa-Soul Pattinson (M) Sdn Bhd
Malaysia
Hongkiat Trading & Co 28 September 2013 till 27
September 2018
POM
1023 BRU13091141P Pulin Injection 10mg/2ml Metoclopramide HCl 10mg/2ml Yung Shin Pharmaceutical Ind. Co. Ltd.,
Taiwan
Asterix United (B) Sdn Bhd 28 September 2013 till 27
September 2018
POM
1024 BRU13091142NP Sulbutiamine 200 capsule Sulbutiamine 200mg Pahang Pharmacy Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 28 September 2013 till 27
September 2018
GSL
1025 BRU13091143P VelcadeTM 3.5mg for Injection Bortezomib 3.5mg Pierre Fabree Medicament Productio
(PFMP), France & BSP Pharmaceuticals Srl
(BSP), Latina, Italy - (1 artwork)
Zuellig Pharma (B) Sdn Bhd 28 September 2013 till 27
September 2018
POM
1026 BRU13091144P Bezamidin Tablet 200mg Bezafibrate 200mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd 28 September 2013 till 27
September 2018
POM
1027 BRU13091145NP A-Bite Cream Crotamiton 10%w/w HOE Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 28 September 2013 till 27
September 2018
GSL
1028 BRU13091146P Tipidin Tablet 250mg Ticolopidine HCl BP 250mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 28 September 2013 till 27
September 2018
POM
1029 BRU13091147P Gynera Tablets Ethinylestradiol 0.03mg; Gestodene
0.075mg
Schering do Brasil Quimica e Farmaceutica
Ltda., Sao Paulo, Brazil
Zuellig Pharma (B) Sdn Bhd 28 September 2013 till 27
September 2018
POM
BDMCA/RMP/1116 Page 60 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1030 BRU13101148P Eumovate™ Cream Clobetasone 17-butyrate 0.05% w/w Glaxo Wellcome Opration, UK Zuellig Pharma (B) Sdn Bhd 31 October 2013 till 31
October 2018
POM
1031 BRU13101149P Erycin Film Coated Tablet 250mg Erythromycin (as stearate) 250mg Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 31 October 2013 till 31
October 2018
POM
1032 BRU13101151NP ENO Fruit Salt Lemon Per 4.3g - Sodium Bicarbonate Coarse
1.468g (34.16%w/w); Sodium Bicarbonate
Fine 0.489g (11.39%w/w); Citric Acid
Anhydrous 1.853g (43.10%w/w); Sodium
Carbonate Anhydrous 0.43g (10.0%w/w)
Sterling Drug (Malaya) Sdn Bhd, Malaysia Kingston Beverage & Creamery
Sdn Bhd
31 October 2013 till 31
October 2018
GSL
1033 BRU13101152P Hycamtin™ Injection 1MG Topotecan (as HCl) 1mg GlaxoSmithKline Manufacturing S.p.A.,
Parma, Italy
Zuellig Pharma (B) Sdn Bhd 31 October 2013 till 31
October 2018
POM
1034 BRU13101153P Clexane 2000 anti-Xa IU/0.2ml
(Pre-filled Syringe for Injection)
Enoxaparin Sodium 2,000 anti-Xa IU/0.2ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 31 October 2013 till 31
October 2018
POM
1035 BRU13101154P Axcel Mefenamic Acid
Suspension
Mefenamic Acid 125mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 31 October 2013 till 31
October 2018
POM
1036 BRU13101155P Ovidrel Solution for Injection
250mcg/0.5ml in Pre-filled
Syringe
Choriogonadotropin alfa 250mcg/0.5ml Merck Serono S.p.A., Italy & Merck
Serono S.A., Switzerland
G & H Trading Company 31 October 2013 till 31
October 2018
POM
1037 BRU13101156P Sandimmun Neoral Capsule
100mg
Ciclosporin 100mg R.P Scherer GmbH & Co, Baden, Germany Zuellig Pharma (B) Sdn Bhd 31 October 2013 till 31
October 2018
POM
1038 BRU13101157P Tobrex Eye Ointment Tobramycin 0.3% (3mg/g) S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 31 October 2013 till 31
October 2018
POM
1039 BRU13101158P Endoxan Tablet 50mg Cyclophosphamide anhydrous (as
monohydrate) 50mg
Prasfarma S.L., Manlleu/Barcelona, Spain;
Haupt Pharma Amareg GmBH, Germany
Zuellig Pharma (B) Sdn Bhd 31 October 2013 till 31
October 2018
POM
1040 BRU13101159P CEF-4® Injection 500mg Ceftazidime (as pentahydrate) 500mg Siam Bheasach Co. Ltd., Bangkok,
Thailand
K-Seri Pharma Sdn Bhd 31 October 2013 till 31
October 2018
POM
1041 BRU13101160P Premarin Tablet 0.625mg Conjugated Estrogens 0.625mg Pfizer Ireland Pharmaceuticals, Kildare,
Ireland
Zuellig Pharma (B) Sdn Bhd 31 October 2013 till 31
October 2018
POM
1042 BRU13101161PS1;
BRU13101161PS2
Revlimid capsules 10mg Lenalidomide 10mg Penn Pharmaceutical Services, Gwent, UK
(S1) & Celgene International Sarl, Boudry,
Switzerlnd (S2)
Zuellig Pharma (B) Sdn Bhd 31 October 2013 till 31
October 2018
POM
1043 BRU13101162P Pharmaniaga Cephalexin
Suspension 125mg
Cephalexin (as anhydrous) 125mg/5ml Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 31 October 2013 till 31
October 2018
POM
1044 BRU13101163P Tolbutamide Tablets 500mg Tolbutamide 500mg Drug Houses Australia Pte Ltd., Singapore G & H Trading Company 31 October 2013 till 31
October 2018
POM
1045 BRU13101164P Isopto Homatropine 2% Sterile
Ophthalmic Solution (
Homatropine Hydrobromide 2%
(20.0mg/ml)
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 31 October 2013 till 31
October 2018
POM
1046 BRU13101165NP Lactacyd Feminine Hygiene Liquid Per 100ml - Lactic Acid 1g; Atomised
Lactoserum (spray dried) 0.93g
Sanofi Synthelabo Vietnam, Ho Chi Minh
City, Viet Nam
Medipharm Sdn Bhd 31 October 2013 till 31
October 2018
GSL
BDMCA/RMP/1116 Page 61 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1047 BRU13121166P SCMC Syrup 125mg/5ml S-Carboxymethyl-cysteine 125mg/5ml Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Co 02 December 2013 till 01
December 2018
P
1048 BRU13121167P Copastin Film Coated Tablets
10mg
Cloperastine Hydrochloride 10mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 02 December 2013 till 01
December 2018
P
1049 BRU13121168P Ucort Cream Per g – Urea 100mg; Hydrocortisone
acetate 10mg
Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 02 December 2013 till 01
December 2018
P
1050 BRU13121169P Pradaxa® Hard Capsules 150mg Dabigatran etexilate 150mg (as mesilate
172.95g)
Boehringer Ingelheim Pharma GmbH &Co,
Ingelheim am Rhein, Germany
Hongkiat Trading & Co 02 December 2013 till 01
December 2018
POM
1051 BRU13121170P Pradaxa® Hard Capsules 110mg Dabigatran etexilate 110mg (as mesilate
126.83g)
Boehringer Ingelheim Pharma GmbH &
Co., KG, Germany
Hongkiat Trading & Co 02 December 2013 till 01
December 2018
POM
1052 BRU13121171P Amoxicillin Capsule 250mg Amoxicillin Trihydrate 250mg Yung Shin Pharmaceutical Ind. Co. Ltd.,
Taiwan
Asterix United (B) Sdn Bhd 02 December 2013 till 01
December 2018
POM
1053 BRU13121172NP Dianeal Low Calcium (2.5mEq/L)
Peritoneal Dialysis Solution with
1.5% Dextrose
Each 100ml contains: Calcium Choloride
18.3mg; Dextrose hydrous 1.5g;
Magnesium Chloride 5.08mg; Sodium
Chloride 538mg; Sodium Lactate 448mg
Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 02 December 2013 till 01
December 2018
POM
1054 BRU13121173NP Refresh Tears Lubricant Eye
Drops 0.5%
Carboxymethylcellulose Sodium 0.5% w/v Allergan Sales LLC, USA Medipharm Sdn Bhd 02 December 2013 till 01
December 2018
GSL
1055 BRU13121174P Temodal Capsules 100mg Temozolomide 100mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 02 December 2013 till 01
December 2018
POM
1056 BRU13121176PS1 &
BRU13121176PS2
Dhasolone Tablet 5mg Prednisolone BP (micronized) 5mg Drug Houses of Australia Private Limited,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 02 December 2013 till 01
December 2018
POM
1057 BRU13121177P Cyclogyl® 1% Sterile Ophthalmic
Solution (T)
Cyclopentolate Hydrochloride 1% S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 02 December 2013 till 01
December 2018
POM
1058 BRU13121178P Betawin Tablet 50mg (T) Metoprolol Tartrate 50mg Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Co 02 December 2013 till 01
December 2018
POM
1059 BRU13121179P Imigran FD Tablets 50mg Sumatriptan 50mg ( as succinate) Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29
December 2018
POM
1060 BRU13121180P Glucovance Tablet 500mg/5mg Metformin HCl 500mg; Glibenclamide 5mg Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29
December 2018
POM
1061 BRU13121181P Priorix-Tetra Powder and Diluent
for Solution for Injection
Composition of Priorix™ per dose (0.5ml):
Live attenuated measles virus (Schwarz
strain) ≥103.0 CCID50, Live attenuated
mumps virus (RIT4385 strain) ≥103.7
CCID50,
Live attenuated rubella virus (Wistar RA
27/3 strain) ≥103.0
CCID50, Live attenuated
Varicella Virus (OKA strain) ≥103.3 PFU
Glaxosmithkline Biologicals S.A., Belgium Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29
December 2018
POM
1062 BRU13121182P Hycamtin Injection 4mg Topotecan (as Hydrochloride) 4mg GlaxoSmithKline Manufacturing S.p.A.,
Italy
Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29
December 2018
POM
BDMCA/RMP/1116 Page 62 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1063 BRU13121183P Anarex Tablets Paracetamol 450mg; Orphenadrine citrate
35mg
Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 December 2013 till 29
December 2018
POM
1064 BRU13121184P Atarax Film-Coated Tablet 25mg Hydroxyzine Hydrochloride 25mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29
December 2018
POM
1065 BRU13121185PS1;
BRU13121185PS2
Propylthiouracil Tablets 50mg Propylthiouracil 50mg Drug Houses of Australia Pte Ltd.,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 30 December 2013 till 29
December 2018
POM
1066 BRU13121186P Xyzal Oral Drops 5mg/ml Per mL - Levocetitrizine Hydrochloride 5mg Aesica Pharmaceuticals S.r.L Pianezza,
Italy
Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29
December 2018
POM
1067 BRU13121187NP 10% Glucose Intravenous Infusion
B.P.
Glucose monohydrate (as equiv. to
anhydrous glucose) 10%
B Braun Industries Sdn Bhd, Malaysia Hongkiat Trading & Co 30 December 2013 till 29
December 2018
POM
1068 BRU13121188P Daivonex Scalp Solution
50mcg/ml
Calcipotriol 50mcg/ml Leo Pharmaceutical Products Ltd., A/S
(Leo Pharma), Denmark
Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29
December 2018
POM
1069 BRU13121189P Heparinised Saline Injection
10iu/ml (5ml)
Heparin Sodium (Bovine Mucosa) 10i.u./ml B Braun Industries Sdn Bhd, Malaysia Hongkiat Trading & Co 30 December 2013 till 29
December 2018
POM
1070 BRU13121190P Rescuvolin Tablet 15mg Calcium Folinate (equiv. to Folinic Acid)
15mg
Teva Pharmaceutical Works Pte Ltd Co.,
Debrecen Site, Hungary
K-Seri Pharma Sdn Bhd 30 December 2013 till 29
December 2018
POM
1071 BRU13121191P Quinax Sterile Ophthalmic
Solution
Sodium Dihydroazapentacene
Polysulfonate 0.15mg/ml
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 30 December 2013 till 29
December 2018
POM
1072 BRU13121192P Nutriflex Lipid Peri Emulsion for
Infusion
1 unit consists of Amino Acid Solution;
Glucose Solution; Lipid Emulsion (For
Detailed Formulation referred to Dossier)
B Braun Industries Sdn Bhd, Malaysia Hongkiat Trading & Co 30 December 2013 till 29
December 2018
POM
1073 BRU14011193PS1 &
BRU14011193PS2
Alimta 500mg Powder for
Solution for Infusion
Pemetrexed (as Pemetrexed disodium)
500mg/vial
Eli Lilly and Company, USA (S1); Lilly
France, France (S2)
Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27
January 2019
POM
1074 BRU14011194P Gemzar 1G Powder for Solution
for Infusion
Gemcitabine 1000mg (as gemcitabine
hydrochloride)
Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27
January 2019
POM
1075 BRU14011195P Imigran FD Tablets 100mg Sumatriptan 100mg (as the succinate) GlaxoSmithKline Pharmaceuticals SA,
Poland
Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27
January 2019
POM
1076 BRU14011196P Largo Tablets 100mg Chlorpromazine HCl 100mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 28 January 2014 till 27
January 2019
POM
1077 BRU14011197NP Axcel Eviline Forte Suspension Each 5ml contains: Magnesium Hydroxide
400mg, Aluminium Hydroxide 400mg and
Simethicone 40mg
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd, Malaysia 28 January 2014 till 27
January 2019
GSL
1078 BRU14011198NP Bepanthen® First Aid Cream Dexpanthenol 5%w/w; Chlorhexidine
hydrochloride 0.5% w/w
GP Grenzach Produktions GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27
January 2019
GSL
1079 BRU14011199NP Dextrose 5% and Sodium Chloride
0.9% Injection USP
Dextrose 5%; Sodium Chloride 0.9% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27
January 2019
POM
1080 BRU14011200NP Macgel® Tablet Magnesium Hydroxide 200mg; Aluminium
Hydroxide Gel Dried 200mg;
Dimethylpolysiloxane 25mg
Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 28 January 2014 till 27
January 2019
GSL
1081 BRU14011201P Prefrin Liquifilm Eye Drops 0.12% Phenylephrine Hydrochloride 0.12% Allergan Sales, LLC., USA MediPharm Sdn Bhd 28 January 2014 till 27
January 2019
P
BDMCA/RMP/1116 Page 63 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1082 BRU14011202NP Refresh Liquigel Lubricant Eye
Drops 1%
Carboxymethylcellulose Sodium 1% w/v Allergan Sales, LLC., USA MediPharm Sdn Bhd 28 January 2014 till 27
January 2019
GSL
1083 BRU14011203P Betaserc 24mg Tablet Betahistine dihydrochloride 24mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27
January 2019
POM
1084 BRU14011204PS1;
BRU14011204PS2
Humalog Mix50 100 units/ml
Kwikpen
Insulin Lispro * 100U/ml (equivalent to
3.5mg) * in the proportion of 50% insulin
lispro solution and 50% insulin lispro
protamine suspension (rDNA origin)
Lilly France S.A.S., France (S1); Eli Lilly
Italia S.p.A., Sesto Fiorentino, (FI) Italy
(S2) (repacker -
Eli Lilly And Company, USA) & Eli Lilly Italia
S.p.A., Sesto Fiorentino, (FI) Italy;
Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27
January 2019
POM
1085 BRU14011205NP Panamol Tablet 500mg Paracetamol 500mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 28 January 2014 till 27
January 2019
GSL
1086 BRU14011206P Seretide™ Evohaler™ 25/50mcg Fluticasone propionate 50mcg; Salmeterol
(as xinafoate) 25mcg
Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27
January 2019
POM
1087 BRU14011207PS1;
BRU14011207PS2
Tobrex® Eye Drops Solution Tobramycin 0.3% (3mg/ml) S.A. Alcon-Couvreur N.V., Belgium (S1);
Alcon Singapore Manufacturing Pte Ltd,
Singapore (S2)
Hongkiat Trading & Company 28 January 2014 till 27
January 2019
POM
1088 BRU14011208P PNEUMOVAX 23 Pneumococcal Polysaccharide Danish
Types 1,2,3,4,5,6B, 7F,8,9N,9V, 10A, 11A,
12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F,
23F, 33F. Each 0.5ml dose contains 25µg of
each polysaccharide type
Merck Sharp & Dohme Corp, USA Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27
January 2019
POM
1089 BRU14011209P NEUPOGEN PRE-FILLED SYRINGE
30MU/0.5ML
Filgrastim 30mu/0.5ml F.Hoffmann-La Roche Ltd, Kaiseraugst
Switzerland
Medipharm Sdn Bhd 28 January 2014 till 27
January 2019
POM
1090 BRU14011210P Axcel Famotidine-20 Capsule Famotidine 20mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd, Malaysia 28 January 2014 till 27
January 2019
POM
1091 BRU14011211NPS1;
BRU14011207PS2
Tears Naturale II Eye Drops
Solution
Dextran 70 0.1% (1mg/ml); Hypromellose
0.3% (3mg/ml)
S.A. Alcon-Couvreur N.V., Belgium (S1);
Alcon Singapore Manufacturing Pte Ltd,
Singapore (S2)
Hongkiat Trading & Company 28 January 2014 till 27
January 2019
GSL
1092 BRU14011212P Axcel Chlorpheniramine-4 Syrup Chlorpheniramine Maleate 4mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd, Malaysia 28 January 2014 till 27
January 2019
P
1093 BRU14011213P Imojev Japanese Encephalitis
vaccine (live, attenuated) MD
Live, attenuated, recombinant Japanese
Encephalitis virus 4.0 - 5.8 log PFU*/dose
(0.5ml) *Plaque Forming Unit
Government Pharmaceutical Organization
- Meriux Biological Products Co., Ltd.,
Thailand
Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27
January 2019
POM
1094 BRU14021214P Panaflex Extra Gel Diclofenac Sodium 10mg/1gm United Biomedical Inc., Asia, Taiwan Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
P
1095 BRU14021215P Havrix 1440 Vaccine Inactivated Hepatitis A virus antigen (HAV),
HM175 strain 1440 ELISA Units (EL.U.)/ml
GlaxoSmithKline Biologicals SA, Rixensart
Belgium; GlaxoSmithKline Biologicals S.A.,
Wavre Belgium
Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
BDMCA/RMP/1116 Page 64 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1096 BRU14021216P Co-Plavix® 75/100 film-coated
tablets
Clopidogrel (as hydrogen sulphate) 75mg;
Acetylsalicylic acid 100mg
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 27 February 2014 till 26
February 2019
POM
1097 BRU14021217P VotrientTM Film-coated tablets
400mg
Pazopanib (as hydrochloride) 400mg Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1098 BRU14021218P Motilium tablets 10mg Domperidone 10mg Janssen Pharmaceutica NV, Belgium Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1099 BRU14021219PS1;
BRU14021219PS2;
BRU14021219PS3
Novorapid® Flexpen® 100IU/ml 1ml of solution contains 100U insulin
aspart (r-DNA) (equivalent to 3.5mg)
Novo Nordisk Producao Farmaceutica do
Brasil Ltda., Brazil (S1); Novo Nordisk A/S,
Denmark (S2); Novo Nordisk Production
SAS, France (S3)
Medipharm Sdn Bhd 27 February 2014 till 26
February 2019
POM
1100 BRU14021220P Omelon Enteric
Microencapsulated capsule 20mg
Omeprazole 20mg Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1101 BRU14021221NP Lactacyd® liquid Lactic acid (1g/100ml) and atomized
lactoserum (0.9g/100ml)
Sanofi Synthelabo Vietnam, Ho Chi Minh
City, Viet Nam
Medipharm Sdn Bhd 27 February 2014 till 26
February 2019
GSL
1102 BRU14021222P Invega® Sustenna Prolonged
Release Suspension for
Intramuscular Injection
25mg/0.25ml
0.25ml of solution contains Paliperidone
(as palmitate 39mg) 25mg
Janssen Pharmaceutica NV, Belgium Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1103 BRU14021223P Invega® Sustenna Prolonged
Release Suspension for
Intramuscular Injection
50mg/0.5ml
0.5ml of solution contains Paliperidone (as
palmitate 78mg) 50mg
Janssen Pharmaceutica NV, Belgium Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1104 BRU14021224P Invega® Sustenna Prolonged
Release Suspension for
Intramuscular Injection
75mg/0.75ml
0.75ml of solution contains Paliperidone
(as palmitate 117mg) 75mg
Janssen Pharmaceutica NV, Belgium Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1105 BRU14021225P Invega® Sustenna Prolonged
Release Suspension for
Intramuscular Injection
100mg/1.0ml
1.0ml of solution contains Paliperidone (as
palmitate 156mg) 100mg
Janssen Pharmaceutica NV, Belgium Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
BDMCA/RMP/1116 Page 65 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1106 BRU14021226P Simvastatin Winthrop 20mg
tablet
Simvastatin 20mg Sanofi-Aventis S.P.Z.O.O., Poland Medipharm Sdn Bhd 27 February 2014 till 26
February 2019
POM
1107 BRU14021227P LumiganTM (Bitamoprost
Ophthalmic Solution) 0.03%
Bimatoprost 0.03% w/v Allergan Sales, LLC, USA Medipharm Sdn Bhd 27 February 2014 till 26
February 2019
POM
1108 BRU14021228NP Refresh Plus Lubricating Eye
Drops 0.5%
Carboxymethylcellulose Sodium 0.5% Allergan Sales, LLC, USA Medipharm Sdn Bhd 27 February 2014 till 26
February 2019
POM
1109 BRU14021229P NovoSeven® Powder and Solvent
for Solution for Injection 2mg
Eptacog Alfa (Activated) 2mg/vial
(corresponds to 100 KIU/vial), 1mg/ml
after reconstitution.
1 KIU equals 1000 IU (International Units)
eptacog alfa (activated) is recombinant
coagulation factor VIIa (rFVIIa) with a
molecular mass of approximately 50,000
Dalton produced in baby hamster kidney
cells (BHK Cells) by recombinant DNA
technology.
Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 27 February 2014 till 26
February 2019
POM
1110 BRU14021230NP Axcel Eviline Tablet Aluminium Hydroxide 200mg, Magnesium
Hydroxide 200mg, Simethicone 20mg
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26
February 2019
GSL
1111 BRU14021231P Axcel Loratadine syrup Loratadine 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26
February 2019
P
1112 BRU14021232P Cymbalta Capsule 30mg Duloxetine (as hydrochloride) 30mg Eli Lilly and Company, Indiana, USA; Lilly
del Caribe, Inc., Puerto Rico
Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1113 BRU14021233P TykerbTM tablets 250mg Lapatinib 250mg (as ditosylate
monohydrate)
Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1114 BRU14021234P Axcel Mefenamic Acid Capsules Mefenamic acid 250mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26
February 2019
POM
1115 BRU14021235P Dostinex tablet 0.5mg Cabergoline 0.5mg Pfizer Italia S.r.I, Italy Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1116 BRU14021236NP Lactated Ringer’s Injection USP4 Sodium Chloride 6g/L; Sodium Lactate
3.1g/L; Potassium Chloride 0.3g/L; Calcium
Chloride 0.2g/L
Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
GSL
BDMCA/RMP/1116 Page 66 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1117 BRU14021237P Imuran 50mg tablet Azathioprine 50mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1118 BRU14021238NP Axcel Dicyclomine-S Syrup Per 5mL: Dicyclomine hydrochloride 5mg
and Simethicone 50mg
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26
February 2019
GSL
1119 BRU14021239P Humulin R Injection 100IU/ml Regular Human Insulin (recombinant DNA
origin) Biosynthetic
Eli Lilly an Company, USA Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1120 BRU14021240NP 5% Dextrose and 0.45% Sodium
Chloride Injection, USP
Dextrose 5%; Sodium Chloride 0.45% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
GSL
1121 BRU14021241P Giona Easyhaler 200mcg/dose
Inhalation Powder
Budesonide 200mcg Orion Corporation, Finland Hongkiat Trading & Co 27 February 2014 till 26
February 2019
POM
1122 BRU14021242P Amoxicillin Capsule 500mg Amoxicillin Trihydrate 500mg Yung Shin Pharmaceutical Ind. Co., Taiwan Asterix United (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1123 BRU14021243NP Neurobion tablet thiamine disulfide 100mg; Pyridoxine
hydroxide 200mg & Cyanocobalamin
200mcg
Merck KGaA & Co, Austria Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
P
1124 BRU14021244P Omeprazole for Injection
(Lyophilised) 40mg/vial
Omeprazole 40mg/vial Gland Pharma Limited, India K-Seri Pharma Sdn Bhd 27 February 2014 till 26
February 2019
POM
1125 BRU14021245P Keppra Concentrate for solution
for (infusion) / intravenous
Levetiracetam 500mg/5ml Patheon Italia S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1126 BRU14021246P Imojev Japanese Encephalitis
Vaccine (live, attenuated)
Live, attenuated, recombinant Japanese
Encephalitis virus 4.0 - 5.8 log PFU*/ dose
(0.5ml) * Plaque Forming Unit
Government Pharmaceutical organization-
Meriux Biological Products Co., Ltd.,
Thailand
Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1127 BRU14021247P Pradaxa® Hard Capsules 75mg Dabigatran etexilate 75mg (as mesilate
86.48mg)
Boehringer Ingelheim Pharma GmbH &
Co., KG, Germany
Hongkiat Trading & Co 27 February 2014 till 26
February 2019
POM
1128 BRU14021248P Axcel Flemin Expectorant Diphenhydramine HCl 12.5mg/5ml;
Ammonium Chloride 130mg/5ml
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26
February 2019
POM
1129 BRU14031249P Tygacil 50mg Lyophilised Powder
for Intravenous Infusion
Tigecycline 50mg Wyeth Lederle S.r.L, Italy Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1130 BRU14031250PS1;BRU14
031250PS2
Levemir Flexpen 100IU/ml Insulin Detemir 100U/ml (equivalent to
14.2mg
Novo Nordisk A/S, Denmark (S1); Novo
Nordisk Producao Farmaceutica do Brasil
Ltda., Brazil (S2)
MediPharm Sdn Bhd 27 March 2014 till 26 March
2019
POM
1131 BRU14031251P Stalevo 75/18.75/200mg Film-
coated Tablet
Levodopa 75mg; Carbidopa 18.75mg;
Entacapone 200mg
Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1132 BRU14031252P Stalevo 200/50/200mg Film-
coated Tablet
Levodopa 200mg; Carbidopa 50mg;
Entacapone 200mg
Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1133 BRU14031253P Humulin N Injection 100iu/vial Insulin (Human) Isophane 100iu/ml Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
BDMCA/RMP/1116 Page 67 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1134 BRU14031254NP Nutrineal PD-4 with 1.1% Amino
Acid Solution
Each 1000ml contains L-Serine 0.510g; L-
Isoleucine 0.850g; L-Leucine 1.020g; L-
Lysine (as Hydrochloride) 0.955g; L-
Methionine 0.850g; L-Phenylalanine
0.570g; L-Threonine 0.646g; L-Tryptophan
0.270g; L-Valine 1.393g; L-Alanine 0.951g; L-
Arginine 1.071g; Glycine 0.510g; L-Histidine
0.714g; L-Proline 0.595g; L-Tyrosine 0.300g;
Sodium Chloride 5.380g; Calcium Chloride
Dihydrate 0.184g; Magnesium Chloride
Hexahydrate 0.051g; Sodium Lactate 4.48g
Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 27 March 2014 till 26 March
2019
POM
1135 BRU14031255P Effient™ Tablet 10mg Prasugrel (as hydrochloride) 10mg Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1136 BRU14031256P Gonal-F 300IU/0.5ml solution for
injection in a pre-filled pen
Each pen (0.5ml) contains 300IU follitropin
alfa (eq. to 22 micrograms)
Merck Serono S.p.A, Italy G&H Trading Company 27 March 2014 till 26 March
2019
POM
BDMCA/RMP/1116 Page 68 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1137 BRU14031257P Gonal-F 900IU/1.5ml Solution for
Injection in a pre-filled pen
Each pen (1.5ml) contains 900IU follitropin
alfa (eq. to 66 micrograms). Each ml of
solution contains 600IU follitropin alfa
(equivalent to 44 micrograms)
Merck Serono S.p.A, Italy G&H Trading Company 27 March 2014 till 26 March
2019
POM
1138 BRU14031258P Volibris 5mg Film-coated Tablet Ambrisentan 5mg Patheon Inc., Ontario, USA Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1139 BRU14031259P Volibris 10mg Film-coated Tablet Ambrisentan 10mg Patheon Inc., Ontario, USA Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1140 BRU14031260P Atarax™ Syrup 2mg/ml Hydroxyzine hydrochloride 2mg/ml NextPharma SAS, France Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1141 BRU14031261P Prograf Capsule 1mg Tacrolimus 1mg Astellas Ireland Ltd, Ireland Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1142 BRU14031262P Loperamil Syrup 1mg/5ml Loperamide HCl 1mg/5ml Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 27 March 2014 till 26 March
2019
POM
1143 BRU14031263P Patanol® Eye Drops, Solution
0.1%
Olopatadine (as HCl) 0.1% S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Company 27 March 2014 till 26 March
2019
POM
1144 BRU14031264PS1;
BRU14031264PS2
Travatan® Eye Drops 40mcg/ml Travoprost 40mcg/ml S.A. Alcon-Couvreur N.V., Belgium (S1);
Alcon Singapore Manufacturing Pte Ltd,
Singapore (S2)
Hongkiat Trading & Company 27 March 2014 till 26 March
2019
POM
1145 BRU14031265P Chlorpheniramine tablet 4mg Chlorpheniramine Maleate 4mg Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 27 March 2014 till 26 March
2019
POM
1146 BRU14031266P Allertyn Tablet 10mg Loratadine (micronized) 10mg Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 27 March 2014 till 26 March
2019
P
1147 BRU14031267P Motilium Suspension 1mg/ml Domperidone 1mg/ml Janssen Pharmaceutica NV, Belgium Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1148 BRU14031268P Elonva Solution for Injection
100mcg/0.5ml
Corifollitropin alfa 100mcg/0.5ml Vetter Pharma-Fertigung GmbH & Co. KG,
Germany
Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
BDMCA/RMP/1116 Page 69 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1149 BRU14031269P Menveo Powder & Solution for
Solution for Injection
One dose (0.5ml of the reconstituted
vaccine) contains:
Originally contained in the powder:
Meninggococcal group A oligosaccharide
10micrograms
(Conjugated to Corynebacterium
diphtheria CRM197 protein 16.7 to 33.3
micrograms)
Originally contained in the solution:
Meninggococcal group C oligosaccharide
5micrograms
(Conjugated to Corynebacterium
diphtheria CRM197 protein…..7.1 to 12.5
micrograms); Meninggococcal group W135
oligosaccharide 5micrograms
(Conjugated to Corynebacterium
diphtheria CRM197 protein 3.3 to 8.3
micrograms); Meninggococcal group Y
oligosaccharide 5micrograms
(Conjugated to Corynebacterium
diphtheria CRM197 protein….5.6 to 10.0.
micrograms)
Novartis Vaccines and Diagnostics GmbH,
Germany; Novartis Vaccines and
Diagnostics S.r.I, Italy
Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1150 BRU14031270P Enbrel® 50mg solution for
Injection in a pre-filled syringe
Etanercept 50.0mg/1.0ml Pfizer Ireland Pharmaceuticals, Ireland Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1151 BRU14031271P Betnovate-N Cream Betamethasone (as betamethasone 17-
valerate BP) 0.1% w/w and Neomycin
sulphate BP 0.5% w/w
Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1152 BRU14031272P Seretide Evohaler dose-counter
25/250mcg
Salmeterol 25mcg (as the xinafoate) and
Fluticasone Propionate 250mcg
Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1153 BRU14031273PS1;
BRU14031273PS2
Galvus Met 50/500mg Film-
coated Tablet
Vildagliptin 50mg; Metformin HCl
500mg(corresponding to 390mg
Metformin)
Novartis Pharma Stein AG, Switzerland
(S1); Novartis Pharma Produktions GmbH,
Germany (S2)
Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1154 BRU14031274PS1;
BRU14031274PS2
Galvus Met 50/1000mg Film-
coated Tablet
Vildagliptin 50mg; Metformin HCl
1000mg(corresponding to 780mg
Metformin)
Novartis Pharma Stein AG, Switzerland
(S1); Novartis Pharma Produktions GmbH,
Germany (S2)
Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1155 BRU14031275PS1;
BRU14031275PS2
Galvus Met 50/850mg Film-
coated Tablet
Vildagliptin 50mg; Metformin HCl
850mg(corresponding to 660mg
Metformin)
Novartis Pharma Stein AG, Switzerland
(S1); Novartis Pharma Produktions GmbH,
Germany (S2)
Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1156 BRU14031276P Galvus 50mg Tablet Vildagliptin 50mg Novartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
BDMCA/RMP/1116 Page 70 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1157 BRU14031277P Duac Once Daily Gel Clindamycin 1% w/w (as Clindamycin
phosphate); Benzoyl Peroxide 5% w/w (as
hydrous Benzoyl Peroxide)
Glaxo Wellcome UK Operations, UK Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1158 BRU14031278P Conazole Cream Miconazole nitrate 2.0% w/w;
Betamethasone 0.1% w/w (as valerate);
Gentamicin (as sulphate) 0.1% w/w
Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 27 March 2014 till 26 March
2019
POM
1159 BRU14031279NP Axcel Paracetamol-250 Syrup
(Orange)
Paracetamol 250mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 March 2014 till 26 March
2019
GSL
1160 BRU14031280P Lamictal Dispersible/Chewable
Tablet 25mg
Lamotrigine 25mg GlaxoSmithKline Pharmaceutical SA,
Poland
Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1161 BRU14031281P Panaco Tablets Paracetamol 500mg; Codeine Phosphate
9mg
Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 27 March 2014 till 26 March
2019
POM
1162 BRU14031282P Voren Injection ‘Yung Shin’
(Diclofenac)
Diclofenac Sodium 75mg/3ml Yung Shin Pharmaceutical Ind, Taiwan,
R.O.C.
Asterix United (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1163 BRU14031283P Dhasolone Syrup 3mg/5ml Prednisolone 3mg/5ml Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 27 March 2014 till 26 March
2019
POM
1164 BRU14031284P Xalatan Eyedrops Latanoprost 0.005% w/v Pfizer Manufacturing Belgium NV,
Belgium
Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March
2019
POM
1165 BRU14041285P Giona Easyhaler® 100mcg/dose
Inhalation Powder
Budesonide 100mcg/dose Orion Corporation, Finland Hongkiat Trading & Company 26 April 2014 till 25 April
2019
POM
1166 BRU14041286P Axcel Nasatab Tablet Paracetamol 500mg; Chlorpheniramine
Maleate 4mg; Pseudoephedrine HCl 60mg
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 26 April 2014 till 25 April
2019
P (10 x 10's)
1167 BRU14041287P XareltoTM Film-coated tablet
15mg
Rivaroxaban 15mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
1168 BRU14041288P XareltoTM Film-coated tablet
20mg
Rivaroxaban 20mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
1169 BRU14041289P Metformin 500 Tablet 500mg Metformin HCl BP 500mg Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
POM
1170 BRU14041290NP Liquifilm TearsTM Ocular Lubricant
1.4%
Polyvinyl Alcohol 1.4% Allergan Pharmaceuticals Ireland, Ireland Medipharm Sdn Bhd 26 April 2014 till 25 April
2019
GSL
1171 BRU14041291NP Sodium Chloride Injection USP
0.9% in Mini-Bag Plus Container
Sodium Chloride 0.9% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
GSL
1172 BRU14041292PS1&
BRU14041292PS2
Rasilez® Film-coated Tablet
300mg
Aliskiren (as hemifumarate) 300mg Novartis Pharma Stein AG, Switzerland
(S1); Novartis Farma S.p.A., Italy (S2)
Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
1173 BRU14041293P Endoxan® Injection 200mg/vial Cyclophosphamide monohydrate 213.8mg
(eq. to anhydrous Cyclophosphamide
200mg)
Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
BDMCA/RMP/1116 Page 71 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1174 BRU14041294P Certican Tablet 0.25mg Everolimus 0.25mg Novartis Pharma Stein, AG, Switzerland Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
1175 BRU14041295P Certican Tablet 0.75mg Everolimus 0.75mg Novartis Pharma Stein, AG, Switzerland Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
1176 BRU14041296P Shincort IM Injection “Yung Shin”
5ml vial
Triamcinolone acetonide 40mg/ml Yung Shin Pharmaceutical Ind. Co. Ltd.,
Taiwan, R.O.C.
Asterix United (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
1177 BRU14041297PS1;
BRU14041297PS2
DuoTrav Eye Drops, Solution Travoprost 40mcg/ml; Timolol 5mg/ml (as
timolol maleate)
S.A. Alcon-Couvreur N.V., Belgium (S1);
Alcon Singapore Manufacturing Pte Ltd,
Singapore (S2)
Hongkiat Trading & Company 26 April 2014 till 25 April
2019
POM
1178 BRU14041298P Chlormine Syrup 4mg/5ml Chlorpheniramine Maleate 4mg/5ml Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
P
1179 BRU14041299P Hypernol 100 Tablets 100mg Atenolol 100mg Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
POM
1180 BRU14041300P Hypernol Tablets 50mg Atenolol 50mg Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
POM
1181 BRU14041301P DermovateTM Ointment Clobetasol Propionate 0.05% w/w Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
1182 BRU14041302P Tasigna Capsule 150mg Nilotinib (as hydrochloride, monohydrate)
150mg
Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
1183 BRU14041303P Tasigna Capsule 200mg Nilotinib (as hydrochloride, monohydrate)
200mg
Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
1184 BRU14041304NP Infusol NSD5 Sodium Chloride 9g/L; Dextrose anhydrous
50g/L
Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 April 2014 till 25 April
2019
POM
1185 BRU14041305NP Lactul Solution 670mg/ml Lactulose 670mg/ml Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 April 2014 till 25 April
2019
GSL
1186 BRU14041306P Kytril for Infusion 1mg/ml Granisetron 1mg (equivalent to
Granisetron hydrochloride 1.12mg)
Cenexi SAS, France Hongkiat Trading & Company 26 April 2014 till 25 April
2019
POM
1187 BRU14041307P Alimta 100mg Powder for
Solution for Infusion
Pemetrexed (as Pemetrexed disodium)
100mg/vial
Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
1188 BRU14041308P Decofam Cough Syrup Per 5mL contains Ephedrine HCl 4mg;
Guaiphenesin 50mg & Ammonium
Chloride 80mg
Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
P
1189 BRU14041309NP RinsCap W (Sterile Water for
Injection BP)
Water for Injection BP Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 April 2014 till 25 April
2019
GSL
1190 BRU14041310PS1;
BRU14041310PS2
Famotin Tablet 40mg Famotidine 40mg Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta,Indonesia (S2)
G&H Trading Company 26 April 2014 till 25 April
2019
POM
1191 BRU14041311P Paradrine Tablet Paracetamol 500mg; Pseudoephedrine HCl
BP 20mg; Chlorpheniramine Maleate BP
2mg
Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
P (10 x 10 x 10's)
1192 BRU14041312P One-Alpha® 0.25mcg Capsule Alfacalcidol 0.25mcg Leo Pharmaceutical Products Ltd., A/S
(Leo Pharma), Denmark
Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
1193 BRU14041313P Ibuprofen Suspension 20mg/ml Ibuprofen 20mg/ml Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 April 2014 till 25 April
2019
P
BDMCA/RMP/1116 Page 72 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1194 BRU14041314NP Sodium Chloride Injection 0.9%,
USP
Sodium Chloride 0.9% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April
2019
GSL
1195 BRU14041315P Rivadem 3mg Capsule Rivastigmine (as hydrogen tartrate) 3mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 26 April 2014 till 25 April
2019
POM
1196 BRU14041316P Rivadem 1.5mg Capsule Rivastigmine (as hydrogen tartrate) 1.5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 26 April 2014 till 25 April
2019
POM
1197 BRU14041317P Rozidal Tablet 1mg Risperidone 1mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G&H Trading Company 26 April 2014 till 25 April
2019
POM
1198 BRU14071318PS1 &
BRU14071318PS2
Rebif ® 44 Pre-filled Syringe
44mcg/0.5ml
Interferon-beta-1a (12MIU) 44mcg/0.5ml Merck Serono S.p.A., Italy G & H Trading Company 02 July 2014 till 01 July 2019 POM
1199 BRU14071319PS1 &
BRU14071319PS2
Mixtard® 30 100IU/ml Insulin Human, rDNA ( as Isophane Insulin)
70%, Insulin Human, rDNA (as soluble
insulin) 30%
Novo Nordisk A/S, Bagsvaerd, Denmark
(S1); Novo Nordisk Productions SAS,
France (S2)
Medipharm Sdn Bhd 02 July 2014 till 01 July 2019 POM
1200 BRU14071320P Protopic® Ointment 0.3% Tacrolimus 0.3mg/g (0.3%) Astellas Pharma Tech Co., Ltd., Japan Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1201 BRU14071321P Beathorphan Elixir 15mg/5ml Dextromethorphan HBr 15mg/5ml Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1202 BRU14071322P Nootropil 1200mg Tablet Piracetam 1200mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1203 BRU14071323P Nootropil 800mg Tablet Piracetam 80mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1204 BRU14071324P Luvox® Film-coated Tablets 50mg Fluvoxamine maleate 50mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1205 BRU14071325P Luvox® Film-coated Tablets
100mg
Fluvoxamine maleate 100mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1206 BRU14071326P TobraDex® Eye Ointment Tobramycin 0.3%, Dexamethasone 0.1% S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1207 BRU14071327P AgrippalTM S1, Suspension for
Injection in pre-filled syringe
Per 0.5ml dose: Split influenza virus*,
inactivated, containing antigens equivalent
to the following strains:
A/California/07/2009 (H1N1) pdm09– like
strain -15μg HA** (A/California/07/2009,
NYMC X-181);
A/Texas/50/2012 (H3N2) – like strain 15μg
HA**, A/Texas/50/2012, NYMC X-223-;
B/Massachusetts/2/2012– like strain
15μgHA** B/Florida/4/2006 wild type.
Novartis Vaccines and Diagnostic S.r.L.,
Italy
Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1208 BRU14071328P Lanvis® Tablet 40mg Thioguanin 40mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1209 BRU14071329NP Axcel Papain Tablet Papain Pure equiv. to proteolytic enzymes
from carica papaya 10,000 USP Units
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 02 July 2014 till 01 July 2019 GSL
BDMCA/RMP/1116 Page 73 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1210 BRU14071330PS1;
BRU14071330PS2
Humalog Kwikpen 100units/ml Insulin Lispro 100units/ml Lilly France S.A.S., France (S1); Eli Lilly
Italia S.p.A., Sesto Fiorentino, (FI) Italy
(S2) (repacker -
Eli Lilly And Company, USA) & Eli Lilly Italia
S.p.A., Sesto Fiorentino, (FI) Italy;
Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1211 BRU14071331P Shincort IM Injection "Yung Shin"
40mg/ml ampoules
Triamcinolone acetonide 40mg Yung Shin Pharmaceutical Ind. Co. Ltd.,
Taiwan
Asterix United (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1212 BRU14071332P Emend IV Powder For Solution for
Infusion 150mg
Fosaprepitant 150mg (as fosaprepitant
dimeglumine)
DSM Pharmaceuticals Inc., USA Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1213 BRU14071333PS1;
BRU14071333PS2
Zytiga Tablets 250mg Abiraterone acetate 250mg Patheon Inc. Canada (S1); Patheon S.A.S.
