BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI...

117
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016) No Product Registration Number Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the end of the validity period as stated) Product Classification 1 BRU07100001P Augmentin Injection 1.2g Co-Amoxiclav 1000/200 - Amoxicillin 1g as sodium salt, clavulanic acid 200mg as potassium salt SmithKline Beecham PLC, Worthing, West Sussex, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05 October 2020 POM 2 BRU07100002P Augmentin Injection 600mg Co-Amoxiclav 500/100 - Amoxicillin 500mg as sodium salt, clavulanic acid 100mg as potassium salt SmithKline Beecham PLC, Worthing, West Sussex, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05 October 2020 POM 3 BRU08010001P Pharmaniaga Aciclovir Tablet 200mg Aciclovir 200mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 4 BRU08010002P Pharmaniaga Ketoconazole Tablet 200mg Ketoconazole 200mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 5 BRU08010003P Pharmaniaga Clarithromycin Tablet 250mg Clarithromycin 250mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 6 BRU08010004P Pharmaniaga Fluconazole 150mg Capsules Fluconazole 150mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 7 BRU08010005P Pharmaniaga Ciprofloxacin Tablet 500mg Ciprofloxacin 500mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 8 BRU08010009P Meronem Injection 1g Meropenem (as trihydrate) 1g AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05 October 2020 POM 9 BRU08020010P Meronem Injection 500mg Meropenem (as trihydrate) 500mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05 October 2020 POM 10 BRU08020011P Bactroban Cream Mupirocin 2% SmithKline Beecham, Philippines Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05 October 2020 POM 11 BRU08020012P Pharmaniaga Cephalexin Capsule 500mg Cephalexin 500mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 12 BRU08020013P Pharmaniaga Metronidazole Tablet 200mg Metronidazole 200mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 13 BRU08020016P Anikef Sterile 750mg Cefuroxime 750mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05 October 2015 (PL extended to 26 March 2017) POM 14 BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05 October 2015 (PL extended to 26 March 2017) POM 15 BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05 October 2015 (PL extended to 26 March 2017) POM BDMCA/RMP/1116 Page 1 of 117

Transcript of BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI...

Page 1: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as stated)

Product

Classification

1 BRU07100001P Augmentin Injection 1.2g Co-Amoxiclav 1000/200 - Amoxicillin 1g as

sodium salt, clavulanic acid 200mg as

potassium salt

SmithKline Beecham PLC, Worthing, West

Sussex, UK

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

2 BRU07100002P Augmentin Injection 600mg Co-Amoxiclav 500/100 - Amoxicillin 500mg

as sodium salt, clavulanic acid 100mg as

potassium salt

SmithKline Beecham PLC, Worthing, West

Sussex, UK

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

3 BRU08010001P Pharmaniaga Aciclovir Tablet

200mg

Aciclovir 200mg Pharmaniaga Manufacturing Berhad

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

4 BRU08010002P Pharmaniaga Ketoconazole

Tablet 200mg

Ketoconazole 200mg Pharmaniaga Manufacturing Berhad

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

5 BRU08010003P Pharmaniaga Clarithromycin

Tablet 250mg

Clarithromycin 250mg Pharmaniaga Manufacturing Berhad

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

6 BRU08010004P Pharmaniaga Fluconazole 150mg

Capsules

Fluconazole 150mg Pharmaniaga Manufacturing Berhad

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

7 BRU08010005P Pharmaniaga Ciprofloxacin Tablet

500mg

Ciprofloxacin 500mg Pharmaniaga Manufacturing Berhad

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

8 BRU08010009P Meronem Injection 1g Meropenem (as trihydrate) 1g AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

9 BRU08020010P Meronem Injection 500mg Meropenem (as trihydrate) 500mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

10 BRU08020011P Bactroban Cream Mupirocin 2% SmithKline Beecham, Philippines Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

11 BRU08020012P Pharmaniaga Cephalexin Capsule

500mg

Cephalexin 500mg Pharmaniaga Manufacturing Berhad

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

12 BRU08020013P Pharmaniaga Metronidazole

Tablet 200mg

Metronidazole 200mg Pharmaniaga Manufacturing Berhad

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

13 BRU08020016P Anikef Sterile 750mg Cefuroxime 750mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

14 BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

15 BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

BDMCA/RMP/1116 Page 1 of 117

Page 2: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

16 BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

17 BRU08020020P Diprivan 10mg/ml (1%) Emulsion

for Injeciton or Infusion (20ml

Ampoule)

Propofol 10mg/ml (1%) Corden Pharma S.P.A Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

18 BRU08020021P Retrovir Capsule 100mg Zidovudine 100mg SmithKline Beecham Plc, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

19 BRU08020022P Bactroban Ointment Mupirocin 2% GlaxoSmithKline Philippines Inc,

Philippines

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

20 BRU08030023P Augmentin Tablet 625mg Amoxycillin 500mg (as trihydrate);

Clavulanic acid 125mg (as Potassium

Clavulanate)

SmithKline Beecham Plc, Worthing, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

21 BRU08030024P Augmentin Syrup 228mg/5ml Amoxycillin 200mg/5ml (as trihydrate);

Clavulanic acid 28.5mg/5ml (as Potassium

Clavulanate)

SmithKline Beecham Plc, Worthing, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

22 BRU08030025P Augmentin Syrup 457mg/5ml Amoxycillin 400mg/5ml (as trihydrate);

Clavulanic acid 57mg/5ml (as Potassium

Clavulanate)

SmithKline Beecham Plc, Worthing, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

23 BRU08030026P Augmentin Tablet 1g Amoxycillin 875mg (as trihydrate);

Clavulanic acid 125mg (as Potassium

Clavulanate)

SmithKline Beecham Plc, Worthing, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

24 BRU08030027P Foban Cream Fusidic acid 2% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

25 BRU08030030P Garasent 80mg Injection Gentamicin 40mg/ml (as Sulphate) Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 06 October 2015 till 05

October 2020

POM

26 BRU08030031P Retrovir 1% IV Infusion Zidovudine 1% Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

27 BRU08030032P Genta Eye Drop 0.3%w/v Gentamicin (as Sulphate) Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

28 BRU08030034P Zinacef Injection 750mg Cefuroxime (as sodium) GlaxoSmithKline Manufacturing SPA, Italy. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

29 BRU08030035P Zinacef Injection 1.5g Cefuroxime (as sodium) GlaxoSmithKline Manufacturing SPA, Italy. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

30 BRU08030036P Zinnat Tablet 125mg Cefuroxime (as axetil) Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

31 BRU08030037P Zinnat Tablet 250mg Cefuroxime (as axetil) Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 2 of 117

Page 3: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

32 BRU08040039P Solulexin Granules 125mg/5ml Cefalexin Monohydrate equivalent to

Cefalexin 125mg/5ml

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

33 BRU08040040P Retrovir Syrup Zidovudine 50mg/5ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

34 BRU08040041PS1 &

BRU08040041PS2

Zeffix Tablet Lamivudine 100mg Glaxo Wellcome Operations UK Ltd, UK

(S1); GlaxoSmithKline Pharmaceuticals

S.A., Poland (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

35 BRU08040042P Combivir Tablet Lamivudine 100mg, Zidovudine 300mg GlaxoSmithKline Pharmaceuticals S.A.,

Poland

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

36 BRU08040043P Zoraxin Syrup Aciclovir 200mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

37 BRU08040046P Genta-Bet Eye Drops Gentamicin (as Sulphate) 0.3%,

Betamethasone Disodium Phosphate 0.1%

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

38 BRU08040047P Bicafar Sterile 2g (vial) Cefoperazone (as Sodium) 2g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

39 BRU08040049P Diflucan IV Infusion 2mg/ml

(50ml)

Fluconazole 2mg/ml Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

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

Cefoperazone (as Sodium) 500mg

Haupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

41 BRU08040051P Beagenta Cream 0.1% Gentamicin (as Sulphate BP) 0.1%w/w Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

42 BRU08040052P Becarin Cream 2% Miconazole Nitrate 2% Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

GSL

43 BRU08050053P Pharmaniaga Aciclovir Tablet

400mg

Aciclovir 400mg Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

44 BRU08050054P Pharmaniaga Cephalexin Capsule

250mg

Cephalexin (as Anhydrous) Cephalexin

250mg

Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

45 BRU08050058P Ketozotan Tablet 200mg Ketoconazole 200mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

46 BRU08050060P Unocef Injection 500mg (Vial) Ceftriaxone (as Sodium) 500mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

BDMCA/RMP/1116 Page 3 of 117

Page 4: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

47 BRU08050061P Unocef Injection 1000mg (Vial) Ceftriaxone (as Sodium) 1000mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

48 BRU08050063P Solulexin Capsule 250mg Cephalexin Monohydrate 262.95mg

equivalent to Cephalexin 250mg

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

49 BRU08050064P Solulexin Capsule 500mg Cephalexin (as Monohydrate) 500mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

50 BRU08050065P Beavate-N Cream Betamethasone-17-valerate equivalent to

Betamethasone 0.1%w/w; Neomycin

Sulphate 0.5%w/w

Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

51 BRU08050066P Beagenta Eye/ Ear Drops Gentamicin Sulphate equivalent to

Gentamicin 0.3%w/w

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

52 BRU08050067P Uphalexin Granules 125 Cephalexin Monohydrate 138mg/5ml

equivalent to Cephalexin 125mg/5ml

Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

53 BRU08050068P Krisovin Tablet 500 Griseofulvin BP 500mg (micronised) Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

54 BRU08050069P Plaquenil Tablet Hydroxychloroquine Sulphate 200mg Sanofi-Aventis, S.A., Riells l Viabrea, Spain Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

55 BRU08050070P Betacin Eye Ear Drop Neomycin Sulphate 0.5% w/v;

Betamethasone Sodium Phosphate

0.1%w/v

Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 06 October 2015 till 05

October 2020

POM

56 BRU08050071P Foban Ointment Sodium Fusidate BP 2% w/v Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

57 BRU08050072P Fobancort Cream Fusidic acid 2%w/w; Betamethasone

Dipropionate 0.064%w/w equivalent to

Betamethasone 0.05%w/w

Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

58 BRU08050073P Dezor Cream Ketoconazole 2%w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

59 BRU08050074P Dezor Shampoo Ketoconazole 2%w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

60 BRU08060075P Genta-Dex Eye Drops Gentamicin 0.3% w/v; Dexamethsone

Phosphate 0.1%w/v

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

BDMCA/RMP/1116 Page 4 of 117

Page 5: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

61 BRU08060077P Aecoras Ointment Econazole Nitrate 10mg; Triamcinolone

Acetonide 1mg

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

62 BRU08060078P Beapen VK Granules 125mg Phenoxymethypenicillin 125mg/5ml Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

63 BRU08060079P Enoxin Tablet 500mg Ciprofloxacin 500mg Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

64 BRU08060080P Beta Eye/ Ear Drops Betamethasone Sodium Phosphate 0.1% Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

65 BRU08060081P Betagen Eye/ Ear Drops Gentamicin 0.3% w/v; Dexamethsone

Phosphate 0.1%w/v

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

66 BRU08060082P Muprin Ointment Mupirocin 2.0%w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

67 BRU08060084P Eryson Granules 400 Erythromycin ethylsuccinate equiv. to

eryhtromycin 400mg/5ml

Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

68 BRU08060085P Neomycin Cream 0.5% Neomycin sulphate 0.5%w/w Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

69 BRU08060086P Foban Hydro Cream Fusidic acid 2%; Hydrocortisone 1% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

70 BRU08060087P Foban Hydro Ointment Sodium Fusidate 2%; Hydrocortisone 1% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

71 BRU08060088P Arava Tablet 10mg Leflunomide 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

72 BRU08060089P Arava Tablet 20mg Leflunomide 20mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

73 BRU08070090P Zinnat Suspension 125mg/5ml Cefuroxime Axetil equivalent to

Cefuroxime 250mg

Glaxo Wellcome Bernard Castle, United

Kingdom

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

74 BRU08070091P Metronol 0.5%w/v Injection Metronidazole 0.5% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 06 October 2015 till 05

October 2020

POM

75 BRU08070094P Ecocort Cream Econazole Nitrate 1% w/w; Triamcinolone

Acetonide 0.1% w/w

Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

76 BRU08070095P Beprogent Ointment Betamethasone 0.05%; Gentamicin 0.1% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 5 of 117

Page 6: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

77 BRU08070096P Betamox Capsule 250mg Amoxicillin Trihydrate equivalent to

Amoxicillin 250mg

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

78 BRU08070097P Aprovel Tablet 300mg Irbesartan 300mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

79 BRU08070099P Atacand Tablet 8mg Candesartan Cilexetil 8mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

80 BRU08070100P Atacand Tablet 16mg Candesartan Cilexetil 16mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

81 BRU08070101P Zovirax Suspension 200mg/5ml Acyclovir 200mg/5ml GlaxoSmithKline GmbH & Co Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

82 BRU08070102P Fortum® Injection 500mg Ceftazidime (as Pentahydrate) 500mg GlaxoSmithKline Manufacturing SPA, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

83 BRU08070103P Fortum® Injection 1g Ceftazidime (as Pentahydrate) 1g GlaxoSmithKline Manufacturing SPA, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

84 BRU08080104P Beavate Cream 0.1% Betamethasone -17- valerate equiv. to

Betamethasone 0.1%

Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

85 BRU08080106P Candazole Cream Clotrimazole 1.0% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

GSL

86 BRU08080107P Gentamicin Cream Gentamicin (as Sulphate) 0.1% Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

87 BRU08080108P Beprogent Cream Betamethasone (as dipropionate) 0.05%,

Gentamicin (as sulphate 0.1%)

Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

88 BRU08080109P Unasyn Tablet 375mg Sultamicillin (as tosilate) 375mg (Ampicillin

250mg & Sulbactam 125mg)

Pfizer Global Supply Japan Inc, Japan Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

89 BRU08080110P Zovirax Dispersable Tablet 200mg Aciclovir 200mg Glaxo Wellcome, S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

90 BRU08080111P Valtrex® 500mg Tablet Valciclovir (as HCl) 500mg Glaxo Wellcome SA, Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

91 BRU08080112P Fortum® Injection 2g Ceftazidime (as pentahydrate) 2g GlaxoSmithKline Manufacturing SPA, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

92 BRU08080113P Uphalexin Capsule 250 Cephalexin (as monohydrate) 250mg Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

93 BRU08080114P Uphalexin Capsule 500 Cephalexin (as monohydrate) 500mg Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

94 BRU08080115P Vaxcel Cefuroxime 750mg

Injection

Cefuroxime (as sodium) 750mg Kotra Pharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

95 BRU08080116P Vaxcel Ceftriaxone 1g Injection Ceftriaxone (as sodium) 1g Kotra Pharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 6 of 117

Page 7: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

96 BRU08080117P Axcel Fusi-Corte Cream Fusidic acid 2%, Betamethasone (as 17-

valerate) 0.1%

Kotra Pharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

97 BRU08090118P Verorab Injection Inactivated rabies virus (Wistar strain

RABIES PM/WI 38-1503-3M) produced on

VERO cell line, inactivated and purifed

Sanofi Pasteur, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

98 BRU08090119P Decocort Cream Miconazole Nitrate 2%w/w;

Hydrocortisone 1% w/w

Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

99 BRU08090120P Fobancort Ointment Sodium Fusidate 2%w/w; Betamethasone

0.05%w/w (as Dipropionate 0.064%)

Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

100 BRU08090121P Candacort Cream Clotrimazole 1.0% w/w; Hydrocortisone

1.0%w/w

Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

101 BRU08090122P Hepsera Tablet 10mg Adefovir dipivoxil 10mg GlaxosmithKline (Tianjin) Co.Ltd, China Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

102 BRU08090124P Ciprobay® 200 Infusion Solution Ciprofloxacin (as lactate) 200mg Bayer Pharma AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

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

October 2020

POM

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

October 2020

POM

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

October 2020

POM

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

October 2020

POM

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

October 2020

GSL

108 BRU08090130P Ciprobay 100 Infusion Solution x

50ml

Ciprofloxacin (as lactate) 100mg Bayer Pharma AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

P

109 BRU08090132P Aroxin Capsule 250mg Amoxicillin (as trihydrate) 250mg Agila Specialties Private Limited, India;

Medreich Limited Unit-1, Bangalore, India

G & H Trading Company 06 October 2015 till 05

October 2020

POM

110 BRU08090133NPS1;

BRU08090133NPS2

Dhamol Suspension 250mg/5ml Paracetamol 250mg/5ml Drug Houses of Australia Pte Ltd,

Singapore (S1); PT Actavis Indonesia,

Jakarta Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

P GSL (60ml)

111 BRU08100134P Decozol Cream Miconazole Nitrate 2%w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

GSL

112 BRU08100135P Betamox Capsule 500mg BRU08090127P Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

113 BRU08100136P Zovirax Dispersable Tablet 800mg Aciclovir 800mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

114 BRU08100137P Neo Deca Eye/Ear Drop Neomycin Sulphate 0.5%; Dexamethasone

Sodium Phosphate 0.1% w/w

CCM Pharmaceutical Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 7 of 117

Page 8: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

115 BRU08100138P Uphalexin Granules 250 Cephalexin (as Monohydrate) 250mg Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

116 BRU08100139P Ciprobay® 500 Tablet Ciprofloxacin (as HCl monohydrate) 500mg Bayer Pharma AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

117 BRU08100140P Avelox Infusion Solution

0.4g/250ml

Moxifloxacin (as Hydrochloride) 400mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

118 BRU08100141P Avelox 400mg Tablet Moxifloxacin (as Hydrochloride) 400mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

119 BRU08100142P Candazole Lotion Clotrimazole 1%w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

GSL

120 BRU08100143P Allopurinol 100mg Tablet Allopurinol 100mg Drug Houses of Australia Pte Ltd G & H Trading Company 06 October 2015 till 05

October 2020

POM

121 BRU08100144PS1;

BRU08100144PS2

Bifen Suspension 100mg/5ml Ibuprofen BP 100mg/5ml Drug Houses of Australia Pte Ltd,

Singapore (S1); PT Actavis Indonesia,

Jakarta Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

P

122 BRU08100145NP Dhamol Tablet 500mg Paracetamol BP 500mg Drug House of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

P (1000's)

123 BRU08100146NP Silfazine Cream Silver Sulfadiazine 1%w/w Sunward Pharmaceutical Sdn Bhd

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

P

124 BRU08100147P Difenac 50 Tablet Diclofenac Sodium BP 50mg Drug House of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

125 BRU08100148P Erythro Ethyl Granules Erythromycin (as ethyl succinate)

200mg/5ml

Drug Houses of Australia Pte. Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

126 BRU08110150P Avaxim 160U Suspension for

Injection in a prefilled Syringe

Inactivated Hepatitis A Virus (GBM strain)

160u/0.5ml

Sanofi Pasteur France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

127 BRU08110151P Aprovel 150mg Tablet Irbesartan 150mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

128 BRU08110152P Zovirax IV for Infusion 250mg Aciclovir 250mg GlaxoSmithKline Manufacturing SPA Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

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

October 2020

POM

130 BRU08110154P Axcel Eryhthromycin ES Tablet

400mg

Erythromycin (as ethyl succinate) 400mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

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

October 2020

POM

132 BRU08110156P Axcel Eryhthromycin ES-200

Suspension

Erythromycin (as Ethylsuccinate)

200mg/5ml

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

133 BRU08110157P Soden Tablet 275mg Naproxen Sodium BP 275mg Drug House of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

134 BRU08110158NP Dhamol Suspension 120mg/5ml Paracetamol BP 120mg/5ml Drug House of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

GSL (100mL)

135 BRU08110159P Miconazole Cream 2.0%w/w Miconazole Nitrate 2.0%w/w Sunward Pharmaceutical Sdn Bhd

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

GSL

BDMCA/RMP/1116 Page 8 of 117

Page 9: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

136 BRU08110160P Malarone Tablet Atovaquone 250mg, Proguanil HCl 100mg GlaxoSmithKline Inc Canada Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

137 BRU08110162P Cordarone Tablet 200mg Amiodarone HCl 200mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

138 BRU08110163P CoAprovel 150/12.5mg Film-

coated Tablet

Irbesartan 150mg, Hydrochlorothiazide

12.5mg

Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

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

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

140 BRU08110165P Betasone Cream 0.1%w/w Betamethasone (as 17-valerate) 0.1%w/w Drug Houses of Australia Pte Ltd G & H Trading Company 06 October 2015 till 05

October 2020

POM

141 BRU08120166P Ciprobay 250 Tablet Ciprofloxacin (as HCl monohydrate) 250mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

142 BRU08120167P Axcel Cephalexin 250mg Caspule Cephalexin (as Monohydrate) 250mg Kotra Pharma (M) Sdn Bhd Malaysia Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

143 BRU08120168P Axcel Cephalexin 125mg

Suspension

Cephalexin (as Monohydrate) 125mg Kotra Pharma (M) Sdn Bhd Malaysia Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

144 BRU08120169P Cloxacillin Capsule 250 Cloxacillin (as Sodium) 250mg Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

145 BRU08120172P Betamox Tablet 125 Amoxicillin (as trihydrate) 125mg Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

146 BRU08120173P Ventolin Respirator Solution Salbutamol (as sulphate) 0.5%w/v Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

147 BRU08120174P Dhacopan Syrup 5mg/5ml Hyoscine (as butylbromide) BP 5mg/5ml Drug Houses of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

148 BRU08120175P Phenexpect Syrup Per 5ml - Diphenhydramine (as HCl)

12.5mg, Ammonium Chloride 135mg

Drug Houses of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

149 BRU08120176P Dhabesol Cream 0.05% Clobetasol (as propionate) 0.05% w/v Drug Houses of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

150 BRU08120177P Beprosalic Lotion Betamethasone (as dipropionate) 0.05%,

Salicylic acid 2.0%

Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

151 BRU08120178PS1;

BRU08120178PS2

Zenmolin Syrup 2mg/5ml Salbutamol (as sulphate) BP 2mg/5ml Drug Houses of Australia Pte Ltd,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

POM

152 BRU08120179P Dhasedyl Syrup Per 5ml - Promethazine (as HCl) 3.85mg,

Epherdrine (as HCl) 6.0mg, Codeine (as

phosphate) 9.0mg

Drug Houses of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

153 BRU08120180P Zithromax Film-coated Tablet

250mg

Azithromycin (as dihydrate) 250mg Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

154 BRU09010181P Unasyn 0.75mg IM/IV Ampicillin (as sodium) 500mg; Sulbactam

(as sodium) 250mg

Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

155 BRU09010182P Unasyn 3.0g IM/IV Ampicillin (as sodium) 2000mg; Sulbactam

(as sodium) 1000mg

Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 9 of 117

Page 10: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

156 BRU09010183P Vaxcel Ceftriaxone-500mg

Injection

Ceftriaxone (as sodium) 500mg Kotra Pharma (M) Sdn Bhd Malaysia Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

157 BRU09010184PS1;

BRU09010184PS2

Aroxin granules 125mg/5ml Amoxicillin (as trihydrate) 125mg/5ml Drug Houses of Australia Pte Ltd,

Singapore (S1); Medreich Limited Unit-1,

India (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

POM

158 BRU09010185P Pacofen Tablet Paracetamol 500mg; Codeine Phosphate

8mg; Caffeine anhydrous 30mg

Drug Houses of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

159 BRU09010186P Plavix Tablet 75mg Clopidogrel (as Hydrogen Sulphate) 75mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

160 BRU09010187P Symbicort Turbuhaler

160/4.5mcg dose

Budenoside 160mcg; Formoterol fumarate

dihydrate 4.5mcg

AstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

161 BRU09010188P CoAprovel 300/12.5mg film-

coated tablet

Irbesartan 300mg; Hydrochlorothiazide

12.5mg

Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

162 BRU09010189PS1;

BRU09010189PS2

Vasican Syrup 4mg/5ml Bromhexine HCl BP 4mg/5ml Drug House of Australia Pte Ltd,

Singapore (S1); PT Actavis Indonesia,

Jakarta

Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

POM

163 BRU09010190P Cardium 30 tablet Diltiazem HCl 30mg Drug House of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

164 BRU09010191PS1 &

BRU09010191PS2

Coversyl 8mg tablet Perindopril tert-butylamine 8mg Les Laboratoires Servier Industrie, France

(S1) & Kotra Pharma (M) Sdn. Bhd,

Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

165 BRU09010192P Dhacopan Tablet Hyoscine (as butylbromide) BP 10mg Drug Houses of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

166 BRU09010194P Pulmicort turbuhaler

100mcg/dose

Budenoside 100mcg AstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

167 BRU09010195P Lantus for Optipen 100iu/ml Insulin glargine 100iu/ml Sanofi Aventis Deutschland, Germany Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

168 BRU09020196P Zovirax Cream 5% Aciclovir 5%w/w Glaxo Wellcome Opertions, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

169 BRU09020197P Zovirax Eye Ointment 3% Aciclovir 3%w/w Jubilant HollisterStier General

Partnership, Canada

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

170 BRU09020198P Adenocor Injection 6mg/2ml Adenosine 6mg/2ml Famar Health Care Services Madrid S.A.U.,

Madrid, Spain

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

171 BRU09020201NPS1,

BRU09020201NPS2

Dhamol Suspension 500mg/5ml Paracetamol BP 500mg/5ml Drug Houses of Australia Pte Ltd,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

P

172 BRU09020205PS1 &

BRU09020205PS2

Fedac Syrup Pseudoephedrine 30mg/5ml; Triprolidine

1.25mg/5ml

Drug House of Australia Pte Ltd,

Singapore (S1); PT Actavis Indonesia,

Jakarta

Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 10 of 117

Page 11: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

173 BRU09020206P Bricanyl Turbuhaler 0.5mg/dose Terbutaline Sulphate 0.5mg/dose AstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

174 BRU09020207P Beprosalic Ointment Betamethasone (as Dipropionate 0.064%)

0.05% & Salicylic acid 3% w/w

HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05

October 2020

POM

175 BRU09020208P Beprogel Topical Solution Betamethasone (as Dipropionate 0.064%)

0.05% w/w

HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05

October 2020

POM

176 BRU09020209P Cloderm Scalp Application Clobetasol (as dipropionate) 0.05% w/v HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05

October 2020

POM

177 BRU09020210P Declovir Cream Acyclovir 5.0% w/w HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05

October 2020

POM

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

Germany

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

179 BRU09020212P Glucobay 50 Tablet Acarbose 50mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

180 BRU09030213P 3TC Tablet 150mg Lamivudine 150mg Glaxo Wellcome Operaions, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

181 BRU09030214P 3TC Oral Solution 10mg/ml Lamivudine 10mg/ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

182 BRU09030215P Dhatrin Tablet Sulphamethoxazole BP 400mg;

Trimethoprim BP 80mg

Drug Houses of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

183 BRU09030216P Cordarone Injection 150mg/3ml Amiodarone 150mg/3ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

184 BRU09030217PS1 &

BRU09030217PS2

Vastarel MR 35mg Tablet Trimetazidine HCl 35mg Les Laboratoires Servier Industrie, France

(S1); Kotra Pharma (M) Sdn. Bhd, Malaysia

(S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

185 BRU09030218P0.5gS &

BRU09030218P0.5gA

Tetavax Suspension for Injection

(Single dose 0.5ml)

Purified Tetanus Toxoid Sanofi Pasteur, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

186 BRU09030219P Cataflam 1.5% Oral Drops

Suspension

Diclofenac Sodium 15mg/ml Novartis Farma SpA, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 11 of 117

Page 12: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

187 BRU09030220P Vaxigrip Influenza Vaccine Strain composition for Influenza Vaccine

complies with the WHO recommendations

and EU Recommendations for the

Northern Hemisphere 2015/2016 year

influenza season.

Active substance(s):

Split influenza virus, inactivated containing

antigens equivalent to the following strains

per one 0.5ml dose:

• A/California/7/2009 (H1N1)pdm09-like

strain (A/California/7/2009, NYMC X-179A)

• A/Switzerland/9715293/2013 (H3N2)-like

strain (A/South Australia/55/2014, IVR-

175)

• B/Phuket/3073/2013

Sanofi Pasteur, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

188 BRU09030221P Lignocaine HCl BP Injection 1%

(5ml)

Lidocaine HCl (Lignocaine HCl) 1%

(50mg/5ml)

Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

189 BRU09030222P Crestor 5mg Tablet Rosuvastatin Calcium 5mg IPR Pharmaceuticals Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

190 BRU09030223P Crestor 20mg Tablet Rosuvastatin Calcium 20mg IPR Pharmaceuticals Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

191 BRU09030224P Beprosone Ointment Betamethasone (as Dipropionate 0.064%)

0.05% w/w

HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 12 of 117

Page 13: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

192 BRU09030225P Beprosone Cream Betamethasone (as Dipropionate 0.064%)

0.05% w/w

HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05

October 2020

POM

193 BRU09030226P Benosone-N Cream Betamethasone (as Valerate 0.12%) 0.1%

w/w; Neomycin Sulphate 0.5%w/w

HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05

October 2020

POM

194 BRU09030227P Pocin H Ear Drop Neomycin Sulphate B.P. 3,400 i.u.;

Polymyxin B Sulphate B.P.10,000 i.u;

Hydrocortisone B.P.10mg

Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

195 BRU09030228P U-Closone Cream Clobetasone butyrate 0.05%w/w HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05

October 2020

POM

196 BRU09040229P Unasyn Powder for Oral

Suspension 250mg/5ml

Sultamicillin (as tosilate) 250mg Pfizer Global Supply Japan, Inc., Japan Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

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

October 2020

POM

198 BRU09040231P Knowful Capsule 400mg Piracetam 400mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

199 BRU09040232P0.5gV &

BRU09040232P0.5gS

Stamaril Vaccine Live attenuated Yellow Fever Virus 17 D-

204 strain (per 0.5ml - Not less than 1000

LD50 units of the virus)

Sanofi Pasteur, Campus Merieux & Sanofi

Pasteur, Parc Insutrial d'Incarville, France

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

200 BRU09040233P Voltaren Suppository 25mg Diclofenac (as Sodium) 25mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

201 BRU09040234P Tidact Capsule 150mg Clindamycin (as hydrochloride) 150mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

202 BRU09040235P Voltaren 75mg/3ml solution for

injection

Diclofenac Sodium 75mg/3ml Novartis Pharma Stein, ag, Switzerland;

Lek Pharmaceuticals d.d, Slovenia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

203 BRU09040236P Vaxigrip Paediatric Injection Split influenza virus*, inactivated

containing antigens equivalent to the

following strains per one 0.25ml dose:

A/California/7/2009 (H1N1)pdm09-derived

strain used NYMC X-179A 7.5mcg HA**;

A/Texas/50/2012(H3N2)-derived strain

used NYMC X-223A 7.5mcg HA**;

B/Massachusetts/02/2012 15mcg HA**

Note - * Propagated in fertilized hens’ egg

from healthy chicken flocks

** haemagglutinin

Sanofi Pasteur, Campus Merieux & Sanofi

Pasteur, Parc Insutrial d'Incarville, France

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

204 BRU09040237P Depo-Medrol Sterile Aqueous

Suspension 40mg/ml (5ml)

Methylprednisolone Acetate 200mg/5ml Pfizer Manufacturing Belgium NV,

Belgium

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 13 of 117

Page 14: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

205 BRU09040238P Typhim Vi Vaccine (20 doses) Per 0.5ml - Purified Vi Capsular

Polysaccharide of Salmonella typhi (Ty2

strain)

Sanofi Pasteur, Campus Merieux & Sanofi

Pasteur, Parc Insutrial d'Incarville, France

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

206 BRU09040239P Bupivacaine Hydrochloride BP

0.5% w/v injection

Bupivacaine hydrochloride BP 0.5%w/v Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

207 BRU09040240P Rhinathiol Capsule 375mg Carbocisteine 375mg Sanofi-aventis Egypt s.a.e., Egypt Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

208 BRU09040241P Celebrex Capsule 200mg Celecoxib 200mg Pfizer Pharmaceutical LLC, Vega Baja

Puerto Rico

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

209 BRU09040242P Voltaren® SR Tablet 100mg Diclofenac sodium 100mg Novartis Farma SPA, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

210 BRU09040243P T3 Mycin Gel Clindamycin (as phosphate) 1.0% HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05

October 2020

POM

211 BRU09040244P Cloderm Cream Clobetasone (as butyrate) 0.05%w/w HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading & Co 06 October 2015 till 05

October 2020

POM

212 BRU09040245P Bisacodyl Suppositroies Bisacodyl (micronised) 10mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 06 October 2015 till 05

October 2020

P

213 BRU09040246P U-Closone Ointment Clobetasol (as propionate) 0.05%w/w HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

214 BRU09040247P Nexium® IV 40mg Esomeprazole (as sodium) 40mg AstraZeneca AB, Sweden G & H Trading Company 06 October 2015 till 05

October 2020

POM

215 BRU09050248NPS1;

BRU09050248NPS2

Dhactulose Syrup Lactulose 67%w/w Drug Houses of Australia Pte Ltd,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

GSL (200mL) &

P(1L)

216 BRU09050249P Vastarel 20mg Tablet Trimetazidine dihydrochloride 20mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

217 BRU09050250P Coversyl Plus Tablet Perindopril tert-butylamine 4mg,

Indapamide 1.25mg

Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

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

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

219 BRU09050252P Glucobay Tablet 100mg Acarbose 100mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

220 BRU09050253P Benosone-N Ointment Betamethasone (as valerate 0.12% w/w)

0.01%, Neomycin Sulphate 0.50%w/w

HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

221 BRU09050254P Benosone Ointment Betamethasone 0.01% w/w HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

222 BRU09050255P Mycosone Cream Miconazole nitrate 2% w/w,

Hydrocortisone ( as acetate1.12%) 1% w/w

Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

223 BRU09050256P H-Cort Ointment Hydrocortisone 1% w/w HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

224 BRU09050257P T3 Mycin Lotion Clindamycin (as phosphate) 1.0% w/v HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 14 of 117

Page 15: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

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

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

226 BRU09060259P Vaxcel Cefuroxime 1.5g Injection Cefuroxime (as sodium) 1.5g Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

227 BRU09060260P Tetavax Suspension for Injection Tetanus toxoid 40i.u/0.5ml dose Sanofi Pasteur, Lyon, Pasteur Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

228 BRU09060262P Betamox Tablet 250mg Amoxicillin (as trihydrate) 250mg Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

229 BRU09060263P Voltaren 50mg Tablets Diclofenac Sodium 50mg Novartis Pharma SPA, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

230 BRU09060264P Voltaren 12.5mg Suppositories Diclofenac Sodium 12.5mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

231 BRU09060265P Voltaren 50mg Suppositories Diclofenac Sodium 50mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

232 BRU09060266P Benosone Cream Betamethasone (as valerate) 0.1%w/w HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

233 BRU09060267NP Uphamol 250 Syrup Paracetamol 250mg/5ml Upha Pharmaceutical Mfg (M) Sdn Bhd Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

GSL (60mL)

234 BRU09060268P Betamethasone Cream Betamethasone (as valerate) 0.1%w/w Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

235 BRU09060269P Zorax Cream Aciclovir 5%w/w Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

236 BRU09060270P Nexium mups 20mg Esomeprazole (as magnesium trihydrate)

20mg

AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

237 BRU09060271P Ebutol-100 Tablet Ethambutol HCl 100mg Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

238 BRU09060272P Neurontin Capsule 300mg Gabapentin 300mg Pfizer Pharmaceuticals LLC, Vega Baja

Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

239 BRU09060274P Relenza® Rotadisks 5mg Zanamivir 5mg GlaxoSmithKline Australia Pty Ltd,

Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

240 BRU09070275P Unasyn IM/IV 1.5g Sulbactam (as sodium 546.4mg) 500mg &

Ampicillin (as sodium 1084.6mg) 1000mg

Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

241 BRU09070277P Avaxim 80u Paediatric Inactivated Hepatitis A virus (GBM strain)

80u per 0.5ml

Sanofi Pasteur, Lyon, Pasteur Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

242 BRU09070278P Fedac Tablet Pseudoephedrine HCl 60mg; Triprolidine

HCl 2.5mg

Drug Houses of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

243 BRU09070279P Salazopyrin® EN-Tabs Sulfasalazine 500mg Kemwell AB, Bjorkgatan 30, SE-751 82

Uppsala, Sweden.

