brunei darussalam medicines control authority - Ministry of ...

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017) 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 2015 till 05 October 2020 POM 14 BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 POM 15 BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 POM 16 BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 POM BDMCA/RMP/0317 Page 1 of 131

Transcript of brunei darussalam medicines control authority - Ministry of ...

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

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, UKZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

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, UKZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

3 BRU08010001PPharmaniaga Aciclovir Tablet

200mgAciclovir 200mg

Pharmaniaga Manufacturing Berhad

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

4 BRU08010002PPharmaniaga Ketoconazole

Tablet 200mgKetoconazole 200mg

Pharmaniaga Manufacturing Berhad

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

5 BRU08010003PPharmaniaga Clarithromycin

Tablet 250mgClarithromycin 250mg

Pharmaniaga Manufacturing Berhad

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

6 BRU08010004PPharmaniaga Fluconazole

150mg CapsulesFluconazole 150mg

Pharmaniaga Manufacturing Berhad

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

7 BRU08010005PPharmaniaga Ciprofloxacin

Tablet 500mgCiprofloxacin 500mg

Pharmaniaga Manufacturing Berhad

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

8 BRU08010009P Meronem Injection 1g Meropenem (as trihydrate) 1g AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

9 BRU08020010P Meronem Injection 500mg Meropenem (as trihydrate) 500mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

10 BRU08020011P Bactroban Cream Mupirocin 2% SmithKline Beecham, Philippines Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

11 BRU08020012PPharmaniaga Cephalexin

Capsule 500mgCephalexin 500mg

Pharmaniaga Manufacturing Berhad

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

12 BRU08020013PPharmaniaga Metronidazole

Tablet 200mg Metronidazole 200mg

Pharmaniaga Manufacturing Berhad

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

13BRU08020016P Anikef Sterile 750mg Cefuroxime 750mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

14BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

15BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

16BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0317 Page 1 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

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 Bhd06 October 2015 till 05

October 2020POM

18 BRU08020021P Retrovir Capsule 100mg Zidovudine 100mg SmithKline Beecham Plc, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

19 BRU08020022P Bactroban Ointment Mupirocin 2%GlaxoSmithKline Philippines Inc,

PhilippinesZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

20 BRU08030023P Augmentin Tablet 625mg

Amoxycillin 500mg (as trihydrate);

Clavulanic acid 125mg (as Potassium

Clavulanate)

SmithKline Beecham Plc, Worthing,

UKZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

21 BRU08030024P Augmentin Syrup 228mg/5ml

Amoxycillin 200mg/5ml (as trihydrate);

Clavulanic acid 28.5mg/5ml (as

Potassium Clavulanate)

SmithKline Beecham Plc, Worthing,

UKZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

22 BRU08030025P Augmentin Syrup 457mg/5ml

Amoxycillin 400mg/5ml (as trihydrate);

Clavulanic acid 57mg/5ml (as

Potassium Clavulanate)

SmithKline Beecham Plc, Worthing,

UKZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

23 BRU08030026P Augmentin Tablet 1g

Amoxycillin 875mg (as trihydrate);

Clavulanic acid 125mg (as Potassium

Clavulanate)

SmithKline Beecham Plc, Worthing,

UKZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

24 BRU08030027P Foban Cream Fusidic acid 2%Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

25 BRU08030030P Garasent 80mg Injection Gentamicin 40mg/ml (as Sulphate) Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd06 October 2015 till 05

October 2020POM

26 BRU08030031P Retrovir 1% IV Infusion Zidovudine 1% Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

27 BRU08030032P Genta Eye Drop 0.3%w/v Gentamicin (as Sulphate) Duopharma (M) Sdn Bhd, MalaysiaHongkiat 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 2020POM

29 BRU08030035P Zinacef Injection 1.5g Cefuroxime (as sodium)GlaxoSmithKline Manufacturing SPA,

Italy.Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

30 BRU08030036P Zinnat Tablet 125mg Cefuroxime (as axetil) Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

31 BRU08030037P Zinnat Tablet 250mg Cefuroxime (as axetil) Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

32 BRU08040039P Solulexin Granules 125mg/5mlCefalexin Monohydrate equivalent to

Cefalexin 125mg/5mlDuopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015 (PL

extended to 26 March

2017)

POM

BDMCA/RMP/0317 Page 2 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

33 BRU08040040P Retrovir Syrup Zidovudine 50mg/5ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

34BRU08040041PS1 &

BRU08040041PS2Zeffix Tablet Lamivudine 100mg

Glaxo Wellcome Operations UK Ltd,

UK (S1); GlaxoSmithKline

Pharmaceuticals S.A., Poland (S2)

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

35 BRU08040042P Combivir Tablet Lamivudine 100mg, Zidovudine 300mgGlaxoSmithKline Pharmaceuticals

S.A., PolandZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

36BRU08040043P Zoraxin Syrup Suspension Aciclovir 200mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

37 BRU08040046P Genta-Bet Eye Drops

Gentamicin (as Sulphate) 0.3%,

Betamethasone Disodium Phosphate

0.1%

Duopharma (M) Sdn Bhd, MalaysiaHongkiat Trading &

Company

06 October 2010 till 05

October 2015 (PL

extended to 26 March

2017)

POM

38BRU08040047P Bicafar Sterile 2g (vial) Cefoperazone (as Sodium) 2g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

39 BRU08040049PDiflucan IV Infusion 2mg/ml

(50ml)Fluconazole 2mg/ml Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

40 BRU08040050P Sulperazone IM/IV 1gSulbactam (as Sodium) 500mg;

Cefoperazone (as Sodium) 500mgHaupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

41 BRU08040051P Beagenta Cream 0.1% Gentamicin (as Sulphate BP) 0.1%w/wUpha 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 BRU08050053PPharmaniaga Aciclovir Tablet

400mgAciclovir 400mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

44 BRU08050054PPharmaniaga Cephalexin

Capsule 250mg

Cephalexin (as Anhydrous) Cephalexin

250mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

45 BRU08050058P Ketozotan Tablet 200mg Ketoconazole 200mg Duopharma (M) Sdn Bhd, MalaysiaHongkiat Trading &

Company

06 October 2010 till 05

October 2015 (PL

extended to 26 March

2017)

POM

46BRU08050060P Unocef Injection 500mg (Vial) Ceftriaxone (as Sodium) 500mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

47BRU08050061P Unocef Injection 1000mg

(Vial)

Ceftriaxone (as Sodium) 1000mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

48 BRU08050063P Solulexin Capsule 250mgCephalexin Monohydrate 262.95mg

equivalent to Cephalexin 250mgDuopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015 (PL

extended to 26 March

2017)

POM

BDMCA/RMP/0317 Page 3 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

49 BRU08050064P Solulexin Capsule 500mg Cephalexin (as Monohydrate) 500mg Duopharma (M) Sdn Bhd, MalaysiaHongkiat 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 DropsGentamicin Sulphate equivalent to

Gentamicin 0.3%w/wDuopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

52 BRU08050067P Uphalexin Granules 125Cephalexin 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 2020POM

54 BRU08050069P Plaquenil Tablet Hydroxychloroquine Sulphate 200mgSanofi-Aventis, S.A., Riells l Viabrea,

SpainMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

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 Bhd06 October 2015 till 05

October 2020POM

56 BRU08050071P Foban Ointment Sodium Fusidate BP 2% w/vHoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

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,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

58 BRU08050073P Dezor Cream Ketoconazole 2%w/wHoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

59 BRU08050074P Dezor Shampoo Ketoconazole 2%w/wHoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

60BRU08060075P 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 2015 till 05

October 2020

POM

61BRU08060077P Aecoras Ointment Econazole Nitrate 10mg;

Triamcinolone Acetonide 1mg

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

62 BRU08060078P Beapen VK Granules 125mg Phenoxymethypenicillin 125mg/5mlUpha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

63 BRU08060079P Enoxin Tablet 500mg Ciprofloxacin 500mgUpha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015 (PL

extended to 26 March

2017)

POM

BDMCA/RMP/0317 Page 4 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

64 BRU08060080P Beta Eye/ Ear DropsBetamethasone 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 DropsGentamicin 0.3% w/v; Dexamethsone

Phosphate 0.1%w/vDuopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020 POM

66 BRU08060082P Muprin Ointment Mupirocin 2.0%w/wHoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

67 BRU08060084P Eryson Granules 400Erythromycin 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/wUpha 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,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

70 BRU08060087P Foban Hydro OintmentSodium Fusidate 2%; Hydrocortisone

1%

Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

71 BRU08060088P Arava Tablet 10mg Leflunomide 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

72 BRU08060089P Arava Tablet 20mg Leflunomide 20mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

73 BRU08070090P Zinnat Suspension 125mg/5mlCefuroxime Axetil equivalent to

Cefuroxime 250mg

Glaxo Wellcome Bernard Castle,

United KingdomZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

74 BRU08070091P Metronol 0.5%w/v Injection Metronidazole 0.5% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah06 October 2015 till 05

October 2020POM

75 BRU08070094P Ecocort CreamEconazole Nitrate 1% w/w;

Triamcinolone Acetonide 0.1% w/w

Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

76 BRU08070095P Beprogent OintmentBetamethasone 0.05%; Gentamicin

0.1%

Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

77 BRU08070096P Betamox Capsule 250mgAmoxicillin Trihydrate equivalent to

Amoxicillin 250mgDuopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

78 BRU08070097P Aprovel Tablet 300mg Irbesartan 300mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

79 BRU08070099P Atacand Tablet 8mg Candesartan Cilexetil 8mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

80 BRU08070100P Atacand Tablet 16mg Candesartan Cilexetil 16mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

81 BRU08070101PZovirax Suspension

200mg/5mlAcyclovir 200mg/5ml

GlaxoSmithKline GmbH & Co

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 5 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

82 BRU08070103P Fortum® Injection 1g Ceftazidime (as Pentahydrate) 1gGlaxoSmithKline Manufacturing SPA,

ItalyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

83 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

84 BRU08080106P Candazole Cream Clotrimazole 1.0%Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020GSL

85 BRU08080107P Gentamicin Cream Gentamicin (as Sulphate) 0.1%Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

86 BRU08080108P Beprogent CreamBetamethasone (as dipropionate)

0.05%, Gentamicin (as sulphate 0.1%)

Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

87 BRU08080109P Unasyn Tablet 375mg

Sultamicillin (as tosilate) 375mg

(Ampicillin 250mg & Sulbactam

125mg)

Pfizer Global Supply Japan Inc, Japan Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

88 BRU08080110PZovirax Dispersable Tablet

200mgAciclovir 200mg Glaxo Wellcome, S.A., Spain Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

89 BRU08080111P Valtrex® 500mg Tablet Valciclovir (as HCl) 500mg Glaxo Wellcome SA, Spain Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

90 BRU08080112P Fortum® Injection 2g Ceftazidime (as pentahydrate) 2gGlaxoSmithKline Manufacturing SPA,

ItalyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

91 BRU08080113P Uphalexin Capsule 250 Cephalexin (as monohydrate) 250mgUpha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015 (PL

extended to 26 March

2017)

POM

92 BRU08080114P Uphalexin Capsule 500 Cephalexin (as monohydrate) 500mgUpha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015 (PL

extended to 26 March

2017)

POM

93 BRU08080115PVaxcel Cefuroxime 750mg

InjectionCefuroxime (as sodium) 750mg Kotra Pharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

94 BRU08080116PVaxcel Ceftriaxone 1g

InjectionCeftriaxone (as sodium) 1g Kotra Pharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

95 BRU08080117P Axcel Fusi-Corte CreamFusidic acid 2%, Betamethasone (as 17-

valerate) 0.1%Kotra Pharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

96 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; Sanofi

Winthrop Industrie (SWI), Le Trait –

France (Diluent)

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

97 BRU08090119P Decocort CreamMiconazole Nitrate 2%w/w;

Hydrocortisone 1% w/w

Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

98 BRU08090120P Fobancort Ointment

Sodium Fusidate 2%w/w;

Betamethasone 0.05%w/w (as

Dipropionate 0.064%)

Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 6 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

99 BRU08090121P Candacort CreamClotrimazole 1.0% w/w;

Hydrocortisone 1.0%w/w

Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

100 BRU08090122P Hepsera Tablet 10mg Adefovir dipivoxil 10mgGlaxosmithKline (Tianjin) Co.Ltd,

ChinaZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

101 BRU08090124PCiprobay® 200 Infusion

SolutionCiprofloxacin (as lactate) 200mg

Bayer Pharma AG, Leverkeusen,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

102 BRU08090125P Vaxcel Ceftazidime 2g Ceftazidime (as pentahydrate) 2g Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

103 BRU08090126P Axcel Fusidic Cream Fusidic acid 2% w/w Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

104 BRU08090127P Axcel Fusidic Ointment Sodium Fusidate 2%w/w Kotra Pharm (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

105 BRU08090128P Vaxcel Ceftazidime 1g Ceftazidime (as pentahydrate) 1g Kotra Pharm (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

106 BRU08090129P Axcel Miconazole Cream Miconazole Nitrate 2% w/w Kotra Pharm (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020GSL

107 BRU08090130PCiprobay 100 Infusion Solution

x 50mlCiprofloxacin (as lactate) 100mg

Bayer Pharma AG, Leverkeusen,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020P

108 BRU08090132P Aroxin Capsule 250mg Amoxicillin (as trihydrate) 250mg

Agila Specialties Private Limited,

India; Medreich Limited Unit-1,

Bangalore, India

G & H Trading Company06 October 2015 till 05

October 2020POM

109BRU08090133NPS1;

BRU08090133NPS2

Dhamol Suspension

250mg/5mlParacetamol 250mg/5ml

Drug Houses of Australia Pte Ltd,

Singapore (S1); PT Actavis Indonesia,

Jakarta Indonesia (S2)

G & H Trading Company06 October 2015 till 05

October 2020GSL (60ml)

110 BRU08100134P Decozol Cream Miconazole Nitrate 2%w/wHoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020GSL

111BRU08100135P Betamox Capsule 500mg Amoxicillin Trihydrate equivalent to

Amoxicillin 500mg

Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

112 BRU08100136PZovirax Dispersable Tablet

800mgAciclovir 800mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

113 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 2020POM

114 BRU08100138P Uphalexin Granules 250 Cephalexin (as Monohydrate) 250mgUpha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015 (PL

extended to 26 March

2017)

POM

115 BRU08100139P Ciprobay® 500 TabletCiprofloxacin (as HCl monohydrate)

500mg

Bayer Pharma AG, Leverkeusen,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

116 BRU08100140PAvelox Infusion Solution

0.4g/250mlMoxifloxacin (as Hydrochloride) 400mg

Bayer Pharma AG, Leverkusen,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

117 BRU08100141P Avelox 400mg Tablet Moxifloxacin (as Hydrochloride) 400mgBayer Pharma AG, Leverkusen,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 7 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

118 BRU08100142P Candazole Lotion Clotrimazole 1%w/wHoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020GSL

119 BRU08100143P Allopurinol 100mg Tablet Allopurinol 100mgDrug Houses of Australia Pte Ltd

G & H Trading Company06 October 2015 till 05

October 2020POM

120BRU08100144PS1;

BRU08100144PS2Bifen 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 2020P

121 BRU08100145NP Dhamol Tablet 500mg Paracetamol BP 500mgDrug House of Australia Pte Ltd,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020P (1000's)

122 BRU08100146NP Silfazine Cream Silver Sulfadiazine 1%w/wSunward Pharmaceutical Sdn Bhd

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020P

123 BRU08100147P Difenac 50 Tablet Diclofenac Sodium BP 50mgDrug House of Australia Pte Ltd,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

124 BRU08100148P Erythro Ethyl GranulesErythromycin (as ethyl succinate)

200mg/5ml

Drug Houses of Australia Pte. Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

125 BRU08110150PAvaxim 160U Suspension for

Injection in a prefilled Syringe

Inactivated Hepatitis A Virus (GBM

strain) 160u/0.5mlSanofi Pasteur France Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

126 BRU08110151P Aprovel 150mg Tablet Irbesartan 150mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

127 BRU08110152P Zovirax IV for Infusion 250mg Aciclovir 250mgGlaxoSmithKline Manufacturing SPA

ItalyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

128 BRU08110153P Axcel Aciclovir Cream 5%w/w Aciclovir 5%w/w Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

129 BRU08110154PAxcel Eryhthromycin ES Tablet

400mg

Erythromycin (as ethyl succinate)

400mgKotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

130 BRU08110155P Axcel Cephalexin-500 Capsule Cephalexin (as monohydrate) 500mg Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

131 BRU08110156PAxcel Eryhthromycin ES-200

Suspension

Erythromycin (as Ethylsuccinate)

200mg/5mlKotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

132 BRU08110157P Soden Tablet 275mg Naproxen Sodium BP 275mgDrug House of Australia Pte Ltd,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

133 BRU08110158NPDhamol Suspension

120mg/5mlParacetamol BP 120mg/5ml

Drug House of Australia Pte Ltd,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020GSL (100mL)

134 BRU08110159P Miconazole Cream 2.0%w/w Miconazole Nitrate 2.0%w/wSunward Pharmaceutical Sdn Bhd

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020GSL

135 BRU08110160P Malarone Tablet Atovaquone 250mg, Proguanil HCl

100mgGlaxoSmithKline Inc Canada Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

136 BRU08110162P Cordarone Tablet 200mg Amiodarone HCl 200mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

137 BRU08110163PCoAprovel 150/12.5mg Film-

coated Tablet

Irbesartan 150mg, Hydrochlorothiazide

12.5mgSanofi Winthrop Industrie, France Medipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

138 BRU08110164P Dhaperazine Tablet 5mg Prochlorperazine (as maleate) 5mgDrug House of Australia Pte Ltd,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 8 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

139BRU08110165P;

BRU08110165PS2Betasone Cream 0.1%w/w

Betamethasone (as 17-valerate)

0.1%w/w

Drug Houses of Australia Pte Ltd; PT

Actavis Indonesia (S2)G & H Trading Company

06 October 2015 till 05

October 2020POM

140 BRU08120166P Ciprobay 250 Tablet Ciprofloxacin (as HCl monohydrate)

250mg

Bayer Pharma AG, Leverkusen,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

141 BRU08120167PAxcel Cephalexin 250mg

CaspuleCephalexin (as Monohydrate) 250mg Kotra Pharma (M) Sdn Bhd Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

142 BRU08120168PAxcel Cephalexin 125mg

SuspensionCephalexin (as Monohydrate) 125mg Kotra Pharma (M) Sdn Bhd Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

143 BRU08120169P Cloxacillin Capsule 250 Cloxacillin (as Sodium) 250mgUpha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

144 BRU08120172P Betamox Tablet 125 Amoxicillin (as trihydrate) 125mg Duopharma (M) Sdn Bhd MalaysiaHongkiat Trading &

Company

06 October 2010 till 05

October 2015 (PL

extended to 26 March

2017)

POM

145 BRU08120173P Ventolin Respirator Solution Salbutamol (as sulphate) 0.5%w/v Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

146 BRU08120174P Dhacopan Syrup 5mg/5mlHyoscine (as butylbromide) BP

5mg/5ml

Drug Houses of Australia Pte Ltd,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

147BRU08120175P;

BRU08120175PS2Phenexpect Syrup

Per 5ml - Diphenhydramine (as HCl)

12.5mg, Ammonium Chloride 135mg

Drug Houses of Australia Pte Ltd,

Singapore; PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company06 October 2015 till 05

October 2020POM

148 BRU08120176P Dhabesol Cream 0.05% Clobetasol (as propionate) 0.05% w/vDrug Houses of Australia Pte Ltd,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

149 BRU08120177P Beprosalic LotionBetamethasone (as dipropionate)

0.05%, Salicylic acid 2.0%

Hoe Pharmaceuticals Sdn Bhd

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

150BRU08120178PS1;

BRU08120178PS2Zenmolin 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 Company06 October 2015 till 05

October 2020POM

151 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 2020POM

152 BRU08120180PZithromax Film-coated Tablet

250mgAzithromycin (as dihydrate) 250mg Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

153 BRU09010181P Unasyn 0.75mg IM/IVAmpicillin (as sodium) 500mg;

Sulbactam (as sodium) 250mgHaupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

154 BRU09010182P Unasyn 3.0g IM/IVAmpicillin (as sodium) 2000mg;

Sulbactam (as sodium) 1000mgHaupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

155 BRU09010183PVaxcel Ceftriaxone-500mg

InjectionCeftriaxone (as sodium) 500mg Kotra Pharma (M) Sdn Bhd Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

156BRU09010184PS1;

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 Company06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 9 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

157 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 2020POM

158 BRU09010186P Plavix Tablet 75mgClopidogrel (as Hydrogen Sulphate)

75mgSanofi Winthrop Industrie, France Medipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

159 BRU09010187PSymbicort Turbuhaler

160/4.5mcg dose

Budenoside 160mcg; Formoterol

fumarate dihydrate 4.5mcgAstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

160 BRU09010188PCoAprovel 300/12.5mg film-

coated tablet

Irbesartan 300mg; Hydrochlorothiazide

12.5mgSanofi Winthrop Industrie, France Medipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

161BRU09010189PS1;

BRU09010189PS2Vasican 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 Company06 October 2015 till 05

October 2020POM

162 BRU09010190P Cardium 30 tablet Diltiazem HCl 30mgDrug House of Australia Pte Ltd,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

163BRU09010191PS1 &

BRU09010191PS2Coversyl 8mg tablet Perindopril tert-butylamine 8mg

Les Laboratoires Servier Industrie,

France (S1) & Kotra Pharma (M) Sdn.

Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

164 BRU09010192P Dhacopan Tablet Hyoscine (as butylbromide) BP 10mgDrug Houses of Australia Pte Ltd,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

165 BRU09010194PPulmicort turbuhaler

100mcg/doseBudenoside 100mcg AstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

166 BRU09010195P Lantus for Optipen 100iu/ml Insulin glargine 100iu/ml Sanofi Aventis Deutschland, Germany Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

167 BRU09020196P Zovirax Cream 5% Aciclovir 5%w/w Glaxo Wellcome Opertions, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

168 BRU09020197P Zovirax Eye Ointment 3% Aciclovir 3%w/wJubilant HollisterStier General

Partnership, CanadaZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

169 BRU09020198P Adenocor Injection 6mg/2ml Adenosine 6mg/2mlFamar Health Care Services Madrid

S.A.U., Madrid, SpainMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

170BRU09020201NPS1,

BRU09020201NPS2

Dhamol Suspension

500mg/5mlParacetamol BP 500mg/5ml

Drug Houses of Australia Pte Ltd,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indonesia (S2) G & H Trading Company06 October 2015 till 05

October 2020P (3.8L)

171BRU09020205PS1 &

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 Company06 October 2015 till 05

October 2020POM

172 BRU09020206PBricanyl Turbuhaler

0.5mg/doseTerbutaline Sulphate 0.5mg/dose AstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 10 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

173 BRU09020207P Beprosalic OintmentBetamethasone (as Dipropionate

0.064%) 0.05% & Salicylic acid 3% w/w

HOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

174 BRU09020208P Beprogel Topical SolutionBetamethasone (as Dipropionate

0.064%) 0.05% w/w

HOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

175 BRU09020209P Cloderm Scalp Application Clobetasol (as dipropionate) 0.05% w/vHOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

176 BRU09020210P Declovir Cream Acyclovir 5.0% w/wHOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

177 BRU09020211P Lantus 100units/ml for Optiset Insulin Glargine (HOE 901) 100units/mlSanofi-Aventis Deutschland GmbH,

GermanyMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

178 BRU09020212P Glucobay 50 Tablet Acarbose 50mgBayer Pharma AG, Leverkusen,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

179 BRU09030213P 3TC Tablet 150mg Lamivudine 150mg Glaxo Wellcome Operaions, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

180 BRU09030214P 3TC Oral Solution 10mg/ml Lamivudine 10mg/ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

181 BRU09030215P Dhatrin TabletSulphamethoxazole BP 400mg;

Trimethoprim BP 80mg

Drug Houses of Australia Pte Ltd,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

182 BRU09030216PCordarone Injection

150mg/3mlAmiodarone 150mg/3ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

183BRU09030217PS1 &

BRU09030217PS2Vastarel MR 35mg Tablet Trimetazidine HCl 35mg

Les Laboratoires Servier Industrie,

France (S1); Kotra Pharma (M) Sdn.

Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

184

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 2020POM

185 BRU09030219PCataflam 1.5% Oral Drops

SuspensionDiclofenac Sodium 15mg/ml Novartis Farma SpA, France Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 11 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

186 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 Bhd06 October 2015 till 05

October 2020POM

187 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 2020POM

188 BRU09030222P Crestor 5mg Tablet Rosuvastatin Calcium 5mg IPR Pharmaceuticals Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

189 BRU09030223P Crestor 20mg Tablet Rosuvastatin Calcium 20mg IPR Pharmaceuticals Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 12 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

190 BRU09030224P Beprosone OintmentBetamethasone (as Dipropionate

0.064%) 0.05% w/w

HOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

191 BRU09030225P Beprosone CreamBetamethasone (as Dipropionate

0.064%) 0.05% w/w

HOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

192 BRU09030226P Benosone-N Cream

Betamethasone (as Valerate 0.12%)

0.1% w/w; Neomycin Sulphate

0.5%w/w

HOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

193 BRU09030227P Pocin H Ear DropNeomycin 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 2020POM

194 BRU09030228P U-Closone Cream Clobetasone butyrate 0.05%w/wHOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

195 BRU09040229PUnasyn Powder for Oral

Suspension 250mg/5mlSultamicillin (as tosilate) 250mg Pfizer Global Supply Japan, Inc., Japan Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

196 BRU09040230P Axcel Cefuroxime-250 Capsule Cefuroxime (as axetil) 250mg Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

197 BRU09040231P Knowful Capsule 400mg Piracetam 400mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd06 October 2015 till 05

October 2020POM

198

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 Bhd06 October 2015 till 05

October 2020POM

199 BRU09040233P Voltaren Suppository 25mg Diclofenac (as Sodium) 25mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

200 BRU09040234P Tidact Capsule 150mg Clindamycin (as hydrochloride) 150mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd06 October 2015 till 05

October 2020POM

201 BRU09040235PVoltaren 75mg/3ml solution

for injectionDiclofenac Sodium 75mg/3ml

Novartis Pharma Stein, ag,

Switzerland; Lek Pharmaceuticals d.d,

Slovenia

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 13 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

202 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 Bhd06 October 2015 till 05

October 2020POM

203 BRU09040237PDepo-Medrol Sterile Aqueous

Suspension 40mg/ml (5ml)

Methylprednisolone Acetate

200mg/5ml

Pfizer Manufacturing Belgium NV,

BelgiumZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

204 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 Bhd06 October 2015 till 05

October 2020POM

205 BRU09040239PBupivacaine Hydrochloride BP

0.5% w/v injectionBupivacaine hydrochloride BP 0.5%w/v Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

206 BRU09040240P Rhinathiol Capsule 375mg Carbocisteine 375mg Sanofi-aventis Egypt s.a.e., Egypt Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

207 BRU09040241P Celebrex Capsule 200mg Celecoxib 200mgPfizer Pharmaceutical LLC, Vega Baja

Puerto RicoZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

208 BRU09040242P Voltaren® SR Tablet 100mg Diclofenac sodium 100mg Novartis Farma SPA, Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

209 BRU09040243P T3 Mycin GelClindamycin (as phosphate) 1.0% HOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

210 BRU09040244P Cloderm Cream Clobetasone (as butyrate) 0.05%w/wHOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

211 BRU09040245P Bisacodyl Suppositroies Bisacodyl (micronised) 10mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd06 October 2015 till 05

October 2020P

212 BRU09040246P U-Closone Ointment Clobetasol (as propionate) 0.05%w/wHOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

213 BRU09040247P Nexium® IV 40mg Esomeprazole (as sodium) 40mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 14 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

214BRU09050248NPS1;

BRU09050248NPS2Dhactulose 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)

215 BRU09050249P Vastarel 20mg Tablet Trimetazidine dihydrochloride 20mgLes Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

216 BRU09050250P Coversyl Plus TabletPerindopril tert-butylamine 4mg,

Indapamide 1.25mg

Les Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

217 BRU09050251P Methyldopa Tablet 250mg Methyldopa (as anhydrous) 250mgDrug House of Australia (Asia) Pte Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

218 BRU09050252P Glucobay Tablet 100mg Acarbose 100mgBayer Pharma AG, Leverkusen,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

219 BRU09050253P Benosone-N Ointment

Betamethasone (as valerate 0.12%

w/w) 0.01%, Neomycin Sulphate

0.50%w/w

HOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

220 BRU09050254P Benosone Ointment Betamethasone 0.01% w/wHOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

221 BRU09050255P Mycosone Cream

Miconazole nitrate 2% w/w,

Hydrocortisone ( as acetate1.12%) 1%

w/w

Sunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

222 BRU09050256P H-Cort Ointment Hydrocortisone 1% w/wHOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

223 BRU09050257P T3 Mycin Lotion Clindamycin (as phosphate) 1.0% w/vHOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

224 BRU09050258P Lobesol Cream Clobetasol (as propionate) 0.05%w/wSunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

225 BRU09060259PVaxcel Cefuroxime 1.5g

InjectionCefuroxime (as sodium) 1.5g Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

226 BRU09060260P

Tetavax Suspension for

Injection (multidose)

(1 vial of 5mL – 10 doses) Tetanus toxoid 40i.u/0.5ml dose Sanofi Pasteur, Lyon, Pasteur Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

227

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

228 BRU09060263P Voltaren 50mg Tablets Diclofenac Sodium 50mg Novartis Pharma SPA, Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

229 BRU09060264P Voltaren 12.5mg Suppositories Diclofenac Sodium 12.5mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

230 BRU09060265P Voltaren 50mg Suppositories Diclofenac Sodium 50mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

231 BRU09060266P Benosone Cream Betamethasone (as valerate) 0.1%w/wHOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 15 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

232 BRU09060267NP Uphamol 250 Syrup Paracetamol 250mg/5mlUpha Pharmaceutical Mfg (M) Sdn

Bhd

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015 (PL

extended to 26 March

2017)

GSL (60mL)

233 BRU09060268P Betamethasone Cream Betamethasone (as valerate) 0.1%w/wSunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

234 BRU09060269P Zorax Cream Aciclovir 5%w/wSunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

235 BRU09060270P Nexium mups 20mgEsomeprazole (as magnesium

trihydrate) 20mgAstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

236 BRU09060271P Ebutol-100 Tablet Ethambutol HCl 100mgSunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

237 BRU09060272P Neurontin Capsule 300mg Gabapentin 300mgPfizer Pharmaceuticals LLC, Vega Baja

Puerto Rico, USAZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

238 BRU09060274P Relenza® Rotadisks 5mg Zanamivir 5mgGlaxoSmithKline Australia Pty Ltd,

AustraliaZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

239 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 Bhd06 October 2015 till 05

October 2020POM

240 BRU09070277P Avaxim 80u Paediatric Inactivated Hepatitis A virus (GBM

strain) 80u per 0.5mlSanofi Pasteur, Lyon, Pasteur Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

241 BRU09070278P Fedac TabletPseudoephedrine HCl 60mg;

Triprolidine HCl 2.5mg

Drug Houses of Australia Pte Ltd,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

242 BRU09070279P Salazopyrin® EN-Tabs Sulfasalazine 500mgKemwell AB, Bjorkgatan 30, SE-751 82

Uppsala, Sweden.Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

243 BRU09070280P Zyloric® 100mg Tablet Allopurinol 100mgGlaxoSmithKline Australia Pty Ltd.,

AustraliaZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

244 BRU09070281P Orrepaste 0.1%w/w Triamcinolone Acetate 0.1%w/wHOE Pharmaceuticals Sdn Bhd,

Malaysia.G & H Trading Company

06 October 2015 till 05

October 2020POM

245 BRU09070282PHydrocortisone Cream 1%

w/wHydrocortisone acetate 1%w/w

Sunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

246 BRU09070283P XanaxTM 0.25mg Tablet Alprazolam 0.25mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

247 BRU09070284P Nexium mups 40mgEsomeprazole (as magnesium

trihydrate) 40mgAstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

248 BRU09070286P XanaxTM 0.5mg Tablet Alprazolam 0.5mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

249 BRU09070287P Zolterol S/R Tablet 100mg Diclofenac Sodium 100mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

250 BRU09070288P Diane-35 TabletCyproterone acetate 2mg;

Ethinylestradiol 0.035mg

Bayer Weimar GmbH und Co. KG,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

251 BRU09070289P Amaryl 3mg Tablet Glimepiride Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 16 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

252 BRU09070290P Diamicron Tablet 80mg Gliclazide 80mgLes Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

253 BRU09070291NP Dulcolax Suppository 10mg Bisacodyl 10mg Istituto De Angeli S.r.l., ItalyHongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

254 BRU09070292P Clotrimazole Cream 1% w/w Clotrimazole 1% w/wBeacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020GSL

255 BRU09070293P Mucosolvon® 30mg Tablet Ambroxol hydrochloride 30mgPT Boehringer Ingelheim Indonesia,

Bogor, Indonesia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

256 BRU09080294P Euvax B Vaccine, RecombinantPurified Hepatitis B surface antigen

(HBsAg) 200µg/10mlLG Life Science Ltd, Korea Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

257 BRU09080295PPulmicort® Turbuhaler®

200mcg/dose

Budesonide (micronised) Ph Eur

200mcg/doseAstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

258 BRU09080296PEpilim Intravenous 400mg/

vial Sodium Valproate 400mg

Gruppo Lepetit S.R.L. ItalyMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

259 BRU09080297P Tritace® 5mg Tablet Ramipril 5mg Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

260 BRU09080298P Ebutol-400 Tablet Ethambutol HCl 400mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

261 BRU09080299PBeafemic Suspension

50mg/5mlMefenamic acid 50mg/5mL

Upha Pharmaceuticals Mfg (M) Sdn

Bhd, MalaysiaHongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

262BRU09080300PS1 &

BRU09080300PS2Diamicron MR Tablet 30mg Gliclazide 30mg

Les Laboratoires Servier Industrie,

France (S1) & Kotra Pharma (M) Sdn.

Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

263 BRU09080301P Deltasolone Tablet 5mg Prednisolone 5mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

264 BRU09080302P Sunprox-275 Tablet Naproxen Sodium 275mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

265 BRU09080303P Spiriva® 18mcgTiotropium 18mcg (as Bromide

Monohydrate 22.5mcg) Boehringer Ingelheim Pharma GmbH

& Co. KG, Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

266 BRU09080304P Prednisolone 1mg Tablet Prednisolone 1mgBeacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

267 BRU09080305NP Poro Suppository 250mg Paracetamol 250mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United Sdn Bhd06 October 2015 till 05

October 2020P (10 x 10's)

268 BRU09080307P Buscopan Tablet 10mg Hyoscine-N-butylbromideDelpharm Reims S.A.S,France

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

269 BRU09080308PAtrovent 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 2020POM

270 BRU09080309P Fenagesic Capsule 250mg Mefenamic acid 250mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

271 BRU09080311P Carinox CapsulePseudoephedrine sulphate 120mg;

Loratadine 5mg

Upha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020 POM

272 BRU09090312PEuvax B Vaccine, Recombinant

(100µg/5ml)

Purified Hepatitis B surface antigen

(HBsAg) 100µg/5mlLG Life Science Ltd, Korea Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 17 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

273 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 Bhd06 October 2015 till 05

October 2020POM

274 BRU09090314P Crestor 10mg Tablet Rosuvastatin Calcium 10mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

275 BRU09090315P Amaryl 2mg Tablet Glimepride 2mg Sanofi-aventis S.p.A, Italy Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

276 BRU09090316P Lamisil® 250mg Tablet Terbinafine HCl 250mgNovartis Pharmaceuticals UK Limited,

UKZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

277 BRU09090317P Voltaren® SR 75 Tablet Diclofenac Sodium 75mgNovartis Farma S.p.A, Italy

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

278 BRU09090318P Cataflam® 50 Tablet Diclofenac Potassium 50mg Novartis Urunleri, Istanbul Turkey Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

279 BRU09090321PMono-Tildiem SR 200mg

CapsuleDiltiazem HCl 200mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

280 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 2020POM

281 BRU09090324P Trenlin SR Tablet 400mg Pentoxifylline 400mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

282 BRU09090325NP Paratab Tablet 500mg Paracetamol 500mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020P (100x10's)

283 BRU09090326P Micardis 40mg Tablet Telmisartan 40mgBoehringer Ingelheim Pharma GmbH

& Co. KG, Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

284 BRU09090327PMetalyse Injection

10,000unitsTenecteplase 10,000units (50mg)

Boehringer Ingelheim Pharma GmbH

& Co. KG, Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

285 BRU09090328NP Hemo RidTM TabletMiconised Diosmin 450mg; Micronised

Hesperidine 50mg

Upha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020GSL

286 BRU09090329P Exforge Tablet 5mg/80mgAmlodipine 5mg (as besylate 6.94mg);

Valsartan 80mgNovartis Farmaceutica SA , Spain Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

287 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 Bhd06 October 2015 till 05

October 2020POM

288 BRU09100331P Cloderm Ointment Clobetasol (as propionate) 0.05%w/wHOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

289 BRU09100332P H-Cort Cream Hydrocortisone 1%w/wHOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

290 BRU09100334P Prelone Syrup 3mg/5ml Prednisolone Sunward Pharmaceutical Sdn Bhd,

Malaysia.G & H Trading Company

06 October 2015 till 05

October 2020POM

291 BRU09100335P Ventolin Nebules 2.5mg/2.5ml Salbutamol Sulphate 2.5mg/2.5mlGlaxoSmithKline Australia Pty Ltd,

AustraliaZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

292 BRU09100336NP Sunquadin Lozenges Dequalinium ChlorideSunward Pharmaceutical Sdn Bhd,

Malaysia.G & H Trading Company

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 18 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

293 BRU09100337P Zoloft Tablet 50mg Sertraline (as hydrochloride) 50mg Pfizer Australia Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

294 BRU09100338NPUphamol 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)

295 BRU09100339P XanaxTM 1mg Tablet Alprazolam 1mg Sanico NV Industriezone, Belgium Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

296 BRU09100340P Pontalon Capsule Mefenamic acid 250mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

297 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 Bhd06 October 2015 till 05

October 2020GSL

298 BRU09100343P Neurontin 600mg Tablet Gabapentin 600mgPfizer Pharmaceutical LLC, Puerto

Rico, USAZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

299 BRU09100345P LipitorTM 40mg TabletAtorvastatin (as Calcium 43.38mg-

crystalline) 40mg

Pfizer pharmaceuticals LLC, vega baja

Puerto Rico, USAZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

300 BRU09100346NP Suniton TabletParacetamol 450mg, Orphenadrine

Citrate 35mg

Sunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

301 BRU09100347P SCMC Plus Syrup 250mg/5mLS-carboxy-methylcysteine 250mg/5mL

(Carbocisteine)

Upha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

302 BRU09100348NP Glyprin Dispersible Tablet Aspirin 100mg, Glycine 45mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015 (PL

extended to 26 March

2017)

POM

303 BRU09100349P Actonel® 35mg TabletRisedronate sodium 35mg (equivalent

to 32.5mg risedronic acid)Norwich Pharmaceuticals Inc., USA

G&H Trading Company06 October 2015 till 05

October 2020POM

304 BRU09110350P Lantus® Solostar® 100units/ml Insulin Glargine (HOE 901)Sanofi-Aventis Deutschland GmbH,

GermanyMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

305 BRU09110353P Tenoretic Tablet Atenolol 100mg; Chlorthalidone 25mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

306 BRU09110354P LipitorTM 10mg TabletAtorvastatin (as calcium 10.85mg -

crystalline) 10mg

Pfizer pharmaceutical LLC, vega baja

Puerto Rico, USAZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

307 BRU09110357PS2Atrovent Unit Dose Vial (UDV)

250mcg/2ml

Ipratropium bromide anhydrous

250mcg (as monohydrate 261mcg)Laboratoire Unither, France (S2)

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

308 BRU09110358PMicardis Plus 40mg/12.5mg

Tablet

Telmisartan 40mg;

Hydrochlorothiazide 12.5mg

Boehringer Ingelheim Pharma GmbH,

Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

309 BRU09110359P Allavin ExpectorantDiphenhydramine 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

BDMCA/RMP/0317 Page 19 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

310 BRU09110361NP Uphamol 500 Tablet Paracetamol 500mgUpha 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)

311 BRU09110362P Carin Tablet 10mg Loratadine 10mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020 P

312 BRU09110363PRhinathiol 2% for Children

SyrupCarbocisteine 100mg/5ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

313 BRU09120365P Tienam IV Injection 500mgImipenem (as monohydrate) 500mg &

Cilastatin Sodium 500mgMerck Sharp & Dohme Corp, USA Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

314BRU09120366PS1 &

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 Bhd06 October 2015 till 05

October 2020POM

315 BRU09120367P Dilantin 100mg Capsule Phenytoin Sodium Pfizer Australia Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

