34th bdmca renewal applications lampiran d documents/traditional medicines... · 2020. 7. 27. ·...
TRANSCRIPT
34TH BDMCA RENEWAL APPLICATIONS LAMPIRAN D
Application ref. No.
()/DRU/DRA.Renewal
/2019
1. 557 BRU11070724P Vesicare® 5mg Tablet Solifenacin Succinate 5mg
Astella Pharma
Europe B.V., The
Netherlands
Medipharm Sdn
Bhd
27 July 2016
till 26 July
2021
27 July 2021 till
26 July 2026POM
2. 574 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
09 Dec 2020 till
08 Dec 2025GSL
3. 575 BRU15101952NPFlexjoint 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
09 Dec 2020 till
08 Dec 2025GSL
4. 576 BRU15101949PAntismine Syrup
2mg/5ml
Chlorpheniramine Maleate
2mg/5ml
Winwa Medical
Sdn Bhd.,
Malaysia
Medicorp Sdn
Bhd
09 Dec 2015
till 08 Dec
2020
09 Dec 2020 till
08 Dec 2025P
5. 577 BRU15081925PApo-Clopidogrel
Tablet 75mg
Clopidogrel (as Bisulfate)
75mg
Apotex Inc.
Canada, Canada
Medicorp Sdn
Bhd
09 Dec 2015
till 08 Dec
2020
09 Dec 2020 till
08 Dec 2025POM
6. 578 BRU10120612PFlixonase 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
29 December
2020 till 28
December 2025
POM
7. 579 BRU09010181P Unasyn 0.75mg IM/IVAmpicillin (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
06 October
2020 till 05
October 2025
POM
8. 580 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
06 October
2020 till 05
October 2025
POM
145th DRC Renewal (16 applications)
No.Product Registration
no.Product Name Active Ingredients Manufacturer Licence Holder
Validity period
following
renewal
Validity of the
licence
Product
Classification
1
34TH BDMCA RENEWAL APPLICATIONS LAMPIRAN D
9. 581 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
06 October
2020 till 05
October 2025
POM
10. 582 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
06 October
2020 till 05
October 2025
POM
Application ref. No.
()/DRU/DRA.Renewal
/2020
11. 1 BRU15021764PMiostat Intraocular
SolutionCarbachol 0.1mg/ml
Alcon Research
LLC, USA
Hongkiat
Trading & Co
19 May 2015
till 18 May
2020
19 May 2020 till
18 May 2025POM
12. 2 BRU11010628POxy-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
26 January
2021 till 25
January 2026
P
13. 3 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
09 Dec 2020 till
08 Dec 2025POM
14. 4 BRU15091931PKlerimed 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
09 Dec 2020 till
08 Dec 2025POM
15. 5 BRU14111622NP Panadol Extra TabletsParacetamol 500mg; Caffeine
65mg
Sterling Drug
(Malaya) Sdn Bhd,
Malaysia
Kingston
Beverage &
Creamery Sdn
Bhd
19 May 2015
till 18 May
2020
19 May 2020 till
18 May 2025GSL (2 x 6's)
16. 6 BRU15091946PAxcel Bromhexine
(Children) Elixir
Bromhexine Hydrochloride
4mg
Kotra Pharma (M)
Sdn Bhd.,
Malaysia
Medicorp Sdn
Bhd.
09 Dec 2015
till 08 Dec
2020
09 Dec 2020 till
08 Dec 2025P
Validity period
following
renewal
Licence HolderValidity of the
licence
Product
ClassificationNo.
Product Registration
no.Product Name Active Ingredients Manufacturer
2
34TH BDMCA RENEWAL APPLICATIONS LAMPIRAN D
Application ref. No.