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

244 BRU09070280P Zyloric® 100mg Tablet Allopurinol 100mg GlaxoSmithKline Australia Pty Ltd.,

Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 15 of 117

Page 16: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

245 BRU09070281P Orrepaste 0.1%w/w Triamcinolone Acetate 0.1%w/w HOE Pharmaceuticals Sdn Bhd, Malaysia. G & H Trading Company 06 October 2015 till 05

October 2020

POM

246 BRU09070282P Hydrocortisone Cream 1% w/w Hydrocortisone acetate 1%w/w Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

247 BRU09070283P XanaxTM 0.25mg Tablet Alprazolam 0.25mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

248 BRU09070284P Nexium mups 40mg Esomeprazole (as magnesium trihydrate)

40mg

AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

249 BRU09070286P XanaxTM 0.5mg Tablet Alprazolam 0.5mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

250 BRU09070287P Zolterol S/R Tablet 100mg Diclofenac Sodium 100mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

251 BRU09070288P Diane-35 Tablet Cyproterone acetate 2mg; Ethinylestradiol

0.035mg

Bayer Weimar GmbH und Co. KG,

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

252 BRU09070289P Amaryl 3mg Tablet Glimepiride Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

253 BRU09070290P Diamicron Tablet 80mg Gliclazide 80mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

254 BRU09070291NP Dulcolax Suppository 10mg Bisacodyl 10mg Istituto De Angeli S.r.l., Italy Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

255 BRU09070292P Clotrimazole Cream 1% w/w Clotrimazole 1% w/w Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

GSL

256 BRU09070293P Mucosolvon® 30mg Tablet Ambroxol hydrochloride 30mg PT Boehringer Ingelheim Indonesia,

Bogor, Indonesia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

257 BRU09080294P Euvax B Vaccine, Recombinant Purified Hepatitis B surface antigen

(HBsAg) 200µg/10ml

LG Life Science Ltd, Korea Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

258 BRU09080295P Pulmicort® Turbuhaler®

200mcg/dose

Budesonide (micronised) Ph Eur

200mcg/dose

AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

259 BRU09080296P Epilim Intravenous 400mg/ vial Sodium Valproate 400mg Gruppo Lepetit S.R.L. Italy Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

260 BRU09080297P Tritace® 5mg Tablet Ramipril 5mg Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

261 BRU09080298P Ebutol-400 Tablet Ethambutol HCl 400mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

262 BRU09080299P Beafemic Suspension 50mg/5ml Mefenamic acid 50mg/5mL Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

263 BRU09080300PS1 &

BRU09080300PS2

Diamicron MR Tablet 30mg Gliclazide 30mg Les Laboratoires Servier Industrie, France

(S1) & Kotra Pharma (M) Sdn. Bhd,

Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

264 BRU09080301P Deltasolone Tablet 5mg Prednisolone 5mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

265 BRU09080302P Sunprox-275 Tablet Naproxen Sodium 275mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

266 BRU09080303P Spiriva® 18mcg Tiotropium 18mcg (as Bromide

Monohydrate 22.5mcg)

Boehringer Ingelheim Pharma GmbH &

Co. KG, Germany

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 16 of 117

Page 17: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

267 BRU09080304P Prednisolone 1mg Tablet Prednisolone 1mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

268 BRU09080305NP Poro Suppository 250mg Paracetamol 250mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United Sdn Bhd 06 October 2015 till 05

October 2020

GSL P (10 x 10's)

269 BRU09080307P Buscopan Tablet 10mg Hyoscine-N-butylbromide Delpharm Reims S.A.S,France Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

270 BRU09080308P Atrovent N 20µg/ puff Metered

Dose Inhaler

Ipratropium bromide anyhdrous 20mcg (as

monohydrate 21mcg)

Boehringer Ingelheim Pharma GmbH &

Co. KG, Germany

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

271 BRU09080309P Fenagesic Capsule 250mg Mefenamic acid 250mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

272 BRU09080311P Carinox Capsule Pseudoephedrine sulphate 120mg;

Loratadine 5mg

Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

273 BRU09090312P Euvax B Vaccine, Recombinant

(100µg/5ml)

Purified Hepatitis B surface antigen

(HBsAg) 100µg/5ml

LG Life Science Ltd, Korea Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

274 BRU09090313P Typhim Vi Single Dose Purified Vi Capsular polysaccharides of

Salmonella typhi (Ty2 strain) 25µg/0.5ml

Sanofi Pasteur, Campus Merieux, France

& Sanofi Pasteur, Parc industrial

d'Incarville, France

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

275 BRU09090314P Crestor 10mg Tablet Rosuvastatin Calcium 10mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

276 BRU09090315P Amaryl 2mg Tablet Glimepride 2mg Sanofi-aventis S.p.A, Italy Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

277 BRU09090316P Lamisil® 250mg Tablet Terbinafine HCl 250mg Novartis Pharmaceuticals UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

278 BRU09090317P Voltaren® SR 75 Tablet Diclofenac Sodium 75mg Novartis Farma S.p.A, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

279 BRU09090318P Cataflam® 50 Tablet Diclofenac Potassium 50mg Novartis Urunleri, Istanbul Turkey Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

280 BRU09090320P Zyrtec-D Tablet Cetirizine Dihydrochloride 5mg;

Pseudoephedrine HCl 120mg

UCB Farchim SA, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

281 BRU09090321P Mono-Tildiem SR 200mg Capsule Diltiazem HCl 200mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

282 BRU09090322P Actilyse® Treatment-Set Recombinant Human Tissue-type

Plasminogen Activator (alteplase) 50mg

Boehringer Ingelheim Pharma GmbH &

Co. KG, Germany

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

283 BRU09090324P Trenlin SR Tablet 400mg Pentoxifylline 400mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

284 BRU09090325NP Paratab Tablet 500mg Paracetamol 500mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

P (100x10's)

285 BRU09090326P Micardis 40mg Tablet Telmisartan 40mg Boehringer Ingelheim Pharma GmbH &

Co. KG, Germany

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

286 BRU09090327P Metalyse Injection 10,000units Tenecteplase 10,000units (50mg) Boehringer Ingelheim Pharma GmbH &

Co. KG, Germany

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

287 BRU09090328NP Hemo RidTM Tablet Miconised Diosmin 450mg; Micronised

Hesperidine 50mg

Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

GSL

288 BRU09090329P Exforge Tablet 5mg/80mg Amlodipine 5mg (as besylate 6.94mg);

Valsartan 80mg

Novartis Farmaceutica SA , Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 17 of 117

Page 18: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

289 BRU09100330P Imovax Polio Vaccine Inactivated Polio Virus: Type 1

(40DU/0.5mL), Type 2 (80DU/0.5mL), Type

3 32DU/0.5mL)

Sanofi Pasteur, Lyon, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

290 BRU09100331P Cloderm Ointment Clobetasol (as propionate) 0.05%w/w HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

291 BRU09100332P H-Cort Cream Hydrocortisone 1%w/w HOE Pharmaceutical Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

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

Malaysia.

G & H Trading Company 06 October 2015 till 05

October 2020

POM

293 BRU09100335P Ventolin Nebules 2.5mg/2.5ml Salbutamol Sulphate 2.5mg/2.5ml GlaxoSmithKline Australia Pty Ltd,

Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

294 BRU09100336NP Sunquadin Lozenges Dequalinium Chloride Sunward Pharmaceutical Sdn Bhd,

Malaysia.

G & H Trading Company 06 October 2015 till 05

October 2020

POM

295 BRU09100337P Zoloft Tablet 50mg Sertraline (as hydrochloride) 50mg Pfizer Australia Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

296 BRU09100338NP Uphamol 250 Suspension (Fruity) Paracetamol 250mg/5mL Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

GSL (60mL and

100mL)

297 BRU09100339P XanaxTM 1mg Tablet Alprazolam 1mg Sanico NV Industriezone, Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

298 BRU09100340P Pontalon Capsule Mefenamic acid 250mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

299 BRU09100342NP Maalox Plus Tablet Aluminium hydroxide dried gel 200mg,

Magnesium hydroxide 200mg, Simethicone

26.25mg (correspond to 25mg of

polydiemthylsiloxane)

Sanofi-Aventis S.p.A., Italy Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

GSL

300 BRU09100343P Neurontin 600mg Tablet Gabapentin Pfizer Pharmaceutical LLC, Puerto Rico,

USA

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

301 BRU09100345P LipitorTM 40mg Tablet Atorvastatin (as Calcium 43.38mg-

crystalline) 40mg

Pfizer pharmaceuticals LLC, vega baja

Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

302 BRU09100346NP Suniton Tablet Paracetamol 450mg, Orphenadrine Citrate

35mg

Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

303 BRU09100347P SCMC Plus Syrup 250mg/5mL S-carboxy-methylcysteine 250mg/5mL

(Carbocisteine)

Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

304 BRU09100348NP Glyprin Dispersible Tablet Aspirin 100mg, Glycine 45mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

305 BRU09100349P Actonel® 35mg Tablet Risedronate sodium 35mg (equivalent to

32.5mg risedronic acid)

Norwich Pharmaceuticals Inc., USA G & H Trading Company 06 October 2015 till 05

October 2020

POM

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

Germany

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 18 of 117

Page 19: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

307 BRU09110353P Tenoretic Tablet Atenolol 100mg; Chlorthalidone 25mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

308 BRU09110354P LipitorTM 10mg Tablet Atorvastatin (as calcium 10.85mg -

crystalline) 10mg

Pfizer pharmaceutical LLC, vega baja

Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

309 BRU09110355P RotarixTM Vaccine 1 reconstituted dose (1ml) contains live

attenuated human rotavirus RIX4414 strain

not less than 106.0

CCID50

GlaxoSmithKline Biologicals SA, Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

310 BRU09110357P Atrovent Unit Dose Vial (UDV)

250mcg/2ml

Ipratropium bromide anhydrous 250mcg

(as monohydrate 261mcg)

Laboratoire Unither, France Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

311 BRU09110358P Micardis Plus 40mg/12.5mg

Tablet

Telmisartan 40mg; Hydrochlorothiazide

12.5mg

Boehringer Ingelheim Pharma GmbH,

Germany

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

312 BRU09110359P Allavin Expectorant Diphenhydramine HCl 14mg/5ml;

Ammonium Chloride 135mg/5ml

Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

313 BRU09110361NP Uphamol 500 Tablet Paracetamol 500mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

P (100 x 10's)

314 BRU09110362P Carin Tablet 10mg Loratadine 10mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

P

315 BRU09110363P Rhinathiol 2% for Children Syrup Carbocisteine 100mg/5ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

316 BRU09120365P Tienam IV Injection 500mg Imipenem (as monohydrate) 500mg &

Cilastatin Sodium 500mg

Merck Sharp & Dohme Corp, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

317 BRU09120366PS1 &

BRU09120366PS2

Opvero (Oral trivalent

poliomyelitis vaccine)

Each 0.1mL (2 drops) contains: Type1

poliomyelitis virus (LS-c2ab strain) ≥ 106.0

CCID50; Type2 poliomyelitis virus

(p712,Ch,2ab strain) ≥ 105.0 CCID50; Type3

poliomyelitis virus (Leon 12a1b strain) ≥

105.8 CCID50;

Sanofi Pasteur, Campus Merieux, France

(S1); Sanofi Pasteur, Parc industrial

d'Incarville, France (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

318 BRU09120367P Dilantin 100mg Capsule Phenytoin Sodium Pfizer Australia Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

319 BRU09120368P Modalim 100mg Tablet Ciprofibrate 100mg Sanofi Winthrop Limited, UK Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

320 BRU09120369P Oral Aid Lotion Lignocaine HCl 2.5%; Triamcinolone

Acetonide 0.1%; Chlorhexidine HCl 0.5%

Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

321 BRU09120370P Primperan 10mg/2ml Injection Metoclopramide HCl 10mg/2ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

322 BRU09120371P Tritace 10mg Tablet Ramipril 10mg Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

323 BRU09120372P Mono-Tildiem SR 300mg Diltiazem HCl 300mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 19 of 117

Page 20: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

324 BRU09120373P Micardis® 80mg Tablet Telmisartan 80mg Boehringer Ingelheim Pharma GmbH,

Germany

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

325 BRU09120374P Micardis Plus 80mg/12.5mg

Tablet

Telmisartan 80mg; Hydrochlorothiazide

12.5mg

Boehringer Ingelheim Pharma GmbH,

Germany

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

326 BRU09120375P Natrilix® SR Tablet Indapamide 1.5mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

327 BRU09120376NP Poro Suppository 125mg Paracetamol 125mg Y.S.P Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 06 October 2015 till 05

October 2020

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

x 10's)

328 BRU09120377P Vascor 40mg Film-coated Tablet Simvastatin 40mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

329 BRU09120379P Covastin Film-coated Tablet 10mg Simvastatin 10mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

330 BRU09120381P Co-Diovan 80/12.5 Film-coated

Tablets

Valsartan 80mg; Hydrochlorothiazide

12.5mg

Novartis Farma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

331 BRU09120382P Rhinathiol® Promethazine syrup Carbocisteine 100mg/5ml; Promethazine

HCl 2.5mg/5ml

Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

332 BRU09120383P Methotrexate Injection BP

1000mg/10ml

Methotrexate 1000mg/10ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

333 BRU10010384P Zyloric 300mg Tablet Allopurinol 300mg GlaxoSmithKline Australia Pty Ltd.

Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

334 BRU10010385PS1 &

BRU10010385PS2

Coversyl 4mg Tablet Perindopril tert-butylamine 4mg Les Laboratoires Servier Industrie, France

(S1) & Kotra Pharma (M) Sdn Bhd.,

Malaysia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

335 BRU10010386P Atrovent Unit Dose Vial

0.5mg/2ml

Ipratropium bromide (as monohydrate)

500mcg/2ml

Laboratoires Unither, Amiens cedex,

France

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

336 BRU10010387P Aspirin EC Tablet 100mg Acetylsalicylic acid 100mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

337 BRU10010388P Exforge Tablet 5mg/160mg Amlodipine 5mg (as besylate 6.94mg);

Valsartan 160mg

Novartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

338 BRU10010389P Taxotere 80mg/2ml Vial Docetaxel anhydrous (as trihydrate) 80mg Sanofi-Aventis Deutschland GmbH,

Germany

MediPharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

339 BRU10010390NPS1,

BRU10010390NPS2 &

BRU10010390NPS3

Dulcolax 5mg Tablet Bisacodyl 5mg Boehringer Ingelheim Korea (S1);

Boehringer Ingelheim France (S2);

Delpharm Reims S.A.S., France (S3)

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

340 BRU10010391P Diovan 80mg Tablet Valsartan 80mg Novartis Farma S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

341 BRU10010392P Co-Diovan 160/25 Film-coated

Tablets

Valsartan 160mg; Hydrochlorothiazide

25mg

Novartis Farma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

342 BRU10010395P Isoket Spray Isosrobide Dinitrate 1.25mg per actuation Schwarz Pharma Ltd, Ireland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

343 BRU10010396P Beafemic Capsule 250mg Mefenamic acid 250mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

344 BRU10010397P Metformin Tablet 500mg Metformin HCl 500mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 20 of 117

Page 21: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

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

Fluticasone propionate 500mcg

GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

346 BRU10010401P VentolinTM Tablet 4mg Salbutamol 4mg (as Sulphate 4.8mg) Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

347 BRU10020402P Solu-Medrol Sterile Powder

500mg

Methyprednisolone (as Sodium succinate)

500mg

Pfizer Manufacturing Belgium N.V.,

Belgium

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

348 BRU10020404P Imdex 60mg CR Tablet Isosorbide-5-Mononitrate 60mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

349 BRU10020405P Vascor Tablet 20mg Simvastatin Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

350 BRU10020406P Combivent Unit Dose Vial 500mcg Per 2.5ml - Ipratropium bromide (as

monohydrate 522mcg) 500mcg;

Salbutamol 2.5mg (as sulphate 3.013mg)

Laboratorie UNITHER , France Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

351 BRU10020408P Guadex Linctus Per 5ml - Dextromethorphan

Hydrobromide 15mg; Guaifenesin 100mg

Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 06 October 2015 till 05

October 2020

POM

352 BRU10020409P Diovan® 160mg Tablet Valsartan 160mg Novartis Farma S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

353 BRU10020410P Etoposide 100mg/5ml Injection Etoposide 100mg/5ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

354 BRU10020411P Decondine Syrup Per 5ml - Triprolidine HCl 1.25mg;

Pseudoephedrine HCl 30mg

Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

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

Fluticasone propionate 100mcg

GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

356 BRU10020413P Optizoline eye drops Tetrahydrozoline HCl 0.05%w/w Xepa-Soul Pattinson (Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

357 BRU10020414P Sunadine Syrup Loratadine 5mg/5ml Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

P

358 BRU10020415P Adalat LA 30 Tablet Nifedipine 30mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

359 BRU10020416P Lipitor 20mg Tablet Atorvastatin (Calcium) 20mg Pfizer Pharmaceutical LLC, Puerto Rico Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

360 BRU10020417P Isosorbide Dinitrate Tablet 10mg Isosorbide Dinitrate BP 10mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

POM

361 BRU10020418P Nitroderm TTS® 5 (5mg/24hr) Glyceryl Trinitrate/ nitroglycerin 25mg Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

362 BRU10020419P Adalat® LA 20 Tablet Nifedipine 20mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

363 BRU10020421P Xatral XL Tablet 10mg Alfuzosin HCl 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

364 BRU10030423P Rhinathiol 5% Adult Expectorant

Syrup

Carbocisteine 5g/100ml Unither Liquid Manufacturing, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

P

BDMCA/RMP/1116 Page 21 of 117

Page 22: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

365 BRU10030425NP Dulcolax Suppository 5mg Bisacodyl 5mg Instituto De Angeli S.R.L., Italy Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

366 BRU10030426P Aromasin 25mg Tablet Exemestane 25mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

367 BRU10030427P Omesec Capsule 20mg Omeprazole 20mg Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

K-Seri Pharma Sdn Bhd 06 October 2015 till 05

October 2020

POM

368 BRU10030428P Adalat LA 60 Tablet Nifedipine 60mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

369 BRU10030429P Polarax 2mg Tablet Dexchlorpheniramine maleate 2mg Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

370 BRU10030430P Pharmorubicin CS 50mg/25ml Epirubicin HCl 50mg/2ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

371 BRU10030432P Cisplatin Injection 50mg/50ml Cisplatin USP 50mg/50ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

372 BRU10030433P Terramycin Ophthalmic Ointment Per g - Oxytetracycline 5mg; Polymyxin B

10,000units

PT Pfizer (Indonesia), Indonesia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

373 BRU10030435P Adriamycin CS Injection

50mg/25ml

Doxorubicin HCl 50mg/25ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

374 BRU10030436NP Maalox® Plus Suspension Per 5ml - Aluminium hydroxide 225mg;

Magnesium hydroxide 200mg; Simethicone

USP 25mg

Sanofi Aventis S.p.A., Italy Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

GSL

375 BRU10030437P Seretide Evohaler 50 Salmeterol Xinafoate (micronised) 25mcg;

Fluticasone Propionate (micronised) 50mcg

Glaxo Wellcome Production, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

376 BRU10030438P Miacalcic® Ampoules 100IU Calcitonin salmon, synthetic 100IU Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

377 BRU10030439P Prozine Syrup 5mg/5ml Promethazine HCl Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

378 BRU10030440P Olmetec Tablet 20mg Olmesartan Medoxomil 20mg Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

379 BRU10040441P Diflucan Capsule 150mg Fluconazole 150mg Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

380 BRU10040442P Diflucan Capsule 100mg Fluconazole 100mg Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

381 BRU10040443P Diflucan Capsule 50mg Fluconazole 50mg Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

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

Fluticasone Propionate 250mcg

GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

383 BRU10040447P Ventolin Tablet 2mg Salbutamol (as sulphate) 2mg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

384 BRU10040448P Zyrtec® Film-coated Tablet 10mg Cetrizine HCl 10mg UCB Farchim S.A., Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

385 BRU10040450P Seretide 125 Evohaler Salmeterol (as Xinafoate, micronised)

25mcg; Fluticasone Propionate 125mcg

Glaxo Wellcome Production, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 22 of 117

Page 23: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

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

(10mg/24hr)

Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

387 BRU10040453P Temodal Capsule 20mg Temozolomide 20mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

388 BRU10040454NP ColimixTM Syrup Per 5ml - Simethicone (activated

dimethicone) 50mg; dicylcomine HCl 5mg

Xepa-Soul Pattinson (Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

GSL

389 BRU10040455P Xepanicol® Eye Drops 0.5% Chloramphenicol 0.5% Xepa-Soul Pattinson (Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

390 BRU10040457P Co-Diovan 160/12.5mg Tablets Valsartan HCl 160mg; Hydrochlorothiazide

12.5mg

Novartis Pharma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

391 BRU10040458P Zyrtec® Oral Drops 10mg/ml Cetrizine diHCl 10mg/ml Aesica Pharmaceuticals S.r.L., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

392 BRU10040459P Atenolol 50mg Tablet Atenolol 50mg Sunward Pharmaceutical Pte Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

393 BRU10040460P Bromhexine Tablet 8mg Bromhexine HCl 8mg Sunward Pharmaceutical Pte Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

394 BRU10040461P Cytarabine® Injection 1000mg in

10ml

Cytarabine 1000mg/10ml Pfizer (Perth) Pty, Ltd., Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

395 BRU10040462P Exelon Oral Solution 2mg/ml Rivastigmine 2mg/ml (as hydrogen

tartrate)

Novartis Pharma S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

396 BRU10050463P Nebido 1000mg/4ml, Solution for

Injection

Testosterone undecanoate 250mg(equiv.

to testosterone 157.9mg)

Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

397 BRU10050464NP Mucosolvon Liquid 30mg/5ml Ambroxol Hydrochloride 30mg/5ml Boehringer Ingelheim, France Hongkiat Trading & Company 06 October 2015 till 05

October 2020

P

398 BRU10050466NP Uphamol Suspension 250

(Orange)

Paracetamol 250mg/5ml Upha Pharmaceuticals Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2010 till 05

October 2015 (PL extended

to 26 March 2017)

GSL (60mL); P

(3.8L)

399 BRU10050467P Taxotere® 20mg/0.5ml

Concentrate and solvent for

solution for Infusion

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

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

400 BRU10050468P Remicade Powder for

Concentrate for Solution for

Infusion 100mg/vial

Infliximab (cA2 IgG) 100mg/vial Patheon Italia S.p.A, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

401 BRU10050470P Pristinex Cream 2% w/w Ketoconazole 2%w/w Xepa-Soul Pattinson (Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

402 BRU10050471P Zyvox Infusion Bag 600mg/300ml Linezolid 600mg/300ml Fresenius Kabi Norge As, Norway Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

403 BRU10050472P Panadeine Tablet Codeine Phosphate 8mg, Paracetamol

500mg

Sanofi India Limited, India Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

404 BRU10050473P Cervagem Pessary 1mg Gemeprost 1mg Ono Pharmaceutical Co Ltd, Japan Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

405 BRU10050474P Provinace Tablet 4mg Perindopril erbumine 4mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 23 of 117

Page 24: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

406 BRU10050475P Zyrtec® Oral Solution 1mg/ml Cetrizine diHCl 1mg/ml (0.1%) Aesica Pharmaceuticals S.r.L., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

407 BRU10050476P Dalacin C Capsule 150mg Clindamycin (as hydrochloride) 150mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

408 BRU10050477P Clozaril® Tablet 100mg Clozapine 100mg Novartis Saglik Gida ve Tarim Urunleri

San. Ve Tic.A.S., Istanbul, Turkey

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

409 BRU10050478P Telfast® 180mg Tablet Fexofenadine HCl 180mg PT Aventis Pharma, Indonesia Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

410 BRU10050479P Cozaar 100mg film-coated tablet Losartan Potassium 100mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

411 BRU10050480P Dalacin T Topical Solution 1% Clindamycin (as phosphate) 10mg/Ml Zoetis P&U LLC, Kalamazoo, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

412 BRU10060484P Miacalcic 50IU Ampoules Salmon calcitonin, synthetic 50IU/1ml Novartis Pharma Stein AG, Switzerland. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

413 BRU10060485P Allersin-F Tablet 4mg Chlorpheniramine maleate 4mg Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

P

414 BRU10060486P Daonil Tablet 5mg Glibenclamide 5mg PT Aventis Pharma, Indonesia Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

415 BRU10060487P Asmol Syrup Salbutamol 2mg/5ml (as Sulphate 2.4mg) Sunward Pharmaceutical Sdn. Bhd.,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

416 BRU10060488P Lescol capsule 40mg Fluvastatin (as the sodium salt) 40mg Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

417 BRU10060489P Lescol XL Tablet 80mg Fluvastatin (as the sodium salt) 80mg Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

418 BRU10060490P Lescol capsule 20mg Fluvastatin (as the sodium salt) 20mg Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

419 BRU10060491P Diatrol Tablet 2mg Loperamide HCl 2mg Sunward Pharmaceutical Sdn. Bhd.,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

420 BRU10060492P Clozaril® 25mg Tablet Clozapine 25mg Novartis Saglik Gida ve Tarim Urunleri

San. Ve Tic.A.S., Istanbul, Turkey

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

421 BRU10060493P Olmetec 10mg Tablet Olmesartan medoxomil 10mg Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

422 BRU10060494P Norvasc Tablet 5mg Amlodipine Besylate 5mg Pfizer Australia Pty. Ltd., NSW Australia. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

423 BRU10060495P Epilim 200mg/5ml Syrup Sodium Valproate 200mg Unither Liquid Manufacturing, France. Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

424 BRU10060496P Stilnox 10mg film-coated tablet Zolpidem tartrate 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

425 BRU10060497P Hyosun syrup Hyoscine-N-Butylbromide (Scopolamine

Butylbromide) 5mg/5ml

Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

426 BRU10060498P Nalol Tablet 40mg Propranalol HCl 40mg Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 24 of 117

Page 25: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

427 BRU10060499P Exelon capsule 1.5mg Rivastigmine 1.5mg (as hydrogen tartrate

2.4mg)

Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

428 BRU10060500P Syntocinon 10IU solution for

injection

Synthetic Oxytocin 10IU/ml Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

429 BRU10060501P Exelon capsule 6mg Rivastigmine 6mg (as hydrogen tartrate

9.6mg)

Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

430 BRU10060502P Zyvox film-coated tablet 600mg Linezolid 600mg Pfizer Pharmaceuticals LLC, Puerto Rico,

United States

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

431 BRU10060504P Sifrol tablet 0.125mg Pramipexole 0.088mg (eqv. to Pramipexole

dihydrochloride monohydrate 0.125mg)

Boehringer Ingelheim Pharma GmbH &

Co. Germany

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

432 BRU10060505P Myfortic Gastro-Resistant tablet

180mg

Mycophenolic Acid 180mg (as Sodium Salt

192.4mg)

Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

433 BRU10070506P Phensedyl Dry Cough Linctus Per 5ml - Promethazine HCl 3.6mg;

Pholcodine 4mg; Ephedrine HCl 7.2mg

Sanofi-Aventis Pakistan Limited, Pakistan Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

434 BRU10070507P Miacalcic® Nasal Spray 200IU Salmon calcitonin, synthetic 200IU Delpharm Huningue S.A.S., Switzerland. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

435 BRU10070508P Norvasc Tablet 10mg Amlodipine Besylate 10mg Pfizer Australia Pty. Ltd., NSW Australia. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

436 BRU10070509P Pseudorine Tablet 60mg Pseudoephedrine HCl 60mg Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

P

437 BRU10070510P Laxodyl Tablet 5mg Bisacodyl 5mg Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

GSL (6's) & P (60's)

438 BRU10070511P Decondine Tablet Tripolidine HCl 2.5mg; Pseudoephedrine

HCl 60mg

Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

439 BRU10070512P Metoclopramide Tablet 10mg Metoclopramide HCl 10mg Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

440 BRU10070513P Desferal 500mg Desferrioxamine Methane Sulphonate Novartis Pharma Stein AG, Switzerland;

Wasserburger Arzneimittelwerk GmbH,

Wasserburg

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

441 BRU10070514P Anafranil® 25mg Tablet Clomipramine HCl 25mg Novartis Farma SpA., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

442 BRU10070515P Zaricort Cream Miconazole Nitrate 2%w/w;

Hydrocortisone 1%w/w

Xepa-Soul Pattinson (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

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

Kingdom

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

444 BRU10070517P Singulair® Chewable Tablet 5mg Montelukast (as sodium) 5mg Merck Sharp & Dohme Ltd., United

Kingdom

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

445 BRU10070518P Lanoxin Injection 0.5mg/2ml Digoxin 0.5mg/2ml GlaxoSmithKline Manufacturing SpA., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

446 BRU10070519P Zithromax IV 500mg Azithromycin (as dehydrate) 500mg Pharmacia & Upjohn Company,

Kalamazoo, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 25 of 117

Page 26: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

447 BRU10070520P Exelon® 4.5mg Capsule Rivastigmine 4.5mg (as Rivastigmine

hydrogen tartrate 7.2mg)

Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

448 BRU10070521P Epilim Chrono 500mg Scored Film-

coated Tablet

Sodium valproate 500mg (Sodium

valproate 333mg & Valproic acid 145mg)

Sanofi Winthrop Industries, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

449 BRU10070522P Ritalin® Modified Release Capsule

30mg

Methylphenidate HCl 30mg Recro Gainsville LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

450 BRU10080523P Exforge 10/160mg FC Tablet Amlodipine 10mg (as besylate); Valsartan

160mg

Novartis Farmaceutica SA, Barbera del

Valles, (Barcelona) Spain

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

451 BRU10080524P Zometa Concentrate for Solution

for Infusion 4mg/5ml

Zoledronic Acid (anhydrous) 4mg

corresponding to zoledronic acid

monohydrate 4.264mg

Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

452 BRU10080528P Imovane 7.5mg Tablet Zopiclone 7.5mg Aventis International France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

453 BRU10080529P Nasacort Aqueous Nasal Spary Triamcinolone Acetonide 55mcg/actuation Aventis Pharma UK Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

454 BRU10080530P Ritalin 10mg Tablet Methylphenidate Hydrochloride 10mg Novartis Pharmaceuticals SA Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

455 BRU10080531P Proctosedyl Suppositories Chinchocaine 5mg; Framycetin sulphate

10mg; Hydrocortisone 5mg; Aesculin 10mg

PT Aventis Pharma, Indonesia Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

456 BRU10080532P Prostin VR Paediatric® Sterile

Solution 500mcg

Alprostadil 500mcg/ml Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

457 BRU10080533P Lioresal 10mg Tablet Baclofen 10mg Novartis Farma SPA Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

458 BRU10080534PS1;

BRU10080534PS2

Fosamax 70mg Tablet Alendronate sodium 91.37 (as trihydrate)

equivalent to alendronic acid 70mg

Merck Sharp & Dohme (Italia) SpA, Italy

(S1); Aesica Pharmaceuticals GmbH,

Germany (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

459 BRU10080535PS1;

BRU10080535PS2

Telfast-D Extended Release

Tablet

Fexofenadine hydrochloride 60mg ;

Pseudoephedrine HCl 120mg

Sanofi-Aventis US LLC USA (S1); Sanofi

Winthrop Industrie, France (S2)

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

460 BRU10080536P Claforan 1.0g Injection Cefotaxime 1g (as Sodium 1.048g) Patheon UK Ltd, England, UK Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

461 BRU10080538P Immucyst ® BCG

Immnuotherapeutic 81mg/vial

Bacillus Calmette-Guerin 81mg Sanofi Pasteur Limited, Toronto, Ontario,

Canada

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

462 BRU10090539P Singulair Tablet 4mg Montelukast 4mg (as sodium 4.16mg) Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

463 BRU10090540P Cozaar Tablet 50mg Losartan Potassium 50mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

464 BRU10090541P Lanoxin Paediatric/ Geriatric Elixir Digoxin 0.05mg/mL Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/1116 Page 26 of 117

Page 27: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

465 BRU10090542PS1;

BRU10090542PS2

Singulair Oral Granules 4mg Montelukast Sodium (free acid equivalent)

4mg

Merck Sharp & Dohme Corp. USA (S1);

DSM Pharmaceuticals, Inc., USA

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

466 BRU10090543P Frisium® 10mg Tablet Clobazam 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

467 BRU10090544P Vytorin Tablet 10mg/20mg Ezetimibe 10mg: Simvastatin 20mg Merck Sharp & Dohme (Italia) SpA, Italy &

MSD International GmbH (Singapore

Branch), Singapore

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

468 BRU10090545P Zocor 10mg Tablet Simvastatin 10mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

469 BRU10090546P Zocor 40mg Tablet Simvastatin 40mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

470 BRU10090547P Bonefos 800mg Tablet Disodium Clodronate Tetrahydrate 1000mg

equivalent to Disodium Clodronate

(anhydrous) 800mg

Bayer Oy, Finland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

471 BRU10090548P Suprefact® 1mg/ml Injection

Solution

Buserelin 1.00mg/ml (as acetate 1.05mg) Aventis-Pharma Deutshland GmbH,

Germany

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

472 BRU10090549P Livial 2.5mg Tablet Tibolone 2.5mg N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

473 BRU10090550P Ritalin LA 20mg Capsules Methylphenidate Hydrochloride 20mg Recro Gainsville LLC, USA. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

474 BRU10090551P Zoladex LA Depot Injection

10.8mg

Goserelin Acetate equivalent to Goserelin

10.8mg

AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

475 BRU10090552P Harnal OCAS 400mcg Film-coated

tablet

Tamsulosin (as hydrochloride 400mcg)

367mcg

Astellas Pharma Europe BV, The

Netherlands

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

476 BRU10090553P ActifedTM Expectorant (100ml) Triprolidine hydrochloride 1.25mg/5mL;

Pseudoephedrine hydrochloride

30mg/5mL; Guaiphenesin 100mg/5mL

Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

P

477 BRU10090554P Proscar® Tablets 5mg Finasteride 5mg MSD International GmbH (Puerto Rico

Branch) LLC., Puerto Rico, USA.

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

478 BRU10090555PS1;

BRU10090555PS2

Elomet Cream 0.1% Mometasone Furoate 0.1% Schering-Plough Labo N.V., Belgium (S1);

PT. Merck Sharp Dohme Pharma Tbk,

Indonesia (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

479 BRU10100556P Myfortic Gastro-Resistant tablet

360mg

Mycophenolic (as sodium) acid 360mg Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

480 BRU10100557P Intron A* 30 million IU Solution

for Injection, Multidose Pen

Interferon Alfa-2b 30 million IU Schering-Plough (Brinny) Co., Ireland Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

481 BRU10100559P Exelon® Capsule 3mg Rivastigmine (as hydrogen tartrate) 3mg Novartis Farmaceutica S.A. Spain Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

482 BRU10100560P Arcoxia 60mg Film-coated tablet Etoricoxib 60mg Frosst Iberica S.A., Spain Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

BDMCA/RMP/1116 Page 27 of 117

Page 28: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

483 BRU10100561P Proctosedyl Ointment Cinchocaine hydrochloride 0.5%;

Framycetin sulphate 1.0%; Hydrocortisone

0.5%; Aesculin 1.0%

Patheon UK Ltd., England Medipharm Sdn Bhd 28 October 2015 till 27

October 2020

POM

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

(9.5mg/24h)

LTS Lohmann Theraphie-System AG,

Germany

Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

485 BRU10100563P Exelon® Patch 5 Rivastigmine base 9mg/5cm2 (4.6mg/24

hours)

LTS Lohmann Theraphie-System AG,

Germany

Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

486 BRU10100564P ATGAM® Sterile Solution

50mg/mL (5mL amp)

Lymphocyte immune globulin, anti-

thymocyte globulin (equine) 250mg/5mL

Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

487 BRU10100565P Ezetrol 10mg Tablet Ezetimibe 10mg 1) MSD International GmbH (Puerto Rico

Branch) LLC, Puerto Rico; 2) MSD

International GmbH (Singapore Branch),

Singapore

Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

488 BRU10100566P Arcoxia 120mg Tablet Etoricoxib 120mg Frosst Iberica S.A., Spain Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

489 BRU10100567P Sun-Glizide Tablet 80mg Gliclazide 80mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Traidng Company 28 October 2015 till 27

October 2020

POM

490 BRU10100568P Zithromax Powder For Oral

Suspension 200mg/5ml

Azithromycin (as dihydrate) 200mg/5ml Haupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

491 BRU10100569P Fosamax Plus 70/2800mcg

Tablets

Alendronic (as sodium 91.37) acid 70mg &

(Vitamin D3 100,000 IU/g) Cholecalciferol

2800mcg

MSD Frosst Iberica, Spain Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

492 BRU10100571P Arimidex 1mg tablet Anastrozole 1mg AstraZeneca Pharmaceuticals USA Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

493 BRU10100572P Casprin Enteric

Microencapsulated Capsule

100mg

Aspirin 100mg Y.S.P. Industries (M) Sdn Bhd, Malaysia. Asterix United (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

494 BRU10100573P Pontalon Tablet 500mg Mefenamic Acid 500mg Y.S.P. Industries (M) Sdn Bhd, Malaysia. Asterix United (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

495 BRU10100576P Albutein® Solution for Infusion

25%

Albumin (Human) 25% Grifols Biologicals Inc., USA Hongkiat Trading & Company 28 October 2015 till 27

October 2020

POM

496 BRU10100577P RebetolTM 200mg Capsule Ribavirin 200mg MSD International GmbH (Puerto Rico

Branch) LLC., Puerto Rico, USA.

Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

497 BRU10100578P Axol Liquid 3mg/ml Ambroxol Hydrochloride 3mg/ml Y.S.P. Industries (M) Sdn Bhd, Malaysia. Asterix United (B) Sdn Bhd 28 October 2015 till 27

October 2020

P (100ml) & POM

(4L)

498 BRU10100579PS1 &

BRU10100579PS1

Vytorin™ Tablets 10mg/10mg Ezetimibe 10mg; Simvastatin 10mg Merck Sharp & Dohme (Italia) S.p.A.,

Italy (S1); MSD International GmbH

(Singapore Branch), Singapore (S2)

Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

499 BRU10110580P Intron A* 18million IU Solution

for Injection, Multidose Pen

Interferon Alfa-2b 18 million IU Schering-Plough (Brinny) Co., Ireland Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

500 BRU10110581PS1;

BRU10110581PS2JanuviaTM Tablet 50mg Sitagliptin (as phosphate) 50mg Merck Sharp & Dohme (Italia) S.p.A.,

Pavia, Italy (S1); Merck Sharp & Dohme

Ltd, England (S2)

Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

BDMCA/RMP/1116 Page 28 of 117

Page 29: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

501 BRU10110582P Arcoxia® 90mg Tablet Etrocoxib 90mg Frosst Iberica S.A., Spain Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

502 BRU10110584P Zocor 20mg Film-coated Tablet Simvastatin 20mg Merck Sharp & Dohme Ltd.,

Northumberland, UK

Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

503 BRU10110585P Sifrol® Tablet 1mg Pramipexole dihydrochloride monohydrate

1mg (equivalent to 0.7mg pramipexole)

Boehringer Ingelheim Pharma GmbH &

Co. KG, Germany

Hongkiat Trading & Company 24 November 2015 till 23

November 2020

POM

504 BRU10110587P Metoclopramide Syrup 5mg/5ml Metoclopramide hydrochloride 5mg/5ml Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Traidng Company 24 November 2015 till 23

November 2020

POM

505 BRU10110588NP Suntacid Tablet Aluminium Hydroxide 250mg, Magnesium

Trisilicate 250mg, Simethicone 30mg

Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Traidng Company 24 November 2015 till 23

November 2020

GSL

506 BRU10110590P Zoladex Depot 3.6mg/dose Goserelin (as acetate) 3.6mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

507 BRU10110591P Voren Enteric Coated Tablet

25mg

Diclofenac Sodium 25mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

508 BRU10110592P Oroxine Tablet 50mcg Levothyroxine Sodium 55.63mcg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

509 BRU10110593P Voren Enteric Coated Tablet

50mg

Diclofenac Sodium 50mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

510 BRU10110595P Zantac™ Injection 25mg/ml Ranitidine hydrochloride 25mg/ml GlaxoSmithKline Manufacturing S.p.A.,

Italy

Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

511 BRU10110596P Beconase™ Aqueous Nasal Spray Beclomethasone Dipropionate (as

monohydrate)

Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

512 BRU10110597P Campto 40mg/2ml Injection Irinotecan hydrochloride trihydrate

40mg/2ml

Pfizer (Perth) Pty Ltd., Australia Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

513 BRU10120599PS1;

BRU10120599PS2 JanuviaTM Tablet 25mg Sitagliptin (as phosphate) 25mg Merck Sharp & Dohme (Italia) S.p.A.,

Pavia, Italy (S1); Merck Sharp & Dohme

Ltd, England

Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

514 BRU10120600P Ritalin® LA Modified Release

Capsule 40mg

Methylphenidate hydrochloride 40mg Recro Gainsville LLC, USA Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

515 BRU10120602P Orgalutron Solution for Injection

0.25mg/0.5ml

Ganirelix acetate 0.25mg/0.5ml Vetter Pharma-Fertigung GmbH & Co. KG,

Germany

Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

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

Indonesia

Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

P

517 BRU10120605P Clarityne Tablet 10mg Loratadine 10mg PT. Merck Sharp Dohme Pharma Tbk,

Indonesia

Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

P

518 BRU10120606P Frotin Pessaries Metronidazole 250mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

519 BRU10120607P Allopurinol Tablet 300mg Allopurinol 300mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

520 BRU10120608P Methergin Tablet 0.125mg Methylergometrine maleate 0.125mg Novartis Pharma Produktions GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

521 BRU10120609P Vesicare Tablet 10mg Solifenacin Succinate 10mg Astellas Pharma Europe B.V., The

Netherlands

Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

BDMCA/RMP/1116 Page 29 of 117

Page 30: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

522 BRU10120611P Voren Suppositories 12.5mg Diclofenac Sodium 12.5mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

523 BRU10120612P Flixonase Aqueous Nasal Spray

0.05%

Fluticasone propionate (micronised) 50mcg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

524 BRU10120613PS1;

BRU10120613PS2

Esmeron® Injection 50mg/5ml

(10mg/ml)

Rocuronium Bromide 50mg/5ml N.V. Organon, The Netherlands; Hameln

Pharmaceuticals GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

525 BRU10120614P Clomid Tablet 50mg Clomifene Citrate 50mg Patheon France S.A., France Medipharm Sdn Bhd 29 December 2015 till 28

December 2020

POM

526 BRU10120615P FlixotideTM EvohalerTM 125mcg Fluticasone propionate 125mcg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

527 BRU10120616P Levitra® film-coated Tablet 5mg Vardenafil 5mg (as monohydrochloride

trihydrate)

Bayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

528 BRU10120617P IRESSATM Tablet 250mg Gefitinib 250mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

529 BRU11010619PS1;

BRU11010619PS2 Januvia

TM Tablet 100mg Sitagliptin (as phosphate) 100mg Merck Sharp & Dohme (Italia) S.p.A.,

Pavia, Italy (S1); Merck Sharp & Dohme

Ltd, England

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

530 BRU11010621P Femara® 2.5mg Tablet Letrozole 2.5mg Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

531 BRU11010623P Allopurinol Tablet 100mg Allopurinol 100mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

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

Indonesia

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

533 BRU11010625 Implanon® 68mg Implant Etonogestrel (Micronised) [Org3236] 68mg N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

534 BRU11010626NP Poro Tablet 500mg Paracetamol 500mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 January 2016 till 25

January 2021

P (10 x 10's), P

(100x10's &

3,000's)535 BRU11010627P Tegretol CR 200 Tablet Carbamazapine 200mg Novartis Farma S.p.A., Torree Annunziata,

Italy

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

536 BRU11010628P Oxy-Nase Paediatric Nasal Spray

0.025%

Oxymetazoline HCl 0.025% HOE Pharmaceuticals Sdn Bhd, Malaysia G&H Trading Company 26 January 2016 till 25

January 2021

P

537 BRU11010629P TrandateTM

Tablets 100mg Labetalol hyrdochloride 100mg Glaxo Wellcome GmbH & Co., Germany Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

538 BRU11010631P Tegretol® CR 400 Tablet Carbamazapine 400mg Novartis Farma S.p.A., Torree Annunziata,

Italy

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

539 BRU11010632P Comtan® Tablet 200mg Entacapone 200mg Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

540 BRU11010633P DF118 Tablet Dihydrocodeine GlaxoSmithKline South Africa (Pty) Ltd.,

South Africa

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

541 BRU11010635P Zantac SyrupTM 150mg/10ml Ranitidine (as hydrochloride) 150mg/10ml Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

542 BRU11010636NP Bisacodyl Suppositories Bisacodyl 5mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

BDMCA/RMP/1116 Page 30 of 117

Page 31: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

543 BRU11010637P EngerixTM-B Adult Dose Vaccine

20mcg/ml

Purified Hepatitis B Surface Antigen

(HBsAg) 20mcg/ml

GlaxoSmithKline Biologicals SA, Rixensart

Belgium; GlaxoSmithKline Biologicals S.A.,

Wavre Belgium

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

544 BRU11010638P HavrixTM720 Junior Vaccine Inactivated Hepatitis A virus antigen (HAV),

HM175 strain 720 EL.U

GlaxoSmithKline Biologicals SA, Rixensart

Belgium; GlaxoSmithKline Biologicals S.A.,

Wavre Belgium

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

545 BRU11010639P HiberixTM Vaccine Purified polyribosyl-ribitol-phosphate

capsular polyaccharide (PRP) of

Haemophilus influenza type b (Hib) 10µg

covalently bound to 20-40µg tetanus

toxoid

GlaxoSmithKline Biologicals SA, Belgium;

GlaxoSmithKline Biologicals S.A., Saint-

Amand-Les-Eaux

France

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

546 BRU11010640P Microgynon® 30 Tablet Levonorgestrel 0.15mg, Ethinylestradiol

0.03mg

Bayer Weimar GmbH und Co., KG,

Germany

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

547 BRU11010641P Ami-hydrotride Tablet Amiloride hydrochloride 5mg &

Hydrochlorthiazide 50mg

Upha Pharmaceutical Mfg (M) Sdn Bhd.,

Malaysia

Hongkiat Trading & Company 26 January 2011 till 25

January 2016 (PL extended

to 26 March 2017)

POM

548 BRU11010642P Virless Tablets 200mg Acyclovir 200mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

549 BRU11020643P Dalacin C 300mg Capsule Clindamycin (as Hydrochloride) 300mg Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

550 BRU11020644P Tegretol® 200mg Tablet Carbamazepine 200mg Novartis Pharma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

551 BRU11020645P OroxineTM Tablet 100mcg Levothyroxine (as sodium) anhydrous

100mcg

Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

552 BRU11020646P ActifedTM Syrup Triprolidine Hydrochloride BP 1.25mg/5ml;

Pseudoephedrine hydrochloride BP

30mg/5ml

Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23

February 2021

P (60ml & 100ml)

553 BRU11020647P Tegretol® 2% Syrup Carbamazepine 100mg/5ml Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

554 BRU11020648P Glivec® 100mg Film-coated Tablet Imatinib (as mesylate) 100mg Novartis Pharma Produktions GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

555 BRU11020649P Sandostatin® Ampoules

0.05mg/ml

Octreotide (as acetate) 0.05mg/ml Novartis Pharma Stein AG., Switzerland Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

556 BRU11020650P Levitra® film-coated Tablet 20mg Vardenafil (as monochloride trihydrate)

20mg

Bayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

557 BRU11020652P Urosin® Film-coated Tablet 50mg Atenolol 50mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

558 BRU11020653P Ibuprofen Film-coated Tablet

400mg

Ibuprofen 400mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 February 2016 till 23

February 2021

P

559 BRU11020654P Promethazine Syrup 5mg/5ml Promethazine HCl 5mg/5ml Drug House of Australia Pte Ltd.,

Singapore

G & H Trading Company 24 February 2016 till 23

February 2021

POM

BDMCA/RMP/1116 Page 31 of 117

Page 32: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

560 BRU11020655P Voren Gel Diclofenac Sodium 10mg/g (as Diclofenac

Acid Diethylamine)

Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 February 2016 till 23

February 2021

GSL

561 BRU11020656P Atacor 20mg Film-coated Tablets Atorvastatin (as Calcium) 20mg Actavis hf., Iceland K-Seri Pharma Sdn Bhd 24 February 2016 till 23

February 2021

POM

562 BRU11020657P Dermosol Cream Clobetasol (as propionate) 0.5%w/w Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

563 BRU11020658P Zendhin 150 Tablet Ranitidine (as hydrochloride) 150mg Drug House of Australia (Asia) Pte Ltd.,

Singapore

G & H Trading Company 24 February 2016 till 23

February 2021

POM

564 BRU11030659PS1 &

BRU11030659PS2

Vytorin Tablet 10mg/40mg Ezetimibe 10mg, Simvastatin 40mg MSD International gmbH (Singapore

Branch), Singapore (S1); Merck Sharp &

Dohme (Italia) S.p.A., Italy (S2)

Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

565 BRU11030660P Oxy-nase® Nasal Spray 0.05% Oxymetazoline HCl 0.05% HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 26 March 2016 till 25 March

2021

P

566 BRU11030661P Primperan® 10mg Suppositories Metoclopramide 10mg Unither Liquid Manufacturing, France. Medipharm Sdn Bhd 26 March 2016 till 25 March

2021

POM

567 BRU11030662P Fucon Film Coated Tablet 10mg Hysocine-n-butylbromide 10mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

568 BRU11030663P Betamethasone Tablet 0.5mg Betamethasone 0.5mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

569 BRU11030664P Trivastal® Retard 50 Tablet Piribedil 50mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

570 BRU11030667P Clarinase Syrup 5mg/5ml Per 5ml: Loratadine 5mg, Pseudoephedrine

Sulphate 60mg

Sanofi Aventis Argentina S.A., Argentina Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

P

571 BRU11030668P Vivaxim Suspension and Solution

for Suspension for Injection

Inactivated Hepatitis A Virus, GBM strain

160 antigen units

Sanofi Pasteur, Parc industriel d'Incarville,

France

Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

572 BRU11030669PS1;

BRU11030669PS2

Caelyx 2mg/ml Concentrate for

Infusion

Doxorubicin HCl 2mg/ml Alza Corporation, USA (S1);

GlaxoSmithKline Manufacturing S.P.A.,

Italy (S2)

Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

573 BRU11030670P Alkeran Tablet 2mg Melphalan 2mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

574 BRU11030671P Hyzaar Forte Tablet 100/25mg Losartan potassium 100mg,

Hydrochlorothiazide 25mg

Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

575 BRU11030672P Avodart Soft Capsules 0.5mg Dutasteride 0.5mg GlaxoSmithKline Pharmaceuticals S.A.,

Poland

Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

576 BRU11030673P Topistin® Solution for IV Infusion

200mg/100ml

Ciprofloxacin (as lactate) 200mg/100ml Elpen Pharmaceutical Co., Inc., Greece. G & H Trading Company 26 March 2016 till 25 March

2021

POM

BDMCA/RMP/1116 Page 32 of 117

Page 33: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

577 BRU11030674P Arixtra Injection 2.5mg/0.5ml Fondporinux sodium 2.5mg/0.5ml Glaxo Wellcome Production, France Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

578 BRU11040675P Puregon® 600iu/0.72ml Solution

for Injection

Recombinant follicle-stimulating hormone

(FSH) (follitrophin beta) [Org 32489]

600iu/0.72ml

Vetter Pharma-Fertigung GmbH & Co. KG.,

Mooswiesen, Revensburg, Germany and

Vetter Pharma-Fertigung GmbH & Co. KG.,

Schutzenstrasse, Ravensburg, Germany

Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

579 BRU11040676PS1;

BRU11040676PS2

Tazocin EF 4.5g Piperacillin (asmonohydrate) 4g;

Tazobactam (as sodium) 0.5g

Wyeth Lederle S.r.I, Catania, Italy (S1);

Pfizer Biotech Corporation,

Hsinchu Plant, Taiwan-Republic of China

(S2)

Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

580 BRU11040677P Vaxigrip Suspension for Injection Split influenza virus*, inactivated

containing antigens equivalent to the

following strains per one 0.5ml dose:

A/California/7/2009 (H1N1)pdm09-derived

strain used NYMC X-179A) 15mcg HA**;

A/Texas/50/2012(H3N2)-derived strain

used NYMC X-223A 15mcg HA**;

B/Massachusetts/2/2012-derived strain

used NYMC BX-51B 15mcg HA**

Note - * Propagated in fertilized hens’ egg

from healthy chicken flocks

** haemagglutinin

Sanofi Pasteur, Lyon, France Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

581 BRU11040678P Euvax B Adult Vaccine

Recombinant

Purified HBs-Ag 20mcg LG Life Science Ltd., Korea Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

582 BRU11040679P TrandateTM Injection 5mg/ml x

5ml

Labetalol HCl 25mg/5ml Hsinchu Plant of UBI Pharma Inc., Taiwan Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

583 BRU11040680P Puregon® 50IU/0.5ml Solution for

Injection

Follitrophin Beta (recombinant follicale-

stimulating hormone (FSH) 50IU/0.5ml

N.V.Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

584 BRU11040681P Oxy-Nase Nasal Drops 0.05% Oxymetazolin Hydrochloride 0.05%w/v HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 30 April 2016 till 29 April

2021

P

585 BRU11040682P Sunolut Tablet 5mg Norethisterone 5mg Sunward Pharmaceutical Pte Ltd.,

Singapore

G & H Trading Company 30 April 2016 till 29 April

2021

POM

586 BRU11040683P Sandostatin® LAR® Injection

10mg

Octreotide 10mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

587 BRU11040684P Vfend TM Film-Coated Tablets

200mg

Voriconazole 200mg Pfizer Italia S.R.L, Italy Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

588 BRU11040685P Voren Suppositories 25mg Diclofenac Sodium 25mg Y.S.P Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

BDMCA/RMP/1116 Page 33 of 117

Page 34: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

589 BRU11040687P Multaq 400mg Film-coated Tablet Dronedarone 400mg (equiv. Dronedarone

HCl 426mg)

Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 30 April 2016 till 29 April

2021

POM

590 BRU11040688P Stablon Coated Tablet 12.5mg Tianeptine (as sodium) 12.5mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

591 BRU11040689P Shinoxol Tablet 30mg Ambroxol HCl 30mg Y.S.P Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

592 BRU11040690P EngerixTM

-B Paediatric Vaccine

10mcg/0.5ml

Purified HBs-Ag 10mcg GlaxoSmithKline Biologicals SA., Rixensart

Belgium; GlaxoSmithKline Biologicals S.A.,

Wavre

Belgium

Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

593 BRU11040691P Elosone Cream Mometasone Furoate 0.1%w/w HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 30 April 2016 till 29 April

2021

POM

594 BRU11040693P Cinna Tablet 25mg Cinnarizine 25mg Y.S.P Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

595 BRU11040694P Stalevo® 100/25/200mg Film-

coated Tablet

Levodopa 100mg; Carbidopa 25mg;

Entacapone 200mg

Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

596 BRU11040695P RevoladeTM

Film-coated Tablet

25mg

Eltrombopag 25mg [as free acid] (as

olamine)

Glaxo Operations UK Ltd (trading as Glaxo

Wellcome Operations), UK

Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

597 BRU11040696P Coversyl® Film-coated Tablet

10mg

Perindopril arginine 20mg (equiv to

perindopril 6.790mg)

Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

598 BRU11040697P Atorvastatin Winthrop® 20mg

Film-coated Tablet

Atorvastatin 20mg (as calcium 20.68mg) Zentiva k.s., Prague, Czech Republic Medipharm Sdn Bhd 30 April 2016 till 29 April

2021

POM

599 BRU11040698P SeroxatTM CR Tablet 12.5mg Paroxetine 12.5mg (as Paroxetine HCl

hemihydrate)

GlaxoSmithKline Inc., Ontario, Canada Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

600 BRU11050699P Avamys® Nasal Spray Fluticasone furoate (micronised) 27.5µg

/spray

Glaxo Operations UK Ltd, United Kingdom Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

601 BRU11050700P Tetraxim Vaccine Purified diphteria toxoid ≥ 30IU; purified

tetanus toxoid ≥ 40IU; Bordetella pertusis

antigens: Adsorbed purified pertusis toxoid

25µg, Adsorbed purified filamentous

haemagglutinin 25µg ; Inactivated

poliomyelitis virus: Type 1 40 D units, Type

2 8 Dunits, Type 3 32 Dunits.

Sanofi Pasteur, Campus Merieux, France;

Sanofi Pasteur, Parc industriel d'Incarville,

France

Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

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

Belgium

Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

603 BRU11050702P Benzhexol Tablet 2mg Benzhexol HCl 2mg Sunward Pharmaceutical Pte Ltd.,

Singapore

G & H Trading Company 25 May 2016 till 24 May

2021

POM

604 BRU11050703P Levitra Film-coated Tablets 10mg Vardenafil (as monohydrochloride

trihydrate) 10mg

Bayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

BDMCA/RMP/1116 Page 34 of 117

Page 35: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

605 BRU11050704P Ventolin Solution for Intravenous

Infusion 5mg/5ml

Salbutamol (as sulphate) 5mg/5ml GlaxoSmithKline Pharmaceutical S.p.A.,

Italy

Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

606 BRU11050705NP Upha B6 10 Tablet Pyridoxine HCl 10mg Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 25 May 2011 till 24 May

2016 (PL extended to 26

March 2017)

P (5 x 50's)

607 BRU11050706P Zofran Injection Flexi-Amp

Ampoules

Ondansetron HCl Dihydrate 8mg/4ml GlaxoSmithKline Australia Pty Ltd.m

Australia

Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

608 BRU11050707P Caverject 20mcg Powder and

solvent for injection

Alprostadil 20µg Pfizer Manufacturing Belgium N.V.,

Belgium

Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

609 BRU11050708NP Essentiale Forte N Capsule Phospholipids fatty mass 392mg

(equivalent to 300mg phospholipids from

soya beans containing 76% of (3-sn-

phosphatidyl) choline)

A. Nattermann & Cie. GmbH., Germany Medipharm Sdn Bhd 25 May 2016 till 24 May

2021

GSL (50's)

610 BRU11050710P Coveram Tablets 5mg/5mg Perindopril arginine 5mg (equiv. to

perindopril 3.395mg); Amlodipine 5mg (as

besilate 6.935mg)

Servier (Ireland) Industries Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

611 BRU11050712P Tracrium Injection 25mg/2.5ml Atracurium besylate 25mg/2.5ml GlaxoSmithKline Manufactuirng S.p.A.,

Italy

Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

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

China

Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM

613 BRU11060715P Oxy-Nase Paediatric Nasal Drop

0.025%w/v

Oxymetazoline HCl 0.025% HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 02 July 2016 till 01 July 2021 POM

614 BRU11060716P Vfend 50mg film-coated Tablet Voriconazole 50mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM

615 BRU11060717P Protaxos 2g Strontium Ranelate 2632mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM

616 BRU11060718P MyleranTM Tablets 2mg Busulphan 2mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM

617 BRU11060719P Amlodipine Winthrop Tablet 5mg Amlodipine (as besilate) Unichem Laboratories Limited, Goa, India Medipharm Sdn Bhd 02 July 2016 till 01 July 2021 POM

618 BRU11060720P Virless Tablet 800mg Acyclovir 800mg Y.S.P. Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM

619 BRU11060721P Atorvastatin Winthrop® 40mg

Tablet

Atorvastatin 40mg (as Calcium 41.36mg) Zentiva k.s., Czech Republic Medipharm Sdn Bhd 02 July 2016 till 01 July 2021 POM

620 BRU11060722P Propecia 1mg Tablet Finasteride 1mg Merck Sharp & Dohme, Puerto Rico, USA Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM

621 BRU11060723P Seroquel XR Extended-Release

Tablets 50mg

Quetiapine 50mg (as fumarate 57.560mg) AstraZeneca Pharmaeuticals LP, USA Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM

622 BRU11070724P Vesicare® 5mg Tablet Solifenacin Succinate 5mg Astella Pharma Europe B.V., The

Netherlands

Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

BDMCA/RMP/1116 Page 35 of 117

Page 36: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

623 BRU11070727P SW Bena-Expectorant Per 5ml: Diphenhydramine HCl 10mg,

Ammonium Chloride 102mg, Sodium

Citrate 46mg

Sunward Pharmaceutical Pte Ltd.,

Singapore

G&H Trading Company 27 July 2016 till 26 July 2021 POM

624 BRU11070729P Priorix TM Composition of Priorix™ per dose (0.5ml):

Live attenuated measles virus (Schwarz

strain) ≥103.0

CCID50, Live attenuated

mumps virus (RIT4385 strain) ≥103.7 CCID50,

Live attenuated rubella virus (Wistar RA

27/3 strain) ≥103.0 CCID50

GlaxoSmithKline Biologicals s.a., Belgium;

FIDIA Farmaceutici S.p.a., Italy

Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

625 BRU11070730P Mirena® Intrauterine System

20mcg/24hr

Levonorgestrel 52mg Bayer Oy, Finland Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

626 BRU11070731P Amlodipine Winthrop® 10mg

Tablet

Amlodipine 10mg (as besilate) Unichem Laboratories Limited, Goa, India Medipharm Sdn Bhd 27 July 2016 till 26 July 2021 POM

627 BRU11070732PS1;

BRU11070732PS2

Zoral 400 Tablet 400mg Acyclovir USP 400mg Drug House of Australia Pte Ltd.,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indoensia (S2)

G & H Trading Company 27 July 2016 till 26 July 2021 POM

628 BRU11070733P ZofranTM Injection 4mg/2ml Ondansetron 4mg/5ml (as HCl dihydrate) GlaxoSmithKline Australia Pty Ltd.,

Australia

Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

629 BRU11070734P Syntometrine® Injection 5IU/ml

Ampoule

Oxytocin 5IU/ml Novartis Pharma Steing AG., Switzerland Medipharm Sdn Bhd 27 July 2016 till 26 July 2021 POM

630 BRU11070735P Elosone Ointment 0.1%w/w Mometasone furoate 0.1% w/w HOE Pharmaceuticals Sdn Bhd., Malaysia G & H Trading Company 27 July 2016 till 26 July 2021 POM

631 BRU11070736P Coveram 5/10mg Tablet Perindopril arginine 5mg (equiv. to

3.395mg perindopril) and amlodipine 10mg

(as besilate 13.870mg)

Servier (Ireland) Industries Ltd, Ireland Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

632 BRU11070737P ZofranTM

Tablets 8mg Ondansetron 8mg (as HCl dihydrate) Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

633 BRU11070738PS1;

BRU11070738PS2

Diamicron® MR 60mg Tablet Gliclazide 60mg Les Laboratoires Servier Industrie, France

(S1); Kotra Pharma (M) Sdn. Bhd, Malaysia

(S2)

Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

634 BRU11070739P Fedac DM Linctus Per 5ml: Triprolidine HCl 12.5mg,

Pesudoephedrine HCl 30mg,

Dextrometorphan HBr 10mg

Drug House of Australia Pte Ltd.,

Singapore

G & H Trading Company 27 July 2016 till 26 July 2021 POM

635 BRU11070740P Tracrium Injection 50mg/5ml Atracurium Besylate 50mg/5ml GlaxoSmithKline Manufacturing S.p.A.,

Parma, Italy

Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

636 BRU11070741P Coralan® Tablet 2.5mg Ivabradine 7.5mg (as HCl 8.085mg) Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

637 BRU11080742P Aclasta 5mg/10ml Solution for

Infusion

Zolendranic acid (anhydrous) 5mg (as

zolendranic acid monohydrate 5.33mg)

Novartis Pharma Stein AG., Switzerland Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

638 BRU11080743P Lanoxin Tablet 250mcg Digoxin 250mcg GlaxoSmithKline Australia Pty Ltd.,

Australia

Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

BDMCA/RMP/1116 Page 36 of 117

Page 37: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

639 BRU11080744P Lanoxin PG Tablet 0.0625mg Digoxin 0.0625mg GlaxoSmithKline Australia Pty Ltd.,

Australia

Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

640 BRU11080745P Glivec® 400mg Film-coated Tablet Imatinib (as mesylate) 400mg Novartis Pharma Stein AG., Switzerland Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

641 BRU11080746P Stalevo 50/12.5/200mg film-

coated tablet

Levodopa 50mg, Carbidopa 12.5mg,

Entacapone 200mg

Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

642 BRU11080747PS1,

BRU11080747PS2,

BRU11080747PS3

Pentaxim Vaccine Composition of final container per dose

(0.5ml): TETRAXIM - Purified diphteria

toxoid ≥ 30 I.U; Purified tetanus toxoid ≥40

I.U; Adsorbed purified pertusis toxoid

25µg; Inactivated poliomyeltis virus type1

40 DU, type 2 8DU, type 3 32 DU; Act-HIB -

Polysaccharide of Haemophilus influenza

type b conjugated to tetanus protein 10µg

Sanofi Pasteur, Campus Merieux, Marcy

I'Etoile, France (S1); Sanofi Pasteur, Parc

Industriel d'Incarville, France (S2); Sanofi

Pasteur, Gruppo Lepeptit, Angani, Italy

(S3)

Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

643 BRU11080748P Campto 100mg/5ml Injection Irinotecan hydrochloride trihydrate Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

644 BRU11080749P Econazine Cream Econazole nitrate 1% w/w, Triamcinolone

actonide 0.1% w/w

Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

645 BRU11080750P Frotin Film Coated 200mg Tablet Metronidazole 200mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

646 BRU11080751P Urosin Film Coated Tablet 100mg Atenolol 100mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

647 BRU11080752P TwinrixTM Vaccine Hepatitis A virus antigen 720 ELISA units; r-

DNA hepatitis B virus surface antigen

(HBsAg)* 20µg *Thiomersal-free

HBsAg purified bulk

GlaxoSmithKline Biologicals SA, Belgium Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

648 BRU11080753P Fukole Capsule 150mg Fluconazole 150mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

649 BRU11080754P CoAprovel Tablet 300/25mg Irbesartan 300mg, Hydrochlorothiazide

25mg

Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 25 August 2016 till 24 August

2021

POM

650 BRU11080755P SeroxatTM CR Tablet 25mg Paroxetine 25mg(as Paroxetine

hydrochloride hemihydrate)

GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

651 BRU11080757P Orphenadol® Tablet Orphenadrine Citrate 50mg, Paracetamol

325mg

Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

652 BRU11080758P Loramide Capsule 2mg Loperamide HCl 2mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

653 BRU11080759P VOREN Suppositories 50mg Diclofenac Sodium 50mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

654 BRU11080760P Decan Tablet 0.75mg Dexamethasone 0.75mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 25 August 2016 till 24 August

2021

POM

655 BRU11090762P Properazine Tablet 5mg Prochlorperazine maleate 5mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 27 September 2016 till 26

September 2021

POM

BDMCA/RMP/1116 Page 37 of 117

Page 38: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

656 BRU11090763P Infanrix HexaTM Composition of reconstiitiuted DTPa-HBV-

IPV+Hib Vaccine per dose (0.5ml):

Diphteria toxoid min. 30 I.U; Tetanus

toxoid min. 40 I.U; Pertusis toxoid (PT)

25µg; Filamentous haemagglutinin (FHA),

adsorbed 25µg; Pertactin, adsorbed 8µg; r-

DNA Hepatitis B surface antigen (HBsAg

purified) 10µg; Inactivated poliomyeltis

virus type I 40 DU, Inactivated poliomyeltis

virus type II 8DU, Inactivated poliomyeltis

virus type III 32 DU;Conjugate of

Haemophilus influenza type b capsular

polysaccharide (PRP) and tetanus toxoid

10µg PRP and ~25µg T

GlaxoSmithKline Biologicals SA, Rixensart

Belgium; GlaxoSmithKline Biologicals S.A.,

Saint-Amand-Les-Eaux

France; GlaxoSmithKline Biologicals S.A.,

Wavre

Belgium;

Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

657 BRU11090764P Eloxatin 5mg/ml Concentrate for

Solution for Infusion (10ml)

Oxaliplatin 50mg/10ml Sanofi-Aventis Deutschland GmbH,

Germany

Medipharm Sdn Bhd 27 September 2016 till 26

September 2021

POM

658 BRU11090765P Eloxatin 5mg/ml Concentrate for

Solution for Infusion (20ml)

Oxaliplatin 100mg/20ml Sanofi-Aventis Deutschland GmbH,

Germany

Medipharm Sdn Bhd 27 September 2016 till 26

September 2021

POM

659 BRU11090766P InfanrixTM

-IPV Vaccine Composition per dose (0.5ml): Diphteria

toxoid (DT), adsorbed min. 30 I.U; Tetanus

toxoid (TT), adsorbed min. 40 I.U; Pertusis

toxoid (PT), adsorbed 25µg; Filamentous

haemagglutinin (FHA), adsorbed 25µg;

Pertactin, adsorbed 8µg; Inactivated

poliomyeltis virus type I 40 DU, Inactivated

poliomyeltis virus type II 8DU, Inactivated

poliomyeltis virus type III 32 DU

GlaxoSmithKline Biologicals SA, Belgium Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

660 BRU11090767P Sandimmun Neoral® Oral

Solution 100mg/ml

Ciclosporin A 100mg/ml Novartis Pharma S.A.S., France Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

661 BRU11090768P Hyzaar® Tablet 50/12.5mg Losartan Potassium 50mg,

Hydrochlorothiazide 12.5mg

Merck Sharp & Dohme, Northumberland,

UK

Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

662 BRU11090769P Hyzaar® Plus Tablet 100/12.5mg Losartan Potassium 100mg,

Hydrochlorothiazide 12.5mg

Merck Sharp & Dohme, Northumberland,

UK

Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

663 BRU11090770P Flebogamma 5% DIF Solution for

Infusion (100mL)

Human Normal Immunoglobulin 50mg/ml Instituo Grifols S.A., Barcelona, Spain Hongkiat Trading & Company 27 September 2016 till 26

September 2021

POM

BDMCA/RMP/1116 Page 38 of 117

Page 39: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

664 BRU11090771P Seroquel XR Tablets 200mg Quetiapine (as fumarate) 200mg AstraZeneca Pharmaeuticals LP, USA Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

665 BRU11090772P Diabetamin Film-coated Tablet

500mg

Metformin HCl 500mg Hovid Bhd, Perak, Malaysia G & H Trading Company 27 September 2016 till 26

September 2021

POM

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

11.9mg/g)

Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

667 BRU11090774P Daunoblastina Injection 20mg Daunoribicin Hydrochloride 20mg Actavis S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

668 BRU11090775P Fucon Capsule 10mg Hyoscine-N-butylbromide 10mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

669 BRU11090776P Virless Cream Acyclovir 50mg/g Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

670 BRU11090777P Solian® 100mg Scored Tablet Amisulpiride 100mg Sanofi Winthrop Industrie, France MediPharm Sdn Bhd 27 September 2016 till 26

September 2021

POM

671 BRU11090778P Hovasc Tablet 5mg Amlodipine 5mg (as besilate 6.90mg) Hovid Bhd, Malaysia G & H Trading Company 27 September 2016 till 26

September 2021

POM

672 BRU11100779P Pariet® Tablet 20mg Sodium Rabeprazole 20mg Bushu Pharmaceuticals Ltd, Japan. , Japan MediPharm Sdn Bhd 31 October 2016 till 30

October 2021

POM

673 BRU11100780P Pariet® Tablet 10mg Sodium Rabeprazole 10mg Bushu Pharmaceuticals Ltd, Japan. , Japan MediPharm Sdn Bhd 31 October 2016 till 30

October 2021

POM

674 BRU11100781P Puregon® 100IU/0.5ml Solution

for Injection

Follitropin beta (recombinant follicle-

stimulating hormone - FSH) 100IU/0.5ml

N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

675 BRU11100782P Gardasil Vaccine HPV Type 6 L1 protein 20mcg/0.5ml; HPV

Type 11 L1 protein 40mcg/0.5ml; HPV Type

16 L1 protein 40mcg/0.5ml; HPV Type 18 L1

protein 20mcg/0.5ml

Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

676 BRU11100783P TypherixTM Vi Polysccharide

Typhoid Vaccine 25mcg/0.5ml

Vi Polysaccaharide of Salmonella Typhi GlaxoSmithKline Biologicals SA, Rixensart

Belgium; GlaxoSmithKline Biologicals S.A.,

Wavre Belgium; Sächsisches Serumwerk

Dresden

Branch of SmithKline Beecham Pharma

GmbH & Co. K.G., Dresden

Germany; GlaxoSmithKline Biologicals,

Saint Amand Les Eaux France

Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

677 BRU11100784P Sandostatin® ampoules 0.1mg/ml Octreotide (as acetate) 0.1mg/ml Novartis Pharma Stein A.G., Switzerland Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

678 BRU11100785P Atorvastatin Winthrop® 10mg

film-coated Tablets

Atorvastatin 10mg (as calsium 10.34mg) Zentiva k.s., Czech Republic MediPharm Sdn Bhd 31 October 2016 till 30

October 2021

POM

679 BRU11100786P Stalevo® 150/37.5/200mg Film-

coated Tablet

Levodopa 150mg; Carbidopa 37.5mg;

Entacapone 200mg

Orion Corporation Fermion, Finland Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

BDMCA/RMP/1116 Page 39 of 117

Page 40: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

680 BRU11100787P Coveram Tablet 10mg/5mg Perindopril arginine 10mg (eqv. To

Perindopril 6.790mg); Amlodipine 5mg (as

besilate 6.935mg)

Servier (Ireland) Industries Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

681 BRU11100788P Coversyl® Fim-coated Tablet 5mg Perindopril arginine 5mg (eqv. Perindopril

3.395mg)

Les Laboratoires Servier Industrie, Gidy,

France

Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

682 BRU11100789P Myonal 50mg Tablet Eperisone Hydrochloride 50mg Eisai Co., Ltd, Saitama Prefecture, Japan MediPharm Sdn Bhd 31 October 2016 till 30

October 2021

POM

683 BRU11100790P VarilrixTM Live attenuated varicella virus (OKA strain) GlaxoSmithKline Biologicals SA, Rixensart,

Belgium (Manufacturer of finished

product); GlaxoSmithKline Biologicals SA,

Rixensart, Belgium (Manufacturing site for

Water for Injection (WFI) diluents in

syringe and ampoule); Delpharm Tours,

Chambray-lès-Tours, France

(Manufacturing site for Water for

Injection (WFI) diluents in ampoules);

GlaxoSmithKline Biologicals S.A., Wavre,

Belgium

& GlaxoSmithKline Biologicals, Saint-

Amand-Les-Eaux, France & Centre de

Recherche et de Nouvelles Applications

(CRNA) SA, Belgium (Manufacturing site

for final packaging operations)

Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

684 BRU11100791P Coveram Tablet 10mg/10mg Perindopril arginine 10mg (eqv. To

Perindopril 6.790mg); Amlodipine 10mg (as

besilate 13.870mg)

Servier (Ireland) Industries Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

685 BRU11100792P Voker Film Coated Tablet 20mg Famotidine 20mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

686 BRU11100793P Solian® 400mg Scored Tablet Amisulpride 400mg Sanofi Winthrop Industrie, France MediPharm Sdn Bhd 31 October 2016 till 30

October 2021

POM

687 BRU11100794P Clarityn-D 12HR EXTENDED

RELEASE TABLET 5mg/120mg

Loratadine 5mg, Pseudoephedrine

sulphate 120mg

Schering Plough Labo N.V., Belgium Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

688 BRU11100795P Euthyrox® Tablet 25mcg Levothyroxine sodium 25mcg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

689 BRU11100796P Concor® 2.5mg Tablet Bisoprolol hemifumarate 2.5mg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

690 BRU11110797P OnglyzaTM

Tablet 2.5mg Saxagliptin 2.5mg (as HCl anhydrous

2.79mg)

Bristol-Myers Squibb Company, Indiana,

USA

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

691 BRU11110798P OnglyzaTM Tablet 5mg Saxagliptin 5mg (as HCl anhydrous 5.58mg) Bristol-Myers Squibb Company, Indiana,

USA

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

BDMCA/RMP/1116 Page 40 of 117

Page 41: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

692 BRU11110799P Sandostatin® LAR® Injection

20mg

Octreotide (as acetate) 20mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

693 BRU11110800P Sandostatin® LAR® Injection

30mg

Octreotide (as acetate) 30mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

694 BRU11110802P GardasilTM Vaccine (Syringe) Per 0.5ml dose - HPV Type 6 L1 protein

20mcg; HPV Type 11 L1 protein 40mcg;

HPV Type 16 L1 protein 40mcg; HPV Type

18 L1 protein 20mcg

Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

695 BRU11110803P Nexavar® 200mg Film-coated

Tablets

Sorafenib Tosylate 200mg Bayer Pharma AG., Leverkusen, Germany;

Bayer Healthcare Manufacturing S.r.l.,

Italy

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

696 BRU11110804P PEG Intron CLEARCLICK for

Injection 150mcg/0.5ml

Recombinant interferon alfa-2b 150mcg

(pegylated to monoethoxy polyethylene

glycol)

MSD International GmbH (Singapore

Branch), Singapore Singapore

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

697 BRU11110805P PEG Intron CLEARCLICK for

Injection 120mcg/0.5ml

Recombinant interferon alfa-2b 120mcg

(pegylated to monoethoxy polyethylene

glycol)

Schering-Plough Ltd., Singapore Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

698 BRU11110806P PEG Intron CLEARCLICK for

Injection 100mcg/0.5ml

Recombinant interferon alfa-2b 100mcg

(pegylated to monoethoxy polyethylene

glycol)

MSD International GmbH (Singapore

Branch), Singapore Singapore

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

699 BRU11110807P PEG Intron CLEARCLICK for

Injection 80mcg/0.5ml

Recombinant interferon alfa-2b 80mcg

(pegylated to monoethoxy polyethylene

glycol)

MSD International GmbH (Singapore

Branch), Singapore Singapore

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

700 BRU11110808P PEG Intron CLEARCLICK for

Injection 50mcg/0.5ml

Recombinant interferon alfa-2b 50mcg

(pegylated to monoethoxy polyethylene

glycol)

MSD International GmbH (Singapore

Branch), Singapore Singapore

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

701 BRU11110809P Dalacin CTM Sterile Solution

150mg/ml x 2ml ampoule

Clindamycin Phosphate 300mg Pfizer Manufacturing Belgium N.V., Puurs,

Belgium

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

702 BRU11110811P Aricept® Tablet 5mg Donepezil HCl 5mg (equiv. to Donepezil

free base 4.56mg)

Eisai Taiwan Inc., Tainan Hsien, Taiwan MediPharm Sdn Bhd 24 November 2011 till 23

November 2016

POM

703 BRU11110812P Euthyrox® Tablet 100mcg Levothyroxine sodium 100mcg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

704 BRU11110813P Ketipinor Film-coated Tablet

200mg

Quetiapine 200mg (as fumarate 230.36mg) Orion Corporation, Espoo, Finland Hongkiat Trading & Company 24 November 2011 till 23

November 2016 (PL

extended to 26 March 2017)

POM

705 BRU11110814P Prednisolone Tablet 5mg Prednisolone 5mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

706 BRU11110815P Granocyte® 34 Injection Lenograstim (rHug-CSF) 33.6 million IU

(equiv. to 263 mcg)/ vial

Sanofi Winthrop Industrie, France MediPharm Sdn Bhd 24 November 2016 till 23

November 2021

POM

707 BRU11120816P Euvax B Pediatric Vaccine

Recombinant (10mcg/0.5ml)

Purified HBs-Ag 10mcg/0.5ml LG Life Science Ltd., Korea Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

BDMCA/RMP/1116 Page 41 of 117

Page 42: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

708 BRU11120817P Puregon® 300IU/0.36 ml Solution

for Injection

Recombinant follicle-stimulating hormone

(FSH) (follitrophin beta) [Org 32489]

600iu/0.72ml

Vetter Pharm-Fertigung GmbH & Co. KG.,

Schutzenstrasse, Ravensburg, Germany:

Vetter Pharm-Fertigung GmbH & Co. KG.,

Mooswiesen, Ravensburg, Germany;

Vetter Pharma-Fertigung GmbH & Co.