316 BRU09120368P Modalim 100mg Tablet Ciprofibrate 100mg Sanofi Winthrop Limited, UK Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

317 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 2020POM

318 BRU09120370P Primperan 10mg/2ml Injection Metoclopramide HCl 10mg/2ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

319 BRU09120371P Tritace 10mg Tablet Ramipril 10mg Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

320 BRU09120372P Mono-Tildiem SR 300mg Diltiazem HCl 300mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

321 BRU09120373P Micardis® 80mg Tablet Telmisartan 80mgBoehringer Ingelheim Pharma GmbH,

Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

322 BRU09120374PMicardis Plus 80mg/12.5mg

Tablet

Telmisartan 80mg;

Hydrochlorothiazide 12.5mg

Boehringer Ingelheim Pharma GmbH,

Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

323 BRU09120375P Natrilix® SR Tablet Indapamide 1.5mgLes Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

324 BRU09120376NP Poro Suppository 125mg Paracetamol 125mgY.S.P Industries (M) Sdn Bhd.,

MalaysiaAsterix United (B) Sdn Bhd

06 October 2015 till 05

October 2020

GSL

(1 x 5's); P(10 x

10's)

325 BRU09120377PVascor 40mg Film-coated

TabletSimvastatin 40mg

Upha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

326 BRU09120379PCovastin Film-coated Tablet

10mgSimvastatin 10mg

Xepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 20 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

327 BRU09120381PS2Co-Diovan 80/12.5 Film-

coated Tablets

Valsartan 80mg; Hydrochlorothiazide

12.5mgNovartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

328 BRU09120382PRhinathiol® Promethazine

syrup

Carbocisteine 100mg/5ml;

Promethazine HCl 2.5mg/5mlSanofi Winthrop Industrie, France Medipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

329 BRU09120383PMethotrexate Injection BP

1000mg/10mlMethotrexate 1000mg/10ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

330 BRU10010384P Zyloric 300mg Tablet Allopurinol 300mgGlaxoSmithKline Australia Pty Ltd.

AustraliaZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

331BRU10010385PS1 &

BRU10010385PS2Coversyl 4mg Tablet Perindopril tert-butylamine 4mg

Les Laboratoires Servier Industrie,

France (S1) & Kotra Pharma (M) Sdn

Bhd., Malaysia

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

332 BRU10010386PS2Atrovent Unit Dose Vial

0.5mg/2ml

Ipratropium bromide (as

monohydrate) 500mcg/2ml

Laboratoires Unither, Amiens cedex,

France (S2)

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

333 BRU10010387P Aspirin EC Tablet 100mg Acetylsalicylic acid 100mgBeacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

334 BRU10010388P Exforge Tablet 5mg/160mgAmlodipine 5mg (as besylate 6.94mg);

Valsartan 160mgNovartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

335 BRU10010389P Taxotere 80mg/2ml VialDocetaxel anhydrous (as trihydrate)

80mg

Sanofi-Aventis Deutschland GmbH,

GermanyMediPharm Sdn Bhd

06 October 2015 till 05

October 2020POM

336

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 2020POM

337 BRU10010391PS2 Diovan 80mg Tablet Valsartan 80mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

338 BRU10010392PS2Co-Diovan 160/25 Film-coated

Tablets

Valsartan 160mg; Hydrochlorothiazide

25mgNovartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

339 BRU10010395P Isoket SprayIsosrobide Dinitrate 1.25mg per

actuationSchwarz Pharma Ltd, Ireland Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

340 BRU10010396P Beafemic Capsule 250mg Mefenamic acid 250mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

341 BRU10010397P Metformin Tablet 500mg Metformin HCl 500mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

342 BRU10010399P Seretide Accuhaler 50/500Salmeterol 50mcg (as Xinafoate),

Fluticasone propionate 500mcgGlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

343 BRU10010401P VentolinTM Tablet 4mg Salbutamol 4mg (as Sulphate 4.8mg) Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

344 BRU10020402PSolu-Medrol Sterile Powder

500mg

Methyprednisolone (as Sodium

succinate) 500mg

Pfizer Manufacturing Belgium N.V.,

BelgiumZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

345 BRU10020404P Imdex 60mg CR Tablet Isosorbide-5-Mononitrate 60mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

346 BRU10020405P Vascor Tablet 20mg SimvastatinUpha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 21 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

347 BRU10020406PCombivent Unit Dose Vial

500mcg

Per 2.5ml - Ipratropium bromide (as

monohydrate 522mcg) 500mcg;

Salbutamol 2.5mg (as sulphate

3.013mg)

Laboratorie UNITHER , FranceHongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

348 BRU10020408P Guadex Linctus

Per 5ml - Dextromethorphan

Hydrobromide 15mg; Guaifenesin

100mg

Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

349 BRU10020409PS2 Diovan® 160mg Tablet Valsartan 160mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

350 BRU10020410PEtoposide 100mg/5ml

InjectionEtoposide 100mg/5ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

351 BRU10020411P Decondine SyrupPer 5ml - Triprolidine HCl 1.25mg;

Pseudoephedrine HCl 30mg

Sunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

352 BRU10020412P Seretide Accuhaler 50/100Salmeterol 50mcg (as Xinafoate),

Fluticasone propionate 100mcgGlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

353 BRU10020413P Optizoline eye drops Tetrahydrozoline HCl 0.05%w/wXepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

354 BRU10020414P Sunadine Syrup Loratadine 5mg/5mlSunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020P

355 BRU10020415P Adalat LA 30 Tablet Nifedipine 30mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

356 BRU10020416P Lipitor 20mg Tablet Atorvastatin (Calcium) 20mgPfizer Pharmaceutical LLC, Puerto

RicoZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

357 BRU10020417PIsosorbide Dinitrate Tablet

10mgIsosorbide 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

358 BRU10020418P Nitroderm TTS® 5 (5mg/24hr) Glyceryl Trinitrate/ nitroglycerin 25mgNovartis Pharma Stein AG,

Switzerland Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

359 BRU10020419P Adalat® LA 20 Tablet Nifedipine 20mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

360 BRU10020421P Xatral XL Tablet 10mg Alfuzosin HCl 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

361 BRU10030423PRhinathiol 5% Adult

Expectorant SyrupCarbocisteine 5g/100ml Unither Liquid Manufacturing, France Medipharm Sdn Bhd

06 October 2015 till 05

October 2020P

362 BRU10030425NP Dulcolax Suppository 5mg Bisacodyl 5mg Instituto De Angeli S.R.L., ItalyHongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

363 BRU10030426P Aromasin 25mg Tablet Exemestane 25mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

364 BRU10030427P Omesec Capsule 20mg Omeprazole 20mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, MalaysiaK-Seri Pharma Sdn Bhd

06 October 2015 till 05

October 2020POM

365 BRU10030428P Adalat LA 60 Tablet Nifedipine 60mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 22 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

366 BRU10030429P Polarax 2mg Tablet Dexchlorpheniramine maleate 2mgSunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

367 BRU10030430P Pharmorubicin CS 50mg/25ml Epirubicin HCl 50mg/2ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

368 BRU10030432P Cisplatin Injection 50mg/50ml Cisplatin USP 50mg/50ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

369 BRU10030433PTerramycin 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 2020POM

370 BRU10030435PAdriamycin CS Injection

50mg/25mlDoxorubicin HCl 50mg/25ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

371 BRU10030436NP Maalox® Plus Suspension

Per 5ml - Aluminium hydroxide 225mg;

Magnesium hydroxide 200mg;

Simethicone USP 25mg

Sanofi Aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05

October 2020GSL

372 BRU10030437P Seretide Evohaler 50

Salmeterol Xinafoate (micronised)

25mcg; Fluticasone Propionate

(micronised) 50mcg

Glaxo Wellcome Production, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

373 BRU10030438P Miacalcic® Ampoules 100IU Calcitonin salmon, synthetic 100IUNovartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

374 BRU10030439P Prozine Syrup 5mg/5ml Promethazine HClSunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

375 BRU10030440P Olmetec Tablet 20mg Olmesartan Medoxomil 20mgDaiichi Sankyo Europe GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

376 BRU10040441P Diflucan Capsule 150mg Fluconazole 150mg Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

377 BRU10040442P Diflucan Capsule 100mg Fluconazole 100mg Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

378 BRU10040443P Diflucan Capsule 50mg Fluconazole 50mg Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

379 BRU10040445P Seretide Accuhaler 50/250Salmeterol (as Xinafoate) 50mcg;

Fluticasone Propionate 250mcgGlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

380 BRU10040447P Ventolin Tablet 2mg Salbutamol (as sulphate) 2mg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

381 BRU10040450P Seretide 125 Evohaler

Salmeterol (as Xinafoate, micronised)

25mcg; Fluticasone Propionate

125mcg

Glaxo Wellcome Production, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

382 BRU10040452P Nitroderm TTS® 10Glyceral trinitrate/ nitroglycerin 50mg

(10mg/24hr)

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

383 BRU10040453P Temodal Capsule 20mg Temozolomide 20mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

384 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 2020GSL

385 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 2020POM

BDMCA/RMP/0317 Page 23 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

386 BRU10040457P S2Co-Diovan 160/12.5mg

Tablets

Valsartan HCl 160mg;

Hydrochlorothiazide 12.5mgNovartis Pharma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

387 BRU10040459P Atenolol 50mg Tablet Atenolol 50mgSunward Pharmaceutical Pte Ltd.,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

388 BRU10040460P Bromhexine Tablet 8mg Bromhexine HCl 8mgSunward Pharmaceutical Pte Ltd.,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

389 BRU10040461PCytarabine® Injection 1000mg

in 10mlCytarabine 1000mg/10ml Pfizer (Perth) Pty, Ltd., Australia Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

390 BRU10040462P Exelon Oral Solution 2mg/mlRivastigmine 2mg/ml (as hydrogen

tartrate)Novartis Pharma S.A.S., France Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

391 BRU10050463PNebido 1000mg/4ml, Solution

for Injection

Testosterone undecanoate

250mg(equiv. to testosterone

157.9mg)

Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

392 BRU10050464NP Mucosolvon Liquid 30mg/5ml Ambroxol Hydrochloride 30mg/5ml Boehringer Ingelheim, FranceHongkiat Trading &

Company

06 October 2015 till 05

October 2020P

393 BRU10050466NPUphamol 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)

394 BRU10050467PTaxotere® 20mg/0.5ml

Concentrate and solvent for

solution for Infusion

Docetaxel 20mg/0.5ml (as trihydrate)Sanofi-Aventis Deutschland GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

395 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 Bhd06 October 2015 till 05

October 2020POM

396 BRU10050470P Pristinex Cream 2% w/w Ketoconazole 2%w/wXepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

397 BRU10050471PZyvox Infusion Bag

600mg/300mlLinezolid 600mg/300ml Fresenius Kabi Norge As, Norway Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

398 BRU10050472P Panadeine TabletCodeine Phosphate 8mg, Paracetamol

500mgSanofi India Limited, India Medipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

399 BRU10050473P Cervagem Pessary 1mg Gemeprost 1mg Ono Pharmaceutical Co Ltd, Japan Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

400 BRU10050474P Provinace Tablet 4mg Perindopril erbumine 4mgXepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

401 BRU10050475P Zyrtec® Oral Solution 1mg/ml Cetrizine diHCl 1mg/ml (0.1%) Aesica Pharmaceuticals S.r.L., Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

402 BRU10050476P Dalacin C Capsule 150mg Clindamycin (as hydrochloride) 150mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

403 BRU10050477P Clozaril® Tablet 100mg Clozapine 100mgNovartis Saglik Gida ve Tarim Urunleri

San. Ve Tic.A.S., Istanbul, TurkeyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 24 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

404 BRU10050478P Telfast® 180mg Tablet Fexofenadine HCl 180mg PT Aventis Pharma, Indonesia Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

405 BRU10050479PCozaar 100mg film-coated

tabletLosartan Potassium 100mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

406 BRU10050480P Dalacin T Topical Solution 1% Clindamycin (as phosphate) 10mg/Ml Zoetis P&U LLC, Kalamazoo, USA Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

407 BRU10060484P Miacalcic 50IU Ampoules Salmon calcitonin, synthetic 50IU/1mlNovartis Pharma Stein AG,

Switzerland.Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

408 BRU10060485P Allersin-F Tablet 4mg Chlorpheniramine maleate 4mgSunward Pharmaceutical Pte. Ltd.,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020P

409 BRU10060486P Daonil Tablet 5mg Glibenclamide 5mg PT Aventis Pharma, Indonesia Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

410 BRU10060487P Asmol SyrupSalbutamol 2mg/5ml (as Sulphate

2.4mg)

Sunward Pharmaceutical Sdn. Bhd.,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

411 BRU10060488P Lescol capsule 40mg Fluvastatin (as the sodium salt) 40mg Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

412 BRU10060489P Lescol XL Tablet 80mg Fluvastatin (as the sodium salt) 80mg Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

413 BRU10060490P Lescol capsule 20mg Fluvastatin (as the sodium salt) 20mg Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

414 BRU10060491P Diatrol Tablet 2mg Loperamide HCl 2mgSunward Pharmaceutical Sdn. Bhd.,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

415 BRU10060492P Clozaril® 25mg Tablet Clozapine 25mgNovartis Saglik Gida ve Tarim Urunleri

San. Ve Tic.A.S., Istanbul, TurkeyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

416 BRU10060493P Olmetec 10mg Tablet Olmesartan medoxomil 10mgDaiichi Sankyo Europe GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

417 BRU10060494P Norvasc Tablet 5mg Amlodipine Besylate 5mgPfizer Australia Pty. Ltd., NSW

Australia.Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

418 BRU10060495P Epilim 200mg/5ml Syrup Sodium Valproate 200mg Unither Liquid Manufacturing, France. Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

419 BRU10060496PStilnox 10mg film-coated

tabletZolpidem tartrate 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

420 BRU10060497P Hyosun syrupHyoscine-N-Butylbromide

(Scopolamine Butylbromide) 5mg/5ml

Sunward Pharmaceutical Pte. Ltd.,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

421 BRU10060498P Nalol Tablet 40mg Propranalol HCl 40mgSunward Pharmaceutical Pte. Ltd.,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

422 BRU10060499P Exelon capsule 1.5mgRivastigmine 1.5mg (as hydrogen

tartrate 2.4mg)Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

423 BRU10060500PSyntocinon 10IU solution for

injectionSynthetic Oxytocin 10IU/ml

Novartis Pharma Stein AG,

Switzerland Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

424 BRU10060501P Exelon capsule 6mgRivastigmine 6mg (as hydrogen

tartrate 9.6mg)Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 25 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

425 BRU10060502PZyvox film-coated tablet

600mgLinezolid 600mg

Pfizer Pharmaceuticals LLC, Puerto

Rico, United StatesZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

426 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 2020POM

427 BRU10060505PMyfortic 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 2020POM

428 BRU10070506P Phensedyl Dry Cough LinctusPer 5ml - Promethazine HCl 3.6mg;

Pholcodine 4mg; Ephedrine HCl 7.2mg

Sanofi-Aventis Pakistan Limited,

PakistanMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

429 BRU10070507P Miacalcic® Nasal Spray 200IU Salmon calcitonin, synthetic 200IUDelpharm Huningue S.A.S.,

Switzerland.Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

430 BRU10070508P Norvasc Tablet 10mg Amlodipine Besylate 10mgPfizer Australia Pty. Ltd., NSW

Australia.Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

431 BRU10070509P Pseudorine Tablet 60mg Pseudoephedrine HCl 60mgSunward Pharmaceutical Pte. Ltd.,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020P

432 BRU10070510P Laxodyl Tablet 5mg Bisacodyl 5mgSunward Pharmaceutical Pte. Ltd.,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020

GSL (6's) & P

(60's)

433 BRU10070511P Decondine TabletTripolidine HCl 2.5mg;

Pseudoephedrine HCl 60mg

Sunward Pharmaceutical Pte. Ltd.,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

434 BRU10070512P Metoclopramide Tablet 10mg Metoclopramide HCl 10mgSunward Pharmaceutical Pte. Ltd.,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

435 BRU10070513P Desferal 500mg Desferrioxamine Methane Sulphonate

Novartis Pharma Stein AG,

Switzerland; Wasserburger

Arzneimittelwerk GmbH, Wasserburg

Germany

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

436 BRU10070514P Anafranil® 25mg Tablet Clomipramine HCl 25mg Novartis Farma SpA., Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

437 BRU10070515P Zaricort CreamMiconazole Nitrate 2%w/w;

Hydrocortisone 1%w/w

Xepa-Soul Pattinson (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

438 BRU10070516P Singulair® Tablet 10mg Montelukast (as sodium) 10mgMerck Sharp & Dohme Ltd., United

KingdomZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

439 BRU10070517PSingulair® Chewable Tablet

5mgMontelukast (as sodium) 5mg

Merck Sharp & Dohme Ltd., United

KingdomZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

440 BRU10070518P Lanoxin Injection 0.5mg/2ml Digoxin 0.5mg/2mlGlaxoSmithKline Manufacturing SpA.,

ItalyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

441 BRU10070519P Zithromax IV 500mg Azithromycin (as dehydrate) 500mgPharmacia & Upjohn Company,

Kalamazoo, USAZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

442 BRU10070520P Exelon® 4.5mg CapsuleRivastigmine 4.5mg (as Rivastigmine

hydrogen tartrate 7.2mg)Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 26 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

443 BRU10070521PEpilim Chrono 500mg Scored

Film-coated Tablet

Sodium valproate 500mg (Sodium

valproate 333mg & Valproic acid

145mg)

Sanofi Winthrop Industries, France Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

444 BRU10070522PRitalin® Modified Release

Capsule 30mgMethylphenidate HCl 30mg Recro Gainsville LLC, USA Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

445 BRU10080523P Exforge 10/160mg FC TabletAmlodipine 10mg (as besylate);

Valsartan 160mg

Novartis Farmaceutica SA, Barbera

del Valles

(Barcelona) SpainZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

446 BRU10080524PZometa Concentrate for

Solution for Infusion 4mg/5ml

Zoledronic Acid (anhydrous) 4mg

corresponding to zoledronic acid

monohydrate 4.264mg

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

447 BRU10080528P Imovane 7.5mg Tablet Zopiclone 7.5mg Aventis International France Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

448 BRU10080529P Nasacort Aqueous Nasal SparyTriamcinolone Acetonide

55mcg/actuationAventis Pharma UK Medipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

449 BRU10080530P Ritalin 10mg Tablet Methylphenidate Hydrochloride 10mg Novartis Pharmaceuticals SA Spain Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

450 BRU10080531P Proctosedyl Suppositories

Chinchocaine 5mg; Framycetin

sulphate 10mg; Hydrocortisone 5mg;

Aesculin 10mg

PT Aventis Pharma, Indonesia Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

451 BRU10080532PProstin VR Paediatric® Sterile

Solution 500mcgAlprostadil 500mcg/ml Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

452 BRU10080533P Lioresal 10mg Tablet Baclofen 10mg Novartis Farma SPA Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

453BRU10080534PS1;

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 Bhd06 October 2015 till 05

October 2020POM

454BRU10080535PS1;

BRU10080535PS2

Telfast-D Extended Release

TabletFexofenadine 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 2020POM

455 BRU10080536P Claforan 1.0g Injection Cefotaxime 1g (as Sodium 1.048g) Patheon UK Ltd, England, UK Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

456 BRU10080538PImmucyst ® BCG

Immnuotherapeutic 81mg/vialBacillus Calmette-Guerin 81mg

Sanofi Pasteur Limited, Toronto,

Ontario, CanadaZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

457 BRU10090539P Singulair Tablet 4mgMontelukast 4mg (as sodium 4.16mg)

Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

458 BRU10090540P Cozaar Tablet 50mg Losartan Potassium 50mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

459 BRU10090541PLanoxin Paediatric/ Geriatric

ElixirDigoxin 0.05mg/mL Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0317 Page 27 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

460BRU10090542PS1;

BRU10090542PS2 Singulair Oral Granules 4mg

Montelukast Sodium (free acid

equivalent) 4mg

Merck Sharp & Dohme Corp. USA

(S1); DSM Pharmaceuticals, Inc., USA

(S2)

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

461 BRU10090543P Frisium® 10mg Tablet Clobazam 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

462 BRU10090544PS2 Vytorin Tablet 10mg/20mg Ezetimibe 10mg: Simvastatin 20mgMSD International GmbH (Singapore

Branch), Singapore (S2)Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

463 BRU10090545P Zocor 10mg Tablet Simvastatin 10mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

464 BRU10090546P Zocor 40mg Tablet Simvastatin 40mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

465 BRU10090547P Bonefos 800mg Tablet

Disodium Clodronate Tetrahydrate

1000mg equivalent to Disodium

Clodronate (anhydrous) 800mg

Bayer Oy, Finland Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

466 BRU10090548PSuprefact® 1mg/ml Injection

Solution

Buserelin 1.00mg/ml (as acetate

1.05mg)

Aventis-Pharma Deutshland GmbH,

GermanyMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

467 BRU10090549P Livial 2.5mg Tablet Tibolone 2.5mg N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

468 BRU10090550P Ritalin LA 20mg Capsules Methylphenidate Hydrochloride 20mg Recro Gainsville LLC, USA. Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

469 BRU10090551PZoladex LA Depot Injection

10.8mg

Goserelin Acetate equivalent to

Goserelin 10.8mgAstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

470 BRU10090552PHarnal OCAS 400mcg Film-

coated tablet

Tamsulosin (as hydrochloride 400mcg)

367mcg

Astellas Pharma Europe BV, The

NetherlandsZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

471 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 Bhd06 October 2015 till 05

October 2020P

472 BRU10090554P Proscar® Tablets 5mg Finasteride 5mgMSD International GmbH (Puerto Rico

Branch) LLC., Puerto Rico, USA.Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

473BRU10090555PS1;

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 Bhd06 October 2015 till 05

October 2020POM

474 BRU10100556PMyfortic Gastro-Resistant

tablet 360mgMycophenolic (as sodium) acid 360mg

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

475 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 Bhd28 October 2015 till 27

October 2020POM

476 BRU10100559P Exelon® Capsule 3mgRivastigmine (as hydrogen tartrate)

3mgNovartis Farmaceutica S.A. Spain Zuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

BDMCA/RMP/0317 Page 28 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

477 BRU10100560PS2 Arcoxia 60mg Film-coated

tabletEtoricoxib 60mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

478 BRU10100561P Proctosedyl Ointment

Cinchocaine hydrochloride 0.5%;

Framycetin sulphate 1.0%;

Hydrocortisone 0.5%; Aesculin 1.0%

Patheon UK Ltd., England Medipharm Sdn Bhd28 October 2015 till 27

October 2020POM

479 BRU10100562P Exelon® Patch 10Rivastigmine Base 18mg / 10cm2

(9.5mg/24h)

LTS Lohmann Theraphie-System AG,

GermanyZuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

480 BRU10100563P Exelon® Patch 5 Rivastigmine base 9mg/5cm2

(4.6mg/24 hours)

LTS Lohmann Theraphie-System AG,

GermanyZuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

481 BRU10100564PATGAM® Sterile Solution

50mg/mL (5mL amp)

Lymphocyte immune globulin, anti-

thymocyte globulin (equine)

250mg/5mL

Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd28 October 2015 till 27

October 2020POM

482 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 Bhd28 October 2015 till 27

October 2020POM

483 BRU10100566PS2 Arcoxia 120mg Tablet Etoricoxib 120mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd28 October 2015 till 27

October 2020POM

484 BRU10100567P Sun-Glizide Tablet 80mg Gliclazide 80mgSunward Pharmaceutical Pte Ltd,

Singapore G & H Traidng Company

28 October 2015 till 27

October 2020POM

485 BRU10100568PZithromax Powder For Oral

Suspension 200mg/5ml

Azithromycin (as dihydrate)

200mg/5mlHaupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

486 BRU10100569PFosamax 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 Bhd28 October 2015 till 27

October 2020POM

487 BRU10100571P Arimidex 1mg tablet Anastrozole 1mg AstraZeneca Pharmaceuticals USA Zuellig Pharma (B) Sdn Bhd28 October 2015 till 27

October 2020POM

488 BRU10100572P

Casprin Enteric

Microencapsulated Capsule

100mg

Aspirin 100mgY.S.P. Industries (M) Sdn Bhd,

Malaysia.Asterix United (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

489 BRU10100573P Pontalon Tablet 500mg Mefenamic Acid 500mgY.S.P. Industries (M) Sdn Bhd,

Malaysia.Asterix United (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

490 BRU10100576PAlbutein® Solution for Infusion

25% Albumin (Human) 25% Grifols Biologicals Inc., USA

Hongkiat Trading &

Company

28 October 2015 till 27

October 2020POM

491 BRU10100577P RebetolTM 200mg Capsule Ribavirin 200mgMSD International GmbH (Puerto Rico

Branch) LLC., Puerto Rico, USA.Zuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

492 BRU10100578P Axol Liquid 3mg/ml Ambroxol Hydrochloride 3mg/mlY.S.P. Industries (M) Sdn Bhd,

Malaysia.Asterix United (B) Sdn Bhd

28 October 2015 till 27

October 2020

P (100ml) &

POM (4L)

493 BRU10100579PS2 Vytorin™ Tablets 10mg/10mg Ezetimibe 10mg; Simvastatin 10mgMSD International GmbH (Singapore

Branch), Singapore (S2) Zuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

BDMCA/RMP/0317 Page 29 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

494 BRU10110580PIntron A* 18million IU Solution

for Injection, Multidose PenInterferon Alfa-2b 18 million IU Schering-Plough (Brinny) Co., Ireland Zuellig Pharma (B) Sdn Bhd

24 November 2015 till 23

November 2020POM

495BRU10110581PS1;

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 Bhd24 November 2015 till 23

November 2020POM

496 BRU10110582PS2 Arcoxia® 90mg Tablet Etrocoxib 90mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd24 November 2015 till 23

November 2020POM

497 BRU10110584PZocor 20mg Film-coated

TabletSimvastatin 20mg

Merck Sharp & Dohme Ltd.,

Northumberland, UKZuellig Pharma (B) Sdn Bhd

24 November 2015 till 23

November 2020POM

498 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 2020POM

499 BRU10110587PMetoclopramide Syrup

5mg/5ml

Metoclopramide hydrochloride

5mg/5ml

Sunward Pharmaceutical Pte Ltd,

Singapore G & H Traidng Company

24 November 2015 till 23

November 2020POM

500 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 2020GSL

501 BRU10110590P Zoladex Depot 3.6mg/dose Goserelin (as acetate) 3.6mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd24 November 2015 till 23

November 2020POM

502 BRU10110591PVoren Enteric Coated Tablet

25mgDiclofenac Sodium 25mg

Y.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

24 November 2015 till 23

November 2020POM

503 BRU10110592P Oroxine Tablet 50mcg Levothyroxine Sodium 55.63mcg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd24 November 2015 till 23

November 2020POM

504 BRU10110593PVoren Enteric Coated Tablet

50mgDiclofenac Sodium 50mg

Y.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

24 November 2015 till 23

November 2020POM

505 BRU10110595P Zantac™ Injection 25mg/ml Ranitidine hydrochloride 25mg/mlGlaxoSmithKline Manufacturing

S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

24 November 2015 till 23

November 2020POM

506 BRU10110596PBeconase™ Aqueous Nasal

Spray

Beclomethasone Dipropionate (as

monohydrate)Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd

24 November 2015 till 23

November 2020POM

507 BRU10110597P Campto 40mg/2ml InjectionIrinotecan hydrochloride trihydrate

40mg/2mlPfizer (Perth) Pty Ltd., Australia Zuellig Pharma (B) Sdn Bhd

24 November 2015 till 23

November 2020POM

508BRU10120599PS1;

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 Bhd29 December 2015 till 28

December 2020POM

509 BRU10120600PRitalin® LA Modified Release

Capsule 40mgMethylphenidate hydrochloride 40mg Recro Gainsville LLC, USA Zuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

510 BRU10120602POrgalutron Solution for

Injection 0.25mg/0.5mlGanirelix acetate 0.25mg/0.5ml

Vetter Pharma-Fertigung GmbH & Co.

KG, GermanyZuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

511 BRU10120604P Afrin Nasal Spray 0.05% Oxymetazoline Hydrochloride 0.05%PT. Merck Sharp Dohme Pharma Tbk,

IndonesiaZuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020P

512 BRU10120605P Clarityne Tablet 10mg Loratadine 10mgPT. Merck Sharp Dohme Pharma Tbk,

IndonesiaZuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020P

BDMCA/RMP/0317 Page 30 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

513 BRU10120606P Frotin Pessaries Metronidazole 250mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

514 BRU10120607P Allopurinol Tablet 300mg Allopurinol 300mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

515 BRU10120608P Methergin Tablet 0.125mg Methylergometrine maleate 0.125mgNovartis Pharma Produktions GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

516 BRU10120609P Vesicare Tablet 10mg Solifenacin Succinate 10mgAstellas Pharma Europe B.V., The

NetherlandsZuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

517 BRU10120611P Voren Suppositories 12.5mg Diclofenac Sodium 12.5mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

518 BRU10120612PFlixonase Aqueous Nasal Spray

0.05%

Fluticasone propionate (micronised)

50mcgGlaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

519BRU10120613PS1;

BRU10120613PS2

Esmeron® Injection 50mg/5ml

(10mg/ml)Rocuronium Bromide 50mg/5ml

N.V. Organon, The Netherlands;

Hameln Pharmaceuticals GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd29 December 2015 till 28

December 2020POM

520 BRU10120614P Clomid Tablet 50mg Clomifene Citrate 50mg Patheon France S.A., France Medipharm Sdn Bhd29 December 2015 till 28

December 2020POM

521 BRU10120615P FlixotideTM EvohalerTM 125mcg Fluticasone propionate 125mcg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd29 December 2015 till 28

December 2020POM

522 BRU10120616PLevitra® film-coated Tablet

5mg

Vardenafil 5mg (as monohydrochloride

trihydrate)Bayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

523 BRU10120617P IRESSATM Tablet 250mg Gefitinib 250mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd29 December 2015 till 28

December 2020POM

524BRU11010619PS1;

BRU11010619PS2 JanuviaTM 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 Bhd26 January 2016 till 25

January 2021POM

525 BRU11010621P Femara® 2.5mg Tablet Letrozole 2.5mgNovartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

526 BRU11010623P Allopurinol Tablet 100mg Allopurinol 100mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

527 BRU11010624P Elomet Ointment 0.1%PT. Merck Sharp Dohme Pharma Tbk,

IndonesiaZuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

528 BRU11010625 Implanon® 68mg ImplantEtonogestrel (Micronised) [Org3236]

68mgN.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

529 BRU11010626NP Poro Tablet 500mg Paracetamol 500mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

26 January 2016 till 25

January 2021

P (10 x 10's), P

(100x10's &

3,000's)

530 BRU11010627P Tegretol CR 200 Tablet Carbamazapine 200mgNovartis Farma S.p.A., Torree

Annunziata, ItalyZuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

531 BRU11010628POxy-Nase Paediatric Nasal

Spray 0.025%Oxymetazoline HCl 0.025%

HOE Pharmaceuticals Sdn Bhd,

MalaysiaG&H Trading Company

26 January 2016 till 25

January 2021P

532 BRU11010629P TrandateTM Tablets 100mg Labetalol hyrdochloride 100mgGlaxo Wellcome GmbH & Co.,

GermanyZuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

BDMCA/RMP/0317 Page 31 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

533 BRU11010631P Tegretol® CR 400 Tablet Carbamazapine 400mgNovartis Farma S.p.A., Torree

Annunziata, ItalyZuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

534 BRU11010632P Comtan® Tablet 200mg Entacapone 200mg Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd26 January 2016 till 25

January 2021POM

535 BRU11010635P Zantac SyrupTM 150mg/10mlRanitidine (as hydrochloride)

150mg/10mlAspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

536 BRU11010636NP Bisacodyl Suppositories Bisacodyl 5mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

537 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 Zuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

538

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 2021POM

539 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 Bhd26 January 2016 till 25

January 2021POM

540 BRU11010640P Microgynon® 30 TabletLevonorgestrel 0.15mg,

Ethinylestradiol 0.03mg

Bayer Weimar GmbH und Co., KG,

GermanyZuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

541 BRU11010641P Ami-hydrotride TabletAmiloride 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

542 BRU11010642P Virless Tablets 200mg Acyclovir 200mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

543 BRU11020643P Dalacin C 300mg Capsule Clindamycin (as Hydrochloride) 300mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd24 February 2016 till 23

February 2021POM

544 BRU11020644P Tegretol® 200mg Tablet Carbamazepine 200mg Novartis Pharma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd24 February 2016 till 23

February 2021POM

545 BRU11020645P OroxineTM Tablet 100mcgLevothyroxine (as sodium) anhydrous

100mcgAspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd

24 February 2016 till 23

February 2021POM

546 BRU11020646P ActifedTM Syrup

Triprolidine Hydrochloride BP

1.25mg/5ml; Pseudoephedrine

hydrochloride BP 30mg/5ml

Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd24 February 2016 till 23

February 2021

P (60ml &

100ml)

547 BRU11020647P Tegretol® 2% Syrup Carbamazepine 100mg/5ml Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd24 February 2016 till 23

February 2021POM

548 BRU11020648PGlivec® 100mg Film-coated

TabletImatinib (as mesylate) 100mg

Novartis Pharma Produktions GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

24 February 2016 till 23

February 2021POM

BDMCA/RMP/0317 Page 32 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

549 BRU11020649PSandostatin® Ampoules

0.05mg/mlOctreotide (as acetate) 0.05mg/ml

Novartis Pharma Stein AG.,

SwitzerlandZuellig Pharma (B) Sdn Bhd

24 February 2016 till 23

February 2021POM

550 BRU11020650PLevitra® film-coated Tablet

20mg

Vardenafil (as monochloride

trihydrate) 20mgBayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd

24 February 2016 till 23

February 2021POM

551 BRU11020652PUrosin® Film-coated Tablet

50mgAtenolol 50mg

Y.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

24 February 2016 till 23

February 2021POM

552 BRU11020653PIbuprofen Film-coated Tablet

400mgIbuprofen 400mg

Y.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

24 February 2016 till 23

February 2021P

553 BRU11020654P Promethazine Syrup 5mg/5ml Promethazine HCl 5mg/5mlDrug House of Australia Pte Ltd.,

SingaporeG & H Trading Company

24 February 2016 till 23

February 2021POM

554 BRU11020655P Voren GelDiclofenac Sodium 10mg/g (as

Diclofenac Acid Diethylamine)

Y.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

24 February 2016 till 23

February 2021GSL

555 BRU11020656PAtacor 20mg Film-coated

TabletsAtorvastatin (as Calcium) 20mg Actavis hf., Iceland K-Seri Pharma Sdn Bhd

24 February 2016 till 23

February 2021POM

556 BRU11020657P Dermosol Cream Clobetasol (as propionate) 0.5%w/wY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

24 February 2016 till 23

February 2021POM

557 BRU11020658P Zendhin 150 Tablet Ranitidine (as hydrochloride) 150mgDrug House of Australia (Asia) Pte

Ltd., SingaporeG & H Trading Company

24 February 2016 till 23

February 2021POM

558 BRU11030660P Oxy-nase® Nasal Spray 0.05% Oxymetazoline HCl 0.05%HOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

26 March 2016 till 25

March 2021P

559 BRU11030661PPrimperan® 10mg

SuppositoriesMetoclopramide 10mg

Unither Liquid Manufacturing,

France.Medipharm Sdn Bhd

26 March 2016 till 25

March 2021POM

560 BRU11030662PFucon Film Coated Tablet

10mgHysocine-n-butylbromide 10mg

Y.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

26 March 2016 till 25

March 2021POM

561 BRU11030663P Betamethasone Tablet 0.5mg Betamethasone 0.5mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

26 March 2016 till 25

March 2021POM

562 BRU11030664P Trivastal® Retard 50 Tablet Piribedil 50mgLes Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

26 March 2016 till 25

March 2021POM

563 BRU11030667P Clarinase Syrup 5mg/5mlPer 5ml: Loratadine 5mg,

Pseudoephedrine Sulphate 60mg

Sanofi Aventis Argentina S.A.,

ArgentinaZuellig Pharma (B) Sdn Bhd

26 March 2016 till 25

March 2021P

564 BRU11030668P

Vivaxim Suspension and

Solution for Suspension for

Injection

Inactivated Hepatitis A Virus, GBM

strain 160 antigen units

Sanofi Pasteur, Parc industriel

d'Incarville, FranceZuellig Pharma (B) Sdn Bhd

26 March 2016 till 25

March 2021POM

565BRU11030669PS1;

BRU11030669PS2

Caelyx 2mg/ml Concentrate

for InfusionDoxorubicin HCl 2mg/ml

Alza Corporation, USA (S1);

GlaxoSmithKline Manufacturing

S.P.A., Italy (S2)

Zuellig Pharma (B) Sdn Bhd26 March 2016 till 25

March 2021POM

BDMCA/RMP/0317 Page 33 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

566 BRU11030670P Alkeran Tablet 2mg Melphalan 2mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd26 March 2016 till 25

March 2021POM

567 BRU11030671P Hyzaar Forte Tablet 100/25mgLosartan potassium 100mg,

Hydrochlorothiazide 25mgMerck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd

26 March 2016 till 25

March 2021POM

568 BRU11030672P Avodart Soft Capsules 0.5mg Dutasteride 0.5mgGlaxoSmithKline Pharmaceuticals

S.A., PolandZuellig Pharma (B) Sdn Bhd

26 March 2016 till 25

March 2021POM

569 BRU11030673PTopistin® 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 2021POM

570 BRU11030674P Arixtra Injection 2.5mg/0.5ml Fondporinux sodium 2.5mg/0.5ml Glaxo Wellcome Production, France Zuellig Pharma (B) Sdn Bhd26 March 2016 till 25

March 2021POM

571 BRU11040675PPuregon® 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 Bhd30 April 2016 till 29 April

2021POM

572BRU11040676PS1;

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 Bhd30 April 2016 till 29 April

2021POM

573 BRU11040677PVaxigrip 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 Bhd30 April 2016 till 29 April

2021POM

574 BRU11040678PEuvax B Adult Vaccine

RecombinantPurified HBs-Ag 20mcg LG Life Science Ltd., Korea Zuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

575 BRU11040679PTrandateTM Injection 5mg/ml x

5mlLabetalol HCl 25mg/5ml

Hsinchu Plant of UBI Pharma Inc.,

TaiwanZuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

BDMCA/RMP/0317 Page 34 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

576 BRU11040680PS2 Puregon® 50IU/0.5ml Solution

for Injection

Follitrophin Beta (recombinant follicale-

stimulating hormone (FSH) 50IU/0.5mlN.V.Organon, The Netherlands (S2) Zuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

577 BRU11040681P Oxy-Nase Nasal Drops 0.05% Oxymetazolin Hydrochloride 0.05%w/vHOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

30 April 2016 till 29 April

2021P

578 BRU11040682P Sunolut Tablet 5mg Norethisterone 5mgSunward Pharmaceutical Pte Ltd.,

SingaporeG & H Trading Company

30 April 2016 till 29 April

2021POM

579 BRU11040683PSandostatin® LAR® Injection

10mgOctreotide 10mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

580 BRU11040684PVfend TM Film-Coated Tablets

200mgVoriconazole 200mg Pfizer Italia S.R.L, Italy Zuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

581 BRU11040685P Voren Suppositories 25mg Diclofenac Sodium 25mgY.S.P Industries (M) Sdn Bhd.,

MalaysiaAsterix United (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

582 BRU11040687PMultaq 400mg Film-coated

Tablet

Dronedarone 400mg (equiv.