()/DRU/DRA.Renewal
/2020
1. 7 BRU10010387PAspirin EC Tablet
100mgAcetylsalicylic acid 100mg
Beacons
Pharmaceuticals
Pte Ltd, Singapore
Hongkiat
Trading &
Company
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
2. 8 BRU09070292PClotrimazole Cream
1% w/wClotrimazole 1% w/w
Beacons
Pharmaceuticals
Pte Ltd, Singapore
Hongkiat
Trading &
Company
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
GSL
3. 9 BRU09080304PPrednisolone 1mg
TabletPrednisolone 1mg
Beacons
Pharmaceuticals
Pte Ltd, Singapore
Hongkiat
Trading &
Company
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
4. 10 BRU14111612PChloramine Tablet
4mg
Chlorpheniramine Maleate
4mg
Beacons
Pharmaceuticals,
Pte ltd, Singapore
Hongkiat
Trading & Co
19 May 2015
till 18 May
2020
19 May 2020 till
18 May 2025P
5. 11 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
09 Dec 2020 till
08 Dec 2025POM
6. 12 BRU09060272PNeurontin Capsule
300mgGabapentin 300mg
Pfizer
Pharmaceuticals
LLC, Vega Baja
Puerto Rico, USA
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
7. 13 BRU09100343PNeurontin 600mg
TabletGabapentin 600mg
Pfizer
Pharmaceutical
LLC, Puerto Rico,
USA
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
8. 14 BRU09110354P LipitorTM 10mg TabletAtorvastatin (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
06 October
2020 till 05
October 2025
POM
No.Product Registration
no.Product Name Active Ingredients Manufacturer Licence Holder
Validity of the
licence
Product
Classification
Validity period
following
renewal
146th DRC Renewal (34 applications)
3
34TH BDMCA RENEWAL APPLICATIONS LAMPIRAN D
9. 15 BRU10020416P Lipitor 20mg Tablet Atorvastatin (Calcium) 20mg
Pfizer
Pharmaceutical
LLC, Puerto Rico
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
10. 16 BRU09100345P LipitorTM 40mg TabletAtorvastatin (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
06 October
2020 till 05
October 2025
POM
11. 17 BRU10060494P Norvasc Tablet 5mg Amlodipine Besylate 5mg
Pfizer
Pharmaceuticals
LLC, Vega Baja,
P.R. 00693,
United States
[primary
packaging site:
Pfizer
Manufacturing
Deutschland
GmbH, Freiburg,
Germany]
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
12. 18 BRU10070508P Norvasc Tablet 10mg Amlodipine Besylate 10mg
Pfizer
Pharmaceuticals
LLC, Vega Baja,
P.R. 00693,
United States
[primary
packaging site:
Pfizer
Manufacturing
Deutschland
GmbH, Freiburg,
Germany
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
13. 19 BRU09040241PCelebrex Capsule
200mgCelecoxib 200mg
Pfizer
Pharmaceutical
LLC, Vega Baja
Puerto Rico
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
4
34TH BDMCA RENEWAL APPLICATIONS LAMPIRAN D
14. 20 BRU09120367PDilantin 100mg
CapsulePhenytoin Sodium 100mg
Pfizer
Pharmaceuticals
LLC, Vega Baja,
USA (Pfizer Vega
Baja)
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
15. 21 BRU15091929P Dilantin Capsule 30mg Phenytoin Sodium 30mg
Pfizer
Pharmaceuticals
LLC, Vega Baja,
USA (Pfizer Vega
Baja)
Zuellig Pharma
(B) Sdn Bhd
09 Dec 2015
till 08 Dec
2020
06 October
2020 till 05
October 2025
POM
16. 22 BRU10060489P Lescol XL Tablet 80mgFluvastatin (as the Sodium
salt) 80mg
Novartis
Farmaceutica
S.A., Spain
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
17. 23 BRU10100556P
Myfortic Gastro-
Resistant Tablet
360mg
Mycophenolic (as Sodium)
Acid 360mg
Novartis Pharma
Produktions
GmbH, Germany
Zuellig Pharma
(B) Sdn Bhd
28 October
2015 till 27
October
2020
28 October
2020 till 27
October 2025
POM
18. 24 BRU09030221PLignocaine 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
06 October
2020 till 05
October 2025
POM
19. 25 BRU10050480PDalacin T Topical
Solution 1%
Clindamycin (as Phosphate)
10mg/ml
Zoetis LLC,
Kalamazoo, USA
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
20. 26 BRU10050476PDalacin C Capsule
150mg
Clindamycin (as
Hydrochloride) 150mg
Fareva Amboise,
France
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
21. 27 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
06 October
2020 till 05
October 2025
POM
5
34TH BDMCA RENEWAL APPLICATIONS LAMPIRAN D
22. 28 BRU11010637PEngerixTM-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
(Formulation and
filling in vials and
syringes, labelling
and packaging );
GlaxoSmithKline
Biologicals, Saint
Amand Les Eaux,
France (Labelling
and packaging in
vials and
syringes);
GlaxoSmithKline
Biologicals,
Dresden,
Germany (filling
in syringes)
Zuellig Pharma
(B) Sdn Bhd
26 January
2016 till 25
January
2021
26 January
2021 till 25
January 2026
POM
23. 29 BRU11010638PHavrixTM720 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
26 January
2021 till 25
January 2026
POM
6
34TH BDMCA RENEWAL APPLICATIONS LAMPIRAN D
24. 30 BRU15111957P Stivarga Tablet 40mg
Regorafenib
(40mg Regorafenib equivalent
to 41.49mg Regorafenib
Monohydrate)
Bayer AG,
Leverkusen,
Germany
Zuellig Pharma
(B) Sdn Bhd
09 Dec 2015
till 08 Dec
2020
09 Dec 2020 till
08 Dec 2025POM
25. 31 BRU08100139P Ciprobay® 500 TabletCiprofloxacin (as HCl
Monohydrate) 500mg
Bayer AG,
Leverkeusen,
Germany
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
26. 32 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
06 October
2020 till 05
October 2025
POM
27.