KG, Eisenbahnstrasse, Langenargen,

Germany and Vetter Pharma-Fertigung

GmbH & Co. KG, Holbeinstrassee,

Ravensburg Germany

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

709 BRU11120818P Clarityn Syrup Loratadine 1mg/ml PT. Merck Sharp Dohme Pharma Tbk,

Indonesia

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

P

710 BRU11120819P SynflorixTM Vaccine 1 dose (0.5ml) contains: Pneumococcal

polysaccharide serotype 11,2

- 1mcg,

Pneumococcal polysaccharide serotype 41,2

- 3mcg, Pneumococcal polysaccharide

serotype 51,2 - 1mcg, Pneumococcal

polysaccharide serotype 6B1,2

- 1mcg,

Pneumococcal polysaccharide serotype

7F1,2 - 1mcg, Pneumococcal polysaccharide

serotype 9V1,2

- 1mcg, Pneumococcal

polysaccharide serotype 141,2 - 1mcg,

Pneumococcal polysaccharide

serotype18C1,3 - 3mcg, Pneumococcal

polysaccharide serotype 19F1,4 - 3mcg,

Pneumococcal polysaccharide serotype

23F1,2 - 1mcg

GlaxoSmithKline Biologicals SA, Rixensart

Belgium; Glaxo SmithKline Biologicals SA,

Saint-Amand-Les-Eaux

France

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

711 BRU11120820P VentolinTM EvohalerTM Salbutamol (as sulphate 120.5mcg) 100mcg Glaxo Wellcome S.A., Burgos, Spain Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

712 BRU11120821P MencevaxTM ACWY Vaccine (1

Dose)

Per 0.5ml : Meningococcal purified

polysaccharides of: Serogroup A - 50mcg,

Serogroup C - 50mcg Serogroup W135 -

50mcg Serogroup W135 - 50mcg Serogroup

Y - 50mcg

GlaxoSmithKline Biologicals SA, Rixensart

Belgium

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

713 BRU11120822P RevoladeTM Film-coated Tablets

50mg

Eltrombopag olamine (eq. to Eltrombopag

50mg as Eltrombopag free acid)

Glaxo Operations UK Ltd (trading as Glaxo

Wellcome Operations) United Kingdom

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

BDMCA/RMP/1116 Page 42 of 117

Page 43: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

714 BRU11120823P Coversyl® Plus 5mg Perindopril arginine 5mg (as besilate

3.395mg); Indapamide 1.25mg

Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

715 BRU11120824P Yasmin® Film-coated Tablets Drospirenone 3mg, Ethinylestradiol 0.03mg Bayer Weimar GmbH und Co. KG

(WEIMAR PLANT), Germany

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

716 BRU11120826NP Arcalion® 200mg Tablet Sulbutiamine 200mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

GSL

717 BRU11120827P Methycobal Injection 500mcg/ml Mecobalamin 500mcg Bushu Pharmaceuticals Ltd, Japan MediPharm Sdn Bhd 22 December 2016 till 21

December 2021

POM

718 BRU11120828P Flebogamma® 5% DIF Solution for

Infusion (200ml)

Human Normal Immunoglobulin

10g/200mL (50mg/ml)

Instituto Grifols, S.A., Spain Hongkiat Trading 22 December 2016 till 21

December 2021

POM

719 BRU11120829NP Shintamet film coated Tablet Cimetidine 400mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 22 December 2011 till 21

December 2016

POM

720 BRU11120830P Dermafin cream 1% Terbinafine Hydrochloride 1%w/w Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 22 December 2016 till 21

December 2021

GSL

721 BRU11120831P Pontalon Tablet 250mg Mefenamic Acid 250mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

722 BRU11120832P Clopivid Tablet 75mg Clopidogrel 75mg (as hydrogen sulphate

97.90mg)

Hovid Bhd, Malaysia G & H Trading Company 22 December 2016 till 21

December 2021

POM

723 BRU11120833P Shincort Injection “Yung Shin”

10mg/ml

Triamcinolone Acetonide 50mg/5ml Yung Shin Pharmaceutical Ind. Co. Ltd.,

Taiwan ROC

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

December 2021

POM

724 BRU11120834P Hovasc Tablet 10mg Amlodipine 10mg (as Besylate 13.8mg) Hovid Bhd, Malaysia G & H Trading Company 22 December 2016 till 21

December 2021

POM

725 BRU11120835P Indomen Capsule 25mg Indomethacin 25mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

726 BRU11120836P Clomiphene Tablet 50mg Clomiphene citrate 50mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 22 December 2011 till 21

December 2016

POM

727 BRU11120837P Primacor® 10mg/10ml Injection Milrinone 10mg/10ml (as lactate) Sanofi Winhtrop Industrie, France MediPharm Sdn Bhd 22 December 2016 till 21

December 2021

POM

728 BRU11120838NP Champs D-Worms 6 Chewable

Tablet (Chocolate)

Albendazole 200mg Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 22 December 2011 till 21

December 2016 (PL

extended to 26 March 2017)

GSL (2's)

729 BRU11120839P Epilim® 200 Enteric Coated

Tablets

Sodium Valproate 200mg Sanofi-Synthelabo Ltd., United Kingdom MediPharm Sdn Bhd 22 December 2016 till 21

December 2021

POM

BDMCA/RMP/1116 Page 43 of 117

Page 44: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

730 BRU12010840P InfanrixTM-IPV+Hib Vaccine (DTPa-

IPV+Hib)

1 dose (0.5ml) contains: Diphteria toxoid

(DT) Min 30 I.U.; Tetanus toxoid (TT) Min

40 I.U.; Pertussis toxoid (PT) Min 25mcg;

Filamentous haemagglutinin (FHA) 25mcg;

Pertactin (69Kda Outer membrance

protein) 8mcg; Inactivated Polio Virus Type

1 (Mahoney seed) 40DU; Inactivated Polio

Virus Type 2 (MEF-1 seed) 8DU; Inactivated

Polio Virus Type 3 (Saukett seed) 32DU;

Conjugate of purified capsular

polysaccharide (10mcg) of Haemophilus

influenza type b covalently bound to

approximately 30mcg to 50 mcg tetanus

toxoid

GlaxoSmithKline Biologicals SA, Rixensart

Belgium; GlaxoSmithkline Biologicals S.A.,

France

Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

731 BRU12010841P Cardura XLTM tablet 4mg Doxazosin Mesylate 4mg Pfizer Pharmaceuticals LLC, Puerto Rico,

USA

Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

732 BRU12010842P Valdoxan® 25mg film-coated

tablet

Agomelatine 25mg Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

733 BRU12010843P Zofran Tablet 4mg Ondansetron (as Hydrochloride Dihydrate)

4mg

Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

734 BRU12010844P Flebogamma® 5% DIF Solution for

Infusion (50ml)

Human Normal Immunoglobulin

2.5g/50mL (50mg/ml)

Instituto Grifols, S.A., Spain Hongkiat Trading & Co 01 February 2017 till 31

January 2022

POM

735 BRU12010845P Coralan® Tablet 5mg Ivabradine 5mg eq. to 5.39mg ivabradine

hydrochloride

Les Laboratoires Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

736 BRU12010846P Seroquel XR tablets 300mg Quetiapine (as fumarate) 300mg Astrazeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

737 BRU12010847P Seroquel XR tablets 400mg Quetiapine (as fumarate) 400mg Astrazeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

738 BRU12010848P Chemix tablet Trimethoprim 80mg, Sulfamethoxazole

400mg

Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 01 February 2012 till 31

January 2017

POM

739 BRU12010849P Sofradex ear/eye drops Dexamethasone (as sodium

metasulphobenzoate) 0.05%w/v,

Framycetin sulphate 0.5% w/v, Gramicidin

0.005% w/v

Patheon UK, UK MediPharm Sdn Bhd 01 February 2017 till 31

January 2022

POM

740 BRU12010850P Enapril tablet 10mg Enalapril maleate 10mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 01 February 2012 till 31

January 2017

POM

741 BRU12010851NP Princi-B Fort® tablet Thiamin mononitrate 250mg, Pyridoxine

hydrochloride 250mg & Cyanocobalamin

1mg

Olic (Thailand) Ltd, Thailand MediPharm Sdn Bhd 01 February 2017 till 31

January 2022

P

742 BRU12010852P Antifungal Cream 2% Miconazole Nitrate 20mg/g (2% w/w) Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 01 February 2012 till 31

January 2017

GSL

BDMCA/RMP/1116 Page 44 of 117

Page 45: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

743 BRU12010853P Concor® 5mg tablet Bisoprolol hemifumarate 5mg Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

744 BRU12010854P Ketipinor film-coated tablet

100mg

Quetiapine (as fumarate 115.13mg) 100mg Orion Corporation, Finland Hongkiat Trading & Co 01 February 2012 till 31

January 2017 (PL extended

to 26 March 2017)

POM

745 BRU12010855P Euthyrox® Tablet 50mg Levothyroxine sodium 50mcg Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

746 BRU12010856NP Panadol Suspension 250mg/5ml Paracetamol 250mg/5ml Smithkline Beecham, Philippines Kingston Beverage & Creamery

Sdn Bhd

01 February 2012 till 31

January 2017

GSL (60ml/120ml)

747 BRU12010857P Targocid® Injection 200mg Teicoplanin 200mg/3ml (200mg/vial) Gruppo Lepetit S.r.I., Italy MediPharm Sdn Bhd 01 February 2017 till 31

January 2022

POM

748 BRU12020858P Sebivo™ Tablet 600mg Telbivudine 600mg Novartis Pharma Stein AG., Switzerland Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28

February 2022

POM

749 BRU12020859P Esonide Nasal Spray

100mcg/dose

Budesonide 2mg/ml equivalent to

100mcg/dose

Kleva S.A., Greece G & H Trading Company 29 February 2012 till 28

February 2017

POM

750 BRU12020860P Yucomy Tablet 200mg Ketoconazole 200mg Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 29 February 2012 till 28

February 2017

POM

751 BRU12020861P Thyrozol® 20mg Film-coated

Tablets

Thiamazole 20mg Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28

February 2022

POM

752 BRU12020862P Ketipinor Film-coated Tablet

25mg

Quetiapine (as fumarate 28.78mg) 25mg Orion Corporation, Finland Hongkiat Trading & Co 29 February 2012 till 28

February 2017 (PL extended

to 26 March 2017)

POM

753 BRU12020863P Taxotere 20mg/1ml concentrate

for solution for infusion

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

Germany

MediPharm Sdn Bhd 29 February 2012 till 28

February 2017

POM

754 BRU12020864P Zanidip® Tablet 10mg Lercanidipine Hydrochloride 10mg (eq. to

9.4mg Lercanidipine)

Recordati Industria Chimica &

Farmaceutica S.p.A, Italy

Hongkiat Trading & Co 29 February 2012 till 28

February 2017 (PL extended

to 26 March 2017)

POM

755 BRU12020865PS1 &

BRU12020865PS2

Nifedipine LA Tablet 30mg Nifedipine 30mg Valpharma International S.p.A, Italy (S1);

Valpharma S.A, Italy (S2)

G & H Trading Company 29 February 2012 till 28

February 2017

POM

756 BRU12020866P Apidra® Solostar® 100units/ml,

Solution for Injection in a Pre-

filled Pen

Insulin Glulisine 100units/ml Sanofi-Aventis Deutschland GmbH,

Germany

MediPharm Sdn Bhd 1 March 2017 till 28

February 2022

POM

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

February 2022

POM

758 BRU12020868P Betnovate™ Cream Betamethasone 0.1%w/w (as

Betamethasone 17-Valerate BP 0.122%

w/w)

Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28

February 2022

POM

759 BRU12020869P Dermovate™ Cream Clobetasol (as propionate) 0.05% w/w Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28

February 2022

POM

760 BRU12020870P Lyrica™ 150mg Capsules Pregabalin 150mg Pfizer Manufacturing Deutshland GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28

February 2022

POM

BDMCA/RMP/1116 Page 45 of 117

Page 46: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

761 BRU12030871NP Panadol® Menstrual Caplet Paracetamol 500mg & Pamabrom 25mg Sterling Drug (Malaya) Sdn Bhd., Malaysia Kingston Beverage & Creamery

Sdn Bhd

30 March 2012 till 29 March

2017

P (12 x 10's)

762 BRU12030872NP Panadol® Pain Relief Patch Glycol Salicylate 1.5%w/w, L-Menthol 1.0%

w/w, DL-Camphor 0.5%w/w, DL-A-

Tocopherol Acetate 0.3%w/w

Teh Seng Pharmaceutical Mfg Co., Ltd.,

Taiwan, ROC

Kingston Beverage & Creamery

Sdn Bhd

30 March 2012 till 29 March

2017

GSL

763 BRU12030873P LacipilTM Tablet 4mg Lacipidine 4mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March

2022

POM

764 BRU12030874P BrilintaTM 90mg F/C Tablet Ticagrelor 90mg AstraZeneca AB., Sweden Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March

2022

POM

765 BRU12030875P DetrusitolTM

SR Capsule 4mg Tolterodine L-Tartrate 4mg (equivalent to

Tolterodine 2.74mg)

Catalent Pharma Solutions LLC, USA Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March

2022

POM

766 BRU12030876NP Ellgy Corns & Warts Treatment

Solution

Salicylic acid 17%w/v HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 30 March 2017 till 29 March

2022

P

767 BRU12030877P Puregon® 900IU/1.08ml Solution

for Injection

Follitropin Beta (Recombinant follicle-

stimulating hormone FSH) [Org 32489]

Vetter Pharma-Fertigung GmbH & Co. KG.,

Schutzenstrasse, Ravensburg, Germany;

Vetter Pharma-Fertigung GmbH & Co. KG.,

Mooswiesn2, Ravensburg, Germany;

Vetter Pharma-Fertigung GmbH & Co. KG.,

Eisenbahnstrasse, Langenargen,

Germany; Vetter Pharma-Fertigung GmbH

& Co. KG., Holbeinstrasse, Ravensburg,

Germany

Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March

2022

POM

768 BRU12030879P Methotrexate Injection BP 50mg

in 2ml

Methotrexate 50mg/2ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March

2022

POM

769 BRU12030880NP Aqua Cream Emulsifying Wax 8% w/w, White Soft

Paraffin 12%w/w, Liquid Paraffin 8%w/w

Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 30 March 2012 till 29 March

2017

GSL

770 BRU12030881P CelebrexTM 400mg Capsule Celecoxib 400mg Pfizer Pharmaceuticals LLC., vega Baja

Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March

2022

POM

771 BRU12030882P Cancidas Powder for Injection

50mg/vial

Caspofungin (as acetate) 50mg/vial Laboratoires Merck Sharp & Dohme

Chibret, France

Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March

2022

POM

772 BRU12030883P Axcel Dextrozine Syrup Dextromethorphan Hydrobromide

15mg/5ml; Promethazine HCl 3.6mg/5ml

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 March 2017 till 29 March

2022

POM

773 BRU12040884P Dilantin Steri Vials 250mg in 5ml Phenytoin Sodium 250mg/5ml Actavis Italy S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April

2022

POM

774 BRU12040885P Jevtana® 60mg Concentrate and

Solvent for Solution for Infusion

Cabazitaxel 60mg/1.5ml Sanofi-Aventis Deutschland GmbH,

Germany

Medipharm Sdn Bhd 30 April 2012 till 29 April

2017

POM

775 BRU12040886P HycamtinTM Hard Capsule 1mg Topotecan 1mg (as hydrochloride) GlaxoSmithKline Manufacturing S.p.A.,

Parma, Italy

Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April

2022

POM

776 BRU12040887NP Panadol Suspension 120mg/5ml Paracetamol 120mg/5ml SmithKline Beecham, Cainta Rizal,

Philippines

Kingston Beverage & Creamey

Sdn Bhd

30 April 2012 till 29 April

2017

GSL (60ml

& 120ml)

BDMCA/RMP/1116 Page 46 of 117

Page 47: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

777 BRU12040888P Cancidas Powder for Injection

70mg/vial

Paracetamol 120mg/5ml Laboratoires Merck Sharp & Dohme

Chibret, France

Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April

2022

POM

778 BRU12040889PS1 &

BRU12040889PS2

Nasonex Aqueous Nasal Spray

0.05%

Mometasone furorate monohydrate,

micronized 0.05%

Schering-Plough Labo N.V., Belgium (S1) &

MSD International GmbH (Singapore

Branch), Singapore (S2)

Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April

2022

POM

779 BRU12040890PS1 &

BRU12040890PS2

Cerazette® Tablet 75mcg Desogestrel 75mcg N.V.Organon, The Netherlands (S1) &

Organon Ireland Limited, Ireland (S2)

Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April

2022

POM

780 BRU12040891P Axcel Diprodin Elixir Diphenhydramine HCl 12.5mg/5ml;

Ephedrine HCl 6mg/5ml

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 April 2017 till 29 April

2022

POM

781 BRU12040892NP Axcel Paracetamol-120 Syrup

(Cherry)

Paracetamol 120mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 April 2017 till 29 April

2022

GSL (60ml &

100ml)

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

2022

POM

783 BRU12040894P Axcel Tridine Syrup Triprolidine HCl 1.25mg/5ml;

Pseudoephedrine HCl 30mg/5ml

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 April 2017 till 29 April

2022

POM

784 BRU12040895P Axcel Lignocaine Sterile Gel

2%w/w

Lignocaine HCl (Equiv. to anhydrous HCl)

2g/100g

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 April 2017 till 29 April

2022

POM

785 BRU12040896P Niquitin 21mg Transdermal Patch Nicotine 114mg (delivers 21mg/24 hours) ALZA Corporation, California, USA Zuellig Pharma (B) Sdn Bhd 30 April 2012 till 29 April

2017

P

786 BRU12050897P VfendTM IV 200mg Voriconazole 200mg Pharmacia & Upjohn Company, USA

(Repacker - Pfizer PGM, France)

Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May

2022

POM

787 BRU12050898P Lamictal Dispersible Tablet 5mg Lamotrigine 5mg GlaxoSmithKline Pharmaceuticals SA.,

Poznan, Poland (Repacker -

GlaxoSmithKline Australia Pty Ltd.,

ViCtoria, Australia)

Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May

2022

POM

788 BRU12050899P HycamtinTM Hard Capsule 0.25mg Topotecan 0.25mg (as hydrochloride) GlaxoSmithKline Manufacturing S.p.A.,

Parma, Italy

Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May

2022

POM

789 BRU12050900P AeriusTM Syrup 0.5mg/ml Desloratadine 0.5mg/ml Schering-Plough Labo N.V., Belgium Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May

2022

POM

790 BRU12050901NP Flamazine Cream 1% w/w Silver Sulfadiazine 1.0%w/w Recipharm Parets S.L., Barcelona, Spain Mc Quipp Technisell Marketing

Sdn Bhd

24 May 2017 till 23 May

2022

P

791 BRU12050902P AeriusTM Tablets 5mg Desloratadine 5mg Schering-Plough Labo N.V., Belgium Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May

2022

POM

792 BRU12050903NP Panadol® ActiFast Caplets Paracetamol 500mg GlaxoSmithKline Dungravan Ltd, Ireland

(Repacker - Sterling Drug (Malaya) Sdn

Bhd., Malaysia

Kingston Beverage & Creamery

Sdn Bhd

24 May 2012 till 23 May

2017

P ( 48's; 80's (8

tabs per blister)

per box)

793 BRU12050904P Vaxcel Heparin Sodium Injection

5000 IU/ml x 5ml

Heparin Sodium (Bovine mucosa)

25,000/5ml

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 24 May 2017 till 23 May

2022

POM

794 BRU12050905P Pregnyl® 5000IU Powder and

Solvent for Injection

Heparin Sodium (Bovine mucosa)

25,000/5ml

Merck & Co. Inc., USA Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May

2022

POM

795 BRU12050906P Niquitin 7mg Transdermal Patch Nicotine 36mg/cm2 (delivers 7mg/24

hours)

ALZA Corporation, California, USA Zuellig Pharma (B) Sdn Bhd 24 May 2012 till 23 May

2017

P

BDMCA/RMP/1116 Page 47 of 117

Page 48: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

796 BRU12050907NP Eye Mo Moist Eye Lubricant (Eye

Drops)

Hydroxypropyl Methycellulose 0.3%w/v GlaxoSmithKline (Tianjin) Co Ltd., China Kingston Beverage & Creamery

Sdn Bhd

24 May 2012 till 23 May

2017

GSL

797 BRU12060908P Methycobal Tablets 500mcg Mecobalamin JP 0.5mg Bushu Pharmaceuticals Ltd, Japan Medipharm Sdn Bhd 30 June 2012 till 29 June

2017

POM

798 BRU12060909P LyricaTM 75mg Capsules Pregabalin 75mg Pfizer Manufacturing Deutschland GmbH,

Freiburg, Germany

Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June

2022

POM

799 BRU12060910NP Panadol® Soluble Tablet 500mg Paracetamol 500mg GlaxoSmithKline Australia Pty Ltd,

Ermington, NSW, Australia

Kingston Beverage & Creamery

Sdn Bhd

30 June 2012 till 29 June

2017

GSL (20's)

& P (144's)

800 BRU12060911NP Panadol For Children Tablets

120mg

Paracetamol 120mg Sterling Drug (Malaya) Sdn Bhd., Selangor,

Malaysia

Kingston Beverage & Creamery

Sdn Bhd

30 June 2012 till 29 June

2017

P (24's & 144's)

801 BRU12060912P Canesten GYN 1 Day Therapy

Vaginal Tablet 0.5g

Clotrimazole 500mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June

2022

POM

802 BRU12060913P Casodex Tablet 50mg Bicalutamide 50mg Corden Pharma GmbH, Plankstadt,

Germany

Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June

2022

POM

803 BRU12060914NP ENO Mint Fruit Salt Sodium Bicarbonate Coarse 1.483g

(34.49%w/w); Sodium Bicarbonate Fine

0.495g (11.51%w/w); Citric Acid Anhydrous

1.860g (43.26%w/w); Sodium Carbonate

Anhydrous 0.43g (10.0%w/w)

Sterling Drug (Malaya) Sdn Bhd., Selangor,

Malaysia

Kingston Beverage & Creamery

Sdn Bhd

30 June 2012 till 29 June

2017

GSL (48's)

804 BRU12060915P Drapolene Cream Cetrimide 0.2%w/w; Benzalkonium

Chloride Solution 0.02%w/w (equiv. to

Benzalkonium Chloride 0.01%w/w)

GlaxoSmithKline Pharmacuetical SA,

Poznan, Poland

Kingston Beverage & Creamery

Sdn Bhd

30 June 2012 till 29 June

2017

GSL (55g)

805 BRU12060916P Rhewlin Gel 1%w/w Diclofenac Diethylamine equiv. to

Diclofenac Sodium 1%w/w

Beacons Pharmaceutical Pte Ltd,

Singapore

Hongkiat Trading & Company 30 June 2012 till 29 June

2017

GSL

806 BRU12060917P Efexor® XR 37.5mg Capsule Venlafaxine Hydrochloride 37.5mg Pfizer Ireland Pharmacueticals, Kildare,

Republic of Ireland

Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June

2022

POM

807 BRU12070918P Beclomet Nasal Aqua

50mcg/dose Nasal Spray

Beclomethasone dipropionate 50mcg/dose Orion Corporation, Kuopio, Finland Hongkiat Trading & Company 30 July 2012 till 29 July 2017 POM

808 BRU12070919P Panadol CF Cold and Flu Caplets Paracetamol 500mg; Pseudoephedrine HCl

30mg; Chlorpheniramine 2mg

Sterling Drug (Malaya) Sdn Bhd., Selangor,

Malaysia

Zuellig Pharma (B) Sdn Bhd 30 July 2012 till 29 July 2017 P (10's)

809 BRU12070920NP Panadol® Biconvex Film-coated

Tablet 500mg

Paracetamol 500mg Sterling Drug (Malaya) Sdn Bhd., Selangor,

Malaysia

Kingston Beverage & Creamery

Sdn Bhd

30 July 2012 till 29 July 2017 P (50's, 3 x 10's &

15 x 10's)810 BRU12070921NP ENO Ginger Fruit Salt Sodium Bicarbonate Coarse 1.462g

(34.002%w/w); Sodium Bicarbonate Fine

0.487g (11.316%w/w); Citric Acid

Anhydrous 1.834g (42.640%w/w); Sodium

Carbonate Anhydrous 0.425g (9.892%w/w)

Sterling Drug (Malaya) Sdn Bhd., Selangor,

Malaysia

Kingston Beverage & Creamery

Sdn Bhd

30 July 2012 till 29 July 2017 GSL

BDMCA/RMP/1116 Page 48 of 117

Page 49: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

811 BRU12070922NP ENO Fruit Salt Sodium Bicarbonate Coarse 1.489g

(34.63%w/w); Sodium Bicarbonate Fine

0.496 (11.54%w/w); Citric Acid Anhydrous

1.873g (43.58%w/w); Sodium Carbonate

Anhydrous 0.43g (10.00%w/w)

Sterling Drug (Malaya) Sdn Bhd., Selangor,

Malaysia

Kingston Beverage & Creamery

Sdn Bhd

30 July 2012 till 29 July 2017 GSL

812 BRU12070923P Coversyl Plus 10mg/2.5mg Tablet Perindopril arginine 10mg (equiv. to

6.79mg perindopril); Indapamide 2.5mg

Servier (Ireland) Industries Ltd, Ireland Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM

813 BRU12070924P RotarixTM

oral Suspension Human rotavirus RIX4414 strain, not less

than 106.0 CCID50

GlaxoSmithKline Biological SA, Belgium Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM

814 BRU12070925P CutivateTM Cream Fluticasone propionate (micronised)

0.05%w/w

Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM

815 BRU12070926NP Bepanthen® Ointment Dexpanthenol 5%w/w GP Genzech Produktions GmbH, Germany Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 GSL

816 BRU12070927P Axcel Hydrocortisone Cream Hydrocortisone (micronised) 1% w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 July 2017 till 29 July 2022 POM

817 BRU12070928P Sevoflurane Inhalation

Anaesthetic Liquid 100%

Sevoflurane 100% (1ml/ml) Baxter Healthcare Corporation, Puerto

Rico, USA

Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM

818 BRU12080929P Niquitin 14mg Transdermal Patch Nicotine 78mg (14mg/24hrs) Alza Corporation, California, USA Zuellig Pharma (B) Sdn Bhd 29 August 2012 till 28 August

2017

P

819 BRU12080930NP Dequadin® Lozenges (Citrus

Flavour)

Dequalinium Chloride 0.25mg Sterling Drug (Malaya) Sdn Bhd., Selangor,

Malaysia

Kingston Beverage & Creamery

Sdn Bhd

29 August 2012 till 28 August

2017

GSL (6x4's & 24's)

820 BRU12080931P Rilutek Tablets 50mg Riluzole 50mg Sanofi Winthrop Industrie, Cedex, France Medipharm Sdn Bhd 29 August 2012 till 28 August

2017

POM

821 BRU12080932P Efexor XR 75mg Capsule Venlafaxine (as HCl) 75mg Pfizer Ireland Pharmaceuticals, Kildare,

Republic of Ireland

Zuellig Pharma (B) Sdn Bhd 29 August 2017 till 28 August

2022

POM

822 BRU12090933P Xarelto® Film-coated Tablet 10mg Rivaroxaban 10mg Bayer Pharma AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 27 September 2012 till 26

September 2017

POM

823 BRU12090934P Nif-Ten Capsule Atenolol 50mh; Nifedipine 20mg Corden Pharma GmbH, Plankstadt,

Germany

Zuellig Pharma (B) Sdn Bhd 27 September 2012 till 26

September 2017

POM

824 BRU12090937P Telfast 6mg/ml Oral Suspension Fexofenadine Hydrochloride 6mg/ml Sanofi-Aventis Farmceutica Ltd, Vila

Areiao Suzano-SP-Brasil

Medipharm Sdn Bhd 27 September 2012 till 26

September 2017

POM

825 BRU12090938P Glucophage® XR 750mg Extended

Release Tablet

Metformin HCl 750mg Merck KGaA, Germany; Merck Sante SAS,

Semoy, France

Zuellig Pharma (B) Sdn Bhd 27 September 2017 till 26

September 2022

POM

826 BRU12090939P Glucophage® Tablet 500mg Metformin HCl 500mg Merck Sante SAS, Semoy, France Zuellig Pharma (B) Sdn Bhd 27 September 2017 till 26

September 2022

POM

827 BRU12100940NP Dermoplex Calamine Cream Calamine (Fine) 4.00%; Zinc Oxide 3.00%

w/w

Upha Pharmaceutical Mfg (M) Sdn Bhd Hongkiat Trading & Company 31 October 2012 till 30

October 2017

GSL

828 BRU12100941P FragminTM Solution for Injection

5,000IU (anti-Xa)/0.2ml

Dalteparin Sodium 5,000IU (anti-Xa)/0.2ml Vetter Pharma-Fertigung GmbH & Co.,

Germany

Zuellig Pharma (B) Sdn Bhd 31 October 2012 till 30

October 2017

POM

BDMCA/RMP/1116 Page 49 of 117

Page 50: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

829 BRU12100942P Prostin E2TM Vaginal Tablet 3mg Dinoprostone 3mg Sanico N.V., Turnhout, Belgium Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30

October 2022

POM

830 BRU12100943NP Dianeal Low Calcium (2.5mEq/L)

Peritoneal Dialysis Solution with

2.5% Dextrose

Dextrose 2.5g; Sodium Chloride 538mg;

Sodium Lactate 448mg; Calcium Chloride

dihydrate 18.3mg; Magnesium Chloride

Hexhydrate 5.08mg

Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 31 October 2012 till 30

October 2017

POM

831 BRU12100944NP Potassium Chloride Tablet 600mg

(Slow release)

Potassium Chloride 600mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 31 October 2012 till 30

October 2017

POM

832 BRU12100945NP Anucare Suppositories Zinc Oxide 300mg; Balsam Peru 50mg;

Benzyl Benzoate 33mg

Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 31 October 2012 till 30

October 2017

GSL

833 BRU12100946P Salbu-Air CFC Free Inhaler Salbutamol Sulphate (micronised) 100mcg

per actuation

Laboratorio Aldo-Union S.A., Barcelona G & H Trading Company 31 October 2012 till 30

October 2017

POM

834 BRU12100947P Illiadin Nasal Decongestant

Solution 0.01%

Oxymetazoline Hydrochloride 0.01% Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 31 October 2012 till 30

October 2017

P

835 BRU12100948P Renvela (Sevelamer Carbonate)

Tablet 800mg

Sevelamer Carbonate 800mg Genzyme Ireland Limited, Ireland Medipharm Sdn Bhd 31 October 2012 till 30

October 2017

POM

836 BRU12100949P Lyrica Capsules 50mg Pregabalin 50mg Pfizer Manufacturing Deutschland GmbH,

Freiburg, Germany

Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30

October 2022

POM

837 BRU12100950P QvarTM 100 Inhaler Beclomethasone dipropionate 100mcg per

inhalation

3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30

October 2021

POM

838 BRU12100951P Prograf Capsule 0.5mg Tacrolimus 0.5mg Astellas Ireland Ltd, Ireland Zuellig Pharma (B) Sdn Bhd 31 October 2012 till 30

October 2017

POM

839 BRU12110952P Panadol C Tablet Paracetamol 500mg; Pseudoephedrine

Hydrochloride 30mg

Sterling Drug (Malaya) Sdn Bhd, Malaysia Zuellig Pharma (B) Sdn Bhd 27 November 2012 till 26

November 2017

P

840 BRU12110953P FragminTM

Solution for Injection

2,500IU (anti-Xa)/0.2ml, Single

dose syringe

Dalteparin Sodium 2,500IU (anti-Xa)/0.2ml Vetter Pharma-Fertigung GmbH & Co.,

Germany

Zuellig Pharma (B) Sdn Bhd 27 November 2012 till 26

November 2017

POM

841 BRU12110954P Efexor XR 150mg Capsule Venlafaxine (as Hydrochloride) 150mg Pfizer Ireland Pharmaceuticals, Kildare,

Republic of Ireland

Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26

November 2022

POM

842 BRU12110955P Eprex® 4000 Prefilled Syringe

4000IU/0.4ml

Epoetin alfa 4,000IU/0.4ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2012 till 26

November 2017

POM

843 BRU121109561P Topamax® 50 Tablets Topiramate 50mg Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2012 till 26

November 2017

POM

844 BRU12110956NP Vitamin C 100mg Tablet Ascorbic Acid 100mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 27 November 2012 till 26

November 2017

GSL

845 BRU12110957PS1;

BRU12110957PS2

Actrapid® 100IU/ml Solution for

Injection

Insulin Human (rDNA) 100iu/ml Novo Nordisk A/S, Denmark (S1); Novo

Nordisk Production SAS, France (S2)

Medipharm Sdn Bhd 27 November 2017 till 26

November 2022

POM

846 BRU12110958P Tretino Cream 0.05% Tretionoin (Retinoic acid) 0.5mg/g Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 27 November 2012 till 26

November 2017

POM

847 BRU12110959P Eprex® 2000 Prefilled Syringe

2000IU/0.5ml

Epoetin alfa 2,000IU/0.5ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2012 till 26

November 2017

POM

BDMCA/RMP/1116 Page 50 of 117

Page 51: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

848 BRU12110960NP Daflon 500mg Tablet Diosmin 450mg; Hesperidin 50mg Les Laboratories Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 27 November 2012 till 26

November 2017

GSL

849 BRU12110962P Tenol-100 Atenolol 100mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 27 November 2012 till 26

November 2017

POM

850 BRU12110963NP Polysilic III Suspension Per 5ml contains Dried Aluminium

Hydroxide Gel 400mg; Magnesium

Trisilicate light 400mg; Simethicone 30mg

Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 27 November 2012 till 26

November 2017

GSL (200ml); GSL

(3.8L)

851 BRU12110964P Exjade 125mg Dispersible Tablets Deferasirox 125mg Novartis Pharmas Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26

November 2022

POM

852 BRU12110965P Exjade 500mg Dispersible Tablets Deferasirox 500mg Novartis Pharmas Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26

November 2022

POM

853 BRU12110966NP Dhamotil Tablets Diphenoxylate HCl BP 2.5mg; Atropine

Sulphate 0.025mg

Drug Houses of Australia Pte Ltd.,

Singapore

G & H Trading Company 27 November 2012 till 26

November 2017

POM

854 BRU12120967P CervarixTM Vaccine (Prefilled

Syringe)

1 dose (0.5ml) contains: Human

Papillomavirus type 16 L1 protein 20mcg;

Human Papillomavirus type 18 L1 protein

20mcg; 3-O-desacyl-4'-monophosphoryl

lipid A (MPL) 50mcg; adsorbed on

aluminium hydroxide, hydrated (Al(OH)3)

0.5mcg Al3+

GlaxoSmithKine Biologicals S.A., Rixensart,

Belgium

Zuellig Pharma (B) Sdn Bhd 27 December 2012 till 26

December 2017

POM

855 BRU12120968NP Dianeal Low Calcium (2.5mEq/L)

Peritoneal Dialysis Sodium with

4.25% Dextrose

Per 100ml contains Calcium Chloride

18.3mg; Dextrose hydrous 4.25g;

Magnesium Chloride 5.08mg; Sodium

Chloride 538mg; Sdoium Lactate 448mg

Baxter Healthcare SA, Singapore Zuellig Pharma (B) Sdn Bhd 27 December 2012 till 26

December 2017

POM

856 BRU12120969NP ENO Orange Each 4.3g contains Citric Acid Anhydrous

1.851g; Sodium Bicarbonate Coarse 1.478g;

Sodium Bicarbonate Fine 0.492; Sodium

Carbonate Anhydrous 0.43g

Sterling Drug (Malaya) Sdn Bhd., Malaysia Kingston Beverage & Creamery

Sdn Bhd

27 December 2012 till 26

December 2017

GSL

857 BRU12120970P Clementin Film Coated Tablet

625mg

Amoxicillin (as Trihydrate) 500mg;