(Patheon-France), France (S2)
Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1214 BRU14071334P Axcel Cefaclor-500 Capsule Cefaclor 500mg (as monohydrate) Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 02 July 2014 till 01 July 2019 POM
1215 BRU14071335P Anlodin Tablet 5mg Amlodipine 5mg (as Besylate 6.93mg) Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1216 BRU14071336P Aldara Cream 5%w/w Imiquimod 5% w/w 3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1217 BRU14071337P Premarin Tablet 0.3mg Conjugated estrogens 0.3mg Pfizer Ireland Pharmaceuticals, Ireland Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1218 BRU14071338PS1;
BRU14071338PS2
Regro Lotion 5% Minoxidil USP 5% w/v Drug Houses of Australia Private Limited,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 02 July 2014 till 01 July 2019 P
1219 BRU14071339PS1;
BRU14071339PS2
Regro Lotion 3% Minoxidil USP 3% w/v Drug Houses of Australia Private Limited,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 02 July 2014 till 01 July 2019 P
1220 BRU14071340NP Dequalinium Lozenges Dequalinium Chloride 0.25mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 02 July 2014 till 01 July 2019 GSL
1221 BRU14071341P DHA-Ketozole Tablet 200mg Ketoconazole 200mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 02 July 2014 till 01 July 2019 POM
1222 BRU14071342P Axcel Ibuprofen Paediatric Syrup Ibuprofen 100mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 02 July 2014 till 01 July 2019 P
1223 BRU14071343P Pharynx Lozenges Cetylpyridinium Chloride 1.50mg,
Benzocaine 3.33mg
Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 02 July 2014 till 01 July 2019 GSL
1224 BRU14071344P Bislan Tablet 8mg Bromhexine Hydrochloride 8mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1225 BRU14071345P Tren Capsules 250mg Tranexamic Acid 250mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1226 BRU14071346P Hydrocort Cream Hydrocortisone acetate 10mg/g (1% w/w) Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1227 BRU14071347P Invoril Tablet 5mg Enalapril Maleate 5mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 02 July 2014 till 01 July 2019 POM
1228 BRU14071348P Atropine Sulphate 1mg/1ml
Injection
Atropine Sulphate 1mg/ml Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 02 July 2014 till 01 July 2019 POM
BDMCA/RMP/1116 Page 74 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1229 BRU14071349P Dhacodine Syrup 15mg/5ml Pholocodine 15mg/5ml Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 02 July 2014 till 01 July 2019 POM
1230 BRU14071350P Roaccutane Capsules 20mg Isotretinion 20mg R P Scherer GmbH & Co KG., Germany Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1231 BRU14071351P Roaccutane Capsule 10mg Isotretinion 10mg R.P. Scherer GmbH & Co. KG., Germany Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1232 BRU14071352P Ipolipid 600mg Tablets Gemfibrozil 600mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1233 BRU14071353P Salbutamol Injection 0.5mg/ml Salbutamol Sulphate 0.5mg/ml (equivalent
to salbutamol base)
Yung Shin Pharmaceutical Ind., Co. Ltd.,
Taichong, Taiwan
Asterix United (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1234 BRU14071354PS1;
BRU14071354PS2
Glipizide Tablet 5mg Glipizide 5mg Drug Houses of Australia Private Limited,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 02 July 2014 till 01 July 2019 POM
1235 BRU14071355P Axcel Dexchlorpheniramine
Tablet
Dexchlorpheniramine 2mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 02 July 2014 till 01 July 2019 POM
1236 BRU14071356P Phenexpect CD Syrup Per 5 ml - Diphenhydramine HCl BP
12.5mg; Ammonium Chloride BP 135mg;
Codeine Phosphate BP 5.7mg
Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 02 July 2014 till 01 July 2019 POM
1237 BRU14071357P Quinine Sulphate Tablet 300mg Quinine Sulphate BP 300mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1238 BRU14071358NP 20% Glucose Intravenous Infusion
BP
Glucose (as monohydrate) 20% B. Braun Medical Industries Sdn Bhd
Malaysia
Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1239 BRU14071359P Pharmaniaga Spironolactone
Tablet 25mg
Spironolactone 25mg Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 02 July 2014 till 01 July 2019 POM
1240 BRU14071360P Maxidex Sterile Opthalmic
Suspension
Dexamethasone 0.1% ( 1mg/ml) S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1241 BRU14071361P Heparinol 1000IU/ml Heparin sodium (bovine) BP 1000IU/ml Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 02 July 2014 till 01 July 2019 POM
1242 BRU14071362P Alphagan Ophthalmic Solution
0.2%
Brimonidine tartrate (anhydrous basis)
2mg/ml
Allergan Pharmaceuticals Ireland, Ireland Medipharm Sdn Bhd 02 July 2014 till 01 July 2019 POM
1243 BRU14071363P Dormicum Injection 15mg/3ml Midazolam 15mg/3ml Cenexi SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1244 BRU14071364P Dormicum Injection 5mg/5ml Midazolam 5mg/5ml Cenexi SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1245 BRU14071365NP 0.18% sodium Chloride and 4.3%
Glucose Intravenous Infusion
0.18% Sodium Chloride 0.18%; Glucose
4.3%
B.Braun Medical Industries Sdn Bhd.,
Malaysia
Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM
1246 BRU14071366PS1 &
BRU14071366PS2
Rasilez Film-coated Tablet 150mg Aliskiren 150mg (as Hemifumarate) Novartis Pharma Stein AG, Switzerland &
Novartis Farma S.p.A., Italy
Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
1247 BRU14071367P Invega Sustenna Prolonged
Release Suspension for IM
Injection 150mg/1.5ml
Paliperidone 150mg/1.5ml (as palmitate
234mg)
Janssen Pharmaceutical NV, Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM
BDMCA/RMP/1116 Page 75 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1248 BRU14071368P Yondelis® Powder for Injection
1mg/vial
Trabectedin 0.05mg/ml Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1249 BRU14071369P Trajenta film-coated tablet 5mg Linagliptin 5mg Boehringer Ingelhein Roxane Inc., USA Hongkiat Trading & Company 24 July 2014 till 23 July 2019 POM
1250 BRU14071370P Novoseven® 1mg Powder and
Solvent for Solution for Injection
Eptacog alfa (activated) 1mg/ml
(corresponds to 50KIU/vial) - 1mg/ml after
reconstitution
Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 24 July 2014 till 23 July 2019 POM
1251 BRU14071371P NovoSeven 5mg/vial, Powder and
Solvent for Solution for Injection
Eptacog alfa (activated) 5mg/vial
(corresponds to 250KIU/vial) - 1mg/ml
after reconstitution
Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 24 July 2014 till 23 July 2019 POM
1252 BRU14071372PS1 &
BRU14071372PS2
Invega® Extended-Release Tablet
9mg
Paliperidone 9mg [Layer 1 - 2.7mg; Layer 2 -
6.3mg]
ALZA Corporation, USA (S1); Janssen Cilag
Manufacturing L.L.C., Puerto Rico (S2)
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1253 BRU14071373PS1 &
BRU14071373PS2
Invega® Extended-Release Tablet
3mg
Paliperidone 3mg [Layer 1 - 0.9mg; Layer 2 -
2.1mg]
ALZA Corporation, USA (S1); Janssen Cilag
Manufacturing L.L.C., Puerto Rico (S2)
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1254 BRU14071374PS1 &
BRU14071374PS2
Invega® Extended-Release Tablet
6mg
Paliperidone 6mg [Layer 1 - 1.8mg; Layer 2 -
4.2mg]
ALZA Corporation, USA (S1); Janssen Cilag
Manufacturing L.L.C., Puerto Rico (S2)
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1255 BRU14071375P Lucentis 10mg/ml Solution for
Injection
Ranibizumab 10mg/ml Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1256 BRU14071376P Onbrez Breezhaler 150mcg
Inhalation Powder, Hard Capsule
Indacterol 150mcg (as maleate 194mcg) Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1257 BRU14071377P Onebrez Breezhaler 300mcg
Inhalation Powder Hard Capsule
Indacterol 300mcg (as maleate 389mcg) Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1258 BRU14071378P Requip PD 24hr Prolong Release
Tablet 2mg
Ropinirole 2mg (as Hydrochloride) Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1259 BRU14071379P Difflam Anti-Inflammatory
Lozenges (with Anti-bacterial)
Benzydamine Hydrochloride 3mg;
Cetylpyridinium Chloride 1.33mg
Unique Pharmaceutical Laboratories,
India
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 GSL
1260 BRU14071380P Vfend Powder For Oral
Suspension 40mg/ml
Voriconazole 40mg/ml Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1261 BRU14071381P Norditropin® Nordilet® Solution
for Injection 10mg/1.5ml
Somatropin (biosynthetic human growth
hormone) 10mg/1.5ml
Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 24 July 2014 till 23 July 2019 POM
1262 BRU14071382P Alphagan P Ophthalmic Solution
0.15%
Brimonidine tartrate 0.15% Allergan Sales LLC, USA Medipharm Sdn Bhd 24 July 2014 till 23 July 2019 POM
1263 BRU14071383P Mapenem® IV Injection 500mg Meropenem 500mg (as trihydrate) Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 24 July 2014 till 23 July 2019 POM
1264 BRU14071384P Curam Powder for oral
Suspension 312.5mg/5ml
Amoxycillin 250mg (as trihydrate);
Clavulanic Acid 62.5mg (as potassium salt)
Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1265 BRU14071385P Topamax® 25 Tablet 25mg Topiramate 25mg CILAG AG, Switzerland Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
BDMCA/RMP/1116 Page 76 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1266 BRU14071386P Tussils 5 Lozenge 5mg Dextromethorphan Hydrobromide 5mg Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1267 BRU14071387P Kivexa Tablets 600mg/300mg Abacavir 600mg (as sulfate); Lamivudine
300mg
Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1268 BRU14071388P Lucrin® depot 3.75mg Injection Leuproprelin acetate 3.75mg Takeda Pharmaceutical Company Limited,
Japan
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1269 BRU14071389P Lucrin® depot 11.25mg Injection Leuproprelin acetate 11.25mg Takeda Pharmaceutical Company Limited,
Japan
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1270 BRU14071390P Axcel Diclofenac-50 Tablet Diclofenac Sodium 50mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 24 July 2014 till 23 July 2019 POM
1271 BRU14071391P Lamictal Tablet 50mg Lamotrigine 50mg Glaxosmithkline Pharmaceuticals SA,
Poland
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1272 BRU14071392P Infasurf® (Calfactant) Intrathecal
Suspension
Per ml - Phospholipids 35mg (including
26mg phosphatidycholine of which 16mg is
disaturated phosphatidycholine) and
0.7mg protein (incuding 0.26mg of SP-
B0Calfactant [Calf lung Surfactant Extract -
CLSE]
ONY Inc., USA K-Seri Pharma 24 July 2014 till 23 July 2019 POM
1273 BRU14071393NP Kaolin & Pectin Mixture Per 5ml - Kaolin Light BP 1g; Pectin 50mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 24 July 2014 till 23 July 2019 P
1274 BRU14071394P Duodart 0.5mg/0.4mg Capsules Dutasteride 0.5mg; Tamsulosin 0.4mg Catalent Germany Schorndorf GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1275 BRU14071395P Axcel Metronidazole-400 Tablet Metronidazole 400mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 24 July 2014 till 23 July 2019 POM
1276 BRU14071396P Cefazolin Sandoz 1g Vial Cefazolin 1g Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1277 BRU14071397PS1 &
BRU14071397PS2 &
BRU14071397PS3
MABTHERA Concentrate for
Solution for Infusion 500mg/50ml
Rituximab 500mg/50ml Genetech Inc., USA (S1); F. Hoffmann-LA
Roche Ltd, Switzerland (S2); and Roche
Diagnostics GmbH, Germany (S3)
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1278 BRU14071398P Lamitor 100mg Tablet Lamotrigine 100mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 24 July 2014 till 23 July 2019 POM
1279 BRU14071399P Vigamox® Ophthalmic Solution
0.5%
Moxifloxacin 0.5% (as hydrochloride) Alcon Laboratories, Inc., USA Hongkiat Trading & Co 24 July 2014 till 23 July 2019 POM
1280 BRU14071400P Cementin Tablet 200mg Cimetidene 200mg Drug Houses of Australia Pte Ltd,
Singapore
G & H Trading Company 24 July 2014 till 23 July 2019 POM
1281 BRU14071401PS1 &
BRU14071401PS2
Voltaren Emulgel 1% Diclofenac diethylamine 1.16g/100g
(equivalent to 1g of diclofenac sodium)
Novartis Pharma Produktions GmbH,
Germany (S1 for pack size 50g) & Novartis
Consumer Health SA, Switzerland (S2 for
pack size 20g)
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 GSL
1282 BRU14071402P Imexa Film-Coated Tablet 250mg Azithromycin 250mg (as dihydrate) Xepa-Soul Pattinson (M) Sdn Bhd
Malaysia
Hongkiat Trading & Co 24 July 2014 till 23 July 2019 POM
BDMCA/RMP/1116 Page 77 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1283 BRU14071403P Cymbalta Capsule 60mg Duloxetine 60mg (as hydrochloride) Eli Lilly and Co., USA & Lilly del Caibe Inc,
Puerto Rico
Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1284 BRU14071404P Beanamine Expectorant Per 5ml - Diphenhydramine BP 10mg;
Ammonium Chloride BP 120mg)
Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 24 July 2014 till 23 July 2019 POM
1285 BRU14071405P Setrof Tablet 50mg Sertraline 50mg Hovid Bhd, Malaysia G & H Trading Company 24 July 2014 till 23 July 2019 POM
1286 BRU14071406P Dimenate Tablet 50mg Dimenhydrinate BP 50mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 24 July 2014 till 23 July 2019 POM (5 x 20 x 10's;
1000's)
1287 BRU14071407P Dhatifen Tablet 1mg Ketotifen 1mg (as hydrogen fumarate
1.38mg)
Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 24 July 2014 till 23 July 2019 POM
1288 BRU14071408P Melashine Cream 4% Hydroquinone 40mg/g Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1289 BRU14071409P Asumalife Syrup 1.38mg/5ml Per 5ml - Ketotifen 1mg (as hydrogen
fumarate 1.38mg)
Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1290 BRU14071410P Lovastin Tablet 20mg Lovastatin 20mg Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1291 BRU14071411P Requip tablet 0.25mg Ropinirole 0.25mg (as Hydrochloride) Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1292 BRU14071412NP Zoben Tablet 200mg Albendazole 200mg Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 24 July 2014 till 23 July 2019 P (10 x 10's)
1293 BRU14071413P Clamentin Injection 600mg Amoxycillin 500mg (as sodium); Clavulanic
Acid 0.1g (as Clavulanate potassium)
Yung Shin Pharmaceutical Ind. Co. Ltd.,
Taiwan, R.O.C.
Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1294 BRU14071414P Garbose Tablet 50mg Acarbose 50mg Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM
1295 BRU14071415P Dexamethasone 4mg Tablet Dexamethasone 4mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 24 July 2014 till 23 July 2019 POM
1296 BRU14081416PS1;
BRU14081416PS2
Sevorane Inhalation Liquid Sevoflurane 100%v/v Aesica Queensborough Ltd, UK (S1);
Abbvie S.R.L, Italy (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1297 BRU14081417P Emend Tri-Pack Capsule Each capsule either contains Aprepitant
80mg or 125mg
Merck Sharp & Dohme Corp. Australia Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1298 BRU14081418P Protopic Ointment 0.1% Tacrolimus 0.1% (as monohydrate) Astellas Pharma Tech Co., Ltd., Japan Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1299 BRU14081419PS1 &
BRU14081419PS2
Exforge HCT 10/160/12.5mg Film-
coated tablet
Amlodipine 10mg (as besylate); Valsartan
160mg; Hydrochlorothiazide 12.5mg
Novartis Pharma Stein AG, Switzerland
(S1) & Novartis Farmaceutica SA,
Barcelona, Spain (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1300 BRU14081420PS1 &
BRU14081420PS2
Exforge HCT 10/160/25mg Film-
coated tablet
Amlodipine 10mg (as besylate); Valsartan
160mg; Hydrochlorothiazide 25mg
Novartis Pharma Stein AG, Switzerland
(S1) & Novartis Farmaceutica SA,
Barcelona, Spain (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1301 BRU14081421PS1 &
BRU14081421PS2
Exforge HCT 5/160/12.5mg Film-
coated tablet
Amlodipine 5mg (as besylate); Valsartan
160mg; Hydrochlorothiazide 12.5mg
Novartis Pharma Stein AG, Switzerland
(S1) & Novartis Farmaceutica SA,
Barcelona, Spain (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
BDMCA/RMP/1116 Page 78 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1302 BRU14081422PS1 &
BRU14081422PS2
Exforge HCT 5/160/25mg Film-
coated tablet
Amlodipine 5mg (as besylate); Valsartan
160mg; Hydrochlorothiazide 25mg
Novartis Pharma Stein AG, Switzerland
(S1) & Novartis Farmaceutica SA,
Barcelona, Spain (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1303 BRU14081423PS1 &
BRU14081423PS2
Exforge HCT 10/320/25mg Film-
coated tablet
Amlodipine 10mg (as besylate); Valsartan
320mg; Hydrochlorothiazide 25mg
Novartis Pharma Stein AG, Switzerland
(S1) & Novartis Farmaceutica SA,
Barcelona, Spain (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1304 BRU14081424P Luveris for Injection 75IU/Vial
(Revised Formula)
Lutropin alfa 75IU (Recombinant Human
Lutenising Hormone)
Merck Serono SA., Switzerland G & H Trading Company 30 August 2014 till 29 August
2019
POM
1305 BRU14081425P Lipanthyl Penta 145 Film-Coated
tablet
Fenofibrate 145mg Recipharm Fontaine, France Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1306 BRU14081426P Dexamethasone Tablet 0.5mg Dexamethasone 0.5mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 August 2014 till 29 August
2019
POM
1307 BRU14081427P FlixotideTM Evohaler 50mcg Fluticasone Propionate 50mcg GlaxoWellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1308 BRU14081428PS1
BRU14081428PS2JanumetTM Tablet 50mg/850mg Sitagliptin 50mg (as phosphate);
Metformin HCl 850mg
Patheon Puerto Rico, Inc., Manati, PR
00674, Puerto Rico (S1) & Aesica
Queensborough Limited, UK (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1309 BRU14081429PS1
BRU14081429PS2Janumet
TM Tablet 50mg/500mg Sitagliptin 50mg (as phosphate);
Metformin HCl 500mg
Patheon Puerto Rico, Inc., Manati, PR
00674, Puerto Rico (S1) & Aesica
Queensborough Limited, UK (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1310 BRU14081430PS1
BRU14081430PS2JanumetTM Tablet 50mg/1000mg Sitagliptin 50mg (as phosphate);
Metformin HCl 1000mg
Patheon Puerto Rico Inc., Manati, Puerto
Rico (S1) & Aesica Queensborough
Limited, UK (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1311 BRU14081431P Napan Capsules 250mg Mefenamic Acid 250mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 30 August 2014 till 29 August
2019
POM
1312 BRU14081432PS1 &
BRU14081432PS2 &
BRU14081432PS3
Mabthera Concentrate for
Solution for Infusion 100mg/10ml
Rituximab 100mg/10ml Genetech Inc., USA; F Hoffmann-LA Roche
Ltd, Switzerland; Roche Diagnostics
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1313 BRU14081433P EraxisTM 100mg for Injection Anidulafungin 100mg/vial Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1314 BRU14081434P Moxiclav 1G Tablet Amoxycillin 875mg (as sodium); Clavulanic
Acid 125mg (as Clavulanate potassium)
Medochemie Ltd., Cyprus Hongkiat Trading & Co 30 August 2014 till 29 August
2019
POM
1315 BRU14081435P Lisdene 10mg tablet Lisinopril 10mg (as dihydrate) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1316 BRU14081436P Dilatrend Tablet 25mg Carvedilol 25mg Roche S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1317 BRU14081437P Dilatrend Tablet 12.5mg Carvedilol 12.5mg Roche S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1318 BRU14081438P Dilatrend Tablet 6.25mg Carvedilol 6.25mg Roche S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1319 BRU14081439P Carzepin 200mg Tablet Carbamazepine 200mg Hovid Bhd, Malaysia G & H Trading Company 30 August 2014 till 29 August
2019
POM
BDMCA/RMP/1116 Page 79 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1320 BRU14081440P Naphcon-A Sterile Ophthalmic
Solution
Naphazoline Hydrochloride 0025%;
Pheniramine maleate 0.3%
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 30 August 2014 till 29 August
2019
P
1321 BRU14081441P Lamictal 100mg Tablet Lamotrigine 100mg Glaxosmithkline Pharmaceuticals SA,
Poland
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1322 BRU14081442P Axcel Loratadine Tablet Loratadine 10mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 August 2014 till 29 August
2019
P
1323 BRU14081443NP Neuroxel Tablet Thiamine Mononitrate 100mg; Pyridoxine
HCl 200mg; Cynocobalamin 200mcg
Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 30 August 2014 till 29 August
2019
P
1324 BRU14081444P Rhiniramine SR Tablet 6mg Dexhlorpheniramine Maleate 6mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 30 August 2014 till 29 August
2019
POM
1325 BRU14081445P Buventhol Easyhaler
100mcg/dose inhalation powder
Salbutamol sulphate 100mcg/actuation
(delivered dose 90mcg/actuation)
Orion Corporation, Finland Hongkiat Trading & Co 30 August 2014 till 29 August
2019
POM
1326 BRU14081446P Buventhol Easyhaler
200mcg/dose inhalation powder
Salbutamol sulphate 300mcg/actuation
(delivered dose 180mcg/actuation)
Orion Corporation, Finland Hongkiat Trading & Co 30 August 2014 till 29 August
2019
POM
1327 BRU14081447P Axcel Cefaclor-125 Suspension Cefaclor 125mg (as monohydrate) Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 August 2014 till 29 August
2019
POM
1328 BRU14081448P Dextramine Tablet 2mg Dexchlorpheniramine 2mg Biosis Pharmaceuticals Sdn Bhd., Malaysia K-Seri Pharma Sdn Bhd 30 August 2014 till 29 August
2019
POM
1329 BRU14081449P Mircera Pre-filled Syringe
75mcg/0.3ml
Methoxy polyethylene glycol-epoetin Beta
75mcg/0.3ml
Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1330 BRU14081450P Creobic (New Formula) Cream Clotrimazole 1%w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 August 2014 till 29 August
2019
GSL
1331 BRU14081451P Axcel Cetirizine Syrup Cetirizine Dihydrochloride 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 August 2014 till 29 August
2019
P
1332 BRU14081452P Tinacort Cream Miconazole nitrate 2%w/w;
Hydrocortisone 1.0% w/w
Hovid Bhd, Malaysia G & H Trading Company 30 August 2014 till 29 August
2019
POM
1333 BRU14081453P Sunex Cough Syrup Per 5ml - Diphenhydramine HCl 14mg;
Ammonium chloride 135mg; Sodium/
Trisodium citrate 57.5mg
Sunward Pharmaceutical Sdn Bhd
Malaysia
G & H Trading Company 30 August 2014 till 29 August
2019
POM
1334 BRU14081454P Loxof Tablets 500mg Levofloxacin 500mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 30 August 2014 till 29 August
2019
POM
1335 BRU14081455P Proluton Depot 250mg Injection Hydroxyprogesterone Caproate 250mg Bayer Pharma AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1336 BRU14081456P Nurofen for Children Ibuprofen 100mg/5ml Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
P
1337 BRU14081457P Axcel Sabutamol Syrup Salbutamol 2mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 August 2014 till 29 August
2019
POM
1338 BRU14081458P Doxymycin Capsule 100mg Doxycycline Hydrochloride 100mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1339 BRU14081459P Clamentin Powder for Syrup
31.25mg/ml
Per ml - Amoxycillin 25mg (as trihydrate);
Clavulanic acid 6.25mg (as potassium salt)
Yung Shin Pharmaceutical Ind. Co., Ltd,
Taiwan, R.O.C.