33 BRU08090124PCiprobay® 200 Infusion
Solution
Ciprofloxacin (as Lactate)
200mg
Bayer AG,
Leverkeusen,
Germany
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
28. 34 BRU10030428P Adalat LA 60 Tablet Nifedipine 60mgBayer AG,
Germany
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
29. 35 BRU10020415P Adalat LA 30 Tablet Nifedipine 30mgBayer AG,
Germany
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
30. 36 BRU15091933PGadovist Injection
1.0mmol/ml
Gadobutrol Pure 604.72mg &
Calcium Sodium Butrol
0.513mg
Bayer Pharma
AG, MÜllerstr.
178
Bayer AG,
MÜllerstraβe
178, Germany
Zuellig Pharma
(B) Sdn Bhd
09 Dec 2015
till 08 Dec
2020
09 Dec 2020 till
08 Dec 2025POM
31. 37 BRU15091932P
Gadovist Injection
1.0mmol/ml Prefilled
syringe 5.0ml
Gadobutrol Pure 604.72mg &
Calcium Sodium Butrol
0.513mg
Bayer AG, Berlin,
Germany
Zuellig Pharma
(B) Sdn Bhd
09 Dec 2015
till 08 Dec
2020
09 Dec 2020 till
08 Dec 2025POM
32. 39 BRU09120383P
Methotrexate
Injection BP
1000mg/10ml
Methotrexate 1000mg/10mlPfizer (Perth) Pty
Limited, Australia
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
7
34TH BDMCA RENEWAL APPLICATIONS LAMPIRAN D
33. 40 BRU10040461PCytarabine® Injection
1000mg in 10mlCytarabine 1000mg/10ml
Pfizer (Perth) Pty,
Ltd., Australia
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
34. 41 BRU10110597PCampto 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
24 November
2020 till 23
November 2025
POM
8
34TH BDMCA RENEWAL APPLICATIONS LAMPIRAN D
Application ref. No.
()/DRU/DRA.Renewal
/2019
1. 565 BRU10040441PDiflucan Capsule
150mgFluconazole 150mg
Fareva Amboise,
France
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
2. 566 BRU10040443P Diflucan Capsule 50mg Fluconazole 50mgFareva Amboise,
France
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
3. 567 BRU10040442PDiflucan Capsule
100mgFluconazole 100mg
Fareva Amboise,
France
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
Application ref. No.
()/DRU/DRA.Renewal
/2020
4. 38 BRU09040229P
Unasyn Powder for
Oral Suspension
250mg/5ml
Sultamicillin (as Tosilate)
250mg
Pfizer Italia S.R.L.,
Latina, Italy
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
5. 42 BRU15021767P Bacitracin-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
19 May 2020 till
18 May 2025POM
6. 43 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
28 October
2020 till 27
October 2025
POM
Product Registration
no.Active Ingredients Manufacturer Licence HolderProduct Name
Validity period
following
renewal
Product
Classification
147th DRC Renewal (47 applications)
Validity of the
licence
Validity period
following
renewal
Product
Classification
No.Product Registration
no.Product Name Active Ingredients Manufacturer Licence Holder
Current
Validity of the
licence
No.