Dronedarone HCl 426mg)Sanofi Winthrop Industrie, France Medipharm Sdn Bhd

30 April 2016 till 29 April

2021POM

583 BRU11040688P Stablon Coated Tablet 12.5mg Tianeptine (as sodium) 12.5mgLes Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

584 BRU11040689P Shinoxol Tablet 30mg Ambroxol HCl 30mgY.S.P Industries (M) Sdn Bhd.,

MalaysiaAsterix United (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

585 BRU11040690PEngerixTM-B Paediatric Vaccine

10mcg/0.5mlPurified HBs-Ag 10mcg

GlaxoSmithKline Biologicals SA.,

Rixensart Belgium; GlaxoSmithKline

Biologicals S.A., Wavre

Belgium

Zuellig Pharma (B) Sdn Bhd30 April 2016 till 29 April

2021POM

586 BRU11040691P Elosone Cream Mometasone Furoate 0.1%w/wHOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

30 April 2016 till 29 April

2021POM

587 BRU11040693P Cinna Tablet 25mg Cinnarizine 25mgY.S.P Industries (M) Sdn Bhd.,

MalaysiaAsterix United (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

588 BRU11040694PStalevo® 100/25/200mg Film-

coated Tablet

Levodopa 100mg; Carbidopa 25mg;

Entacapone 200mgOrion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

589 BRU11040695PRevoladeTM Film-coated Tablet

25mg

Eltrombopag 25mg [as free acid] (as

olamine)

Glaxo Operations UK Ltd (trading as

Glaxo Wellcome Operations), UKZuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

590 BRU11040696PCoversyl® Film-coated Tablet

10mg

Perindopril arginine 20mg (equiv to

perindopril 6.790mg)

Les Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

591 BRU11040697PAtorvastatin 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

2021POM

592 BRU11040698P SeroxatTM CR Tablet 12.5mgParoxetine 12.5mg (as Paroxetine HCl

hemihydrate) GlaxoSmithKline Inc., Ontario, Canada Zuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

593 BRU11050699P Avamys® Nasal Spray Fluticasone furoate (micronised)

27.5µg /spray

Glaxo Operations UK Ltd, United

KingdomZuellig Pharma (B) Sdn Bhd

25 May 2016 till 24 May

2021POM

BDMCA/RMP/0317 Page 35 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

594 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 Bhd25 May 2016 till 24 May

2021POM

595 BRU11050701P Depo-Provera Vial 150mg/3ml Medroxyprogesterone acetate 150mgPfizer Manufacturing Belgium N.V.,

BelgiumZuellig Pharma (B) Sdn Bhd

25 May 2016 till 24 May

2021POM

596 BRU11050702P Benzhexol Tablet 2mg Benzhexol HCl 2mgSunward Pharmaceutical Pte Ltd.,

SingaporeG & H Trading Company

25 May 2016 till 24 May

2021POM

597 BRU11050703PLevitra Film-coated Tablets

10mg

Vardenafil (as monohydrochloride

trihydrate) 10mgBayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd

25 May 2016 till 24 May

2021POM

598 BRU11050704PVentolin Solution for

Intravenous Infusion 5mg/5mlSalbutamol (as sulphate) 5mg/5ml

GlaxoSmithKline Pharmaceutical

S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

25 May 2016 till 24 May

2021POM

599 BRU11050705NP Upha B6 10 Tablet Pyridoxine HCl 10mgUpha 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)

600 BRU11050706PZofran Injection Flexi-Amp

AmpoulesOndansetron HCl Dihydrate 8mg/4ml

GlaxoSmithKline Australia Pty Ltd.m

AustraliaZuellig Pharma (B) Sdn Bhd

25 May 2016 till 24 May

2021POM

601 BRU11050707PCaverject 20mcg Powder and

solvent for injectionAlprostadil 20µg

Pfizer Manufacturing Belgium N.V.,

BelgiumZuellig Pharma (B) Sdn Bhd

25 May 2016 till 24 May

2021POM

602 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.,

GermanyMedipharm Sdn Bhd

25 May 2016 till 24 May

2021GSL (50's)

603 BRU11050710P Coveram Tablets 5mg/5mg

Perindopril arginine 5mg (equiv. to

perindopril 3.395mg); Amlodipine 5mg

(as besilate 6.935mg)

Servier (Ireland) Industries Ltd.,

IrelandZuellig Pharma (B) Sdn Bhd

25 May 2016 till 24 May

2021POM

604 BRU11050712PTracrium Injection

25mg/2.5mlAtracurium besylate 25mg/2.5ml

GlaxoSmithKline Manufactuirng

S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

25 May 2016 till 24 May

2021POM

605 BRU11060714P Zantac 150mg Tablet Ranitidine 150mg (as HCl 168mg)GlaxoSmithKline (Tianjin) Co. Ltd., PR

ChinaZuellig Pharma (B) Sdn Bhd

02 July 2016 till 01 July

2021POM

606 BRU11060715POxy-Nase Paediatric Nasal

Drop 0.025%w/vOxymetazoline HCl 0.025%

HOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

02 July 2016 till 01 July

2021POM

607 BRU11060716PVfend 50mg film-coated

TabletVoriconazole 50mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd

02 July 2016 till 01 July

2021POM

608 BRU11060717P Protaxos 2g Strontium Ranelate 2632mgLes Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

02 July 2016 till 01 July

2021POM

BDMCA/RMP/0317 Page 36 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

609 BRU11060718P MyleranTM Tablets 2mg Busulphan 2mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd02 July 2016 till 01 July

2021POM

610 BRU11060719PAmlodipine Winthrop Tablet

5mgAmlodipine (as besilate)

Unichem Laboratories Limited, Goa,

IndiaMedipharm Sdn Bhd

02 July 2016 till 01 July

2021POM

611 BRU11060720P Virless Tablet 800mg Acyclovir 800mgY.S.P. Industries (M) Sdn Bhd.,

MalaysiaAsterix United (B) Sdn Bhd

02 July 2016 till 01 July

2021POM

612 BRU11060721PAtorvastatin Winthrop® 40mg

Tablet

Atorvastatin 40mg (as Calcium

41.36mg) Zentiva k.s., Czech Republic Medipharm Sdn Bhd

02 July 2016 till 01 July

2021POM

613 BRU11060722P Propecia 1mg Tablet Finasteride 1mgMerck Sharp & Dohme, Puerto Rico,

USAZuellig Pharma (B) Sdn Bhd

02 July 2016 till 01 July

2021POM

614 BRU11060723PSeroquel 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

2021POM

615 BRU11070724P Vesicare® 5mg Tablet Solifenacin Succinate 5mgAstella Pharma Europe B.V., The

NetherlandsZuellig Pharma (B) Sdn Bhd

27 July 2016 till 26 July

2021POM

616 BRU11070727P SW Bena-Expectorant

Per 5ml: Diphenhydramine HCl 10mg,

Ammonium Chloride 102mg, Sodium

Citrate 46mg

Sunward Pharmaceutical Pte Ltd.,

SingaporeG&H Trading Company

27 July 2016 till 26 July

2021POM

617 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 Bhd27 July 2016 till 26 July

2021POM

618 BRU11070730PMirena® Intrauterine System

20mcg/24hrLevonorgestrel 52mg Bayer Oy, Finland Zuellig Pharma (B) Sdn Bhd

27 July 2016 till 26 July

2021POM

619 BRU11070731PAmlodipine Winthrop® 10mg

TabletAmlodipine 10mg (as besilate)

Unichem Laboratories Limited, Goa,

IndiaMedipharm Sdn Bhd

27 July 2016 till 26 July

2021POM

620BRU11070732PS1;

BRU11070732PS2Zoral 400 Tablet 400mg Acyclovir USP 400mg

Drug House of Australia Pte Ltd.,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indoensia (S2)

G & H Trading Company27 July 2016 till 26 July

2021POM

621 BRU11070733P ZofranTM Injection 4mg/2mlOndansetron 4mg/5ml (as HCl

dihydrate)

GlaxoSmithKline Australia Pty Ltd.,

AustraliaZuellig Pharma (B) Sdn Bhd

27 July 2016 till 26 July

2021POM

622 BRU11070734PSyntometrine® Injection

5IU/ml AmpouleOxytocin 5IU/ml

Novartis Pharma Steing AG.,

SwitzerlandMedipharm Sdn Bhd

27 July 2016 till 26 July

2021POM

623 BRU11070735P Elosone Ointment 0.1%w/w Mometasone furoate 0.1% w/wHOE Pharmaceuticals Sdn Bhd.,

MalaysiaG & H Trading Company

27 July 2016 till 26 July

2021POM

BDMCA/RMP/0317 Page 37 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

624 BRU11070736P Coveram 5/10mg Tablet

Perindopril arginine 5mg (equiv. to

3.395mg perindopril) and amlodipine

10mg (as besilate 13.870mg)

Servier (Ireland) Industries Ltd,

IrelandZuellig Pharma (B) Sdn Bhd

27 July 2016 till 26 July

2021POM

625 BRU11070737P ZofranTM Tablets 8mg Ondansetron 8mg (as HCl dihydrate) Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd27 July 2016 till 26 July

2021POM

626BRU11070738PS1;

BRU11070738PS2 Diamicron® MR 60mg Tablet Gliclazide 60mg

Les Laboratoires Servier Industrie,

France (S1); Kotra Pharma (M) Sdn.

Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd27 July 2016 till 26 July

2021POM

627 BRU11070739P Fedac DM Linctus

Per 5ml: Triprolidine HCl 12.5mg,

Pesudoephedrine HCl 30mg,

Dextrometorphan HBr 10mg

Drug House of Australia Pte Ltd.,

SingaporeG & H Trading Company

27 July 2016 till 26 July

2021POM

628 BRU11070740P Tracrium Injection 50mg/5ml Atracurium Besylate 50mg/5mlGlaxoSmithKline Manufacturing

S.p.A., Parma, ItalyZuellig Pharma (B) Sdn Bhd

27 July 2016 till 26 July

2021POM

629 BRU11070741P Coralan® Tablet 2.5mg Ivabradine 7.5mg (as HCl 8.085mg)Les Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

27 July 2016 till 26 July

2021POM

630 BRU11080742PAclasta 5mg/10ml Solution for

Infusion

Zolendranic acid (anhydrous) 5mg (as

zolendranic acid monohydrate 5.33mg)

Novartis Pharma Stein AG.,

SwitzerlandZuellig Pharma (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

631 BRU11080743P Lanoxin Tablet 250mcg Digoxin 250mcg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd25 August 2016 till 24

August 2021POM

632 BRU11080744P Lanoxin PG Tablet 0.0625mg Digoxin 0.0625mg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd25 August 2016 till 24

August 2021POM

633 BRU11080745PGlivec® 400mg Film-coated

TabletImatinib (as mesylate) 400mg

Novartis Pharma Stein AG.,

SwitzerlandZuellig Pharma (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

634 BRU11080746PStalevo 50/12.5/200mg film-

coated tablet

Levodopa 50mg, Carbidopa 12.5mg,

Entacapone 200mgOrion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

635

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 Bhd25 August 2016 till 24

August 2021POM

636 BRU11080748P Campto 100mg/5ml Injection Irinotecan hydrochloride trihydrate Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd25 August 2016 till 24

August 2021POM

637 BRU11080749P Econazine CreamEconazole nitrate 1% w/w,

Triamcinolone actonide 0.1% w/w

Y.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

BDMCA/RMP/0317 Page 38 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

638 BRU11080750PFrotin Film Coated 200mg

Tablet Metronidazole 200mg

Y.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

639 BRU11080751PUrosin Film Coated Tablet

100mgAtenolol 100mg

Y.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

640 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,

BelgiumZuellig Pharma (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

641 BRU11080753P Fukole Capsule 150mg Fluconazole 150mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

642 BRU11080754P CoAprovel Tablet 300/25mgIrbesartan 300mg, Hydrochlorothiazide

25mgSanofi Winthrop Industrie, France Medipharm Sdn Bhd

25 August 2016 till 24

August 2021POM

643 BRU11080755P SeroxatTM CR Tablet 25mgParoxetine 25mg(as Paroxetine

hydrochloride hemihydrate)GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

644 BRU11080757P Orphenadol® TabletOrphenadrine Citrate 50mg,

Paracetamol 325mg

Y.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

645 BRU11080758P Loramide Capsule 2mg Loperamide HCl 2mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

646 BRU11080759P VOREN Suppositories 50mg Diclofenac Sodium 50mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

647 BRU11080760P Decan Tablet 0.75mg Dexamethasone 0.75mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

648 BRU11090762P Properazine Tablet 5mg Prochlorperazine maleate 5mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

27 September 2016 till 26

September 2021POM

649 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 Bhd27 September 2016 till 26

September 2021POM

BDMCA/RMP/0317 Page 39 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

650 BRU11090764P

Eloxatin 5mg/ml Concentrate

for Solution for Infusion

(10ml)

Oxaliplatin 50mg/10mlSanofi-Aventis Deutschland GmbH,

GermanyMedipharm Sdn Bhd

27 September 2016 till 26

September 2021POM

651 BRU11090765P

Eloxatin 5mg/ml Concentrate

for Solution for Infusion

(20ml)

Oxaliplatin 100mg/20mlSanofi-Aventis Deutschland GmbH,

GermanyMedipharm Sdn Bhd

27 September 2016 till 26

September 2021POM

652 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,

BelgiumZuellig Pharma (B) Sdn Bhd

27 September 2016 till 26

September 2021POM

653 BRU11090767PSandimmun Neoral® Oral

Solution 100mg/mlCiclosporin A 100mg/ml Novartis Pharma S.A.S., France Zuellig Pharma (B) Sdn Bhd

27 September 2016 till 26

September 2021POM

654 BRU11090768P Hyzaar® Tablet 50/12.5mgLosartan Potassium 50mg,

Hydrochlorothiazide 12.5mg

Merck Sharp & Dohme,

Northumberland, UKZuellig Pharma (B) Sdn Bhd

27 September 2016 till 26

September 2021POM

655 BRU11090769PHyzaar® Plus Tablet

100/12.5mg

Losartan Potassium 100mg,

Hydrochlorothiazide 12.5mg

Merck Sharp & Dohme,

Northumberland, UKZuellig Pharma (B) Sdn Bhd

27 September 2016 till 26

September 2021POM

656 BRU11090770PFlebogamma 5% DIF Solution

for Infusion (100mL)

Human Normal Immunoglobulin

50mg/mlInstituo Grifols S.A., Barcelona, Spain

Hongkiat Trading &

Company

27 September 2016 till 26

September 2021POM

657 BRU11090771P Seroquel XR Tablets 200mg Quetiapine (as fumarate) 200mg AstraZeneca Pharmaeuticals LP, USA Zuellig Pharma (B) Sdn Bhd27 September 2016 till 26

September 2021POM

658 BRU11090772PDiabetamin Film-coated

Tablet 500mgMetformin HCl 500mg Hovid Bhd, Perak, Malaysia G & H Trading Company

27 September 2016 till 26

September 2021POM

659 BRU11090773P Tidact Gel 1%Clindamycin 10mg/g (as phosphate

11.9mg/g)

Y.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

27 September 2016 till 26

September 2021POM

660 BRU11090774P Daunoblastina Injection 20mg Daunoribicin Hydrochloride 20mg Actavis S.p.A., Italy Zuellig Pharma (B) Sdn Bhd27 September 2016 till 26

September 2021POM

661 BRU11090775P Fucon Capsule 10mg Hyoscine-N-butylbromide 10mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

27 September 2016 till 26

September 2021POM

662 BRU11090776P Virless Cream Acyclovir 50mg/gY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

27 September 2016 till 26

September 2021POM

663 BRU11090777P Solian® 100mg Scored Tablet Amisulpiride 100mg Sanofi Winthrop Industrie, France MediPharm Sdn Bhd27 September 2016 till 26

September 2021POM

664 BRU11090778P Hovasc Tablet 5mg Amlodipine 5mg (as besilate 6.90mg) Hovid Bhd, Malaysia G & H Trading Company27 September 2016 till 26

September 2021POM

BDMCA/RMP/0317 Page 40 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

665 BRU11100779P Pariet® Tablet 20mg Sodium Rabeprazole 20mgBushu Pharmaceuticals Ltd, Japan. ,

JapanMediPharm Sdn Bhd

31 October 2016 till 30

October 2021POM

666 BRU11100780P Pariet® Tablet 10mg Sodium Rabeprazole 10mgBushu Pharmaceuticals Ltd, Japan. ,

JapanMediPharm Sdn Bhd

31 October 2016 till 30

October 2021POM

667 BRU11100781PS2Puregon® 100IU/0.5ml

Solution for Injection

Follitropin beta (recombinant follicle-

stimulating hormone - FSH)

100IU/0.5ml

N.V. Organon, The Netherlands (S2) Zuellig Pharma (B) Sdn Bhd31 October 2016 till 30

October 2021POM

668 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 Bhd31 October 2016 till 30

October 2021POM

669 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 Bhd31 October 2016 till 30

October 2021POM

670 BRU11100784PSandostatin® ampoules

0.1mg/mlOctreotide (as acetate) 0.1mg/ml

Novartis Pharma Stein A.G.,

SwitzerlandZuellig Pharma (B) Sdn Bhd

31 October 2016 till 30

October 2021POM

671 BRU11100785PAtorvastatin 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 2021POM

672 BRU11100786PStalevo® 150/37.5/200mg

Film-coated Tablet

Levodopa 150mg; Carbidopa 37.5mg;

Entacapone 200mgOrion Corporation Fermion, Finland Zuellig Pharma (B) Sdn Bhd

31 October 2016 till 30

October 2021POM

673 BRU11100787P Coveram Tablet 10mg/5mg

Perindopril arginine 10mg (eqv. To

Perindopril 6.790mg); Amlodipine 5mg

(as besilate 6.935mg)

Servier (Ireland) Industries Ltd.,

IrelandZuellig Pharma (B) Sdn Bhd

31 October 2016 till 30

October 2021POM

674 BRU11100788PCoversyl® Fim-coated Tablet

5mg

Perindopril arginine 5mg (eqv.

Perindopril 3.395mg)

Les Laboratoires Servier Industrie,

Gidy, FranceZuellig Pharma (B) Sdn Bhd

31 October 2016 till 30

October 2021POM

675 BRU11100789P Myonal 50mg Tablet Eperisone Hydrochloride 50mgEisai Co., Ltd, Saitama Prefecture,

JapanMediPharm Sdn Bhd

31 October 2016 till 30

October 2021POM

BDMCA/RMP/0317 Page 41 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

676

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

677 BRU11100791P Coveram Tablet 10mg/10mg

Perindopril arginine 10mg (eqv. To

Perindopril 6.790mg); Amlodipine

10mg (as besilate 13.870mg)

Servier (Ireland) Industries Ltd.,

IrelandZuellig Pharma (B) Sdn Bhd

31 October 2016 till 30

October 2021POM

678 BRU11100792PVoker Film Coated Tablet

20mgFamotidine 20mg

Y.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

31 October 2016 till 30

October 2021POM

679 BRU11100793P Solian® 400mg Scored Tablet Amisulpride 400mg Sanofi Winthrop Industrie, France MediPharm Sdn Bhd31 October 2016 till 30

October 2021POM

680 BRU11100794PClarityn-D 12HR EXTENDED

RELEASE TABLET 5mg/120mg

Loratadine 5mg, Pseudoephedrine

sulphate 120mgSchering Plough Labo N.V., Belgium Zuellig Pharma (B) Sdn Bhd

31 October 2016 till 30

October 2021POM

681 BRU11100795P Euthyrox® Tablet 25mcg Levothyroxine sodium 25mcg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd31 October 2016 till 30

October 2021POM

682 BRU11100796P Concor® 2.5mg Tablet Bisoprolol hemifumarate 2.5mg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd31 October 2016 till 30

October 2021POM

BDMCA/RMP/0317 Page 42 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

683 BRU11110797P OnglyzaTM Tablet 2.5mgSaxagliptin 2.5mg (as HCl anhydrous

2.79mg)

Bristol-Myers Squibb Company,

Indiana, USAZuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

684 BRU11110798P OnglyzaTM Tablet 5mgSaxagliptin 5mg (as HCl anhydrous

5.58mg)

Bristol-Myers Squibb Company,

Indiana, USAZuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

685 BRU11110799PSandostatin® LAR® Injection

20mgOctreotide (as acetate) 20mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

686 BRU11110800PSandostatin® LAR® Injection

30mgOctreotide (as acetate) 30mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

687 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 Bhd24 November 2016 till 23

November 2021POM

688 BRU11110803PNexavar® 200mg Film-coated

TabletsSorafenib Tosylate 200mg

Bayer Pharma AG., Leverkusen,

Germany; Bayer Healthcare

Manufacturing S.r.l., Italy

Zuellig Pharma (B) Sdn Bhd24 November 2016 till 23

November 2021POM

689 BRU11110804PPEG Intron CLEARCLICK for

Injection 150mcg/0.5ml

Recombinant interferon alfa-2b

150mcg (pegylated to monoethoxy

polyethylene glycol)

MSD International GmbH (Singapore

Branch), Singapore SingaporeZuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

690 BRU11110805PPEG 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 Bhd24 November 2016 till 23

November 2021POM

691 BRU11110806PPEG Intron CLEARCLICK for

Injection 100mcg/0.5ml

Recombinant interferon alfa-2b

100mcg (pegylated to monoethoxy

polyethylene glycol)

MSD International GmbH (Singapore

Branch), Singapore SingaporeZuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

BDMCA/RMP/0317 Page 43 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

692 BRU11110807PPEG Intron CLEARCLICK for

Injection 80mcg/0.5ml

Recombinant interferon alfa-2b 80mcg

(pegylated to monoethoxy

polyethylene glycol)

MSD International GmbH (Singapore

Branch), Singapore SingaporeZuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

693 BRU11110808PPEG Intron CLEARCLICK for

Injection 50mcg/0.5ml

Recombinant interferon alfa-2b 50mcg

(pegylated to monoethoxy

polyethylene glycol)

MSD International GmbH (Singapore

Branch), Singapore SingaporeZuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

694 BRU11110809PDalacin CTM Sterile Solution

150mg/ml x 2ml ampouleClindamycin Phosphate 300mg

Pfizer Manufacturing Belgium N.V.,

Puurs, BelgiumZuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

695 BRU11110812P Euthyrox® Tablet 100mcg Levothyroxine sodium 100mcg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd24 November 2016 till 23

November 2021POM

696 BRU11110813PKetipinor 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

697 BRU11110814P Prednisolone Tablet 5mg Prednisolone 5mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

698 BRU11110815P Granocyte® 34 InjectionLenograstim (rHug-CSF) 33.6 million IU

(equiv. to 263 mcg)/ vialSanofi Winthrop Industrie, France MediPharm Sdn Bhd

24 November 2016 till 23

November 2021POM

699 BRU11120816PEuvax 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 2021POM

700 BRU11120817PPuregon® 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 Bhd22 December 2016 till 21

December 2021POM

701 BRU11120818P Clarityn Syrup Loratadine 1mg/mlPT. Merck Sharp Dohme Pharma Tbk,

IndonesiaZuellig Pharma (B) Sdn Bhd

22 December 2016 till 21

December 2021P

BDMCA/RMP/0317 Page 44 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

702 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 Bhd22 December 2016 till 21

December 2021POM

703 BRU11120820P VentolinTM EvohalerTM Salbutamol (as sulphate 120.5mcg)

100mcgGlaxo Wellcome S.A., Burgos, Spain Zuellig Pharma (B) Sdn Bhd

22 December 2016 till 21

December 2021POM

704 BRU11120821PMencevaxTM 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 BelgiumZuellig Pharma (B) Sdn Bhd

22 December 2016 till 21

December 2021POM

705 BRU11120822PRevoladeTM 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 Bhd22 December 2016 till 21

December 2021POM

706 BRU11120823P Coversyl® Plus 5mgPerindopril arginine 5mg (as besilate

3.395mg); Indapamide 1.25mg

Les Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

22 December 2016 till 21

December 2021POM

707 BRU11120824P Yasmin® Film-coated TabletsDrospirenone 3mg, Ethinylestradiol

0.03mg

Bayer Weimar GmbH und Co. KG

(WEIMAR PLANT), GermanyZuellig Pharma (B) Sdn Bhd

22 December 2016 till 21

December 2021POM

708 BRU11120826NP Arcalion® 200mg Tablet Sulbutiamine 200mgLes Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

22 December 2016 till 21

December 2021GSL

709 BRU11120827PMethycobal Injection

500mcg/mlMecobalamin 500mcg Bushu Pharmaceuticals Ltd, Japan MediPharm Sdn Bhd

22 December 2016 till 21

December 2021POM

BDMCA/RMP/0317 Page 45 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

710 BRU11120828PFlebogamma® 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 2021POM

711 BRU11120829NP Shintamet film coated Tablet Cimetidine 400mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

22 December 2016 till 21

December 2021POM

712 BRU11120830P Dermafin cream 1% Terbinafine Hydrochloride 1%w/wY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

22 December 2016 till 21

December 2021GSL

713 BRU11120831P Pontalon Tablet 250mg Mefenamic Acid 250mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

22 December 2016 till 21

December 2021POM

714 BRU11120832P Clopivid Tablet 75mgClopidogrel 75mg (as hydrogen

sulphate 97.90mg)Hovid Bhd, Malaysia G & H Trading Company

22 December 2016 till 21

December 2021POM

715 BRU11120833PShincort Injection “Yung Shin”

10mg/mlTriamcinolone Acetonide 50mg/5ml

Yung Shin Pharmaceutical Ind. Co.

Ltd., Taiwan ROCAsterix United (B) Sdn Bhd

22 December 2016 till 21

December 2021POM

716 BRU11120834P Hovasc Tablet 10mg Amlodipine 10mg (as Besylate 13.8mg) Hovid Bhd, Malaysia G & H Trading Company22 December 2016 till 21

December 2021POM

717 BRU11120835P Indomen Capsule 25mg Indomethacin 25mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd 22 December 2016 till 21

December 2021POM

718 BRU11120836P Clomiphene Tablet 50mg Clomiphene citrate 50mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd 22 December 2016 till 21

December 2021POM

719 BRU11120837PPrimacor® 10mg/10ml

InjectionMilrinone 10mg/10ml (as lactate) Sanofi Winhtrop Industrie, France MediPharm Sdn Bhd

22 December 2016 till 21

December 2021POM

720 BRU11120838NPChamps 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)

721 BRU11120839PEpilim® 200 Enteric Coated

TabletsSodium Valproate 200mg

Sanofi-Synthelabo Ltd., United

KingdomMediPharm Sdn Bhd

22 December 2016 till 21

December 2021POM

BDMCA/RMP/0317 Page 46 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

722 BRU12010840PInfanrixTM-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 Bhd01 February 2017 till 31

January 2022POM

723 BRU12010841P Cardura XLTM tablet 4mg Doxazosin Mesylate 4mgPfizer Pharmaceuticals LLC, Puerto

Rico, USAZuellig Pharma (B) Sdn Bhd

01 February 2017 till 31

January 2022POM

724 BRU12010842PValdoxan® 25mg film-coated

tabletAgomelatine 25mg

Les Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

01 February 2017 till 31

January 2022POM

725 BRU12010843P Zofran Tablet 4mgOndansetron (as Hydrochloride

Dihydrate) 4mgAspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd

01 February 2017 till 31

January 2022POM

726 BRU12010844PFlebogamma® 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 2022POM

727 BRU12010845P Coralan® Tablet 5mgIvabradine 5mg eq. to 5.39mg

ivabradine hydrochloride

Les Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

01 February 2017 till 31

January 2022POM

728 BRU12010846P Seroquel XR tablets 300mg Quetiapine (as fumarate) 300mg Astrazeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd01 February 2017 till 31

January 2022POM

729 BRU12010847P Seroquel XR tablets 400mg Quetiapine (as fumarate) 400mg Astrazeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd01 February 2017 till 31

January 2022POM

730 BRU12010848P Chemix tabletTrimethoprim 80mg, Sulfamethoxazole

400mg

Y.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

01 February 2012 till 31

January 2017POM

731 BRU12010850P Enapril tablet 10mg Enalapril maleate 10mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

01 February 2017 till 31

January 2022POM

732 BRU12010851NP Princi-B Fort® tablet

Thiamin mononitrate 250mg,

Pyridoxine hydrochloride 250mg &

Cyanocobalamin 1mg

Olic (Thailand) Ltd, Thailand MediPharm Sdn Bhd01 February 2017 till 31

January 2022P

733 BRU12010852P Antifungal Cream 2% Miconazole Nitrate 20mg/g (2% w/w)Y.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

01 February 2017 till 31

January 2022GSL

734 BRU12010853P Concor® 5mg tabletBisoprolol hemifumarate 5mg

Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd01 February 2017 till 31

January 2022POM

BDMCA/RMP/0317 Page 47 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

735 BRU12010854PKetipinor film-coated tablet

100mg

Quetiapine (as fumarate 115.13mg)

100mgOrion Corporation, Finland Hongkiat Trading & Co

01 February 2012 till 31

January 2017 (PL

extended to 26 March

2017)

POM

736 BRU12010855P Euthyrox® Tablet 50mgLevothyroxine sodium 50mcg

Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd01 February 2017 till 31

January 2022POM

737 BRU12010856NPPanadol Suspension

250mg/5mlParacetamol 250mg/5ml Smithkline Beecham, Philippines

Kingston Beverage &

Creamery Sdn Bhd

01 February 2012 till 31

January 2017

GSL

(60ml/120ml)

738 BRU12010857P Targocid® Injection 200mg Teicoplanin 200mg/3ml (200mg/vial) Gruppo Lepetit S.r.I., Italy MediPharm Sdn Bhd01 February 2017 till 31

January 2022POM

739 BRU12020858P Sebivo™ Tablet 600mg Telbivudine 600mgNovartis Pharma Stein AG.,

SwitzerlandZuellig Pharma (B) Sdn Bhd

1 March 2017 till 28

February 2022 POM

740 BRU12020859PEsonide Nasal Spray

100mcg/dose

Budesonide 2mg/ml equivalent to

100mcg/doseKleva S.A., Greece G & H Trading Company

29 February 2012 till 28

February 2017 POM

741 BRU12020860P Yucomy Tablet 200mg Ketoconazole 200mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

1 March 2017 till 28

February 2022 POM

742 BRU12020861PThyrozol® 20mg Film-coated

TabletsThiamazole 20mg Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd

1 March 2017 till 28

February 2022 POM

743 BRU12020862PKetipinor Film-coated Tablet

25mg

Quetiapine (as fumarate 28.78mg)

25mgOrion Corporation, Finland Hongkiat Trading & Co

29 February 2012 till 28

February 2017 (PL

extended to 26 March

2017)

POM

744 BRU12020863P

Taxotere 20mg/1ml

concentrate for solution for

infusion

Docetaxel (as trihydrate) 20mg/mlSanofi-Aventis Deutschland GmbH,

GermanyMediPharm Sdn Bhd

29 February 2012 till 28

February 2017 POM

745 BRU12020864P Zanidip® Tablet 10mgLercanidipine Hydrochloride 10mg (eq.

to 9.4mg Lercanidipine)

Recordati Industria Chimica &

Farmaceutica S.p.A, ItalyHongkiat Trading & Co

1 March 2017 till 28

February 2022 POM

746BRU12020865PS1 &

BRU12020865PS2Nifedipine LA Tablet 30mg Nifedipine 30mg

Valpharma International S.p.A, Italy

(S1); Valpharma S.A, Italy (S2)G & H Trading Company

1 March 2017 till 28

February 2022 POM

747 BRU12020866P

Apidra® Solostar®

100units/ml, Solution for

Injection in a Pre-filled Pen

Insulin Glulisine 100units/mlSanofi-Aventis Deutschland GmbH,

GermanyMediPharm Sdn Bhd

1 March 2017 till 28

February 2022 POM

748 BRU12020867P Zavedos CS Injection vials Idarubicin hydrochloride 1mg/ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd1 March 2017 till 28

February 2022 POM

749 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 Bhd1 March 2017 till 28

February 2022 POM

750 BRU12020869P Dermovate™ Cream Clobetasol (as propionate) 0.05% w/w Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd1 March 2017 till 28

February 2022 POM

751 BRU12020870P Lyrica™ 150mg Capsules Pregabalin 150mg Pfizer Manufacturing Deutshland

GmbH, GermanyZuellig Pharma (B) Sdn Bhd

1 March 2017 till 28

February 2022 POM

BDMCA/RMP/0317 Page 48 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

752 BRU12030871NP Panadol® Menstrual CapletParacetamol 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)

753 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

754 BRU12030873P LacipilTM Tablet 4mg Lacipidine 4mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd30 March 2017 till 29

March 2022 POM

755 BRU12030874P BrilintaTM 90mg F/C Tablet Ticagrelor 90mg AstraZeneca AB., Sweden Zuellig Pharma (B) Sdn Bhd30 March 2017 till 29

March 2022 POM

756 BRU12030875P DetrusitolTM SR Capsule 4mgTolterodine 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

757 BRU12030876NPEllgy Corns & Warts

Treatment SolutionSalicylic acid 17%w/v

HOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

30 March 2017 till 29

March 2022 P

758 BRU12030877PPuregon® 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 Bhd30 March 2017 till 29

March 2022 POM

759 BRU12030879PMethotrexate Injection BP

50mg in 2mlMethotrexate 50mg/2ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd

30 March 2017 till 29

March 2022 POM

760 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

761 BRU12030881P CelebrexTM 400mg Capsule Celecoxib 400mgPfizer Pharmaceuticals LLC., vega Baja

Puerto Rico, USAZuellig Pharma (B) Sdn Bhd

30 March 2017 till 29

March 2022 POM

762 BRU12030882PCancidas Powder for Injection

50mg/vialCaspofungin (as acetate) 50mg/vial

Laboratoires Merck Sharp & Dohme

Chibret, FranceZuellig Pharma (B) Sdn Bhd

30 March 2017 till 29

March 2022 POM

763 BRU12030883P Axcel Dextrozine Syrup

Dextromethorphan Hydrobromide

15mg/5ml; Promethazine HCl

3.6mg/5ml

Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd

30 March 2017 till 29

March 2022 POM

764 BRU12040884PDilantin Steri Vials 250mg in

5mlPhenytoin Sodium 250mg/5ml Actavis Italy S.p.A., Italy Zuellig Pharma (B) Sdn Bhd

30 April 2017 till 29 April

2022 POM

765 BRU12040885P

Jevtana® 60mg Concentrate

and Solvent for Solution for

Infusion

Cabazitaxel 60mg/1.5mlSanofi-Aventis Deutschland GmbH,

GermanyMedipharm Sdn Bhd

30 April 2012 till 29 April

2017 POM

BDMCA/RMP/0317 Page 49 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

766 BRU12040886P HycamtinTM Hard Capsule 1mg Topotecan 1mg (as hydrochloride) GlaxoSmithKline Manufacturing

S.p.A., Parma, ItalyZuellig Pharma (B) Sdn Bhd

30 April 2017 till 29 April

2022POM

767 BRU12040887NPPanadol Suspension

120mg/5mlParacetamol 120mg/5ml

SmithKline Beecham, Cainta Rizal,

Philippines

Kingston Beverage &

Creamey Sdn Bhd

30 April 2012 till 29 April

2017

GSL

(60ml & 120ml)

768 BRU12040888PCancidas Powder for Injection

70mg/vialCaspofungin (as acetate) 70mg/vial

Laboratoires Merck Sharp & Dohme

Chibret, FranceZuellig Pharma (B) Sdn Bhd

30 April 2017 till 29 April

2022 POM

769BRU12040889PS1 &

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 Bhd30 April 2017 till 29 April

2022 POM

770 BRU12040891P Axcel Diprodin ElixirDiphenhydramine HCl 12.5mg/5ml;

Ephedrine HCl 6mg/5mlKotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd30 April 2017 till 29 April

2022POM

771 BRU12040892NPAxcel 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)

772 BRU12040893P Axcel Clobetasol 0.05% Cream Clobetasol propionate 0.05%w/w Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 30 April 2017 till 29 April

2022POM

773 BRU12040894P Axcel Tridine SyrupTriprolidine HCl 1.25mg/5ml;

Pseudoephedrine HCl 30mg/5mlKotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 April 2017 till 29 April

2022POM

774 BRU12040895PAxcel Lignocaine Sterile Gel

2%w/w

Lignocaine HCl (Equiv. to anhydrous

HCl) 2g/100gKotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 April 2017 till 29 April

2022POM

775 BRU12040896PNiquitin 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

776 BRU12050897P VfendTM IV 200mg Voriconazole 200mgPharmacia & Upjohn Company, USA

(Repacker - Pfizer PGM, France)Zuellig Pharma (B) Sdn Bhd

24 May 2017 till 23 May

2022 POM

777 BRU12050898PLamictal Dispersible Tablet

5mgLamotrigine 5mg

GlaxoSmithKline Pharmaceuticals SA.,

Poznan, Poland (Repacker -

GlaxoSmithKline Australia Pty Ltd.,

ViCtoria, Australia)

Zuellig Pharma (B) Sdn Bhd24 May 2017 till 23 May

2022 POM

778 BRU12050899PHycamtinTM Hard Capsule

0.25mgTopotecan 0.25mg (as hydrochloride)

GlaxoSmithKline Manufacturing

S.p.A., Parma, ItalyZuellig Pharma (B) Sdn Bhd

24 May 2017 till 23 May

2022POM

779 BRU12050900P AeriusTM Syrup 0.5mg/ml Desloratadine 0.5mg/ml Schering-Plough Labo N.V., Belgium Zuellig Pharma (B) Sdn Bhd24 May 2017 till 23 May

2022POM

780 BRU12050901NP Flamazine Cream 1% w/w Silver Sulfadiazine 1.0%w/wRecipharm Parets S.L., Barcelona,

SpainMc Quipp Technisell

Marketing Sdn Bhd

24 May 2017 till 23 May

2022P

781 BRU12050902P AeriusTM Tablets 5mg Desloratadine 5mg Schering-Plough Labo N.V., Belgium Zuellig Pharma (B) Sdn Bhd24 May 2017 till 23 May

2022POM

BDMCA/RMP/0317 Page 50 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

782 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)

783 BRU12050904PVaxcel Heparin Sodium

Injection 5000 IU/ml x 5ml

Heparin Sodium (Bovine mucosa)

25,000/5mlKotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 24 May 2017 till 23 May

2022POM

784 BRU12050905PPregnyl® 5000IU Powder and

Solvent for Injection

Heparin Sodium (Bovine mucosa)

25,000/5mlMerck & Co. Inc., USA Zuellig Pharma (B) Sdn Bhd

24 May 2017 till 23 May

2022POM

785 BRU12050906PNiquitin 7mg Transdermal

PatchNicotine 36mg/cm2 (delivers 7mg/24

hours)ALZA Corporation, California, USA Zuellig Pharma (B) Sdn Bhd

24 May 2012 till 23 May

2017 P

786 BRU12050907NPEye 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

787 BRU12060908P Methycobal Tablets 500mcg Mecobalamin JP 0.5mg Bushu Pharmaceuticals Ltd, Japan Medipharm Sdn Bhd30 June 2017 till 29 June

2022 POM

788 BRU12060909P LyricaTM 75mg Capsules Pregabalin 75mgPfizer Manufacturing Deutschland

GmbH, Freiburg, GermanyZuellig Pharma (B) Sdn Bhd

30 June 2017 till 29 June

2022 POM

789 BRU12060910NPPanadol® Soluble Tablet

500mgParacetamol 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)

790 BRU12060911NPPanadol For Children Tablets

120mgParacetamol 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)

791 BRU12060912PCanesten GYN 1 Day Therapy

Vaginal Tablet 0.5gClotrimazole 500mg

Bayer Pharma AG, Leverkusen,

GermanyZuellig Pharma (B) Sdn Bhd

30 June 2017 till 29 June

2022 POM

792 BRU12060913P Casodex Tablet 50mg Bicalutamide 50mgCorden Pharma GmbH, Plankstadt,

GermanyZuellig Pharma (B) Sdn Bhd

30 June 2017 till 29 June

2022 POM

793 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)

794 BRU12060915NP 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)

795 BRU12060916P Rhewlin Gel 1%w/wDiclofenac Diethylamine equiv. to

Diclofenac Sodium 1%w/w

Beacons Pharmaceutical Pte Ltd,

Singapore

Hongkiat Trading &

Company

30 June 2012 till 29 June

2017 GSL

796 BRU12060917P Efexor® XR 37.5mg Capsule Venlafaxine Hydrochloride 37.5mgPfizer Ireland Pharmacueticals,

Kildare, Republic of IrelandZuellig Pharma (B) Sdn Bhd

30 June 2017 till 29 June

2022 POM

BDMCA/RMP/0317 Page 51 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

797 BRU12070918PBeclomet Nasal Aqua

50mcg/dose Nasal Spray

Beclomethasone dipropionate

50mcg/doseOrion Corporation, Kuopio, Finland

Hongkiat Trading &

Company

30 July 2012 till 29 July

2017 POM

798 BRU12070919PPanadol CF Cold and Flu

Caplets

Paracetamol 500mg; Pseudoephedrine

HCl 30mg; Chlorpheniramine 2mg

Sterling Drug (Malaya) Sdn Bhd.,

Selangor, MalaysiaZuellig Pharma (B) Sdn Bhd

30 July 2017 till 29 July

2022 P (10's)

799 BRU12070920NPPanadol® Biconvex Film-

coated Tablet 500mgParacetamol 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)

800 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

801 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

802 BRU12070923PCoversyl Plus 10mg/2.5mg

Tablet

Perindopril arginine 10mg (equiv. to

6.79mg perindopril); Indapamide

2.5mg

Servier (Ireland) Industries Ltd,

IrelandZuellig Pharma (B) Sdn Bhd

30 July 2017 till 29 July

2022POM

803 BRU12070924P RotarixTM oral SuspensionHuman rotavirus RIX4414 strain, not

less than 106.0 CCID50

GlaxoSmithKline Biological SA,

BelgiumZuellig Pharma (B) Sdn Bhd

30 July 2017 till 29 July

2022POM

804 BRU12070925P CutivateTM CreamFluticasone propionate (micronised)

0.05%w/wGlaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd

30 July 2017 till 29 July

2022POM

805 BRU12070926NP Bepanthen® Ointment Dexpanthenol 5%w/wGP Genzech Produktions GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