Asterix United (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
BDMCA/RMP/1116 Page 80 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1340 BRU14081460P Clarimycin Film Coated Tablet
500mg
Clarithromycin 500mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1341 BRU14081461NP Mentar Shampoo Coal Tar solution 9% v/v; Menthol 1% w/w HOE Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 30 August 2014 till 29 August
2019
GSL
1342 BRU14081462NP Menzza Cream Methyl Salicylate 25%w/w; Menthol
5%w/w
Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 30 August 2014 till 29 August
2019
GSL
1343 BRU14081463P Difnal OD Tablet 100mg Methyl Salicylate 25%w/w; Menthol
5%w/w
Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 30 August 2014 till 29 August
2019
POM
1344 BRU14081464PS1;
BRU14081464PS2
Humulin N Injection 100IU/ml
(Catridges)
Human Insulin 100IU/ml (recombinant
DNA oigin)
Lilly France SAS, France (S1); Eli Lily Italia
S.p.A., Sesto Fiorentino,
(FI) Italy (S2)
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1345 BRU14081465NP Bayer Aspirin Tablet 500mg Aspirin 500mg (Acetylsalicylic acid) PT Bayer Indonesia
Jl. Raya Bogor Km 32
Cimanggis, Depok 16416
Indonesia
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
GSL
1346 BRU14081466P Doridone Tablet 10mg Domperidone 10mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 30 August 2014 till 29 August
2019
POM
1347 BRU14081467P Tobradex® Eye Drops Suspension Tobramycin 0.3%; Dexamethasone 0.1% S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 30 August 2014 till 29 August
2019
POM
1348 BRU14081468NP Ferrous Fumarate Tablet 200mg Ferrous fumarate 200mg (equivalent to
65mg of elemental iron)
Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 30 August 2014 till 29 August
2019
GSL
1349 BRU14081469P Tamoxifen 20mg Tablet Tamoxifen 20mg (as citrate 30.4mg) Teva Pharmaceutical Industries Ltd, Israel K-Seri Pharma Sdn Bhd 30 August 2014 till 29 August
2019
POM
1350 BRU14081470P Rotaqor 10mg film-coated tablet Atorvastatin 10mg (as calcium) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1351 BRU14081471P Zoral 200 tablet 200mg Acyclovir USP 200mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 30 August 2014 till 29 August
2019
POM
1352 BRU14081472P Vamlo Tablets 5mg Amlodipine 5mg (as besilate) Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 30 August 2014 till 29 August
2019
POM
1353 BRU14081473P Clofenac SR Tablet Diclofenac Sodium 100mg Hovid Bhd, Malaysia G & H Trading Company 30 August 2014 till 29 August
2019
POM
1354 BRU14081474P Strepsils Max Plus Lozenges 2,4 Dichlorobenzyl alcohol 1.2mg;
amymetacresol 0.6mg; Lignocaine
Hydrochloride 10mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
GSL
1355 BRU14081475P Cera-Scalp Ointment Coal Tar solution 12% w/w; Salicylic acid
2%; Sulphur 4% w/w
HOE Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 30 August 2014 till 29 August
2019
GSL
1356 BRU14081476P Lisdene 20mg Tablet Lisinopril 20mg (as dihydrate) Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August
2019
POM
1357 BRU14091477P Suprane Inhalation Liquid 100% Desflurane 100% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1358 BRU14091478P Buclizine Tablet 25mg Buclizine 25mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 September 2014 till 29
September 2019
P
BDMCA/RMP/1116 Page 81 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1359 BRU14091479PS1;
BRU14091479PS2
Cetrotide Injection 0.25mg Cetrotrelix 0.25mg (as Acetate) Baxter Oncology GmbH, Germany (S1);
Pierre Fabre Medicament Production,
France (S2)
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1360 BRU14091480P Mivacron Injection 10mg/5ml Mivacurium Chloride 10mg/5ml GlaxoSmithKline Manufacturing S.p.A.,
Italy
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1361 BRU14091481P Xolair Powder and Solvent for
Solution for Injection
Omalizumab 150mg Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1362 BRU14091482P Frusemide Tablet 40mg Furosemide 40mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1363 BRU14091483P Penegesic 50 Capsule Tramadol HCl 50mg Hovid Bhd, Malaysia G & H Trading Company 30 September 2014 till 29
September 2019
POM
1364 BRU14091486P Crinone Progestrone Vaginal Gel
8%
Progestrone 8% Fleet Laboratories Ltd, United Kingdom G & H Trading Company 30 September 2014 till 29
September 2019
POM
1365 BRU14091487NP Pinetarsol Gel Tar 1.6% EGO Pharmaceuticals Pty Ltd., Australia Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
GSL
1366 BRU14091488P Defungo (Vaginal Tablet 0.1g) Clotrimazole 0.1g Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 30 September 2014 till 29
September 2019
POM
1367 BRU14091489P Magrilan 20mg capsules Fluoxetine 20mg (as Hydrochloride) Medochemie Ltd., Cyprus Hongkiat Trading & Co 30 September 2014 till 29
September 2019
POM
1368 BRU14091490P Trileptal 600mg Film-coated
Tablets
Oxcarbazepine 600mg Novartis Farma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1369 BRU14091491P Binozyt 500mg film-coated tablet Azithromycin 500mg (as monohydrate) Novartis (Bangladesh) Ltd., Bangladesh Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1370 BRU14091492P Nurofen 400 Caplet Ibuprofen 400mg Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
P
1371 BRU14091493P Recormon Pre-filled Syringe
30,000Iu/0.6ml
Epoetin beta 30,000 IU/0.6ml Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1372 BRU14091494P Eprex® 10000 Prefilled Syringes
10,000iu/1ml
Epoetin alfa 10,000 IU/ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1373 BRU14091495P Metformin Tablet 250mg Metformin Hydrochloride 250mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1374 BRU14091496PS1;
BRU14091496PS2
Hydrochlorothiazide Tablet 50mg Hydrochlorothiazide BP 50mg Drug Houses of Australia Private Limited,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1375 BRU14091497PS1;
BRU14091497PS2
Famotin Tablet 20mg Famotidine USP 20mg Drug Houses of Australia Private Limited,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1376 BRU14091498P Difenac Tablet 25mg Diclofenac (as Sodium) 25mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1377 BRU14091501P Yucomy cream Ketoconazole 20g/g Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1378 BRU14091502P Loradine Tablet 10mg Loratadine 10mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
p
1379 BRU14091503P Rasitol Tablet 40mg Furosemide 40mg YSP Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
BDMCA/RMP/1116 Page 82 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1380 BRU14091504P Betoptic S Eye Drops Betaxolol 2.5mg/ml (as Hydrochloride
2.8mg)
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 30 September 2014 till 29
September 2019
POM
1381 BRU14091505P Nurofen Caplet 200mg Ibuprofen 200mg Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
p
1382 BRU14091506P Rhiniramine Syrup 2mg/5ml Dexchlorpheniramine maleate BP 2mg/5ml Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1383 BRU14091507P Afinitor 2.5mg Tablet Everolimus 2.5mg Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1384 BRU14091508P Glucagen® 1mg Powder and
Solvent for Solution for Injection
Glucagon 1mg (as hydrochloride) Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 30 September 2014 till 29
September 2019
POM
1385 BRU14091509P Chloramine Syrup 4mg/5ml Chlorpheniramine maleate 4mg/5ml Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 September 2014 till 29
September 2019
p
1386 BRU14091510P Difnal-K Tablet 50mg Diclofenac Potassium 50mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 30 September 2014 till 29
September 2019
POM
1387 BRU14091511NP 0.9% Sodium Chloride Injection,
B.P. (10ml)
Sodium Chloride 0.9% B. Braun Medical Industries Sdn Bhd
Malaysia
Hongkiat Trading & Co 30 September 2014 till 29
September 2019
GSL
1388 BRU14091512NP Compound Sodium Lactate
Intravenous Infusion B.P.
(Hartmann's Solution)
Per 1000ml contains: Sodium Chloride 6g;
Sodium Lactate solution 6.24g (50% w/w);
Potassium Chloride 0.40g; Calcium Chloride
dehydrate 0.27g
B. Braun Medical Industries Sdn Bhd
Malaysia
Hongkiat Trading & Co 30 September 2014 till 29
September 2019
POM
1389 BRU14091513P HBVaxPro® 5mcg/0.5ml Injection Hepatitis B surface Antigen 5mcg/0.5ml Merck Sharp & Dohme Corp., West Point,
Pensylvania, USA
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1390 BRU14091514P HBVaxPro® 10mcg/1.0ml
Injection
Hepatitis B surface Antigen 10mcg/1.0ml Merck Sharp & Dohme Corp., West Point,
Pensylvania, USA
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1391 BRU14091515P HBvaxPro® 40mcg/1.0ml Injection Hepatitis B surface Antigen 40mcg/1.0ml Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1392 BRU14091516P Emthexate 2.5mg Tablet Methotrexate 2.5mg (as disodium) Teva Czech Industries S.R.O., Czech
Republic
K-Seri Pharma Sdn Bhd 30 September 2014 till 29
September 2019
POM
1393 BRU14091517P Stalevo 125/31.25/200mg film-
coated tablet
Levodopa 125mg, Carbidopa 31.25mg,
Entacapone 200mg
Baxter Bioscience Manufacturing Sarl,
Switzerland
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1394 BRU14091518P Axcel Dextromethorphan-30
Syrup
Dextromethorphan Hydrobromide
30mg/5ml
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 September 2014 till 29
September 2019
POM
1395 BRU14091519P Afinitor 5mg Tablet Everolimus 5mg Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1396 BRU14091520P Renacid K8 Each 1 Litre contains: Sodium Chloride
161.43g, Potassium Chloride 5.49g,
Calcium Chloride 2H2O 6.77g, Magnesium
Chloride 6H2O 3.74g, Glacial acetic acid
8.85g
Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 30 September 2014 till 29
September 2019
POM
1397 BRU14091521P Ospexin 500mg Film-coated
Tablets
Cefalexin 500mg (as monohydrate) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
BDMCA/RMP/1116 Page 83 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1398 BRU14091522PS1 &
BRU14091522PS2
Androcur Tablet 50mg Cyproterone acetate 50mg Delpharm Lille SAS, France Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1399 BRU14091523P Poviderm Ointment Povidone Iodine 10% w/w Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 30 September 2014 till 29
September 2019
GSL
1400 BRU14091524P Melaquin Cream 4% w/w Hydroquinone 40mg/g Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
P
1401 BRU14091525P Calumid 50mg Film-coated Bicalutamide 50mg Gedeon Richter Plc., Hungary K-Seri Pharma Sdn Bhd 30 September 2014 till 29
September 2019
POM
1402 BRU14091526P Glucomet Tablet 500mg Metformin Hydrochloride 500mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1403 BRU14091527P Quemox Tablet 500mg Mebendazole 500mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
P
1404 BRU14091528P Campto 300mg/15ml Injection Irinotecan Hydrochloride Trihydrate
300mg/15ml
Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1405 BRU14091529NP Strepsils Cool Lozenges Each lozenge contains: Amymetacresol
0.6mg, 2,4-Dichlorobezyl alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 30 September 2014 till 29
September 2019
GSL
1406 BRU14091530NP Strepsils Sugar Free Lemon
Lozenges
Each lozenge contains: Amymetacresol
0.6mg, 2,4-Dichlorobezyl alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 30 September 2014 till 29
September 2019
GSL
1407 BRU14091531P Nordette 21 Tablet Levonogestrel 150mcg, Ethinyl estradiol
30mcg
Haupt Pharma Munster GmbH., Germany Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1408 BRU14091532P Primocal Solution Per Litre: Sodium 140mmol, Magnesium
0.5mmol, Lactate 3mmol, Bicarbonate
32mmol, Chloride 106mmol
Gambro Dasco S.p.A., Italy Medicorp Sdn Bhd 30 September 2014 till 29
September 2019
POM
1409 BRU14091533P Ansures Extended Release Tablet
500mg
Metformin Hydrochloride 500mg Siu Guan Chem, Ind. Co. Ltd., Taiwan G & H Trading Company 30 September 2014 till 29
September 2019
POM
1410 BRU14091534P Deplatt Tablet 75mg Clopidogrel 75mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 30 September 2014 till 29
September 2019
POM
1411 BRU14091535NP Livolin Forte Softgel Capsules Per Capsule: Lecithin [PC 35%] 857.13mg
(equivalent to Phosphatidylcholine
300mg), Di-alpha-tocopheryl acetate 10mg,
Thiamine mononitrate 10mg, Riboflavin
6mg, Pyridoxine hydrochloride 10mg,
Vitamin B12 0.1% WS 15mg (equivalent to
Vitamin B12 0.015mg), Nicotinamide 30mg.
Mega Lifesciences Public Company
Limited, Thailand
Hongkiat Trading & Co 30 September 2014 till 29
September 2019
GSL
1412 BRU14091536NP Pharmaniaga Aqueous Cream White Soft Paraffin 15%, Emulsifying Wax
9%, Liquid Paraffin 6%
Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 30 September 2014 till 29
September 2019
GSL
1413 BRU14091537P Synagis 100mg Powder and
Solvent for Solution for Injection
Palivizumab 100mg Boehringer Ingelheim Pharma KG,
Germany
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
BDMCA/RMP/1116 Page 84 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1414 BRU14091538P Clamentin Injection 1.2g Amoxicillin 1g (as sodium), Clavulanic acid
0.2g (as clavulanate potassium)
Yung Shin Phamaceutical Ind. Co Ltd,
Taiwan, ROC
Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1415 BRU14091539P ZmaxTM Extended-Release
Granules for Oral Suspension 2g
Azithromycin 2g (as dihydrate) Pfizer Pharmaceuticals LLC Vega Baja,
Puerto Rico
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1416 BRU14091540P Eturion 10mg Film Coated Tablet Atorvastatin 10mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceuticals LLC, Puerto Rico Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1417 BRU14091541P Eturion 20mg Film Coated Tablet Atorvastatin 20mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceuticals LLC, Puerto Rico,
USA
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1418 BRU14091542P Eturion 40mg Film Coated Tablet Atorvastatin 40mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceutical LLC, Puerto Rico,
USA
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1419 BRU14091543P Eturion 80mg Film Coated Tablet Atorvastatin 80mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceuticals LLC, Puerto Rico,
USA
Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1420 BRU14111544P (vial) EYLEA Solution for Injection (vial) Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc., New
York, USA
Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1421 BRU14111545P EYLEA Solution for Injection (pre-
filled syringe)
Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc., New
York, USA
Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1422 BRU14111546P Binocrit Solution for Injection
2000 IU/ml in Pre-filled Syringe
Epoetin Alfa 2,000 IU/ml IDT Biologika GmbH, Germany Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1423 BRU14111547P Binocrit Solution for Injection
4000 IU/0.4ml in Pre-filled
Syringe
Epoetin Alfa 4,000IU/0.4ml IDT Biologika GmbH, Germany Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1424 BRU14111548P Nootropil Infusion 12g/60ml Piracetam 12g/60ml Aesica Pharmaceuticals SRL., Italy Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1425 BRU14111549P Nootropil Injection 1g/5ml Piracetam 1g/5ml UCB Pharma S.P.A., Italy Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1426 BRU14111550P Advagraf Prolonged Release Hard
Capsule 0.5mg
Tacrolimus 0.5mg (as monohydrate) Astellas Ireland Co Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1427 BRU14111551P Advagraf Prolonged Release Hard
Capsule 1mg
Tacrolimus 1mg (as monohydrate) Astellas Ireland Co Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1428 BRU14111552P Advagraf Prolonged Release Hard
Capsule 5mg
Tacrolimus 5mg (as monohydrate) Astellas Ireland Co Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1429 BRU14111553P Dynastat Powder and Solvent for
Solution for Injection 40mg
Parecoxib (as Sodium) 40mg Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1430 BRU14111554P Invanz Powder for Injection
1g/vial
Ertapenem 1g (as Sodium 1.046g) Laboratories Merck Sharp & Dohme-
Chibret, France
Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1431 BRU14111555PS1;
BRU14111555PS2
Humalog Mix25 100 units/ml
Kwikpen
Insulin Lispro 100IU/ml [In the proportion
of 25% Insulin Lisporo & 75% Insulin Lispro
Protamine Suspension (rDNA origin)
Lilly France S.A.S., France (S1); Eli Lilly
Italia S.p.A., Sesto Fiorentino, (FI) Italy
(S2) (repacker -
Eli Lilly And Company, USA) & Eli Lilly Italia
S.p.A., Sesto Fiorentino, (FI) Italy;
Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
BDMCA/RMP/1116 Page 85 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1432 BRU14111556P Brozil Capsule 300mg Gemfibrozil 300mg YSP Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1433 BRU14111557NP Menzza Ice Gel Menthol 4% w/w Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 01 November 2014 till 31
October 2019
GSL
1434 BRU14111558P Trileptal Film-coated Tablets
300mg
Oxcarbazepine 300mg Novartis Pharma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1435 BRU14111559NP Alka Seltzer Lemon Acetylsalicylic Acid 324mg; Sodium
Bicarbonate 1.737g; Citric Acid (anhydrous)
1.223g.
Bayer de Mexico SA De CV, Mexico Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
GSL
1436 BRU14111560P Voren Plus Gel Diclofenac sodium 10mg/g (1%w/w) Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 01 November 2014 till 31
October 2019
GSL
1437 BRU14111561NP Strepsils Original Lozenges Amylmetacresol 0.6mg; 2,4-Dichlorobenzyl
Alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 01 November 2014 till 31
October 2019
GSL
1438 BRU14111562NP Strepsils Orange with Vitamin C
Lozenges
Amylmetacresol 0.6mg; 2,4-Dichlorobenzyl
Alcohol 1.2mg; Ascorbic Acid 33.5mg;
Sodium Ascorbate 74.9mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 01 November 2014 till 31
October 2019
GSL
1439 BRU14111563P Loette 21 Tablet Levonorgetsrel 100mcg; ethinylestradiol
20mcg
Haupt Pharma Munster GmbH., Germany Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1440 BRU14111564P Axcel Promethazine-5 Syrup Promethazine Hydrochloride 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 01 November 2014 till 31
October 2019
POM
1441 BRU14111565P NIMBEXTM Injection 2mg/ml (5ml) Cisatracurium Besylate 10mg/5ml GLaxoSmithKline Manufacturing S.p.A.,
Italy
Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1442 BRU14111566P Aggrastat Concentrate for
Infusion 0.25mg/ml
Tirofibon 0.25mg/ml (as hydrochloride
monohydrate 0.281mg/ml)
DSM Pharmaceuticals Inc., USA & Orion
Corporation, Espoo, Finland
Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1443 BRU14111567P Promezine Syrup 1mg/ml Promethazine Hydrochloride 1mg/ml Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1444 BRU14111568P Cephanmycin Capsules 500mg Cephalexin 500mg Yung Shin Pharmaceutical Ind. Co. Ltd.,
Taiwan
Asterix United (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1445 BRU14111569P Ferinject® 50mg Iron/ml solution
for Injection/Infusion
Iron 50mg/ml (as ferric carboxymaltose) BIPSO GmbH, Germany K-Seri Pharma Sdn Bhd 01 November 2014 till 31
October 2019
POM
1446 BRU14111570P Olmetec Plus 20/12.5mg Film-
coated Tablet
Olmesartan Medoxomil 20mg;
Hydrochlorothiazide 12.5mg
Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1447 BRU14111571P Norfox 400 Tablet Norfloxacin 400mg The United Drug (1996) Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 01 November 2014 till 31
October 2019
POM
1448 BRU14111572P Rotateq® Rotavirus Vaccine, Live,
Oral, PentavalentHuman-bovine Rotavirus G1 ≥ 2.2 x 106IU;
Human-bovine Rotavirus G2 ≥ 2.8 x 106IU;
Human-bovine Rotavirus G3 ≥ 2.2 x 106IU;
Human-bovine Rotavirus G4 ≥ 2.0 x 106IU;
Human-bovine Rotavirus P1 ≥ 2.3 x 106IU
Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
BDMCA/RMP/1116 Page 86 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1449 BRU14111573P Eliquis Film-coated Tablets 2.5mg Apixaban 2.5mg Bristol-Myers Squibb Manufacturing
Company, Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1450 BRU14111574P Tren Injection 100mg/ml Tranexamic Acid 100mg/ml Yung Shin Pharmaceutical Ind. Co. Ltd.,
Taiwan
Asterix United (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1451 BRU14111575P Ryzodeg Flex Touch 100 units/ml Per 1 ml: Insulin Degludec 70%; Insulin
Aspart 30%
Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 01 November 2014 till 31
October 2019
POM
1452 BRU14111576NP Folic Acid Tablets 5mg Folic Acid BP 5mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 01 November 2014 till 31
October 2019
GSL
1453 BRU14111577NP Dettol Antiseptic Germicide
Liquid
Parachlorometaxylenol 4.8%w/v Pt. Reckitt Benckiser Indonesia Syarikat Aliaa Sdn Bhd 01 November 2014 till 31
October 2019
GSL
1454 BRU14111578P Tolanz Tablet 5mg Olanzapine 5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 01 November 2014 till 31
October 2019
POM
1455 BRU14111579P Tolanz Tablet 10mg Olanzapine 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 01 November 2014 till 31
October 2019
POM
1456 BRU14111580P Somin Tablet 2mg Dexchlorpheniramine Maleate 2mg Y.S.P Industries (M) Sdn. Bhd., Malaysia Asterix United (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1457 BRU14111581P Vaminolact Solution Per 100ml: L-Alanine 6.3 g; L-Arginine 4.1g;
L-Aspartic Acid 4.1g; L-Cysteine / L-Cystine
1g; L-Glutamic Acid 7.1g; Glycine (Amino
Acetic Acid) 2.1g; L-Histidine 2.1g; L-
Isoleucine3.1g; L-Leucine 7g; L-Lysine 5.6g;
L-Methionine 1.3g; L-Phenylalanine 2.7g; L-
Proline 5.6g; L-Serine 3.8g; Taurine 300mg;
L-Threonine 3.6g; L-Tryptophan 1.4g; L-
Tyrosine 500mg; L-Valine 3.6g
Fresenius Kabi Austria GmbH, Austria Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31
October 2019
P
1458 BRU14111582P Covinace Tablet 4mg Perindopril Ter-butylamine 4mg Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 01 November 2014 till 31
October 2019
POM
1459 BRU14111583NP Oralite Natural Oral Rehydration
Salts
Per 4.92g sachet: Glucose anhydrous 3.24g;
Sodium Chloride 0.624g; Trisodium citrate
dihydrate 0.696g; Potassium Chloride 0.36g
Royce Pharma Manufacturing Sdn. Bhd.,
Malaysia
SWL Biomed Sales & Services 01 November 2014 till 31
October 2019
GSL
1460 BRU14111584NP Panamol Forte Suspension
250mg/5ml
Paracetamol 250mg/5ml Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 01 November 2014 till 31
October 2019
P (3.8L)
1461 BRU14111585PS1,
BRU14111585PS2,
BRU14111585PS3,
BRU14111585PS4
Avastin 100mg/4ml Bevacizumab 25mg/ml (Humanised anti-
VEGF monoclonal antibody)
Genentech Inc., USA (S1); F-Hoffman-La
Roche Ltd, Basel, Switzerland (S2); Roche