Clavulanic Acid (as Potassium Salt) 125mg

Yung Shin Pharmaceutical Ind. Co. Ltd.,

Taichung, Taiwan

Asterix United (B) Sdn Bhd 27 December 2012 till 26

December 2017

POM

858 BRU12120971P Survanta® Beractant Intratracheal

Suspension

Beractant (as phospholipids) 25mg/ml AbbVie Inc., USA Zuellig Pharma (B) Sdn Bhd 27 December 2012 till 26

December 2017

POM

859 BRU12120972P Humira Solution for Injection

40mg/0.8ml

Adalimumab 40mg/0.8ml Vetter-Pharma-Fertigung GmbH & Co.,

KG, Ravensburg, Germany

Zuellig Pharma (B) Sdn Bhd 27 December 2012 till 26

December 2017

POM

860 BRU12120973P ZyrprexaTM

Tablet 10mg Olanzapine 10mg Lily del Caribe Inc, Puerto Rico, USA & Lilly

S.A., Madrid, Spain

Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

861 BRU12120974P SutentTM Hard Capsules 12.5mg Sunitinib 12.5mg (as Malate) Pfizer Italia S.r.l., Ascoli Piceno, Italy Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

BDMCA/RMP/1116 Page 51 of 117

Page 52: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

862 BRU12120975P Stelara Solution for Injection in

pre-filled syringe 45mg/0.5ml

Ustekinumab 45mg/0.5ml Baxter Pharmaceutical Solutions LLC,

Blommington, United States

Zuellig Pharma (B) Sdn Bhd 27 December 2012 till 26

December 2017

POM

863 BRU12120976P Viagra 50mg Tablet Sildenafil 50mg (as Citrate) Pfizer PGM Amboise, France Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

864 BRU12120977P Viagra 100mg Tablet Sildenafil 100mg (as Citrate) Pfizer PGM Amboise, France Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

865 BRU12120978P Aerrane (Isoflurane USP)

Inhalation Liquid

Isoflurane USP 100% Baxter Healthcare Corporation, Puerto

Rico, USA

Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

866 BRU12120979P Kogenate FS for Injection

250IU/vial

Antihaemophilic Factor (recombinant)

sucrose formulated 250IU

Bayer Healthcare LLC., United States Zuellig Pharma (B) Sdn Bhd 27 December 2012 till 26

December 2017

POM

867 BRU12120980P Potcit Mixture Per 5ml contains Potassium Citrate 1g;

Citric acid anhydrous 200mg

Beacons Pharmaceutical Pte Ltd.,

Singapore

Hongkiat Trading & Company 27 December 2012 till 26

December 2017

POM

868 BRU12120981P Garbose Tablet 100mg Acarbose 100mg Y.S.P Industries (M) Sdn Bhd., Selangor

Darul Ehsan, Malaysia

Asterix United (B) Sdn Bhd 27 December 2012 till 26

December 2017

POM

869 BRU13010982P KombiglyzeTM XR Tablet

5/1000mg

Saxagliptin HCl 5mg (as anhydrous

5.58mg); Metformin Hydrochloride

1000mg

Bristol Myers Squibb Company USA Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25

January 2018

POM

870 BRU13010983P KombiglyzeTM XR Tablet 5/500mg Saxagliptin HCl 5mg (as anhydrous

5.58mg); Metformin Hydrochloride 500mg

Bristol Myers Squibb Company USA Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25

January 2018

POM

871 BRU13010984P KombiglyzeTM XR Tablet

2.5/1000mg

Saxagliptin HCl 2.5mg (as anhydrous

2.79mg); Metformin Hydrochloride

1000mg

Bristol Myers Squibb Company USA Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25

January 2018

POM

872 BRU13010985P Zanidip® 20mg Tablet Lercanidipine HCl 20mg Recordati Industria Chimica &

Farmaceutica S.p.A., Milan, Italy

Hongkiat Trading & Co 26 January 2013 till 25

January 2018

POM

873 BRU13010986NP Eye Mo Eye Drops Boric acid 12.98mg/ml (1.298% w/v);

Sodium Borate (equivalent to) 2.04mg/ml

(0.204%w/v)

GlaxoSmithKline (Tianjin) Co. Ltd., China Kingston Beverage & Creamery

Sdn Bhd

26 January 2013 till 25

January 2018

GSL

874 BRU13010987P Pontalon Tablet 500mg Mefenamic Acid 500mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 26 January 2013 till 25

January 2018

POM

875 BRU13010988P Co-Trimexazole Suspension Per 5ml - Sulphamethoxazole BP 200mg;

Trimethoprim 40mg

Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & CO 26 January 2013 till 25

January 2018

POM

876 BRU13010989P Opticrom® Eye Drops 2% w/v Sodium Cromoglycate BP 2% w/v Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 26 January 2013 till 25

January 2018

P

877 BRU13010990NP Panamol Paed. Suspension

120mg/5ml

Paracetamol 120mg/5ml Beacons Pharmaceuticals Pte ltd,

Singapore

Hongkiat Trading & Co 26 January 2013 till 25

January 2018

P (3.8L)

878 BRU13010991P Humulin 30/70 Injection 100iu/ml

(vial)

Human Insulin 100IU/ml (recombinant) -

30% Soluble insulin & 70% Isophane Insulin

Eli Lilly and Co., USA Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25

January 2023

POM

879 BRU13010993P FML® Liquifilm Sterile Opthalmic

Solution 0.1%

Fluorometholone 0.1%w/v Allergan Pharmaceuticals Ireland, Ireland Medipharm Sdn Bhd 26 January 2013 till 25

January 2018

POM

880 BRU13010994NP Lacri-Lube S.O.P. Lubricants Eye

Ointment

Liquid Paraffin (Mineral Oil) 42.5%w/w;

Soft White Paraffin (White Petrolatum)

56.8% w/w

Allergan Sales LLC, United States Medipharm Sdn Bhd 26 January 2013 till 25

January 2018

GSL

BDMCA/RMP/1116 Page 52 of 117

Page 53: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

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

Ireland

Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25

January 2018

POM

882 BRU13010996P Seretide Evohaler 25/125mcg Per actuation - Fluticasone propionate

125mcg; Salmetarol 25mcg (as xinafoate)

Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25

January 2018

POM

883 BRU13010997P Glucophage® Tablet 850mg Metformin HCl 850mg (~Metformin

662.9mg)

Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25

January 2018

POM

884 BRU13010998P Revlimid® Capsules 5mg Lenalidomide 5mg Penn Pharmaceutical Services Limited, UK

& Celgene International Sarl, Switzerland

Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25

January 2018

POM

885 BRU13010999NP Infusol® NS Sodium Chloride 0.9% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 January 2013 till 25

January 2018

GSL

886 BRU13011000P Inpanol Tablets 10mg Propranolol BP 10mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 26 January 2013 till 25

January 2018

POM

887 BRU13011001P Ciloxan Eyedrops Per ml - Ciprofloxacin HCl 3mg (as

Ciprofloxacin HCl monohydrate 3.5%)

S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 26 January 2013 till 25

January 2018

POM

888 BRU13011002P One-Alpha® Capsule 1mcg Alfacalcidol 1mcg (1α-Hydroxy-vitamin D3) Leo Pharmaceutical Products Ltd., A/S

(Leo Pharma), Denmark

Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25

January 2018

POM

889 BRU13011003P Nimotop Infusion Solution 0.02% Nimodipine 0.01g/50ml Bayer Schering Pharma AG, Leverkeusen,

Germany

Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25

January 2018

POM

890 BRU13011004P Gemzar 200mg Powder for

Solution for Infusion

Gemcitabine 200mg (as HCl) Eli Lilly and Company, Indiana, USA Zuellig Pharma (B) Sdn Bhd 26 January 2013 till 25

January 2018

POM

891 BRU13011005P ZyprexaTM 5mg Tablet Olanzapine 5mg Lilly del Caribe Inc., Puerto Rico, USA &

Lilly, S.A., Spain

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25

January 2023

POM

892 BRU13021006P Canesten GYN Vaginal Tablet

100mg - 3 day therapy

Clotrimazole 100mg Bayer Consumer AG, Basel, Switzerland Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25

February 2018

POM

893 BRU13021008P Prevenar 13 Suspension for

Injection

Per 0.5ml - Pneumococcal Polysaccharide

Serotype 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A,

19F, 23F - 2.2mcg; Pneumococcal

Polysaccharide Serotype 6B - 4.4mcg

Pfizer Ireland Pharmaceuticals, Dublin,

Ireland

Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25

February 2018

POM

894 BRU13021009P Hemabate Sterile Solution

250mcg/ml

Carboprost (as tromethamine) 250mcg/ml Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25

February 2018

POM

895 BRU13021010PS1;

BRU13021010PS2

Humulin® 30/70 Injection

100iu/ml (catridge)

Human Insulin 100IU/ml (recombinant) -

30% Soluble insulin & 70% Isophane Insulin

Eli Lilly and Company, Indiana, USA (S1);

Eli Lily Italia S.p.A., Sesto Fiorentino,

(FI) Italy (S2)

Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25

February 2023

GSL

896 BRU13021011P Extraneal Peritoneal Dialysis

Solution 75g/L

Per 100ml: Icodextrin 7.5g; Sodium

Chloride 538mg; Sodium Lactate 448mg;

Calcium Chloride 25.7mg; Magnesium

Chloride 5.08mg

Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 26 February 2013 till 25

February 2018

POM

897 BRU13021012P Afinitor Tablet 10mg Everolimus 10mg Novartis Pharma Stein AG, Stein,

Switzerland

Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25

February 2018

POM

BDMCA/RMP/1116 Page 53 of 117

Page 54: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

898 BRU13021013P Ketovid Cream 2% Ketoconazole 2.0% w/w Hovid Bhd, Perak, Malaysia G & H Trading Company 26 February 2013 till 25

February 2018

POM

899 BRU13021014P Progynova® Tablet 2mg Estradiol Valerate 2mg Delpharm Lille SAS, Lys Les Lannoy, Franc Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25

February 2018

POM

900 BRU13021015P Azopt Eye Drops, Suspension Brinzolamide 10mg/ml (1.0%w/w) S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 26 February 2013 till 25

February 2018

POM

901 BRU13021016P Rhewlin SR Tablet Diclofenac Sodium 100mg Beacons Pharmaceutical Pte Ltd,

Singapore

Hongkiat Trading & Co 26 February 2013 till 25

February 2018

POM

902 BRU13021017P Hydrogen Peroxide Solution 6% Hydrogen Peroxide 6% w/v (equivalent to

20 volumes of oxygen)

Xepa-Soul Pattinson (Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading & Co 26 February 2013 till 25

February 2018

P

903 BRU13021018P Inpanol Tablets 40mg Propranolol BP 40mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 26 February 2013 till 25

February 2018

POM

904 BRU13021019P Stilamin 3000 for Injection

3mg/ampoule

Somatostatin (as acetate) 3mg Merck Serono SA, Aubonne, Switzerland G&H Trading Company 26 February 2013 till 25

February 2018

POM

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

Darul Ehsan, Malaysia

Asterix United (B) Sdn Bhd 26 February 2013 till 25

February 2018

P

906 BRU13021021P Decozol Oral Gel 2% w/w Miconazole 2% w/w HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 26 February 2013 till 25

February 2018

GSL

907 BRU13021022P Rasitol Injection 20mg/2ml Furosemide 20mg/2ml Yung Shin Pharmaceutical Ind. Co. Ltd.,

Taiwan, ROC

Asterix United (B) Sdn Bhd 26 February 2013 till 25

February 2018

POM

908 BRU13021023P Fusate-250 Tablet Sodium fusidate 250mg Noripharma Sdn Bhd, Selangor Darul

Ehsan, Malaysia

K-Seri Pharma Sdn Bhd 26 February 2013 till 25

February 2018

POM

909 BRU13021024P Premarin Vaginal Cream Conjugated Oestrogen (CE) 0.625mg/g Pfizer Canada Inc., Canada Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25

February 2018

POM

910 BRU13021025NP Dhalgesic Rub 15% w/w Methyl salicylate 15% w/w; Menthol 5%

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

Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 26 February 2013 till 25

February 2018

GSL

911 BRU13021026P Kaletra Film-coated Tablet

200mg/50mg

Lopinavir 200mg; Ritonavir 50mg AbbVie Deutschland GmbH & Co. KG,

Germany

Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25

February 2018

POM

912 BRU13021027P Sustanon 250 Per 1ml - Testosterone decanoate 100mg;

Testosterone phenylpropionate 60mg;

Testosterone isocaproate 60mg;

Testosterone propionate 30mg [Equivalent

to Testosterone 176mg/ml]

Merck Sharp & Dohme, the Netherlands Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25

February 2018

POM

913 BRU13021028P Holoxan for Injection Ifosfamide 1g Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd 26 February 2013 till 25

February 2018

POM

914 BRU13031029NP Panadol Extend Tablet Paracetamol 665mg GlaxoSmithKline Australia Pty Ltd,

Australia

Kingston Beverage & Creamery

Sdn Bhd

28 March 2013 till 27 March

2018

P (8 x 6's)

915 BRU13031030P Canesten Cream 1% w/w Clotrimazole 1% w/w Encube Ethicals Private Ltd, India Zuellig Pharma (B) Sdn Bhd 28 March 2013 till 27 March

2018

GSL

916 BRU13031032P Pantaprazole Winthrop 20mg

Tablet

Pantoprazole (as sodium sesquihydrate)

20mg

Sanofi-Aventis S.P.Z.O.O., Poland Medipharm Sdn Bhd 28 March 2013 till 27 March

2018

POM

BDMCA/RMP/1116 Page 54 of 117

Page 55: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

917 BRU13031033PS1;

BRU13031033PS2

Metoclopramide Tablet 10mg Metoclopramide HCl BP (equivalent to

Metoclopramide HCl anhydrous 10mg)

Drug House of Australia Pte Ltd,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company 28 March 2013 till 27 March

2018

POM

918 BRU13031034P Loperamil Tablet 2mg Loperamide 2mg Drug House of Australia Pte Ltd,

Singapore

G & H Trading Company 28 March 2013 till 27 March

2018

POM

919 BRU13031035P Hydralazine Tablet 50mg Hydralazine HCl 50mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Co 28 March 2013 till 27 March

2018

POM

920 BRU13031036P Dhacort Cream 1%w/w Hydrocortisone acetate BP (micronised) 1%

w/w

Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 28 March 2013 till 27 March

2018

POM

921 BRU13031037P Tracidol Capsule 50mg Tramadol HCl 50mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 28 March 2013 till 27 March

2018

POM

922 BRU13031038P Solcoseryl Dental Adhesive Paste Per g - Solcoseryl CMC 2.125mg;

Polidocanol 10mg

Legacy Pharmaceuticals Switzreland

GmbH, Switzerland

Zuellig Pharma (B) Sdn Bhd 28 March 2013 till 27 March

2018

POM

923 BRU13031039NP Infusol® S3 Sodium Chloride 3% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 28 March 2013 till 27 March

2018

POM

924 BRU13031040P Indapamide SR Tablet 1.5mg Indapamide 1.5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 28 March 2013 till 27 March

2018

POM

925 BRU13031041P Dhatifen Syrup 1mg/5ml Ketotifen (as hydrogen fumarate) 1mg/5ml Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 28 March 2013 till 27 March

2018

POM

926 BRU13031042P Inox Capsule 100mg Itraconazole 100mg Hovid Bhd, Malaysia G & H Trading Company 28 March 2013 till 27 March

2018

POM

927 BRU13031043P Doxycap capsule 100mg Anhydrous Doxycycline 100mg Hovid Bhd, Malaysia G & H Trading Company 28 March 2013 till 27 March

2018

POM

928 BRU13031044P Zenmolin tablet 2mg Salbutamol (as sulphate) 2mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 28 March 2013 till 27 March

2018

POM

929 BRU13031045P Recormon Pre-filled Syringe

2000IU/0.3ml

Erythropoetin Beta 2,000iu/0.3ml Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 March 2013 till 27 March

2018

POM

930 BRU13031046P Leukeran Tablet 2mg Chlorambucil 2mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 March 2013 till 27 March

2018

POM

931 BRU13031047P Recormon Pre-filled Syringe

4000IU/0.3ml

Erythropoetin Beta 4,000iu/0.3ml Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 March 2013 till 27 March

2018

POM

932 BRU13031049P Saizen for Injection 3.33mg/vial Somatropin 3.33mg (10 IU) Merck Serono S.A., Switzerland G & H Trading Company 28 March 2013 till 27 March

2018

POM

933 BRU13031050P Isentress 400mg Tablet Raltegravir 400mg (as potassium 434.4mg) MSD Technology Singapore Pte Ltd.,

Singapore

Zuellig Pharma (B) Sdn Bhd 28 March 2013 till 27 March

2018

POM

934 BRU13041051P Taxotere 80mg/4ml Concentrate

for Solution for Infusion

Docetaxel trihydrate 80mg/4ml Sanofi-Aventis Deutschland GmbH,

Germany

Medipharm Sdn Bhd 30 April 2013 till 29 April

2018

POM

935 BRU13041052P Fosamax Plus Tablet

70mg/5600IU

Alendronic Acid 70mg (as Sodium

91.37mg); Colecalciferol 140mcg (5,600IU)

MSD Frosst Iberica, S.A., Madrid, Spain Zuellig Pharma (B) Sdn Bhd 30 April 2013 till 29 April

2018

POM

936 BRU13041053P Glucovance Tablet 500mg/2.5mg Metformin HCl 500mg, Glibenclamide

2.5mg

Merck Sante SAS, Semoy, France Zuellig Pharma (B) Sdn Bhd 30 April 2013 till 29 April

2018

POM

937 BRU13041054PS1 &

BRU13041054PS2

Rebif ® Pre-filled Syringe

22mcg/0.5ml

Interferon beta-1a 22mcg (6MIU) / 0.5ml Merck Serono S.p.A., Modugno, Italy (S1);

Merck Serono S.A., Aubonne, Switzerland

G & H Trading Company 30 April 2013 till 29 April

2018

POM

BDMCA/RMP/1116 Page 55 of 117

Page 56: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

938 BRU13041055P Alpranax Tablet 0.5mg Alprazolam 0.5mg Y.S.P Industries (M) Sdn Bhd Malaysia K-Seri Pharma Sdn Bhd 30 April 2013 till 29 April

2018

POM

939 BRU13041056NP Liquid Paraffin Liquid Paraffin 100%w/w Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 April 2013 till 29 April

2018

GSL

940 BRU13041057P Fucithalmic® Eye Drops 1% Fusidic acid 10mg/g (1.0%w/w) LEO Laboratories Ltd, Dublin, Ireland Zuellig Pharma (B) Sdn Bhd 30 April 2013 till 29 April

2018

POM

941 BRU13041058P Pegasys Pre-filled Syringe

180mcg/0.5ml

Peginterferon alfa-2a 180mcg/0.5ml F Hoffman-La Roche Ltd, Switzerland;

Roche Diagnostic GmbH, Germany; F

Hoffman-La Roche Ltd, Betriebsstandort

Kaiseraugst (Parenterals), Switzerland

Hongkiat Trading & Co 30 April 2013 till 29 April

2018

POM

942 BRU13041059P Borymycin Capsule 50mg Minocycline HCl 50mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 April 2013 till 29 April

2018

POM

943 BRU13041060P Kytril Tablet 1mg Granisetron 1mg (as HCl) Roche S.p.A., Italy Hongkiat Trading & Co 30 April 2013 till 29 April

2018

POM

944 BRU13041061P Venofer® Solution for Injection

100mg/5ml

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

complex] 100mg/5ml

IDT Biologika GmbH, Germany; BIPSO

GmbH, Germany

Hongkiat Trading & Co 30 April 2013 till 29 April

2018

POM

945 BRU13041062NP Calamine cream Calamine 4%w/w; Zinc Oxide 3% w/w Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 April 2013 till 29 April

2018

GSL

946 BRU13041063P Apuzin tablet 25mg Captopril 25mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 April 2013 till 29 April

2018

POM

947 BRU13041064P Lezpain film-coated tablet 135mg Mebeverine HCl 135mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 April 2013 till 29 April

2018

POM

948 BRU13041065P Copegus Tablet 200mg Ribavarin 200mg Hoffman-La Roche Inc., USA; Patheon Inc.,

Ontario, Canada

Hongkiat Trading & Co 30 April 2013 till 29 April

2018

POM

949 BRU13041066P Celexin 250 Film-coated Tablet Cephalexin 250mg (as monohydrate) Hovid Bhd, Malaysia K-Seri Pharma Sdn Bhd 30 April 2013 till 29 April

2018

POM

950 BRU13041067NP White Soft Paraffin White Soft Paraffin Sasaol Wax GmbH, Germany Hongkiat Trading & Co 30 April 2013 till 29 April

2018

GSL

951 BRU13041068NP Calamine Lotion 15% w/v Calamine 15%w/v Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 April 2013 till 29 April

2018

GSL

952 BRU13061069P Votrient™ Film-coated tablets

200mg

Pazopanib (as hydrochloride) 200mg Glaxo Operations UK Ltd, Hertfordshire,

UK

Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June

2018

POM

953 BRU13061070PS1;

BRU13061070PS2;

BRU13061070PS3

NovoMix® 30 FlexPen®

Suspension for Injection 100 U/ml

1ml contains 100u of Soluble Insulin aspart

30% and Protamine-crystallised Insulin

aspart 70%

Novo Nordisk Producao Farmaceutica do

Brasil Ltda., Brazil (S1); Novo Nordisk A/S,

Bagsværd, Denmark (S2); Novo Nordisk

Production SAS, France (S3)

Medipharm Sdn Bhd 04 June 2013 till 03 June

2018

POM

954 BRU13061071P Duphaston Tablet 10mg Dydrogesterone 10mg Abbott Biologicals B.V., The Netherlands Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June

2018

POM

BDMCA/RMP/1116 Page 56 of 117

Page 57: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

955 BRU13061072NP Nutravit™ Syrup Per 5ml - Riboflavine 1.46mg; Calcium

Pantothenate 3.25mg; Ascorbic Acid

17.5mg; Vitamin A 4000iu; Vitamin D

400iu; Nicotinamide 10.00mg; Lysine HCl/

Monochloride 100.00mg; Thiamine HCl/

Vit. B1 2.00mg; Cynocobalamine/ Vit B12

1.5mcg; Pyridoxine HCl/Vit B6 2.00mg

Hovid Bhd, Malaysia G & H Trading Company 04 June 2013 till 03 June

2018

GSL

956 BRU13061073P Prednisolone Tablet 20mg Prednisolone 20mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 04 June 2013 till 03 June

2018

POM

957 BRU13061074P Kytril For Infusion 3mg/3ml Granisetron 3mg (as HCl 3.36mg) Cenexi SAS, France Hongkiat Trading & Co 04 June 2013 till 03 June

2018

POM

958 BRU13061075P Minison Tablet 1mg Prazosin 1mg (as HCl 1.095mg) Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 04 June 2013 till 03 June

2018

POM

959 BRU13061076P Xeloda™ Tablets 500mg Capecatibine 500mg Productos Roche S.A. de C.V, Mexico Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June

2018

POM

960 BRU13061077P Chloramphenicol Eye Ointment Chloramphenicol 10mg/g KRKA d.d., Slovenia K-Seri Pharma Sdn Bhd 04 June 2013 till 03 June

2018

POM

961 BRU13061078NP Zentel Tablet 200mg Albendazole 200mg Tianjin SKF Labs Ltd, Tianjin, China Kingston Beverage & Creamery

Sdn Bhd

04 June 2013 till 03 June

2018

GSL (2's)

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

polymaltose complex] 10mg/ml

Vifor S.A., Switzerland & Vifor

(International) Inc., Switzerland

Medipharm Sdn Bhd 04 June 2013 till 03 June

2018

GSL

963 BRU13061080P Noriday® Tablet Norethisterone 0.35mg Piramal Healthcare UK Limited, United

Kingdom

Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June

2018

POM

964 BRU13061081P Keppra 250mg Film-coated Tablet Levetiracetam 250mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June

2018

POM

965 BRU13061082P Keppra 500mg Film-coated Tablet Levetiracetam 500mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June

2018

POM

966 BRU13061083PS1,

BRU13061083PS2,BRU13

061083PS3,

BRU13061083PS4

Avastin Concentrate For Solution

For Infusion 400mg/16ml

Bevacizumab 400mg/16ml Genentech Inc., USA (S1); F-Hoffman-La

Roche Ltd, Basel, Switzerland (S2); Roche

Diagnostics GmbH, Manheim, Germany

(S3); F Hoffmann-La Roche Ltd,

Kaiseraugst, Switzerland (S4)

Medicare 04 June 2013 till 03 June

2018

POM

967 BRU13061084P Xeloda Tablet 150mg Capecatibine 150mg Productos Roche S.A. de C.V, Mexico Zuellig Pharma (B) Sdn Bhd 04 June 2013 till 03 June

2018

POM

968 BRU13061085P Uripax Film-coated Tablet 200mg Flavoxate HCl 200mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 04 June 2013 till 03 June

2018

POM

969 BRU13061086P Atorvas Tablets 10mg Atorvastatin (as calcium) 10mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 04 June 2013 till 03 June

2018

POM

970 BRU13061087P Elonva Solution for Injection

150mcg/0.5ml

Corifollitrophin alfa 150mcg/0.5ml Vetter Pharma-Fertigung GmbH & Co. KG,

Germany

Zuellig Pharma (B) Sdn Bhd 27 June 2013 till 26 June

2018

POM

BDMCA/RMP/1116 Page 57 of 117

Page 58: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

971 BRU13061088P Maxitrol Eye Ointment Per g: Neomycin Sulfate 3,500 IU;

Polymyxin B Sulfate 6,000IU;

Dexamethasone 0.1%

S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 27 June 2013 till 26 June

2018

POM

972 BRU13061089P Maxidex® Eye Ointment Dexamethasone 0.1% w/w S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 27 June 2013 till 26 June

2018

POM

973 BRU13061090NP Ciproxol (Ciprofloxacin) 0.2% w/v

Intravenous Infusion BP

Ciprofloxacin 0.2% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 June 2013 till 26 June

2018

POM

974 BRU13061091NP Infusol® W Intravenous Infusion

BP

Water for Injection BP Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 June 2013 till 26 June

2018

GSL

975 BRU13061092P Isoket Ampoule 10mg/10ml Isosorbide Dinitrate 10mg/10ml (0.1%) EVER Pharma Jena GmbH, Germany Zuellig Pharma (B) Sdn Bhd 27 June 2013 till 26 June

2018

POM

976 BRU13061093P Invoril tablets 10mg Enalapril maleate 10mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 27 June 2013 till 26 June

2018

POM

977 BRU13061094P Pharmaniaga Simvastatin tablet

10mg

Simvastatin 10mg Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 27 June 2013 till 26 June

2018

POM

978 BRU13061095P Vitamin B1 Tablet Thiamine HCl 10mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 27 June 2013 till 26 June

2018

POM

979 BRU13061096P Invoril tablets 20mg Enalapril maleate 20mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 27 June 2013 till 26 June

2018

POM

980 BRU13061097P Seldron Cleaning Lotion Selenium Sulphide USP 2.5% w/v ICM Pharma Pte Ltd, Singapore Mc Quipp Technisell Marketing

Sdn Bhd

27 June 2013 till 26 June

2018

p

981 BRU13071098NP Cortal for Children Tablet Acetaminophen (Paracetamol) 80mg Sterling Drug (Malaya) Sdn Bhd, Malaysia Kingston Beverage & Creamery

Sdn Bhd

30 July 2013 till 29 July 2018 P 12

x 12's (144's)

982 BRU13071099P Champix 1mg film-coated tablet Varenicline Tartrate 1mg Pfizer Manufacturing Deutschland GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM

983 BRU13071100P Iodosorb Ointment Cardexomar Iodine (eq. to Iodine 0.9%) Perstorp Speciality Chemicals, Sweden Mc Quipp Technisell Marketing

Sdn Bhd

30 July 2013 till 29 July 2018 POM

984 BRU13071101P Glucophage XR 500mg Extended

Release Tablet

Metformin HCl 500mg Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM

985 BRU13071102P Victrelis Capsule 200mg Boceprevir 200mg Schering-Plough (Singapore) Pte Ltd,

Singapore

Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM

986 BRU13071103P Axcel Cefaclor-250 Capsule Cefaclor (as monohydrate) 250mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 July 2013 till 29 July 2018 POM

987 BRU13071104P Gonal-F Powder and Solvent for

Solution for Injection 75IU

(5.5mcg)/ vial

Follitrophin Alfa 75 IU ( 5.5mcg) Merck Serono S.p.A., Bari (MSB), Italy;

Merck Serono S.A. (MSA), Swizerland

G & H Trading Company 30 July 2013 till 29 July 2018 POM

988 BRU13071105P Lignocaine Injection 2% x 5ml Lignocaine Hydrochloride 20mg/ml Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM

989 BRU13071106P Pred Mild® Sterile Ophthalmic

Suspension 0.12%

Prednisolone acetate 0.12% w/v Allergen Pharmaceuticals Ireland,

Wesport, Ireland

Medipharm Sdn Bhd 30 July 2013 till 29 July 2018 POM

990 BRU13071107P Tamiflu Capsules 75mg Oseltamivir 75mg Cenexi SAS, France; Catalent Germany

Schorndorf GmbH, Germany; Roche

S.p.A., Italy

Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM

BDMCA/RMP/1116 Page 58 of 117

Page 59: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

991 BRU13071108P Revlimid® Capsules 25mg Lenalidomide 25mg Penn Pharmaceutical Services Limited, UK

& Celgene International Sarl, Switzerland

Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM

992 BRU13071109P Revlimid® Capsules 15mg Lenalidomide 15mg Penn Pharmaceutical Services Limited, UK

& Celgene International Sarl, Switzerland

Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM

993 BRU13071110P Solcoseryl Eye Gel Solcoseryl 120 Concentrate 8.3mg/g Legacy Pharmaceuticals Switzreland

GmbH, Switzerland

Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM

994 BRU13071111P Micosten-H Cream Miconazole Nitrate 2%; Hydrocortisone 1% Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd 30 July 2013 till 29 July 2018 POM

995 BRU13071112P Pharmaniaga Labetalol Tablet

100mg

Labetalol Hydrochloride 100mg Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 30 July 2013 till 29 July 2018 POM

996 BRU13071113P Hydralazine Tablet 10mg Hydralazine Hydrochloride 10mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 30 July 2013 till 29 July 2018 POM

997 BRU13071114P Sandimmun Neoral Capsule 25mg Ciclosporin A 25mg R.P. Scherer GmbH & Co. KG., Germany Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM

998 BRU13081115P Champix 0.5mg & 1mg Tablet Varenicline Tartrate 0.5mg & Varenicline

Tartrate 1mg

Pfizer Manufacturing Deutschland GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 27 August 2013 till 26 August

2018

POM

999 BRU13081116P Daktarin Oral Gel 2% Miconzaole 2% Janssen Pharmaceutical NV, Belgium Zuellig Pharma (B) Sdn Bhd 27 August 2013 till 26 August

2018

P

1000 BRU13081117P Dhasedyl DM Syrup Per 5ml - Dextromethorphan HBr 10mg;

Promethazine HCl 3.6mg/ Ephedrine HCl

6mg

Drug House of Australia (Asia) Pte Ltd,

Singapore

G & H Trading Company 27 August 2013 till 26 August

2018

POM

1001 BRU13081118P Daivonex® Cream Calcipotriol 50mcg/g (0.0005% w/w) LEO Laboratories Ltd (LEO Pharma),

Ireland

Zuellig Pharma (B) Sdn Bhd 27 August 2013 till 26 August

2018

POM

1002 BRU13081119PS1;

BRU13081119PS2

Zoral Cream Acyclovir USP 5% w/w Drug Houses of Australia Private Limited,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company 27 August 2013 till 26 August

2018

POM

1003 BRU13081120P Enbrel® 25mg solution for

injection in pre-filled syringe

Etanercept 25mg/0.5ml Pfizer Ireland Pharmaceuticals, Ireland Zuellig Pharma (B) Sdn Bhd 27 August 2013 till 26 August

2018

POM

1004 BRU13081121P Xenical Capsule 120mg Orlistat 120mg Roche SpA, Italy Zuellig Pharma (B) Sdn Bhd 27 August 2013 till 26 August

2018

POM

1005 BRU13081122P Requip® Tablet 1mg Ropinirole (as Hydrochloride) 1mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 27 August 2013 till 26 August

2018

POM

1006 BRU13081123P Minazol Powder 2% Miconzaole Nitrate 2% w/w Biosis Pharmaceuticals Sdn Bhd., Malaysia K-Seri Pharma Sdn Bhd 27 August 2013 till 26 August

2018

P

1007 BRU13081124P Heparinol 5000IU/ml Heparin Sodium (bovine) 5,000IU/ml Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 August 2013 till 26 August

2018

POM

1008 BRU13081125P Pharmaniaga Pyrazinamide

Tablet 500mg

Pyrazinamide 500mg Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 27 August 2013 till 26 August

2018

POM

1009 BRU13081126P Sathrocin ES Tablet 400mg Erythromycin (as ethylsuccinate) 400mg Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 27 August 2013 till 26 August

2018

POM

1010 BRU13081127P Ketovid Shampoo 2% w/v Ketoconazole (micronised) 2% w/w Hovid Bhd, Malaysia G & H Trading Company 27 August 2013 till 26 August

2018

POM

BDMCA/RMP/1116 Page 59 of 117

Page 60: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1011 BRU13081128P Maxitrol Eye Drops Per 1ml - Dexamethasone 0.1%; Neomycin

Sulphate 3,500IU; Polymyxin B Sulphate

6,000 IU

S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 27 August 2013 till 26 August

2018

POM

1012 BRU13091129P VentolinTM Syrup 2mg/5ml (T) Salbutamol Sulphate (as sulphate)

5mg/5ml

SmithKlineBeecham, Rizal, Philippines Zuellig Pharma (B) Sdn Bhd 28 September 2013 till 27

September 2018

POM

1013 BRU13091130P Erbitux® 5mg/ml Solution for

Infusion

Cetuximab 5mg/ml Boehringer Ingelheim, Germany & Merck

KGaA, Germany (1 Artwork)

Zuellig Pharma (B) Sdn Bhd 28 September 2013 till 27

September 2018

POM

1014 BRU13091132NP Beafort Syrup Each 5ml contains: Thiamine HCl 5mg;

Riboflavin 2.5mg; Pyridoxine HCl 2mg;

Cyanocobalamin 5mcg; Nicotinamide

20mg; Calcium Panthothenate 1.5mg

Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 28 September 2013 till 27

September 2018

GSL

1015 BRU13091133P Clexane 4000/0.4ml Anti XA Pre-

filled Syringe

Enoxaprin sodium 4,000 anti-Xa IU/0.4ml

equivalent to 40mg/0.4ml

Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 28 September 2013 till 27

September 2018

POM

1016 BRU13091134P Pantaprazole Winthrop 40mg

Tablet

Pantoprazole (as sodium Sesquihydate)

40mg

Sanofi-Aventis S.P.Z.O.O., Poland Medipharm Sdn Bhd 28 September 2013 till 27

September 2018

POM

1017 BRU13091135P Iodosorb Powder Cadexomer 99.1% w/w, with Iodine

0.9%w/w

Perstorp Speciality Chemicals AB, Sweden Mc Quipp Technisell Marketing

Sdn Bhd

28 September 2013 till 27

September 2018

P

1018 BRU13091136P Anlodin Tablet 10mg Amlodipine (as besylate) 10mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 28 September 2013 till 27

September 2018

POM

1019 BRU13091137P Effient Tablet 5mg Prasugrel HCl 5mg Eli Lilly & Co., USA Zuellig Pharma (B) Sdn Bhd 28 September 2013 till 27

September 2018

POM

1020 BRU13091138P Clexane 6000/0.6ml Anti-Xa IU

Pre-filled Syringe

Enoxaprin sodium 6,000 anti-Xa IU/0.6ml

equivalent to 60mg/0.6ml

Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 28 September 2013 till 27

September 2018

POM

1021 BRU13091139P Simvastatin Winthrop 40mg

Tablet

Simvastatin 40mg Sanofi Aventis S.p.z.o.o, Poland Medipharm Sdn Bhd 28 September 2013 till 27

September 2018

POM

1022 BRU13091140P Camazol Tablet 5mg Carbimazole 5mg Xepa-Soul Pattinson (M) Sdn Bhd

Malaysia

Hongkiat Trading & Co 28 September 2013 till 27

September 2018

POM

1023 BRU13091141P Pulin Injection 10mg/2ml Metoclopramide HCl 10mg/2ml Yung Shin Pharmaceutical Ind. Co. Ltd.,

Taiwan

Asterix United (B) Sdn Bhd 28 September 2013 till 27

September 2018

POM

1024 BRU13091142NP Sulbutiamine 200 capsule Sulbutiamine 200mg Pahang Pharmacy Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 28 September 2013 till 27

September 2018

GSL

1025 BRU13091143P VelcadeTM 3.5mg for Injection Bortezomib 3.5mg Pierre Fabree Medicament Productio

(PFMP), France & BSP Pharmaceuticals Srl

(BSP), Latina, Italy - (1 artwork)

Zuellig Pharma (B) Sdn Bhd 28 September 2013 till 27

September 2018

POM

1026 BRU13091144P Bezamidin Tablet 200mg Bezafibrate 200mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd 28 September 2013 till 27

September 2018

POM

1027 BRU13091145NP A-Bite Cream Crotamiton 10%w/w HOE Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 28 September 2013 till 27

September 2018

GSL

1028 BRU13091146P Tipidin Tablet 250mg Ticolopidine HCl BP 250mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 28 September 2013 till 27

September 2018

POM

1029 BRU13091147P Gynera Tablets Ethinylestradiol 0.03mg; Gestodene

0.075mg

Schering do Brasil Quimica e Farmaceutica

Ltda., Sao Paulo, Brazil

Zuellig Pharma (B) Sdn Bhd 28 September 2013 till 27

September 2018

POM

BDMCA/RMP/1116 Page 60 of 117

Page 61: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1030 BRU13101148P Eumovate™ Cream Clobetasone 17-butyrate 0.05% w/w Glaxo Wellcome Opration, UK Zuellig Pharma (B) Sdn Bhd 31 October 2013 till 31