30 July 2017 till 29 July

2022GSL

806 BRU12070927P Axcel Hydrocortisone Cream Hydrocortisone (micronised) 1% w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 July 2017 till 29 July

2022POM

807 BRU12070928PSevoflurane 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

2022POM

808 BRU12080929PNiquitin 14mg Transdermal

PatchNicotine 78mg (14mg/24hrs) Alza Corporation, California, USA Zuellig Pharma (B) Sdn Bhd

29 August 2012 till 28

August 2017 P

809 BRU12080930NPDequadin® 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)

810 BRU12080931P Rilutek Tablets 50mg Riluzole 50mgSanofi Winthrop Industrie, Cedex,

FranceMedipharm Sdn Bhd

29 August 2017 till 28

August 2022 POM

BDMCA/RMP/0317 Page 52 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

811 BRU12080932P Efexor XR 75mg Capsule Venlafaxine (as HCl) 75mgPfizer Ireland Pharmaceuticals,

Kildare, Republic of IrelandZuellig Pharma (B) Sdn Bhd

29 August 2017 till 28

August 2022 POM

812 BRU12090933PXarelto® Film-coated Tablet

10mgRivaroxaban 10mg

Bayer Pharma AG, Leverkusen,

GermanyZuellig Pharma (B) Sdn Bhd

27 September 2017 till 26

September 2022 POM

813 BRU12090934P Nif-Ten Capsule Atenolol 50mg; Nifedipine 20mgCorden Pharma GmbH, Plankstadt,

GermanyZuellig Pharma (B) Sdn Bhd

27 September 2017 till 26

September 2022 POM

814 BRU12090937PTelfast 6mg/ml Oral

SuspensionFexofenadine Hydrochloride 6mg/ml

Sanofi-Aventis Farmceutica Ltd, Vila

Areiao Suzano-SP-BrasilMedipharm Sdn Bhd

27 September 2017 till 26

September 2022 POM

815 BRU12090938PGlucophage® XR 750mg

Extended Release TabletMetformin HCl 750mg

Merck KGaA, Germany; Merck Sante

SAS, Semoy, FranceZuellig Pharma (B) Sdn Bhd

27 September 2017 till 26

September 2022 POM

816 BRU12090939P Glucophage® Tablet 500mg Metformin HCl 500mg Merck Sante SAS, Semoy, France Zuellig Pharma (B) Sdn Bhd27 September 2017 till 26

September 2022 POM

817 BRU12100940NP Dermoplex Calamine CreamCalamine (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

818 BRU12100941PFragminTM Solution for

Injection 5,000IU (anti-

Xa)/0.2ml

Dalteparin Sodium 5,000IU (anti-

Xa)/0.2ml

Vetter Pharma-Fertigung GmbH &

Co., GermanyZuellig Pharma (B) Sdn Bhd

31 October 2017 till 30

October 2022 POM

819 BRU12100942PProstin E2TM Vaginal Tablet

3mgDinoprostone 3mg Sanico N.V., Turnhout, Belgium Zuellig Pharma (B) Sdn Bhd

31 October 2017 till 30

October 2022 POM

820 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 Bhd31 October 2017 till 30

October 2022 POM

821 BRU12100944NPPotassium Chloride Tablet

600mg (Slow release)Potassium Chloride 600mg

Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

31 October 2012 till 30

October 2017 POM

822 BRU12100945NP Anucare SuppositoriesZinc Oxide 300mg; Balsam Peru 50mg;

Benzyl Benzoate 33mg

Y.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

31 October 2012 till 30

October 2017 GSL

823 BRU12100946P Salbu-Air CFC Free InhalerSalbutamol Sulphate (micronised)

100mcg per actuation

Laboratorio Aldo-Union S.A.,

BarcelonaG & H Trading Company

31 October 2012 till 30

October 2017 POM

824 BRU12100947PIlliadin 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

825 BRU12100948PRenvela (Sevelamer

Carbonate) Tablet 800mgSevelamer Carbonate 800mg Genzyme Ireland Limited, Ireland Medipharm Sdn Bhd

31 October 2012 till 30

October 2017 POM

826 BRU12100949P Lyrica Capsules 50mg Pregabalin 50mgPfizer Manufacturing Deutschland

GmbH, Freiburg, GermanyZuellig Pharma (B) Sdn Bhd

31 October 2017 till 30

October 2022 POM

827 BRU12100950P QvarTM 100 InhalerBeclomethasone dipropionate 100mcg

per inhalation3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd

31 October 2017 till 30

October 2021 POM

BDMCA/RMP/0317 Page 53 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

828 BRU12100951P Prograf Capsule 0.5mg Tacrolimus 0.5mg Astellas Ireland Ltd, Ireland Zuellig Pharma (B) Sdn Bhd31 October 2017 till 30

October 2021 POM

829 BRU12110952P Panadol C TabletParacetamol 500mg; Pseudoephedrine

Hydrochloride 30mg

Sterling Drug (Malaya) Sdn Bhd,

MalaysiaZuellig Pharma (B) Sdn Bhd

27 November 2012 till 26

November 2017 P (10's)

830 BRU12110953PFragminTM 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., GermanyZuellig Pharma (B) Sdn Bhd

27 November 2017 till 26

November 2022 POM

831 BRU12110954P Efexor XR 150mg Capsule Venlafaxine (as Hydrochloride) 150mgPfizer Ireland Pharmaceuticals,

Kildare, Republic of IrelandZuellig Pharma (B) Sdn Bhd

27 November 2017 till 26

November 2022 POM

832 BRU12110955PEprex® 4000 Prefilled Syringe

4000IU/0.4mlEpoetin alfa 4,000IU/0.4ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd

27 November 2017 till 26

November 2022 POM

833 BRU121109561P Topamax® 50 Tablets Topiramate 50mg Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd27 November 2017 till 26

November 2022 POM

834 BRU12110956NP Vitamin C 100mg Tablet Ascorbic Acid 100mgBeacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

27 November 2012 till 26

November 2017 GSL

835BRU12110957PS1;

BRU12110957PS2

Actrapid® 100IU/ml Solution

for InjectionInsulin Human (rDNA) 100iu/ml

Novo Nordisk A/S, Denmark (S1);

Novo Nordisk Production SAS, France

(S2)

Medipharm Sdn Bhd27 November 2017 till 26

November 2022 POM

836 BRU12110958P Tretinon Cream 0.05% Tretinoin (Retinoic acid) 0.5mg/gY.S.P. Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

27 November 2017 till 26

November 2022 POM

837 BRU12110959PEprex® 2000 Prefilled Syringe

2000IU/0.5mlEpoetin alfa 2,000IU/0.5ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd

27 November 2017 till 26

November 2022 POM

838 BRU12110960NP Daflon 500mg Tablet Diosmin 450mg; Hesperidin 50mgLes Laboratories Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

27 November 2017 till 26

November 2022 GSL

839 BRU12110962P Tenol-100 Atenolol 100mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

27 November 2017 till 26

November 2022 POM

840 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)

841 BRU12110964PExjade 125mg Dispersible

TabletsDeferasirox 125mg

Novartis Pharmas Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

27 November 2017 till 26

November 2022 POM

842 BRU12110965PExjade 500mg Dispersible

TabletsDeferasirox 500mg

Novartis Pharmas Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

27 November 2017 till 26

November 2022 POM

843 BRU12110966NP Dhamotil TabletsDiphenoxylate HCl BP 2.5mg; Atropine

Sulphate 0.025mg

Drug Houses of Australia Pte Ltd.,

SingaporeG & H Trading Company

27 November 2012 till 26

November 2017 POM

BDMCA/RMP/0317 Page 54 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

844 BRU12120967PCervarixTM 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, BelgiumZuellig Pharma (B) Sdn Bhd

27 November 2017 till 26

November 2022 POM

845 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 Bhd27 November 2017 till 26

November 2022 POM

846 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

847 BRU12120970PClementin Film Coated Tablet

625mg

Amoxicillin (as Trihydrate) 500mg;

Clavulanic Acid (as Potassium Salt)

125mg

Yung Shin Pharmaceutical Ind. Co.

Ltd., Taichung, TaiwanAsterix United (B) Sdn Bhd

27 December 2012 till 26

December 2017 POM

848 BRU12120971PSurvanta® Beractant

Intratracheal SuspensionBeractant (as phospholipids) 25mg/ml AbbVie Inc., USA Zuellig Pharma (B) Sdn Bhd

27 December 2017 till 26

December 2022POM

849 BRU12120972PHumira Solution for Injection

40mg/0.8mlAdalimumab 40mg/0.8ml

Vetter-Pharma-Fertigung GmbH &

Co., KG, Ravensburg, GermanyZuellig Pharma (B) Sdn Bhd

27 December 2017 till 26

December 2022POM

850 BRU12120973P ZyrprexaTM Tablet 10mg Olanzapine 10mgLily del Caribe Inc, Puerto Rico, USA &

Lilly S.A., Madrid, SpainZuellig Pharma (B) Sdn Bhd

27 December 2017 till 26

December 2022POM

851 BRU12120974PSutentTM Hard Capsules

12.5mgSunitinib 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

852 BRU12120975P

Stelara Solution for Injection

in pre-filled syringe

45mg/0.5ml

Ustekinumab 45mg/0.5mlBaxter Pharmaceutical Solutions LLC,

Blommington, United StatesZuellig Pharma (B) Sdn Bhd

27 December 2017 till 26

December 2022 POM

853 BRU12120976P Viagra 50mg Tablet Sildenafil 50mg (as Citrate) Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd27 December 2017 till 26

December 2022 POM

854 BRU12120977P Viagra 100mg Tablet Sildenafil 100mg (as Citrate) Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd27 December 2017 till 26

December 2022 POM

855 BRU12120978PAerrane (Isoflurane USP)

Inhalation LiquidIsoflurane USP 100%

Baxter Healthcare Corporation,

Puerto Rico, USAZuellig Pharma (B) Sdn Bhd

27 December 2017 till 26

December 2022 POM

856 BRU12120979PKogenate FS for Injection

250IU/vial

Antihaemophilic Factor (recombinant)

sucrose formulated 250IUBayer Healthcare LLC., United States Zuellig Pharma (B) Sdn Bhd

27 December 2017 till 26

December 2022 POM

BDMCA/RMP/0317 Page 55 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

857 BRU12120980P Potcit MixturePer 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

858 BRU12120981P Garbose Tablet 100mg Acarbose 100mgY.S.P Industries (M) Sdn Bhd.,

Selangor Darul Ehsan, MalaysiaAsterix United (B) Sdn Bhd

27 December 2012 till 26

December 2017 POM

859 BRU13010982PKombiglyzeTM XR Tablet

5/1000mg

Saxagliptin HCl 5mg (as anhydrous

5.58mg); Metformin Hydrochloride

1000mg

AstraZeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd26 January 2013 till 25

January 2018 POM

860 BRU13010983PKombiglyzeTM XR Tablet

5/500mg

Saxagliptin HCl 5mg (as anhydrous

5.58mg); Metformin Hydrochloride

500mg

AstraZeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd26 January 2013 till 25

January 2018 POM

861 BRU13010984PKombiglyzeTM XR Tablet

2.5/1000mg

Saxagliptin HCl 2.5mg (as anhydrous

2.79mg); Metformin Hydrochloride

1000mg

AstraZeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd26 January 2013 till 25

January 2018 POM

862 BRU13010985P Zanidip® 20mg Tablet Lercanidipine HCl 20mgRecordati Industria Chimica &

Farmaceutica S.p.A., Milan, ItalyHongkiat Trading & Co

26 January 2018 till 25

January 2023 POM

863 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

864 BRU13010987P Pontalon Tablet 500mg Mefenamic Acid 500mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd26 January 2013 till 25

January 2018 POM

865 BRU13010988P Co-Trimexazole SuspensionPer 5ml - Sulphamethoxazole BP

200mg; Trimethoprim 40mg

Beacons Pharmaceuticals Pte Ltd,

SingaporeHongkiat Trading & CO

26 January 2013 till 25

January 2018 POM

866 BRU13010989P Opticrom® Eye Drops 2% w/v Sodium Cromoglycate BP 2% w/v Sanofi Winthrop Industrie, France Medipharm Sdn Bhd26 January 2013 till 25

January 2018 P

867 BRU13010990NPPanamol Paed. Suspension

120mg/5mlParacetamol 120mg/5ml

Beacons Pharmaceuticals Pte ltd,

SingaporeHongkiat Trading & Co

26 January 2013 till 25

January 2018 P (3.8L)

868 BRU13010991PHumulin 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 Bhd26 January 2018 till 25

January 2023 POM

869 BRU13010993PFML® Liquifilm Sterile

Opthalmic Solution 0.1%Fluorometholone 0.1%w/v

Allergan Pharmaceuticals Ireland,

IrelandMedipharm Sdn Bhd

26 January 2018 till 25

January 2023 POM

870 BRU13010994NPLacri-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 Bhd26 January 2013 till 25

January 2018 GSL

871 BRU13010995P Daivonex® Ointment Calcipotriol 50mcg/g (0.005% w/w)LEO Laboratories Ltd (LEO Pharma),

IrelandZuellig Pharma (B) Sdn Bhd

26 January 2018 till 25

January 2023 POM

872 BRU13010996P Seretide Evohaler 25/125mcg

Per actuation - Fluticasone propionate

125mcg; Salmetarol 25mcg (as

xinafoate)

Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd26 January 2018 till 25

January 2023 POM

873 BRU13010997P Glucophage® Tablet 850mgMetformin HCl 850mg (~Metformin

662.9mg)Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd

26 January 2018 till 25

January 2023 POM

BDMCA/RMP/0317 Page 56 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

874 BRU13010998P Revlimid® Capsules 5mg Lenalidomide 5mg

Penn Pharmaceutical Services

Limited, UK & Celgene International

Sarl, Switzerland

Zuellig Pharma (B) Sdn Bhd26 January 2018 till 25

January 2023 POM

875 BRU13010999NP Infusol® NS Sodium Chloride 0.9% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah26 January 2013 till 25

January 2018 GSL

876 BRU13011000P Inpanol Tablets 10mg Propranolol BP 10mgDrug Houses of Australia Private

Limited, SingaporeG & H Trading Company

26 January 2013 till 25

January 2018 POM

877 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

878 BRU13011002P One-Alpha® Capsule 1mcgAlfacalcidol 1mcg (1α-Hydroxy-vitamin

D3)

Leo Pharmaceutical Products Ltd., A/S

(Leo Pharma), DenmarkZuellig Pharma (B) Sdn Bhd

26 January 2013 till 25

January 2018 POM

879 BRU13011003PNimotop Infusion Solution

0.02%Nimodipine 0.01g/50ml

Bayer Schering Pharma AG,

Leverkeusen, GermanyZuellig Pharma (B) Sdn Bhd

26 January 2013 till 25

January 2018 POM

880 BRU13011004PGemzar 200mg Powder for

Solution for InfusionGemcitabine 200mg (as HCl) Eli Lilly and Company, Indiana, USA Zuellig Pharma (B) Sdn Bhd

26 January 2013 till 25

January 2018 POM

881 BRU13011005P ZyprexaTM 5mg Tablet Olanzapine 5mgLilly del Caribe Inc., Puerto Rico, USA

& Lilly, S.A., SpainZuellig Pharma (B) Sdn Bhd

26 January 2018 till 25

January 2023 POM

882 BRU13021006PCanesten GYN Vaginal Tablet

100mg - 3 day therapyClotrimazole 100mg

Bayer Consumer AG, Basel,

SwitzerlandZuellig Pharma (B) Sdn Bhd

26 February 2013 till 25

February 2018 POM

883 BRU13021008PPrevenar 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, IrelandZuellig Pharma (B) Sdn Bhd

26 February 2013 till 25

February 2018 POM

884 BRU13021009PHemabate Sterile Solution

250mcg/ml

Carboprost (as tromethamine)

250mcg/mlPharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd

26 February 2013 till 25

February 2018 POM

885BRU13021010PS1;

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 Bhd26 February 2018 till 25

February 2023 GSL

886 BRU13021011PExtraneal 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 Bhd26 February 2018 till 25

February 2023 POM

887 BRU13021012P Afinitor Tablet 10mg Everolimus 10mgNovartis Pharma Stein AG, Stein,

SwitzerlandZuellig Pharma (B) Sdn Bhd

26 February 2013 till 25

February 2018 POM

888 BRU13021013P Ketovid Cream 2% Ketoconazole 2.0% w/w Hovid Bhd, Perak, Malaysia G & H Trading Company26 February 2013 till 25

February 2018 POM

889 BRU13021014P Progynova® Tablet 2mg Estradiol Valerate 2mgDelpharm Lille SAS, Lys Les Lannoy,

FrancZuellig Pharma (B) Sdn Bhd

26 February 2013 till 25

February 2018 POM

BDMCA/RMP/0317 Page 57 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

890 BRU13021015P Azopt Eye Drops, Suspension Brinzolamide 10mg/ml (1.0%w/w) S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co26 February 2013 till 25

February 2018 POM

891 BRU13021016P Rhewlin SR Tablet Diclofenac Sodium 100mgBeacons Pharmaceutical Pte Ltd,

SingaporeHongkiat Trading & Co

26 February 2013 till 25

February 2018 POM

892 BRU13021017PHydrogen Peroxide Solution

6%

Hydrogen Peroxide 6% w/v (equivalent

to 20 volumes of oxygen)

Xepa-Soul Pattinson (Malaysia) Sdn

Bhd, MalaysiaHongkiat Trading & Co

26 February 2013 till 25

February 2018 P

893 BRU13021018P Inpanol Tablets 40mg Propranolol BP 40mgDrug Houses of Australia Private

Limited, SingaporeG & H Trading Company

26 February 2013 till 25

February 2018 POM

894 BRU13021019PStilamin 3000 for Injection

3mg/ampouleSomatostatin (as acetate) 3mg

Merck Serono SA, Aubonne,

SwitzerlandG&H Trading Company

26 February 2018 till 25

February 2023 POM

895 BRU13021020P Loradine Syrup 1mg/ml Loratadine 1mg/mlY.S.P Industries (M) Sdn Bhd, Selangor

Darul Ehsan, MalaysiaAsterix United (B) Sdn Bhd

26 February 2013 till 25

February 2018 P

896 BRU13021021P Decozol Oral Gel 2% w/w Miconazole 2% w/wHOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

26 February 2013 till 25

February 2018 GSL

897 BRU13021022P Rasitol Injection 20mg/2ml Furosemide 20mg/2mlYung Shin Pharmaceutical Ind. Co.

Ltd., Taiwan, ROCAsterix United (B) Sdn Bhd

26 February 2013 till 25

February 2018 POM

898 BRU13021023P Fusate-250 Tablet Sodium fusidate 250mgNoripharma Sdn Bhd, Selangor Darul

Ehsan, MalaysiaK-Seri Pharma Sdn Bhd

26 February 2013 till 25

February 2018 POM

899 BRU13021024P Premarin Vaginal Cream Conjugated Oestrogen (CE) 0.625mg/g Pfizer Canada Inc., Canada Zuellig Pharma (B) Sdn Bhd26 February 2013 till 25

February 2018 POM

900 BRU13021025NP Dhalgesic Rub 15% w/wMethyl salicylate 15% w/w; Menthol

5% w/w; Camphor (racemic) 2% w/w

Drug Houses of Australia Private

Limited, SingaporeG & H Trading Company

26 February 2013 till 25

February 2018 GSL

901 BRU13021026PKaletra Film-coated Tablet

200mg/50mgLopinavir 200mg; Ritonavir 50mg

AbbVie Deutschland GmbH & Co. KG,

GermanyZuellig Pharma (B) Sdn Bhd

26 February 2013 till 25

February 2018 POM

902 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

NetherlandsZuellig Pharma (B) Sdn Bhd

26 February 2013 till 25

February 2018 POM

903 BRU13021028P Holoxan for Injection Ifosfamide 1g Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd26 February 2018 till 25

February 2023 POM

904 BRU13031029NP Panadol Extend Tablet Paracetamol 665mgGlaxoSmithKline Australia Pty Ltd,

Australia

Kingston Beverage &

Creamery Sdn Bhd

28 March 2013 till 27

March 2018 P (8 x 6's)

905 BRU13031030P Canesten Cream 1% w/w Clotrimazole 1% w/w Encube Ethicals Private Ltd, India Zuellig Pharma (B) Sdn Bhd28 March 2018 till 27

March 2023 GSL

906 BRU13031032PPantaprazole Winthrop 20mg

Tablet

Pantoprazole (as sodium

sesquihydrate) 20mgSanofi-Aventis S.P.Z.O.O., Poland Medipharm Sdn Bhd

28 March 2013 till 27

March 2018 POM

907BRU13031033PS1;

BRU13031033PS2Metoclopramide 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 Company28 March 2013 till 27

March 2018 POM

BDMCA/RMP/0317 Page 58 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

908 BRU13031034P Loperamil Tablet 2mg Loperamide 2mgDrug House of Australia Pte Ltd,

SingaporeG & H Trading Company

28 March 2013 till 27

March 2018 POM

909 BRU13031035P Hydralazine Tablet 50mg Hydralazine HCl 50mgBeacons Pharmaceuticals Pte Ltd,

SingaporeHongkiat Trading & Co

28 March 2013 till 27

March 2018 POM

910 BRU13031036P Dhacort Cream 1%w/wHydrocortisone acetate BP

(micronised) 1% w/w

Drug Houses of Australia Private

Limited, SingaporeG & H Trading Company

28 March 2013 till 27

March 2018 POM

911 BRU13031037P Tracidol Capsule 50mg Tramadol HCl 50mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd28 March 2013 till 27

March 2018 POM

912 BRU13031038PSolcoseryl Dental Adhesive

Paste

Per g - Solcoseryl CMC 2.125mg;

Polidocanol 10mg

Legacy Pharmaceuticals Switzreland

GmbH, SwitzerlandZuellig Pharma (B) Sdn Bhd

28 March 2018 till 27

March 2023 POM

913 BRU13031039NP Infusol® S3 Sodium Chloride 3% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah28 March 2013 till 27

March 2018 POM

914 BRU13031040P Indapamide SR Tablet 1.5mg Indapamide 1.5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd28 March 2013 till 27

March 2018 POM

915 BRU13031041P Dhatifen Syrup 1mg/5mlKetotifen (as hydrogen fumarate)

1mg/5ml

Drug Houses of Australia Private

Limited, SingaporeG & H Trading Company

28 March 2013 till 27

March 2018 POM

916 BRU13031042P Inox Capsule 100mg Itraconazole 100mg Hovid Bhd, Malaysia G & H Trading Company28 March 2013 till 27

March 2018 POM

917 BRU13031043P Doxycap capsule 100mg Anhydrous Doxycycline 100mg Hovid Bhd, Malaysia G & H Trading Company28 March 2013 till 27

March 2018 POM

918 BRU13031044P Zenmolin tablet 2mg Salbutamol (as sulphate) 2mgDrug Houses of Australia Private

Limited, SingaporeG & H Trading Company

28 March 2013 till 27

March 2018 POM

919 BRU13031045PRecormon Pre-filled Syringe

2000IU/0.3mlErythropoetin Beta 2,000iu/0.3ml Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd

28 March 2013 till 27

March 2018 POM

920 BRU13031046P Leukeran Tablet 2mg Chlorambucil 2mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd28 March 2013 till 27

March 2018 POM

921 BRU13031047PRecormon Pre-filled Syringe

4000IU/0.3mlErythropoetin Beta 4,000iu/0.3ml Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd

28 March 2013 till 27

March 2018 POM

922 BRU13031049PSaizen for Injection

3.33mg/vialSomatropin 3.33mg (10 IU) Merck Serono S.A., Switzerland G & H Trading Company

28 March 2013 till 27

March 2018 POM

923 BRU13031050P Isentress 400mg TabletRaltegravir 400mg (as potassium

434.4mg)

MSD Technology Singapore Pte Ltd.,

SingaporeZuellig Pharma (B) Sdn Bhd

28 March 2018 till 27

March 2023 POM

924 BRU13041051P

Taxotere 80mg/4ml

Concentrate for Solution for

Infusion

Docetaxel trihydrate 80mg/4mlSanofi-Aventis Deutschland GmbH,

GermanyMedipharm Sdn Bhd

30 April 2013 till 29 April

2018 POM

925 BRU13041052PFosamax Plus Tablet

70mg/5600IU

Alendronic Acid 70mg (as Sodium

91.37mg); Colecalciferol 140mcg

(5,600IU)

MSD Frosst Iberica, S.A., Madrid,

SpainZuellig Pharma (B) Sdn Bhd

30 April 2018 till 29 April

2023 POM

926 BRU13041053PGlucovance Tablet

500mg/2.5mg

Metformin HCl 500mg, Glibenclamide

2.5mgMerck Sante SAS, Semoy, France Zuellig Pharma (B) Sdn Bhd

30 April 2013 till 29 April

2018 POM

927BRU13041054PS1 &

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 (S2)

G & H Trading Company30 April 2013 till 29 April

2018 POM

BDMCA/RMP/0317 Page 59 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

928 BRU13041055P Alpranax Tablet 0.5mg Alprazolam 0.5mg Y.S.P Industries (M) Sdn Bhd Malaysia K-Seri Pharma Sdn Bhd30 April 2013 till 29 April

2018 POM

929 BRU13041056NP Liquid Paraffin Liquid Paraffin 100%w/wBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

30 April 2013 till 29 April

2018 GSL

930 BRU13041058PPegasys Pre-filled Syringe

180mcg/0.5mlPeginterferon 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 & Co30 April 2013 till 29 April

2018 POM

931 BRU13041059P Borymycin Capsule 50mg Minocycline HCl 50mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd30 April 2013 till 29 April

2018 POM

932 BRU13041060P Kytril Tablet 1mg Granisetron 1mg (as HCl) Roche S.p.A., Italy Hongkiat Trading & Co30 April 2013 till 29 April

2018 POM

933 BRU13041061PVenofer® Solution for

Injection 100mg/5ml

Iron (III) [as Iron (III)-hydroxide

sucrose complex] 100mg/5ml

IDT Biologika GmbH, Germany; BIPSO

GmbH, GermanyHongkiat Trading & Co

30 April 2013 till 29 April

2018 POM

934 BRU13041062NP Calamine cream Calamine 4%w/w; Zinc Oxide 3% w/wBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

30 April 2013 till 29 April

2018 GSL

935 BRU13041063P Apuzin tablet 25mg Captopril 25mgY.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

30 April 2013 till 29 April

2018 POM

936 BRU13041064PLezpain film-coated tablet

135mgMebeverine HCl 135mg

Y.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

30 April 2013 till 29 April

2018 POM

937 BRU13041065P Copegus Tablet 200mg Ribavarin 200mgHoffman-La Roche Inc., USA; Patheon

Inc., Ontario, CanadaHongkiat Trading & Co

30 April 2013 till 29 April

2018 POM

938 BRU13041066P Celexin 250 Film-coated Tablet Cephalexin 250mg (as monohydrate) Hovid Bhd, Malaysia K-Seri Pharma Sdn Bhd30 April 2013 till 29 April

2018 POM

939 BRU13041067NP White Soft Paraffin White Soft Paraffin Sasaol Wax GmbH, Germany Hongkiat Trading & Co30 April 2013 till 29 April

2018 GSL

940 BRU13041068NP Calamine Lotion 15% w/v Calamine 15%w/vBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

30 April 2013 till 29 April

2018 GSL

941 BRU13061069PVotrient™ Film-coated tablets

200mgPazopanib (as hydrochloride) 200mg

Glaxo Operations UK Ltd,

Hertfordshire, UKZuellig Pharma (B) Sdn Bhd

04 June 2013 till 03 June

2018 POM

942

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 Bhd04 June 2013 till 03 June

2018 POM

943 BRU13061071P Duphaston Tablet 10mg Dydrogesterone 10mgAbbott Biologicals B.V., The

NetherlandsZuellig Pharma (B) Sdn Bhd

04 June 2013 till 03 June

2018 POM

BDMCA/RMP/0317 Page 60 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

944 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 Company04 June 2013 till 03 June

2018 GSL

945 BRU13061073P Prednisolone Tablet 20mg Prednisolone 20mgBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

04 June 2013 till 03 June

2018 POM

946 BRU13061074P Kytril For Infusion 3mg/3ml Granisetron 3mg (as HCl 3.36mg) Cenexi SAS, France Hongkiat Trading & Co04 June 2013 till 03 June

2018 POM

947 BRU13061075P Minison Tablet 1mg Prazosin 1mg (as HCl 1.095mg)Y.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

04 June 2013 till 03 June

2018 POM

948 BRU13061076P Xeloda™ Tablets 500mg Capecatibine 500mg Productos Roche S.A. de C.V, Mexico Zuellig Pharma (B) Sdn Bhd04 June 2013 till 03 June

2018 POM

949 BRU13061077PChloramphenicol Eye

OintmentChloramphenicol 10mg/g KRKA d.d., Slovenia K-Seri Pharma Sdn Bhd

04 June 2013 till 03 June

2018 POM

950 BRU13061078NP Zentel Tablet 200mg Albendazole 200mg Tianjin SKF Labs Ltd, Tianjin, ChinaKingston Beverage &

Creamery Sdn Bhd

04 June 2013 till 03 June

2018 GSL (2's)

951 BRU13061079NP Maltofer® Syrup Iron (III) [as Iron (III)-hydroxide-

polymaltose complex] 10mg/ml

Vifor S.A., Switzerland & Vifor

(International) Inc., SwitzerlandMedipharm Sdn Bhd

04 June 2013 till 03 June

2018 GSL

952 BRU13061080P Noriday® Tablet Norethisterone 0.35mgPiramal Healthcare UK Limited,

United KingdomZuellig Pharma (B) Sdn Bhd

04 June 2013 till 03 June

2018 POM

953 BRU13061081PKeppra 250mg Film-coated

TabletLevetiracetam 250mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd

04 June 2013 till 03 June

2018 POM

954 BRU13061082PKeppra 500mg Film-coated

TabletLevetiracetam 500mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd

04 June 2013 till 03 June

2018 POM

955

BRU13061083PS1,

BRU13061083PS2,BRU

13061083PS3,

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)

Hongkiat Trading & Co04 June 2013 till 03 June

2018 POM

956 BRU13061084P Xeloda Tablet 150mg Capecatibine 150mg Productos Roche S.A. de C.V, Mexico Zuellig Pharma (B) Sdn Bhd04 June 2013 till 03 June

2018 POM

957 BRU13061085PUripax Film-coated Tablet

200mgFlavoxate HCl 200mg

Y.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

04 June 2013 till 03 June

2018 POM

958 BRU13061086PAtorvas Tablets 10mg

Atorvastatin (as calcium) 10mgRanbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

04 June 2013 till 03 June

2018 POM

959 BRU13061087PElonva Solution for Injection

150mcg/0.5mlCorifollitrophin alfa 150mcg/0.5ml

Vetter Pharma-Fertigung GmbH & Co.

KG, GermanyZuellig Pharma (B) Sdn Bhd

27 June 2013 till 26 June

2018 POM

BDMCA/RMP/0317 Page 61 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

960 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 & Co27 June 2013 till 26 June

2018 POM

961 BRU13061089P Maxidex® Eye Ointment Dexamethasone 0.1% w/w S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co27 June 2013 till 26 June

2018 POM

962 BRU13061090NPCiproxol (Ciprofloxacin) 0.2%

w/v Intravenous Infusion BPCiprofloxacin 0.2% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah

27 June 2013 till 26 June

2018 POM

963 BRU13061091NPInfusol® W Intravenous

Infusion BPWater for Injection BP Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah

27 June 2013 till 26 June

2018 GSL

964 BRU13061092P Isoket Ampoule 10mg/10ml Isosorbide Dinitrate 10mg/10ml (0.1%) EVER Pharma Jena GmbH, Germany Zuellig Pharma (B) Sdn Bhd27 June 2013 till 26 June

2018 POM

965 BRU13061093P Invoril tablets 10mg Enalapril maleate 10mgRanbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

27 June 2013 till 26 June

2018 POM

966 BRU13061094PPharmaniaga Simvastatin

tablet 10mgSimvastatin 10mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

27 June 2013 till 26 June

2018 POM

967 BRU13061095P Vitamin B1 Tablet Thiamine HCl 10mgBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

27 June 2013 till 26 June

2018 POM

968 BRU13061096P Invoril tablets 20mg Enalapril maleate 20mgRanbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

27 June 2013 till 26 June

2018 POM

969 BRU13061097P Seldron Cleaning Lotion Selenium Sulphide USP 2.5% w/v ICM Pharma Pte Ltd, SingaporeMc Quipp Technisell

Marketing Sdn Bhd

27 June 2013 till 26 June

2018 p

970 BRU13071098NP Cortal for Children Tablet Acetaminophen (Paracetamol) 80mgSterling Drug (Malaya) Sdn Bhd,

Malaysia

Kingston Beverage &

Creamery Sdn Bhd

30 July 2013 till 29 July

2018

P

12 x 12's (144's)

971 BRU13071099PChampix 1mg film-coated

tabletVarenicline Tartrate 1mg

Pfizer Manufacturing Deutschland

GmbH, GermanyZuellig Pharma (B) Sdn Bhd

30 July 2013 till 29 July

2018 POM

972 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

973 BRU13071101PGlucophage XR 500mg

Extended Release TabletMetformin HCl 500mg Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd

30 July 2013 till 29 July

2018 POM

974 BRU13071102P Victrelis Capsule 200mg Boceprevir 200mgSchering-Plough (Singapore) Pte Ltd,

SingaporeZuellig Pharma (B) Sdn Bhd

30 July 2013 till 29 July

2018 POM

975 BRU13071103P Axcel Cefaclor-250 Capsule Cefaclor (as monohydrate) 250mg Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd

30 July 2013 till 29 July

2018 POM

976 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), SwizerlandG & H Trading Company

30 July 2013 till 29 July

2018 POM

977 BRU13071105P Lignocaine Injection 2% x 5ml Lignocaine Hydrochloride 20mg/ml Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd30 July 2013 till 29 July

2018 POM

978 BRU13071106PPred Mild® Sterile Ophthalmic

Suspension 0.12%Prednisolone acetate 0.12% w/v

Allergen Pharmaceuticals Ireland,

Wesport, IrelandMedipharm Sdn Bhd

30 July 2013 till 29 July

2018 POM

BDMCA/RMP/0317 Page 62 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

979 BRU13071107P Tamiflu Capsules 75mg Oseltamivir 75mg

Cenexi SAS, France; Catalent Germany

Schorndorf GmbH, Germany; Roche

S.p.A., Italy

Zuellig Pharma (B) Sdn Bhd30 July 2013 till 29 July

2018 POM

980 BRU13071108P Revlimid® Capsules 25mg Lenalidomide 25mg

Penn Pharmaceutical Services

Limited, UK & Celgene International

Sarl, Switzerland

Zuellig Pharma (B) Sdn Bhd30 July 2013 till 29 July

2018 POM

981 BRU13071109P Revlimid® Capsules 15mg Lenalidomide 15mg

Penn Pharmaceutical Services

Limited, UK & Celgene International

Sarl, Switzerland

Zuellig Pharma (B) Sdn Bhd30 July 2013 till 29 July

2018 POM

982 BRU13071110P Solcoseryl Eye Gel Solcoseryl 120 Concentrate 8.3mg/gLegacy Pharmaceuticals Switzreland

GmbH, SwitzerlandZuellig Pharma (B) Sdn Bhd

30 July 2018 till 29 July

2023POM

983 BRU13071111P Micosten-H CreamMiconazole Nitrate 2%;

Hydrocortisone 1%Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd

30 July 2013 till 29 July

2018 POM

984 BRU13071112PPharmaniaga Labetalol Tablet

100mgLabetalol Hydrochloride 100mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

30 July 2013 till 29 July

2018 POM

985 BRU13071113P Hydralazine Tablet 10mg Hydralazine Hydrochloride 10mgDrug Houses of Australia Private

Limited, SingaporeG & H Trading Company

30 July 2013 till 29 July

2018 POM

986 BRU13071114PSandimmun Neoral Capsule

25mgCiclosporin A 25mg

R.P. Scherer GmbH & Co. KG.,

GermanyZuellig Pharma (B) Sdn Bhd

30 July 2013 till 29 July

2018 POM

987 BRU13081115P Champix 0.5mg & 1mg TabletVarenicline Tartrate 0.5mg &

Varenicline Tartrate 1mg

Pfizer Manufacturing Deutschland

GmbH, GermanyZuellig Pharma (B) Sdn Bhd

27 August 2013 till 26

August 2018 POM

988 BRU13081116P Daktarin Oral Gel 2% Miconzaole 2% Janssen Pharmaceutical NV, Belgium Zuellig Pharma (B) Sdn Bhd27 August 2013 till 26

August 2018 P

989 BRU13081117P Dhasedyl DM Syrup

Per 5ml - Dextromethorphan HBr

10mg; Promethazine HCl 3.6mg/

Ephedrine HCl 6mg

Drug House of Australia (Asia) Pte Ltd,

SingaporeG & H Trading Company

27 August 2013 till 26

August 2018 POM

990 BRU13081118P Daivonex® Cream Calcipotriol 50mcg/g (0.0005% w/w)LEO Laboratories Ltd (LEO Pharma),

IrelandZuellig Pharma (B) Sdn Bhd

27 August 2013 till 26

August 2018 POM

991BRU13081119PS1;

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

992 BRU13081120PEnbrel® 25mg solution for

injection in pre-filled syringeEtanercept 25mg/0.5ml

Pfizer Ireland Pharmaceuticals,

IrelandZuellig Pharma (B) Sdn Bhd

27 August 2013 till 26

August 2018 POM

993 BRU13081121P Xenical Capsule 120mg Orlistat 120mg Roche SpA, Italy Zuellig Pharma (B) Sdn Bhd27 August 2013 till 26

August 2018 POM

994 BRU13081122P Requip® Tablet 1mg Ropinirole (as Hydrochloride) 1mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd27 August 2013 till 26

August 2018 POM

995 BRU13081123P Minazol Powder 2% Miconzaole Nitrate 2% w/wBiosis Pharmaceuticals Sdn Bhd.,

MalaysiaK-Seri Pharma Sdn Bhd

27 August 2013 till 26

August 2018 P

996 BRU13081124P Heparinol 5000IU/ml Heparin Sodium (bovine) 5,000IU/ml Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah27 August 2013 till 26

August 2018 POM

BDMCA/RMP/0317 Page 63 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

997 BRU13081125PPharmaniaga Pyrazinamide

Tablet 500mgPyrazinamide 500mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

27 August 2013 till 26

August 2018 POM

998 BRU13081126P Sathrocin ES Tablet 400mgErythromycin (as ethylsuccinate)

400mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

27 August 2013 till 26

August 2018 POM

999 BRU13081127P Ketovid Shampoo 2% w/v Ketoconazole (micronised) 2% w/w Hovid Bhd, Malaysia G & H Trading Company27 August 2013 till 26

August 2018 POM

1000 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 & Co27 August 2013 till 26

August 2018 POM

1001 BRU13091129P VentolinTM Syrup 2mg/5ml Salbutamol Sulphate (as sulphate)

5mg/5mlSmithKlineBeecham, Rizal, Philippines Zuellig Pharma (B) Sdn Bhd

28 September 2013 till 27

September 2018 POM

1002 BRU13091130PErbitux® 5mg/ml Solution for

InfusionCetuximab 5mg/ml

Boehringer Ingelheim, Germany &

Merck KGaA, Germany (1 Artwork)Zuellig Pharma (B) Sdn Bhd

28 September 2013 till 27

September 2018 POM

1003 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,

SingaporeHongkiat Trading & Co

28 September 2013 till 27

September 2018 GSL

1004 BRU13091133PClexane 4000/0.4ml Anti XA

Pre-filled Syringe

Enoxaprin sodium 4,000 anti-Xa

IU/0.4ml equivalent to 40mg/0.4mlSanofi Winthrop Industrie, France Medipharm Sdn Bhd

28 September 2013 till 27

September 2018 POM

1005 BRU13091134PPantaprazole Winthrop 40mg

Tablet

Pantoprazole (as sodium

Sesquihydate) 40mgSanofi-Aventis S.P.Z.O.O., Poland Medipharm Sdn Bhd

28 September 2013 till 27

September 2018 POM

1006 BRU13091135P Iodosorb PowderCadexomer 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

1007 BRU13091136P Anlodin Tablet 10mg Amlodipine (as besylate) 10mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd28 September 2013 till 27