Diagnostics GmbH, Manheim, Germany
(S3); F Hoffmann-La Roche Ltd,
Kaiseraugst, Switzerland (S4)
Medicare 01 November 2014 till 31
October 2019
POM
1462 BRU14111586P Zyvox 20mg/ml Granules For Oral
Suspension
Linezolid 100mg/5ml Pfizer Pharmaceuticals LLC, USA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 87 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1463 BRU14111587P Axcel Cimetidine-400 Tablet Cimetidine 400mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1464 BRU14111588PS1;
BRU14111588PS2
Humulin R Injection 100IU/ml
(Catridges)
Human Insulin (Recombinant DNA origin)
100IU/ml
Lilly France SAS, France (S1); Eli Lily Italia
S.p.A., Sesto Fiorentino,
(FI) Italy (S2)
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1465 BRU14111589P Resolor film-coated tablet 1mg Prucalopride 1mg (as succinate 1.321mg) Janssen-Cilag SpA., Italy Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1466 BRU14111590NP Maltofer Fol Chewable Tablet Iron (III) 100mg (as hydroxide-polymaltose
Complex); Folic acid 0.35mg
Vifor S.A., Switzerland & Iberfar-Industria
Farmacetutica S.A., Barcelona, Portugal
Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1467 BRU14111591P Pristiq 50mg Extended-Release
Tablets
Desvenlafaxine 50mg (as succinate
75.87mg)
Pfizer Ireland Pharmaceuticals, Ireland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1468 BRU14111592P ElIquis 5mg Film-coated Tablet Apixaban 5mg Bristol-Myers Squibb Manufacturing
Company, Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1469 BRU14111593P Pulin Film-coated Tablet 10mg Metoclopramide HCl 10mg ( as Mono HCl
10.5mg)
Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1470 BRU14111594P Rocephin for Injection 1g IV Ceftriaxone 1g F.Hoffmann-La Roche Ltd., Basel,
Switzerland
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1471 BRU14111595P Advate 250 IU Powder and
Solvent for Solution for Injection
Octocog alfa (recombinant human
coagulation factor VIII) 250 IU
Baxter Bioscience Manufacturing Sarl,
Switzerland
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1472 BRU14111596P Glibenclamide Tablet 5mg Glibenclamide 5mg Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1473 BRU14111597NP 0.45% Sodium Chloride and 5%
Dextrose Intravenous Infusion B.P
Per 1L - Sodium Chloride 4.5g; Glucose
anhdyrous 50g (as monohydrate 55g)
B.Braun Medical Industries Sdn Bhd.,
Malaysia
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1474 BRU14111598P Gonal-F 1050IU/1.75ml
(77mcg/1.75ml) Powder and
Solution for Injection
Per Pen (1.75ml) - Follitropin Alfa 1050IU
(equivalent 77mcg) [Per ml of solution
contains 600IU Follitropin alfa ~ 44mcg]
Merck Serono S.p.A., Italy & Merck
Serono S.A., Switzerland
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1475 BRU14111599P Cardiol Tablet 6.25mg Carvedilol 6.25mg Yung Shin Pharmaceutical Ind. Co. Ltd.,
Taiwan
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1476 BRU14111600P Cardiol Tablet 25mg Carvedilol 25mg Yung Shin Pharmaceutical Ind. Co. Ltd.,
Taiwan
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1477 BRU14111601NP T3 Pimple Gel Rescorcinol 2% w/w HOE Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1478 BRU14111602NP BSS® (Balanced Salt Solution)
Sterile Irrigation Solution
Per 1L - Sodium Chloride 6.4g; Potassium
Chloride 0.75g; Calcium Chloride,
dehydrate 0.48; Magnesium Chloride,
hexahydrate 0.3; Sodium Citrate,
dehydrate 1.7; Sodium acetate, trihydrate
3.9
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 19 May 2015 till 18 May
2020
GSL
1479 BRU14111603P Domper Tablet 10mg Domperidone 10mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 88 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1480 BRU14111604NP Davmorid film-coated Tablet Diosmin 450mg; Hesperidin 50mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1481 BRU14111605P Zimmex Tablet 10mg Simvastatin 10mg Silom Medical Co. Ltd., Thailand Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1482 BRU14111606NP Strepsils Warm Lozenges Amymetacresol 0.6mg; 2,4-Dichlorobenzyl
Alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1483 BRU14111607NP Sodium Bicarbonate 8.4% w/v
Injection (10ml glass ampoule)
Sodium Bicarbonate 8.4%w/v (84mg/ml) Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1484 BRU14111608P Binozyt 200mg/5ml Powder for
Oral Suspension
Azithromycin 200mg Sandoz S.R.L., Romania Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1485 BRU14111609NP Renacid K4 Per Litre - Sodium Chloride BP 161.43g;
Potassium Chloride BP 5.49g; Calcium
Chloride 2H2O BP 9.75g; Magnesium
Chloride 6H2O BP 3.74g; Gacial Acetic Acid
BP 8.85g
Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 19 May 2015 till 18 May
2020
POM
1486 BRU14111610NP Renacarb K2 Per Litre - Sodium Chloride BP 30.5g;
Sodium Bicarbonate BP 66.0g
Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 19 May 2015 till 18 May
2020
POM
1487 BRU14111611P Kogrel 75mg Film Coated Tablet Clopidogrel 75mg (as bisulfate 97.875mg) Sandoz Private Limited, Mumbai, India Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1488 BRU14111612P Chloramine Tablet 4mg Chlorpheniramine maleate 4mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
P
1489 BRU14111613P Tolnaderm Cream 1% Tolnaftate 1% w/w HOE Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1490 BRU14111614P Medoflucon Capsule 50mg Fluconazole 50mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1491 BRU14111615P Curam 156.25mg/5ml Powder for
Oral Suspension
Per 5ml - Amoxycillin 125mg (as
trihydrate); Clavulanic acid 31.25mg
Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1492 BRU14111617P Nospan Tablet 30mg Dextromethorphan Hydrobromide 30mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1493 BRU14111618NP Strepsils Extra Strong Lozenge Amymetacresol 0.6mg; 2,4-Dichlorobenzyl
Alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1494 BRU14111619P Crixan Tablet 250mg Clarithromycin 250mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1495 BRU14111620P Storvas Tablet 20mg Atorvastatin 20mg (as calcium) Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1496 BRU14111621P Brozil Film coated Tablet 600mg Gemfibrozil 600mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1497 BRU14111622NP Panadol Extra Tablets Paracetamol 500mg; Caffeine 65mg Sterling Drug (Malaya) Sdn Bhd, Malaysia Kingston Beverage & Creamery
Sdn Bhd
19 May 2015 till 18 May
2020
GSL
1498 BRU14111623P Botox (Botulinium Toxin, Type A)
Injection 100units/vial
Clostridium Botulinum Toxin Type A
Purified Neurotoxin Complex 100Units/vial
Allergan Pharmaceuticals Ireland, Ireland Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 89 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1499 BRU14111624P Botox (Botulinium Toxin, Type A)
Injection 50units/vial
Clostridium Botulinum Toxin Type A
Purified Neurotoxin Complex 50Units/vial
Allergan Pharmaceuticals Ireland, Ireland Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
1500 BRU14111625P Botox (Botulinium Toxin, Type A)
Injection 200units/vial
Clostridium Botulinum Toxin Type A
Purified Neurotoxin Complex 200Units/vial
Allergan Pharmaceuticals Ireland, Ireland Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
1501 BRU14111626P Lovir Tablets 200mg Acyclovir 200mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1502 BRU14111627P Cellcept Tablet 500mg Mycophenolate mofetil 500mg Roche S.p.A., Italy Medicare 19 May 2015 till 18 May
2020
POM
1503 BRU14111628NP 0.45% Sodium Chloride
Intravenous Infusion B.P
Sodium Chloride 0.45% B.Braun Medical Industries Sdn Bhd.,
Malaysia
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
P
1504 BRU14111629P Xorimax 500mg Coated Tablet Cefuroxime 500mg (as axetil) PenCef Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1505 BRU14111630P Xorimax 250mg Coated Tablet Cefuroxime 250mg (as axetil) PenCef Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1506 BRU14111631P Peditrace Concentrate for
Solution for Infusion
Per 1ml - Zinc Chloride 521mcg; Copper
Chloride 2H2O 53.7mcg; Manganese
Chloride 4H2O 3.60mcg; Sodium Selenite
anhydrous 4.38mcg; Sodium Fluoride
126mcg; Potassium Iodide 1.31mcg
Fresenius Kabo Nolge AS, Norway Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1507 BRU14111632P Axcel Orlistat 120 Tablet Orlistat 120mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1508 BRU14111633P Pharmaniaga Salbutamol
Respirator Solution 0.5%w/v
Salbutamol 0.5%w/v (as sulphate) Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1509 BRU14111634P Epimate 50mg Tablet Topiramate 50mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1510 BRU14111635NP Aqueous Cream Emulsifying wax 9.0%w/w; White Soft
Paraffin 15% w/w; Liquid Paraffin 6.0%
w/w
Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1511 BRU14111636P Melomet Cream 0.1% w/w Mometasone Furoate 0.1% w/w Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1512 BRU14111637NP Poro Suspension 250mg/5ml Paracetamol 250mg/5ml Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1513 BRU14111638P Primovists 0.25mmol/ml solution
for injection
Gadoxetic acid, Sodium 0.25mmol/ml Bayer Pharma AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1514 BRU14111639P Servidipine 30mg Film-coated
Tablets
Nifedipine 30mg Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1515 BRU14111640P Servidipine 60mg Film-coated
Tablets
Nifedipine 60mg Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1516 BRU14111641NP Hoemal Oral Suspension Paracetamol 250mg/5ml (5%) Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1517 BRU14111642P Manace Injection 5mg/ml
(Haloperidol 5mg/ml)
Haloperidol 5mg/ml Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 90 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1518 BRU14111643NP Woodward's Gripe Water
(Alcohol Free)
Per 5ml - Terpeneless Dill Seed Oil 2.3mg;
Sodium Bicarbonate 52.5mg
IDS Manufacturing Sdn Bhd, Malaysia Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1519 BRU14111644P Buston Injection 20mg/ml Hyoscine-N-butylbromide 20mg/ml Siu Guan Chem, Ind. Co. Ltd., Taiwan G & H Trading Company 19 May 2015 till 18 May
2020
POM
1520 BRU14111645P Tolnaderm lotion 1.0%w/v Tolnaftate 1% w/w Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1521 BRU14111646NP Oralite Orange Oral Rehydration
Salts
Per 4.95g - Glucose anhydrous 3.24g;
Sodium Chloride 0.624g; Trisodium citrate
dihydrate 0.696g; Potassium Chloride 0.36g
Royce Pharma Manufacturing Sdn. Bhd.,
Malaysia
SWL Biomed Sales & Services 19 May 2015 till 18 May
2020
GSL
1522 BRU14111647P Vesyca Film Coated Tablet 150mg Ranitidine 150mg (as hydrochloride) Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1523 BRU14111648P Pharmaniaga Cetirizine 10mg
tablet
Cetirizine 10mg (as hydrochloride) Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
P
1524 BRU14111649P Hovid Lipiduce-20 Tablet Atorvastatin 20mg (as calcium) Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1525 BRU14111650P Invokana Film-coated Tablet
100mg
Canagliflozin 100mg (as hemihydrate) Janssen-Cilag SpA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1526 BRU14111651P Axcel Chlorpheniramine-2 Syrup Chlorpheniramine maleate 2mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
P
1527 BRU14111652P Binozyt Film-Coated Tablet
250mg
Azithromycin 250mg (as monohydrate) Novartis (Bangladesh) Ltd., Bangladesh Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1528 BRU14111653P Asmol 2 tablet Salbutamol 2mg (as sulphate) Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1529 BRU14111654NP Paracetamol Kabi Solution for
infusion 10mg/ml
Paracetamol 10mg/ml i) Fresenius Kabi Germany AB ii) Fresenius
Kabi Austria
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1530 BRU14111655P Risperdal Solution 1mg/ml Risperidone 1mg/ml Janssen Pharmaceutical NV, Belgium Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1531 BRU14111656P Visudyne Injection Verteprofin 15mg Par Sterile Products LLC, United States Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1532 BRU14121661P Kastipron Tablet 375mg S-Carboxymethylcysteine 375mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1533 BRU14121662P Ipolipid Capsules 300mg Gemfibrozil 300mg Medochemic Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1534 BRU14121663P Curam 625mg Film-coated Tablet Amoxicillin 500mg; Clavulanic acid as
potassium salt 125mg
Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1535 BRU14121664P Vesyca Injection 25mg/ml Ranitidine (as hydrochloride) 25mg/ml Yung Shin Pharmaceutical Ind. Co., Ltd,
Taiwan, R.O.C.
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1536 BRU14121666P Amoxicap 500 Capsule Amoxicillin (as trihydrate 574mg) 500mg Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1537 BRU14121667NP Wintosal Cream Methyl salicylate 15.0% w/w; Menthol
2.3% w/w and Cmaphor 4.0% w/w
Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1538 BRU14121668NP 50% Glucose Intravenous Infusion
B.P.
Glucose monohydrate (550.00g) eq. to
anhydrous glucose 500.0g/1000ml
B.Braun Medical Industries Sdn Bhd.,
Malaysia
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 91 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1539 BRU14121669P Visanne 2mg Tablet Dienogest 2mg Bayer Weimar GmbH und. Co. KG.,
Dobereinesrtr. 20, D-99427, Weimar,
Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1540 BRU14121670P Medoflucon Capsule 150mg Fluconazole 150mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1541 BRU14121671P Topamax 100 Tablets 100mg Topiramate 100mg Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1542 BRU14121672NP Duratears Ocular Lubricant
Ointment
Mineral Oil 30.0mg/g, Anhydrous liquid
lanolin 30.0mg/g and white petrolatum q.s.
ad 1g
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 19 May 2015 till 18 May
2020
GSL
1543 BRU14121673P Eprex® 40,000 Prefilled Syringes
40,000iu/1ml
Epoetin alfa 40,000IU/ml Vetter Pharma-Fertigung GmbH & Co. KG,
Germany; Cilag AG, Switzerland
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1544 BRU14121674P Milosec Capsule 20mg Omeprazole 20mg The United Drug (1966) Co. Ltd., Thailand Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1545 BRU14121675P Ziagen Oral Solution Abacavir (as Abacavir Sulfate) 20mg/ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1546 BRU14121676P Minulet 21 Tablet Gestodene 75mcg; ethinylestradiol 30mcg Haupt Pharma Munster GmbH., Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1547 BRU14121677P Pataday Olopatadine Ophthalmic
Solution 0.2%
Olopatadine hydrochloride 2.22mg (eq. to
Olopatadine 2mg (0.2%)
Alcon Laboratories, Inc., USA Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1548 BRU14121678P Provironum Tablet 25mg Mesterolone 25mg Schering Do Brasil Quimica e
Farmaceutica Ltda., San Paulo-SP, Brazil
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1549 BRU14121681NP Strepsils Strawberry Sugar Free
Children
Amylmetacresol 0.6mg; 2.4-Dichlorobenzyl
Alcohol 1.2mg
Reckitt Benckiser Healthcare International
Limited, UK
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1550 BRU14121682P Axcel Sodium Fusidate 250 Tablet Sodium Fusidate (Micronized) 250mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1551 BRU14121683P Pencor 1mg tablet Doxazosin Mesylate (eq. to Doxazosin 1mg) Unison Laboratories Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1552 BRU14121684P Pencor 2mg tablet Doxazosin Mesylate (eq. to Doxazosin 2mg) Unison Laboratories Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1553 BRU14121685P Pencor 4 Tablet Doxazosin Mesylate (eq. to Doxazosin 4mg) Unison Laboratories Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1554 BRU14121686P Decan Injection 2mg/ml Dexamethasone Sodium Phosphate 2.2mg
(eq. to Dexamethasone Phosphate 2mg)
Yung Shin Pharmaceutical Ind. Co., Ltd,
Taiwan, R.O.C.
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1555 BRU14121687P Primodil-10 Tablet Amlodipine Besilate 13.87mg (eq. to
Amlodipine 10mg)
Medley Pharmaceuticals Limited, India Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1556 BRU14121688P Cuvarlix Capsule 120mg Orlistat 120mg Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1557 BRU14121689NP Calcium Lactate 300mg tablet Calcium lactate 300mg Drug Houses of Australia Pte Ltd.,
Singapore
G & H Trading Company 19 May 2015 till 18 May
2020
GSL
(1000's)
1558 BRU14121690P Seladin 500mg tablet Naproxen 500mg Y.S.P. Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 92 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1559 BRU14121691P Driminate 50mg Suppository Dimenhydrinate 50mg Y.S.P. Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
P (10 x 10's)
1560 BRU14121692NP Hurix's Panau Salap &Gatal-Gatal
Kecil
Zinc oxide 5% w/w; Menthol 1% w/w;
Salicylic Acid/2-Hydroxybenzoic acid 5%
w/w & Camphor 3% w/w
Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May
2020
GSL
1561 BRU14121693NP Hurix Corn Rid Solution 5% w/w lactic Acid 5% w/v; Salicylic Acid 17% w/v Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May
2020
GSL
1562 BRU14121694NP Hurix Corn Solution 17% Salicylic Acid 0.17g(17%w/v) Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May
2020
GSL
1563 BRU14121695P Axcel Fungicort Cream Miconazole nitrate 2%w/w;
Hydrocortisone 1% w/w
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1564 BRU14121696P Methacid 25mg tablet Indomethacin 25mg Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1565 BRU14121697NP Dettol Antiseptic Wound Wash
Spray
benzalkonium chloride 0.198% Reckitt Benckiser Healthcare (UK) Ltd., UK Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1566 BRU14121698P Edurant Film-Coated 25mg tablet Rilpivirine (as hydrochloride) 25mg Janssen-Cilag S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1567 BRU14121699P Invokana 300mg FCT Canagliflozin 300mg (as hemihydrate) Janssen Ortho, LLC, Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1568 BRU14121700P Amlodipine Tablet 10mg Amlodipine Tablet 10mg Jubilant Generics, Limited, India Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1569 BRU14121701P Borymycin Capsule 100mg Minocycline HCl 100mg Y.S.P., Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1570 BRU14121702NP Septi-Sol Solution Chlorhexidine Gluconate 20% Solution -
0.5% w/v; Ethanol 94% - 77% v/v
Pahang Pharmacy Sdn Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1571 BRU14121703P Atoris Film-coated Tablet 20mg Atorvastatin (as calcium) 20mg KRKA, d.d., Slovenia K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1572 BRU14121704NP Nutrilite Glucosamine HCl
Capsule 375mg
Glucosamine HCl 375mg Pharmaniaga Manufacturing Berhad,
Malaysia
Amway Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1573 BRU14121705P Ultibro Breezhaler 110/50 mcg
Inhalation Powder Hard Capsule
Indacaterol (as maleate) 110mcg (143
mcg); Glycopyrronium (as bromide) 50mcg
(63 mcg)
Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1574 BRU15011706P Zyprexa Zydis
OrodispersibleTablet 5mg
Olanzapine micronized 5mg Catalent UK Swindon Zydis Ltd, UK Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1575 BRU15011707P Zyprexa Zydis
OrodispersibleTablet 10mg
Olanzapine micronized 10mg Catalent UK Swindon Zydis Ltd, UK Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1576 BRU15011708P Requip PD 24hr 8mg Prolong
Release Tablet
Ropinirole 8mg (as hydrochloride) Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1577 BRU15011709P Klacid MR 500mg Tablet Clarithromycin 500mg Aesica Queensborough Ltd, UK Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1578 BRU15011710P Klerimed 250mg FC Tablets Clarithromycin 250mg (as anhydrous) Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 93 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1579 BRU15011711P DiSuf-B Cream Fusidic acid (micronized) 2.0% w/w &
Betamethasone 0.1%w/w (as valerate)
Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1580 BRU15011712NP Dhalumag Suspension Per 5ml - Magnesium trisilicate BP 500mg,
Dried Aluminium Hydroxide BP 250mg
Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1581 BRU15011713P Binoclar® 500mg Film-coated
Tablets
Clarithromycin 500mg Novartis Bangladesh Ltd, Bangladesh Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1582 BRU15011714P Ospamox 250mcg/5ml granules
for suspension
Amoxicillin 250mg (as trihydrate 287mg) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1583 BRU15011715P Ospamox 250mg Capsule Amoxicillin 250mg (as trihydrate 287mg) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1584 BRU15011716P Ospamox 500mg Film-coated
Tablet
Amoxicillin 500mg (as trihydrate 574mg) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1585 BRU15011717P Salofalk® 500mg Gastro-Resistant
Prolonged-Release Granules
Mesalazine 500mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1586 BRU15011718P Salofalk® 1000mg Gastro-
Resistant Prolonged-Release
Granules
Mesalazine 1000mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1587 BRU15011719P Vaqta® Vaccine 50U/ml Hepatitis A Virus, Purified, Inactivated
50U/ml
Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1588 BRU15011720P Vaqta® Vaccine 25U/0.5ml Hepatitis A Virus, Purified, Inactivated
25U/0.5ml
Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1589 BRU15011721P Salofalk® 3000mg Gastro-
Resistant Prolonged-Release
Granules
Mesalazine 3g Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1590 BRU15011722P T3 Ada Gel 0.1% Adapalene 0.1% Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1591 BRU15011723P Clarimycin Film Coated Tablet
250mg
Clarithromycin 250mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1592 BRU15011724P Forteo Injection 20mcg/80mcl Each ml contains 250mcg of Teriparatide
(recombinant of human parathyroid
hormone (1-34) [rhPTH (1-34)])
Lilly France SAS, France Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1593 BRU15011725P Torisel Concentrate for Injection
25mg/ml
Temsirolimus 25mg/ml Pierre Fabre Medicament Production
(PFMP), France
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1594 BRU15011726P Ursofalk 500mg Film-coated
Tablets
Ursodeoxycholic acid 500mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1595 BRU15011727P Bactigen Eye Drops 0.3% Gentamicin 0.3% (as Gentamicin Sulphate) FDC Limited, India K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 94 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1596 BRU15011728P Hexaxim Suspension for Injection Per dose (0.5ml):
Dipththeria toxoid 30 Lf (≥ 20IU), Tetanus
toxoid 10 Lf (≥ 40IU), Bordetella pertussis
antigens: Pertussis toxoid 25µg,
Filamentous haemagglutinin 25µg, Polio
Virus (Inactivated): Type 1 (Mahoney) 40