October 2018

POM

1031 BRU13101149P Erycin Film Coated Tablet 250mg Erythromycin (as stearate) 250mg Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 31 October 2013 till 31

October 2018

POM

1032 BRU13101151NP ENO Fruit Salt Lemon Per 4.3g - Sodium Bicarbonate Coarse

1.468g (34.16%w/w); Sodium Bicarbonate

Fine 0.489g (11.39%w/w); Citric Acid

Anhydrous 1.853g (43.10%w/w); Sodium

Carbonate Anhydrous 0.43g (10.0%w/w)

Sterling Drug (Malaya) Sdn Bhd, Malaysia Kingston Beverage & Creamery

Sdn Bhd

31 October 2013 till 31

October 2018

GSL

1033 BRU13101152P Hycamtin™ Injection 1MG Topotecan (as HCl) 1mg GlaxoSmithKline Manufacturing S.p.A.,

Parma, Italy

Zuellig Pharma (B) Sdn Bhd 31 October 2013 till 31

October 2018

POM

1034 BRU13101153P Clexane 2000 anti-Xa IU/0.2ml

(Pre-filled Syringe for Injection)

Enoxaparin Sodium 2,000 anti-Xa IU/0.2ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 31 October 2013 till 31

October 2018

POM

1035 BRU13101154P Axcel Mefenamic Acid

Suspension

Mefenamic Acid 125mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 31 October 2013 till 31

October 2018

POM

1036 BRU13101155P Ovidrel Solution for Injection

250mcg/0.5ml in Pre-filled

Syringe

Choriogonadotropin alfa 250mcg/0.5ml Merck Serono S.p.A., Italy & Merck

Serono S.A., Switzerland

G & H Trading Company 31 October 2013 till 31

October 2018

POM

1037 BRU13101156P Sandimmun Neoral Capsule

100mg

Ciclosporin 100mg R.P Scherer GmbH & Co, Baden, Germany Zuellig Pharma (B) Sdn Bhd 31 October 2013 till 31

October 2018

POM

1038 BRU13101157P Tobrex Eye Ointment Tobramycin 0.3% (3mg/g) S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 31 October 2013 till 31

October 2018

POM

1039 BRU13101158P Endoxan Tablet 50mg Cyclophosphamide anhydrous (as

monohydrate) 50mg

Prasfarma S.L., Manlleu/Barcelona, Spain;

Haupt Pharma Amareg GmBH, Germany

Zuellig Pharma (B) Sdn Bhd 31 October 2013 till 31

October 2018

POM

1040 BRU13101159P CEF-4® Injection 500mg Ceftazidime (as pentahydrate) 500mg Siam Bheasach Co. Ltd., Bangkok,

Thailand

K-Seri Pharma Sdn Bhd 31 October 2013 till 31

October 2018

POM

1041 BRU13101160P Premarin Tablet 0.625mg Conjugated Estrogens 0.625mg Pfizer Ireland Pharmaceuticals, Kildare,

Ireland

Zuellig Pharma (B) Sdn Bhd 31 October 2013 till 31

October 2018

POM

1042 BRU13101161PS1;

BRU13101161PS2

Revlimid capsules 10mg Lenalidomide 10mg Penn Pharmaceutical Services, Gwent, UK

(S1) & Celgene International Sarl, Boudry,

Switzerlnd (S2)

Zuellig Pharma (B) Sdn Bhd 31 October 2013 till 31

October 2018

POM

1043 BRU13101162P Pharmaniaga Cephalexin

Suspension 125mg

Cephalexin (as anhydrous) 125mg/5ml Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 31 October 2013 till 31

October 2018

POM

1044 BRU13101163P Tolbutamide Tablets 500mg Tolbutamide 500mg Drug Houses Australia Pte Ltd., Singapore G & H Trading Company 31 October 2013 till 31

October 2018

POM

1045 BRU13101164P Isopto Homatropine 2% Sterile

Ophthalmic Solution (

Homatropine Hydrobromide 2%

(20.0mg/ml)

S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 31 October 2013 till 31

October 2018

POM

1046 BRU13101165NP Lactacyd Feminine Hygiene Liquid Per 100ml - Lactic Acid 1g; Atomised

Lactoserum (spray dried) 0.93g

Sanofi Synthelabo Vietnam, Ho Chi Minh

City, Viet Nam

Medipharm Sdn Bhd 31 October 2013 till 31

October 2018

GSL

BDMCA/RMP/1116 Page 61 of 117

Page 62: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1047 BRU13121166P SCMC Syrup 125mg/5ml S-Carboxymethyl-cysteine 125mg/5ml Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Co 02 December 2013 till 01

December 2018

P

1048 BRU13121167P Copastin Film Coated Tablets

10mg

Cloperastine Hydrochloride 10mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 02 December 2013 till 01

December 2018

P

1049 BRU13121168P Ucort Cream Per g – Urea 100mg; Hydrocortisone

acetate 10mg

Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 02 December 2013 till 01

December 2018

P

1050 BRU13121169P Pradaxa® Hard Capsules 150mg Dabigatran etexilate 150mg (as mesilate

172.95g)

Boehringer Ingelheim Pharma GmbH &Co,

Ingelheim am Rhein, Germany

Hongkiat Trading & Co 02 December 2013 till 01

December 2018

POM

1051 BRU13121170P Pradaxa® Hard Capsules 110mg Dabigatran etexilate 110mg (as mesilate

126.83g)

Boehringer Ingelheim Pharma GmbH &

Co., KG, Germany

Hongkiat Trading & Co 02 December 2013 till 01

December 2018

POM

1052 BRU13121171P Amoxicillin Capsule 250mg Amoxicillin Trihydrate 250mg Yung Shin Pharmaceutical Ind. Co. Ltd.,

Taiwan

Asterix United (B) Sdn Bhd 02 December 2013 till 01

December 2018

POM

1053 BRU13121172NP Dianeal Low Calcium (2.5mEq/L)

Peritoneal Dialysis Solution with

1.5% Dextrose

Each 100ml contains: Calcium Choloride

18.3mg; Dextrose hydrous 1.5g;

Magnesium Chloride 5.08mg; Sodium

Chloride 538mg; Sodium Lactate 448mg

Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 02 December 2013 till 01

December 2018

POM

1054 BRU13121173NP Refresh Tears Lubricant Eye

Drops 0.5%

Carboxymethylcellulose Sodium 0.5% w/v Allergan Sales LLC, USA Medipharm Sdn Bhd 02 December 2013 till 01

December 2018

GSL

1055 BRU13121174P Temodal Capsules 100mg Temozolomide 100mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 02 December 2013 till 01

December 2018

POM

1056 BRU13121176PS1 &

BRU13121176PS2

Dhasolone Tablet 5mg Prednisolone BP (micronized) 5mg Drug Houses of Australia Private Limited,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company 02 December 2013 till 01

December 2018

POM

1057 BRU13121177P Cyclogyl® 1% Sterile Ophthalmic

Solution (T)

Cyclopentolate Hydrochloride 1% S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 02 December 2013 till 01

December 2018

POM

1058 BRU13121178P Betawin Tablet 50mg (T) Metoprolol Tartrate 50mg Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Co 02 December 2013 till 01

December 2018

POM

1059 BRU13121179P Imigran FD Tablets 50mg Sumatriptan 50mg ( as succinate) Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29

December 2018

POM

1060 BRU13121180P Glucovance Tablet 500mg/5mg Metformin HCl 500mg; Glibenclamide 5mg Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29

December 2018

POM

1061 BRU13121181P Priorix-Tetra Powder and Diluent

for Solution for Injection

Composition of Priorix™ per dose (0.5ml):

Live attenuated measles virus (Schwarz

strain) ≥103.0 CCID50, Live attenuated

mumps virus (RIT4385 strain) ≥103.7

CCID50,

Live attenuated rubella virus (Wistar RA

27/3 strain) ≥103.0

CCID50, Live attenuated

Varicella Virus (OKA strain) ≥103.3 PFU

Glaxosmithkline Biologicals S.A., Belgium Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29

December 2018

POM

1062 BRU13121182P Hycamtin Injection 4mg Topotecan (as Hydrochloride) 4mg GlaxoSmithKline Manufacturing S.p.A.,

Italy

Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29

December 2018

POM

BDMCA/RMP/1116 Page 62 of 117

Page 63: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1063 BRU13121183P Anarex Tablets Paracetamol 450mg; Orphenadrine citrate

35mg

Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 December 2013 till 29

December 2018

POM

1064 BRU13121184P Atarax Film-Coated Tablet 25mg Hydroxyzine Hydrochloride 25mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29

December 2018

POM

1065 BRU13121185PS1;

BRU13121185PS2

Propylthiouracil Tablets 50mg Propylthiouracil 50mg Drug Houses of Australia Pte Ltd.,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company 30 December 2013 till 29

December 2018

POM

1066 BRU13121186P Xyzal Oral Drops 5mg/ml Per mL - Levocetitrizine Hydrochloride 5mg Aesica Pharmaceuticals S.r.L Pianezza,

Italy

Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29

December 2018

POM

1067 BRU13121187NP 10% Glucose Intravenous Infusion

B.P.

Glucose monohydrate (as equiv. to

anhydrous glucose) 10%

B Braun Industries Sdn Bhd, Malaysia Hongkiat Trading & Co 30 December 2013 till 29

December 2018

POM

1068 BRU13121188P Daivonex Scalp Solution

50mcg/ml

Calcipotriol 50mcg/ml Leo Pharmaceutical Products Ltd., A/S

(Leo Pharma), Denmark

Zuellig Pharma (B) Sdn Bhd 30 December 2013 till 29

December 2018

POM

1069 BRU13121189P Heparinised Saline Injection

10iu/ml (5ml)

Heparin Sodium (Bovine Mucosa) 10i.u./ml B Braun Industries Sdn Bhd, Malaysia Hongkiat Trading & Co 30 December 2013 till 29

December 2018

POM

1070 BRU13121190P Rescuvolin Tablet 15mg Calcium Folinate (equiv. to Folinic Acid)

15mg

Teva Pharmaceutical Works Pte Ltd Co.,

Debrecen Site, Hungary

K-Seri Pharma Sdn Bhd 30 December 2013 till 29

December 2018

POM

1071 BRU13121191P Quinax Sterile Ophthalmic

Solution

Sodium Dihydroazapentacene

Polysulfonate 0.15mg/ml

S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 30 December 2013 till 29

December 2018

POM

1072 BRU13121192P Nutriflex Lipid Peri Emulsion for

Infusion

1 unit consists of Amino Acid Solution;

Glucose Solution; Lipid Emulsion (For

Detailed Formulation referred to Dossier)

B Braun Industries Sdn Bhd, Malaysia Hongkiat Trading & Co 30 December 2013 till 29

December 2018

POM

1073 BRU14011193PS1 &

BRU14011193PS2

Alimta 500mg Powder for

Solution for Infusion

Pemetrexed (as Pemetrexed disodium)

500mg/vial

Eli Lilly and Company, USA (S1); Lilly

France, France (S2)

Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27

January 2019

POM

1074 BRU14011194P Gemzar 1G Powder for Solution

for Infusion

Gemcitabine 1000mg (as gemcitabine

hydrochloride)

Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27

January 2019

POM

1075 BRU14011195P Imigran FD Tablets 100mg Sumatriptan 100mg (as the succinate) GlaxoSmithKline Pharmaceuticals SA,

Poland

Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27

January 2019

POM

1076 BRU14011196P Largo Tablets 100mg Chlorpromazine HCl 100mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 28 January 2014 till 27

January 2019

POM

1077 BRU14011197NP Axcel Eviline Forte Suspension Each 5ml contains: Magnesium Hydroxide

400mg, Aluminium Hydroxide 400mg and

Simethicone 40mg

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd, Malaysia 28 January 2014 till 27

January 2019

GSL

1078 BRU14011198NP Bepanthen® First Aid Cream Dexpanthenol 5%w/w; Chlorhexidine

hydrochloride 0.5% w/w

GP Grenzach Produktions GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27

January 2019

GSL

1079 BRU14011199NP Dextrose 5% and Sodium Chloride

0.9% Injection USP

Dextrose 5%; Sodium Chloride 0.9% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27

January 2019

POM

1080 BRU14011200NP Macgel® Tablet Magnesium Hydroxide 200mg; Aluminium

Hydroxide Gel Dried 200mg;

Dimethylpolysiloxane 25mg

Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 28 January 2014 till 27

January 2019

GSL

1081 BRU14011201P Prefrin Liquifilm Eye Drops 0.12% Phenylephrine Hydrochloride 0.12% Allergan Sales, LLC., USA MediPharm Sdn Bhd 28 January 2014 till 27

January 2019

P

BDMCA/RMP/1116 Page 63 of 117

Page 64: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1082 BRU14011202NP Refresh Liquigel Lubricant Eye

Drops 1%

Carboxymethylcellulose Sodium 1% w/v Allergan Sales, LLC., USA MediPharm Sdn Bhd 28 January 2014 till 27

January 2019

GSL

1083 BRU14011203P Betaserc 24mg Tablet Betahistine dihydrochloride 24mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27

January 2019

POM

1084 BRU14011204PS1;

BRU14011204PS2

Humalog Mix50 100 units/ml

Kwikpen

Insulin Lispro * 100U/ml (equivalent to

3.5mg) * in the proportion of 50% insulin

lispro solution and 50% insulin lispro

protamine suspension (rDNA origin)

Lilly France S.A.S., France (S1); Eli Lilly

Italia S.p.A., Sesto Fiorentino, (FI) Italy

(S2) (repacker -

Eli Lilly And Company, USA) & Eli Lilly Italia

S.p.A., Sesto Fiorentino, (FI) Italy;

Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27

January 2019

POM

1085 BRU14011205NP Panamol Tablet 500mg Paracetamol 500mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 28 January 2014 till 27

January 2019

GSL

1086 BRU14011206P Seretide™ Evohaler™ 25/50mcg Fluticasone propionate 50mcg; Salmeterol

(as xinafoate) 25mcg

Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27

January 2019

POM

1087 BRU14011207PS1;

BRU14011207PS2

Tobrex® Eye Drops Solution Tobramycin 0.3% (3mg/ml) S.A. Alcon-Couvreur N.V., Belgium (S1);

Alcon Singapore Manufacturing Pte Ltd,

Singapore (S2)

Hongkiat Trading & Company 28 January 2014 till 27

January 2019

POM

1088 BRU14011208P PNEUMOVAX 23 Pneumococcal Polysaccharide Danish

Types 1,2,3,4,5,6B, 7F,8,9N,9V, 10A, 11A,

12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F,

23F, 33F. Each 0.5ml dose contains 25µg of

each polysaccharide type

Merck Sharp & Dohme Corp, USA Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27

January 2019

POM

1089 BRU14011209P NEUPOGEN PRE-FILLED SYRINGE

30MU/0.5ML

Filgrastim 30mu/0.5ml F.Hoffmann-La Roche Ltd, Kaiseraugst

Switzerland

Medipharm Sdn Bhd 28 January 2014 till 27

January 2019

POM

1090 BRU14011210P Axcel Famotidine-20 Capsule Famotidine 20mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd, Malaysia 28 January 2014 till 27

January 2019

POM

1091 BRU14011211NPS1;

BRU14011207PS2

Tears Naturale II Eye Drops

Solution

Dextran 70 0.1% (1mg/ml); Hypromellose

0.3% (3mg/ml)

S.A. Alcon-Couvreur N.V., Belgium (S1);

Alcon Singapore Manufacturing Pte Ltd,

Singapore (S2)

Hongkiat Trading & Company 28 January 2014 till 27

January 2019

GSL

1092 BRU14011212P Axcel Chlorpheniramine-4 Syrup Chlorpheniramine Maleate 4mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd, Malaysia 28 January 2014 till 27

January 2019

P

1093 BRU14011213P Imojev Japanese Encephalitis

vaccine (live, attenuated) MD

Live, attenuated, recombinant Japanese

Encephalitis virus 4.0 - 5.8 log PFU*/dose

(0.5ml) *Plaque Forming Unit

Government Pharmaceutical Organization

- Meriux Biological Products Co., Ltd.,

Thailand

Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27

January 2019

POM

1094 BRU14021214P Panaflex Extra Gel Diclofenac Sodium 10mg/1gm United Biomedical Inc., Asia, Taiwan Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

P

1095 BRU14021215P Havrix 1440 Vaccine Inactivated Hepatitis A virus antigen (HAV),

HM175 strain 1440 ELISA Units (EL.U.)/ml

GlaxoSmithKline Biologicals SA, Rixensart

Belgium; GlaxoSmithKline Biologicals S.A.,

Wavre Belgium

Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

BDMCA/RMP/1116 Page 64 of 117

Page 65: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1096 BRU14021216P Co-Plavix® 75/100 film-coated

tablets

Clopidogrel (as hydrogen sulphate) 75mg;

Acetylsalicylic acid 100mg

Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 27 February 2014 till 26

February 2019

POM

1097 BRU14021217P VotrientTM Film-coated tablets

400mg

Pazopanib (as hydrochloride) 400mg Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

1098 BRU14021218P Motilium tablets 10mg Domperidone 10mg Janssen Pharmaceutica NV, Belgium Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

1099 BRU14021219PS1;

BRU14021219PS2;

BRU14021219PS3

Novorapid® Flexpen® 100IU/ml 1ml of solution contains 100U insulin

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

Novo Nordisk Producao Farmaceutica do

Brasil Ltda., Brazil (S1); Novo Nordisk A/S,

Denmark (S2); Novo Nordisk Production

SAS, France (S3)

Medipharm Sdn Bhd 27 February 2014 till 26

February 2019

POM

1100 BRU14021220P Omelon Enteric

Microencapsulated capsule 20mg

Omeprazole 20mg Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

1101 BRU14021221NP Lactacyd® liquid Lactic acid (1g/100ml) and atomized

lactoserum (0.9g/100ml)

Sanofi Synthelabo Vietnam, Ho Chi Minh

City, Viet Nam

Medipharm Sdn Bhd 27 February 2014 till 26

February 2019

GSL

1102 BRU14021222P Invega® Sustenna Prolonged

Release Suspension for

Intramuscular Injection

25mg/0.25ml

0.25ml of solution contains Paliperidone

(as palmitate 39mg) 25mg

Janssen Pharmaceutica NV, Belgium Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

1103 BRU14021223P Invega® Sustenna Prolonged

Release Suspension for

Intramuscular Injection

50mg/0.5ml

0.5ml of solution contains Paliperidone (as

palmitate 78mg) 50mg

Janssen Pharmaceutica NV, Belgium Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

1104 BRU14021224P Invega® Sustenna Prolonged

Release Suspension for

Intramuscular Injection

75mg/0.75ml

0.75ml of solution contains Paliperidone

(as palmitate 117mg) 75mg

Janssen Pharmaceutica NV, Belgium Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

1105 BRU14021225P Invega® Sustenna Prolonged

Release Suspension for

Intramuscular Injection

100mg/1.0ml

1.0ml of solution contains Paliperidone (as

palmitate 156mg) 100mg

Janssen Pharmaceutica NV, Belgium Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

BDMCA/RMP/1116 Page 65 of 117

Page 66: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1106 BRU14021226P Simvastatin Winthrop 20mg

tablet

Simvastatin 20mg Sanofi-Aventis S.P.Z.O.O., Poland Medipharm Sdn Bhd 27 February 2014 till 26

February 2019

POM

1107 BRU14021227P LumiganTM (Bitamoprost

Ophthalmic Solution) 0.03%

Bimatoprost 0.03% w/v Allergan Sales, LLC, USA Medipharm Sdn Bhd 27 February 2014 till 26

February 2019

POM

1108 BRU14021228NP Refresh Plus Lubricating Eye

Drops 0.5%

Carboxymethylcellulose Sodium 0.5% Allergan Sales, LLC, USA Medipharm Sdn Bhd 27 February 2014 till 26

February 2019

POM

1109 BRU14021229P NovoSeven® Powder and Solvent

for Solution for Injection 2mg

Eptacog Alfa (Activated) 2mg/vial

(corresponds to 100 KIU/vial), 1mg/ml

after reconstitution.

1 KIU equals 1000 IU (International Units)

eptacog alfa (activated) is recombinant

coagulation factor VIIa (rFVIIa) with a

molecular mass of approximately 50,000

Dalton produced in baby hamster kidney

cells (BHK Cells) by recombinant DNA

technology.

Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 27 February 2014 till 26

February 2019

POM

1110 BRU14021230NP Axcel Eviline Tablet Aluminium Hydroxide 200mg, Magnesium

Hydroxide 200mg, Simethicone 20mg

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26

February 2019

GSL

1111 BRU14021231P Axcel Loratadine syrup Loratadine 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26

February 2019

P

1112 BRU14021232P Cymbalta Capsule 30mg Duloxetine (as hydrochloride) 30mg Eli Lilly and Company, Indiana, USA; Lilly

del Caribe, Inc., Puerto Rico

Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

1113 BRU14021233P TykerbTM tablets 250mg Lapatinib 250mg (as ditosylate

monohydrate)

Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

1114 BRU14021234P Axcel Mefenamic Acid Capsules Mefenamic acid 250mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26

February 2019

POM

1115 BRU14021235P Dostinex tablet 0.5mg Cabergoline 0.5mg Pfizer Italia S.r.I, Italy Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

1116 BRU14021236NP Lactated Ringer’s Injection USP4 Sodium Chloride 6g/L; Sodium Lactate

3.1g/L; Potassium Chloride 0.3g/L; Calcium

Chloride 0.2g/L

Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

GSL

BDMCA/RMP/1116 Page 66 of 117

Page 67: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1117 BRU14021237P Imuran 50mg tablet Azathioprine 50mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

1118 BRU14021238NP Axcel Dicyclomine-S Syrup Per 5mL: Dicyclomine hydrochloride 5mg

and Simethicone 50mg

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26

February 2019

GSL

1119 BRU14021239P Humulin R Injection 100IU/ml Regular Human Insulin (recombinant DNA

origin) Biosynthetic

Eli Lilly an Company, USA Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

1120 BRU14021240NP 5% Dextrose and 0.45% Sodium

Chloride Injection, USP

Dextrose 5%; Sodium Chloride 0.45% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

GSL

1121 BRU14021241P Giona Easyhaler 200mcg/dose

Inhalation Powder

Budesonide 200mcg Orion Corporation, Finland Hongkiat Trading & Co 27 February 2014 till 26

February 2019

POM

1122 BRU14021242P Amoxicillin Capsule 500mg Amoxicillin Trihydrate 500mg Yung Shin Pharmaceutical Ind. Co., Taiwan Asterix United (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

1123 BRU14021243NP Neurobion tablet thiamine disulfide 100mg; Pyridoxine

hydroxide 200mg & Cyanocobalamin

200mcg

Merck KGaA & Co, Austria Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

P

1124 BRU14021244P Omeprazole for Injection

(Lyophilised) 40mg/vial

Omeprazole 40mg/vial Gland Pharma Limited, India K-Seri Pharma Sdn Bhd 27 February 2014 till 26

February 2019

POM

1125 BRU14021245P Keppra Concentrate for solution

for (infusion) / intravenous

Levetiracetam 500mg/5ml Patheon Italia S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

1126 BRU14021246P Imojev Japanese Encephalitis

Vaccine (live, attenuated)

Live, attenuated, recombinant Japanese

Encephalitis virus 4.0 - 5.8 log PFU*/ dose

(0.5ml) * Plaque Forming Unit

Government Pharmaceutical organization-

Meriux Biological Products Co., Ltd.,

Thailand

Zuellig Pharma (B) Sdn Bhd 27 February 2014 till 26

February 2019

POM

1127 BRU14021247P Pradaxa® Hard Capsules 75mg Dabigatran etexilate 75mg (as mesilate

86.48mg)

Boehringer Ingelheim Pharma GmbH &

Co., KG, Germany

Hongkiat Trading & Co 27 February 2014 till 26

February 2019

POM

1128 BRU14021248P Axcel Flemin Expectorant Diphenhydramine HCl 12.5mg/5ml;

Ammonium Chloride 130mg/5ml

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26

February 2019

POM

1129 BRU14031249P Tygacil 50mg Lyophilised Powder

for Intravenous Infusion

Tigecycline 50mg Wyeth Lederle S.r.L, Italy Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1130 BRU14031250PS1;BRU14

031250PS2

Levemir Flexpen 100IU/ml Insulin Detemir 100U/ml (equivalent to

14.2mg

Novo Nordisk A/S, Denmark (S1); Novo

Nordisk Producao Farmaceutica do Brasil

Ltda., Brazil (S2)

MediPharm Sdn Bhd 27 March 2014 till 26 March

2019

POM

1131 BRU14031251P Stalevo 75/18.75/200mg Film-

coated Tablet

Levodopa 75mg; Carbidopa 18.75mg;

Entacapone 200mg

Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1132 BRU14031252P Stalevo 200/50/200mg Film-

coated Tablet

Levodopa 200mg; Carbidopa 50mg;

Entacapone 200mg

Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1133 BRU14031253P Humulin N Injection 100iu/vial Insulin (Human) Isophane 100iu/ml Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

BDMCA/RMP/1116 Page 67 of 117

Page 68: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1134 BRU14031254NP Nutrineal PD-4 with 1.1% Amino

Acid Solution

Each 1000ml contains L-Serine 0.510g; L-

Isoleucine 0.850g; L-Leucine 1.020g; L-

Lysine (as Hydrochloride) 0.955g; L-

Methionine 0.850g; L-Phenylalanine

0.570g; L-Threonine 0.646g; L-Tryptophan

0.270g; L-Valine 1.393g; L-Alanine 0.951g; L-

Arginine 1.071g; Glycine 0.510g; L-Histidine

0.714g; L-Proline 0.595g; L-Tyrosine 0.300g;

Sodium Chloride 5.380g; Calcium Chloride

Dihydrate 0.184g; Magnesium Chloride

Hexahydrate 0.051g; Sodium Lactate 4.48g

Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 27 March 2014 till 26 March

2019

POM

1135 BRU14031255P Effient™ Tablet 10mg Prasugrel (as hydrochloride) 10mg Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1136 BRU14031256P Gonal-F 300IU/0.5ml solution for

injection in a pre-filled pen

Each pen (0.5ml) contains 300IU follitropin

alfa (eq. to 22 micrograms)

Merck Serono S.p.A, Italy G&H Trading Company 27 March 2014 till 26 March

2019

POM

BDMCA/RMP/1116 Page 68 of 117

Page 69: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1137 BRU14031257P Gonal-F 900IU/1.5ml Solution for

Injection in a pre-filled pen

Each pen (1.5ml) contains 900IU follitropin

alfa (eq. to 66 micrograms). Each ml of

solution contains 600IU follitropin alfa

(equivalent to 44 micrograms)

Merck Serono S.p.A, Italy G&H Trading Company 27 March 2014 till 26 March

2019

POM

1138 BRU14031258P Volibris 5mg Film-coated Tablet Ambrisentan 5mg Patheon Inc., Ontario, USA Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1139 BRU14031259P Volibris 10mg Film-coated Tablet Ambrisentan 10mg Patheon Inc., Ontario, USA Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1140 BRU14031260P Atarax™ Syrup 2mg/ml Hydroxyzine hydrochloride 2mg/ml NextPharma SAS, France Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1141 BRU14031261P Prograf Capsule 1mg Tacrolimus 1mg Astellas Ireland Ltd, Ireland Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1142 BRU14031262P Loperamil Syrup 1mg/5ml Loperamide HCl 1mg/5ml Drug Houses of Australia Pte Ltd,

Singapore

G&H Trading Company 27 March 2014 till 26 March

2019

POM

1143 BRU14031263P Patanol® Eye Drops, Solution

0.1%

Olopatadine (as HCl) 0.1% S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Company 27 March 2014 till 26 March

2019

POM

1144 BRU14031264PS1;

BRU14031264PS2

Travatan® Eye Drops 40mcg/ml Travoprost 40mcg/ml S.A. Alcon-Couvreur N.V., Belgium (S1);

Alcon Singapore Manufacturing Pte Ltd,

Singapore (S2)

Hongkiat Trading & Company 27 March 2014 till 26 March

2019

POM

1145 BRU14031265P Chlorpheniramine tablet 4mg Chlorpheniramine Maleate 4mg Drug Houses of Australia Pte Ltd,

Singapore

G&H Trading Company 27 March 2014 till 26 March

2019

POM

1146 BRU14031266P Allertyn Tablet 10mg Loratadine (micronized) 10mg Drug Houses of Australia Pte Ltd,

Singapore

G&H Trading Company 27 March 2014 till 26 March

2019

P

1147 BRU14031267P Motilium Suspension 1mg/ml Domperidone 1mg/ml Janssen Pharmaceutica NV, Belgium Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1148 BRU14031268P Elonva Solution for Injection

100mcg/0.5ml

Corifollitropin alfa 100mcg/0.5ml Vetter Pharma-Fertigung GmbH & Co. KG,

Germany

Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

BDMCA/RMP/1116 Page 69 of 117

Page 70: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1149 BRU14031269P Menveo Powder & Solution for

Solution for Injection

One dose (0.5ml of the reconstituted

vaccine) contains:

Originally contained in the powder:

Meninggococcal group A oligosaccharide

10micrograms

(Conjugated to Corynebacterium

diphtheria CRM197 protein 16.7 to 33.3

micrograms)

Originally contained in the solution:

Meninggococcal group C oligosaccharide

5micrograms

(Conjugated to Corynebacterium

diphtheria CRM197 protein…..7.1 to 12.5

micrograms); Meninggococcal group W135

oligosaccharide 5micrograms

(Conjugated to Corynebacterium

diphtheria CRM197 protein 3.3 to 8.3

micrograms); Meninggococcal group Y

oligosaccharide 5micrograms

(Conjugated to Corynebacterium

diphtheria CRM197 protein….5.6 to 10.0.

micrograms)

Novartis Vaccines and Diagnostics GmbH,

Germany; Novartis Vaccines and

Diagnostics S.r.I, Italy

Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1150 BRU14031270P Enbrel® 50mg solution for

Injection in a pre-filled syringe

Etanercept 50.0mg/1.0ml Pfizer Ireland Pharmaceuticals, Ireland Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1151 BRU14031271P Betnovate-N Cream Betamethasone (as betamethasone 17-

valerate BP) 0.1% w/w and Neomycin

sulphate BP 0.5% w/w

Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1152 BRU14031272P Seretide Evohaler dose-counter

25/250mcg

Salmeterol 25mcg (as the xinafoate) and

Fluticasone Propionate 250mcg

Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1153 BRU14031273PS1;

BRU14031273PS2

Galvus Met 50/500mg Film-

coated Tablet

Vildagliptin 50mg; Metformin HCl

500mg(corresponding to 390mg

Metformin)

Novartis Pharma Stein AG, Switzerland

(S1); Novartis Pharma Produktions GmbH,

Germany (S2)

Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1154 BRU14031274PS1;

BRU14031274PS2

Galvus Met 50/1000mg Film-

coated Tablet

Vildagliptin 50mg; Metformin HCl

1000mg(corresponding to 780mg

Metformin)

Novartis Pharma Stein AG, Switzerland

(S1); Novartis Pharma Produktions GmbH,

Germany (S2)

Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1155 BRU14031275PS1;

BRU14031275PS2

Galvus Met 50/850mg Film-

coated Tablet

Vildagliptin 50mg; Metformin HCl

850mg(corresponding to 660mg

Metformin)

Novartis Pharma Stein AG, Switzerland

(S1); Novartis Pharma Produktions GmbH,

Germany (S2)

Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1156 BRU14031276P Galvus 50mg Tablet Vildagliptin 50mg Novartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

BDMCA/RMP/1116 Page 70 of 117

Page 71: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1157 BRU14031277P Duac Once Daily Gel Clindamycin 1% w/w (as Clindamycin

phosphate); Benzoyl Peroxide 5% w/w (as

hydrous Benzoyl Peroxide)

Glaxo Wellcome UK Operations, UK Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1158 BRU14031278P Conazole Cream Miconazole nitrate 2.0% w/w;

Betamethasone 0.1% w/w (as valerate);

Gentamicin (as sulphate) 0.1% w/w

Drug Houses of Australia Pte Ltd,

Singapore

G&H Trading Company 27 March 2014 till 26 March

2019

POM

1159 BRU14031279NP Axcel Paracetamol-250 Syrup

(Orange)

Paracetamol 250mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 March 2014 till 26 March

2019

GSL

1160 BRU14031280P Lamictal Dispersible/Chewable

Tablet 25mg

Lamotrigine 25mg GlaxoSmithKline Pharmaceutical SA,

Poland

Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1161 BRU14031281P Panaco Tablets Paracetamol 500mg; Codeine Phosphate

9mg

Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 27 March 2014 till 26 March

2019

POM

1162 BRU14031282P Voren Injection ‘Yung Shin’

(Diclofenac)

Diclofenac Sodium 75mg/3ml Yung Shin Pharmaceutical Ind, Taiwan,

R.O.C.

Asterix United (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1163 BRU14031283P Dhasolone Syrup 3mg/5ml Prednisolone 3mg/5ml Drug Houses of Australia Pte Ltd,

Singapore

G&H Trading Company 27 March 2014 till 26 March

2019

POM

1164 BRU14031284P Xalatan Eyedrops Latanoprost 0.005% w/v Pfizer Manufacturing Belgium NV,

Belgium

Zuellig Pharma (B) Sdn Bhd 27 March 2014 till 26 March

2019

POM

1165 BRU14041285P Giona Easyhaler® 100mcg/dose

Inhalation Powder

Budesonide 100mcg/dose Orion Corporation, Finland Hongkiat Trading & Company 26 April 2014 till 25 April

2019

POM

1166 BRU14041286P Axcel Nasatab Tablet Paracetamol 500mg; Chlorpheniramine

Maleate 4mg; Pseudoephedrine HCl 60mg

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 26 April 2014 till 25 April

2019

P (10 x 10's)

1167 BRU14041287P XareltoTM Film-coated tablet

15mg

Rivaroxaban 15mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April

2019

POM

1168 BRU14041288P XareltoTM Film-coated tablet

20mg

Rivaroxaban 20mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April

2019

POM

1169 BRU14041289P Metformin 500 Tablet 500mg Metformin HCl BP 500mg Drug Houses of Australia Pte Ltd,

Singapore

G&H Trading Company 26 April 2014 till 25 April

2019

POM

1170 BRU14041290NP Liquifilm TearsTM Ocular Lubricant

1.4%

Polyvinyl Alcohol 1.4% Allergan Pharmaceuticals Ireland, Ireland Medipharm Sdn Bhd 26 April 2014 till 25 April

2019

GSL

1171 BRU14041291NP Sodium Chloride Injection USP

0.9% in Mini-Bag Plus Container

Sodium Chloride 0.9% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April

2019

GSL

1172 BRU14041292PS1&

BRU14041292PS2

Rasilez® Film-coated Tablet

300mg

Aliskiren (as hemifumarate) 300mg Novartis Pharma Stein AG, Switzerland

(S1); Novartis Farma S.p.A., Italy (S2)

Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April

2019

POM

1173 BRU14041293P Endoxan® Injection 200mg/vial Cyclophosphamide monohydrate 213.8mg

(eq. to anhydrous Cyclophosphamide

200mg)

Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April

2019

POM

BDMCA/RMP/1116 Page 71 of 117

Page 72: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1174 BRU14041294P Certican Tablet 0.25mg Everolimus 0.25mg Novartis Pharma Stein, AG, Switzerland Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April

2019

POM

1175 BRU14041295P Certican Tablet 0.75mg Everolimus 0.75mg Novartis Pharma Stein, AG, Switzerland Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April

2019

POM

1176 BRU14041296P Shincort IM Injection “Yung Shin”

5ml vial

Triamcinolone acetonide 40mg/ml Yung Shin Pharmaceutical Ind. Co. Ltd.,

Taiwan, R.O.C.