September 2018 POM

1008 BRU13091137P Effient Tablet 5mg Prasugrel HCl 5mg Eli Lilly & Co., USA Zuellig Pharma (B) Sdn Bhd28 September 2013 till 27

September 2018 POM

1009 BRU13091138PClexane 6000/0.6ml Anti-Xa

IU Pre-filled Syringe

Enoxaprin sodium 6,000 anti-Xa

IU/0.6ml equivalent to 60mg/0.6mlSanofi Winthrop Industrie, France Medipharm Sdn Bhd

28 September 2013 till 27

September 2018 POM

1010 BRU13091139PSimvastatin Winthrop 40mg

TabletSimvastatin 40mg Sanofi Aventis S.p.z.o.o, Poland Medipharm Sdn Bhd

28 September 2013 till 27

September 2018 POM

1011 BRU13091140P Camazol Tablet 5mg Carbimazole 5mgXepa-Soul Pattinson (M) Sdn Bhd

MalaysiaHongkiat Trading & Co

28 September 2013 till 27

September 2018 POM

1012 BRU13091141P Pulin Injection 10mg/2ml Metoclopramide HCl 10mg/2mlYung Shin Pharmaceutical Ind. Co.

Ltd., TaiwanAsterix United (B) Sdn Bhd

28 September 2013 till 27

September 2018 POM

1013 BRU13091142NP Sulbutiamine 200 capsule Sulbutiamine 200mg Pahang Pharmacy Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd28 September 2013 till 27

September 2018 GSL

BDMCA/RMP/0317 Page 64 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1014 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 Bhd28 September 2013 till 27

September 2018 POM

1015 BRU13091144P Bezamidin Tablet 200mg Bezafibrate 200mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd28 September 2013 till 27

September 2018 POM

1016 BRU13091145NP A-Bite Cream Crotamiton 10%w/wHOE Pharmaceuticals Sdn Bhd

MalaysiaG & H Trading Company

28 September 2013 till 27

September 2018 GSL

1017 BRU13091146P Tipidin Tablet 250mg Ticolopidine HCl BP 250mgDrug Houses of Australia Private

Limited, SingaporeG & H Trading Company

28 September 2013 till 27

September 2018 POM

1018 BRU13091147P Gynera Tablets Ethinylestradiol 0.03mg; Gestodene

0.075mg

Schering do Brasil Quimica e

Farmaceutica Ltda., Sao Paulo, BrazilZuellig Pharma (B) Sdn Bhd

28 September 2013 till 27

September 2018 POM

1019 BRU13101148P Eumovate™ Cream Clobetasone 17-butyrate 0.05% w/w Glaxo Wellcome Opration, UK Zuellig Pharma (B) Sdn Bhd31 October 2013 till 31

October 2018 POM

1020 BRU13101149PErycin Film Coated Tablet

250mgErythromycin (as stearate) 250mg

Y.S.P. Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

31 October 2013 till 31

October 2018 POM

1021 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

1022 BRU13101152P Hycamtin™ Injection 1MG Topotecan (as HCl) 1mgGlaxoSmithKline Manufacturing

S.p.A., Parma, ItalyZuellig Pharma (B) Sdn Bhd

31 October 2013 till 31

October 2018 POM

1023 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

1024 BRU13101154PAxcel Mefenamic Acid

SuspensionMefenamic Acid 125mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

31 October 2013 till 31

October 2018 POM

1025 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., SwitzerlandG & H Trading Company

31 October 2013 till 31

October 2018 POM

1026 BRU13101156PSandimmun Neoral Capsule

100mgCiclosporin 100mg

R.P Scherer GmbH & Co, Baden,

GermanyZuellig Pharma (B) Sdn Bhd

31 October 2013 till 31

October 2018 POM

1027 BRU13101157P Tobrex Eye Ointment Tobramycin 0.3% (3mg/g) S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co31 October 2013 till 31

October 2018 POM

1028 BRU13101158P Endoxan Tablet 50mgCyclophosphamide anhydrous (as

monohydrate) 50mg

Prasfarma S.L., Manlleu/Barcelona,

Spain; Haupt Pharma Amareg GmBH,

Germany

Zuellig Pharma (B) Sdn Bhd31 October 2013 till 31

October 2018 POM

1029 BRU13101159P CEF-4® Injection 500mg Ceftazidime (as pentahydrate) 500mgSiam Bheasach Co. Ltd., Bangkok,

ThailandK-Seri Pharma Sdn Bhd

31 October 2013 till 31

October 2018 POM

BDMCA/RMP/0317 Page 65 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1030 BRU13101160P Premarin Tablet 0.625mg Conjugated Estrogens 0.625mgPfizer Ireland Pharmaceuticals,

Kildare, IrelandZuellig Pharma (B) Sdn Bhd

31 October 2013 till 31

October 2018 POM

1031BRU13101161PS1;

BRU13101161PS2Revlimid capsules 10mg Lenalidomide 10mg

Penn Pharmaceutical Services, Gwent,

UK (S1) & Celgene International Sarl,

Boudry, Switzerlnd (S2)

Zuellig Pharma (B) Sdn Bhd31 October 2013 till 31

October 2018 POM

1032 BRU13101162PPharmaniaga Cephalexin

Suspension 125mg Cephalexin (as anhydrous) 125mg/5ml

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

31 October 2013 till 31

October 2018 POM

1033 BRU13101163P Tolbutamide Tablets 500mg Tolbutamide 500mgDrug Houses Australia Pte Ltd.,

SingaporeG & H Trading Company

31 October 2013 till 31

October 2018 POM

1034 BRU13101164PIsopto 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

1035 BRU13101165NPLactacyd Feminine Hygiene

Liquid

Per 100ml - Lactic Acid 1g; Atomised

Lactoserum (spray dried) 0.93g

Sanofi Synthelabo Vietnam, Ho Chi

Minh City, Viet NamMedipharm Sdn Bhd

31 October 2013 till 31

October 2018 GSL

1036 BRU13121166P SCMC Syrup 125mg/5ml S-Carboxymethyl-cysteine 125mg/5mlUpha Pharmaceutical Mfg (M) Sdn

Bhd, MalaysiaHongkiat Trading & Co

02 December 2013 till 01

December 2018 P

1037 BRU13121167PCopastin Film Coated Tablets

10mgCloperastine Hydrochloride 10mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd

02 December 2013 till 01

December 2018 P

1038 BRU13121168P Ucort CreamPer g – Urea 100mg; Hydrocortisone

acetate 10mgY.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd

02 December 2013 till 01

December 2018 P

1039 BRU13121169PPradaxa® Hard Capsules

150mg

Dabigatran etexilate 150mg (as

mesilate 172.95g)

Boehringer Ingelheim Pharma GmbH

&Co, Ingelheim am Rhein, GermanyHongkiat Trading & Co

02 December 2013 till 01

December 2018 POM

1040 BRU13121170PPradaxa® Hard Capsules

110mg

Dabigatran etexilate 110mg (as

mesilate 126.83g)

Boehringer Ingelheim Pharma GmbH

& Co., KG, GermanyHongkiat Trading & Co

02 December 2013 till 01

December 2018 POM

1041 BRU13121171P Amoxicillin Capsule 250mg Amoxicillin Trihydrate 250mgYung Shin Pharmaceutical Ind. Co.

Ltd., TaiwanAsterix United (B) Sdn Bhd

02 December 2013 till 01

December 2018 POM

1042 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 Bhd02 December 2013 till 01

December 2018 POM

1043 BRU13121173NPRefresh Tears Lubricant Eye

Drops 0.5%

Carboxymethylcellulose Sodium 0.5%

w/vAllergan Sales LLC, USA Medipharm Sdn Bhd

02 December 2013 till 01

December 2018 GSL

1044 BRU13121174P Temodal Capsules 100mg Temozolomide 100mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd02 December 2013 till 01

December 2018 POM

1045BRU13121176PS1 &

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

BDMCA/RMP/0317 Page 66 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1046 BRU13121177PCyclogyl® 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

1047 BRU13121178P Betawin Tablet 50mg (T) Metoprolol Tartrate 50mg Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Co02 December 2013 till 01

December 2018 POM

1048 BRU13121179P Imigran FD Tablets 50mg Sumatriptan 50mg ( as succinate) Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd30 December 2013 till 29

December 2018 POM

1049 BRU13121180PGlucovance Tablet

500mg/5mg

Metformin HCl 500mg; Glibenclamide

5mgMerck Sante SAS, France Zuellig Pharma (B) Sdn Bhd

30 December 2013 till 29

December 2018 POM

1050 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.,

BelgiumZuellig Pharma (B) Sdn Bhd

30 December 2013 till 29

December 2018 POM

1051 BRU13121182P Hycamtin Injection 4mg Topotecan (as Hydrochloride) 4mgGlaxoSmithKline Manufacturing

S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

30 December 2013 till 29

December 2018 POM

1052 BRU13121183P Anarex TabletsParacetamol 450mg; Orphenadrine

citrate 35mg

Beacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

30 December 2013 till 29

December 2018 POM

1053 BRU13121184PAtarax Film-Coated Tablet

25mgHydroxyzine Hydrochloride 25mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd

30 December 2013 till 29

December 2018 POM

1054BRU13121185PS1;

BRU13121185PS2Propylthiouracil Tablets 50mg Propylthiouracil 50mg

Drug Houses of Australia Pte Ltd.,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company30 December 2013 till 29

December 2018 POM

1055 BRU13121186P Xyzal Oral Drops 5mg/mlPer mL - Levocetitrizine Hydrochloride

5mg

Aesica Pharmaceuticals S.r.L Pianezza,

ItalyZuellig Pharma (B) Sdn Bhd

30 December 2013 till 29

December 2018 POM

1056 BRU13121187NP10% 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

1057 BRU13121188PDaivonex Scalp Solution

50mcg/mlCalcipotriol 50mcg/ml

Leo Pharmaceutical Products Ltd., A/S

(Leo Pharma), DenmarkZuellig Pharma (B) Sdn Bhd

30 December 2013 till 29

December 2018 POM

1058 BRU13121189PHeparinised Saline Injection

10iu/ml (5ml)

Heparin Sodium (Bovine Mucosa)

10i.u./mlB Braun Industries Sdn Bhd, Malaysia Hongkiat Trading & Co

30 December 2013 till 29

December 2018 POM

1059 BRU13121190P Rescuvolin Tablet 15mgCalcium Folinate (equiv. to Folinic Acid)

15mg

Teva Pharmaceutical Works Pte Ltd

Co., Debrecen Site, HungaryK-Seri Pharma Sdn Bhd

30 December 2013 till 29

December 2018 POM

1060 BRU13121191PQuinax Sterile Ophthalmic

Solution

Sodium Dihydroazapentacene

Polysulfonate 0.15mg/mlS.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co

30 December 2013 till 29

December 2018 POM

1061 BRU13121192PNutriflex 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 & Co30 December 2013 till 29

December 2018 POM

BDMCA/RMP/0317 Page 67 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1062BRU14011193PS1 &

BRU14011193PS2

Alimta 500mg Powder for

Solution for InfusionPemetrexed (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 2019POM

1063BRU14011194P

Gemzar 1G Powder for

Solution for InfusionGemcitabine 1000mg (as gemcitabine

hydrochloride)

Eli Lilly and Company, USAZuellig Pharma (B) Sdn Bhd

28 January 2014 till 27

January 2019POM

1064 BRU14011196P Largo Tablets 100mgChlorpromazine HCl 100mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

28 January 2014 till 27

January 2019POM

1065 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

1066 BRU14011198NP Bepanthen® First Aid CreamDexpanthenol 5%w/w; Chlorhexidine

hydrochloride 0.5% w/w

GP Grenzach Produktions GmbH,

Germany Zuellig Pharma (B) Sdn Bhd28 January 2014 till 27

January 2019 GSL

1067 BRU14011199NPDextrose 5% and Sodium

Chloride 0.9% Injection USP

Dextrose 5%; Sodium Chloride 0.9% Baxter Healthcare Corporation, USAZuellig Pharma (B) Sdn Bhd

28 January 2014 till 27

January 2019 POM

1068 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

1069 BRU14011201PPrefrin Liquifilm Eye Drops

0.12%Phenylephrine Hydrochloride 0.12% Allergan Sales, LLC., USA MediPharm Sdn Bhd 28 January 2014 till 27

January 2019P

1070 BRU14011202NPRefresh Liquigel Lubricant Eye

Drops 1%Carboxymethylcellulose Sodium 1%

w/v

Allergan Sales, LLC., USA MediPharm Sdn Bhd 28 January 2014 till 27

January 2019GSL

1071 BRU14011203P Betaserc 24mg TabletBetahistine dihydrochloride 24mg Abbott Healthcare SAS, France

Zuellig Pharma (B) Sdn Bhd28 January 2014 till 27

January 2019POM

1072BRU14011204PS1;

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

1073 BRU14011205NP Panamol Tablet 500mgParacetamol 500mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

28 January 2014 till 27

January 2019GSL (100 x 10's)

1074 BRU14011206PSeretide™ Evohaler™

25/50mcgFluticasone propionate 50mcg;

Salmeterol (as xinafoate) 25mcg

Glaxo Wellcome S.A., SpainZuellig Pharma (B) Sdn Bhd

28 January 2014 till 27

January 2019POM

1075BRU14011207PS1;

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

BDMCA/RMP/0317 Page 68 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1076 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

1077 BRU14011209PNEUPOGEN 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

1078 BRU14011210P Axcel Famotidine-20 CapsuleFamotidine 20mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd,

Malaysia

28 January 2014 till 27

January 2019POM

1079BRU14011211NPS1;

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

1080 BRU14011212PAxcel Chlorpheniramine-4

SyrupChlorpheniramine Maleate 4mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd,

Malaysia

28 January 2014 till 27

January 2019P

1081 BRU14011213PImojev 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., ThailandZuellig Pharma (B) Sdn Bhd

28 January 2014 till 27

January 2019 POM

1082BRU14021214P Panaflex Extra Gel Diclofenac Sodium 10mg/1gm United Biomedical Inc., Asia, Taiwan

Zuellig Pharma (B) Sdn Bhd27 February 2014 till 26

February 2019

P

1083

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

1084BRU14021216P 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

1085BRU14021217P VotrientTM Film-coated tablets

400mg

Pazopanib (as hydrochloride) 400mg Glaxo Operations UK Limited, UKZuellig Pharma (B) Sdn Bhd

27 February 2014 till 26

February 2019

POM

1086BRU14021218P Motilium tablets 10mg Domperidone 10mg Janssen Pharmaceutica NV, Belgium

Zuellig Pharma (B) Sdn Bhd27 February 2014 till 26

February 2019

POM

1087

BRU14021219PS1;

BRU14021219PS2;

BRU14021219PS3

Novorapid® Flexpen®

100IU/ml

1ml of solution contains 100U insulin

aspart (r-DNA) (equivalent to 3.5mg)

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

1088BRU14021220P 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

BDMCA/RMP/0317 Page 69 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1089BRU14021221NP 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

1090

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

1091

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

1092

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

1093

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

1094BRU14021226P 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

1095

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

1096BRU14021228NP 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

1097

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

BDMCA/RMP/0317 Page 70 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1098BRU14021230NP 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

1099BRU14021231P Axcel Loratadine syrup Loratadine 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26

February 2019

P

1100BRU14021232P Cymbalta Capsule 30mg Duloxetine (as hydrochloride) 30mg Eli Lilly and Company, Indiana, USA;

Lilly del Caribe, Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd27 February 2014 till 26

February 2019

POM

1101BRU14021233P TykerbTM tablets 250mg Lapatinib 250mg (as ditosylate

monohydrate)

Glaxo Wellcome Operations, UKZuellig Pharma (B) Sdn Bhd

27 February 2014 till 26

February 2019

POM

1102BRU14021234P Axcel Mefenamic Acid

Capsules

Mefenamic acid 250mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26

February 2019

POM

1103BRU14021235P Dostinex tablet 0.5mg Cabergoline 0.5mg Pfizer Italia S.r.I, Italy

Zuellig Pharma (B) Sdn Bhd27 February 2014 till 26

February 2019

POM

1104BRU14021236NP 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, USAZuellig Pharma (B) Sdn Bhd

27 February 2014 till 26

February 2019

GSL

1105BRU14021237P Imuran 50mg tablet Azathioprine 50mg Excella GmbH, Germany

Zuellig Pharma (B) Sdn Bhd27 February 2014 till 26

February 2019

POM

1106

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

1107BRU14021239P Humulin R Injection 100IU/ml Regular Human Insulin (recombinant

DNA origin) Biosynthetic

Eli Lilly an Company, USAZuellig Pharma (B) Sdn Bhd

27 February 2014 till 26

February 2019

POM

1108BRU14021240NP 5% Dextrose and 0.45%

Sodium Chloride Injection,

USP

Dextrose 5%; Sodium Chloride 0.45% Baxter Healthcare Corporation, USAZuellig Pharma (B) Sdn Bhd

27 February 2014 till 26

February 2019

GSL

1109BRU14021241P Giona Easyhaler 200mcg/dose

Inhalation Powder

Budesonide 200mcg Orion Corporation, Finland Hongkiat Trading & Co 27 February 2014 till 26

February 2019

POM

1110BRU14021242P 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

1111BRU14021243NP Neurobion tablet Thiamine disulfide 100mg; Pyridoxine

hydroxide 200mg & Cyanocobalamin

200mcg

Merck KGaA & Co, AustriaZuellig Pharma (B) Sdn Bhd

27 February 2014 till 26

February 2019

P

BDMCA/RMP/0317 Page 71 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1112BRU14021244P 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

1113BRU14021245P Keppra Concentrate for

solution for (infusion) /

intravenous

Levetiracetam 500mg/5ml Patheon Italia S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

27 February 2014 till 26

February 2019

POM

1114

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., ThailandZuellig Pharma (B) Sdn Bhd

27 February 2014 till 26

February 2019

POM

1115BRU14021247P Pradaxa® Hard Capsules 75mg Dabigatran etexilate 75mg (as mesilate

86.48mg)

Boehringer Ingelheim Pharma GmbH

& Co., KG, GermanyHongkiat Trading & Co 27 February 2014 till 26

February 2019

POM

1116BRU14021248P 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

1117BRU14031249P Tygacil 50mg Lyophilised

Powder for Intravenous

Infusion

Tigecycline 50mg Wyeth Lederle S.r.L, ItalyZuellig Pharma (B) Sdn Bhd

27 March 2014 till 26

March 2019

POM

1118

BRU14031250PS1;

BRU14031250PS2;

BRU14031250PS3

Levemir Flexpen 100IU/ml Insulin Detemir 100U/ml (equivalent to

14.2mg

Novo Nordisk A/S, Bagsværd,

Denmark (S1); Novo Nordisk

Producao Farmaceutica do Brasil

Ltda., Brazil (S2); Novo Nordisk

Production SAS, France (S3)

MediPharm Sdn Bhd 27 March 2014 till 26

March 2019

POM

1119BRU14031251P Stalevo 75/18.75/200mg Film-

coated Tablet

Levodopa 75mg; Carbidopa 18.75mg;

Entacapone 200mg

Orion Corporation, FinlandZuellig Pharma (B) Sdn Bhd

27 March 2014 till 26

March 2019

POM

1120BRU14031252P Stalevo 200/50/200mg Film-

coated Tablet

Levodopa 200mg; Carbidopa 50mg;

Entacapone 200mg

Orion Corporation, FinlandZuellig Pharma (B) Sdn Bhd

27 March 2014 till 26

March 2019

POM

1121BRU14031253P Humulin N Injection 100iu/vial Insulin (Human) Isophane 100iu/ml Eli Lilly and Company, USA

Zuellig Pharma (B) Sdn Bhd27 March 2014 till 26

March 2019

POM

1122

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

BDMCA/RMP/0317 Page 72 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1123BRU14031255P Effient™ Tablet 10mg Prasugrel (as hydrochloride) 10mg Eli Lilly and Company, USA

Zuellig Pharma (B) Sdn Bhd27 March 2014 till 26

March 2019

POM

1124BRU14031256P 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

1125

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

1126BRU14031258P Volibris 5mg Film-coated

TabletAmbrisentan 5mg Patheon Inc., Ontario, USA Zuellig Pharma (B) Sdn Bhd

27 March 2014 till 26

March 2019

POM

1127BRU14031259P Volibris 10mg Film-coated

TabletAmbrisentan 10mg Patheon Inc., Ontario, USA Zuellig Pharma (B) Sdn Bhd

27 March 2014 till 26

March 2019

POM

1128BRU14031260P Atarax™ Syrup 2mg/ml

Hydroxyzine hydrochloride 2mg/ml NextPharma SAS, France Zuellig Pharma (B) Sdn Bhd27 March 2014 till 26

March 2019

POM

1129BRU14031261P Prograf Capsule 1mg

Tacrolimus 1mg Astellas Ireland Ltd, Ireland Zuellig Pharma (B) Sdn Bhd27 March 2014 till 26

March 2019

POM

1130BRU14031262P Loperamil Syrup 1mg/5ml

Loperamide HCl 1mg/5mlDrug Houses of Australia Pte Ltd,

SingaporeG&H Trading Company

27 March 2014 till 26

March 2019

POM

1131BRU14031263P;

BRU14031263PS2

Patanol® Eye Drops, Solution

0.1% Olopatadine (as HCl) 0.1%

S.A. Alcon-Couvreur N.V., Belgium;

Alcon Singapore Manufacturing Pte.

Ltd., Singapore (S2)

Hongkiat Trading &

Company

27 March 2014 till 26

March 2019

POM

1132

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

1133BRU14031265P;

BRU14031265PS2

Chlorpheniramine tablet 4mgChlorpheniramine Maleate 4mg

Drug Houses of Australia Pte Ltd,

Singapore; PT Actavis Indonesia,

Indonesia (S2)

G&H Trading Company 27 March 2014 till 26

March 2019

POM

1134BRU14031266P Allertyn Tablet 10mg

Loratadine (micronized) 10mgDrug Houses of Australia Pte Ltd,

SingaporeG&H Trading Company

27 March 2014 till 26

March 2019

P

BDMCA/RMP/0317 Page 73 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1135

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

1136BRU14031268P Elonva Solution for Injection

100mcg/0.5mlCorifollitropin alfa 100mcg/0.5ml

Vetter Pharma-Fertigung GmbH & Co.

KG, GermanyZuellig Pharma (B) Sdn Bhd

27 March 2014 till 26

March 2019

POM

BDMCA/RMP/0317 Page 74 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1137

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

1138BRU14031270P Enbrel® 50mg solution for

Injection in a pre-filled syringe Etanercept 50.0mg/1.0mlPfizer Ireland Pharmaceuticals,

IrelandZuellig Pharma (B) Sdn Bhd

27 March 2014 till 26

March 2019

POM

1139BRU14031272P Seretide Evohaler dose-

counter 25/250mcgSalmeterol 25mcg (as the xinafoate)

and Fluticasone Propionate 250mcgGlaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd

27 March 2014 till 26

March 2019

POM

1140

BRU14031273PS1;

BRU14031273PS2

Galvus Met 50/500mg Film-

coated TabletVildagliptin 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

1141

BRU14031274PS1;

BRU14031274PS2

Galvus Met 50/1000mg Film-

coated TabletVildagliptin 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

1142

BRU14031275PS1;

BRU14031275PS2

Galvus Met 50/850mg Film-

coated TabletVildagliptin 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

BDMCA/RMP/0317 Page 75 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1143BRU14031276P Galvus 50mg Tablet

Vildagliptin 50mg Novartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd27 March 2014 till 26

March 2019

POM

1144

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

1145

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

1146BRU14031279NP 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 (60 mL &

100 mL)

1147BRU14031280P Lamictal Dispersible/Chewable

Tablet 25mg

Lamotrigine 25mg GlaxoSmithKline Pharmaceutical SA,

Poland Zuellig Pharma (B) Sdn Bhd27 March 2014 till 26

March 2019

POM

1148BRU14031281P Panaco Tablets Paracetamol 500mg; Codeine

Phosphate 9mg

Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

27 March 2014 till 26

March 2019

POM

1149BRU14031282P 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

1150BRU14031283P 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

1151BRU14031284P Xalatan Eyedrops Latanoprost 0.005% w/v Pfizer Manufacturing Belgium NV,

BelgiumZuellig Pharma (B) Sdn Bhd

27 March 2014 till 26

March 2019

POM

1152

BRU14041285P Giona Easyhaler®

100mcg/dose Inhalation

Powder

Budesonide 100mcg/dose Orion Corporation, Finland Hongkiat Trading &

Company

26 April 2014 till 25 April

2019

POM

1153BRU14041286P 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)

1154BRU14041287P XareltoTM Film-coated tablet

15mg

Rivaroxaban 15mg Bayer Pharma AG, GermanyZuellig Pharma (B) Sdn Bhd

26 April 2014 till 25 April

2019

POM

1155BRU14041288P XareltoTM Film-coated tablet

20mg

Rivaroxaban 20mg Bayer Pharma AG, GermanyZuellig Pharma (B) Sdn Bhd

26 April 2014 till 25 April

2019

POM

1156BRU14041289P 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

1157BRU14041290NP 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

1158BRU14041291NP Sodium Chloride Injection USP

0.9% in Mini-Bag Plus

Container

Sodium Chloride 0.9% Baxter Healthcare Corporation, USAZuellig Pharma (B) Sdn Bhd

26 April 2014 till 25 April

2019

GSL

1159BRU14041292PS1&

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 Bhd26 April 2014 till 25 April

2019

POM

BDMCA/RMP/0317 Page 76 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1160BRU14041293P Endoxan® Injection 200mg/vial Cyclophosphamide monohydrate

213.8mg (eq. to anhydrous

Cyclophosphamide 200mg)

Baxter Oncology GmbH, GermanyZuellig Pharma (B) Sdn Bhd

26 April 2014 till 25 April

2019

POM

1161BRU14041294P Certican Tablet 0.25mg Everolimus 0.25mg Novartis Pharma Stein, AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

26 April 2014 till 25 April

2019

POM

1162BRU14041295P Certican Tablet 0.75mg Everolimus 0.75mg Novartis Pharma Stein, AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

26 April 2014 till 25 April

2019

POM

1163BRU14041296P 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

1164

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

1165BRU14041298P 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

1166BRU14041299P 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

1167BRU14041300P Hypernol Tablets 50mg Atenolol 50mg Drug Houses of Australia Pte Ltd,

Singapore

G&H Trading Company 26 April 2014 till 25 April

2019

POM

1168BRU14041301P DermovateTM Ointment Clobetasol Propionate 0.05% w/w Glaxo Wellcome Operations, UK

Zuellig Pharma (B) Sdn Bhd26 April 2014 till 25 April

2019

POM

1169BRU14041302P Tasigna Capsule 150mg Nilotinib (as hydrochloride,

monohydrate) 150mg

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

26 April 2014 till 25 April

2019

POM

1170BRU14041303P Tasigna Capsule 200mg Nilotinib (as hydrochloride,

monohydrate) 200mg

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

26 April 2014 till 25 April

2019

POM

1171BRU14041304NP 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

1172BRU14041305NP 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

1173BRU14041306P 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

1174BRU14041307P Alimta 100mg Powder for

Solution for Infusion

Pemetrexed (as Pemetrexed disodium)

100mg/vial

Eli Lilly and Company, USAZuellig Pharma (B) Sdn Bhd

26 April 2014 till 25 April

2019

POM

1175BRU14041308P 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

1176BRU14041309NP 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

1177

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

BDMCA/RMP/0317 Page 77 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1178BRU14041311P 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)

1179BRU14041312P One-Alpha® 0.25mcg Capsule Alfacalcidol 0.25mcg Leo Pharmaceutical Products Ltd., A/S

(Leo Pharma), DenmarkZuellig Pharma (B) Sdn Bhd

26 April 2014 till 25 April

2019

POM

1180BRU14041313P 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

1181BRU14041314NP Sodium Chloride Injection

0.9%, USP

Sodium Chloride 0.9% Baxter Healthcare Corporation, USAZuellig Pharma (B) Sdn Bhd

26 April 2014 till 25 April

2019

GSL

1182BRU14041315P 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

1183BRU14041316P 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

1184BRU14041317P Rozidal Tablet 1mg Risperidone 1mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G&H Trading Company 26 April 2014 till 25 April

2019

POM

1185BRU14071318PS1 &

BRU14071318PS2

Rebif ® 44 Pre-filled Syringe

44mcg/0.5ml

Interferon-beta-1a (12MIU)

44mcg/0.5mlMerck Serono S.p.A., Italy G & H Trading Company

02 July 2014 till 01 July

2019POM

1186BRU14071319PS1 &

BRU14071319PS2Mixtard® 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 Bhd02 July 2014 till 01 July

2019POM

1187 BRU14071320P Protopic Ointment 0.03% Tacrolimus 0.3mg/g (0.03%) Astellas Pharma Tech Co., Ltd., Japan Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July

2019POM

1188 BRU14071321P Beathorphan Elixir 15mg/5ml Dextromethorphan HBr 15mg/5mlBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

02 July 2014 till 01 July

2019POM

1189 BRU14071322P Nootropil 1200mg Tablet Piracetam 1200mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July

2019POM

1190 BRU14071323P Nootropil 800mg Tablet Piracetam 800mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July

2019POM

1191 BRU14071324PLuvox® Film-coated Tablets

50mgFluvoxamine maleate 50mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd

02 July 2014 till 01 July

2019POM

1192 BRU14071325PLuvox® Film-coated Tablets

100mgFluvoxamine maleate 100mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd

02 July 2014 till 01 July

2019POM

1193 BRU14071326P TobraDex® Eye OintmentTobramycin 0.3%, Dexamethasone

0.1%S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co

02 July 2014 till 01 July

2019POM

BDMCA/RMP/0317 Page 78 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1194 BRU14071327PAgrippalTM 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., ItalyZuellig Pharma (B) Sdn Bhd

02 July 2014 till 01 July

2019POM

1195 BRU14071328P Lanvis® Tablet 40mg Thioguanin 40mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July

2019POM

1196 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 Bhd02 July 2014 till 01 July

2019GSL

1197BRU14071330PS1;

BRU14071330PS2Humalog 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 Bhd02 July 2014 till 01 July

2019POM

1198 BRU14071331PShincort IM Injection "Yung

Shin" 40mg/ml ampoulesTriamcinolone acetonide 40mg

Yung Shin Pharmaceutical Ind. Co.

Ltd., TaiwanAsterix United (B) Sdn Bhd

02 July 2014 till 01 July

2019POM

1199 BRU14071332PEmend 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

2019POM

1200BRU14071333PS1;

BRU14071333PS2Zytiga 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

2019POM

1201 BRU14071334P Axcel Cefaclor-500 Capsule Cefaclor 500mg (as monohydrate) Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd02 July 2014 till 01 July

2019POM

1202 BRU14071335P Anlodin Tablet 5mg Amlodipine 5mg (as Besylate 6.93mg) Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd02 July 2014 till 01 July

2019POM

1203 BRU14071336P Aldara Cream 5%w/w Imiquimod 5% w/w 3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July

2019POM

1204 BRU14071337P Premarin Tablet 0.3mg Conjugated estrogens 0.3mgPfizer Ireland Pharmaceuticals,

IrelandZuellig Pharma (B) Sdn Bhd

02 July 2014 till 01 July

2019POM

BDMCA/RMP/0317 Page 79 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1205BRU14071338PS1;

BRU14071338PS2Regro Lotion 5% Minoxidil USP 5% w/v

Drug Houses of Australia Private

Limited, Singapore (S1); PT Actavis

Indonesia, Jakarta, Indonesia (S2)

G & H Trading Company02 July 2014 till 01 July

2019P

1206BRU14071339PS1;

BRU14071339PS2Regro Lotion 3% Minoxidil USP 3% w/v

Drug Houses of Australia Private

Limited, Singapore (S1); PT Actavis

Indonesia, Jakarta, Indonesia (S2)

G & H Trading Company02 July 2014 till 01 July

2019P

1207 BRU14071340NP Dequalinium Lozenges Dequalinium Chloride 0.25mgDrug Houses of Australia Private

Limited, SingaporeG & H Trading Company

02 July 2014 till 01 July

2019GSL

1208 BRU14071341P DHA-Ketozole Tablet 200mg Ketoconazole 200mgDrug Houses of Australia Private

Limited, SingaporeG & H Trading Company

02 July 2014 till 01 July

2019POM

1209 BRU14071342PAxcel Ibuprofen Paediatric

SyrupIbuprofen 100mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

02 July 2014 till 01 July

2019P

1210 BRU14071343P Pharynx LozengesCetylpyridinium Chloride 1.50mg,

Benzocaine 3.33mg

Drug Houses of Australia Private

Limited, SingaporeG & H Trading Company

02 July 2014 till 01 July

2019GSL

1211 BRU14071344P Bislan Tablet 8mg Bromhexine Hydrochloride 8mgY.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

02 July 2014 till 01 July

2019POM

1212 BRU14071345P Tren Capsules 250mg Tranexamic Acid 250mgY.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

02 July 2014 till 01 July

2019POM

1213 BRU14071346P Hydrocort Cream Hydrocortisone acetate 10mg/g (1%

w/w)

Y.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

02 July 2014 till 01 July

2019POM

1214 BRU14071347P Invoril Tablet 5mg Enalapril Maleate 5mgRanbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

02 July 2014 till 01 July

2019POM

1215 BRU14071348PAtropine Sulphate 1mg/1ml

InjectionAtropine Sulphate 1mg/ml

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

02 July 2014 till 01 July

2019POM

1216BRU14071349P;

BRU14071349PS2Dhacodine Syrup 15mg/5ml Pholocodine 15mg/5ml

Drug Houses of Australia Private

Limited, Singapore; ICM PHARMA PTE

LTD, Singapore (S2)

G & H Trading Company02 July 2014 till 01 July

2019POM

1217 BRU14071350P Roaccutane Capsules 20mg Isotretinion 20mg R P Scherer GmbH & Co KG., Germany Hongkiat Trading & Co02 July 2014 till 01 July

2019POM

1218 BRU14071351P Roaccutane Capsule 10mg Isotretinion 10mgR.P. Scherer GmbH & Co. KG.,

GermanyHongkiat Trading & Co

02 July 2014 till 01 July

2019POM

1219 BRU14071352P Ipolipid 600mg Tablets Gemfibrozil 600mg Medochemie Ltd., Cyprus Hongkiat Trading & Co02 July 2014 till 01 July

2019POM

1220 BRU14071353PSalbutamol Injection

0.5mg/ml

Salbutamol Sulphate 0.5mg/ml

(equivalent to salbutamol base)

Yung Shin Pharmaceutical Ind., Co.

Ltd., Taichong, TaiwanAsterix United (B) Sdn Bhd

02 July 2014 till 01 July

2019POM

1221BRU14071354PS1;

BRU14071354PS2Glipizide Tablet 5mg Glipizide 5mg

Drug Houses of Australia Private

Limited, Singapore (S1); PT Actavis

Indonesia, Jakarta, Indonesia (S2)

G & H Trading Company02 July 2014 till 01 July

2019POM

1222 BRU14071355PAxcel Dexchlorpheniramine

TabletDexchlorpheniramine 2mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

02 July 2014 till 01 July

2019POM

BDMCA/RMP/0317 Page 80 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1223BRU14071356P;

BRU14071356PS2Phenexpect 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; ICM PHARMA PTE

LTD, Singapore (S2)

G & H Trading Company02 July 2014 till 01 July

2019POM

1224 BRU14071357PQuinine Sulphate Tablet

300mgQuinine Sulphate BP 300mg

Beacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

02 July 2014 till 01 July

2019POM

1225 BRU14071358NP20% Glucose Intravenous

Infusion BPGlucose (as monohydrate) 20%

B. Braun Medical Industries Sdn Bhd

MalaysiaHongkiat Trading & Co

02 July 2014 till 01 July

2019POM

1226 BRU14071359PPharmaniaga Spironolactone

Tablet 25mgSpironolactone 25mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

02 July 2014 till 01 July

2019POM

1227 BRU14071360PMaxidex Sterile Opthalmic

SuspensionDexamethasone 0.1% ( 1mg/ml) S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co

02 July 2014 till 01 July

2019POM

1228 BRU14071361P Heparinol 1000IU/ml Heparin sodium (bovine) BP 1000IU/ml Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah02 July 2014 till 01 July

2019POM

1229 BRU14071362PAlphagan Ophthalmic Solution

0.2%

Brimonidine tartrate (anhydrous basis)

2mg/ml

Allergan Pharmaceuticals Ireland,

IrelandMedipharm Sdn Bhd

02 July 2014 till 01 July

2019POM

1230 BRU14071363P Dormicum Injection 15mg/3ml Midazolam 15mg/3ml Cenexi SAS, France Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July

2019POM

1231 BRU14071364P Dormicum Injection 5mg/5ml Midazolam 5mg/5ml Cenexi SAS, France Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July

2019POM

1232 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.,

MalaysiaHongkiat Trading & Co

02 July 2014 till 01 July

2019POM

1233BRU14071366PS1 &

BRU14071366PS2

Rasilez Film-coated Tablet

150mgAliskiren 150mg (as Hemifumarate)

Novartis Pharma Stein AG,

Switzerland & Novartis Farma S.p.A.,

Italy

Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July

2019POM

1234 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

2019POM

1235 BRU14071368PYondelis® Powder for Injection

1mg/vial Trabectedin 0.05mg/ml Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1236 BRU14071369PTrajenta film-coated tablet

5mgLinagliptin 5mg Boehringer Ingelhein Roxane Inc., USA

Hongkiat Trading &

Company

24 July 2014 till 23 July

2019POM

1237 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 Bhd24 July 2014 till 23 July

2019POM

1238 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 Bhd24 July 2014 till 23 July

2019POM

1239BRU14071372PS1 &

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 Bhd24 July 2014 till 23 July

2019POM

BDMCA/RMP/0317 Page 81 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1240BRU14071373PS1 &

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 Bhd24 July 2014 till 23 July

2019POM

1241BRU14071374PS1 &

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 Bhd24 July 2014 till 23 July

2019POM

1242 BRU14071375PLucentis 10mg/ml Solution for

InjectionRanibizumab 10mg/ml

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1243 BRU14071376P

Onbrez Breezhaler 150mcg

Inhalation Powder, Hard

Capsule

Indacterol 150mcg (as maleate

194mcg)

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1244 BRU14071377P

Onebrez Breezhaler 300mcg

Inhalation Powder Hard

Capsule

Indacterol 300mcg (as maleate

389mcg)

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1245 BRU14071378PRequip PD 24hr Prolong

Release Tablet 2mgRopinirole 2mg (as Hydrochloride) Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1246 BRU14071379PDifflam Anti-Inflammatory

Lozenges (with Anti-bacterial)

Benzydamine Hydrochloride 3mg;

Cetylpyridinium Chloride 1.33mg

Unique Pharmaceutical Laboratories,

IndiaZuellig Pharma (B) Sdn Bhd

24 July 2014 till 23 July

2019GSL

1247 BRU14071380PVfend Powder For Oral

Suspension 40mg/mlVoriconazole 40mg/ml Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1248 BRU14071381P

Norditropin® Nordilet®

Solution for Injection

10mg/1.5ml

Somatropin (biosynthetic human

growth hormone) 10mg/1.5mlNovo Nordisk A/S, Denmark Medipharm Sdn Bhd

24 July 2014 till 23 July

2019POM

1249 BRU14071382PAlphagan P Ophthalmic

Solution 0.15%Brimonidine tartrate 0.15% Allergan Sales LLC, USA Medipharm Sdn Bhd

24 July 2014 till 23 July

2019POM

1250 BRU14071383PMapenem® IV Injection

500mgMeropenem 500mg (as trihydrate) Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd

24 July 2014 till 23 July

2019POM

1251 BRU14071384PCuram 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 Bhd24 July 2014 till 23 July

2019POM

1252 BRU14071385P Topamax® 25 Tablet 25mg Topiramate 25mg CILAG AG, Switzerland Zuellig Pharma (B) Sdn Bhd24 July 2014 till 23 July

2019POM

1253 BRU14071386P Tussils 5 Lozenge 5mgDextromethorphan Hydrobromide

5mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd24 July 2014 till 23 July

2019POM

1254 BRU14071387P Kivexa Tablets 600mg/300mgAbacavir 600mg (as sulfate);

Lamivudine 300mgGlaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1255 BRU14071388PLucrin® depot 3.75mg

InjectionLeuproprelin acetate 3.75mg

Takeda Pharmaceutical Company

Limited, JapanZuellig Pharma (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1256 BRU14071389PLucrin® depot 11.25mg

InjectionLeuproprelin acetate 11.25mg

Takeda Pharmaceutical Company

Limited, Japan Zuellig Pharma (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1257 BRU14071390P Axcel Diclofenac-50 Tablet Diclofenac Sodium 50mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd24 July 2014 till 23 July

2019POM

BDMCA/RMP/0317 Page 82 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1258 BRU14071391P Lamictal Tablet 50mg Lamotrigine 50mgGlaxosmithkline Pharmaceuticals SA,