DU, Type 2 (MEF-1) 8 DU, Type 3 (Saukett)
32 DU, Hepatitis B surface antigen 10 µg,
Haemophilus influenzae tybe b
polysaccharide (Polyribosylribitol
phosphate) . 12µg, conjugated to Tetanus
protein (PRP-T) 22-36µg
Sanofi Pasteur Marcy I’Etoile (MLE),
France; Sanofi Pasteur Val de Reuil,
France; Sanofi Pasteur SPA, Italy
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1597 BRU15011729P Nootropil Solution 20% Piracetam 20g/100ml NextPharma SAS., France Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1598 BRU15011730P Bridion Solution for Injection
100mg/ml
Sugammadex 100mg/ml N.V. Organon, The Netherlands; Organon
(Ireland) Ltd., Ireland; Patheon
Manufacturing Services LLC, USA
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1599 BRU15011731P Serlift Tablets 100mg Setraline hydrochloride 100mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1600 BRU15011732NP Strepsils Soothing Honey &
Lemon
Amylmetacresol 0.6ml; 2,4-Dichlorobenzyl
alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1601 BRU15011733NP Strepsils Max Blackcurrant
Lozenge
Hexylresorcinol 2.4mg Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1602 BRU15011734P Implanon NXT Implant 68mg Etonogestrel N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1603 BRU15011735PS1 &
BRU15011735PS2
Stocrin Tablet 200mg Efavirenz 200mg Merck Sharp & Dohme (Australia) Pte Ltd
Australia; Zhejian Huahai Pharmaceutical
Co. Ltd., China
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1604 BRU15011736PS1 &
BRU15011736PS2
Stocrin Tablet 600mg Efavirenz 600mg Merck Sharp & Dohme (Australia) Pte Ltd
Australia; Zhejian Huahai Pharmaceutical
Co. Ltd., China
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1605 BRU15011737P Magnevist Injection 469mg/ml Each ml contains 0.5mmol gadopentetate
dimeglumine (eqv. to 469.01mg
gadopentetate dimeglumine)
Bayer Pharma AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1606 BRU15011738NP Bactidol Mouthwash Hexetidine 0.1% w/v Interphill Laboratories Inc., Philippines LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1607 BRU15011739P Nicotinell TTS 10 Nicotine 17.5mg (delivers 7mg/24hours) LTS Lohmann Therapie-System AG,
Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
GSL
BDMCA/RMP/1116 Page 95 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1608 BRU15011740P Nicotinell TTS 20 Nicotine 35mg (delivers 14mg/24 hours) LTS Lohmann Therapie-System AG,
Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1609 BRU15011741P Nicotinell TTS 30 Nicotine 52.5mg (delivers 21mg/24 hours) LTS Lohmann Therapie-System AG,
Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1610 BRU15011742NP Natzema Eczema Relief Cream Benzoin tincture 10mg/g; Lavender
Angustifolia Oil 5mg/g; Citrus Sinensis Peel
Oil 5mg/g
Cosmetics Manufacturer (Aust) Pty Ltd,
Australia
Bossom Buddies Enterprise 19 May 2015 till 18 May
2020
GSL
1611 BRU15011743P Pharmaniaga Germacid Cream 2% Fusidic acid 2.0% w/w Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1612 BRU15011744P Extraneal Peritoneal Dialysis
Solution 75g/l (2L Ultrabag)
Each 100ml contains Icodextrin 7.5g,
Sodium Chloride 538mg,
Sodium lactate 448mg, Calcium chloride
dihydrate 25.7mg and Magnesium Chloride
Hexahydrate 5.08mg
Baxter Healthcare SA., Singapore Branch Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1613 BRU15011745P Seladin 250mg tablet Naproxen 250mg Y.S.P Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1614 BRU15011746NP Vitalipid N Adult 1ml contains: Vitamin A 330IU (as retinoyl
palmitate 99mg), Ergocalciferol
0.5mg(»Vitamin D2 20IU), All-rac-a-
Tocopherol 0.91mg(»Vitamin E 1IU),
Phytomenadione (Vitamin K1) 15mg
Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1615 BRU15011747NP Vitalipid N Infant 1ml contains: Vitamin A 230IU (as retinoyl
palmitate 69mg), Ergocalciferol
1.0mg(»Vitamin D2 40IU), All-rac-a-
Tocopherol 0.64mg(»Vitamin E 0.71IU),
Phytomenadione (Vitamin K1) 20mg
Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1616 BRU15011748P Caslot 6.25mg tablet Carvedilol 6.25mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1617 BRU15011749P Caslot 12.5mg tablet Carvedilol 12.5mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1618 BRU15011750NP Prismasol BO Each 1000ml contains (before
reconstitution): Calcium chloride dihydrate
5.145g, Magnesium chloride hexahydrate
2.033g, Lactic acid 5.4g, Sodium chloride
6.45g & Sodium bicarbonate 3.09g
Gambro Dasco S.p.A., Italy Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1619 BRU15021751P Kogenate FS for Injection
1000IU/vial
Antihemophilic factor (recombinant)
sucrose formulated 1000IU
Vetter Pharma-Fertigung GmbH & Co. KG,
Germany; Bayer Pharma AG, Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1620 BRU15021752P Kogenate FS for Injection
500IU/vial
Antihemophilic factor (recombinant)
sucrose formulated 500IU
Bayer Healthcare LLC, United States Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 96 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1621 BRU15021753P Dimenate Syrup 15mg/5ml Dimenhydrinate 15mg/5ml Drug Houses of Australia Private Limited,
Singapore
G & H Trading Company 19 May 2015 till 18 May
2020
POM (3.8L)
1622 BRU15021754P Cernevit Multivitamin Powder for
Injection
Each vial contains: Retinol palmitate
(VitaminA) 3500 IU, Cholecalciferol
(Vitamin D3) 220 IU, DL alpha tocopherol
(Vitamin E) 10.2 mg, Ascorbic acid (Vitamin
C) 125mg, Cocarboxylase tetrahydrate
(Vitamin B1) 5.8mg, Riboflavin sodium
phosphate dehydrate (Vitamin B2) 5.67mg,
Pyridoxine hydrochloride (Vitamin B6)
5.5mg, Cyanocobalamin (Vitamin B12)
0.006mg, Folic acid 0.414mg,
Dexpanthenol 16.15mg, Biotin 0.069mg,
Nicotinamide 46mg
Baxter SA, Belgium Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1623 BRU15021755P Baneocin Ointment Bacitracin Zinc 250IU/1g; Neomycin
Sulphate 5000 IU (5mg)/1g
Merck Kommanditgesellschaft Auf Aktein
& Co., Werk, Austria
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1624 BRU15021756P Ospexin 125mg/5ml granules for
oral suspension
Cephalexin 125mg/5ml Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1625 BRU15021757P Simponi Solution for Injection in
Pre-filled Syringe 50mg/0.5ml
Golimumab 50mg/0.5ml Baxter Pharmaceutical Solutions LLC, USA
(Repacker - Cilag AG, Switzerland)
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1626 BRU15021758P Histac Tablets 150mg Ranitidine Hydrochloride 150mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1627 BRU15021759P Beclazone 100micrograms CFC-
Free Inhaler
Beclomethasone Dipropionate
100micrograms/metered inhalation
Norton Waterford T/A Ivax
Pharmaceuticals Ireland
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1628 BRU15021760PS1 &
BRU15021760PS2
Insulatard 100IU/ml Suspension
for Injection (vial)
1ml of suspension contain 100IU (3.5g) of
insulin
Novo Nordisk A/S, Denmark (S1); Novo
Nordisk Production SAS, France (S2)
Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
1629 BRU15021761P Covapril Tablet 4mg Perindopril Erbumine Upha Pharmaceutical Mfg (M) Sdn Bhd,
Malaysia
K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1630 BRU15021762P Axcel Amlodipine 5mg Tablet Amlodipine Besylate equivalent to
Amlodipine 5mg
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1631 BRU15021763P Neurontin Capsule 400mg Gabapentin 400mg Pfizer Pharmaceuticals LLC., Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1632 BRU15021764P Miostat Intraocular Solution Carbachol 0.1mg/ml Alcon Laboratories Inc., USA Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1633 BRU15021765P NutrIflex Lipid Plus 1 unit consists of Amino Acid Solution;
Glucose Solution; Lipid Emulsion* (For
Detailed Formulation referred to Dossier)
B.Braun Melsungen AG, Germany Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1634 BRU15021766P Neulastim Pre-filled Syringe
6mg/0.6ml
Pegfilgrastim 6mg/0.6ml F-Hoffman-La Roche Ltd., Switzerland Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 97 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1635 BRU15021767P Bacitrecin-N Ointment Bacitracin Zinc 12.5mg (potency)
(Equivalent to Bacitracin Zinc 500 units);
Polymyxin B Sulfate 0.83mg (potency)
(Equivalent to Polymyxin B Sulfate 5,000
units); Neomycin Sulfate 3.5mg (potency)
Y.s.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1636 BRU15021768P Exelon Patch 15 Rivastigmine base 27mg / 15cm2 (In vivo
release rate 13.3mg/24h)
LTS Lohmann Therapie-Systeme AG,
Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1637 BRU15021769P Zellox-II, Double Strength Liquid
Antacid
Per 10ml - Aluminium Hydroxide 800mg;
Magnesium Hydroxide 800mg;
Simethicone 60mg
Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1638 BRU15021770P Bonjela Gel 15g tube Choline Salicylate 8.714% & Cetalkonium
chloride 0.01%
Reckitt Benckiser Healthcare (UK) Ltd., UK Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1639 BRU15021771P Gilenya 0.5mg hard capsule Fingolimod 0.5mg (corresponding to
0.56mg Fingolimod Hydrochloride)
Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1640 BRU15021772P Presolin 150 tablet Irbesartan 150mg Unison Laboratories Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1641 BRU15021773P Presolin 300 tablet Irbesartan 300mg Unison Laboratories Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1642 BRU15021774P Tracidol Injection 50mg/ml Tramadol Hydrochloride 50mg/ml Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1643 BRU15021775P Hurix Skin Ointment 5%w/w Benzoic acid 5%; Sulphur 25; Salicyllic acid
5%; Camphor 3%; Menthol 1% w/w
Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May
2020
GSL
1644 BRU15021776P Apo-Risperidone 2mg tablet Risperidone 2mg Apotex Inc, Canada Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1645 BRU15021777P Apo-Megestrol 160mg tablet Megestrol acetate 160mg Apotex Inc, Canada Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1646 BRU15021778P Olapine 5mg FCT Megestrol acetate 160mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1647 BRU15021779P Trajenta Duo 2.5mg/500mg FCT
tablet
Linagliptin 2.5mg; Metformin
hydrochloride 500mg
Boehringer Ingelheim GmbH and Co. KG.,
Germany
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1648 BRU15021780P Trajenta Duo 2.5mg/850mg FCT Linagliptin 2.5mg; Metformin
hydrochloride 850mg
Boehringer Ingelheim GmbH and Co. KG.,
Germany
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1649 BRU15021781P Trajenta Duo 2.5mg/1000mg film-
coated tablets
Linagliptin 2.5mg; Metformin
hydrochloride 1000mg
Boehringer Ingelheim GmbH and Co. KG.,
Germany
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1650 BRU15021782P Humalog 100u/ml (Catridge) Insulin Lispro 100 units/ml Lillly France, France Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1651 BRU15021783P Acustop Cataplasma Flurbiprofen 40mg Green Cross Corporation, Korea Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1652 BRU15021784P Toviaz 4mg prolonged-release
tablet
Fesoterodine fumarate equivalent to
3.1mg fesoterodine
Aesica Pharmaceuticals GmbH, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1653 BRU15021785P Toviaz 8mg prolonged-release
tablet
Fesoterodine fumarate equivalent to
6.2mg fesoterodine
Aesica Pharmaceuticals GmbH, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 98 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1654 BRU15021786P Giotrif 20mg film-coated tablets
(Afatinib 20mg)
Afatinib (as dimaleate) 20mg Boehringer Ingelheim GmbH and Co. KG.,
Germany
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1655 BRU15021787P Giotrif 30mg film-coated tablets
(Afatinib 20mg)
Afatinib (as dimaleate) 30mg Boehringer Ingelheim GmbH and Co. KG.,
Germany
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1656 BRU15021788P Giotrif 40mg film-coated tablets
(Afatinib 20mg)
Afatinib (as dimaleate) 40mg Boehringer Ingelheim GmbH and Co. KG.,
Germany
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1657 BRU15021789P Giotrif 50mg film-coated tablets
(Afatinib 20mg)
Afatinib (as dimaleate) 50mg Boehringer Ingelheim GmbH and Co. KG.,
Germany
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1658 BRU15021790P Mikostat oral suspension 30ml
(Nystatin 100,000 IU/ml)
Nystatin 100,000 IU/ml Gulf Pharmaceutical Industries (Julphar),
United Arab Emirates
K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1659 BRU15021791P Losartan Winthrop 50mg tablet Losartan Potassium 50mg Zentiva, a.as., Slovak Republic Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
1660 BRU15021792P Losartan Winthrop 100mg tablet Losartan Potassium 100mg Zentiva, a.as., Slovak Republic Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
1661 BRU15021793P SMOFlipid 20% Emulsion for
Infusion
1000ml contain: Soya-bean oil, refined 60
g, Medium-chain triglycerides 60 g, Olive
oil, refined 50 g, Fish oil, rich in omega-2-
acids 30 g
Fresenius Kabi Austria GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1662 BRU15021794NP Aminoven 10% Isoleucine 5.00g/L; Leucine 7.4g/L; Lysine
acetate= Lysine 9.31g/L; Methionine
4.3g/L; Phenylalanine 5.1g/L; Threonine
4.4g/L; Tryptophan 2.0 g/L; Valine 6.2 g/L;
Arginine 12.0g/L; Histidine 3.0 g/L, Alanine
14.0 g/L, Glycine 11.0 g/L; Proline 11.2 g/L;
Serine 6.5g/L; Tyrosine 0.4g/L; Taurine
1.0g/L.
Fresenius Kabi Austria GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1663 BRU15021795P Ceflour CFT 250mg Cefuroxime (as Cefuroxime Axetil) 250mg Yung Shin Pharmaceutical Ind. Co. Ltd.,
Republic of China
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1664 BRU15021796P Montelair 10mg film-coated
tablet
Montelukast (as Montelukast Sodium)
10mg
Hovid Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1665 BRU15021797P Amlibon 10mg tablet Amlodipine (as Amlodipine Besilate) 10mg Lek Pharmaceuticals D.D., Solvenia Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1666 BRU15021798NP Dianeal Low Calcium (2.5MEq/L)
Peritoneal Dialysis Solution with
4.25% Dextrose (2L Ultrabag)
Each 100ml contains: Dextrose Hydrous
4.25g; Sodium Chloride 538mg; Sodium
Lactate 448mg; Calcium Chloride dihydrate
18.3mg; and Magnesium Chloride
Hexhydrate 5.08mg
Baxter Healthcare SA., Singapore Branch Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 99 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1667 BRU15021799NP Dianeal Low Calcium (2.5MEq/L)
Peritoneal Dialysis Solution 2.5%
Dextrose (2L Ultrabag and 2.5L
Ultrabag)
Each 100ml contains: Dextrose Hydrous
2.5g; Sodium Chloride 538mg; Sodium
Lactate 448mg; Calcium Chloride dihydrate
18.3mg; and Magnesium Chloride
Hexhydrate 5.08mg
Baxter Healthcare SA., Singapore Branch Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1668 BRU15021800NP Dianeal Low Calcium (2.5MEq/L)
Peritoneal Dialysis Solution 1.5%
Dextrose (2L Ultrabag and 2.5L
Ultrabag)
Each 100ml contains: Dextrose Hydrous
1.5g; Sodium Chloride 538mg; Sodium
Lactate 448mg; Calcium Chloride dihydrate
18.3mg; and Magnesium Chloride
Hexhydrate 5.08mg
Baxter Healthcare SA., Singapore Branch Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1669 BRU15021801NP Calactate 300mg tab Calcium Lactate pentahydrate 300mg Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1670 BRU15021802P Xylid 250mg tab Cefuroxime Axetil 250mg Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1671 BRU15021803P Colospan 10mg sugar coated
tablet
Hyoscine Butylbromide 10mg Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1672 BRU15021804P Caslot 25mg tablet Carvedilol 25mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1673 BRU15021805P Serenata 50mg Tablet Sertraline hydrochloride 56mg equivalent
to Sertraline 50mg
Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1674 BRU15021806P Gammaplex 5% w/v 2.5g Human Immunoglobulin G 2.5g/50ml Bio Product Lab, UK Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
1675 BRU15021807P Gammaplex 5% w/v 5g Human Immunoglobulin G 5g/100ml Bio Product Lab, UK Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
1676 BRU15021808P Gammaplex 5% w/v 10g Human Immunoglobulin G 10g/200ml Bio Product Lab, UK Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
1677 BRU15031809P Moxiclav Forte Dry Powder for
Oral Suspension 312.5mg/5ml
Amoxicillin (as trihydrate) 250mg &
Clavulanic acid 62.5mg
Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May
2020
POM
1678 BRU15031810P Moxiclav 625mg Tablets Amoxicllin trihydrate (574mg) 500mg;
clavulanate potassium microcrystalline
cellulose (297.8mg) eq. to clavulanic acid
125mg
Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May
2020
POM
1679 BRU15031811P Zemplar Injection Paricalcitol 5mcg/ml Hospira S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1680 BRU15031812P Lamotrix 100mg Tablets Lamotrigine 100mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May
2020
POM
1681 BRU15031813P Lamotrix 50mg Tablets Lamotrigine 50mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 100 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1682 BRU15031814P NimenrixTM (Meningococcal
polysaccharide serogroups A,C,W-
135, Y) Vaccine
MenAAH-TT-conjugate (Mean TT/PS ratio:3)
5mcg PSA~15mcg TT, MenCAH-TT-conjugate
(Mean TT/PS ratio:3) 5mcg PSC~15mcg TT,
MenW-TT-conjugate (Mean TT/PS
ratio:1.5) 5mcg PSW~7.5mcg TT, MenY-TT-
conjugate (Mean TT/PS ratio:1.3) 5mcg
PSY~6.5mcg TT
Glaxosmithkline Biologicals s.a., Rixensart,
Belgium; GlaxoSmithKline Biologicals,
Branch of SmithKline Beecham Pharma
GmbH & Co. KG., Dresden
Germany (diluent Ampoule); Delpharm
Tours, Chambray-lès-Tours
France (Diluent ampoule);
GlaxoSmithKline Biologicals SA, Rixensart
Belgium (diluent PFS); Catalent Belgium
SA, Brussels, Belgium (diluent PFS);
GlaxoSmithKline Biologicals S.A. , Wavre
Belgium (Additional facility for
formulation)
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1683 BRU15031815P Cialis 2.5mg Tablet Tadalafil 2.5mg Lily del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1684 BRU15031816P Cialis 5mg Tablet Tadalafil 5mg Lily del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1685 BRU15031817P Cialis 20mg Tablet Tadalafil 20mg Lily del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1686 BRU15031818NP Tempol Tablet 500mg Paracetamol Tablet 500mg Duopharma (M) Sdn. Bhd., Malaysia Hongkiat Trading & Company 19 May 2015 till 18 May
2020
P (50 x 10’s)
1687 BRU15031819P Placta Film-coated Tablets 75mg Clopidogrel (as bisulphate) 75mg Actavis Ltd., Malta G&H Trading Company 19 May 2015 till 18 May
2020
POM
1688 BRU15031820P SmofKabiven Peripheral Emulsion
for Infusion
1 unit consists of Amino Acid Solution;
Glucose Solution; Lipid Emulsion (For
detailed formulation referred to dossier)
Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1689 BRU15031821P Ometec capsule 20mg Omeprazole 20mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May
2020
POM
1690 BRU15031822P Elantan® long sustained-release
capsule
Isosorbide-5-mononitrate 50mg GlaxoSmithKline Pharmaceuticals Sdn.
Bhd., Malaysia
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1691 BRU15031823P ADVATE 500IU Powder and
Solvent for Solution for Injection
Octocog alfa (recombinant human
coagulation factor VIII)
Baxter BioScience Manufacturing Sàrl,
Switzerland
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1692 BRU15031824NP Livovid Forte Capsule Lecithin soya bean (300mg phosphatidyl
choline) 858.0mg, Thiamine hydrochloride
(4.7mg vitamin B1) 6mg, Riboflavin 6mg,
Pyridoxine hydrochloride (4.93mg of
vitamin B6) 6mg, Cyanocobalamin
0.006mg, Nicotinamide 30mg, dl-alpha-
tocopherol acetate 6IU
Hovid Bhd., Malaysia G&H Trading Company 19 May 2015 till 18 May
2020
GSL
BDMCA/RMP/1116 Page 101 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1693 BRU15031825P Saizen® Liquid 12mg (8mg/ml) Somatropin 12mg/1.5ml (recombinant
human growth hormone)
Merck Serono S.p.A., Italy G&H Trading Company 19 May 2015 till 18 May
2020
POM
1694 BRU15031826P Saizen® Liquid 6mg (5.83mg/ml) Somatropin 6mg/1.03ml (recombinant
human growth hormone)
Merck Serono S.p.A., Italy G&H Trading Company 19 May 2015 till 18 May
2020
POM
1695 BRU15031827P Torpezil Tablets 10mg Donepezil hydrochloride 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May
2020
POM
1696 BRU15031828P Torpezil Tablets 5mg Donepezil hydrochloride 5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May
2020
POM
1697 BRU15031829NP BrevoxylTM 4% cream Hydrous Benzoyl Peroxide (eq. to benzoyl
peroxide 4%)
Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1698 BRU15031830NP Gaviscon Liquid Sachet Each 10ml contains: Sodium alginate
500mg, Sodium bicarbonate 267mg and
Calcium carbonate 160mg
Reckitt Benckiser Healthcare (UK) Ltd., UK Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1699 BRU15031831NP Fisherman’s Friend Sugar-Free
Apple & Cinnamon Lozenges
Menthol 4.025mg IDS Manufacturing Sdn. Bhd., Malaysia Kingston Beverage & Creamery
Sdn. Bhd.
19 May 2015 till 18 May
2020
GSL
1700 BRU15031832NP Fisherman’s Friend Sugar-Free
Mandarin & Ginger Lozenges
Menthol 4.6mg IDS Manufacturing Sdn. Bhd., Malaysia Kingston Beverage & Creamery
Sdn. Bhd.
19 May 2015 till 18 May
2020
GSL
1701 BRU15031833NP Fisherman’s Friend Sugar-Free
Lemon Lozenges
Menthol 4.6mg IDS Manufacturing Sdn. Bhd., Malaysia Kingston Beverage & Creamery
Sdn. Bhd.
19 May 2015 till 18 May
2020
GSL
1702 BRU15041834P Rotaqor 20mg film-coated tablet Atorvastatin Calcium 20mg Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1703 BRU15041835P Jakavi 20mg tablet Ruxolitinib (as phosphate 26.40mg) 20mg Novartis Pharma Stein, AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1704 BRU15041836P Jakavi 15mg tablet Ruxolitinib (as phosphate 19.8mg) 15mg Novartis Pharma Stein, AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1705 BRU15041837P Jakavi 5mg tablet Ruxolitinib (as phosphate 6.6mg) 5mg Novartis Pharma Stein, AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1706 BRU15041838P Rocephin for Injection 250mg IM Ceftriaxone sodium (eq. to ceftriaxone
250mg/vial)
F.Hoffman-La Roche Ltd., France Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1707 BRU15041839P Archifar 500mg powder for
injection/infusion
Meropenem (as trihydrate) 500mg Medochemie Ltd, Cyprus Hong Kiat Trading & Co. 19 May 2015 till 18 May
2020
POM
1708 BRU15041840P Ciproflo 2mg/ml solution for IV
infusion
Ciprofloxacin 2mg/ml (as hydrochloride) Sin Guan Chem. Ind. Co. Ltd., Republic of
China
K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May
2020
POM
1709 BRU15041841P Omezole 20mg capsule Omeprazole 20mg Hovid Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1710 BRU15041842P B-Mycin cream Betamethasone dipropionate 0.643mg (eq.