Asterix United (B) Sdn Bhd 26 April 2014 till 25 April

2019

POM

1177 BRU14041297PS1;

BRU14041297PS2

DuoTrav Eye Drops, Solution Travoprost 40mcg/ml; Timolol 5mg/ml (as

timolol maleate)

S.A. Alcon-Couvreur N.V., Belgium (S1);

Alcon Singapore Manufacturing Pte Ltd,

Singapore (S2)

Hongkiat Trading & Company 26 April 2014 till 25 April

2019

POM

1178 BRU14041298P Chlormine Syrup 4mg/5ml Chlorpheniramine Maleate 4mg/5ml Drug Houses of Australia Pte Ltd,

Singapore

G&H Trading Company 26 April 2014 till 25 April

2019

P

1179 BRU14041299P Hypernol 100 Tablets 100mg Atenolol 100mg Drug Houses of Australia Pte Ltd,

Singapore

G&H Trading Company 26 April 2014 till 25 April

2019

POM

1180 BRU14041300P Hypernol Tablets 50mg Atenolol 50mg Drug Houses of Australia Pte Ltd,

Singapore

G&H Trading Company 26 April 2014 till 25 April

2019

POM

1181 BRU14041301P DermovateTM Ointment Clobetasol Propionate 0.05% w/w Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April

2019

POM

1182 BRU14041302P Tasigna Capsule 150mg Nilotinib (as hydrochloride, monohydrate)

150mg

Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April

2019

POM

1183 BRU14041303P Tasigna Capsule 200mg Nilotinib (as hydrochloride, monohydrate)

200mg

Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April

2019

POM

1184 BRU14041304NP Infusol NSD5 Sodium Chloride 9g/L; Dextrose anhydrous

50g/L

Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 April 2014 till 25 April

2019

POM

1185 BRU14041305NP Lactul Solution 670mg/ml Lactulose 670mg/ml Y.S.P Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 April 2014 till 25 April

2019

GSL

1186 BRU14041306P Kytril for Infusion 1mg/ml Granisetron 1mg (equivalent to

Granisetron hydrochloride 1.12mg)

Cenexi SAS, France Hongkiat Trading & Company 26 April 2014 till 25 April

2019

POM

1187 BRU14041307P Alimta 100mg Powder for

Solution for Infusion

Pemetrexed (as Pemetrexed disodium)

100mg/vial

Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April

2019

POM

1188 BRU14041308P Decofam Cough Syrup Per 5mL contains Ephedrine HCl 4mg;

Guaiphenesin 50mg & Ammonium

Chloride 80mg

Drug Houses of Australia Pte Ltd,

Singapore

G&H Trading Company 26 April 2014 till 25 April

2019

P

1189 BRU14041309NP RinsCap W (Sterile Water for

Injection BP)

Water for Injection BP Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 April 2014 till 25 April

2019

GSL

1190 BRU14041310PS1;

BRU14041310PS2

Famotin Tablet 40mg Famotidine 40mg Drug Houses of Australia Pte Ltd,

Singapore (S1); PT Actavis Indonesia,

Jakarta,Indonesia (S2)

G&H Trading Company 26 April 2014 till 25 April

2019

POM

1191 BRU14041311P Paradrine Tablet Paracetamol 500mg; Pseudoephedrine HCl

BP 20mg; Chlorpheniramine Maleate BP

2mg

Drug Houses of Australia Pte Ltd,

Singapore

G&H Trading Company 26 April 2014 till 25 April

2019

P (10 x 10 x 10's)

1192 BRU14041312P One-Alpha® 0.25mcg Capsule Alfacalcidol 0.25mcg Leo Pharmaceutical Products Ltd., A/S

(Leo Pharma), Denmark

Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April

2019

POM

1193 BRU14041313P Ibuprofen Suspension 20mg/ml Ibuprofen 20mg/ml Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 26 April 2014 till 25 April

2019

P

BDMCA/RMP/1116 Page 72 of 117

Page 73: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1194 BRU14041314NP Sodium Chloride Injection 0.9%,

USP

Sodium Chloride 0.9% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 26 April 2014 till 25 April

2019

GSL

1195 BRU14041315P Rivadem 3mg Capsule Rivastigmine (as hydrogen tartrate) 3mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 26 April 2014 till 25 April

2019

POM

1196 BRU14041316P Rivadem 1.5mg Capsule Rivastigmine (as hydrogen tartrate) 1.5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 26 April 2014 till 25 April

2019

POM

1197 BRU14041317P Rozidal Tablet 1mg Risperidone 1mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G&H Trading Company 26 April 2014 till 25 April

2019

POM

1198 BRU14071318PS1 &

BRU14071318PS2

Rebif ® 44 Pre-filled Syringe

44mcg/0.5ml

Interferon-beta-1a (12MIU) 44mcg/0.5ml Merck Serono S.p.A., Italy G & H Trading Company 02 July 2014 till 01 July 2019 POM

1199 BRU14071319PS1 &

BRU14071319PS2

Mixtard® 30 100IU/ml Insulin Human, rDNA ( as Isophane Insulin)

70%, Insulin Human, rDNA (as soluble

insulin) 30%

Novo Nordisk A/S, Bagsvaerd, Denmark

(S1); Novo Nordisk Productions SAS,

France (S2)

Medipharm Sdn Bhd 02 July 2014 till 01 July 2019 POM

1200 BRU14071320P Protopic® Ointment 0.3% Tacrolimus 0.3mg/g (0.3%) Astellas Pharma Tech Co., Ltd., Japan Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1201 BRU14071321P Beathorphan Elixir 15mg/5ml Dextromethorphan HBr 15mg/5ml Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM

1202 BRU14071322P Nootropil 1200mg Tablet Piracetam 1200mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1203 BRU14071323P Nootropil 800mg Tablet Piracetam 80mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1204 BRU14071324P Luvox® Film-coated Tablets 50mg Fluvoxamine maleate 50mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1205 BRU14071325P Luvox® Film-coated Tablets

100mg

Fluvoxamine maleate 100mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1206 BRU14071326P TobraDex® Eye Ointment Tobramycin 0.3%, Dexamethasone 0.1% S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM

1207 BRU14071327P AgrippalTM S1, Suspension for

Injection in pre-filled syringe

Per 0.5ml dose: Split influenza virus*,

inactivated, containing antigens equivalent

to the following strains:

A/California/07/2009 (H1N1) pdm09– like

strain -15μg HA** (A/California/07/2009,

NYMC X-181);

A/Texas/50/2012 (H3N2) – like strain 15μg

HA**, A/Texas/50/2012, NYMC X-223-;

B/Massachusetts/2/2012– like strain

15μgHA** B/Florida/4/2006 wild type.

Novartis Vaccines and Diagnostic S.r.L.,

Italy

Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1208 BRU14071328P Lanvis® Tablet 40mg Thioguanin 40mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1209 BRU14071329NP Axcel Papain Tablet Papain Pure equiv. to proteolytic enzymes

from carica papaya 10,000 USP Units

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 02 July 2014 till 01 July 2019 GSL

BDMCA/RMP/1116 Page 73 of 117

Page 74: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1210 BRU14071330PS1;

BRU14071330PS2

Humalog Kwikpen 100units/ml Insulin Lispro 100units/ml Lilly France S.A.S., France (S1); Eli Lilly

Italia S.p.A., Sesto Fiorentino, (FI) Italy

(S2) (repacker -

Eli Lilly And Company, USA) & Eli Lilly Italia

S.p.A., Sesto Fiorentino, (FI) Italy;

Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1211 BRU14071331P Shincort IM Injection "Yung Shin"

40mg/ml ampoules

Triamcinolone acetonide 40mg Yung Shin Pharmaceutical Ind. Co. Ltd.,

Taiwan

Asterix United (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1212 BRU14071332P Emend IV Powder For Solution for

Infusion 150mg

Fosaprepitant 150mg (as fosaprepitant

dimeglumine)

DSM Pharmaceuticals Inc., USA Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1213 BRU14071333PS1;

BRU14071333PS2

Zytiga Tablets 250mg Abiraterone acetate 250mg Patheon Inc. Canada (S1); Patheon S.A.S.

(Patheon-France), France (S2)

Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1214 BRU14071334P Axcel Cefaclor-500 Capsule Cefaclor 500mg (as monohydrate) Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 02 July 2014 till 01 July 2019 POM

1215 BRU14071335P Anlodin Tablet 5mg Amlodipine 5mg (as Besylate 6.93mg) Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1216 BRU14071336P Aldara Cream 5%w/w Imiquimod 5% w/w 3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1217 BRU14071337P Premarin Tablet 0.3mg Conjugated estrogens 0.3mg Pfizer Ireland Pharmaceuticals, Ireland Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1218 BRU14071338PS1;

BRU14071338PS2

Regro Lotion 5% Minoxidil USP 5% w/v Drug Houses of Australia Private Limited,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company 02 July 2014 till 01 July 2019 P

1219 BRU14071339PS1;

BRU14071339PS2

Regro Lotion 3% Minoxidil USP 3% w/v Drug Houses of Australia Private Limited,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company 02 July 2014 till 01 July 2019 P

1220 BRU14071340NP Dequalinium Lozenges Dequalinium Chloride 0.25mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 02 July 2014 till 01 July 2019 GSL

1221 BRU14071341P DHA-Ketozole Tablet 200mg Ketoconazole 200mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 02 July 2014 till 01 July 2019 POM

1222 BRU14071342P Axcel Ibuprofen Paediatric Syrup Ibuprofen 100mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 02 July 2014 till 01 July 2019 P

1223 BRU14071343P Pharynx Lozenges Cetylpyridinium Chloride 1.50mg,

Benzocaine 3.33mg

Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 02 July 2014 till 01 July 2019 GSL

1224 BRU14071344P Bislan Tablet 8mg Bromhexine Hydrochloride 8mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1225 BRU14071345P Tren Capsules 250mg Tranexamic Acid 250mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1226 BRU14071346P Hydrocort Cream Hydrocortisone acetate 10mg/g (1% w/w) Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1227 BRU14071347P Invoril Tablet 5mg Enalapril Maleate 5mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 02 July 2014 till 01 July 2019 POM

1228 BRU14071348P Atropine Sulphate 1mg/1ml

Injection

Atropine Sulphate 1mg/ml Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 02 July 2014 till 01 July 2019 POM

BDMCA/RMP/1116 Page 74 of 117

Page 75: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1229 BRU14071349P Dhacodine Syrup 15mg/5ml Pholocodine 15mg/5ml Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 02 July 2014 till 01 July 2019 POM

1230 BRU14071350P Roaccutane Capsules 20mg Isotretinion 20mg R P Scherer GmbH & Co KG., Germany Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM

1231 BRU14071351P Roaccutane Capsule 10mg Isotretinion 10mg R.P. Scherer GmbH & Co. KG., Germany Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM

1232 BRU14071352P Ipolipid 600mg Tablets Gemfibrozil 600mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM

1233 BRU14071353P Salbutamol Injection 0.5mg/ml Salbutamol Sulphate 0.5mg/ml (equivalent

to salbutamol base)

Yung Shin Pharmaceutical Ind., Co. Ltd.,

Taichong, Taiwan

Asterix United (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1234 BRU14071354PS1;

BRU14071354PS2

Glipizide Tablet 5mg Glipizide 5mg Drug Houses of Australia Private Limited,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company 02 July 2014 till 01 July 2019 POM

1235 BRU14071355P Axcel Dexchlorpheniramine

Tablet

Dexchlorpheniramine 2mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 02 July 2014 till 01 July 2019 POM

1236 BRU14071356P Phenexpect CD Syrup Per 5 ml - Diphenhydramine HCl BP

12.5mg; Ammonium Chloride BP 135mg;

Codeine Phosphate BP 5.7mg

Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 02 July 2014 till 01 July 2019 POM

1237 BRU14071357P Quinine Sulphate Tablet 300mg Quinine Sulphate BP 300mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM

1238 BRU14071358NP 20% Glucose Intravenous Infusion

BP

Glucose (as monohydrate) 20% B. Braun Medical Industries Sdn Bhd

Malaysia

Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM

1239 BRU14071359P Pharmaniaga Spironolactone

Tablet 25mg

Spironolactone 25mg Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 02 July 2014 till 01 July 2019 POM

1240 BRU14071360P Maxidex Sterile Opthalmic

Suspension

Dexamethasone 0.1% ( 1mg/ml) S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM

1241 BRU14071361P Heparinol 1000IU/ml Heparin sodium (bovine) BP 1000IU/ml Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 02 July 2014 till 01 July 2019 POM

1242 BRU14071362P Alphagan Ophthalmic Solution

0.2%

Brimonidine tartrate (anhydrous basis)

2mg/ml

Allergan Pharmaceuticals Ireland, Ireland Medipharm Sdn Bhd 02 July 2014 till 01 July 2019 POM

1243 BRU14071363P Dormicum Injection 15mg/3ml Midazolam 15mg/3ml Cenexi SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1244 BRU14071364P Dormicum Injection 5mg/5ml Midazolam 5mg/5ml Cenexi SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1245 BRU14071365NP 0.18% sodium Chloride and 4.3%

Glucose Intravenous Infusion

0.18% Sodium Chloride 0.18%; Glucose

4.3%

B.Braun Medical Industries Sdn Bhd.,

Malaysia

Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM

1246 BRU14071366PS1 &

BRU14071366PS2

Rasilez Film-coated Tablet 150mg Aliskiren 150mg (as Hemifumarate) Novartis Pharma Stein AG, Switzerland &

Novartis Farma S.p.A., Italy

Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

1247 BRU14071367P Invega Sustenna Prolonged

Release Suspension for IM

Injection 150mg/1.5ml

Paliperidone 150mg/1.5ml (as palmitate

234mg)

Janssen Pharmaceutical NV, Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2014 till 01 July 2019 POM

BDMCA/RMP/1116 Page 75 of 117

Page 76: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1248 BRU14071368P Yondelis® Powder for Injection

1mg/vial

Trabectedin 0.05mg/ml Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1249 BRU14071369P Trajenta film-coated tablet 5mg Linagliptin 5mg Boehringer Ingelhein Roxane Inc., USA Hongkiat Trading & Company 24 July 2014 till 23 July 2019 POM

1250 BRU14071370P Novoseven® 1mg Powder and

Solvent for Solution for Injection

Eptacog alfa (activated) 1mg/ml

(corresponds to 50KIU/vial) - 1mg/ml after

reconstitution

Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 24 July 2014 till 23 July 2019 POM

1251 BRU14071371P NovoSeven 5mg/vial, Powder and

Solvent for Solution for Injection

Eptacog alfa (activated) 5mg/vial

(corresponds to 250KIU/vial) - 1mg/ml

after reconstitution

Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 24 July 2014 till 23 July 2019 POM

1252 BRU14071372PS1 &

BRU14071372PS2

Invega® Extended-Release Tablet

9mg

Paliperidone 9mg [Layer 1 - 2.7mg; Layer 2 -

6.3mg]

ALZA Corporation, USA (S1); Janssen Cilag

Manufacturing L.L.C., Puerto Rico (S2)

Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1253 BRU14071373PS1 &

BRU14071373PS2

Invega® Extended-Release Tablet

3mg

Paliperidone 3mg [Layer 1 - 0.9mg; Layer 2 -

2.1mg]

ALZA Corporation, USA (S1); Janssen Cilag

Manufacturing L.L.C., Puerto Rico (S2)

Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1254 BRU14071374PS1 &

BRU14071374PS2

Invega® Extended-Release Tablet

6mg

Paliperidone 6mg [Layer 1 - 1.8mg; Layer 2 -

4.2mg]

ALZA Corporation, USA (S1); Janssen Cilag

Manufacturing L.L.C., Puerto Rico (S2)

Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1255 BRU14071375P Lucentis 10mg/ml Solution for

Injection

Ranibizumab 10mg/ml Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1256 BRU14071376P Onbrez Breezhaler 150mcg

Inhalation Powder, Hard Capsule

Indacterol 150mcg (as maleate 194mcg) Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1257 BRU14071377P Onebrez Breezhaler 300mcg

Inhalation Powder Hard Capsule

Indacterol 300mcg (as maleate 389mcg) Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1258 BRU14071378P Requip PD 24hr Prolong Release

Tablet 2mg

Ropinirole 2mg (as Hydrochloride) Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1259 BRU14071379P Difflam Anti-Inflammatory

Lozenges (with Anti-bacterial)

Benzydamine Hydrochloride 3mg;

Cetylpyridinium Chloride 1.33mg

Unique Pharmaceutical Laboratories,

India

Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 GSL

1260 BRU14071380P Vfend Powder For Oral

Suspension 40mg/ml

Voriconazole 40mg/ml Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1261 BRU14071381P Norditropin® Nordilet® Solution

for Injection 10mg/1.5ml

Somatropin (biosynthetic human growth

hormone) 10mg/1.5ml

Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 24 July 2014 till 23 July 2019 POM

1262 BRU14071382P Alphagan P Ophthalmic Solution

0.15%

Brimonidine tartrate 0.15% Allergan Sales LLC, USA Medipharm Sdn Bhd 24 July 2014 till 23 July 2019 POM

1263 BRU14071383P Mapenem® IV Injection 500mg Meropenem 500mg (as trihydrate) Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 24 July 2014 till 23 July 2019 POM

1264 BRU14071384P Curam Powder for oral

Suspension 312.5mg/5ml

Amoxycillin 250mg (as trihydrate);

Clavulanic Acid 62.5mg (as potassium salt)

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1265 BRU14071385P Topamax® 25 Tablet 25mg Topiramate 25mg CILAG AG, Switzerland Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

BDMCA/RMP/1116 Page 76 of 117

Page 77: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1266 BRU14071386P Tussils 5 Lozenge 5mg Dextromethorphan Hydrobromide 5mg Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1267 BRU14071387P Kivexa Tablets 600mg/300mg Abacavir 600mg (as sulfate); Lamivudine

300mg

Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1268 BRU14071388P Lucrin® depot 3.75mg Injection Leuproprelin acetate 3.75mg Takeda Pharmaceutical Company Limited,

Japan

Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1269 BRU14071389P Lucrin® depot 11.25mg Injection Leuproprelin acetate 11.25mg Takeda Pharmaceutical Company Limited,

Japan

Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1270 BRU14071390P Axcel Diclofenac-50 Tablet Diclofenac Sodium 50mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 24 July 2014 till 23 July 2019 POM

1271 BRU14071391P Lamictal Tablet 50mg Lamotrigine 50mg Glaxosmithkline Pharmaceuticals SA,

Poland

Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1272 BRU14071392P Infasurf® (Calfactant) Intrathecal

Suspension

Per ml - Phospholipids 35mg (including

26mg phosphatidycholine of which 16mg is

disaturated phosphatidycholine) and

0.7mg protein (incuding 0.26mg of SP-

B0Calfactant [Calf lung Surfactant Extract -

CLSE]

ONY Inc., USA K-Seri Pharma 24 July 2014 till 23 July 2019 POM

1273 BRU14071393NP Kaolin & Pectin Mixture Per 5ml - Kaolin Light BP 1g; Pectin 50mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 24 July 2014 till 23 July 2019 P

1274 BRU14071394P Duodart 0.5mg/0.4mg Capsules Dutasteride 0.5mg; Tamsulosin 0.4mg Catalent Germany Schorndorf GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1275 BRU14071395P Axcel Metronidazole-400 Tablet Metronidazole 400mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 24 July 2014 till 23 July 2019 POM

1276 BRU14071396P Cefazolin Sandoz 1g Vial Cefazolin 1g Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1277 BRU14071397PS1 &

BRU14071397PS2 &

BRU14071397PS3

MABTHERA Concentrate for

Solution for Infusion 500mg/50ml

Rituximab 500mg/50ml Genetech Inc., USA (S1); F. Hoffmann-LA

Roche Ltd, Switzerland (S2); and Roche

Diagnostics GmbH, Germany (S3)

Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1278 BRU14071398P Lamitor 100mg Tablet Lamotrigine 100mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 24 July 2014 till 23 July 2019 POM

1279 BRU14071399P Vigamox® Ophthalmic Solution

0.5%

Moxifloxacin 0.5% (as hydrochloride) Alcon Laboratories, Inc., USA Hongkiat Trading & Co 24 July 2014 till 23 July 2019 POM

1280 BRU14071400P Cementin Tablet 200mg Cimetidene 200mg Drug Houses of Australia Pte Ltd,

Singapore

G & H Trading Company 24 July 2014 till 23 July 2019 POM

1281 BRU14071401PS1 &

BRU14071401PS2

Voltaren Emulgel 1% Diclofenac diethylamine 1.16g/100g

(equivalent to 1g of diclofenac sodium)

Novartis Pharma Produktions GmbH,

Germany (S1 for pack size 50g) & Novartis

Consumer Health SA, Switzerland (S2 for

pack size 20g)

Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 GSL

1282 BRU14071402P Imexa Film-Coated Tablet 250mg Azithromycin 250mg (as dihydrate) Xepa-Soul Pattinson (M) Sdn Bhd

Malaysia

Hongkiat Trading & Co 24 July 2014 till 23 July 2019 POM

BDMCA/RMP/1116 Page 77 of 117

Page 78: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1283 BRU14071403P Cymbalta Capsule 60mg Duloxetine 60mg (as hydrochloride) Eli Lilly and Co., USA & Lilly del Caibe Inc,

Puerto Rico

Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1284 BRU14071404P Beanamine Expectorant Per 5ml - Diphenhydramine BP 10mg;

Ammonium Chloride BP 120mg)

Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 24 July 2014 till 23 July 2019 POM

1285 BRU14071405P Setrof Tablet 50mg Sertraline 50mg Hovid Bhd, Malaysia G & H Trading Company 24 July 2014 till 23 July 2019 POM

1286 BRU14071406P Dimenate Tablet 50mg Dimenhydrinate BP 50mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 24 July 2014 till 23 July 2019 POM (5 x 20 x 10's;

1000's)

1287 BRU14071407P Dhatifen Tablet 1mg Ketotifen 1mg (as hydrogen fumarate

1.38mg)

Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 24 July 2014 till 23 July 2019 POM

1288 BRU14071408P Melashine Cream 4% Hydroquinone 40mg/g Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1289 BRU14071409P Asumalife Syrup 1.38mg/5ml Per 5ml - Ketotifen 1mg (as hydrogen

fumarate 1.38mg)

Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1290 BRU14071410P Lovastin Tablet 20mg Lovastatin 20mg Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1291 BRU14071411P Requip tablet 0.25mg Ropinirole 0.25mg (as Hydrochloride) Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1292 BRU14071412NP Zoben Tablet 200mg Albendazole 200mg Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 24 July 2014 till 23 July 2019 P (10 x 10's)

1293 BRU14071413P Clamentin Injection 600mg Amoxycillin 500mg (as sodium); Clavulanic

Acid 0.1g (as Clavulanate potassium)

Yung Shin Pharmaceutical Ind. Co. Ltd.,

Taiwan, R.O.C.

Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1294 BRU14071414P Garbose Tablet 50mg Acarbose 50mg Y.S.P. Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 24 July 2014 till 23 July 2019 POM

1295 BRU14071415P Dexamethasone 4mg Tablet Dexamethasone 4mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 24 July 2014 till 23 July 2019 POM

1296 BRU14081416PS1;

BRU14081416PS2

Sevorane Inhalation Liquid Sevoflurane 100%v/v Aesica Queensborough Ltd, UK (S1);

Abbvie S.R.L, Italy (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1297 BRU14081417P Emend Tri-Pack Capsule Each capsule either contains Aprepitant

80mg or 125mg

Merck Sharp & Dohme Corp. Australia Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1298 BRU14081418P Protopic Ointment 0.1% Tacrolimus 0.1% (as monohydrate) Astellas Pharma Tech Co., Ltd., Japan Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1299 BRU14081419PS1 &

BRU14081419PS2

Exforge HCT 10/160/12.5mg Film-

coated tablet

Amlodipine 10mg (as besylate); Valsartan

160mg; Hydrochlorothiazide 12.5mg

Novartis Pharma Stein AG, Switzerland

(S1) & Novartis Farmaceutica SA,

Barcelona, Spain (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1300 BRU14081420PS1 &

BRU14081420PS2

Exforge HCT 10/160/25mg Film-

coated tablet

Amlodipine 10mg (as besylate); Valsartan

160mg; Hydrochlorothiazide 25mg

Novartis Pharma Stein AG, Switzerland

(S1) & Novartis Farmaceutica SA,

Barcelona, Spain (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1301 BRU14081421PS1 &

BRU14081421PS2

Exforge HCT 5/160/12.5mg Film-

coated tablet

Amlodipine 5mg (as besylate); Valsartan

160mg; Hydrochlorothiazide 12.5mg

Novartis Pharma Stein AG, Switzerland

(S1) & Novartis Farmaceutica SA,

Barcelona, Spain (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

BDMCA/RMP/1116 Page 78 of 117

Page 79: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1302 BRU14081422PS1 &

BRU14081422PS2

Exforge HCT 5/160/25mg Film-

coated tablet

Amlodipine 5mg (as besylate); Valsartan

160mg; Hydrochlorothiazide 25mg

Novartis Pharma Stein AG, Switzerland

(S1) & Novartis Farmaceutica SA,

Barcelona, Spain (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1303 BRU14081423PS1 &

BRU14081423PS2

Exforge HCT 10/320/25mg Film-

coated tablet

Amlodipine 10mg (as besylate); Valsartan

320mg; Hydrochlorothiazide 25mg

Novartis Pharma Stein AG, Switzerland

(S1) & Novartis Farmaceutica SA,

Barcelona, Spain (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1304 BRU14081424P Luveris for Injection 75IU/Vial

(Revised Formula)

Lutropin alfa 75IU (Recombinant Human

Lutenising Hormone)

Merck Serono SA., Switzerland G & H Trading Company 30 August 2014 till 29 August

2019

POM

1305 BRU14081425P Lipanthyl Penta 145 Film-Coated

tablet

Fenofibrate 145mg Recipharm Fontaine, France Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1306 BRU14081426P Dexamethasone Tablet 0.5mg Dexamethasone 0.5mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 August 2014 till 29 August

2019

POM

1307 BRU14081427P FlixotideTM Evohaler 50mcg Fluticasone Propionate 50mcg GlaxoWellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1308 BRU14081428PS1

BRU14081428PS2JanumetTM Tablet 50mg/850mg Sitagliptin 50mg (as phosphate);

Metformin HCl 850mg

Patheon Puerto Rico, Inc., Manati, PR

00674, Puerto Rico (S1) & Aesica

Queensborough Limited, UK (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1309 BRU14081429PS1

BRU14081429PS2Janumet

TM Tablet 50mg/500mg Sitagliptin 50mg (as phosphate);

Metformin HCl 500mg

Patheon Puerto Rico, Inc., Manati, PR

00674, Puerto Rico (S1) & Aesica

Queensborough Limited, UK (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1310 BRU14081430PS1

BRU14081430PS2JanumetTM Tablet 50mg/1000mg Sitagliptin 50mg (as phosphate);

Metformin HCl 1000mg

Patheon Puerto Rico Inc., Manati, Puerto

Rico (S1) & Aesica Queensborough

Limited, UK (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1311 BRU14081431P Napan Capsules 250mg Mefenamic Acid 250mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 30 August 2014 till 29 August

2019

POM

1312 BRU14081432PS1 &

BRU14081432PS2 &

BRU14081432PS3

Mabthera Concentrate for

Solution for Infusion 100mg/10ml

Rituximab 100mg/10ml Genetech Inc., USA; F Hoffmann-LA Roche

Ltd, Switzerland; Roche Diagnostics

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1313 BRU14081433P EraxisTM 100mg for Injection Anidulafungin 100mg/vial Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1314 BRU14081434P Moxiclav 1G Tablet Amoxycillin 875mg (as sodium); Clavulanic

Acid 125mg (as Clavulanate potassium)

Medochemie Ltd., Cyprus Hongkiat Trading & Co 30 August 2014 till 29 August

2019

POM

1315 BRU14081435P Lisdene 10mg tablet Lisinopril 10mg (as dihydrate) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1316 BRU14081436P Dilatrend Tablet 25mg Carvedilol 25mg Roche S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1317 BRU14081437P Dilatrend Tablet 12.5mg Carvedilol 12.5mg Roche S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1318 BRU14081438P Dilatrend Tablet 6.25mg Carvedilol 6.25mg Roche S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1319 BRU14081439P Carzepin 200mg Tablet Carbamazepine 200mg Hovid Bhd, Malaysia G & H Trading Company 30 August 2014 till 29 August

2019

POM

BDMCA/RMP/1116 Page 79 of 117

Page 80: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1320 BRU14081440P Naphcon-A Sterile Ophthalmic

Solution

Naphazoline Hydrochloride 0025%;

Pheniramine maleate 0.3%

S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 30 August 2014 till 29 August

2019

P

1321 BRU14081441P Lamictal 100mg Tablet Lamotrigine 100mg Glaxosmithkline Pharmaceuticals SA,

Poland

Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1322 BRU14081442P Axcel Loratadine Tablet Loratadine 10mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 August 2014 till 29 August

2019

P

1323 BRU14081443NP Neuroxel Tablet Thiamine Mononitrate 100mg; Pyridoxine

HCl 200mg; Cynocobalamin 200mcg

Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 30 August 2014 till 29 August

2019

P

1324 BRU14081444P Rhiniramine SR Tablet 6mg Dexhlorpheniramine Maleate 6mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 30 August 2014 till 29 August

2019

POM

1325 BRU14081445P Buventhol Easyhaler

100mcg/dose inhalation powder

Salbutamol sulphate 100mcg/actuation

(delivered dose 90mcg/actuation)

Orion Corporation, Finland Hongkiat Trading & Co 30 August 2014 till 29 August

2019

POM

1326 BRU14081446P Buventhol Easyhaler

200mcg/dose inhalation powder

Salbutamol sulphate 300mcg/actuation

(delivered dose 180mcg/actuation)

Orion Corporation, Finland Hongkiat Trading & Co 30 August 2014 till 29 August

2019

POM

1327 BRU14081447P Axcel Cefaclor-125 Suspension Cefaclor 125mg (as monohydrate) Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 August 2014 till 29 August

2019

POM

1328 BRU14081448P Dextramine Tablet 2mg Dexchlorpheniramine 2mg Biosis Pharmaceuticals Sdn Bhd., Malaysia K-Seri Pharma Sdn Bhd 30 August 2014 till 29 August

2019

POM

1329 BRU14081449P Mircera Pre-filled Syringe

75mcg/0.3ml

Methoxy polyethylene glycol-epoetin Beta

75mcg/0.3ml

Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1330 BRU14081450P Creobic (New Formula) Cream Clotrimazole 1%w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 August 2014 till 29 August

2019

GSL

1331 BRU14081451P Axcel Cetirizine Syrup Cetirizine Dihydrochloride 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 August 2014 till 29 August

2019

P

1332 BRU14081452P Tinacort Cream Miconazole nitrate 2%w/w;

Hydrocortisone 1.0% w/w

Hovid Bhd, Malaysia G & H Trading Company 30 August 2014 till 29 August

2019

POM

1333 BRU14081453P Sunex Cough Syrup Per 5ml - Diphenhydramine HCl 14mg;

Ammonium chloride 135mg; Sodium/

Trisodium citrate 57.5mg

Sunward Pharmaceutical Sdn Bhd

Malaysia

G & H Trading Company 30 August 2014 till 29 August

2019

POM

1334 BRU14081454P Loxof Tablets 500mg Levofloxacin 500mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 30 August 2014 till 29 August

2019

POM

1335 BRU14081455P Proluton Depot 250mg Injection Hydroxyprogesterone Caproate 250mg Bayer Pharma AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1336 BRU14081456P Nurofen for Children Ibuprofen 100mg/5ml Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

P

1337 BRU14081457P Axcel Sabutamol Syrup Salbutamol 2mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 August 2014 till 29 August

2019

POM

1338 BRU14081458P Doxymycin Capsule 100mg Doxycycline Hydrochloride 100mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1339 BRU14081459P Clamentin Powder for Syrup

31.25mg/ml

Per ml - Amoxycillin 25mg (as trihydrate);

Clavulanic acid 6.25mg (as potassium salt)

Yung Shin Pharmaceutical Ind. Co., Ltd,

Taiwan, R.O.C.

Asterix United (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

BDMCA/RMP/1116 Page 80 of 117

Page 81: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1340 BRU14081460P Clarimycin Film Coated Tablet

500mg

Clarithromycin 500mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1341 BRU14081461NP Mentar Shampoo Coal Tar solution 9% v/v; Menthol 1% w/w HOE Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 30 August 2014 till 29 August

2019

GSL

1342 BRU14081462NP Menzza Cream Methyl Salicylate 25%w/w; Menthol

5%w/w

Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 30 August 2014 till 29 August

2019

GSL

1343 BRU14081463P Difnal OD Tablet 100mg Methyl Salicylate 25%w/w; Menthol

5%w/w

Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 30 August 2014 till 29 August

2019

POM

1344 BRU14081464PS1;

BRU14081464PS2

Humulin N Injection 100IU/ml

(Catridges)

Human Insulin 100IU/ml (recombinant

DNA oigin)

Lilly France SAS, France (S1); Eli Lily Italia

S.p.A., Sesto Fiorentino,

(FI) Italy (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1345 BRU14081465NP Bayer Aspirin Tablet 500mg Aspirin 500mg (Acetylsalicylic acid) PT Bayer Indonesia

Jl. Raya Bogor Km 32

Cimanggis, Depok 16416

Indonesia

Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

GSL

1346 BRU14081466P Doridone Tablet 10mg Domperidone 10mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 30 August 2014 till 29 August

2019

POM

1347 BRU14081467P Tobradex® Eye Drops Suspension Tobramycin 0.3%; Dexamethasone 0.1% S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 30 August 2014 till 29 August

2019

POM

1348 BRU14081468NP Ferrous Fumarate Tablet 200mg Ferrous fumarate 200mg (equivalent to

65mg of elemental iron)

Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 30 August 2014 till 29 August

2019

GSL

1349 BRU14081469P Tamoxifen 20mg Tablet Tamoxifen 20mg (as citrate 30.4mg) Teva Pharmaceutical Industries Ltd, Israel K-Seri Pharma Sdn Bhd 30 August 2014 till 29 August

2019

POM

1350 BRU14081470P Rotaqor 10mg film-coated tablet Atorvastatin 10mg (as calcium) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1351 BRU14081471P Zoral 200 tablet 200mg Acyclovir USP 200mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 30 August 2014 till 29 August

2019

POM

1352 BRU14081472P Vamlo Tablets 5mg Amlodipine 5mg (as besilate) Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 30 August 2014 till 29 August

2019

POM

1353 BRU14081473P Clofenac SR Tablet Diclofenac Sodium 100mg Hovid Bhd, Malaysia G & H Trading Company 30 August 2014 till 29 August

2019

POM

1354 BRU14081474P Strepsils Max Plus Lozenges 2,4 Dichlorobenzyl alcohol 1.2mg;

amymetacresol 0.6mg; Lignocaine

Hydrochloride 10mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

GSL

1355 BRU14081475P Cera-Scalp Ointment Coal Tar solution 12% w/w; Salicylic acid

2%; Sulphur 4% w/w

HOE Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 30 August 2014 till 29 August

2019

GSL

1356 BRU14081476P Lisdene 20mg Tablet Lisinopril 20mg (as dihydrate) Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd 30 August 2014 till 29 August

2019

POM

1357 BRU14091477P Suprane Inhalation Liquid 100% Desflurane 100% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1358 BRU14091478P Buclizine Tablet 25mg Buclizine 25mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 September 2014 till 29

September 2019

P

BDMCA/RMP/1116 Page 81 of 117

Page 82: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1359 BRU14091479PS1;

BRU14091479PS2

Cetrotide Injection 0.25mg Cetrotrelix 0.25mg (as Acetate) Baxter Oncology GmbH, Germany (S1);

Pierre Fabre Medicament Production,

France (S2)

G & H Trading Company 30 September 2014 till 29

September 2019

POM

1360 BRU14091480P Mivacron Injection 10mg/5ml Mivacurium Chloride 10mg/5ml GlaxoSmithKline Manufacturing S.p.A.,

Italy

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1361 BRU14091481P Xolair Powder and Solvent for

Solution for Injection

Omalizumab 150mg Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1362 BRU14091482P Frusemide Tablet 40mg Furosemide 40mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 30 September 2014 till 29

September 2019

POM

1363 BRU14091483P Penegesic 50 Capsule Tramadol HCl 50mg Hovid Bhd, Malaysia G & H Trading Company 30 September 2014 till 29

September 2019

POM

1364 BRU14091486P Crinone Progestrone Vaginal Gel

8%

Progestrone 8% Fleet Laboratories Ltd, United Kingdom G & H Trading Company 30 September 2014 till 29

September 2019

POM

1365 BRU14091487NP Pinetarsol Gel Tar 1.6% EGO Pharmaceuticals Pty Ltd., Australia Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

GSL

1366 BRU14091488P Defungo (Vaginal Tablet 0.1g) Clotrimazole 0.1g Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 30 September 2014 till 29

September 2019

POM

1367 BRU14091489P Magrilan 20mg capsules Fluoxetine 20mg (as Hydrochloride) Medochemie Ltd., Cyprus Hongkiat Trading & Co 30 September 2014 till 29

September 2019

POM

1368 BRU14091490P Trileptal 600mg Film-coated

Tablets

Oxcarbazepine 600mg Novartis Farma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1369 BRU14091491P Binozyt 500mg film-coated tablet Azithromycin 500mg (as monohydrate) Novartis (Bangladesh) Ltd., Bangladesh Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1370 BRU14091492P Nurofen 400 Caplet Ibuprofen 400mg Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

P

1371 BRU14091493P Recormon Pre-filled Syringe

30,000Iu/0.6ml

Epoetin beta 30,000 IU/0.6ml Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1372 BRU14091494P Eprex® 10000 Prefilled Syringes

10,000iu/1ml

Epoetin alfa 10,000 IU/ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1373 BRU14091495P Metformin Tablet 250mg Metformin Hydrochloride 250mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 30 September 2014 till 29

September 2019

POM

1374 BRU14091496PS1;

BRU14091496PS2

Hydrochlorothiazide Tablet 50mg Hydrochlorothiazide BP 50mg Drug Houses of Australia Private Limited,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company 30 September 2014 till 29

September 2019

POM

1375 BRU14091497PS1;

BRU14091497PS2

Famotin Tablet 20mg Famotidine USP 20mg Drug Houses of Australia Private Limited,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company 30 September 2014 till 29

September 2019

POM

1376 BRU14091498P Difenac Tablet 25mg Diclofenac (as Sodium) 25mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 30 September 2014 till 29

September 2019

POM

1377 BRU14091501P Yucomy cream Ketoconazole 20g/g Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1378 BRU14091502P Loradine Tablet 10mg Loratadine 10mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29

September 2019

p

1379 BRU14091503P Rasitol Tablet 40mg Furosemide 40mg YSP Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

BDMCA/RMP/1116 Page 82 of 117

Page 83: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1380 BRU14091504P Betoptic S Eye Drops Betaxolol 2.5mg/ml (as Hydrochloride

2.8mg)

S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 30 September 2014 till 29

September 2019

POM

1381 BRU14091505P Nurofen Caplet 200mg Ibuprofen 200mg Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

p

1382 BRU14091506P Rhiniramine Syrup 2mg/5ml Dexchlorpheniramine maleate BP 2mg/5ml Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 30 September 2014 till 29

September 2019

POM

1383 BRU14091507P Afinitor 2.5mg Tablet Everolimus 2.5mg Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1384 BRU14091508P Glucagen® 1mg Powder and

Solvent for Solution for Injection

Glucagon 1mg (as hydrochloride) Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 30 September 2014 till 29

September 2019

POM

1385 BRU14091509P Chloramine Syrup 4mg/5ml Chlorpheniramine maleate 4mg/5ml Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 September 2014 till 29

September 2019

p

1386 BRU14091510P Difnal-K Tablet 50mg Diclofenac Potassium 50mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 30 September 2014 till 29

September 2019

POM

1387 BRU14091511NP 0.9% Sodium Chloride Injection,

B.P. (10ml)

Sodium Chloride 0.9% B. Braun Medical Industries Sdn Bhd

Malaysia

Hongkiat Trading & Co 30 September 2014 till 29

September 2019

GSL

1388 BRU14091512NP Compound Sodium Lactate

Intravenous Infusion B.P.