PolandZuellig Pharma (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1259 BRU14071392PInfasurf® (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 Pharma24 July 2014 till 23 July

2019POM

1260 BRU14071393NP Kaolin & Pectin MixturePer 5ml - Kaolin Light BP 1g; Pectin

50mg

Drug Houses of Australia Private

Limited, SingaporeG & H Trading Company

24 July 2014 till 23 July

2019P

1261 BRU14071394PDuodart 0.5mg/0.4mg

CapsulesDutasteride 0.5mg; Tamsulosin 0.4mg

Catalent Germany Schorndorf GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1262 BRU14071395PAxcel Metronidazole-400

TabletMetronidazole 400mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

24 July 2014 till 23 July

2019POM

1263 BRU14071396P Cefazolin Sandoz 1g Vial Cefazolin 1g Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd24 July 2014 till 23 July

2019POM

1264

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 Bhd24 July 2014 till 23 July

2019POM

1265 BRU14071398P Lamitor 100mg Tablet Lamotrigine 100mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd24 July 2014 till 23 July

2019POM

1266 BRU14071399PVigamox® Ophthalmic

Solution 0.5% Moxifloxacin 0.5% (as hydrochloride) Alcon Laboratories, Inc., USA Hongkiat Trading & Co

24 July 2014 till 23 July

2019POM

1267 BRU14071400P Cementin Tablet 200mg Cimetidene 200mgDrug Houses of Australia Pte Ltd,

SingaporeG & H Trading Company

24 July 2014 till 23 July

2019POM

1268BRU14071401PS1 &

BRU14071401PS2Voltaren 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 Bhd24 July 2014 till 23 July

2019GSL

1269 BRU14071402PImexa Film-Coated Tablet

250mgAzithromycin 250mg (as dihydrate)

Xepa-Soul Pattinson (M) Sdn Bhd

MalaysiaHongkiat Trading & Co

24 July 2014 till 23 July

2019POM

1270 BRU14071403P Cymbalta Capsule 60mg Duloxetine 60mg (as hydrochloride)Eli Lilly and Co., USA & Lilly del Caibe

Inc, Puerto RicoZuellig Pharma (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1271 BRU14071404P Beanamine Expectorant Per 5ml - Diphenhydramine BP 10mg;

Ammonium Chloride BP 120mg)

Beacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

24 July 2014 till 23 July

2019POM

1272 BRU14071405P Setrof Tablet 50mg Sertraline 50mg Hovid Bhd, Malaysia G & H Trading Company24 July 2014 till 23 July

2019POM

1273 BRU14071406P Dimenate Tablet 50mg Dimenhydrinate BP 50mgDrug Houses of Australia Private

Limited, SingaporeG & H Trading Company

24 July 2014 till 23 July

2019

POM (5 x 20 x

10's; 1000's)

BDMCA/RMP/0317 Page 83 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1274 BRU14071407P Dhatifen Tablet 1mgKetotifen 1mg (as hydrogen fumarate

1.38mg)

Drug Houses of Australia Private

Limited, SingaporeG & H Trading Company

24 July 2014 till 23 July

2019POM

1275 BRU14071408P Melashine Cream 4% Hydroquinone 40mg/gY.S.P. Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1276 BRU14071409P Asumalife Syrup 1.38mg/5mlPer 5ml - Ketotifen 1mg (as hydrogen

fumarate 1.38mg)

Y.S.P. Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1277 BRU14071410P Lovastin Tablet 20mg Lovastatin 20mgY.S.P. Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1278 BRU14071411P Requip tablet 0.25mg Ropinirole 0.25mg (as Hydrochloride) Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd24 July 2014 till 23 July

2019POM

1279 BRU14071412NP Zoben Tablet 200mg Albendazole 200mgPharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

24 July 2014 till 23 July

2019P (10 x 10's)

1280 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

2019POM

1281 BRU14071414P Garbose Tablet 50mg Acarbose 50mgY.S.P. Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

24 July 2014 till 23 July

2019POM

1282 BRU14071415P Dexamethasone 4mg Tablet Dexamethasone 4mgBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

24 July 2014 till 23 July

2019POM

1283BRU14081416PS1;

BRU14081416PS2Sevorane 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 2019POM

1284 BRU14081417P Emend Tri-Pack CapsuleEach capsule either contains

Aprepitant 80mg or 125mgMerck Sharp & Dohme Corp. Australia Zuellig Pharma (B) Sdn Bhd

30 August 2014 till 29

August 2019POM

1285 BRU14081418P Protopic Ointment 0.1%Tacrolimus (as Tacrolimus

monohydrate) 0.1% Astellas Pharma Tech Co., Ltd., Japan Zuellig Pharma (B) Sdn Bhd

30 August 2014 till 29

August 2019POM

1286BRU14081419PS1 &

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 Bhd30 August 2014 till 29

August 2019POM

1287BRU14081420PS1 &

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 Bhd30 August 2014 till 29

August 2019POM

1288BRU14081421PS1 &

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 Bhd30 August 2014 till 29

August 2019POM

1289BRU14081422PS1 &

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 Bhd30 August 2014 till 29

August 2019POM

BDMCA/RMP/0317 Page 84 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1290BRU14081423PS1 &

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 Bhd30 August 2014 till 29

August 2019POM

1291 BRU14081424PLuveris 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 2019POM

1292 BRU14081425PLipanthyl Penta 145 Film-

Coated tabletFenofibrate 145mg Recipharm Fontaine, France Zuellig Pharma (B) Sdn Bhd

30 August 2014 till 29

August 2019POM

1293 BRU14081426P Dexamethasone Tablet 0.5mg Dexamethasone 0.5mgBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

30 August 2014 till 29

August 2019POM

1294 BRU14081427P FlixotideTM Evohaler 50mcg Fluticasone Propionate 50mcg GlaxoWellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29

August 2019POM

1295BRU14081428PS1

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 Bhd30 August 2014 till 29

August 2019POM

1296BRU14081429PS1

BRU14081429PS2JanumetTM 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 Bhd30 August 2014 till 29

August 2019POM

1297BRU14081430PS1

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 Bhd30 August 2014 till 29

August 2019POM

1298 BRU14081431P Napan Capsules 250mg Mefenamic Acid 250mgDrug Houses of Australia Private

Limited, SingaporeG & H Trading Company

30 August 2014 till 29

August 2019POM

1299

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 Bhd30 August 2014 till 29

August 2019POM

1300 BRU14081433P EraxisTM 100mg for Injection Anidulafungin 100mg/vial Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29

August 2019POM

1301 BRU14081434P Moxiclav 1G Tablet

Amoxycillin 875mg (as sodium);

Clavulanic Acid 125mg (as Clavulanate

potassium)

Medochemie Ltd., Cyprus Hongkiat Trading & Co30 August 2014 till 29

August 2019POM

1302 BRU14081435P Lisdene 10mg tablet Lisinopril 10mg (as dihydrate) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29

August 2019POM

1303 BRU14081436P Dilatrend Tablet 25mg Carvedilol 25mg Roche S.p.A., Italy Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29

August 2019POM

1304 BRU14081437P Dilatrend Tablet 12.5mg Carvedilol 12.5mg Roche S.p.A., Italy Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29

August 2019POM

1305 BRU14081438P Dilatrend Tablet 6.25mg Carvedilol 6.25mg Roche S.p.A., Italy Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29

August 2019POM

BDMCA/RMP/0317 Page 85 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1306 BRU14081439P Carzepin 200mg Tablet Carbamazepine 200mg Hovid Bhd, Malaysia G & H Trading Company30 August 2014 till 29

August 2019POM

1307 BRU14081440PNaphcon-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 2019P

1308 BRU14081441P Lamictal 100mg Tablet Lamotrigine 100mgGlaxosmithkline Pharmaceuticals SA,

PolandZuellig Pharma (B) Sdn Bhd

30 August 2014 till 29

August 2019POM

1309 BRU14081442P Axcel Loratadine Tablet Loratadine 10mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 August 2014 till 29

August 2019P

1310 BRU14081443NP Neuroxel Tablet

Thiamine Mononitrate 100mg;

Pyridoxine HCl 200mg; Cynocobalamin

200mcg

Drug Houses of Australia Private

Limited, SingaporeG & H Trading Company

30 August 2014 till 29

August 2019P

1311 BRU14081444P Rhiniramine SR Tablet 6mg Dexhlorpheniramine Maleate 6mgDrug Houses of Australia Private

Limited, SingaporeG & H Trading Company

30 August 2014 till 29

August 2019POM

1312 BRU14081445P

Buventhol Easyhaler

100mcg/dose inhalation

powder

Salbutamol sulphate

100mcg/actuation (delivered dose

90mcg/actuation)

Orion Corporation, Finland Hongkiat Trading & Co30 August 2014 till 29

August 2019POM

1313 BRU14081446P

Buventhol Easyhaler

200mcg/dose inhalation

powder

Salbutamol sulphate

300mcg/actuation (delivered dose

180mcg/actuation)

Orion Corporation, Finland Hongkiat Trading & Co30 August 2014 till 29

August 2019POM

1314 BRU14081447P Axcel Cefaclor-125 Suspension Cefaclor 125mg (as monohydrate) Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 August 2014 till 29

August 2019POM

1315 BRU14081448P Dextramine Tablet 2mg Dexchlorpheniramine 2mgBiosis Pharmaceuticals Sdn Bhd.,

MalaysiaK-Seri Pharma Sdn Bhd

30 August 2014 till 29

August 2019POM

1316 BRU14081449PMircera Pre-filled Syringe

75mcg/0.3ml

Methoxy polyethylene glycol-epoetin

Beta 75mcg/0.3mlRoche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd

30 August 2014 till 29

August 2019POM

1317 BRU14081450P Creobic (New Formula) Cream Clotrimazole 1%w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 August 2014 till 29

August 2019GSL

1318 BRU14081451P Axcel Cetirizine Syrup Cetirizine Dihydrochloride 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 August 2014 till 29

August 2019P

1319 BRU14081452P Tinacort CreamMiconazole nitrate 2%w/w;

Hydrocortisone 1.0% w/wHovid Bhd, Malaysia G & H Trading Company

30 August 2014 till 29

August 2019POM

1320 BRU14081453P Sunex Cough Syrup

Per 5ml - Diphenhydramine HCl 14mg;

Ammonium chloride 135mg; Sodium/

Trisodium citrate 57.5mg

Sunward Pharmaceutical Sdn Bhd

MalaysiaG & H Trading Company

30 August 2014 till 29

August 2019POM

1321 BRU14081454P Loxof Tablets 500mg Levofloxacin 500mgRanbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

30 August 2014 till 29

August 2019POM

1322 BRU14081455PProluton Depot 250mg

InjectionHydroxyprogesterone Caproate 250mg

Bayer Pharma AG, Leverkeusen,

GermanyZuellig Pharma (B) Sdn Bhd

30 August 2014 till 29

August 2019POM

1323 BRU14081456P Nurofen for Children Ibuprofen 100mg/5ml

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29

August 2019P

1324 BRU14081457P Axcel Sabutamol Syrup Salbutamol 2mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 August 2014 till 29

August 2019POM

BDMCA/RMP/0317 Page 86 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1325 BRU14081458P Doxymycin Capsule 100mg Doxycycline Hydrochloride 100mgY.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

30 August 2014 till 29

August 2019POM

1326 BRU14081459PClamentin 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 2019POM

1327 BRU14081460PClarimycin Film Coated Tablet

500mgClarithromycin 500mg

Y.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

30 August 2014 till 29

August 2019POM

1328 BRU14081461NP Mentar ShampooCoal Tar solution 9% v/v; Menthol 1%

w/w

HOE Pharmaceuticals Sdn Bhd

MalaysiaG & H Trading Company

30 August 2014 till 29

August 2019GSL

1329 BRU14081462NP Menzza CreamMethyl Salicylate 25%w/w; Menthol

5%w/w

Hoe Pharmaceuticals Sdn Bhd

MalaysiaG & H Trading Company

30 August 2014 till 29

August 2019GSL

1330 BRU14081463P Difnal OD Tablet 100mgMethyl Salicylate 25%w/w; Menthol

5%w/w

Ranbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

30 August 2014 till 29

August 2019POM

1331BRU14081464PS1;

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 2019POM

1332 BRU14081465NP Bayer Aspirin Tablet 500mg Aspirin 500mg (Acetylsalicylic acid)

PT Bayer Indonesia,

Indonesia Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29

August 2019GSL

1333 BRU14081466P Doridone Tablet 10mg Domperidone 10mgDrug Houses of Australia Private

Limited, SingaporeG & H Trading Company

30 August 2014 till 29

August 2019POM

1334 BRU14081467PTobradex® 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 2019POM

1335 BRU14081468NPFerrous Fumarate Tablet

200mg

Ferrous fumarate 200mg (equivalent

to 65mg of elemental iron)

Drug Houses of Australia Private

Limited, SingaporeG & H Trading Company

30 August 2014 till 29

August 2019GSL

1336 BRU14081469P Tamoxifen 20mg Tablet Tamoxifen 20mg (as citrate 30.4mg)Teva Pharmaceutical Industries Ltd,

IsraelK-Seri Pharma Sdn Bhd

30 August 2014 till 29

August 2019POM

1337 BRU14081470PRotaqor 10mg film-coated

tabletAtorvastatin 10mg (as calcium) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd

30 August 2014 till 29

August 2019POM

1338BRU14081471P;

BRU14081471PS2Zoral 200 tablet 200mg Acyclovir USP 200mg

Drug Houses of Australia Private

Limited, Singapore; PT Actavis

Indonesia, Indonesia (S2)

G & H Trading Company30 August 2014 till 29

August 2019POM

1339 BRU14081472P Vamlo Tablets 5mg Amlodipine 5mg (as besilate)Ranbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

30 August 2014 till 29

August 2019POM

1340 BRU14081473P Clofenac SR Tablet Diclofenac Sodium 100mg Hovid Bhd, Malaysia G & H Trading Company30 August 2014 till 29

August 2019POM

1341 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 Bhd30 August 2014 till 29

August 2019GSL

1342 BRU14081475P Cera-Scalp OintmentCoal Tar solution 12% w/w; Salicylic

acid 2%; Sulphur 4% w/w

HOE Pharmaceuticals Sdn Bhd

MalaysiaG & H Trading Company

30 August 2014 till 29

August 2019GSL

BDMCA/RMP/0317 Page 87 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1343 BRU14081476P Lisdene 20mg Tablet Lisinopril 20mg (as dihydrate) Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29

August 2019POM

1344BRU14091477P Suprane Inhalation Liquid

100%

Desflurane 100% Baxter Healthcare Corporation, USAZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1345BRU14091478P Buclizine Tablet 25mg Buclizine 25mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 September 2014 till 29

September 2019

P

1346BRU14091479PS1;

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

1347BRU14091480P Mivacron Injection 10mg/5ml Mivacurium Chloride 10mg/5ml GlaxoSmithKline Manufacturing

S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1348BRU14091481P Xolair Powder and Solvent for

Solution for Injection

Omalizumab 150mg Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1349BRU14091482P Frusemide Tablet 40mg Furosemide 40mg Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 30 September 2014 till 29

September 2019

POM

1350BRU14091483P Penegesic 50 Capsule Tramadol HCl 50mg Hovid Bhd, Malaysia G & H Trading Company 30 September 2014 till 29

September 2019

POM

1351BRU14091486P Crinone Progestrone Vaginal

Gel 8%

Progestrone 8% Fleet Laboratories Ltd, United

Kingdom

G & H Trading Company 30 September 2014 till 29

September 2019

POM

1352BRU14091487NP Pinetarsol Gel Tar 1.6% EGO Pharmaceuticals Pty Ltd.,

AustraliaZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

GSL

1353BRU14091488P 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

1354BRU14091489P Magrilan 20mg capsules Fluoxetine 20mg (as Hydrochloride) Medochemie Ltd., Cyprus Hongkiat Trading & Co 30 September 2014 till 29

September 2019

POM

1355BRU14091490P Trileptal 600mg Film-coated

Tablets

Oxcarbazepine 600mg Novartis Farma S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1356BRU14091491P Binozyt 500mg film-coated

tablet

Azithromycin 500mg (as monohydrate) Novartis (Bangladesh) Ltd.,

BangladeshZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1357BRU14091492P Nurofen 400 Caplet Ibuprofen 400mg Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd30 September 2014 till 29

September 2019

P

1358BRU14091493P Recormon Pre-filled Syringe

30,000Iu/0.6ml

Epoetin beta 30,000 IU/0.6ml Roche Diagnostics GmbH, GermanyZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1359BRU14091494P Eprex® 10000 Prefilled

Syringes 10,000iu/1ml

Epoetin alfa 10,000 IU/ml Cilag AG, SwitzerlandZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1360BRU14091495P 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

1361

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

BDMCA/RMP/0317 Page 88 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1362

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

1363BRU14091498P 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

1364BRU14091501P 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

1365BRU14091502P 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

1366BRU14091503P Rasitol Tablet 40mg Furosemide 40mg YSP Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1367BRU14091504P 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

1368BRU14091505P Nurofen Caplet 200mg Ibuprofen 200mg Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd30 September 2014 till 29

September 2019

p

1369BRU14091506P 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

1370BRU14091507P Afinitor 2.5mg Tablet Everolimus 2.5mg Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1371BRU14091508P 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

1372BRU14091509P Chloramine Syrup 4mg/5ml Chlorpheniramine maleate 4mg/5ml Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 September 2014 till 29

September 2019

p

1373BRU14091510P Difnal-K Tablet 50mg Diclofenac Potassium 50mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 30 September 2014 till 29

September 2019

POM

1374BRU14091511NP 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

1375

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

1376BRU14091513P HBVaxPro® 5mcg/0.5ml

Injection

Hepatitis B surface Antigen

5mcg/0.5ml

Merck Sharp & Dohme Corp., West

Point, Pensylvania, USAZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1377BRU14091514P HBVaxPro® 10mcg/1.0ml

Injection

Hepatitis B surface Antigen

10mcg/1.0ml

Merck Sharp & Dohme Corp., West

Point, Pensylvania, USAZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1378BRU14091515P HBvaxPro® 40mcg/1.0ml

Injection

Hepatitis B surface Antigen

40mcg/1.0ml

Merck Sharp & Dohme Corp., USAZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1379BRU14091516P 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

BDMCA/RMP/0317 Page 89 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1380BRU14091517P Stalevo 125/31.25/200mg film-

coated tablet

Levodopa 125mg, Carbidopa 31.25mg,

Entacapone 200mg

Baxter Bioscience Manufacturing Sarl,

SwitzerlandZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1381BRU14091518P 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

1382BRU14091519P Afinitor 5mg Tablet Everolimus 5mg Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1383

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

1384BRU14091521P Ospexin 500mg Film-coated

Tablets

Cefalexin 500mg (as monohydrate) Sandoz GmbH, AustriaZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1385BRU14091522PS1 &

BRU14091522PS2

Androcur Tablet 50mg Cyproterone acetate 50mg Delpharm Lille SAS, FranceZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1386BRU14091523NP Poviderm Ointment Povidone Iodine 10% w/w Hoe Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 30 September 2014 till 29

September 2019

GSL

1387BRU14091524P 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

1388BRU14091525P Calumid 50mg Film-coated Bicalutamide 50mg Gedeon Richter Plc., Hungary K-Seri Pharma Sdn Bhd 30 September 2014 till 29

September 2019

POM

1389BRU14091526P 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

1390BRU14091527P 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

1391BRU14091528P Campto 300mg/15ml Injection Irinotecan Hydrochloride Trihydrate

300mg/15ml

Pfizer (Perth) Pty Ltd, AustraliaZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1392BRU14091529NP 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

1393BRU14091530NP 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

1394BRU14091531P Nordette 21 Tablet Levonogestrel 150mcg, Ethinyl

estradiol 30mcg

Haupt Pharma Munster GmbH.,

GermanyZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1395

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

1396BRU14091533P 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

BDMCA/RMP/0317 Page 90 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1397BRU14091534P Deplatt Tablet 75mg Clopidogrel 75mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 30 September 2014 till 29

September 2019

POM

1398

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

1399BRU14091536NP 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

1400BRU14091537P Synagis 100mg Powder and

Solvent for Solution for

Injection

Palivizumab 100mg Boehringer Ingelheim Pharma KG,

Germany Zuellig Pharma (B) Sdn Bhd30 September 2014 till 29

September 2019

POM

1401BRU14091538P 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

1402

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

1403BRU14091540P Eturion 10mg Film Coated

Tablet

Atorvastatin 10mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceuticals LLC, Puerto

RicoZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1404BRU14091541P Eturion 20mg Film Coated

Tablet

Atorvastatin 20mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceuticals LLC, Puerto

Rico, USAZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1405BRU14091542P Eturion 40mg Film Coated

Tablet

Atorvastatin 40mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceutical LLC, Puerto

Rico, USAZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1406BRU14091543P Eturion 80mg Film Coated

Tablet

Atorvastatin 80mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceuticals LLC, Puerto

Rico, USAZuellig Pharma (B) Sdn Bhd

30 September 2014 till 29

September 2019

POM

1407BRU14111544P (vial) EYLEA Solution for Injection

(vial)

Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc., New

York, USAZuellig Pharma (B) Sdn Bhd

01 November 2014 till 31

October 2019

POM

1408BRU14111545P EYLEA Solution for Injection

(pre-filled syringe)

Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc., New

York, USA Zuellig Pharma (B) Sdn Bhd01 November 2014 till 31

October 2019

POM

1409BRU14111546P Binocrit Solution for Injection

2000 IU/ml in Pre-filled

Syringe

Epoetin Alfa 2,000 IU/ml IDT Biologika GmbH, GermanyZuellig Pharma (B) Sdn Bhd

01 November 2014 till 31

October 2019

POM

1410BRU14111547P Binocrit Solution for Injection

4000 IU/0.4ml in Pre-filled

Syringe

Epoetin Alfa 4,000IU/0.4ml IDT Biologika GmbH, GermanyZuellig Pharma (B) Sdn Bhd

01 November 2014 till 31

October 2019

POM

BDMCA/RMP/0317 Page 91 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1411BRU14111548P Nootropil Infusion 12g/60ml Piracetam 12g/60ml Aesica Pharmaceuticals SRL., Italy

Zuellig Pharma (B) Sdn Bhd01 November 2014 till 31

October 2019

POM

1412BRU14111549P Nootropil Injection 1g/5ml Piracetam 1g/5ml UCB Pharma S.P.A., Italy

Zuellig Pharma (B) Sdn Bhd01 November 2014 till 31

October 2019

POM

1413BRU14111550P Advagraf Prolonged Release

Hard Capsule 0.5mg

Tacrolimus 0.5mg (as monohydrate) Astellas Ireland Co Ltd., IrelandZuellig Pharma (B) Sdn Bhd

01 November 2014 till 31

October 2019

POM

1414BRU14111551P Advagraf Prolonged Release

Hard Capsule 1mg

Tacrolimus 1mg (as monohydrate) Astellas Ireland Co Ltd., IrelandZuellig Pharma (B) Sdn Bhd

01 November 2014 till 31

October 2019

POM

1415BRU14111552P Advagraf Prolonged Release

Hard Capsule 5mg

Tacrolimus 5mg (as monohydrate) Astellas Ireland Co Ltd., IrelandZuellig Pharma (B) Sdn Bhd

01 November 2014 till 31

October 2019

POM

1416BRU14111553P Dynastat Powder and Solvent

for Solution for Injection 40mg

Parecoxib (as Sodium) 40mg Pharmacia & Upjohn Company, USAZuellig Pharma (B) Sdn Bhd

01 November 2014 till 31

October 2019

POM

1417BRU14111554P Invanz Powder for Injection

1g/vial

Ertapenem 1g (as Sodium 1.046g) Laboratories Merck Sharp & Dohme-

Chibret, FranceZuellig Pharma (B) Sdn Bhd

01 November 2014 till 31

October 2019

POM

1418

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

1419BRU14111556P Brozil Capsule 300mg Gemfibrozil 300mg YSP Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1420BRU14111557NP Menzza Ice Gel Menthol 4% w/w Hoe Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 01 November 2014 till 31

October 2019

GSL

1421BRU14111558P Trileptal Film-coated Tablets

300mg

Oxcarbazepine 300mg Novartis Pharma S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

01 November 2014 till 31

October 2019

POM

1422BRU14111559NP Alka Seltzer Lemon Acetylsalicylic Acid 324mg; Sodium

Bicarbonate 1.737g; Citric Acid

(anhydrous) 1.223g.

Bayer de Mexico SA De CV, MexicoZuellig Pharma (B) Sdn Bhd

01 November 2014 till 31

October 2019

GSL

1423BRU14111560P 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

1424BRU14111561NP 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

1425

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

1426BRU14111563P Loette 21 Tablet Levonorgetsrel 100mcg;

ethinylestradiol 20mcg

Haupt Pharma Munster GmbH.,

GermanyZuellig Pharma (B) Sdn Bhd

01 November 2014 till 31

October 2019

POM

1427BRU14111564P 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

BDMCA/RMP/0317 Page 92 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1428BRU14111565P NIMBEXTM Injection 2mg/ml

(5ml)

Cisatracurium Besylate 10mg/5ml GLaxoSmithKline Manufacturing

S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

01 November 2014 till 31

October 2019

POM

1429BRU14111566P 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 Bhd01 November 2014 till 31

October 2019

POM

1430BRU14111567P 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

1431BRU14111568P 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

1432BRU14111569P 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

1433BRU14111570P Olmetec Plus 20/12.5mg Film-

coated Tablet

Olmesartan Medoxomil 20mg;

Hydrochlorothiazide 12.5mg

Daiichi Sankyo Europe GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

01 November 2014 till 31

October 2019

POM

1434BRU14111571P 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

1435

BRU14111572P Rotateq® Rotavirus Vaccine,

Live, Oral, Pentavalent

Human-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

1436BRU14111573P Eliquis Film-coated Tablets

2.5mg

Apixaban 2.5mg Bristol-Myers Squibb Manufacturing

Company, Puerto Rico, USA Zuellig Pharma (B) Sdn Bhd01 November 2014 till 31

October 2019

POM

1437BRU14111574P 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

1438BRU14111575P 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

1439BRU14111576NP 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

1440BRU14111577NP 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

1441BRU14111578P Tolanz Tablet 5mg Olanzapine 5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 01 November 2014 till 31

October 2019

POM

1442BRU14111579P Tolanz Tablet 10mg Olanzapine 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 01 November 2014 till 31

October 2019

POM

1443BRU14111580P 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

BDMCA/RMP/0317 Page 93 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1444

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

1445BRU14111582P Covinace Tablet 4mg Perindopril Ter-butylamine 4mg Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 01 November 2014 till 31

October 2019

POM

1446

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

1447BRU14111584NP 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)

1448

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)

Hongkiat Trading & Co 01 November 2014 till 31

October 2019

POM

1449BRU14111586P Zyvox 20mg/ml Granules For

Oral Suspension

Linezolid 100mg/5ml Pfizer Pharmaceuticals LLC, USAZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1450BRU14111587P Axcel Cimetidine-400 Tablet Cimetidine 400mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1451

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

1452BRU14111589P Resolor film-coated tablet

1mg

Prucalopride 1mg (as succinate

1.321mg)

Janssen-Cilag SpA., ItalyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1453BRU14111590NP 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

1454BRU14111591P Pristiq 50mg Extended-

Release Tablets

Desvenlafaxine 50mg (as succinate

75.87mg)

Pfizer Ireland Pharmaceuticals,

IrelandZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

BDMCA/RMP/0317 Page 94 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1455BRU14111592P ElIquis 5mg Film-coated Tablet Apixaban 5mg Bristol-Myers Squibb Manufacturing

Company, Puerto Rico, USA Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020

POM

1456BRU14111593P 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

1457BRU14111594P Rocephin for Injection 1g IV Ceftriaxone 1g F.Hoffmann-La Roche Ltd., Basel,

SwitzerlandZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1458BRU14111595P Advate 250 IU Powder and

Solvent for Solution for

Injection

Octocog alfa (recombinant human

coagulation factor VIII) 250 IU

Baxalta Manufacturing Sarl,

Switzerland Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020

POM

1459BRU14111596P Glibenclamide Tablet 5mg Glibenclamide 5mg Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1460BRU14111597NP 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

1461

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

1462BRU14111599P 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

1463BRU14111600P 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

1464BRU14111601NP T3 Pimple Gel Rescorcinol 2% w/w HOE Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1465

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

1466BRU14111603P 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

1467BRU14111604NP 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

1468BRU14111605P Zimmex Tablet 10mg Simvastatin 10mg Silom Medical Co. Ltd., Thailand Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1469BRU14111606NP 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

1470BRU14111607NP 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

BDMCA/RMP/0317 Page 95 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1471BRU14111608P Binozyt 200mg/5ml Powder

for Oral Suspension

Azithromycin 200mg Sandoz S.R.L., RomaniaZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1472

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

1473BRU14111610NP 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

1474BRU14111611P Kogrel 75mg Film Coated

Tablet

Clopidogrel 75mg (as bisulfate

97.875mg)

Sandoz Private Limited, Mumbai,

IndiaZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1475BRU14111612P Chloramine Tablet 4mg Chlorpheniramine maleate 4mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

P

1476BRU14111613NP Tolnaderm Cream 1% Tolnaftate 1% w/w HOE Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1477BRU14111614P Medoflucon Capsule 50mg Fluconazole 50mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1478BRU14111615P Curam 156.25mg/5ml Powder

for Oral Suspension

Per 5ml - Amoxycillin 125mg (as

trihydrate); Clavulanic acid 31.25mg

Sandoz GmbH, AustriaZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1479BRU14111617P 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

1480BRU14111618NP 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

1481BRU14111619P Crixan Tablet 250mg Clarithromycin 250mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1482BRU14111620P Storvas Tablet 20mg Atorvastatin 20mg (as calcium) Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1483BRU14111621P 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

1484BRU14111622NP 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 (2 x 6's)

1485BRU14111623P 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

1486BRU14111624P 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

BDMCA/RMP/0317 Page 96 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1487BRU14111625P 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

1488BRU14111626P Lovir Tablets 200mg Acyclovir 200mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1489BRU14111627P Cellcept Tablet 500mg Mycophenolate mofetil 500mg Roche S.p.A., Italy Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1490BRU14111628NP 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

1491BRU14111629P Xorimax 500mg Coated Tablet Cefuroxime 500mg (as axetil) PenCef Pharma GmbH, Germany

Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020

POM

1492BRU14111630P Xorimax 250mg Coated Tablet Cefuroxime 250mg (as axetil) PenCef Pharma GmbH, Germany

Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020

POM

1493

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

1494BRU14111632P Axcel Orlistat 120 Tablet Orlistat 120mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1495BRU14111633P 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

1496BRU14111634P Epimate 50mg Tablet Topiramate 50mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1497BRU14111635NP 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

1498BRU14111636P 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

1499BRU14111637NP 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 ( 60 mL &

100 mL)

1500BRU14111638P Primovists 0.25mmol/ml

solution for injection

Gadoxetic acid, Sodium 0.25mmol/ml Bayer Pharma AG, Leverkeusen,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1501BRU14111639P Servidipine 30mg Film-coated

Tablets

Nifedipine 30mg Lek Pharmaceuticals D.D., SloveniaZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1502BRU14111640P Servidipine 60mg Film-coated

Tablets

Nifedipine 60mg Lek Pharmaceuticals D.D., SloveniaZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1503BRU14111641NP Hoemal Oral Suspension Paracetamol 250mg/5ml (5%) Hoe Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

GSL (60mL)

BDMCA/RMP/0317 Page 97 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1504BRU14111642P 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

1505BRU14111643NP 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

1506BRU14111644P 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

1507BRU14111645NP 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

1508

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

1509BRU14111647P 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

1510BRU14111648P Pharmaniaga Cetirizine 10mg

tablet

Cetirizine 10mg (as hydrochloride) Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

P

1511BRU14111649P Hovid Lipiduce-20 Tablet Atorvastatin 20mg (as calcium) Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1512BRU14111650P Invokana Film-coated Tablet

100mg

Canagliflozin 100mg (as hemihydrate) Janssen-Cilag SpAZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1513BRU14111651P 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

1514BRU14111652P Binozyt Film-Coated Tablet

250mg

Azithromycin 250mg (as monohydrate) Novartis (Bangladesh) Ltd.,

BangladeshZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1515BRU14111653P Asmol 2 tablet Salbutamol 2mg (as sulphate) Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1516BRU14111654NP Paracetamol Kabi Solution for

infusion 10mg/ml

Paracetamol 10mg/ml i) Fresenius Kabi Germany AB ii)

Fresenius Kabi AustriaZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1517BRU14111655P Risperdal Solution 1mg/ml Risperidone 1mg/ml Janssen Pharmaceutical NV, Belgium

Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020

POM

1518BRU14111656P Visudyne Injection Verteprofin 15mg Par Sterile Products LLC, United

StatesZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1519 BRU14121661P Kastipron Tablet 375mgS-Carboxymethylcysteine 375mg Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1520 BRU14121662P Ipolipid Capsules 300mgGemfibrozil 300mg Medochemic Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1521 BRU14121663PCuram 625mg Film-coated

TabletAmoxicillin 500mg; Clavulanic acid as

potassium salt 125mg

Sandoz GmbH, AustriaZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1522 BRU14121664P Vesyca Injection 25mg/mlRanitidine (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

1523 BRU14121666P Amoxicap 500 CapsuleAmoxicillin (as trihydrate 574mg)

500mg

Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/0317 Page 98 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1524 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

1525 BRU14121668NP50% 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

1526 BRU14121669P Visanne 2mg TabletDienogest 2mg Bayer Weimar GmbH und. Co. KG.,

Dobereinesrtr. 20, D-99427, Weimar,

Germany

Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020

POM

1527 BRU14121670P Medoflucon Capsule 150mgFluconazole 150mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1528 BRU14121671P Topamax 100 Tablets 100mgTopiramate 100mg Cilag AG, Switzerland

Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020

POM

1529 BRU14121672NPDuratears 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

1530 BRU14121673PEprex® 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 Bhd19 May 2015 till 18 May

2020

POM

1531 BRU14121674P Milosec Capsule 20mgOmeprazole 20mg The United Drug (1966) Co. Ltd.,

Thailand

Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1532 BRU14121675P Ziagen Oral SolutionAbacavir (as Abacavir Sulfate) 20mg/ml GlaxoSmithKline Inc., Canada

Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020

POM

1533 BRU14121676P Minulet 21 TabletGestodene 75mcg; ethinylestradiol

30mcg

Haupt Pharma Munster GmbH.,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1534 BRU14121677PPataday 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

1535 BRU14121678P Provironum Tablet 25mgMesterolone 25mg Schering Do Brasil Quimica e

Farmaceutica Ltda., San Paulo-SP,

Brazil

Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020

POM

1536 BRU14121681NPStrepsils Strawberry Sugar

Free ChildrenAmylmetacresol 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

1537 BRU14121682PAxcel Sodium Fusidate 250

TabletSodium Fusidate (Micronized) 250mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1538 BRU14121683P Pencor 1mg tabletDoxazosin Mesylate (eq. to Doxazosin

1mg)

Unison Laboratories Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1539 BRU14121684P Pencor 2mg tabletDoxazosin Mesylate (eq. to Doxazosin

2mg)

Unison Laboratories Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1540 BRU14121685P Pencor 4 TabletDoxazosin Mesylate (eq. to Doxazosin

4mg)

Unison Laboratories Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1541 BRU14121686P Decan Injection 2mg/mlDexamethasone 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

BDMCA/RMP/0317 Page 99 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1542 BRU14121687P Primodil-10 TabletAmlodipine Besilate 13.87mg (eq. to

Amlodipine 10mg)

Medley Pharmaceuticals Limited,

India

Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1543 BRU14121688P Cuvarlix Capsule 120mgOrlistat 120mg Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1544 BRU14121689NP Calcium Lactate 300mg tabletCalcium lactate 300mg Drug Houses of Australia Pte Ltd.,

Singapore

G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1545 BRU14121690P Seladin 500mg tabletNaproxen 500mg Y.S.P. Industries (M) Sdn Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1546 BRU14121691P Driminate 50mg SuppositoryDimenhydrinate 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)

1547 BRU14121692NPHurix'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

1548 BRU14121693NPHurix Corn Rid Solution 5%

w/wlactic 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

1549 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

1550 BRU14121695P Axcel Fungicort CreamMiconazole 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

1551 BRU14121696P Methacid 25mg tabletIndomethacin 25mg Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1552 BRU14121697NPDettol Antiseptic Wound

Wash Spraybenzalkonium chloride 0.198% Reckitt Benckiser Healthcare (UK)

Ltd., UK

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1553 BRU14121698PEdurant Film-Coated 25mg

tabletRilpivirine (as hydrochloride) 25mg Janssen-Cilag S.p.A., Italy

Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020

POM

1554 BRU14121699P Invokana 300mg FCTCanagliflozin 300mg (as hemihydrate) Janssen Ortho, LLC, Puerto Rico

Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020

POM

1555 BRU14121700P Amlodipine Tablet 10mgAmlodipine Tablet 10mg Jubilant Generics, Limited, India Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1556 BRU14121701P Borymycin Capsule 100mgMinocycline HCl 100mg Y.S.P., Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1557 BRU14121702NP Septi-Sol SolutionChlorhexidine 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

1558 BRU14121703PAtoris Film-coated Tablet

20mgAtorvastatin (as calcium) 20mg KRKA, d.d., Slovenia K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1559 BRU14121704NPNutrilite Glucosamine HCl

Capsule 375mgGlucosamine HCl 375mg Pharmaniaga Manufacturing Berhad,

Malaysia

Amway Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1560 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 Bhd19 May 2015 till 18 May

2020

POM

1561 BRU15011706PZyprexa Zydis

OrodispersibleTablet 5mgOlanzapine micronized 5mg Catalent UK Swindon Zydis Ltd, UK Zuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

BDMCA/RMP/0317 Page 100 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1562 BRU15011707PZyprexa Zydis

OrodispersibleTablet 10mgOlanzapine micronized 10mg Catalent UK Swindon Zydis Ltd, UK Zuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020 POM

1563 BRU15011709P Klacid MR 500mg Tablet Clarithromycin 500mg Aesica Queensborough Ltd, UK Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020POM

1564 BRU15011710P Klerimed 250mg FC Tablets Clarithromycin 250mg (as anhydrous) Medochemie Ltd., Cyprus Hongkiat Trading & Co19 May 2015 till 18 May

2020POM

1565 BRU15011711P DiSuf-B CreamFusidic 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

1566 BRU15011712NP Dhalumag Suspension

Per 5ml - Magnesium trisilicate BP

500mg, Dried Aluminium Hydroxide BP

250mg

Drug Houses of Australia Private

Limited, SingaporeG & H Trading Company

19 May 2015 till 18 May

2020 GSL

1567 BRU15011713PBinoclar® 500mg Film-coated

TabletsClarithromycin 500mg Novartis Bangladesh Ltd, Bangladesh Zuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1568 BRU15011714POspamox 250mcg/5ml

granules for suspension

Amoxicillin 250mg (as trihydrate

287mg) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1569 BRU15011715P Ospamox 250mg CapsuleAmoxicillin 250mg (as trihydrate

287mg) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1570 BRU15011716POspamox 500mg Film-coated

Tablet

Amoxicillin 500mg (as trihydrate

574mg)Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1571 BRU15011717P

Salofalk® 500mg Gastro-

Resistant Prolonged-Release

Granules

Mesalazine 500mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd19 May 2015 till 18 May

2020 POM

1572 BRU15011718P

Salofalk® 1000mg Gastro-

Resistant Prolonged-Release

Granules

Mesalazine 1000mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd19 May 2015 till 18 May

2020 POM

1573 BRU15011719P Vaqta® Vaccine 50U/mlHepatitis A Virus, Purified, Inactivated

50U/mlMerck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1574 BRU15011720P Vaqta® Vaccine 25U/0.5mlHepatitis A Virus, Purified, Inactivated

25U/0.5mlMerck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1575 BRU15011721P

Salofalk® 3000mg Gastro-

Resistant Prolonged-Release

Granules

Mesalazine 3g Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd19 May 2015 till 18 May

2020 POM

1576 BRU15011722P T3 Ada Gel 0.1% Adapalene 0.1%Hoe Pharmaceuticals Sdn Bhd

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020POM

1577 BRU15011723PClarimycin Film Coated Tablet

250mgClarithromycin 250mg

Y.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1578 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

1579 BRU15011725PTorisel Concentrate for

Injection 25mg/mlTemsirolimus 25mg/ml

Pierre Fabre Medicament Production

(PFMP), FranceZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

BDMCA/RMP/0317 Page 101 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1580 BRU15011726PUrsofalk 500mg Film-coated

TabletsUrsodeoxycholic acid 500mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd

19 May 2015 till 18 May

2020POM

1581 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

2020POM

1582 BRU15011728PHexaxim 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

1583 BRU15011730PBridion Solution for Injection

100mg/mlSugammadex 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

1584 BRU15011731P Serlift Tablets 100mg Setraline hydrochloride 100mgRanbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020POM

1585 BRU15011732NPStrepsils Soothing Honey &

Lemon

Amylmetacresol 0.6ml; 2,4-

Dichlorobenzyl alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd19 May 2015 till 18 May

2020 GSL

1586 BRU15011733NPStrepsils Max Blackcurrant

LozengeHexylresorcinol 2.4mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd19 May 2015 till 18 May

2020 GSL

1587 BRU15011734P Implanon NXT Implant 68mg Etonogestrel N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020POM

1588BRU15011735PS1 &

BRU15011735PS2Stocrin Tablet 200mg Efavirenz 200mg

Merck Sharp & Dohme (Australia) Pte

Ltd Australia; Zhejian Huahai

Pharmaceutical Co. Ltd., China

Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020 POM

1589BRU15011736PS1 &

BRU15011736PS2Stocrin Tablet 600mg Efavirenz 600mg

Merck Sharp & Dohme (Australia) Pte

Ltd Australia; Zhejian Huahai

Pharmaceutical Co. Ltd., China

Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020 POM

1590 BRU15011737P Magnevist Injection 469mg/ml

Each ml contains 0.5mmol

gadopentetate dimeglumine (eqv. to

469.01mg gadopentetate

dimeglumine)

Bayer Pharma AG, Leverkeusen,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020 POM

BDMCA/RMP/0317 Page 102 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1591 BRU15011738NP Bactidol Mouthwash Hexetidine 0.1% w/vInterphill Laboratories Inc.,

PhilippinesLF Asia (Borneo) Sdn Bhd

19 May 2015 till 18 May

2020GSL

1592 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

2020GSL

1593 BRU15011740P Nicotinell TTS 20 Nicotine 35mg (delivers 14mg/24

hours)

LTS Lohmann Therapie-System AG,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020GSL

1594 BRU15011741P Nicotinell TTS 30 Nicotine 52.5mg (delivers 21mg/24

hours)

LTS Lohmann Therapie-System AG,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020GSL

1595 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, AustraliaBossom Buddies Enterprise

19 May 2015 till 18 May

2020 GSL

1596 BRU15011743PPharmaniaga Germacid Cream

2%Fusidic acid 2.0% w/w

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020POM

1597 BRU15011744PExtraneal 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

BranchZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1598 BRU15011745P Seladin 250mg tablet Naproxen 250mgY.S.P Industries (M) Sdn Bhd.,

MalaysiaAsterix United (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1599 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

1600 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

1601 BRU15011748P Caslot 6.25mg tablet Carvedilol 6.25mgRanbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020POM

1602 BRU15011749P Caslot 12.5mg tablet Carvedilol 12.5mgRanbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020POM

BDMCA/RMP/0317 Page 103 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1603 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

1604 BRU15021751PKogenate 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 Bhd19 May 2015 till 18 May

2020 POM

1605 BRU15021752PKogenate FS for Injection

500IU/vial

Antihemophilic factor (recombinant)

sucrose formulated 500IUBayer Healthcare LLC, United States Zuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020 POM

1606 BRU15021753P Dimenate Syrup 15mg/5ml Dimenhydrinate 15mg/5mlDrug Houses of Australia Private

Limited, SingaporeG & H Trading Company

19 May 2015 till 18 May

2020POM (3.8L)

1607 BRU15021754PCernevit 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

1608 BRU15021755P Baneocin OintmentBacitracin Zinc 250IU/1g; Neomycin

Sulphate 5000 IU (5mg)/1g

Merck Kommanditgesellschaft Auf

Aktein & Co., Werk, AustriaZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020 POM

1609 BRU15021756POspexin 125mg/5ml granules

for oral suspensionCephalexin 125mg/5ml Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020 POM

1610 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 Bhd19 May 2015 till 18 May

2020 POM

1611 BRU15021758P Histac Tablets 150mg Ranitidine Hydrochloride 150mgRanbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020POM

1612 BRU15021759PBeclazone 100micrograms CFC-

Free Inhaler

Beclomethasone Dipropionate

100micrograms/metered inhalation

Norton Waterford T/A Ivax

Pharmaceuticals IrelandG & H Trading Company

19 May 2015 till 18 May

2020 POM

BDMCA/RMP/0317 Page 104 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1613BRU15021760PS1 &

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 Bhd19 May 2015 till 18 May

2020 POM

1614 BRU15021761P Covapril Tablet 4mg Perindopril ErbumineUpha Pharmaceutical Mfg (M) Sdn

Bhd, MalaysiaK-Seri Pharma Sdn Bhd

19 May 2015 till 18 May

2020POM

1615 BRU15021762P Axcel Amlodipine 5mg TabletAmlodipine Besylate equivalent to

Amlodipine 5mgKotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

19 May 2015 till 18 May

2020POM

1616 BRU15021763P Neurontin Capsule 400mg Gabapentin 400mgPfizer Pharmaceuticals LLC., Puerto

RicoZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1617 BRU15021764P Miostat Intraocular Solution Carbachol 0.1mg/ml Alcon Laboratories Inc., USA Hongkiat Trading & Co19 May 2015 till 18 May

2020POM

1618 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

1619 BRU15021766PNeulastim Pre-filled Syringe

6mg/0.6mlPegfilgrastim 6mg/0.6ml F-Hoffman-La Roche Ltd., Switzerland Medipharm Sdn Bhd

19 May 2015 till 18 May

2020POM

1620 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

1621 BRU15021768P Exelon Patch 15Rivastigmine base 27mg / 15cm2 (In

vivo release rate 13.3mg/24h)

LTS Lohmann Therapie-Systeme AG,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1622 BRU15021769PZellox-II, Double Strength

Liquid Antacid

Per 10ml - Aluminium Hydroxide

800mg; Magnesium Hydroxide 800mg;

Simethicone 60mg

Hoe Pharmaceuticals Sdn Bhd

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020 GSL

1623 BRU15021770P Bonjela Gel 15g tubeCholine Salicylate 8.714% &

Cetalkonium chloride 0.01%

Reckitt Benckiser Healthcare (UK)

Ltd., UKSyarikat Aliaa Sdn Bhd

19 May 2015 till 18 May

2020GSL

1624 BRU15021771P Gilenya 0.5mg hard capsuleFingolimod 0.5mg (corresponding to

0.56mg Fingolimod Hydrochloride)

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020 POM

1625 BRU15021772P Presolin 150 tablet Irbesartan 150mg Unison Laboratories Co. Ltd., Thailand K-Seri Pharma Sdn Bhd19 May 2015 till 18 May

2020POM

1626 BRU15021773P Presolin 300 tablet Irbesartan 300mg Unison Laboratories Co. Ltd., Thailand K-Seri Pharma Sdn Bhd19 May 2015 till 18 May

2020POM

1627 BRU15021774P Tracidol Injection 50mg/ml Tramadol Hydrochloride 50mg/mlY.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1628 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

BDMCA/RMP/0317 Page 105 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1629 BRU15021776P Apo-Risperidone 2mg tablet Risperidone 2mg Apotex Inc, Canada Medicorp Sdn Bhd19 May 2015 till 18 May

2020POM

1630 BRU15021777P Apo-Megestrol 160mg tablet Megestrol acetate 160mg Apotex Inc, Canada Medicorp Sdn Bhd19 May 2015 till 18 May

2020POM

1631 BRU15021778P Olapine 5mg FCT Megestrol acetate 160mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020POM

1632 BRU15021779PTrajenta Duo 2.5mg/500mg

FCT tablet

Linagliptin 2.5mg; Metformin

hydrochloride 500mg

Boehringer Ingelheim GmbH and Co.

KG., GermanyHongkiat Trading & Co

19 May 2015 till 18 May

2020POM

1633 BRU15021780PTrajenta Duo 2.5mg/850mg

FCT

Linagliptin 2.5mg; Metformin

hydrochloride 850mg

Boehringer Ingelheim GmbH and Co.

KG., GermanyHongkiat Trading & Co

19 May 2015 till 18 May

2020POM

1634 BRU15021781PTrajenta Duo 2.5mg/1000mg

film-coated tablets

Linagliptin 2.5mg; Metformin

hydrochloride 1000mg

Boehringer Ingelheim GmbH and Co.

KG., GermanyHongkiat Trading & Co

19 May 2015 till 18 May

2020 POM

1635BRU15021782P;

BRU15021782PS2Humalog 100u/ml (Catridge) Insulin Lispro 100 units/ml

Lillly France, France; Eli Lilly Italia

S.p.A., Fiorentino, (FI) Italy (S2)Zuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020 POM

1636 BRU15021783P Acustop Cataplasma Flurbiprofen 40mg Green Cross Corporation, Korea Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020POM

1637 BRU15021784PToviaz 4mg prolonged-release

tablet

Fesoterodine fumarate equivalent to

3.1mg fesoterodine

Aesica Pharmaceuticals GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1638 BRU15021785PToviaz 8mg prolonged-release

tablet

Fesoterodine fumarate equivalent to

6.2mg fesoterodine

Aesica Pharmaceuticals GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1639 BRU15021786PGiotrif 20mg film-coated

tablets (Afatinib 20mg)Afatinib (as dimaleate) 20mg

Boehringer Ingelheim GmbH and Co.

KG., GermanyHongkiat Trading & Co

19 May 2015 till 18 May

2020POM

1640 BRU15021787PGiotrif 30mg film-coated

tablets (Afatinib 20mg)Afatinib (as dimaleate) 30mg

Boehringer Ingelheim GmbH and Co.

KG., GermanyHongkiat Trading & Co

19 May 2015 till 18 May

2020POM

1641 BRU15021788PGiotrif 40mg film-coated

tablets (Afatinib 20mg)Afatinib (as dimaleate) 40mg

Boehringer Ingelheim GmbH and Co.

KG., GermanyHongkiat Trading & Co

19 May 2015 till 18 May

2020POM

1642 BRU15021789PGiotrif 50mg film-coated

tablets (Afatinib 20mg)Afatinib (as dimaleate) 50mg

Boehringer Ingelheim GmbH and Co.

KG., GermanyHongkiat Trading & Co

19 May 2015 till 18 May

2020POM

1643 BRU15021790PMikostat oral suspension 30ml

(Nystatin 100,000 IU/ml)Nystatin 100,000 IU/ml

Gulf Pharmaceutical Industries

(Julphar), United Arab EmiratesK-Seri Pharma Sdn Bhd

19 May 2015 till 18 May

2020 POM

1644 BRU15021791PLosartan Winthrop 50mg

tabletLosartan Potassium 50mg Zentiva, a.as., Slovak Republic Medipharm Sdn Bhd

19 May 2015 till 18 May

2020POM

1645 BRU15021792PLosartan Winthrop 100mg

tabletLosartan Potassium 100mg Zentiva, a.as., Slovak Republic Medipharm Sdn Bhd

19 May 2015 till 18 May

2020POM

1646 BRU15021793PSMOFlipid 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

2020POM

BDMCA/RMP/0317 Page 106 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1647 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

1648 BRU15021795P Ceflour CFT 250mgCefuroxime (as Cefuroxime Axetil)

250mg

Yung Shin Pharmaceutical Ind. Co.

Ltd., Republic of ChinaAsterix United (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1649 BRU15021796PMontelair 10mg film-coated

tablet

Montelukast (as Montelukast Sodium)

10mgHovid Bhd., Malaysia G & H Trading Company

19 May 2015 till 18 May

2020POM

1650 BRU15021797P Amlibon 10mg tablet Amlodipine (as Amlodipine Besilate)

10mgLek Pharmaceuticals D.D., Solvenia Zuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1651 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

BranchZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1652 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

BranchZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1653 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

BranchZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1654 BRU15021801NP Calactate 300mg tab Calcium Lactate pentahydrate 300mg Hovid Bhd, Malaysia G & H Trading Company19 May 2015 till 18 May

2020GSL

1655 BRU15021802P Xylid 250mg tab Cefuroxime Axetil 250mgPharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020POM

1656 BRU15021803PColospan 10mg sugar coated

tabletHyoscine Butylbromide 10mg Hovid Bhd, Malaysia G & H Trading Company

19 May 2015 till 18 May

2020POM

1657 BRU15021804P Caslot 25mg tablet Carvedilol 25mgRanbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020POM

1658 BRU15021805P Serenata 50mg TabletSertraline hydrochloride 56mg

equivalent to Sertraline 50mgTorrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd

19 May 2015 till 18 May

2020POM

BDMCA/RMP/0317 Page 107 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1659 BRU15021806P Gammaplex 5% w/v 2.5g Human Immunoglobulin G 2.5g/50ml Bio Product Lab, UK Medipharm Sdn Bhd19 May 2015 till 18 May

2020POM

1660 BRU15021807P Gammaplex 5% w/v 5g Human Immunoglobulin G 5g/100ml Bio Product Lab, UK Medipharm Sdn Bhd19 May 2015 till 18 May

2020POM

1661 BRU15021808P Gammaplex 5% w/v 10g Human Immunoglobulin G 10g/200ml Bio Product Lab, UK Medipharm Sdn Bhd19 May 2015 till 18 May

2020POM

1662 BRU15031809PMoxiclav Forte Dry Powder for

Oral Suspension 312.5mg/5ml

Amoxicillin (as trihydrate) 250mg &

Clavulanic acid 62.5mgMedochemie Ltd., Cyprus

Hongkiat Trading &

Company

19 May 2015 till 18 May

2020 POM

1663 BRU15031810P Moxiclav 625mg Tablets

Amoxicllin trihydrate (574mg) 500mg;

clavulanate potassium microcrystalline

cellulose (297.8mg) eq. to clavulanic

acid 125mg

Medochemie Ltd., CyprusHongkiat Trading &

Company

19 May 2015 till 18 May

2020POM

1664 BRU15031811P Zemplar Injection Paricalcitol 5mcg/ml Hospira S.p.A., Italy Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020POM

1665 BRU15031812P Lamotrix 100mg Tablets Lamotrigine 100mg Medochemie Ltd., CyprusHongkiat Trading &

Company19 May 2015 till 18 May

2020POM

1666 BRU15031813P Lamotrix 50mg Tablets Lamotrigine 50mg Medochemie Ltd., CyprusHongkiat Trading &

Company19 May 2015 till 18 May

2020POM

1667 BRU15031814PNimenrixTM (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

1668 BRU15031815P Cialis 2.5mg Tablet Tadalafil 2.5mg Lily del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020POM

1669 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

BDMCA/RMP/0317 Page 108 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1670 BRU15031817P Cialis 20mg Tablet Tadalafil 20mg Lily del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020POM

1671 BRU15031818NP Tempol Tablet 500mg Paracetamol Tablet 500mg Duopharma (M) Sdn. Bhd., MalaysiaHongkiat Trading &

Company19 May 2015 till 18 May

2020P (50 x 10’s)

1672 BRU15031819PPlacta Film-coated Tablets

75mgClopidogrel (as bisulphate) 75mg Actavis Ltd., Malta G&H Trading Company

19 May 2015 till 18 May

2020POM

1673 BRU15031820PSmofKabiven 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

1674 BRU15031821P Ometec capsule 20mg Omeprazole 20mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn. Bhd.19 May 2015 till 18 May

2020POM

1675 BRU15031823P

ADVATE 500IU Powder and

Solvent for Solution for

Injection

Octocog alfa (recombinant human

coagulation factor VIII)

Baxalta Manufacturing Sarl,

Switzerland Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020 POM

1676 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

1677 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

1678 BRU15031826PSaizen® 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

1679 BRU15031827P Torpezil Tablets 10mg Donepezil hydrochloride 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn. Bhd.19 May 2015 till 18 May

2020POM

1680 BRU15031828P Torpezil Tablets 5mg Donepezil hydrochloride 5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn. Bhd.19 May 2015 till 18 May

2020POM

1681 BRU15031829NP BrevoxylTM 4% creamHydrous Benzoyl Peroxide (eq. to

benzoyl peroxide 4%)Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020GSL

1682 BRU15031830NP Gaviscon Liquid Sachet

Each 10ml contains: Sodium alginate

500mg, Sodium bicarbonate 267mg

and Calcium carbonate 160mg

Reckitt Benckiser Healthcare (UK)

Ltd., UKSyarikat Aliaa Sdn Bhd

19 May 2015 till 18 May

2020 GSL

1683 BRU15031831NPFisherman’s Friend Sugar-Free

Apple & Cinnamon LozengesMenthol 4.025mg

IDS Manufacturing Sdn. Bhd.,

Malaysia

Kingston Beverage &

Creamery Sdn. Bhd.

19 May 2015 till 18 May

2020 GSL

BDMCA/RMP/0317 Page 109 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1684 BRU15031832NPFisherman’s Friend Sugar-Free

Mandarin & Ginger LozengesMenthol 4.6mg

IDS Manufacturing Sdn. Bhd.,

Malaysia

Kingston Beverage &

Creamery Sdn. Bhd.

19 May 2015 till 18 May

2020 GSL

1685 BRU15031833NPFisherman’s Friend Sugar-Free

Lemon LozengesMenthol 4.6mg

IDS Manufacturing Sdn. Bhd.,

Malaysia

Kingston Beverage &

Creamery Sdn. Bhd.19 May 2015 till 18 May

2020GSL

1686 BRU15041834PRotaqor 20mg film-coated

tabletAtorvastatin Calcium 20mg Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1687 BRU15041835P Jakavi 20mg tabletRuxolitinib (as phosphate 26.40mg)

20mg

Novartis Pharma Stein, AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1688 BRU15041836P Jakavi 15mg tabletRuxolitinib (as phosphate 19.8mg)

15mg

Novartis Pharma Stein, AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1689 BRU15041837P Jakavi 5mg tablet Ruxolitinib (as phosphate 6.6mg) 5mgNovartis Pharma Stein, AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1690 BRU15041838PRocephin 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

2020POM

1691 BRU15041839PArchifar 500mg powder for

injection/infusionMeropenem (as trihydrate) 500mg Medochemie Ltd, Cyprus Hong Kiat Trading & Co.

19 May 2015 till 18 May

2020POM

1692 BRU15041840PCiproflo 2mg/ml solution for

IV infusion

Ciprofloxacin 2mg/ml (as

hydrochloride)

Sin Guan Chem. Ind. Co. Ltd., Republic

of ChinaK-Seri Pharma Sdn. Bhd.

19 May 2015 till 18 May

2020POM

1693 BRU15041841P Omezole 20mg capsule Omeprazole 20mg Hovid Bhd., Malaysia G & H Trading Company19 May 2015 till 18 May

2020POM

1694 BRU15041842P B-Mycin cream

Betamethasone dipropionate 0.643mg

(eq. to 0.5mg betamethasone);

Gentamicin Sulfate 1mg (potency)

Y.S.P. Industries (M) Sdn. Bhd.,

MalaysiaAsterix United (B) Sdn Bhd

19 May 2015 till 18 May

2020 POM

1695 BRU15041843P Mucodin syrup 250mg/5ml Carbocysteine 250mg/5mlSunward Pharmaceutical Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020P

1696 BRU15041844PPharmaniaga Loratadine

tablet 10mgLoratadine 10mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020

P

1697 BRU15041845P Curam 1000mg tablet

Amoxycillin 875 (as trihydrate);

clavulanic acid 125mg (as potassium

clavulanate)

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020 POM

1698 BRU15041846P Vancotex Injection 500mg Vancomycin (as hydrochloride) 500mg Fisiopharma S.r.L., Italy K-Seri Pharma Sdn. Bhd.19 May 2015 till 18 May

2020POM

1699 BRU15041847P Sunadine tablet 10mg Loratadine 10mgSunward Pharmaceutical Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020

P

BDMCA/RMP/0317 Page 110 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1700 BRU15041848NPSoluvit 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

hydrochloride 4.9mg (corresponding to

vitamin B6 4.0mg); Sodium

panthothenate 16.5mg (corresponding

to pantothenic acid 15.0mg); Sodium

ascorbate 113mg (corresponding to

Vitamin C 100mg); Biotin 60mcg; Folic

acid 0.40mg; cyanocobalamin 5.0mcg

Sino Swed Pharmaceutical Corp. Ltd.,

ChinaZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1701 BRU15041849NP Folic acid 5mg tablet Folic acid 5mgSunward Pharmaceutical Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020P

1702 BRU15041850P Estelle-35 tabletCyproterone acetate 2mg;

Ethinylestradiol 0.03mg

Douglas Manufacturing Limited, New

ZealandG & H Trading Company

19 May 2015 till 18 May

2020POM

1703 BRU15041851NPCetomacragol emulsifying

ointment

Cetomacragol emulsifying wax 30%

w/w; liquid paraffin 20%; white soft

paraffin 50%

Hovid Bhd., Malaysia G & H Trading Company19 May 2015 till 18 May

2020 GSL

1704BRU15041852PS1/

BRU15041852PS2

Glucophage® XR 1000mg

Extended-release tablet

Metformin (as hydrochloride 1000mg)

780mg

1. Merck Sante SAS, France;

2. Merck KGaA, GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1705 BRU15041853P Duofilm LiquidSalicylic 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

2020P

1706 BRU15041854NPVoluven Solution for Infusion

6%

Per 1000ml: Poly (O-2-hydroxyethyl)

starch 60.0g; sodium chloride 9.00g

Frensius Kabi Deutschland GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020 POM

1707 BRU15041855NP Iris eye dropsHydroxypropyl methylcellulose 3mg;

dextran 70 1mg

Sam Chun Dang Pharm Co Ltd, South

KoreaMedipharm Sdn Bhd

19 May 2015 till 18 May

2020GSL

1708 BRU15041856POnzapin film-coated tablet

5mgOlanzapine 5mg Actavis Ltd., Malta G & H Trading Company

19 May 2015 till 18 May

2020POM

1709 BRU15041857POnzapin film-coated tablet

10mgOlanzapine 10mg Actavis Ltd., Malta G & H Trading Company

19 May 2015 till 18 May

2020POM

1710 BRU15041858NPFisherman’s friend aniseed

lozengesMenthol 5.75mg Lofthouse of Fleetwood Limited, UK

Kingston Beverage &

Creamery Sdn Bhd19 May 2015 till 18 May

2020GSL

1711 BRU15041859NPFisherman’s Friend Sugar Free

Mint LozengesMenthol 3.45mg Lofthouse of Fleetwood Limited, UK

Kingston Beverage &

Creamery Sdn Bhd19 May 2015 till 18 May

2020GSL

1712 BRU15041860NP

Fisherman’s Friend Sugar Free

Cherry Lozenges With

Menthol 6.9mg

Menthol 6.9mg Lofthouse of Fleetwood Limited, UKKingston Beverage &

Creamery Sdn Bhd

19 May 2015 till 18 May

2020 GSL

BDMCA/RMP/0317 Page 111 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1713 BRU15041861NPChlorHex 5% Concentrate

Solution

Chlorhexidine gluconate 5% w/v;

isopropylaocohol 3.15% w/vPahang Pharmacy Sdn Bhd, Malaysia G & H Trading Company

19 May 2015 till 18 May

2020 GSL

1714 BRU15041862P Salmax CR tablet 4mg Salbutamol sulphate 4mgUpha Pharmaceuticals Sdn Bhd,

MalaysiaHongkiat Trading & Co

19 May 2015 till 18 May

2020POM

1715BRU15051863NP SP Pharma Paracetamol

Tablets 500mg

Paracetamol 500mg Simpor Pharma Sendirian Berhad,

Brunei Darussalam

Simpor Pharma Sendirian

Berhad19 May 2015 till 18 May

2020 P (200’s)

1716

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

Fresenius Kabi Norge AS, Norway Zuellig Pharma (B) Sdn Bhd28 July 2015 till 27 July

2020

POM

1717BRU15051865NP

Dettol Moisturing Formula

Antiseptic Cream

Triclosan 0.3%; Chloroxylenol 0.3%;

Edetic acid 0.2%

Reckitt Benckiser Healthcare (UK)

Ltd., UKSyarikat Aliaa Sdn Bhd

28 July 2015 till 27 July

2020 GSL

1718BRU15051866P

Dophilin Tablets 2mg Doxazosin (as mesylate) 2mgTaiwan Biotech Co. Ltd., Taiwan

R.O.C.K-Seri Pharma Sdn Bhd

28 July 2015 till 27 July

2020 POM

1719

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 Bhd28 July 2015 till 27 July

2020

POM

BDMCA/RMP/0317 Page 112 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1720

BRU15051868NP Kabiven Emulsion for Infusion1000ml of the mixture contain:

Purified soybean oil 39g; Glucose

(anhydrous) 97g; Alanine 4.7g;

Arginine 3.3g; Aspartic acid 0.99g;

Phenylalanine 2.3g; Glutamic acid 1.6g;

Glycine 2.3g; Histidine 2.0g; Isoleucine

1.6g; Leucine 2.3g; Lysine 2.6g;

Methionine 1.6g; Proline 2.0g; Serine

1.3g; Threonine 1.6g; Tryptophan

0.56g; Tyrosine 0.07g; Valine 2.1g;

Sodium glycerophosphate (anhydrous)

1.5g; Calcium chloride 0.22g;

Potassium chloride 1.7g; Magnesium

sulphate 0.47g; Sodium acetate 1.4g

Fresenius Kabi AB, Uppsala, Sweden Zuellig Pharma (B) Sdn Bhd28 July 2015 till 27 July

2020

POM

1721BRU15051869P

Dopatab M250 Tablet Methyldopa 250mg Hovid Bhd., Malaysia G & H Trading Company28 July 2015 till 27 July

2020POM

1722BRU15051870P

Fenagesic Tablet 250mg Mefenamic acid 250mgSunward Pharmaceutical Pte Ltd.,

SingaporeG & H Trading Company

28 July 2015 till 27 July

2020POM

1723BRU15051871P

Metta SR Tablets 500mg Metformin Hydrochloride USP 500mgTorrent Pharmaceuticals Ltd., Indrad,

IndiaK-Seri Pharma Sdn Bhd

28 July 2015 till 27 July

2020POM

1724BRU15051872P

Diamitex Tablet 80mg Gliclazide 80mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd28 July 2015 till 27 July

2020POM

1725BRU15051873NP

Calamine Lotion Calamine BP 15% w/vRoyce Pharma Manufacturing Sdn

Bhd, Malaysia

SWL Biomed Sales &

Services

28 July 2015 till 27 July

2020 GSL

1726BRU15051874NP

Fisherman’s Friend Original

Lozenges

Menthol 10.35mg; Eucalyptus oil

1.73mgLofthouse of Fleetwood Limited, UK

Kingston beverage &

Creamary Sdn Bhd

28 July 2015 till 27 July

2020 GSL

1727BRU15051875NP

Fisherman’s Friend Mint

Lozenges

Menthol 4.6mg; Peppermint oil

11.270mgLofthouse of Fleetwood Limited, UK

Kingston beverage &

Creamary Sdn Bhd

28 July 2015 till 27 July

2020 GSL

1728BRU15051876NP

Fisherman’s Friend Sugar Free

Original LozengesMenthol 9.2mg IDS Manufacturing Sdn Bhd, Malaysia

Kingston beverage &

Creamary Sdn Bhd

28 July 2015 till 27 July

2020 GSL

1729

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.,

GermanyZuellig Pharma (B) Sdn Bhd

28 July 2015 till 27 July

2020POM

1730BRU15051878P

Loratyn-10 Loratadine 10mg Hovid Bhd., Malaysia G & H Trading Company28 July 2015 till 27 July

2020POM (100's); P

(20's)

1731BRU15051879P

Candazole V Single Dose

Cream 10% w/wClotrimazole 10% w/w

HOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

28 July 2015 till 27 July

2020 POM

1732BRU15061880P Keppra® Oral Solution

100mg/ml

Levetiracetam 10mg/ml NextPharma SAS., FranceZuellig Pharma (B) Sdn Bhd

28 July 2015 till 27 July

2020

POM

BDMCA/RMP/0317 Page 113 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1733

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

1734BRU15061882P Aceprin 10mg tablet Aspirin 100mg Hovid Bhd, Malaysia G & H Trading Company 28 July 2015 till 27 July

2020

POM

1735BRU15061883NP 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

1736BRU15061884P 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

1737BRU15061885P Zorax Suspension 200mg/5ml Aciclovir 200mg/5ml Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 28 July 2015 till 27 July

2020

POM

1738BRU15061886P Ganaton 50mg tablet Itopride hydrochloride 50mg Abbott Japan Co. Ltd., Japan

Zuellig Pharma (B) Sdn Bhd28 July 2015 till 27 July

2020

POM

1739BRU15061887NP 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

1740BRU15061888P 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

1741BRU15061889P Azoren 20mg/5mg Film-

Coated Tablet

Olmesartan medoxomil 20mg and

Amlodipine (as amlodipine

besylate) 5mg

Daiichi Sankyo Europe GmbH,

Germany Zuellig Pharma (B) Sdn Bhd28 July 2015 till 27 July

2020

POM

1742BRU15061890P Azoren 40mg/10mg Film-

Coated Tablet

Olmesartan medoxomil 40mg and

Amlodipine (as amlodipine

besylate) 10mg

Daiichi Sankyo Europe GmbH,

Germany Zuellig Pharma (B) Sdn Bhd28 July 2015 till 27 July

2020

POM

1743BRU15061891P Azoren 40mg/5mg Film-

Coated Tablet

Olmesartan medoxomil 40mg and

Amlodipine (as amlodipine

besylate) 5mg

Daiichi Sankyo Europe GmbH,

Germany Zuellig Pharma (B) Sdn Bhd28 July 2015 till 27 July

2020

POM

1744BRU15061892P Perindosyl 4mg Tablet Perindopril tert-butylamine 4mg (eqv.

to 3.338mg perindopril)

Lek Pharmaceuticals DD., SloveniaZuellig Pharma (B) Sdn Bhd

28 July 2015 till 27 July

2020

POM

1745BRU15061893NP 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

1746BRU15061894NP Oxy Cover Cream Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam) Co.

Ltd., Vietnam

Hamitan Marketing 28 July 2015 till 27 July

2020

GSL

1747BRU15061895NP Oxy Acne Wash Triclosan 0.30% Rohto-Mentholatum (Vietnam) Co.

Ltd., Vietnam

Hamitan Marketing 28 July 2015 till 27 July

2020

GSL

1748BRU15061896NP Hocodin Lozenge 250mcg Dequalinium chloride 250mcg Winwa Medical Sdn. Bhd., Malaysia Medicorp Sdn. Bhd. 28 July 2015 till 27 July

2020

GSL

1749

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

BDMCA/RMP/0317 Page 114 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1750BRU15071898P Celluvisc Lubricating Eye

Drops 1%

Carboxymethylcellulose sodium 1% Allergan Sales, LLC, USA Medipharm Sdn Bhd 09 Dec 2015 till 08 Dec

2020

GSL

1751BRU15071899P 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

1752BRU15071900NP Gaviscon Liquid Per 10ml - Sodium alginate 500mg;

Sodium bicarbonate 267mg; Calcium

carbonate 160mg

Reckitt Benckiser Healthcare (UK) Ltd,

UK Syarikat Aliaa Sdn Bhd09 Dec 2015 till 08 Dec

2020

GSL

1753BRU15071901P Zapine 100mg Tablet Clozapine100mg Taiwan Biotech Co. Ltd, Taiwan G & H Trading Company 09 Dec 2015 till 08 Dec

2020

POM

1754BRU15071902P Alendronate Sandoz 70mg FCT Alendronic acid 70mg Lek Pharmaceuticals D.D., Ljubljana

Zuellig Pharma (B) Sdn Bhd09 Dec 2015 till 08 Dec

2020

POM

1755BRU15071903NP Chlorhex 4% antiseptic

solution

Chlorhexidine gluconate 4% Pahang Pharmacy Sdn Bhd., Malaysia G & H Trading Company 09 Dec 2015 till 08 Dec

2020

GSL

1756BRU15071904P Resolor Film-coated Tablet

2mg

Prucalopride succinate 2.642mg eqv

Prucalopride 2mg

Janssen-Cilag S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020

POM

1757BRU15071905P Proglutrol 500 Extended

Release Tablets

Metformin Hydrochloride 500mg Inventia Healthcare Pvt. Ltd., India Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec

2020

POM

1758BRU15071906NP Gaviscon Double Action Liquid Per 10ml - Sodium Alginate 500mg;

Sodium Bicarbonate 213mg; Calcium

Carbonate 325mg

Reckitt Benckiser Healthcare (UK) Ltd,

UK Syarikat Aliaa Sdn Bhd09 Dec 2015 till 08 Dec

2020

GSL

1759BRU15071907NP Gaviscon Double Action Tablet Sodium Alginate 250mg; Sodium

Bicarbonate 106.5mg; Calcium

Carbonate 187.5mg

Reckitt Benckiser Healthcare (UK) Ltd,

UK Syarikat Aliaa Sdn Bhd09 Dec 2015 till 08 Dec

2020

GSL

1760BRU15071908P Daivobet Gel Calcipotriol (as monohydrate) 50mcg/g

& betamethasone (as dipropionate)

0.5mg/g

LEO Laboratories Ltd., IrelandZuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020

POM

1761BRU15071909NP Oxy 10 Lotion Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam) Co.

Ltd., Vietnam

Hamitan Marketing 09 Dec 2015 till 08 Dec

2020

GSL

1762BRU15071910NP Oxy 5 Lotion Benzoyl peroxide 5% w/w Rohto-Mentholatum (Vietnam) Co.

Ltd., Vietnam

Hamitan Marketing 09 Dec 2015 till 08 Dec

2020

GSL

1763BRU15071911P 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

1764BRU15071912P Keppra Film-coated Tablet

1000mg

Levetiracetam 1000mg UCB Pharma SA, BelgiumZuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020

POM

1765BRU15081913NP 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)

1766BRU15081914P 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 Bhd09 Dec 2015 till 08 Dec

2020

POM

1767BRU15081915P 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

BDMCA/RMP/0317 Page 115 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1768BRU15081916P 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

1769BRU15081917P Olmetec 40 Tablet Olmesartan Medoxomil 40mg Daiichi Sankyo Europe GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020

POM

1770BRU15081918P Olanzapine Orodispersible

Tablets 5mg

Olanzapine 5mg Jubilant Life Sciences Ltd., India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec

2020

POM

1771BRU15081919P Olanzapine Orodispersible

Tablets 10mg

Olanzapine 10mg Jubilant Life Sciences Ltd., India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec

2020

POM

1772BRU15081920P Metrogyl Injection 5mg/ml Metronidazole 500mg/100mL Unique Pharmaceutical Laboratories,

India

K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec

2020

POM

1773BRU15081921P 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

1774BRU15081922P Olmetec Plus 40/12.5mg Film-

Coated Tablet

Olmesartan Medoxomil 40mg;

Hydrochlorothiazide 12.5mg

Daiichi Sankyo Europe GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020

POM

1775BRU15081923P Risperdal Tablet 1mg Risperidone 1mg Janssen Cilag SPA, Italy

Zuellig Pharma (B) Sdn Bhd09 Dec 2015 till 08 Dec

2020

POM

1776BRU15081924P Risperdal Tablet 2mg Risperidone 2mg Janssen Cilag SPA, Italy

Zuellig Pharma (B) Sdn Bhd09 Dec 2015 till 08 Dec

2020

POM

1777BRU15081925P Apo-Clopidogrel Tablet 75mg Clopidogrel (as bisulfate) 75mg Apotex Inc. Canada, Canada Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec

2020

POM

1778

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

1779 BRU15091927P Axcel Piroxicam-10 Capsule Piroxicam 10mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd09 Dec 2015 till 08 Dec

2020POM

1780 BRU15091928PAcular Ophthalmic Solution

0.5%Ketorolac Trometamol 0.50% w/v

Allergan Pharmaceuticals Ireland,

IrelandMediPharm Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1781 BRU15091929P Dilantin capsule 30mg Phenytoin Sodium 30mg Pfizer Australia Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd09 Dec 2015 till 08 Dec

2020POM

1782 BRU15091930PZymar® (gatifloxacin

opthalmic solution) 0.3%Gatifloxacin 0.3% Allergan Sales, United States MediPharm Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1783 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

2020POM

1784 BRU15091932P

Gadovist Injection

1.0mmol/ml Prefilled syringe

5.0ml

Gadobutrol pure 604.72mg & Calcium

sodium butrol 0.513mgBayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020 POM

1785 BRU15091933PGadovist Injection

1.0mmol/ml

Gadobutrol pure 604.72mg & Calcium

sodium butrol 0.513mgBayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

BDMCA/RMP/0317 Page 116 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1786 BRU15091934P

Neostigmine Methysulphate –

Fresenius 2.5mg/1ml

(Ampoules)

Neostigmine methylsulphate 2.5mg/mlFresenius Kabi Manufacturing SA (Pty)

Ltd., Republic of South Africa.K-Seri Pharma Sdn. Bhd.

09 Dec 2015 till 08 Dec

2020 POM

1787 BRU15091935P Cardiprin 100 Tablet Aspirin 100mgReckitt Benckiser Healthcare

(UK),United KingdomZuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1788 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

1789 BRU15091937P Guafensin Syrup 20mg/ml Guaifenesin 20mg/mlY.S.P. Industries (M) Sdn. Bhd.,

MalaysiaAsterix United (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1790 BRU15091938P Storvas C Tablets 10mgAtorvastatin 10mg as Atorvastatin

Calcium Trihydrate

Ranbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

09 Dec 2015 till 08 Dec

2020POM

1791 BRU15091939NP Zinc Cream Zinc Oxide 32% w/wHOE Pharmaceuticals Sdn. Bhd.,

MalaysiaG & H Trading Company

09 Dec 2015 till 08 Dec

2020GSL

1792 BRU15091940PPirimat Injection 10mg/ml

(1ml ampoule)Chlorpheniramine Maleate 10mg/m Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company09 Dec 2015 till 08 Dec

2020POM

1793 BRU15091941P Irprestan Tablet 150mg Irbesartan 150mg Actavis ehf, Iceland G & H Trading Company09 Dec 2015 till 08 Dec

2020POM

1794 BRU15091942P Irprestan Tablet 300mg Irbesartan 300mg Actavis ehf, Iceland G & H Trading Company09 Dec 2015 till 08 Dec

2020POM

1795 BRU15091943PHeparinol® 10 Sterile

Heparinised Saline InjectionHeparin Sodium (Bovine) 10 IU/ml Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah

09 Dec 2015 till 08 Dec

2020 POM

1796 BRU15091944P Fucid Ointment 2% w/wSodium Fusidate (Micronised) 20mg/g

(2% w/w)Noripharma Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1797 BRU15091945PActemra Concentrate for

Solution for Infusion 20mg/mlTocilizumab 20mg/ml

Chugai Pharma Manufacturing Co.,

Ltd, Japan

Hongkiat Trading &

Company

09 Dec 2015 till 08 Dec

2020 POM

1798 BRU15091946PAxcel Bromhexine (Children)

ElixirBromhexine Hydrochloride 4mg Kotra Pharma (M) Sdn Bhd., Malaysia Medicorp Sdn Bhd.