to 0.5mg betamethasone); Gentamicin
Sulfate 1mg (potency)
Y.S.P. Industries (M) Sdn. Bhd., Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1711 BRU15041843P Mucodin syrup 250mg/5ml Carbocysteine 250mg/5ml Sunward Pharmaceutical Sdn. Bhd.,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
P
BDMCA/RMP/1116 Page 102 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1712 BRU15041844P Pharmaniaga Loratadine tablet
10mg
Loratadine 10mg Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
P
1713 BRU15041845P Curam 1000mg tablet Amoxycillin 875 (as trihydrate); clavulanic
acid 125mg (as potassium clavulanate)
Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1714 BRU15041846P Vancotex Injection 500mg Vancomycin (as hydrochloride) 500mg Fisiopharma S.r.L., Italy K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May
2020
POM
1715 BRU15041847P Sunadine tablet 10mg Loratadine 10mg Sunward Pharmaceutical Sdn. Bhd.,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
P
1716 BRU15041848NP Soluvit N Powder for Solution for
Infusion
Thiamine mononitrate 3.1mg
(corresponding to vitamin B1 2.5mg);
Riboflavine sodium phosphate 4.9mg
(corresponding to vitamin B2
3.6mg);Nicotinamide 40mg; Pyridoxine
Sino Swed Pharmaceutical Corp. Ltd.,
China
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1717 BRU15041849NP Folic acid 5mg tablet Folic acid 5mg Sunward Pharmaceutical Sdn. Bhd.,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
P
1718 BRU15041850P Estelle-35 tablet Cyproterone acetate 2mg; Ethinylestradiol
0.03mg
Douglas Manufacturing Limited, New
Zealand
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1719 BRU15041851NP Cetomacragol emulsifying
ointment
Cetomacragol emulsifying wax 30% w/w;
liquid paraffin 20%; white soft paraffin
50%
Hovid Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1720 BRU15041852PS1/
BRU15041852PS2
Glucophage® XR 1000mg
Extended-release tablet
Metformin (as hydrochloride 1000mg)
780mg
1. Merck Sante SAS, France;
2. Merck KGaA, Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1721 BRU15041853P Duofilm Liquid Salicylic acid 16.7% w/w; lactic acid 16.7% Stiefel Labs (Ireland) Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
P
1722 BRU15041854NP Voluven Solution for Infusion 6% Per 1000ml: Poly (O-2-hydroxyethyl) starch
60.0g; sodium chloride 9.00g
Frensius Kabi Deutschland GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1723 BRU15041855NP Iris eye drops Hydroxypropyl methylcellulose 3mg;
dextran 70 1mg
Sam Chun Dang Pharm Co Ltd, South
Korea
Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1724 BRU15041856P Onzapin film-coated tablet 5mg Olanzapine 5mg Actavis Ltd., Malta G & H Trading Company 19 May 2015 till 18 May
2020
POM
1725 BRU15041857P Onzapin film-coated tablet 10mg Olanzapine 10mg Actavis Ltd., Malta G & H Trading Company 19 May 2015 till 18 May
2020
POM
1726 BRU15041858NP Fisherman’s friend aniseed
lozenges
Menthol 5.75mg Lofthouse of Fleetwood Limited, UK Kingston Beverage & Creamery
Sdn Bhd
19 May 2015 till 18 May
2020
GSL
1727 BRU15041859NP Fisherman’s Friend Sugar Free
Mint Lozenges
Menthol 3.45mg Lofthouse of Fleetwood Limited, UK Kingston Beverage & Creamery
Sdn Bhd
19 May 2015 till 18 May
2020
GSL
1728 BRU15041860NP Fisherman’s Friend Sugar Free
Cherry Lozenges With Menthol
6.9mg
Menthol 6.9mg Lofthouse of Fleetwood Limited, UK Kingston Beverage & Creamery
Sdn Bhd
19 May 2015 till 18 May
2020
GSL
1729 BRU15041861NP ChlorHex 5% Concentrate
Solution
Chlorhexidine gluconate 5% w/v;
isopropylaocohol 3.15% w/v
Pahang Pharmacy Sdn Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1730 BRU15041862P Salmax CR tablet 4mg Salbutamol sulphate 4mg Upha Pharmaceuticals Sdn Bhd, Malaysia Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/1116 Page 103 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1731 BRU15051863NP SP Pharma Paracetamol Tablets
500mg
Paracetamol 500mg Simpor Pharma Sendirian Berhad, Brunei
Darussalam
Simpor Pharma Sendirian
Berhad
19 May 2015 till 18 May
2020
P (200’s)
1732 BRU15051864NP Addamel™ N Concentrate for
Infusion
1 mL contains: Chromic chloride 6 H2O 5.33
µg; Copper chloride 2 H2O 340 µg; Ferric
chloride 6 H2O 540 µg; Manganese
chloride 4 H2O 99 µg; Potassium iodide
16.6 µg; Sodium fluoride 210 µg; Sodium
molybdate 2 H2O 4.85 µg; Sodium selenite
anhydrous 6.90 µg; Zinc chloride 1.36 mg
Fresenius Kabi Norge AS, Norway Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1733 BRU15051865NP Dettol Moisturing Formula
Antiseptic Cream
Triclosan 0.3%; Chloroxylenol 0.3%; Edetic
acid 0.2%
Reckitt Benckiser Healthcare (UK) Ltd., UK Syarikat Aliaa Sdn Bhd 28 July 2015 till 27 July 2020 GSL
1734 BRU15051866P Dophilin Tablets 2mg Doxazosin (as mesylate) 2mg Taiwan Biotech Co. Ltd., Taiwan R.O.C. K-Seri Pharma Sdn Bhd 28 July 2015 till 27 July 2020 POM
1735 BRU15051867NP Kabiven Peripheral Emulsion for
Infusion
1000ml of the mixture contain: Purified
soybean oil 35g; Glucose (anhydrous) 68g;
Alanine 3.3g; Arginine 2.4g; Aspartic acid
0.71g; Phenylalanine 1.6g; Glutamic acid
1.2g; Glycine 1.6g; Histidine 1.4g;
Isoleucine 1.2g; Leucine 1.6g; Lysine 1.9g;
Methionine 1.2g; Proline 1.4g; Serine
0.94g; Threonine 1.2g; Tryptophan 0.40g;
Tyrosine 0.05g; Valine 1.5g; Sodium
glycerophosphate (anhydrous) 1.0g;
Calcium chloride 0.15g; Potassium chloride
1.2g; Magnesium sulphate 0.33g; Sodium
acetate 1.0g
Fresenius Kabi AB, Uppsala, Sweden Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1736 BRU15051868NP Kabiven Emulsion for Infusion Fresenius Kabi AB, Uppsala, Sweden Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1737 BRU15051869P Dopatab M250 Tablet Methyldopa 250mg Hovid Bhd., Malaysia G & H Trading Company 28 July 2015 till 27 July 2020 POM
1738 BRU15051870P Fenagesic Tablet 250mg Mefenamic acid 250mg Sunward Pharmaceutical Pte Ltd.,
Singapore
G & H Trading Company 28 July 2015 till 27 July 2020 POM
1739 BRU15051871P Metta SR Tablets 500mg Metformin Hydrochloride USP 500mg Torrent Pharmaceuticals Ltd., Indrad,
India
K-Seri Pharma Sdn Bhd 28 July 2015 till 27 July 2020 POM
1740 BRU15051872P Diamitex Tablet 80mg Gliclazide 80mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 28 July 2015 till 27 July 2020 POM
1741 BRU15051873NP Calamine Lotion Calamine BP 15% w/v Royce Pharma Manufacturing Sdn Bhd,
Malaysia
SWL Biomed Sales & Services 28 July 2015 till 27 July 2020 GSL
1742 BRU15051874NP Fisherman’s Friend Original
Lozenges
Menthol 10.35mg; Eucalyptus oil 1.73mg Lofthouse of Fleetwood Limited, UK Kingston beverage & Creamary
Sdn Bhd
28 July 2015 till 27 July 2020 GSL
BDMCA/RMP/1116 Page 104 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1743 BRU15051875NP Fisherman’s Friend Mint Lozenges Menthol 4.6mg; Peppermint oil 11.270mg Lofthouse of Fleetwood Limited, UK Kingston beverage & Creamary
Sdn Bhd
28 July 2015 till 27 July 2020 GSL
1744 BRU15051876NP Fisherman’s Friend Sugar Free
Original Lozenges
Menthol 9.2mg IDS Manufacturing Sdn Bhd, Malaysia Kingston beverage & Creamary
Sdn Bhd
28 July 2015 till 27 July 2020 GSL
1745 BRU15051877P Progyluton Tablet Estradiol Valerate (in brown tablet) 2mg;
Estradiol Valerate (in white tablet) 2mg;
Norgestrel (in brown tablet) 0.5mg
Bayer Weimar GmbH und Co. KG.,
Germany
Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1746 BRU15051878P Loratyn-10 Loratadine 10mg Hovid Bhd., Malaysia G & H Trading Company 28 July 2015 till 27 July 2020 POM (100's); P
(20's)
1747 BRU15051879P Candazole V Single Dose Cream
10% w/w
Clotrimazole 10% w/w HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 28 July 2015 till 27 July 2020 POM
1748 BRU15052038P GPO-L-OneTM 500mg Tablet Deferiprone 500mg The Government Pharmaceutical
Organization (GPO), Thailand
K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1749 BRU15061880P Keppra® Oral Solution 100mg/ml Levetiracetam 10mg/ml NextPharma SAS., France Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1750 BRU15061881P Norditrophin Nordilet Inejction
5mg/1.5ml Pre-filled Pen,
Solution for Injection
Somatropin (rDNA) 3.3mg/ml Nove Nordisk A/A, Denmark Medipharm Sdn Bhd 28 July 2015 till 27 July 2020 POM
1751 BRU15061882P Aceprin 10mg tablet Aspirin 100mg Hovid Bhd, Malaysia G & H Trading Company 28 July 2015 till 27 July 2020 POM
1752 BRU15061883P Povidone Iodine solution 10%
w/v
Povidone Iodine 10% w/v Royce Pharma Manufacturing Sdn. Bhd.,
Malaysia
SWL Biomed Sales & Services 28 July 2015 till 27 July 2020 GSL
1753 BRU15061884P Pharmaniaga Cephalexin
Suspension 250mg
Cephalexin (as Cephalexin Anhydrous)
250mg/5mL
Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 28 July 2015 till 27 July 2020 POM
1754 BRU15061885P Zorax Suspension 200mg/5ml Aciclovir 200mg/5ml Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 28 July 2015 till 27 July 2020 POM
1755 BRU15061886P Ganaton 50mg tablet Itopride hydrochloride 50mg Abbott Japan Co. Ltd., Japan Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1756 BRU15061887P PVP Iodine Solution Povidone-Iodine 10% w/v (equivalent to
1% available Iodine)
Dynapharm (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd 28 July 2015 till 27 July 2020 GSL
1757 BRU15061888P Herceptin Powder for Injection
440mg/vial
Trastuzumab 440mg Genentech Inc., California, USA;
Genentech Inc., Oregon, USA
Medicare 28 July 2015 till 27 July 2020 POM
1758 BRU15061889P Azoren 20mg/5mg Film-Coated
Tablet
Olmesartan medoxomil 20mg and
Amlodipine (as amlodipine
besylate) 5mg
Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1759 BRU15061890P Azoren 40mg/10mg Film-Coated
Tablet
Olmesartan medoxomil 40mg and
Amlodipine (as amlodipine
besylate) 10mg
Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1760 BRU15061891P Azoren 40mg/5mg Film-Coated
Tablet
Olmesartan medoxomil 40mg and
Amlodipine (as amlodipine
besylate) 5mg
Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
BDMCA/RMP/1116 Page 105 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1761 BRU15061892P Perindosyl 4mg Tablet Perindopril tert-butylamine 4mg (eqv. to
3.338mg perindopril)
Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM
1762 BRU15061893NP Mentholatum Deep Heating Rub Methyl Salicylate 12.7% & Menthol 5.8% The Mentholatum Co., Inc., USA Hamitan Marketing 28 July 2015 till 27 July 2020 GSL
1763 BRU15061894NP Oxy Cover Cream Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam) Co. Ltd.,
Vietnam
Hamitan Marketing 28 July 2015 till 27 July 2020 GSL
1764 BRU15061895NP Oxy Acne Wash Triclosan 0.30% Rohto-Mentholatum (Vietnam) Co. Ltd.,
Vietnam
Hamitan Marketing 28 July 2015 till 27 July 2020 GSL
1765 BRU15061896NP Hocodin Lozenge 250mcg Dequalinium chloride 250mcg Winwa Medical Sdn. Bhd., Malaysia Medicorp Sdn. Bhd. 28 July 2015 till 27 July 2020 GSL
1766 BRU15061897NP Gaviscon Advance Peppermint Sodium alginate 500mg/5ml
Potassium bicarbonate 100mg/5ml
Reckitt Benckiser Healthcare (UK) Ltd., UK Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 GSL
1767 BRU15071898P Celluvisc Lubricating Eye Drops
1%
Carboxymethylcellulose sodium 1% Allergan Sales, LLC, USA Medipharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL
1768 BRU15071899P Cavumox 625mg Tablet Amoxicillin (as trihydrate) 500mg;
Clavulanic acid (as potassium salt) 125mg
Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1769 BRU15071900NP Gaviscon Liquid Per 10ml - Sodium alginate 500mg; Sodium
bicarbonate 267mg; Calcium carbonate
160mg
Reckitt Benckiser Healthcare (UK) Ltd, UK Syarikat Aliaa Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL
1770 BRU15071901P Zapine 100mg Tablet Clozapine100mg Taiwan Biotech Co. Ltd, Taiwan G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
1771 BRU15071902P Alendronate Sandoz 70mg FCT Alendronic acid 70mg Lek Pharmaceuticals D.D., Ljubljana Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1772 BRU15071903NP Chlorhex 4% antiseptic solution Chlorhexidine gluconate 4% Pahang Pharmacy Sdn Bhd., Malaysia G & H Trading Company 09 Dec 2015 till 08 Dec 2020 GSL
1773 BRU15071904P Resolor Film-coated Tablet 2mg Prucalopride succinate 2.642mg eqv
Prucalopride 2mg
Janssen-Cilag S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1774 BRU15071905P Proglutrol 500 Extended Release
Tablets
Metformin Hydrochloride 500mg Inventia Healthcare Pvt. Ltd., India Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1775 BRU15071906NP Gaviscon Double Action Liquid Per 10ml - Sodium Alginate 500mg; Sodium
Bicarbonate 213mg; Calcium Carbonate
325mg
Reckitt Benckiser Healthcare (UK) Ltd, UK Syarikat Aliaa Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL
1776 BRU15071907NP Gaviscon Double Action Tablet Sodium Alginate 250mg; Sodium
Bicarbonate 106.5mg; Calcium Carbonate
187.5mg
Reckitt Benckiser Healthcare (UK) Ltd, UK Syarikat Aliaa Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL
1777 BRU15071908P Daivobet Gel Calcipotriol (as monohydrate) 50mcg/g &
betamethasone (as dipropionate) 0.5mg/g
LEO Laboratories Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1778 BRU15071909NP Oxy 10 Lotion Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam) Co. Ltd.,
Vietnam
Hamitan Marketing 09 Dec 2015 till 08 Dec 2020 GSL
1779 BRU15071910NP Oxy 5 Lotion Benzoyl peroxide 5% w/w Rohto-Mentholatum (Vietnam) Co. Ltd.,
Vietnam
Hamitan Marketing 09 Dec 2015 till 08 Dec 2020 GSL
BDMCA/RMP/1116 Page 106 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1780 BRU15071911P Hydrogen Peroxide Solution (6%) Hydrogen Peroxide 6% w/v (equivalent to
20 volumes of available oxygen)
The Government Pharmaceutical
Organization, Thailand
SWL Biomed Sales & Services 09 Dec 2015 till 08 Dec 2020 P
1781 BRU15071912P Keppra Film-coated Tablet
1000mg
Levetiracetam 1000mg UCB Pharma SA, Belgium Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1782 BRU15081913NP Zentel Suspension 400mg/10ml Albendazole 400mg/10ml Smithkline Beecham, Philippines Kingston Beverage & Creamery
Sdn Bhd
09 Dec 2015 till 08 Dec 2020 GSL (1's x 10ml)
1783 BRU15081914P Xalacom Eye Drops 1ml contains latanoprost 50 micrograms
and timolol maleate 6.8mg (eq to 5mg
timolol)
Pfizer Manufacturing Belgium NV,
Belgium
Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1784 BRU15081915P Dormicum Tablet 15mg Midazolam Maleate 20.40mg eqv. to
Midazolam 15mg
Productos Roche S.A. de C.V. Via Isidro
Fabela Nte., Edo de Mexico.
Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1785 BRU15081916P Unihepa 5000IU/ml Injection (5ml
vial)
Heparin sodium 5000IU/ml Duopharma (M) Sdn Bhd., Malaysia K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1786 BRU15081917P Olmetec 40 Tablet Olmesartan Medoxomil 40mg Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1787 BRU15081918P Olanzapine Orodispersible
Tablets 5mg
Olanzapine 5mg Jubilant Life Sciences Ltd., India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1788 BRU15081919P Olanzapine Orodispersible
Tablets 10mg
Olanzapine 10mg Jubilant Life Sciences Ltd., India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1789 BRU15081920P Metrogyl Injection 5mg/ml Metronidazole 500mg/100mL Unique Pharmaceutical Laboratories,
India
K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1790 BRU15081921P Pharmaniaga Dermapro Ointment
0.05% w/w
Clobetasol propionate 0.05% w/w Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
1791 BRU15081922P Olmetec Plus 40/12.5mg Film-
Coated Tablet
Olmesartan Medoxomil 40mg;
Hydrochlorothiazide 12.5mg
Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1792 BRU15081923P Risperdal Tablet 1mg Risperidone 1mg Janssen Cilag SPA, Italy Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1793 BRU15081924P Risperdal Tablet 2mg Risperidone 2mg Janssen Cilag SPA, Italy Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1794 BRU15081925P Apo-Clopidogrel Tablet 75mg Clopidogrel (as bisulfate) 75mg Apotex Inc. Canada, Canada Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1795 BRU15081926NP Win-Aqueous Cream Emulsifying Wax 8%w/w; Liquid Paraffin
5% w/w; White Soft Paraffin 13% w/w
Winwa Medical Sdn Bhd., Pulau Pinang,
Malaysia
Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL
1796 BRU15091927P Axcel Piroxicam-10 Capsule Piroxicam 10mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1797 BRU15091928P Acular Ophthalmic Solution 0.5% Ketorolac Trometamol 0.50% w/v Allergan Pharmaceuticals Ireland, Ireland MediPharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1798 BRU15091929P Dilantin capsule 30mg Phenytoin Sodium 30mg Pfizer Australia Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1799 BRU15091930P Zymar® (gatifloxacin opthalmic
solution) 0.3%
Gatifloxacin 0.3% Allergan Sales, United States MediPharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
BDMCA/RMP/1116 Page 107 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1800 BRU15091931P Klerimed 500mg Film-Coated
Tablets
Clarithromycin 515mg (equivalent to
anhydrous clarithromycin 500mg)
1. Medochmie Ltd (Factory AZ), Cyprus
2. Medochmie Ltd (Central Factory),
Cyprus
Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM
1801 BRU15091932P Gadovist Injection 1.0mmol/ml
Prefilled syringe 5.0ml
Gadobutrol pure 604.72mg & Calcium
sodium butrol 0.513mg
Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1802 BRU15091933P Gadovist Injection 1.0mmol/ml Gadobutrol pure 604.72mg & Calcium
sodium butrol 0.513mg
Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1803 BRU15091934P Neostigmine Methysulphate –
Fresenius 2.5mg/1ml (Ampoules)
Neostigmine methylsulphate 2.5mg/ml Fresenius Kabi Manufacturing SA (Pty)
Ltd., Republic of South Africa.
K-Seri Pharma Sdn. Bhd. 09 Dec 2015 till 08 Dec 2020 POM
1804 BRU15091935P Cardiprin 100 Tablet Aspirin 100mg Reckitt Benckiser Healthcare (UK),United
Kingdom
Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1805 BRU15091936P Calact 300mg Tablets Calcium Lactate USP Eq. to Calcium Lactate
Pentahydrate 300mg.
Elemental Calcium 39mg (from Calcium
lactate pentahydrate 300mg).
Unique Pharmaceutical Laboratories (A
Division of J.B. Chemicals &
Pharmaceuticals Limited), India.
K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1806 BRU15091937P Guafensin Syrup 20mg/ml Guaifenesin 20mg/ml Y.S.P. Industries (M) Sdn. Bhd., Malaysia Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1807 BRU15091938P Storvas C Tablets 10mg Atorvastatin 10mg as Atorvastatin Calcium
Trihydrate
Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
1808 BRU15091939NP Zinc Cream Zinc Oxide 32% w/w HOE Pharmaceuticals Sdn. Bhd., Malaysia G & H Trading Company 09 Dec 2015 till 08 Dec 2020 GSL
1809 BRU15091940P Pirimat Injection 10mg/ml (1ml
ampoule)
Chlorpheniramine Maleate 10mg/m Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM
1810 BRU15091941P Irprestan Tablet 150mg Irbesartan 150mg Actavis ehf, Iceland G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
1811 BRU15091942P Irprestan Tablet 300mg Irbesartan 300mg Actavis ehf, Iceland G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
1812 BRU15091943P Heparinol® 10 Sterile Heparinised
Saline Injection
Heparin Sodium (Bovine) 10 IU/ml Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 09 Dec 2015 till 08 Dec 2020 POM
1813 BRU15091944P Fucid Ointment 2% w/w Sodium Fusidate (Micronised) 20mg/g (2%
w/w)
Noripharma Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1814 BRU15091945P Actemra Concentrate for Solution
for Infusion 20mg/ml
Tocilizumab 20mg/ml Chugai Pharma Manufacturing Co., Ltd,
Japan
Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM
1815 BRU15091946P Axcel Bromhexine (Children) Elixir Bromhexine Hydrochloride 4mg Kotra Pharma (M) Sdn Bhd., Malaysia Medicorp Sdn Bhd. 09 Dec 2015 till 08 Dec 2020 POM
1816 BRU15101947P Cetyrol 10mg Film-coated Tablet Cetirizine dihydrochloride 10mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
BDMCA/RMP/1116 Page 108 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1817 BRU15101948P Archifar 1g Powder for Solution
for Injection/Infusion
Meropenem (as trihydrate) 1g Medochemie Ltd., Cyprus Hongkiat Trading & Co 09 Dec 2015 till 08 Dec 2020 POM
1818 BRU15101949P Antismine Syrup 2mg/5ml Chlorpheniramine maleate 2mg/5ml Winwa Medical Sdn Bhd., Malaysia Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 P
1819 BRU15101950P Respidon 2mg Tablets Risperidone 2mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1820 BRU15101951P Respidon 1mg Tablets Risperidone 1mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1821 BRU15101952NP Flexjoint 1500mg Powder Crystalline glucosamine sulphate 1884mg
(equivalent to glucosamine sulphate
1500mg)
Winwa Medical Sdn Bhd., Malaysia Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL
1822 BRU15101953NP Colin Cough Syrup 100mg Guaiphenesin 100mg/5ml Winwa Medical Sdn Bhd., Malaysia Yuh Hua Trading Company 09 Dec 2015 till 08 Dec 2020 GSL
1823 BRU15101954P Tystatin Oral Suspension Nystatin BP 100,000 units T.O. Chemicals (1979) Co. Ltd., Thailand Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1824 BRU15101955P Ezede Tablet 10mg Loratadine 10mg Xepa-Soul Pattinson (M) Sdn Bhd.,
Malaysia
Hongkiat Trading & Co 09 Dec 2015 till 08 Dec 2020 P
1825 BRU15101956P Pred Forte Sterile Ophthalmic
Suspension 1%
Prednisolone acetate 1% w/v Allergan Pharmaceuticals Ireland, Mayo,
Ireland
Medipharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1826 BRU15111957P Stivarga Tablet 40mg Regorafenib
(40mg Regorafenib equivalent to 41.49mg
Regorafenib monohydrate)
Bayer Pharma AG, Germany. Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1827 BRU15111958P A Scabs Lotion Permethrin 5.0% w/v HOE Pharmaceuticals Sdn. Bhd., Malaysia G & H Trading Company 09 Dec 2015 till 08 Dec 2020 GSL
1828 BRU15111959P Insugen-N (NPH) Insulin Injection, Isophane Ph. Eur. (Human
Insulin rDNA origin) 100IU/ml
Biocon Limited, India Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM
1829 BRU15111960P Tetradox Capsules 100mg Doxycycline Hydrochloride/Hcylate eq to
Doxycycline 100mg
Ranbaxy (Malaysia) Sdn Bhd, Malaysia G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM
1830 BRU15111961NP Infusol® NS (Ampoule) Sodium chloride 0.9%w/v AIN Medicare Sdn. Bhd., Malaysia Syarikat Pakatan Indah 09 Dec 2015 till 08 Dec 2020 GSL
1831 BRU15111962NP Infusol W (Sterilised Water for
Injection BP)
Water for injection BP AIN Medicare Sdn. Bhd., Malaysia Syarikat Pakatan Indah 09 Dec 2015 till 08 Dec 2020 GSL
1832 BRU15111963P Elan Forte Cream Tolnaftate 10mg/g; Chlorhexidine HCl
2mg/g
Y.S.P. Industries (M) Sdn. Bhd.,Malaysia Asterix United (B) Sdn Bhd. 09 Dec 2015 till 08 Dec 2020 GSL
1833 BRU15111964P Valparin XR 500mg Tablet i) Sodium Valproate 333mg
ii) Valproic Acid 145mg
(Both together correspond to sodium
valproate 500mg)
Torrent Pharmaceuticals Limited, India K-Seri Pharma Sdn Bhd., 09 Dec 2015 till 08 Dec 2020 POM
1834 BRU15111965P Axcel Betamethasone Cream Betamethasone 17-Valerate (micronized)
equivalent to Betamethasone 0.1% w/w
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM
1835 BRU15111966P Freederm Gel Terbinafine HCl 1%w/w Winwa Medical Sdn Bhd., Malaysia Yuh Hua Trading Company 09 Dec 2015 till 08 Dec 2020 GSL
BDMCA/RMP/1116 Page 109 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1836 BRU15111967P Cough-En Linctus Dextromethorphan Hydrobromide
15mg/5ml;
Tripolidine Hydrochloride 1.25mg/5ml;
Pseudoephedrine Hydrochloride 30mg/5ml
Xepa-Soul Pattinson (Malaysia) Sdn. Bhd.,
Malaysia
Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM
1837 BRU15111968PT Atehexal Comp Mite Tablet Atenolol 50mg; Chlorthalidone 12.5mg Salutas Pharma GmbH, Federal Republic
of Germany
Medicorp 09 Dec 2015 till 28 April 2019 POM
1838 BRU15111969PT Hurricaine Topical Anaesthetic
Gel – Original Wild Cherry
Benzocaine 20% Dental Technologies Inc. , United States L S Kai Care 09 Dec 2015 till 16 Feb 2018 POM
1839 BRU15111970PT Duocaine Cream 5% w/w Lidocaine 2.5% w/w; Prilocaine 2.5% w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Co 09 Dec 2015 till 14 Jan 2019 POM
1840 BRU15111971PT SOLIRIS Concentrate for Solution
for Infusion 300mg
Eculizumab 300mg DSM Pharmaceuticals Inc, USA Medipharm Sdn Bhd 09 Dec 2015 till 23/11/2018 POM
1841 BRU15121972PS1 &
BRU15121972PS2
Varivax (refrigerated) Varicella Virus Vaccine Live (Oka / Merck)
1350PFU / 0.5ml
Merck Sharp & Dohme Corp.,
Pennsylvania USA (S1)
ii) Merck Sharp and Dohme Corp., North
Carolina, US (S2)
Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1842 BRU15121973P SW-Dexasone Tablet Dexamethasone 0.5mg Sunward Pharmaceutical Sdn Bhd.,
Singapore
G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1843 BRU15121974P Paracetamol Codeine Tablet Paracetamol 500mg and Codeine
Phosphate 8mg
Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1844 BRU15121975NP Mentholatum Deep Heat Sport
Pain Relief Spray
Methyl Nicotinate 16mg/g; Glycol
Salicylate 50mg/g; Methyl Salicylate
10mg/g; Ethyl salicylate 50mg/g
Ensign Labs Pty. Ltd., Australia Hamitan Marketing 21 Jun 2016 till 20 Jun 2021 GSL
1845 BRU15121976NP Mentholatum Deep Cold Ice Gel
Therapy
Menthol 20g/g Mentholatum Australia Pty. Ltd., Australia Hamitan Marketing 21 Jun 2016 till 20 Jun 2021 GSL
1846 BRU15121977NP Axcel Urea Cream Urea 10% w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1847 BRU15121978P Axcel Clomiphene Tablet Clomiphene Citrate 50mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1848 BRU15121979P Medocef 1g Powder for Solution
for Injection or Infusion
Cefoperazone (as sodium) 1g Medochemie Ltd., Cyprus Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1849 BRU15121980NP Dexxon Lozenges Dequalinium Chloride 0.25mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1850 BRU15121981P Oragel Pain Relief Choline Salicylate 9% w/w &
Cetylpyridinium Chloride 0.05% w/w
Winwa Medical Sdn. Bhd., Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1851 BRU16011982NP 0.9% Sodium Chloride Solution,
USP
Sodium Chloride USP 0.9% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
BDMCA/RMP/1116 Page 110 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1852 BRU16011983P Amlibon 5mg Tablet Amlodipine (as Amlodipine Besilate) 5mg Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1853 BRU16011984P Ospexin 250mg/5ml Granules for
Oral Suspension
Cephalexin 250mg/5ml Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1854 BRU16011985P Azukon MR 30mg Tablet Gliclazide 30mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1855 BRU16011986P Espran 10mg Tablet Escitalopram (as Oxalate) 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1856 BRU16011987P Zenalb 20% Human albumin 20%w/v Bio Product Lab, UK Medipharm Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1857 BRU16011988P Lestric Tablets 20mg Lovastatin 20mg Ranbaxy (Malaysia) Sdn Bhd., Malaysia G&H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1858 BRU16011989P Potassium Chloride 10% w/v
Injection
Potassium Chloride 10% w/v Pharmaniaga Manufacturing Berhad,
Malaysia
G&H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1859 BRU16011990P Gastografin Solution 1ml contains Sodium amidotrizoate 0.1g
and Meglumine amidotrizoate 0.66g
Belimed SA, Spain Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1860 BRU16011991P Rabotide Capsule 20mg (as
enteric coated pellets)
Rabeprazole Sodium 20mg Inventia Healthcare Pvt Ltd., India Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1861 BRU16011992P Pharmaniaga Gliclazide Tablet
80mg
Gliclazide 80mg Pharmaniaga Manufacturing Berhad,
Malaysia
G&H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1862 BRU16011993NP Betadine Antiseptic Ointment Povidone-Iodine 10% w/w Pt. Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1863 BRU16011994NP Betadine Feminine Wash with
Douching Apparatus 10% w/v
Povidone-Iodine 10% w/v Pt. Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1864 BRU16011995NP Betadine Feminine Wash Povidone-Iodine 10% w/v Pt. Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1865 BRU16011996NP Coxan Tablets 500mg Paracetamol 500mg Prime Pharmaceuticals Sdn Bhd., Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1866 BRU16011997P Soluwax Ear Drops Docusate sodium 0.5% w/v Hoe Pharmaceuticals Sdn Bhd., Malaysia G&H Trading Company 21 Jun 2016 till 20 Jun 2021 GSL
1867 BRU1602070P Sifrol Extended Release 1.5mg
tablet
Pramipexole
Dihydrochloride
Monohydrate 1.5mg
(eqv. to 1.05mg
pramipexole free base)
Boehringer Ingelheim Pharma gmbH &
Co. KG, Germany
Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM
1868 BRU16021998P Insugen-R (NPH) Insulin Injection, Soluble Ph. Eur. (Insulin,
Human of recombinant DNA origin) 100
IU/ml
Biocon Limited, India Hongkiat Trading & Co 21 Jun 2016 till 20 Jun 2021 POM
1869 BRU16021999P Levetiracetam tablet 500mg Levetiracetam 500mg Jubilant Generics, Limited, India Axterix United (B) Sdn. Bhd 21 Jun 2016 till 20 Jun 2021 POM
1870 BRU16022000P Glimicron 80mg tablet Gliclazide 80mg HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun 2021 POM
BDMCA/RMP/1116 Page 111 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1871 BRU16022001NP Liquid Paraffin Liquid Paraffin BP 100% HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun 2021 GSL
1872 BRU16022002NP Noxworm Suspension (chocolate)
400mg
Albendazole 200mg/5mL Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL
1873 BRU16022003P Mircera pre-filled syringe
100mcg/0.3ml
Methoxy polyethylene glycol-epoetin beta
100mcg/0.3ml
Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1874 BRU16022004P Glucodex tablet Gliclazide 80mg PT Dexa Medica, Indonesia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1875 BRU16022005P Rocaltrol capsule 0.5mcg Calcitriol 0.5mcg Catalent Germany Eberbach GmbH,
Germany for F.Hoffmann-La Roche Ltd.,
Switzerland
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM
1876 BRU16022006P Rocaltrol capsule 0.25mcg Calcitriol 0.25mcg Catalent Germany Eberbach GmbH,
Germany for F.Hoffmann-La Roche Ltd.,
Switzerland
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM
1877 BRU16022007P Adezio Oral Suspension Cetirizine Hydrochloride 1mg/ml Xepa-Soul Pattinson (Malaysia) Sdn
Bhd,
Malaysia
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 P
1878 BRU16022008P Zarin cream Miconazole nitrate 2%w/w Xepa-Soul Pattinson (Malaysia) Sdn
Bhd,
Malaysia
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 GSL
1879 BRU16022009P Jumex (Selegiline HCl) tablet 5mg Selegiline Hydrochloride 5mg Chinoin Pharmaceutical and Chemical
Works Co. Ltd., Hungary.