9
34TH BDMCA RENEWAL APPLICATIONS LAMPIRAN D
7. 44 BRU14111604NPDavmorid 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
19 May 2020 till
18 May 2025GSL
8. 45 BRU15091937PGuafensin Syrup
20mg/mlGuaifenesin 20mg/ml
Y.S.P. Industries
(M) Sdn. Bhd.,
Malaysia
Asterix United
(B) Sdn Bhd
09 Dec 2015
till 08 Dec
2020
09 Dec 2020 till
08 Dec 2025POM
9. 46 BRU14111593PPulin 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
19 May 2020 till
18 May 2025POM
10. 47 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
26 January
2021 till 25
January 2026
POM
11. 48 BRU11030671PHyzaar 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
26 March 2021
till 25 March
2026
POM
12. 49 BRU15011717P
Salofalk® 500mg
Gastro-Resistant
Prolonged-Release
Granules
Mesalazine 500mgLosan Pharma
GmbH, Germany
DCH Auriga
(Borneo) Sdn
Bhd
19 May 2015
till 18 May
2020
19 May 2020 till
18 May 2025POM
13. 50 BRU15011718P
Salofalk® 1000mg
Gastro-Resistant
Prolonged-Release
Granules
Mesalazine 1000mgLosan Pharma
GmbH, Germany
DCH Auriga
(Borneo) Sdn
Bhd
19 May 2015
till 18 May
2020
19 May 2020 till
18 May 2025POM
14. 51 BRU15011721P
Salofalk® 3000mg
Gastro-Resistant
Prolonged-Release
Granules
Mesalazine 3gLosan Pharma
GmbH, Germany
DCH Auriga
(Borneo) Sdn
Bhd
19 May 2015
till 18 May
2020
19 May 2020 till
18 May 2025POM
10
34TH BDMCA RENEWAL APPLICATIONS LAMPIRAN D
15. 52 BRU15011726PUrsofalk 500mg Film-
coated TabletsUrsodeoxycholic acid 500mg
Losan Pharma
GmbH, Germany
DCH Auriga
(Borneo) Sdn
Bhd
19 May 2015
till 18 May
2020
19 May 2020 till
18 May 2025POM
16. 53 BRU11030660POxy-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
26 March 2021
till 25 March
2026
P
17. 54 BRU11040681POxy-Nase Nasal Drops
0.05%
Oxymetazoline Hydrochloride
0.05%w/v
HOE
Pharmaceuticals
Sdn Bhd,
Malaysia
G & H Trading
Company
30 April
2016 till 29
April 2021
30 April 2021
till 29 April
2026
P
18. 55 BRU11040691P Elosone CreamMometasone Furoate
0.1%w/w
HOE
Pharmaceuticals
Sdn Bhd,
Malaysia
G & H Trading
Company
30 April
2016 till 29
April 2021
30 April 2021
till 29 April
2026
POM
19. 56 BRU09120375P Natrilix® SR Tablet Indapamide 1.5mg
Les Laboratoires
Servier Industrie,
France
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
20. 57 BRU09070290PDiamicron Tablet
80mgGliclazide 80mg
Les Laboratoires
Servier Industrie,
France
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
21. 58 BRU08100140PAvelox Infusion
Solution 0.4g/250ml
Moxifloxacin (as
Hydrochloride) 400mg
Bayer AG,
Leverkusen,
Germany
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
22. 59 BRU08100141P Avelox 400mg TabletMoxifloxacin (as
Hydrochloride) 400mg
Bayer AG,
Leverkusen,
Germany
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
23. 60 BRU09040245NPBisacodyl
SuppositoriesBisacodyl (micronised) 10mg
YSP Industries (M)
Sdn Bhd,
Malaysia
Asterix United
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
P
11
34TH BDMCA RENEWAL APPLICATIONS LAMPIRAN D
24. 61 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
29 December
2020 till 28
December 2025
POM
25. 62 BRU10110591PVoren Enteric Coated
Tablet 25mgDiclofenac Sodium 25mg
Y.S.P Industries
(M) Sdn Bhd,
Malaysia
Asterix United
(B) Sdn Bhd
24
November
2015 till 23
November
2020
24 November
2020 till 23
November 2025
POM
26. 63 BRU10120611PVoren Suppositories
12.5mgDiclofenac Sodium 12.5mg
Y.S.P Industries
(M) Sdn Bhd,
Malaysia
Asterix United
(B) Sdn Bhd
29
December
2015 till 28
December
2020
29 December
2020 till 28
December 2025
POM
27. 64 BRU11090772PDiabetmin Film-coated
Tablet 500mgMetformin HCl 500mg
Hovid Bhd, Perak,
Malaysia
G & H Trading
Company
27
September
2016 till 26
September
2021
27 September
2021 till 26
September
2026
POM (10 x 10's;
5 x 20's)
28. 65 BRU16022000P Glimicron 80mg tablet Gliclazide 80mgHOVID Bhd,
Malaysia
G & H Trading
Co
21 Jun 2016
till 20 Jun
2021
21 Jun 2021 till
20 Jun 2026POM
29. 66 BRU11090778P Hovasc Tablet 5mgAmlodipine 5mg (as besilate
6.90mg)
Hovid Bhd,
Malaysia
G & H Trading
Company
27
September
2016 till 26
September
2021
27 September
2021 till 26
September
2026
POM
30. 67 BRU16032014PTinazol Cream 2%
(15g)Miconazole nitrate 2% w/w
Hovid Bhd,
Malaysia.