09 Dec 2015 till 08 Dec

2020POM

1799 BRU15101947PCetyrol 10mg Film-coated

TabletCetirizine dihydrochloride 10mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1800 BRU15101948PArchifar 1g Powder for

Solution for Injection/InfusionMeropenem (as trihydrate) 1g Medochemie Ltd., Cyprus Hongkiat Trading & Co

09 Dec 2015 till 08 Dec

2020 POM

1801 BRU15101949P Antismine Syrup 2mg/5ml Chlorpheniramine maleate 2mg/5ml Winwa Medical Sdn Bhd., Malaysia Medicorp Sdn Bhd09 Dec 2015 till 08 Dec

2020P

1802 BRU15101950P Respidon 2mg Tablets Risperidone 2mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd09 Dec 2015 till 08 Dec

2020POM

BDMCA/RMP/0317 Page 117 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1803 BRU15101951P Respidon 1mg Tablets Risperidone 1mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd09 Dec 2015 till 08 Dec

2020POM

1804 BRU15101952NP Flexjoint 1500mg Powder

Crystalline glucosamine sulphate

1884mg (equivalent to glucosamine

sulphate 1500mg)

Winwa Medical Sdn Bhd., Malaysia Medicorp Sdn Bhd09 Dec 2015 till 08 Dec

2020 GSL

1805 BRU15101953NP Colin Cough Syrup 100mg Guaiphenesin 100mg/5ml Winwa Medical Sdn Bhd., Malaysia Yuh Hua Trading Company09 Dec 2015 till 08 Dec

2020GSL

1806 BRU15101954P Tystatin Oral Suspension Nystatin BP 100,000 unitsT.O. Chemicals (1979) Co. Ltd.,

ThailandMedicorp Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1807 BRU15101955P Ezede Tablet 10mg Loratadine 10mgXepa-Soul Pattinson (M) Sdn Bhd.,

MalaysiaHongkiat Trading & Co

09 Dec 2015 till 08 Dec

2020P

1808 BRU15101956PPred Forte Sterile Ophthalmic

Suspension 1%Prednisolone acetate 1% w/v

Allergan Pharmaceuticals Ireland,

Mayo, IrelandMedipharm Sdn Bhd

09 Dec 2015 till 08 Dec

2020 POM

1809 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

1810 BRU15111958P A Scabs Lotion Permethrin 5.0% w/vHOE Pharmaceuticals Sdn. Bhd.,

MalaysiaG & H Trading Company

09 Dec 2015 till 08 Dec

2020GSL

1811 BRU15111959P Insugen-N (NPH)Insulin Injection, Isophane Ph. Eur.

(Human Insulin rDNA origin) 100IU/mlBiocon Limited, India

Hongkiat Trading &

Company

09 Dec 2015 till 08 Dec

2020 POM

1812 BRU15111960P Tetradox Capsules 100mgDoxycycline Hydrochloride/Hcylate eq

to Doxycycline 100mgRanbaxy (Malaysia) Sdn Bhd, Malaysia G & H Trading Company

09 Dec 2015 till 08 Dec

2020 POM

1813 BRU15111961NP Infusol® NS (Ampoule) Sodium chloride 0.9%w/v AIN Medicare Sdn. Bhd., Malaysia Syarikat Pakatan Indah09 Dec 2015 till 08 Dec

2020GSL

1814 BRU15111962NPInfusol W (Sterilised Water for

Injection BP)Water for injection BP AIN Medicare Sdn. Bhd., Malaysia Syarikat Pakatan Indah

09 Dec 2015 till 08 Dec

2020GSL

1815 BRU15111963P Elan Forte CreamTolnaftate 10mg/g; Chlorhexidine HCl

2mg/g

Y.S.P. Industries (M) Sdn.

Bhd.,MalaysiaAsterix United (B) Sdn Bhd.

09 Dec 2015 till 08 Dec

2020GSL

1816 BRU15111964P Valparin XR 500mg Tablet

i) Sodium Valproate 333mg

ii) Valproic Acid 145mg

(Both together correspond to sodium

valproate 500mg)

Torrent Pharmaceuticals Limited,

IndiaK-Seri Pharma Sdn Bhd.,

09 Dec 2015 till 08 Dec

2020 POM

1817 BRU15111965P Axcel Betamethasone Cream

Betamethasone 17-Valerate

(micronized) equivalent to

Betamethasone 0.1% w/w

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd09 Dec 2015 till 08 Dec

2020 POM

1818 BRU15111966P Freederm Gel Terbinafine HCl 1%w/w Winwa Medical Sdn Bhd., Malaysia Yuh Hua Trading Company 09 Dec 2015 till 08 Dec

2020GSL

BDMCA/RMP/0317 Page 118 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1819 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

1820 BRU15111968PT Atehexal Comp Mite Tablet Atenolol 50mg; Chlorthalidone 12.5mgSalutas Pharma GmbH, Federal

Republic of Germany Medicorp

09 Dec 2015 till 28 April

2019POM

1821 BRU15111969PTHurricaine Topical Anaesthetic

Gel – Original Wild CherryBenzocaine 20%

Dental Technologies Inc. , United

States L S Kai Care09 Dec 2015 till 16 Feb

2018POM

1822 BRU15111970PT Duocaine Cream 5% w/wLidocaine 2.5% w/w; Prilocaine 2.5%

w/wHoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Co

09 Dec 2015 till 14 Jan

2019POM

1823 BRU15111971PTSOLIRIS Concentrate for

Solution for Infusion 300mgEculizumab 300mg

DSM Pharmaceuticals Inc, USAMedipharm Sdn Bhd

09 December 2015 till 23

November 2018POM

1824

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

1825BRU15121973P SW-Dexasone Tablet Dexamethasone 0.5mg Sunward Pharmaceutical Sdn Bhd.,

Singapore

G & H Trading Company 21 Jun 2016 till 20 Jun

2021

POM

1826BRU15121974P 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

1827

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

1828BRU15121976NP Mentholatum Deep Cold Ice

Gel Therapy

Menthol 20g/g Mentholatum Australia Pty. Ltd.,

Australia

Hamitan Marketing 21 Jun 2016 till 20 Jun

2021

GSL

1829BRU15121977NP Axcel Urea Cream Urea 10% w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun

2021

GSL

1830BRU15121978P Axcel Clomiphene Tablet Clomiphene Citrate 50mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun

2021

POM

1831BRU15121979P 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

1832BRU15121980NP Dexxon Lozenges Dequalinium Chloride 0.25mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun

2021

GSL

1833BRU15121981P 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

BDMCA/RMP/0317 Page 119 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1834 BRU16011982NP0.9% Sodium Chloride

Injection, USPSodium Chloride USP 0.9% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd

21 Jun 2016 till 20 Jun

2021GSL

1835 BRU16011983P Amlibon 5mg TabletAmlodipine (as Amlodipine Besilate)

5mgLek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd

21 Jun 2016 till 20 Jun

2021POM

1836 BRU16011984POspexin 250mg/5ml Granules

for Oral SuspensionCephalexin 250mg/5ml Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd

21 Jun 2016 till 20 Jun

2021 POM

1837 BRU16011985P Azukon MR 30mg Tablet Gliclazide 30mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd21 Jun 2016 till 20 Jun

2021POM

1838 BRU16011986P Espran 10mg Tablet Escitalopram (as Oxalate) 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd21 Jun 2016 till 20 Jun

2021POM

1839 BRU16011987P Zenalb 20% Human albumin 20%w/v Bio Product Lab, UK Medipharm Sdn Bhd21 Jun 2016 till 20 Jun

2021POM

1840 BRU16011988P Lestric Tablets 20mg Lovastatin 20mgRanbaxy (Malaysia) Sdn Bhd.,

MalaysiaG&H Trading Company

21 Jun 2016 till 20 Jun

2021POM

1841 BRU16011989PPotassium Chloride 10% w/v

InjectionPotassium Chloride 10% w/v

Pharmaniaga Manufacturing Berhad,

MalaysiaG&H Trading Company

21 Jun 2016 till 20 Jun

2021POM

1842 BRU16011990P Gastografin Solution

1ml contains Sodium amidotrizoate

0.1g and Meglumine amidotrizoate

0.66g

Belimed SA, Spain Zuellig Pharma (B) Sdn Bhd21 Jun 2016 till 20 Jun

2021 POM

1843 BRU16011991PRabotide Capsule 20mg (as

enteric coated pellets)Rabeprazole Sodium 20mg Inventia Healthcare Pvt Ltd., India Medicorp Sdn Bhd

21 Jun 2016 till 20 Jun

2021POM

1844 BRU16011992PPharmaniaga Gliclazide Tablet

80mgGliclazide 80mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG&H Trading Company

21 Jun 2016 till 20 Jun

2021POM

1845 BRU16011993NP Betadine Antiseptic Ointment Povidone-Iodine 10% w/w Pt. Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd21 Jun 2016 till 20 Jun

2021GSL

1846 BRU16011994NPBetadine Feminine Wash with

Douching Apparatus 10% w/vPovidone-Iodine 10% w/v Pt. Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd

21 Jun 2016 till 20 Jun

2021 GSL

1847 BRU16011995NP Betadine Feminine Wash Povidone-Iodine 10% w/v Pt. Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd21 Jun 2016 till 20 Jun

2021GSL

1848 BRU16011996NP Coxan Tablets 500mg Paracetamol 500mgPrime Pharmaceuticals Sdn Bhd.,

MalaysiaMedicorp Sdn Bhd

21 Jun 2016 till 20 Jun

2021GSL (10 x 10’s)

1849 BRU16011997P Soluwax Ear Drops Docusate sodium 0.5% w/vHoe Pharmaceuticals Sdn Bhd.,

MalaysiaG&H Trading Company

21 Jun 2016 till 20 Jun

2021GSL

1850BRU16021998P 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

1851BRU16021999P Levetiracetam tablet 500mg Levetiracetam 500mg Jubilant Generics, Limited, India Axterix United (B) Sdn. Bhd 21 Jun 2016 till 20 Jun

2021

POM

1852BRU16022000P Glimicron 80mg tablet Gliclazide 80mg HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun

2021

POM

1853BRU16022001NP Liquid Paraffin Liquid Paraffin BP 100% HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun

2021

GSL

BDMCA/RMP/0317 Page 120 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1854BRU16022002NP Noxworm Suspension

(chocolate) 400mg

Albendazole 200mg/5mL Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 21 Jun 2016 till 20 Jun

2021

GSL

1855BRU16022003P Mircera pre-filled syringe

100mcg/0.3ml

Methoxy polyethylene glycol-epoetin

beta 100mcg/0.3ml

Roche Diagnostics GmbH, GermanyZuellig Pharma (B) Sdn Bhd

21 Jun 2016 till 20 Jun

2021

POM

1856BRU16022004P Glucodex tablet Gliclazide 80mg PT Dexa Medica, Indonesia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun

2021

POM

1857BRU16022005P 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

1858BRU16022006P 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

1859BRU16022007P 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

1860BRU16022008P 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

1861BRU16022009P 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

1862BRU16022010P 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

1863BRU16022011P

Pantor 20Pantoprazole (as sodium

sesquihydrate) 20mg

Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun

2021

POM

1864BRU16022012P Pantor 40 Pantoprazole (as sodium

sesquihydrate) 40mg

Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun

2021

POM

1865BRU16032013P Ceritec Film Coated Tablet

10mgCetirizine Hydrochloride 10mg

Y.S.P. Industries (M) Sdn. Bhd.,

Malaysia.Asterix United (B) Sdn Bhd

21 Jun 2016 till 20 Jun

2021P

1866BRU16032014P

Tinazol Cream 2% (15g) Miconazole nitrate 2% w/w Hovid Bhd, Malaysia. G & H Trading Company21 Jun 2016 till 20 Jun

2021GSL

1867

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

1868

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

BDMCA/RMP/0317 Page 121 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1869BRU16032017P Natrixam 1.5mg/10mg

modified-release tablet

Indapamide 1.5mg & Amlodipine 10mg

(as besilate)

Les Laboratories Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

21 Jun 2016 till 20 Jun

2021POM

1870

BRU16032018PNatrixam 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

1871BRU16032019P

Levetiracetam 250mg tablet Levetiracetam 250mg Jubilant Generics Limited, India Asterix United (B)Sdn Bhd.,21 Jun 2016 till 20 Jun

2021POM

1872BRU16032020NP

Mifuko OintmentZinc 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

2021GSL

1873BRU16032021P

Primodil 5 Tablet Amlodipine Besilate 6.94mg

(equivalent to Amlodipine 5mg)Medley Pharmaceuticals Ltd, India Medicorp Sdn Bhd

21 Jun 2016 till 20 Jun

2021POM

1874BRU16032022P Oxair Film Coated Tablet

10mg

Montelukast Sodium 10.4mg

(equivalent to Montelukast 10mg)

Y.S.P. Industries (M) Sdn Bhd.,

MalaysiaAsterix United (B) Sdn Bhd

21 Jun 2016 till 20 Jun

2021POM

1875BRU16032023NP Bacidin Antiseptic Cream 1%

w/wChlorhexidine Gluconate 1% w/w

Xepa-soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company21 Jun 2016 till 20 Jun

2021GSL

1876BRU16032024P Axcel Oxymetazoline 0.05%

Nasal Spray

Oxymetazoline Hydrochloride 0.05%

w/vKotra Pharma (M) Sdn Bhd., Malaysia. Medicorp Sdn Bhd

21 Jun 2016 till 20 Jun

2021P

1877 BRU16042025P Romesec 20mg Capsules Omeprazole USP 20mgRanbaxy (Malaysia) Sdn. Bhd.,

Malaysia.G & H Trading Company

21 Jun 2016 till 20 Jun

2021POM

1878

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

1879 BRU16042027NPPotassium Chloride Injectable

Solution 10%Potassium chloride 1g / 10ml

DEMO SA Pharmaceutical Industry,

Greece. Medicorp Sdn Bhd

21 Jun 2016 till 20 Jun

2021POM

1880 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

1881 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

1882 BRU16042030NPOsteoactiv 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

2021GSL

BDMCA/RMP/0317 Page 122 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1883 BRU16042031NPOsteoactiv 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

2021GSL

1884 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

1885 BRU16042033PAloxi 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

1886 BRU16042034P Taver Tablet 200mg Carbamazepine 200mg Medochemie Ltd., Cyprus. Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun

2021POM

1887 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

1888 BRU16042036PPharmaniaga Allopurinol

Tablet 300mgAllopurinol 300mg

Pharmaniaga Manufacturing Berhad,

Malaysia.G & H Trading Company

21 Jun 2016 till 20 Jun

2021POM

1889 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

1890 BRU16052038P GPO-L-OneTM 500mg Tablet Deferiprone 500mgThe Government Pharmaceutical

Organization (GPO), ThailandK-Seri Pharma Sdn Bhd

21 Jun 2016 till 20 Jun

2021POM

1891 BRU16052039NP Noxworm Chewtab Albendazole 200mg Winwa Medical Sdn. Bhd., Malaysia Yuh Hua Trading Company21 Jun 2016 till 20 Jun

2021GSL

1892 BRU16052040NP Betadine® Antiseptic Solution Povidone-Iodine 10% w/v PT Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd21 Jun 2016 till 20 Jun

2021GSL

1893 BRU16052041P Zoratadine Syrup 5mg/5ml Loratadine 5mg/5mlHOE Pharmaceuticals Sdn. Bhd.,

MalaysiaG&H Trading Company

21 Jun 2016 till 20 Jun

2021P

1894 BRU16052042PAxcel Oxymetazoline 0.025%

Nasal Drop

Oxymetazoline hydrochloride 0.025%

w/vKotra Pharma (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd

21 Jun 2016 till 20 Jun

2021P

1895 BRU16052043PAxcel Dextromethorphan-15

Syrup

Dextromethorphan hydrobromide

15mg/5mlKotra Pharma (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd

21 Jun 2016 till 20 Jun

2021POM

1896 BRU16052044PZometa Solution for Infusion

4mg/100ml

Zoledronic Acid (anhydrous)

4mg/100ml corresponding to 4.264mg

Zoledronic Acid Monohydrate

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

21 Jun 2016 till 20 Jun

2021 POM

1897 BRU16052045P Novomin Tablet 50mg Dimenhydrinate 50mgXepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia.

Hongkiat Trading &

Company21 Jun 2016 till 20 Jun

2021POM

BDMCA/RMP/0317 Page 123 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1898 BRU16062046P Valzaar 80mg Tablets Valsartan 80mg Torrent Pharmaceuticals Ltd, India K-Seri Pharma Sdn. Bhd08 November 2016 till 07

November 2021POM

1899BRU16062047P

Valzaar 160mg Tablets Valsartan 160mg Torrent Pharmaceuticals Ltd, India K-Seri Pharma Sdn. Bhd08 November 2016 till 07

November 2021POM

1900 BRU16062048P Tozaar 50mg tablet Losartan potassium 50mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd08 November 2016 till 07

November 2021POM

1901 BRU16062049P

Seebri Breezhaler 50mcg

Inhalation Powder Hard

Capsules

Glycopyrronium bromide 63mcg

(corresponding to 50 mcg

Glycopyrronium)

Novartis Pharma Stein AG.,

SwitzerlandZuellig Pharma (B) Sdn Bhd

08 November 2016 till 07

November 2021POM

1902 BRU16062050P Neotigason Capsule 10mg Acitretin 10mg Patheon Inc., Canada G & H Trading Company08 November 2016 till 07

November 2021POM

1903 BRU16062051P Neotigason Capsule 25mg Acitretin 25mg Patheon Inc., Canada G & H Trading Company08 November 2016 till 07

November 2021POM

1904 BRU16062052P Tidact Injection 150mg/ml Clindamycin (as phosphate) 150mg/mlYung Shin Pharmaceutical Ind. Co.

Ltd., Republic of ChinaAsterix United (B) Sdn Bhd

08 November 2016 till 07

November 2021POM

1905 BRU16062053P APO-Risperidone Tablets 1mg Risperidone 1mg Apotex Inc, Canada Medicorp Sdn Bhd08 November 2016 till 07

November 2021POM

1906 BRU16062054PBetmiga Prolonged-Release

Tablets 25mgMirabegron 25mg Astellas Pharma Technologies Inc., US Medipharm Sdn Bhd

08 November 2016 till 07

November 2021POM

1907 BRU16062055PBetmiga Prolonged-Release

Tablets 50mgMirabegron 50mg Astellas Pharma Technologies Inc., US Medipharm Sdn Bhd

08 November 2016 till 07

November 2021POM

1908 BRU16062056PAxcel Mometasone 0.1%

Cream

Mometasone furoate (micronised)

0.1% w/wKotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

08 November 2016 till 07

November 2021POM

1909BRU16072057P Dipeptiven Infusion 200mg/ml N(2)-L-Alanyl-L-glutamine 200mg/ml Frensius Kabi Austria GmbH, Austria

Zuellig Pharma (B) Sdn Bhd08 November 2016 till 07

November 2021POM

1910BRU16072058P Noxafl 100mg tablet Posaconazole 100mg N.V Organon, Netherlan

Zuellig Pharma (B) Sdn Bhd08 November 2016 till 07

November 2021POM

1911BRU16072059P Onegaba 300mg capsules Gabapentin 300mg Aurobindo Pharma Limited (Unit

III), India

K-Seri Pharma Sdn Bhd 08 November 2016 till 07

November 2021POM

1912BRU16072060P Pethidine-Hameln Solution for

Injection 50mg/ml

Pethidine Hydrochloride

50mg/ml

Hameln Pharmaceuticals GmbH,

Langes Feld 13, 31789 Ham

eln, Germany

Medicorp Sdn Bhd08 November 2016 till 07

November 2021

POM

1913BRU16072061P 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 2021POM

1914BRU16072062P Prednisolone syrup 5mg/5ml Each 5ml contains:

Prednisolone (as salt of

prednisolone) 5mg

Beacons Pharmaceutical Pte Ltd,

Singapore

Hong Kiat Trading & Co08 November 2016 till 07

November 2021

POM

1915 BRU16082063NPZenalb 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 2021POM

1916 BRU16082064PAxcel Lamivudine 100mg

TabletLamivudine 100mg Kotra Pharma (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd

08 November 2016 till 07

November 2021POM

1917 BRU16082065P Calpo Suspension Mebendazole 100mg/5ml Winwa Medical Sdn. Bhd., Malaysia Yuh Hua Trading Company08 November 2016 till 07

November 2021GSL

BDMCA/RMP/0317 Page 124 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1918 BRU16082066NP Alphanate® 250IUFactor VII 250IU and von Willebrand

Factor >400IU/1000IU Factor VIIGrifols Bilogicals Inc., USA

Hongkiat Trading &

Company

08 November 2016 till 07

November 2021POM

1919 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), UKZuellig Pharma (B) Sdn Bhd

08 November 2016 till 07

November 2021POM

1920 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 Indah08 November 2016 till 07

November 2021GSL

1921

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

Hongkiat Trading &

Company

08 November 2016 till 07

November 2021

POM

1922

BRU16092070P 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 Hongkiat Trading &

Company

08 November 2016 till 07

November 2021

POM

1923BRU16092071NP 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 2021GSL

1924

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

08 November 2016 till 07

November 2021

POM

1925BRU16092073P Adrenaline (Epinephrine)

Injection 1:1000

Adrenaline (Epinephrine) as acid

tartrate

Mc Carthys Laboratories Ltd., UK Medicorp Sdn Bhd 08 November 2016 till 07

November 2021POM

1926BRU16092074P Axcel Mometasone 0.1%

Ointment Mometasone Furoate

(micronised) 0.1% w/w

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd08 November 2016 till 07

November 2021

POM

1927BRU16092075P 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 2021POM

BDMCA/RMP/0317 Page 125 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1928

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

GSL

1929BRU16102077PT Olanzapine Genmark 10mg

Tablet

Olanzapine 10mg Glenmark Pharmaceuticals Europe

Limited, United Kingdom

Hongkiat Trading &

Company

08 November 2016 till 23

Nov 2018

POM

1930BRU16102078PT Olanzapine Genmark 5mg

Tablet

Olanzapine 5mg Glenmark Pharmaceuticals Europe

Limited, United Kingdom

Hongkiat Trading &

Company

08 November 2016 till 14

Jan 2019

POM

1931BRU16102079PT Baxter Chlorhexidine Acetate

0.1% w/v Antiseptic Solution

Chlorhexidine (as

Acetate)

Baxter Healthcare Pty Ltd, AustraliaZuellig Pharma (B) Sdn Bhd

08 November 2016 till 26

Jan 2019

GSL

1932BRU16102080P 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

1933BRU16102081P Magurol 4mg 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

1934BRU16102082P Xyzal Film-coated tablet 5mg Levocetirizine dihydrochloride

5mg

UCB Farchim SA, SwitzerlandZuellig Pharma (B) Sdn Bhd

08 November 2016 till 07

November 2021

POM

1935

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., MalaysiaZuellig Pharma (B) Sdn Bhd

08 November 2016 till 07

November 2021

POM

1936BRU16102084P Bilaxten 20mg tablet Bilastine 20mg A.Menarini Manufacturing Logistic

and Services S.r.l., ItalyZuellig Pharma (B) Sdn Bhd

08 November 2016 till 07

November 2021

POM

1937BRU16102085P Loxin Injection (5ml amp)

(Dopamine HCl)

Dopamine hydrochloride Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

08 November 2016 till 07

November 2021

POM

1938BRU16102086P Mycamine 50mg/vial Powder

for Solution for Infusion

Micafungin (as sodium)

50mg/via

Astellas Pharma Tech Co., Ltd., Japan MediPharm Sdn Bhd 08 November 2016 till 07

November 2021

POM

1939BRU16102087P Vaxcel Fluconazole 2mg/ml IV

Infusion

Fluconazole 2mg/ml Kotra Pharma (M) Sdn. Bhd.,Malaysia Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

1940BRU16102088P 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

P

BDMCA/RMP/0317 Page 126 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1941

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

1942BRU16102090NP 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

1943BRU16102091P 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

1944 BRU16112092PRisperidone Orally

Disintegrating Tablet 3mgRisperidone 3.0mg Jubilant Generics Ltd, India Asterix United (B) Sdn Bhd

21 March 2017 till

20 March 2022POM

1945 BRU16112093PRisperidone Orally

Disintegrating Tablet 2mgRisperidone 2.0mg Jubilant Generics Ltd, India Asterix United (B) Sdn Bhd

21 March 2017 till

20 March 2022POM

1946 BRU16112094P Goutnor 0.5mg tablet Colchicine 0.5mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn. Bhd.21 March 2017 till

20 March 2022POM

1947 BRU16112095P Salbutamol Syrup 2mg/5ml Salbutamol sulphate 2mg/5mlY.S.P. Industries (M) Sdn. Bhd.,

MalaysiaAsterix United (B) Sdn Bhd.

21 March 2017 till

20 March 2022POM

1948 BRU16112096POspexin 1000mg Film-coated

TabletCephalexin 1000mg Sandoz GmBH, Austria Zuellig Pharma Sdn Bhd.

21 March 2017 till

20 March 2022POM

1949 BRU16112097NP Noflux Tablet 90mg Lysozyme chloride 90mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd.

21 March 2017 till

20 March 2022GSL

1950 BRU16112098NP Calamine Lotion with MentholCalamine powder 15% w/v, zinc oxide

5% w/v and menthol 0.4% w/v

Beacons Pharmaceuticals Pte Ltd.,

Singapore

Hongkiat Trading &

Company

21 March 2017 till

20 March 2022 GSL

1951 BRU16112099PToujeo 300 units/ml Solution

For Injection In Pre-Filled Pen

Insulin glargine 300units/ml

(10.91mg/ml)

Sanofi-Aventis Deutschland GmbH,

GermanyMediPharm Sdn Bhd.

21 March 2017 till

20 March 2022 POM

1952 BRU16112100PApo-Levocarb Tablet

100mg/25mgLevodopa 100mg; Carbidopa 25mg Apotex Inc., Canada Medicorp Sdn Bhd,

21 March 2017 till

20 March 2022POM

1953 BRU16112101PExviera 250mg Film Coated

Tablets

Dasabuvir (as sodium monohydrate)

250mgAbbVie Ireland NL B.V, Ireland Zuellig Pharma Sdn Bhd

21 March 2017 till

20 March 2022POM

1954 BRU16112102NPWhite Balsem, Three Legs

Brand

Methyl salicylate 18% w/w, Menthol

9% w/w and Camphor 5% w/w

Syarikat Wen Ken Drug Sdn Bhd,

MalaysiaSyarikat Rajamas Bersama

21 March 2017 till

20 March 2022 GSL

1955 BRU16112103NPTinea Skin Solution, Three

Legs Brand

Salicylic acid 5% w/v and Benzoic acid

2% w/v

Syarikat Wen Ken Drug Sdn Bhd,

MalaysiaSyarikat Rajamas Bersama

21 March 2017 till

20 March 2022GSL

BDMCA/RMP/0317 Page 127 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1956 BRU16112104NP Three Legs Yellow Lotion Acriflavine 0.1%w/vSyarikat Wen Ken Drug Sdn Bhd,

MalaysiaSyarikat Rajamas Bersama

21 March 2017 till

20 March 2022GSL

1957 BRU16112105PFurosemide-hameln 10mg/ml

InjectionFurosemide 10mg/ml

Hameln Pharmaceuticals

GmbH,Germany Medicorp Sdn Bhd

21 March 2017 till

20 March 2022POM

1958 BRU16112106NPTolnaftate Cream Three Legs

BrandTolnaftate 1% w/v

Syarikat Wen Ken Drug Sdn Bhd,

MalaysiaSyarikat Rajamas Bersama

21 March 2017 till

20 March 2022GSL

1959 BRU16112107NPUbat Serbuk Cap Kaki Tiga

600mg/sac

Acetylsalicylic acid (Aspirin) 600mg /

sachet

Syarikat Wen Ken Drug Sdn Bhd,

MalaysiaSyarikat Rajamas Bersama

21 March 2017 till

20 March 2022GSL

1960 BRU16112108P Denkan (1) Injection

i) Lignocaine HCl monohydrate eq. to

Lignocaine HCl Anhydrous 20mg

(2%w/v)

ii) Epinephrine Acid Tartrate eq. to

Epinephrine 0.01mg (1:100 000)

Duopharma (M) Sdn Bhd., Malaysia. K-Seri Pharma Sdn Bhd.

21 March 2017 till

20 March 2022

POM

1961 BRU16112109NP

5% Dextrose in 0.9% Sodium

Chloride Solution for

Intravenous Infusion

Each 100ml contains: Dextrose

monohydrate 5.00g and Sodium

Chloride 900mg

Euro-Med Laboratories Phil., Inc.,

Philippines Medicorp Sdn Bhd,

21 March 2017 till

20 March 2022 POM

1962 BRU16112110P Zylovaa Tablet 100mg Losartan potassium 100mgXepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company21 March 2017 till

20 March 2022POM

1963 BRU16122111P Ceflour Injection 0.75g Cefuroxime Sodium 0.75gYung Shin Pharmaceutical Ind. Co.

Ind., Republic of ChinaK-Seri Pharma Sdn. Bhd.

21 March 2017 till

20 March 2022POM

1964 BRU16122112P Ziagen Tablets 300mg Abacavir 300mg (as abacavir sulphate)GlaxoSmithKline Pharmaceuticals

S.A., PolandZuellig Pharma (B) Sdn Bhd

21 March 2017 till

20 March 2022POM

1965 BRU16122113P Apo-Alendronate 70mg tabletAlendronate Sodium Trihydrate eq to

Alendronic acid 70mgApotex Inc. Canada MediPharm Sdn Bhd

21 March 2017 till

20 March 2022POM

1966 BRU16122114PTensiber Film Coated Tablet

300mgIrbesartan 300mg Lek Pharmaceuticals d.d., Slovenia Medicorp Sdn. Bhd

21 March 2017 till

20 March 2022POM

1967 BRU16122115P Cala-My Lotion Calamine 15% w/v, Zinc Oxide 5% w/vHOE Pharmaceuticals Sdn. Bhd.,

MalaysiaG & H Trading Company

21 March 2017 till

20 March 2022GSL

1968 BRU16122116P Apo-Quetiapine 25mg TabletQuetiapine Fumarate equivalent to

25mg QuetiapineApotex Inc, Canada MediPharm Sdn Bhd

21 March 2017 till

20 March 2022POM

1969 BRU16122117P Apo-Quetiapine 100mg TabletQuetiapine Fumarate equivalent to

100mg QuetiapineApotex Inc, Canada MediPharm Sdn Bhd

21 March 2017 till

20 March 2022POM

1970 BRU16122118P Apo-Quetiapine 200mg TabletQuetiapine Fumarate equivalent to

200mg QuetiapineApotex Inc, Canada MediPharm Sdn Bhd

21 March 2017 till

20 March 2022POM

1971 BRU16122119NP Actimax 500 tablet Paracetamol 500mg Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company21 March 2017 till

20 March 2022GSL (10’s x 15,

10’s x 50 )

1972 BRU16122120NPBetadine® Dry Powder Spray

2.5%Povidone –Iodine 2.5%

Mundipharma Pharmaceuticals

Limited, CyprusZuellig Pharma (B) Sdn. Bhd.

21 March 2017 till

20 March 2022GSL

1973 BRU16122121P Flanil Analgesic Cream

Methyl Salicylate 10.20% w/w,

Menthol 5.44% w/w and

Eugenol1.36% w/w

Biolab Company Ltd., Thailand Hongkiat Trading & Co.21 March 2017 till

20 March 2022 GSL

BDMCA/RMP/0317 Page 128 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1974 BRU16122122NPBetadine® Antiseptic Skin

Cleanser 7.5% w/vPovidone-Iodine 7.5% w/v PT Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn. Bhd.

21 March 2017 till

20 March 2022GSL

1975 BRU16122123POxynorm Sterile Solution for

Injection or Infusion 10mg/mL

Oxycodone hydrochloride 10mg/ml

(equivalent to 9 mg/ml Oxycodone)Hamol Ltd, United Kingdom Zuellig Pharma (B) Sdn. Bhd.

21 March 2017 till

20 March 2022 POM

1976 BRU16122124P Ferriprox 500mg Tablet Deferiprone 500mg Apotex Inc., Canada Medicare21 March 2017 till

20 March 2022POM

1977 BRU16122125P Vaxcel Lignocaine 2% Injection Lignocaine Hydrochloride 2%

(200mg/10ml) Kotra Pharma (M) Sdn. Bhd.,Malaysia Medicorp Sdn. Bhd

21 March 2017 till

20 March 2022POM

1978 BRU16122126POxynorm Oral Solution

5mg/5mL

Each 5ml contains oxycodone base

4.5mg as oxycodone hydrochloride

5mg

Mundipharma Pharmaceuticals

Limited, CyprusZuellig Pharma (B) Sdn. Bhd.

21 March 2017 till

20 March 2022 POM

1979 BRU16122127PShintamet Film Coated Tablet

200mgCimetidine 200mg

Y.S.P. Industries (M) Sdn. Bhd.,

MalaysiaAsterix United (B) Sdn. Bhd.

21 March 2017 till

20 March 2022POM

1980

BRU17012128P Zaltrap™

Concentrate for Solution for

Infusion 25mg/ml (4ml

vial)

Aflibercept 25mg/ml Sanofi-Aventis Deutschland GmbH,

Germany

Medipharm Sdn Bhd 21 March 2017 till

20 March 2022

POM

1981

BRU17012129P Zaltrap™

Concentrate for Solution for

Infusion 25mg/ml (8ml

vial)

Aflibercept 25mg/ml Sanofi-Aventis Deutschland GmbH,

Germany

Medipharm Sdn Bhd 21 March 2017 till

20 March 2022

POM

1982BRU17012130PS1&

BRU17012130PS2

Tarceva Tablet 100mg Erlotinib 100mg (i) Kremers Urban Pharmaceuticals

inc., USA; (ii) Roche SpA, Italy

Hongkiat Trading & Co 21 March 2017 till

20 March 2022

POM

1983BRU17012131PS1 &

BRU17012131PS2

Tarceva Tablet 150mg Erlotinib 150mg (i) Kremers Urban Pharmaceuticals

inc., USA; (ii) Roche SpA, Italy

Hongkiat Trading & Co 21 March 2017 till

20 March 2022

POM

1984BRU17012132P Apo-Gliclazide 30mr MR

tablet

Gliclazide 30mg Apotex Inc. Canada Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

POM

1985BRU17012133P Glitrol Controlled Release

Capsules 30mg

Gliclazide

30mg

Inventia Healthcare Pte Ltd, India Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

POM

1986BRU17012134NP Orregel Choline salicylate 8.70% w/w; and

Cetylpyridinium Chloride

0.10% w/w

HOE Pharmaceuticals Sdn. Bhd.,

Malaysia

G & H Trading Company 21 March 2017 till

20 March 2022

GSL

1987

BRU17012135P Gaviscon peppermint tablets Sodium alginate 250mg

Sodium bicarbonate 133.5mg

Calcium carbonate 80mg

Reckitt Benckiser Healthcare (UK)

Limited, Dansom Lane, East Yo

rkshire, Hull HU8

7DS, United Kingdom

Syarikat Aliaa Sdn Bhd 21 March 2017 till

20 March 2022

GSL

1988BRU17012136NP Senokot tablet Sennoside B 7.5mg Reckitt Benckiser Healthcare (UK)

Ltd., UK

Zuellig Pharma Sdn Bhd 21 March 2017 till

20 March 2022

GSL

1989BRU17012137P Tussidex Forte Linctus Dextromethorphan hydrobromide

15mg/5ml

Xepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hong Kiat Tradin

g Co

21 March 2017 till

20 March 2022

POM

BDMCA/RMP/0317 Page 129 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

1990BRU17012138P Floctil 250mg Capsule Azithromycin dihydrate eq. to

Azithromycin 250mg

Unison Laboratories Co. Ltd, Thailand Hong Kiat Tradin

g Co

21 March 2017 till

20 March 2022

POM

1991BRU17012139P Selegos 5mg Tablet Selegiline

Hydrochloride 5mg

Medochemie Ltd., Cyprus Hong Kiat Tradin

g Co

21 March 2017 till

20 March 2022

POM

1992BRU17012140P

Timolol-POS 0.5% Eye DropTimolol maleate 6.84mg/ml Ursapharm Arzneimittel GmbH,

Germany

Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

POM

1993BRU17012141P

Metformin Tablet 500mgMetformin Hydrochloride 500mg Dynapharm (M) Sdn Bhd., Malaysia Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

POM

1994BRU17012142P Axcel Cinnarizine Tablet Cinnarizine 25mg Kotra Pharma (M) Sdn. Bhd.,Malaysia Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

POM

1995BRU17012143NP

UO Cream 100mg/g (10%)

Carbonyldiamide (Urea)

100mg/g (10%)

Y.S.P. Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd, 21 March 2017 till

20 March 2022

GSL

1996

BRU17012144NP Axcel Vitalic Tablet Vitamin B1 (Thiamine) 100mg

Vitamin B6 (Pyridoxine) 200mg

Vitamin B12 (Cyanocobalamine)

200mcg

Kotra Pharma (M) Sdn. Bhd.,Malaysia Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

P

1997BRU17012145P Iqnyde Tablet 50mg Sildenafil Citrate 70.25mg

equivalent to Sildenafil 50mg

Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 21 March 2017 till

20 March 2022

POM

1998 BRU17022146P Azarga Eye Drops SuspensionBrinzolamide 10mg/ml

Timolol maleate 5mg/mlS.A. Alcon, Couvreur N.V., Belgium

Hongkiat Trading &

Company21 March 2017 till

20 March 2022POM

1999 BRU17022147PPharmaniaga Dermasole

Cream 0.1% w/wBetamethasone 17-valerate 0.1% w/w

Pharmaniaga Manufacturing Berhad,

MalaysiaG&H Trading Co

21 March 2017 till

20 March 2022POM

2000 BRU17022148PJardiance 10mg Film-coated

TabletEmpagliflozin 10mg

Boehringer Ingelheim Pharma GmbH

& Co. KG, Germany

Hongkiat Trading &

Company21 March 2017 till

20 March 2022POM

2001 BRU17022149PJardiance 25mg Film-coated

TabletEmpagliflozin 25mg

Boehringer Ingelheim Pharma GmbH

& Co. KG, Germany

Hongkiat Trading &

Company21 March 2017 till

20 March 2022POM

2002 BRU17022150PMeraparon 1000mg Powder

for Solution for Injection

Meropenem Trihydrate equivalent to

1000mg Anhydrous MeropenemSandoz Private Limited, India Zuellig Pharma Sdn Bhd

21 March 2017 till

20 March 2022 POM

2003 BRU17022151PMeraparon 500mg Powder for

Solution for Injection

Meropenem Trihydrate equivalent to

500mg Anhydrous MeropenemSandoz Private Limited, India Zuellig Pharma Sdn Bhd

21 March 2017 till

20 March 2022POM

2004 BRU17022152P Glumet DC Tablet 500mg Metformin hydrochloride 500mgPharmaniaga Manufacturing Berhad,

MalaysiaG&H Trading Co

21 March 2017 till

20 March 2022POM

2005 BRU17022153PTargin Prolonged Release

Tablets 5mg/2.5mg

Each tablet contains:

4.5mg of oxycodone as 5mg

oxycodone hydrochloride

2.25mg of naloxone as 2.5mg naloxone

hydrochloride.

Bard Pharmaceuticals Limited, UK Zuellig Pharma Sdn Bhd

21 March 2017 till

20 March 2022POM

2006 BRU17022154PTargin Prolonged Release

Tablets 10mg/5mg

Each tablet contains:

9mg of oxycodone as 10mg oxycodone

hydrochloride

4.5mg of naloxone as 5mg naloxone

hydrochloride.

Bard Pharmaceuticals Limited, UK Zuellig Pharma Sdn Bhd

21 March 2017 till

20 March 2022POM

BDMCA/RMP/0317 Page 130 of 131

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)

2007 BRU17022155PTargin Prolonged Release

Tablets 20mg/10mg

Each tablet contains:

18mg of oxycodone as 20mg

oxycodone hydrochloride

9mg of naloxone as 10mg naloxone

hydrochloride.

Bard Pharmaceuticals Limited, UK Zuellig Pharma Sdn Bhd

21 March 2017 till

20 March 2022POM

2008 BRU17022156PTargin Prolonged Release

Tablets 40mg/20mg

Each tablet contains:

36mg of oxycodone as 40mg

oxycodone hydrochloride

18mg of naloxone as 20mg naloxone

hydrochloride.

Bard Pharmaceuticals Limited, UK Zuellig Pharma Sdn Bhd

21 March 2017 till

20 March 2022

POM

2009 BRU17022157P Pristine Shampoo 2% w/w Ketoconazole 2% w/wXepa-Soul Pattinson (Malaysia) Sdn

Bhd

Hongkiat Trading &

Company21 March 2017 till

20 March 2022POM

2010 BRU17022158NPEffervescent Mouthwash

Tablets

Thymol EP 0.77mg;

Menthol EP 1.87mg JL Bragg Ltd, UKHongkiat Trading &

Company

21 March 2017 till

20 March 2022 GSL

2011 BRU17022159P Salmol Expectorant

Each 5ml contains:

Salbutamol Sulfate equivalent to

Salbutamol 1.0 mg;

Guaiphenesin 50.0 mg

Biolab Co., Ltd, ThailandHongkiat Trading &

Company

21 March 2017 till

20 March 2022 POM

2012 BRU17022160P Acnotin 10 Capsule Isotretinoin 10mgMega Lifesceinces Public Company

Limited, ThailandG&H Trading Co

21 March 2017 till

20 March 2022POM

2013 BRU17022161P Acnotin 20 Capsule Isotretinoin 20mgMega Lifesceinces Public Company

Limited, ThailandG&H Trading Co

21 March 2017 till

20 March 2022POM

2014 BRU17022162P Ketobid Shampoo Ketoconazole 2% w/vSM Pharmaceuticals Sdn Bhd,

MalaysiaG&H Trading Co

21 March 2017 till

20 March 2022POM

2015 BRU17022163P Axcel Glucosamine-500 Tablet

Crystalline Glucosamine Sulphate

Potassium Chloride 665mg equivalent

to Glucosamine Sulphate 500mg

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

21 March 2017 till

20 March 2022 GSL

2016 BRU17022164P Cef-4 1G Injection Ceftazidime (as pentahydrate) 1g Siam Bheasach Co., Ltd., Thailand K-Seri Pharma Sdn Bhd21 March 2017 till

20 March 2022POM

BDMCA/RMP/0317 Page 131 of 131