MediPharm Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1880 BRU16022010P Bena
®
Expectorant
Diphenhydramine hydrochloride
14mg/5ml and ammonium
chloride 135mg/5ml
Xepa-Soul Pattinson (Malaysia) Sdn
Bhd,
Malaysia
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM
1881 BRU16022011P Pantor 20 Pantoprazole (as sodium
sesquihydrate) 20mg
Torrent Pharmaceuticals Limited, India K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1882 BRU16022012P Pantor 40 Pantoprazole (as sodium
sesquihydrate) 40mg
Torrent Pharmaceuticals Limited, India K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1883 BRU16032013P Ceritec Film Coated Tablet 10mg Cetirizine Hydrochloride 10mg Y.S.P. Industries (M) Sdn. Bhd., Malaysia. Asterix United (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 P
1884 BRU16032014P Tinazol Cream 2% (15g) Miconazole nitrate 2% w/w Hovid Bhd, Malaysia. G & H Trading Company 21 Jun 2016 till 20 Jun 2021 GSL
1885 BRU16032015PS1 &
BRU16032015PS2
M-M-R II® Vaccine Live, attenuated virus derived from
Edmonston B strain of measles - 3.0 log
TCID50, Live attenuated Jeryl LynnTM strain
of mumps - 4.1 log TCID50, Live, attenuated
Wistar RA 27/3 strain of rubella - 3.0 log
TCID50
1. Merck Sharp & Dohme Corp.,
Pennsylvania, USA,
2. Merck Sharp & Dohme Corp., North
Carolina, U.S.A
Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1886 BRU16032016P Insugen-30/70 (Biphasic) Insulin Injection, Biphasic Isophane Ph. Eur.
(Insulin, Human recombinant DNA origin)
100 IU/ml
Biocon Limited, India Hongkiat Trading & Co. 21 Jun 2016 till 20 Jun 2021 POM
1887 BRU16032017P Natrixam 1.5mg/10mg modified-
release tablet
Indapamide 1.5mg & Amlodipine 10mg (as
besilate)
Les Laboratories Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
BDMCA/RMP/1116 Page 112 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1888 BRU16032018P Natrixam 1.5mg/5mg modified-
release tablet
Indapamide 1.5mg & Amlodipine 5mg (as
besilate)
Les Laboratories Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1889 BRU16032019P Levetiracetam 250mg tablet Levetiracetam 250mg Jubilant Generics Limited, India Asterix United (B)Sdn Bhd., 21 Jun 2016 till 20 Jun 2021 POM
1890 BRU16032020NP Mifuko Ointment Zinc Oxide 6% (w/w) and Salicylic acid 5%
(w/w)
Winwa Medical Sdn Bhd, Malaysia. Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL
1891 BRU16032021P Primodil 5 Tablet Amlodipine Besilate 6.94mg (equivalent to
Amlodipine 5mg)
Medley Pharmaceuticals Ltd, India Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1892 BRU16032022P Oxair Film Coated Tablet 10mg Montelukast Sodium 10.4mg (equivalent to
Montelukast 10mg)
Y.S.P. Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1893 BRU16032023NP Bacidin Antiseptic Cream 1% w/w Chlorhexidine Gluconate 1% w/w Xepa-soul Pattinson (Malaysia) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 GSL
1894 BRU16032024P Axcel Oxymetazoline 0.05% Nasal
Spray
Oxymetazoline Hydrochloride 0.05% w/v Kotra Pharma (M) Sdn Bhd., Malaysia. Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 P
1895 BRU16042025P Romesec 20mg Capsules Omeprazole USP 20mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia. G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1896 BRU16042026NP Migrate Q10 Coenzyme Q10………….100mg;
Lycopene………………….... 5mg; L-
Arginine…………….…..100mg;
Zinc Sulphate monohydrate (eq to
Elemental zinc)..22.5mg;
Piperine………………………..5mg; Sodium
selenite (eq to Elemental selenium)
….70mcg
Goodman Pharmaceuticals, India. MediBiotech 21 Jun 2016 till 20 Jun 2021 GSL
1897 BRU16042027NP Potassium Chloride Injectable
Solution 10%
Potassium chloride 1g / 10ml DEMO SA Pharmaceutical Industry,
Greece.
Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1898 BRU16042028P Oratane 20mg Capsules Isotretinoin 20mg Swiss Caps AG, Switzerland, Contract Mfg.
for Douglas Pharmaceuticals Limited, New
Zealand.
K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1899 BRU16042029P Oratane 10mg Capsules Isotretinoin 10mg Swiss Caps AG, Switzerland, Contract Mfg.
for Douglas Pharmaceuticals Limited, New
Zealand.
K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1900 BRU16042030NP Osteoactiv 3 in 1 Joint Formula
Powder
Glucosamine Hydrochloride 1000mg,
Methylsulfonylmethane 1000mg,
Chondroitin Sulphate Sodium 880.4mg
(equivalent to 800mg chondroitin)
Winwa Medical Sdn. Bhd., Malaysia. Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1901 BRU16042031NP Osteoactiv 3 in 1 Joint Formula
Tablet
Glucosamine Hydrochloride 250mg,
Methylsulfonylmethane 250mg,
Chondroitin Sulphate Sodium 220mg
(equivalent to 200mg chondroitin)
Winwa Medical Sdn. Bhd., Malaysia. Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
BDMCA/RMP/1116 Page 113 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1902 BRU16042032P Sedilix-DM Linctus Dextromethorphan (as Hydrobromide)
15mg/5mL; Pseudoephedrine (as
Hydrochloride) 30mg/5mL; Promethazine
(as Hydrochloride) 3.125mg/5mL
Xepa-Soul Pattinson (M) Sdn Bhd,
Malaysia.
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM
1903 BRU16042033P Aloxi Solution for Injection
50mcg/ml
Palonosetron Hydrochloride 56 mcg eqv to
Palonosetron 50 mcg (0.050 mg)
Pierre-Fabre Medicament Production,
France.
Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1904 BRU16042034P Taver Tablet 200mg Carbamazepine 200mg Medochemie Ltd., Cyprus. Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1905 BRU16042035NP Axcel B Complex Tablet Vitamin B1 10mg; Vitamin B2 3mg;
Vitamin B6 1mg; Cyanocobalamine 5mcg;
Calcium Pantothenate 1mg; Nicotinamide
25mg
Kotra Pharma (M) Sdn Bhd, Malaysia. Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1906 BRU16042036P Pharmaniaga Allopurinol Tablet
300mg
Allopurinol 300mg Pharmaniaga Manufacturing Berhad,
Malaysia.
G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM
1907 BRU16042037NP Povidin Solution 10% Povidone-Iodine 10% w/v (equivalent to
1% of Available Iodine)
Xepa-soul Pattinson (Malaysia) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 GSL
1908 BRU16052039NP Noxworm Chewtab Albendazole 200mg Winwa Medical Sdn. Bhd., Malaysia Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL
1909 BRU16052040P Betadine® Antiseptic Solution Povidone-Iodine 10% w/v PT Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL
1910 BRU16052041P Zoratadine Syrup 5mg/5ml Loratadine 5mg/5ml HOE Pharmaceuticals Sdn. Bhd., Malaysia G&H Trading Company 21 Jun 2016 till 20 Jun 2021 P
1911 BRU16052042P Axcel Oxymetazoline 0.025%
Nasal Drop
Oxymetazoline hydrochloride 0.025% w/v Kotra Pharma (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 P
1912 BRU16052043P Axcel Dextromethorphan-15
Syrup
Dextromethorphan hydrobromide
15mg/5ml
Kotra Pharma (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1913 BRU16052044P Zometa Solution for Infusion
4mg/100ml
Zoledronic Acid (anhydrous) 4mg/100ml
corresponding to 4.264mg Zoledronic Acid
Monohydrate
Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM
1914 BRU16052045P Novomin Tablet 50mg Dimenhydrinate 50mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd,
Malaysia.
Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM
1915 BRU16062046P Valzaar 80mg Tablets Valsartan 80mg Torrent Pharmaceuticals Ltd, India K-Seri Pharma Sdn. Bhd 08 November 2016 till 07
November 2021
POM
1916 BRU16062047P Valzaar 160mg Tablets Valsartan 160mg Torrent Pharmaceuticals Ltd, India K-Seri Pharma Sdn. Bhd 08 November 2016 till 07
November 2021
POM
1917 BRU16062048P Tozaar 50mg tablet Losartan potassium 50mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 08 November 2016 till 07
November 2021
POM
1918 BRU16062049P Seebri Breezhaler 50mcg
Inhalation Powder Hard Capsules
Glycopyrronium bromide 63mcg
(corresponding to 50 mcg Glycopyrronium)
Novartis Pharma Stein AG., Switzerland Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM
BDMCA/RMP/1116 Page 114 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1919 BRU16062050P Neotigason Capsule 10mg Acitretin 10mg Patheon Inc., Canada G & H Trading Company 08 November 2016 till 07
November 2021
POM
1920 BRU16062051P Neotigason Capsule 25mg Acitretin 25mg Patheon Inc., Canada G & H Trading Company 08 November 2016 till 07
November 2021
POM
1921 BRU16062052P Tidact Injection 150mg/ml Clindamycin (as phosphate) 150mg/ml Yung Shin Pharmaceutical Ind. Co. Ltd.,
Republic of China
Asterix United (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM
1922 BRU16062053P APO-Risperidone Tablets 1mg Risperidone 1mg Apotex Inc, Canada Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1923 BRU16062054P Betmiga Prolonged-Release
Tablets 25mg
Mirabegron 25mg Astellas Pharma Technologies Inc., US Medipharm Sdn Bhd 08 November 2016 till 07
November 2021
POM
1924 BRU16062055P Betmiga Prolonged-Release
Tablets 50mg
Mirabegron 50mg Astellas Pharma Technologies Inc., US Medipharm Sdn Bhd 08 November 2016 till 07
November 2021
POM
1925 BRU16062056P Axcel Mometasone 0.1% Cream Mometasone furoate (micronised) 0.1%
w/w
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1926 BRU16072057P Dipeptiven Infusion 200mg/ml N(2)-L-Alanyl-L-glutamine 200mg/ml Frensius Kabi Austria GmbH, Austria Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM
1927 BRU16072058P Noxafl 100mg tablet Posaconazole 100mg N.V Organon, Netherlan Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM
1928 BRU16072059P Onegaba 300mg capsules Gabapentin 300mg Aurobindo Pharma Limited (Unit III),
India
K-Seri Pharma Sdn Bhd 08 November 2016 till 07
November 2021
POM
1929 BRU16072060P Pethidine-Hameln Solution for
Injection 50mg/ml
Pethidine Hydrochloride
50mg/ml
Hameln Pharmaceuticals GmbH, Langes
Feld 13, 31789 Ham
eln, Germany
Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1930 BRU16072061P Axcel Clobetasol 0.05 Ointment Clobetasol Propionate (micronized) 0.05%
w/w
Kotra Pharma (M) Sdn Bhd.,
Malaysia.
Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1931 BRU16072062P Prednisolone syrup 5mg/5ml Each 5ml contains:
Prednisolone (as salt of
prednisolone) 5mg
Beacons Pharmaceutical Pte Ltd,
Singapore
Hong Kiat Trading & Co 08 November 2016 till 07
November 2021
POM
1932 BRU16082063NP Zenalb 4.5%, Human Albumin
Solution 4.5%
Human Albumin Solution 4.5% Bio Products Laboratory Limited, UK MediPharm Sdn Bhd 08 November 2016 till 07
November 2021
POM
1933 BRU16082064P Axcel Lamivudine 100mg Tablet Lamivudine 100mg Kotra Pharma (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1934 BRU16082065P Calpo Suspension Mebendazole 100mg/5ml Winwa Medical Sdn. Bhd., Malaysia Yuh Hua Trading Company 08 November 2016 till 07
November 2021
GSL
1935 BRU16082066NP Alphanate® 250IU Factor VII 250IU and von Willebrand Factor
>400IU/1000IU Factor VII
Grifols Bilogicals Inc., USA Hongkiat Trading & Company 08 November 2016 till 07
November 2021
POM
1936 BRU16082067P Anoro Ellipta 62.5/25 micrograms
inhalation powder, pre-dispensed
Each pre-dispensed dose contains 62.5
micrograms umeclidinium (equivalent to
74.2 micrograms of umeclidinium bromide)
and 25 micrograms vilanterol (as
trifenatate)
Glaxo Operations UK Ltd (trading as Glaxo
Wellcome Operations), UK
Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM
1937 BRU16082068NP RINS® NS Sodium Chloride 0.9%
w/v Irrigation Solution BP
Sodium Chloride 0.9% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 08 November 2016 till 07
November 2021
GSL
BDMCA/RMP/1116 Page 115 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1938 BRU16092069P Sifrol Extended Release 0.375mg
tablet
Pramipexole
Dihydrochloride
Monohydrate 0.375mg
(eq
v.
to 0.26mg
pramipexole free base)
Boehringer Ingelheim Pharma gmbH &
Co. KG, Germany
Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM
1939 BRU16092071NP Mentholatum Deep Heating Rub
Extra Strength Cream
Methyl Salicylate 30%; Menthol
8%
The Mentholatum Co., USA. Hamitan Marketng, Brunei
Darussalam
08 November 2016 till 07
November 2021
GSL
1940 BRU16092072P GlobalVacc Al-Shifa HIB Each dose of 0.5ml contains:
Purified Capsular Polysaccharide Hib
(PRP) –10mcg
(Hib Polysaccharide) (PRP) Tetanus Toxoid
(carrier protein) –19 to 33mcg
Serum Institute India Ltd., India Bruvac Pharma Sdn Bhd,
Brunei Darussalam
08 November 2016 till 07
November 2021
POM
1941 BRU16092073P Adrenaline (Epinephrine)
Injection 1:1000
Adrenaline (Epinephrine) as acid
tartrate
Mc Carthys Laboratories Ltd., UK Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1942 BRU16092074P Axcel Mometasone 0.1%
Ointment Mometasone Furoate
(micronised) 0.1% w/w
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1943 BRU16092075P Amphotret for Injection U.S.P.
50mg
Amphotericin B U.S.P. 50mg Bharat Serums And Vaccines Ltd, India K-Seri Pharma Sdn Bhd 08 November 2016 till 07
November 2021
POM
1944 BRU16092076NP Alumag Plus Tablet Per tablet:
Aluminium Hydroxide Dried Gel 250mg;
Magnesium Trisilicate Light 250mg;
Simethicone
30mg
Beacons Pharmaceuticals Pte Ltd,
Singapore
HongKiat Trading Co 08 November 2016 till 07
November 2021
POM
1945 BRU16102077PT Olanzapine Genmark 10mg Tablet Olanzapine 10mg Glenmark Pharmaceuticals Europe
Limited, United Kingdom
Hongkiat Trading & Company 08 November 2016 till 23
Nov 2018
POM (2 X 14's)
1946 BRU16102078PT Olanzapine Genmark 5mg Tablet Olanzapine 5mg Glenmark Pharmaceuticals Europe
Limited, United Kingdom
Hongkiat Trading & Company 08 November 2016 till 14
Jan 2019
POM (2 X 14's)
1947 BRU16102079PT Baxter Chlorhexidine Acetate
0.1% w/v Antiseptic Solution
Chlorhexidine (as
Acetate)
Baxter Healthcare Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 26
Jan 2019
GSL (100ml)
1948 BRU16102080P Magurol 2mg tablet Doxazosin mesilate eq. to
doxazosin base 2
mg
Medochemie Ltd Central Factory, Cyprus Medicorp Sdn. Bhd 08 November 2016 till 07
November 2021
POM (2 x 10’s and
100 x 10’s)
1949 BRU16102081P Magurol 2mg tablet Doxazosin mesilate eq. to
doxazosin base 4
mg
Medochemie Ltd Central Factory, Cyprus Medicorp Sdn. Bhd 08 November 2016 till 07
November 2021
POM (2 x 10’s and
100 x 10’s)
1950 BRU16102082P Xyzal Film-coated tablet 5mg Levocetirizine dihydrochloride
5mg
UCB Farchim SA, Switzerland Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM (50's)
BDMCA/RMP/1116 Page 116 of 117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)
1951 BRU16102083P Xolair 75mg powder for solution
for injection
Omalizumab 75mg.
Reconstituted Xolair contains
125mg/ml of omalizumab (75mg
in
0.6ml)
Novartis Corporation (Malaysia) Sdn.
Bhd., Malaysia
Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM (1 vial of
powder & 1
ampoule of
solvent 2ml/ pack)
1952 BRU16102084P Bilaxten 20mg tablet Bilastine 20mg A.Menarini Manufacturing Logistic and
Services S.r.l., Italy
Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07
November 2021
POM (1X 4's; 1X
10's; 2X10's; 3x
10'S; 4 x 10'S and
5 x10's)1953 BRU16102085P Loxin Injection (5ml amp)
(Dopamine HCl)
Dopamine hydrochloride Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 08 November 2016 till 07
November 2021
POM (10's)
1954 BRU16102086P Mycamine 50mg/vial Powder for
Solution for Infusion
Micafungin (as sodium)
50mg/via
Astellas Pharma Tech Co., Ltd., Japan MediPharm Sdn Bhd, Brunei
Darussalam
08 November 2016 till 07
November 2021
POM (1’s x
10ml/vial and
10’s x 10ml/vial)
1955 BRU16102087P Vaxcel Fluconazole 2mg/ml IV
Infusion
Fluconazole 2mg/ml Kotra Pharma (M) Sdn. Bhd.,Malaysia Medicorp Sdn Bhd, Malaysia 08 November 2016 till 07
November 2021
POM (50ml/vial)
1956 BRU16102088P Sellon Shampoo Selenium sulfide 2.5% w/v Unison Laboratories Co., Ltd., Thailand K-Seri Pharma Sdn Bhd, 08 November 2016 till 07
November 2021
POM (120ml)
1957 BRU16102089NP Daily-vite multivitamin syrup for
children
Each 5mL contains:
Vitamin A: 2,000 IU
Vitamin D :400 IU
Vitamin B1 (Thiamine HCl): 1.5 mg
Vitamin B2 (Riboflavin): 1.2 mg
Vitamin B6 (Pyridoxine HCl): 1.0 mg
Vitamin B12 (cyanocobalamin): 3.0 mcg
Niacinamide: 10mg
Vitamin C (Ascorbic Acid): 50 mg
L-Lysine Monohydrochloride: 37.5 mg
Dynapharm (M) Sdn Bhd, Malaysia Medicorp Sdn. Bhd 08 November 2016 till 07
November 2021
GSL (100ml)
1958 BRU16102090NP Ubat Batok Cap Kaki Tiga
(Solution)
Guaifenesin 100mg/5ml Syarikat Wen Ken Drug Sdn Bhd, ,
Malaysia
Syarikat Rajamas Bersama 08 November 2016 till 07
November 2021
GSL (60ml, 120ml)
1959 BRU16102091P Vaxcel Lignocaine 1% Injection Lignocaine Hydrochloride
1% (50mg/5ml)
Kotra Pharma (M) Sdn. Bhd.,Malaysia Medicorp Sdn. Bhd 08 November 2016 till 07
November 2021
POM (5 X 10's)
BDMCA/RMP/1116 Page 117 of 117
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