G & H Trading
Company
21 Jun 2016
till 20 Jun
2021
21 Jun 2021 till
20 Jun 2026GSL
12
34TH BDMCA RENEWAL APPLICATIONS LAMPIRAN D
31. 68 BRU15071899PCavumox 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
09 Dec 2020 till
08 Dec 2025POM
32. 69 BRU11010629PTrandateTM Tablets
100mg
Labetalol hyrdochloride
100mg
Aspen Bad
Oldesloe GmbH,
Germany
Zuellig Pharma
(B) Sdn Bhd
26 January
2016 till 25
January
2021
26 January
2021 till 25
January 2026
POM
33. 71 BRU11030672PAvodart Soft Capsules
0.5mgDutasteride 0.5mg
GlaxoSmithKline
Pharmaceuticals
S.A., Poland
Zuellig Pharma
(B) Sdn Bhd
26 March
2016 till 25
March 2021
26 March 2021
till 25 March
2026
POM
34. 72 BRU11040680PS2 Puregon® 50IU/0.5ml
Solution for Injection
Follitrophin Beta
(recombinant follicale-
stimulating hormone (FSH)
50IU/0.5ml
N.V.Organon, The
Netherlands (S2)
Zuellig Pharma
(B) Sdn Bhd
30 April
2016 till 29
April 2021
30 April 2021
till 29 April
2026
POM
35. 73 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
30 April 2021
till 29 April
2026
POM
36. 74 BRU11030670P Alkeran Tablet 2mg Melphalan 2mgExcella GmbH &
Co. KG, Germany
Zuellig Pharma
(B) Sdn Bhd
26 March
2016 till 25
March 2021
26 March 2021
till 25 March
2026
POM
37. 75 BRU11020645POroxineTM Tablet
100mcg
Levothyroxine (as sodium)
anhydrous 100mcg
Aspen Bad
Oldesloe GmbH,
Germany
Zuellig Pharma
(B) Sdn Bhd
24 February
2016 till 23
February
2021
24 February
2021 till 23
February 2026
POM
13
34TH BDMCA RENEWAL APPLICATIONS LAMPIRAN D
38. 76 BRU14121674P Milosec Capsule 20mg Omeprazole 20mg
The United Drug
(1966) Co. Ltd.,
Thailand
Medicorp Sdn
Bhd
19 May 2015
till 18 May
2020
19 May 2020 till
18 May 2025POM
39. 77 BRU14111605P Zimmex Tablet 10mg Simvastatin 10mgSilom Medical Co.
Ltd., Thailand
Medicorp Sdn
Bhd
19 May 2015
till 18 May
2020
19 May 2020 till
18 May 2025POM
40. 78 BRU09050250P Coversyl Plus TabletPerindopril tert-butylamine
4mg, Indapamide 1.25mg
Les Laboratoires
Servier Industrie,
France
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
41. 79BRU09010191PS1 &
BRU09010191PS2Coversyl 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
06 October
2020 till 05
October 2025
POM
42. 80BRU10010385PS1 &
BRU10010385PS2Coversyl 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
06 October
2020 till 05
October 2025
POM
43. 81 BRU10120600PRitalin® LA Modified
Release Capsule 40mg
Methylphenidate
hydrochloride 40mg
Recro Gainsville
LLC, USA
Zuellig Pharma
(B) Sdn Bhd
29
December
2015 till 28
December
2020
29 December
2020 till 28
December 2025
POM
14
34TH BDMCA RENEWAL APPLICATIONS LAMPIRAN D
44. 82 BRU10120616PLevitra® film-coated
Tablet 5mg
Vardenafil 5mg (as
monohydrochloride
trihydrate)
Bayer AG.,
Leverkusen,
Germany
Zuellig Pharma
(B) Sdn Bhd
29
December
2015 till 28
December
2020
29 December
2020 till 28
December 2025
POM
45. 83 BRU10050463PNebido 1000mg/4ml,
Solution for Injection
Testosterone undecanoate
250mg(equiv. to testosterone
157.9mg)
Bayer AG,
Germany
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
46. 84 BRU09050252PGlucobay Tablet
100mgAcarbose 100mg
Bayer AG,
Leverkusen,
Germany
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
47. 85 BRU09020212P Glucobay 50 Tablet Acarbose 50mg
Bayer AG,
Leverkusen,
Germany
Zuellig Pharma
(B) Sdn Bhd
06 October
2015 till 05
October
2020
06 October
2020 till 05
October 2025
POM
15