(Hartmann's Solution)

Per 1000ml contains: Sodium Chloride 6g;

Sodium Lactate solution 6.24g (50% w/w);

Potassium Chloride 0.40g; Calcium Chloride

dehydrate 0.27g

B. Braun Medical Industries Sdn Bhd

Malaysia

Hongkiat Trading & Co 30 September 2014 till 29

September 2019

POM

1389 BRU14091513P HBVaxPro® 5mcg/0.5ml Injection Hepatitis B surface Antigen 5mcg/0.5ml Merck Sharp & Dohme Corp., West Point,

Pensylvania, USA

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1390 BRU14091514P HBVaxPro® 10mcg/1.0ml

Injection

Hepatitis B surface Antigen 10mcg/1.0ml Merck Sharp & Dohme Corp., West Point,

Pensylvania, USA

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1391 BRU14091515P HBvaxPro® 40mcg/1.0ml Injection Hepatitis B surface Antigen 40mcg/1.0ml Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1392 BRU14091516P Emthexate 2.5mg Tablet Methotrexate 2.5mg (as disodium) Teva Czech Industries S.R.O., Czech

Republic

K-Seri Pharma Sdn Bhd 30 September 2014 till 29

September 2019

POM

1393 BRU14091517P Stalevo 125/31.25/200mg film-

coated tablet

Levodopa 125mg, Carbidopa 31.25mg,

Entacapone 200mg

Baxter Bioscience Manufacturing Sarl,

Switzerland

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1394 BRU14091518P Axcel Dextromethorphan-30

Syrup

Dextromethorphan Hydrobromide

30mg/5ml

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 September 2014 till 29

September 2019

POM

1395 BRU14091519P Afinitor 5mg Tablet Everolimus 5mg Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1396 BRU14091520P Renacid K8 Each 1 Litre contains: Sodium Chloride

161.43g, Potassium Chloride 5.49g,

Calcium Chloride 2H2O 6.77g, Magnesium

Chloride 6H2O 3.74g, Glacial acetic acid

8.85g

Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 30 September 2014 till 29

September 2019

POM

1397 BRU14091521P Ospexin 500mg Film-coated

Tablets

Cefalexin 500mg (as monohydrate) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

BDMCA/RMP/1116 Page 83 of 117

Page 84: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1398 BRU14091522PS1 &

BRU14091522PS2

Androcur Tablet 50mg Cyproterone acetate 50mg Delpharm Lille SAS, France Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1399 BRU14091523P Poviderm Ointment Povidone Iodine 10% w/w Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 30 September 2014 till 29

September 2019

GSL

1400 BRU14091524P Melaquin Cream 4% w/w Hydroquinone 40mg/g Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29

September 2019

P

1401 BRU14091525P Calumid 50mg Film-coated Bicalutamide 50mg Gedeon Richter Plc., Hungary K-Seri Pharma Sdn Bhd 30 September 2014 till 29

September 2019

POM

1402 BRU14091526P Glucomet Tablet 500mg Metformin Hydrochloride 500mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1403 BRU14091527P Quemox Tablet 500mg Mebendazole 500mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29

September 2019

P

1404 BRU14091528P Campto 300mg/15ml Injection Irinotecan Hydrochloride Trihydrate

300mg/15ml

Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1405 BRU14091529NP Strepsils Cool Lozenges Each lozenge contains: Amymetacresol

0.6mg, 2,4-Dichlorobezyl alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd 30 September 2014 till 29

September 2019

GSL

1406 BRU14091530NP Strepsils Sugar Free Lemon

Lozenges

Each lozenge contains: Amymetacresol

0.6mg, 2,4-Dichlorobezyl alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd 30 September 2014 till 29

September 2019

GSL

1407 BRU14091531P Nordette 21 Tablet Levonogestrel 150mcg, Ethinyl estradiol

30mcg

Haupt Pharma Munster GmbH., Germany Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1408 BRU14091532P Primocal Solution Per Litre: Sodium 140mmol, Magnesium

0.5mmol, Lactate 3mmol, Bicarbonate

32mmol, Chloride 106mmol

Gambro Dasco S.p.A., Italy Medicorp Sdn Bhd 30 September 2014 till 29

September 2019

POM

1409 BRU14091533P Ansures Extended Release Tablet

500mg

Metformin Hydrochloride 500mg Siu Guan Chem, Ind. Co. Ltd., Taiwan G & H Trading Company 30 September 2014 till 29

September 2019

POM

1410 BRU14091534P Deplatt Tablet 75mg Clopidogrel 75mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 30 September 2014 till 29

September 2019

POM

1411 BRU14091535NP Livolin Forte Softgel Capsules Per Capsule: Lecithin [PC 35%] 857.13mg

(equivalent to Phosphatidylcholine

300mg), Di-alpha-tocopheryl acetate 10mg,

Thiamine mononitrate 10mg, Riboflavin

6mg, Pyridoxine hydrochloride 10mg,

Vitamin B12 0.1% WS 15mg (equivalent to

Vitamin B12 0.015mg), Nicotinamide 30mg.

Mega Lifesciences Public Company

Limited, Thailand

Hongkiat Trading & Co 30 September 2014 till 29

September 2019

GSL

1412 BRU14091536NP Pharmaniaga Aqueous Cream White Soft Paraffin 15%, Emulsifying Wax

9%, Liquid Paraffin 6%

Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 30 September 2014 till 29

September 2019

GSL

1413 BRU14091537P Synagis 100mg Powder and

Solvent for Solution for Injection

Palivizumab 100mg Boehringer Ingelheim Pharma KG,

Germany

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

BDMCA/RMP/1116 Page 84 of 117

Page 85: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1414 BRU14091538P Clamentin Injection 1.2g Amoxicillin 1g (as sodium), Clavulanic acid

0.2g (as clavulanate potassium)

Yung Shin Phamaceutical Ind. Co Ltd,

Taiwan, ROC

Asterix United (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1415 BRU14091539P ZmaxTM Extended-Release

Granules for Oral Suspension 2g

Azithromycin 2g (as dihydrate) Pfizer Pharmaceuticals LLC Vega Baja,

Puerto Rico

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1416 BRU14091540P Eturion 10mg Film Coated Tablet Atorvastatin 10mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceuticals LLC, Puerto Rico Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1417 BRU14091541P Eturion 20mg Film Coated Tablet Atorvastatin 20mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceuticals LLC, Puerto Rico,

USA

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1418 BRU14091542P Eturion 40mg Film Coated Tablet Atorvastatin 40mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceutical LLC, Puerto Rico,

USA

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1419 BRU14091543P Eturion 80mg Film Coated Tablet Atorvastatin 80mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceuticals LLC, Puerto Rico,

USA

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1420 BRU14111544P (vial) EYLEA Solution for Injection (vial) Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc., New

York, USA

Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1421 BRU14111545P EYLEA Solution for Injection (pre-

filled syringe)

Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc., New

York, USA

Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1422 BRU14111546P Binocrit Solution for Injection

2000 IU/ml in Pre-filled Syringe

Epoetin Alfa 2,000 IU/ml IDT Biologika GmbH, Germany Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1423 BRU14111547P Binocrit Solution for Injection

4000 IU/0.4ml in Pre-filled

Syringe

Epoetin Alfa 4,000IU/0.4ml IDT Biologika GmbH, Germany Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1424 BRU14111548P Nootropil Infusion 12g/60ml Piracetam 12g/60ml Aesica Pharmaceuticals SRL., Italy Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1425 BRU14111549P Nootropil Injection 1g/5ml Piracetam 1g/5ml UCB Pharma S.P.A., Italy Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1426 BRU14111550P Advagraf Prolonged Release Hard

Capsule 0.5mg

Tacrolimus 0.5mg (as monohydrate) Astellas Ireland Co Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1427 BRU14111551P Advagraf Prolonged Release Hard

Capsule 1mg

Tacrolimus 1mg (as monohydrate) Astellas Ireland Co Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1428 BRU14111552P Advagraf Prolonged Release Hard

Capsule 5mg

Tacrolimus 5mg (as monohydrate) Astellas Ireland Co Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1429 BRU14111553P Dynastat Powder and Solvent for

Solution for Injection 40mg

Parecoxib (as Sodium) 40mg Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1430 BRU14111554P Invanz Powder for Injection

1g/vial

Ertapenem 1g (as Sodium 1.046g) Laboratories Merck Sharp & Dohme-

Chibret, France

Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1431 BRU14111555PS1;

BRU14111555PS2

Humalog Mix25 100 units/ml

Kwikpen

Insulin Lispro 100IU/ml [In the proportion

of 25% Insulin Lisporo & 75% Insulin Lispro

Protamine Suspension (rDNA origin)

Lilly France S.A.S., France (S1); Eli Lilly

Italia S.p.A., Sesto Fiorentino, (FI) Italy

(S2) (repacker -

Eli Lilly And Company, USA) & Eli Lilly Italia

S.p.A., Sesto Fiorentino, (FI) Italy;

Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

BDMCA/RMP/1116 Page 85 of 117

Page 86: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1432 BRU14111556P Brozil Capsule 300mg Gemfibrozil 300mg YSP Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1433 BRU14111557NP Menzza Ice Gel Menthol 4% w/w Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 01 November 2014 till 31

October 2019

GSL

1434 BRU14111558P Trileptal Film-coated Tablets

300mg

Oxcarbazepine 300mg Novartis Pharma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1435 BRU14111559NP Alka Seltzer Lemon Acetylsalicylic Acid 324mg; Sodium

Bicarbonate 1.737g; Citric Acid (anhydrous)

1.223g.

Bayer de Mexico SA De CV, Mexico Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

GSL

1436 BRU14111560P Voren Plus Gel Diclofenac sodium 10mg/g (1%w/w) Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 01 November 2014 till 31

October 2019

GSL

1437 BRU14111561NP Strepsils Original Lozenges Amylmetacresol 0.6mg; 2,4-Dichlorobenzyl

Alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd 01 November 2014 till 31

October 2019

GSL

1438 BRU14111562NP Strepsils Orange with Vitamin C

Lozenges

Amylmetacresol 0.6mg; 2,4-Dichlorobenzyl

Alcohol 1.2mg; Ascorbic Acid 33.5mg;

Sodium Ascorbate 74.9mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd 01 November 2014 till 31

October 2019

GSL

1439 BRU14111563P Loette 21 Tablet Levonorgetsrel 100mcg; ethinylestradiol

20mcg

Haupt Pharma Munster GmbH., Germany Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1440 BRU14111564P Axcel Promethazine-5 Syrup Promethazine Hydrochloride 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 01 November 2014 till 31

October 2019

POM

1441 BRU14111565P NIMBEXTM Injection 2mg/ml (5ml) Cisatracurium Besylate 10mg/5ml GLaxoSmithKline Manufacturing S.p.A.,

Italy

Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1442 BRU14111566P Aggrastat Concentrate for

Infusion 0.25mg/ml

Tirofibon 0.25mg/ml (as hydrochloride

monohydrate 0.281mg/ml)

DSM Pharmaceuticals Inc., USA & Orion

Corporation, Espoo, Finland

Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1443 BRU14111567P Promezine Syrup 1mg/ml Promethazine Hydrochloride 1mg/ml Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1444 BRU14111568P Cephanmycin Capsules 500mg Cephalexin 500mg Yung Shin Pharmaceutical Ind. Co. Ltd.,

Taiwan

Asterix United (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1445 BRU14111569P Ferinject® 50mg Iron/ml solution

for Injection/Infusion

Iron 50mg/ml (as ferric carboxymaltose) BIPSO GmbH, Germany K-Seri Pharma Sdn Bhd 01 November 2014 till 31

October 2019

POM

1446 BRU14111570P Olmetec Plus 20/12.5mg Film-

coated Tablet

Olmesartan Medoxomil 20mg;

Hydrochlorothiazide 12.5mg

Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1447 BRU14111571P Norfox 400 Tablet Norfloxacin 400mg The United Drug (1996) Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 01 November 2014 till 31

October 2019

POM

1448 BRU14111572P Rotateq® Rotavirus Vaccine, Live,

Oral, PentavalentHuman-bovine Rotavirus G1 ≥ 2.2 x 106IU;

Human-bovine Rotavirus G2 ≥ 2.8 x 106IU;

Human-bovine Rotavirus G3 ≥ 2.2 x 106IU;

Human-bovine Rotavirus G4 ≥ 2.0 x 106IU;

Human-bovine Rotavirus P1 ≥ 2.3 x 106IU

Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

BDMCA/RMP/1116 Page 86 of 117

Page 87: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1449 BRU14111573P Eliquis Film-coated Tablets 2.5mg Apixaban 2.5mg Bristol-Myers Squibb Manufacturing

Company, Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1450 BRU14111574P Tren Injection 100mg/ml Tranexamic Acid 100mg/ml Yung Shin Pharmaceutical Ind. Co. Ltd.,

Taiwan

Asterix United (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1451 BRU14111575P Ryzodeg Flex Touch 100 units/ml Per 1 ml: Insulin Degludec 70%; Insulin

Aspart 30%

Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 01 November 2014 till 31

October 2019

POM

1452 BRU14111576NP Folic Acid Tablets 5mg Folic Acid BP 5mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 01 November 2014 till 31

October 2019

GSL

1453 BRU14111577NP Dettol Antiseptic Germicide

Liquid

Parachlorometaxylenol 4.8%w/v Pt. Reckitt Benckiser Indonesia Syarikat Aliaa Sdn Bhd 01 November 2014 till 31

October 2019

GSL

1454 BRU14111578P Tolanz Tablet 5mg Olanzapine 5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 01 November 2014 till 31

October 2019

POM

1455 BRU14111579P Tolanz Tablet 10mg Olanzapine 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 01 November 2014 till 31

October 2019

POM

1456 BRU14111580P Somin Tablet 2mg Dexchlorpheniramine Maleate 2mg Y.S.P Industries (M) Sdn. Bhd., Malaysia Asterix United (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1457 BRU14111581P Vaminolact Solution Per 100ml: L-Alanine 6.3 g; L-Arginine 4.1g;

L-Aspartic Acid 4.1g; L-Cysteine / L-Cystine

1g; L-Glutamic Acid 7.1g; Glycine (Amino

Acetic Acid) 2.1g; L-Histidine 2.1g; L-

Isoleucine3.1g; L-Leucine 7g; L-Lysine 5.6g;

L-Methionine 1.3g; L-Phenylalanine 2.7g; L-

Proline 5.6g; L-Serine 3.8g; Taurine 300mg;

L-Threonine 3.6g; L-Tryptophan 1.4g; L-

Tyrosine 500mg; L-Valine 3.6g

Fresenius Kabi Austria GmbH, Austria Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

P

1458 BRU14111582P Covinace Tablet 4mg Perindopril Ter-butylamine 4mg Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 01 November 2014 till 31

October 2019

POM

1459 BRU14111583NP Oralite Natural Oral Rehydration

Salts

Per 4.92g sachet: Glucose anhydrous 3.24g;

Sodium Chloride 0.624g; Trisodium citrate

dihydrate 0.696g; Potassium Chloride 0.36g

Royce Pharma Manufacturing Sdn. Bhd.,

Malaysia

SWL Biomed Sales & Services 01 November 2014 till 31

October 2019

GSL

1460 BRU14111584NP Panamol Forte Suspension

250mg/5ml

Paracetamol 250mg/5ml Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 01 November 2014 till 31

October 2019

P (3.8L)

1461 BRU14111585PS1,

BRU14111585PS2,

BRU14111585PS3,

BRU14111585PS4

Avastin 100mg/4ml Bevacizumab 25mg/ml (Humanised anti-

VEGF monoclonal antibody)

Genentech Inc., USA (S1); F-Hoffman-La

Roche Ltd, Basel, Switzerland (S2); Roche

Diagnostics GmbH, Manheim, Germany

(S3); F Hoffmann-La Roche Ltd,

Kaiseraugst, Switzerland (S4)

Medicare 01 November 2014 till 31

October 2019

POM

1462 BRU14111586P Zyvox 20mg/ml Granules For Oral

Suspension

Linezolid 100mg/5ml Pfizer Pharmaceuticals LLC, USA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/1116 Page 87 of 117

Page 88: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1463 BRU14111587P Axcel Cimetidine-400 Tablet Cimetidine 400mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1464 BRU14111588PS1;

BRU14111588PS2

Humulin R Injection 100IU/ml

(Catridges)

Human Insulin (Recombinant DNA origin)

100IU/ml

Lilly France SAS, France (S1); Eli Lily Italia

S.p.A., Sesto Fiorentino,

(FI) Italy (S2)

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1465 BRU14111589P Resolor film-coated tablet 1mg Prucalopride 1mg (as succinate 1.321mg) Janssen-Cilag SpA., Italy Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1466 BRU14111590NP Maltofer Fol Chewable Tablet Iron (III) 100mg (as hydroxide-polymaltose

Complex); Folic acid 0.35mg

Vifor S.A., Switzerland & Iberfar-Industria

Farmacetutica S.A., Barcelona, Portugal

Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1467 BRU14111591P Pristiq 50mg Extended-Release

Tablets

Desvenlafaxine 50mg (as succinate

75.87mg)

Pfizer Ireland Pharmaceuticals, Ireland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1468 BRU14111592P ElIquis 5mg Film-coated Tablet Apixaban 5mg Bristol-Myers Squibb Manufacturing

Company, Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1469 BRU14111593P Pulin Film-coated Tablet 10mg Metoclopramide HCl 10mg ( as Mono HCl

10.5mg)

Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1470 BRU14111594P Rocephin for Injection 1g IV Ceftriaxone 1g F.Hoffmann-La Roche Ltd., Basel,

Switzerland

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1471 BRU14111595P Advate 250 IU Powder and

Solvent for Solution for Injection

Octocog alfa (recombinant human

coagulation factor VIII) 250 IU

Baxter Bioscience Manufacturing Sarl,

Switzerland

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1472 BRU14111596P Glibenclamide Tablet 5mg Glibenclamide 5mg Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1473 BRU14111597NP 0.45% Sodium Chloride and 5%

Dextrose Intravenous Infusion B.P

Per 1L - Sodium Chloride 4.5g; Glucose

anhdyrous 50g (as monohydrate 55g)

B.Braun Medical Industries Sdn Bhd.,

Malaysia

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1474 BRU14111598P Gonal-F 1050IU/1.75ml

(77mcg/1.75ml) Powder and

Solution for Injection

Per Pen (1.75ml) - Follitropin Alfa 1050IU

(equivalent 77mcg) [Per ml of solution

contains 600IU Follitropin alfa ~ 44mcg]

Merck Serono S.p.A., Italy & Merck

Serono S.A., Switzerland

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1475 BRU14111599P Cardiol Tablet 6.25mg Carvedilol 6.25mg Yung Shin Pharmaceutical Ind. Co. Ltd.,

Taiwan

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1476 BRU14111600P Cardiol Tablet 25mg Carvedilol 25mg Yung Shin Pharmaceutical Ind. Co. Ltd.,

Taiwan

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1477 BRU14111601NP T3 Pimple Gel Rescorcinol 2% w/w HOE Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1478 BRU14111602NP BSS® (Balanced Salt Solution)

Sterile Irrigation Solution

Per 1L - Sodium Chloride 6.4g; Potassium

Chloride 0.75g; Calcium Chloride,

dehydrate 0.48; Magnesium Chloride,

hexahydrate 0.3; Sodium Citrate,

dehydrate 1.7; Sodium acetate, trihydrate

3.9

S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 19 May 2015 till 18 May

2020

GSL

1479 BRU14111603P Domper Tablet 10mg Domperidone 10mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/1116 Page 88 of 117

Page 89: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1480 BRU14111604NP Davmorid film-coated Tablet Diosmin 450mg; Hesperidin 50mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1481 BRU14111605P Zimmex Tablet 10mg Simvastatin 10mg Silom Medical Co. Ltd., Thailand Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1482 BRU14111606NP Strepsils Warm Lozenges Amymetacresol 0.6mg; 2,4-Dichlorobenzyl

Alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1483 BRU14111607NP Sodium Bicarbonate 8.4% w/v

Injection (10ml glass ampoule)

Sodium Bicarbonate 8.4%w/v (84mg/ml) Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1484 BRU14111608P Binozyt 200mg/5ml Powder for

Oral Suspension

Azithromycin 200mg Sandoz S.R.L., Romania Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1485 BRU14111609NP Renacid K4 Per Litre - Sodium Chloride BP 161.43g;

Potassium Chloride BP 5.49g; Calcium

Chloride 2H2O BP 9.75g; Magnesium

Chloride 6H2O BP 3.74g; Gacial Acetic Acid

BP 8.85g

Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 19 May 2015 till 18 May

2020

POM

1486 BRU14111610NP Renacarb K2 Per Litre - Sodium Chloride BP 30.5g;

Sodium Bicarbonate BP 66.0g

Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 19 May 2015 till 18 May

2020

POM

1487 BRU14111611P Kogrel 75mg Film Coated Tablet Clopidogrel 75mg (as bisulfate 97.875mg) Sandoz Private Limited, Mumbai, India Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1488 BRU14111612P Chloramine Tablet 4mg Chlorpheniramine maleate 4mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

P

1489 BRU14111613P Tolnaderm Cream 1% Tolnaftate 1% w/w HOE Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1490 BRU14111614P Medoflucon Capsule 50mg Fluconazole 50mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1491 BRU14111615P Curam 156.25mg/5ml Powder for

Oral Suspension

Per 5ml - Amoxycillin 125mg (as

trihydrate); Clavulanic acid 31.25mg

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1492 BRU14111617P Nospan Tablet 30mg Dextromethorphan Hydrobromide 30mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1493 BRU14111618NP Strepsils Extra Strong Lozenge Amymetacresol 0.6mg; 2,4-Dichlorobenzyl

Alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1494 BRU14111619P Crixan Tablet 250mg Clarithromycin 250mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1495 BRU14111620P Storvas Tablet 20mg Atorvastatin 20mg (as calcium) Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1496 BRU14111621P Brozil Film coated Tablet 600mg Gemfibrozil 600mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1497 BRU14111622NP Panadol Extra Tablets Paracetamol 500mg; Caffeine 65mg Sterling Drug (Malaya) Sdn Bhd, Malaysia Kingston Beverage & Creamery

Sdn Bhd

19 May 2015 till 18 May

2020

GSL

1498 BRU14111623P Botox (Botulinium Toxin, Type A)

Injection 100units/vial

Clostridium Botulinum Toxin Type A

Purified Neurotoxin Complex 100Units/vial

Allergan Pharmaceuticals Ireland, Ireland Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/1116 Page 89 of 117

Page 90: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1499 BRU14111624P Botox (Botulinium Toxin, Type A)

Injection 50units/vial

Clostridium Botulinum Toxin Type A

Purified Neurotoxin Complex 50Units/vial

Allergan Pharmaceuticals Ireland, Ireland Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

POM

1500 BRU14111625P Botox (Botulinium Toxin, Type A)

Injection 200units/vial

Clostridium Botulinum Toxin Type A

Purified Neurotoxin Complex 200Units/vial

Allergan Pharmaceuticals Ireland, Ireland Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

POM

1501 BRU14111626P Lovir Tablets 200mg Acyclovir 200mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1502 BRU14111627P Cellcept Tablet 500mg Mycophenolate mofetil 500mg Roche S.p.A., Italy Medicare 19 May 2015 till 18 May

2020

POM

1503 BRU14111628NP 0.45% Sodium Chloride

Intravenous Infusion B.P

Sodium Chloride 0.45% B.Braun Medical Industries Sdn Bhd.,

Malaysia

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

P

1504 BRU14111629P Xorimax 500mg Coated Tablet Cefuroxime 500mg (as axetil) PenCef Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1505 BRU14111630P Xorimax 250mg Coated Tablet Cefuroxime 250mg (as axetil) PenCef Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1506 BRU14111631P Peditrace Concentrate for

Solution for Infusion

Per 1ml - Zinc Chloride 521mcg; Copper

Chloride 2H2O 53.7mcg; Manganese

Chloride 4H2O 3.60mcg; Sodium Selenite

anhydrous 4.38mcg; Sodium Fluoride

126mcg; Potassium Iodide 1.31mcg

Fresenius Kabo Nolge AS, Norway Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1507 BRU14111632P Axcel Orlistat 120 Tablet Orlistat 120mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1508 BRU14111633P Pharmaniaga Salbutamol

Respirator Solution 0.5%w/v

Salbutamol 0.5%w/v (as sulphate) Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1509 BRU14111634P Epimate 50mg Tablet Topiramate 50mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1510 BRU14111635NP Aqueous Cream Emulsifying wax 9.0%w/w; White Soft

Paraffin 15% w/w; Liquid Paraffin 6.0%

w/w

Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1511 BRU14111636P Melomet Cream 0.1% w/w Mometasone Furoate 0.1% w/w Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1512 BRU14111637NP Poro Suspension 250mg/5ml Paracetamol 250mg/5ml Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1513 BRU14111638P Primovists 0.25mmol/ml solution

for injection

Gadoxetic acid, Sodium 0.25mmol/ml Bayer Pharma AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1514 BRU14111639P Servidipine 30mg Film-coated

Tablets

Nifedipine 30mg Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1515 BRU14111640P Servidipine 60mg Film-coated

Tablets

Nifedipine 60mg Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1516 BRU14111641NP Hoemal Oral Suspension Paracetamol 250mg/5ml (5%) Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1517 BRU14111642P Manace Injection 5mg/ml

(Haloperidol 5mg/ml)

Haloperidol 5mg/ml Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/1116 Page 90 of 117

Page 91: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1518 BRU14111643NP Woodward's Gripe Water

(Alcohol Free)

Per 5ml - Terpeneless Dill Seed Oil 2.3mg;

Sodium Bicarbonate 52.5mg

IDS Manufacturing Sdn Bhd, Malaysia Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1519 BRU14111644P Buston Injection 20mg/ml Hyoscine-N-butylbromide 20mg/ml Siu Guan Chem, Ind. Co. Ltd., Taiwan G & H Trading Company 19 May 2015 till 18 May

2020

POM

1520 BRU14111645P Tolnaderm lotion 1.0%w/v Tolnaftate 1% w/w Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1521 BRU14111646NP Oralite Orange Oral Rehydration

Salts

Per 4.95g - Glucose anhydrous 3.24g;

Sodium Chloride 0.624g; Trisodium citrate

dihydrate 0.696g; Potassium Chloride 0.36g

Royce Pharma Manufacturing Sdn. Bhd.,

Malaysia

SWL Biomed Sales & Services 19 May 2015 till 18 May

2020

GSL

1522 BRU14111647P Vesyca Film Coated Tablet 150mg Ranitidine 150mg (as hydrochloride) Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1523 BRU14111648P Pharmaniaga Cetirizine 10mg

tablet

Cetirizine 10mg (as hydrochloride) Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

P

1524 BRU14111649P Hovid Lipiduce-20 Tablet Atorvastatin 20mg (as calcium) Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1525 BRU14111650P Invokana Film-coated Tablet

100mg

Canagliflozin 100mg (as hemihydrate) Janssen-Cilag SpA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1526 BRU14111651P Axcel Chlorpheniramine-2 Syrup Chlorpheniramine maleate 2mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

P

1527 BRU14111652P Binozyt Film-Coated Tablet

250mg

Azithromycin 250mg (as monohydrate) Novartis (Bangladesh) Ltd., Bangladesh Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1528 BRU14111653P Asmol 2 tablet Salbutamol 2mg (as sulphate) Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1529 BRU14111654NP Paracetamol Kabi Solution for

infusion 10mg/ml

Paracetamol 10mg/ml i) Fresenius Kabi Germany AB ii) Fresenius

Kabi Austria

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1530 BRU14111655P Risperdal Solution 1mg/ml Risperidone 1mg/ml Janssen Pharmaceutical NV, Belgium Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1531 BRU14111656P Visudyne Injection Verteprofin 15mg Par Sterile Products LLC, United States Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1532 BRU14121661P Kastipron Tablet 375mg S-Carboxymethylcysteine 375mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1533 BRU14121662P Ipolipid Capsules 300mg Gemfibrozil 300mg Medochemic Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1534 BRU14121663P Curam 625mg Film-coated Tablet Amoxicillin 500mg; Clavulanic acid as

potassium salt 125mg

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1535 BRU14121664P Vesyca Injection 25mg/ml Ranitidine (as hydrochloride) 25mg/ml Yung Shin Pharmaceutical Ind. Co., Ltd,

Taiwan, R.O.C.

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1536 BRU14121666P Amoxicap 500 Capsule Amoxicillin (as trihydrate 574mg) 500mg Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1537 BRU14121667NP Wintosal Cream Methyl salicylate 15.0% w/w; Menthol

2.3% w/w and Cmaphor 4.0% w/w

Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1538 BRU14121668NP 50% Glucose Intravenous Infusion

B.P.

Glucose monohydrate (550.00g) eq. to

anhydrous glucose 500.0g/1000ml

B.Braun Medical Industries Sdn Bhd.,

Malaysia

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/1116 Page 91 of 117

Page 92: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1539 BRU14121669P Visanne 2mg Tablet Dienogest 2mg Bayer Weimar GmbH und. Co. KG.,

Dobereinesrtr. 20, D-99427, Weimar,

Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1540 BRU14121670P Medoflucon Capsule 150mg Fluconazole 150mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1541 BRU14121671P Topamax 100 Tablets 100mg Topiramate 100mg Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1542 BRU14121672NP Duratears Ocular Lubricant

Ointment

Mineral Oil 30.0mg/g, Anhydrous liquid

lanolin 30.0mg/g and white petrolatum q.s.

ad 1g

S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 19 May 2015 till 18 May

2020

GSL

1543 BRU14121673P Eprex® 40,000 Prefilled Syringes

40,000iu/1ml

Epoetin alfa 40,000IU/ml Vetter Pharma-Fertigung GmbH & Co. KG,

Germany; Cilag AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1544 BRU14121674P Milosec Capsule 20mg Omeprazole 20mg The United Drug (1966) Co. Ltd., Thailand Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1545 BRU14121675P Ziagen Oral Solution Abacavir (as Abacavir Sulfate) 20mg/ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1546 BRU14121676P Minulet 21 Tablet Gestodene 75mcg; ethinylestradiol 30mcg Haupt Pharma Munster GmbH., Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1547 BRU14121677P Pataday Olopatadine Ophthalmic

Solution 0.2%

Olopatadine hydrochloride 2.22mg (eq. to

Olopatadine 2mg (0.2%)

Alcon Laboratories, Inc., USA Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1548 BRU14121678P Provironum Tablet 25mg Mesterolone 25mg Schering Do Brasil Quimica e

Farmaceutica Ltda., San Paulo-SP, Brazil

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1549 BRU14121681NP Strepsils Strawberry Sugar Free

Children

Amylmetacresol 0.6mg; 2.4-Dichlorobenzyl

Alcohol 1.2mg

Reckitt Benckiser Healthcare International

Limited, UK

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1550 BRU14121682P Axcel Sodium Fusidate 250 Tablet Sodium Fusidate (Micronized) 250mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1551 BRU14121683P Pencor 1mg tablet Doxazosin Mesylate (eq. to Doxazosin 1mg) Unison Laboratories Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1552 BRU14121684P Pencor 2mg tablet Doxazosin Mesylate (eq. to Doxazosin 2mg) Unison Laboratories Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1553 BRU14121685P Pencor 4 Tablet Doxazosin Mesylate (eq. to Doxazosin 4mg) Unison Laboratories Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1554 BRU14121686P Decan Injection 2mg/ml Dexamethasone Sodium Phosphate 2.2mg

(eq. to Dexamethasone Phosphate 2mg)

Yung Shin Pharmaceutical Ind. Co., Ltd,

Taiwan, R.O.C.

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1555 BRU14121687P Primodil-10 Tablet Amlodipine Besilate 13.87mg (eq. to

Amlodipine 10mg)

Medley Pharmaceuticals Limited, India Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1556 BRU14121688P Cuvarlix Capsule 120mg Orlistat 120mg Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1557 BRU14121689NP Calcium Lactate 300mg tablet Calcium lactate 300mg Drug Houses of Australia Pte Ltd.,

Singapore

G & H Trading Company 19 May 2015 till 18 May

2020

GSL

(1000's)

1558 BRU14121690P Seladin 500mg tablet Naproxen 500mg Y.S.P. Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/1116 Page 92 of 117

Page 93: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1559 BRU14121691P Driminate 50mg Suppository Dimenhydrinate 50mg Y.S.P. Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

P (10 x 10's)

1560 BRU14121692NP Hurix's Panau Salap &Gatal-Gatal

Kecil

Zinc oxide 5% w/w; Menthol 1% w/w;

Salicylic Acid/2-Hydroxybenzoic acid 5%

w/w & Camphor 3% w/w

Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May

2020

GSL

1561 BRU14121693NP Hurix Corn Rid Solution 5% w/w lactic Acid 5% w/v; Salicylic Acid 17% w/v Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May

2020

GSL

1562 BRU14121694NP Hurix Corn Solution 17% Salicylic Acid 0.17g(17%w/v) Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May

2020

GSL

1563 BRU14121695P Axcel Fungicort Cream Miconazole nitrate 2%w/w;

Hydrocortisone 1% w/w

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1564 BRU14121696P Methacid 25mg tablet Indomethacin 25mg Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1565 BRU14121697NP Dettol Antiseptic Wound Wash

Spray

benzalkonium chloride 0.198% Reckitt Benckiser Healthcare (UK) Ltd., UK Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1566 BRU14121698P Edurant Film-Coated 25mg tablet Rilpivirine (as hydrochloride) 25mg Janssen-Cilag S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1567 BRU14121699P Invokana 300mg FCT Canagliflozin 300mg (as hemihydrate) Janssen Ortho, LLC, Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1568 BRU14121700P Amlodipine Tablet 10mg Amlodipine Tablet 10mg Jubilant Generics, Limited, India Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1569 BRU14121701P Borymycin Capsule 100mg Minocycline HCl 100mg Y.S.P., Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1570 BRU14121702NP Septi-Sol Solution Chlorhexidine Gluconate 20% Solution -

0.5% w/v; Ethanol 94% - 77% v/v

Pahang Pharmacy Sdn Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1571 BRU14121703P Atoris Film-coated Tablet 20mg Atorvastatin (as calcium) 20mg KRKA, d.d., Slovenia K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1572 BRU14121704NP Nutrilite Glucosamine HCl

Capsule 375mg

Glucosamine HCl 375mg Pharmaniaga Manufacturing Berhad,

Malaysia

Amway Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1573 BRU14121705P Ultibro Breezhaler 110/50 mcg

Inhalation Powder Hard Capsule

Indacaterol (as maleate) 110mcg (143

mcg); Glycopyrronium (as bromide) 50mcg

(63 mcg)

Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1574 BRU15011706P Zyprexa Zydis

OrodispersibleTablet 5mg

Olanzapine micronized 5mg Catalent UK Swindon Zydis Ltd, UK Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1575 BRU15011707P Zyprexa Zydis

OrodispersibleTablet 10mg

Olanzapine micronized 10mg Catalent UK Swindon Zydis Ltd, UK Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1576 BRU15011708P Requip PD 24hr 8mg Prolong

Release Tablet

Ropinirole 8mg (as hydrochloride) Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1577 BRU15011709P Klacid MR 500mg Tablet Clarithromycin 500mg Aesica Queensborough Ltd, UK Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1578 BRU15011710P Klerimed 250mg FC Tablets Clarithromycin 250mg (as anhydrous) Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/1116 Page 93 of 117

Page 94: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1579 BRU15011711P DiSuf-B Cream Fusidic acid (micronized) 2.0% w/w &

Betamethasone 0.1%w/w (as valerate)

Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1580 BRU15011712NP Dhalumag Suspension Per 5ml - Magnesium trisilicate BP 500mg,

Dried Aluminium Hydroxide BP 250mg

Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1581 BRU15011713P Binoclar® 500mg Film-coated

Tablets

Clarithromycin 500mg Novartis Bangladesh Ltd, Bangladesh Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1582 BRU15011714P Ospamox 250mcg/5ml granules

for suspension

Amoxicillin 250mg (as trihydrate 287mg) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1583 BRU15011715P Ospamox 250mg Capsule Amoxicillin 250mg (as trihydrate 287mg) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1584 BRU15011716P Ospamox 500mg Film-coated

Tablet

Amoxicillin 500mg (as trihydrate 574mg) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1585 BRU15011717P Salofalk® 500mg Gastro-Resistant

Prolonged-Release Granules

Mesalazine 500mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1586 BRU15011718P Salofalk® 1000mg Gastro-

Resistant Prolonged-Release

Granules

Mesalazine 1000mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1587 BRU15011719P Vaqta® Vaccine 50U/ml Hepatitis A Virus, Purified, Inactivated

50U/ml

Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1588 BRU15011720P Vaqta® Vaccine 25U/0.5ml Hepatitis A Virus, Purified, Inactivated

25U/0.5ml

Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1589 BRU15011721P Salofalk® 3000mg Gastro-

Resistant Prolonged-Release

Granules

Mesalazine 3g Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1590 BRU15011722P T3 Ada Gel 0.1% Adapalene 0.1% Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1591 BRU15011723P Clarimycin Film Coated Tablet

250mg

Clarithromycin 250mg Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1592 BRU15011724P Forteo Injection 20mcg/80mcl Each ml contains 250mcg of Teriparatide

(recombinant of human parathyroid

hormone (1-34) [rhPTH (1-34)])

Lilly France SAS, France Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1593 BRU15011725P Torisel Concentrate for Injection

25mg/ml

Temsirolimus 25mg/ml Pierre Fabre Medicament Production

(PFMP), France

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1594 BRU15011726P Ursofalk 500mg Film-coated

Tablets

Ursodeoxycholic acid 500mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1595 BRU15011727P Bactigen Eye Drops 0.3% Gentamicin 0.3% (as Gentamicin Sulphate) FDC Limited, India K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/1116 Page 94 of 117

Page 95: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1596 BRU15011728P Hexaxim Suspension for Injection Per dose (0.5ml):

Dipththeria toxoid 30 Lf (≥ 20IU), Tetanus

toxoid 10 Lf (≥ 40IU), Bordetella pertussis

antigens: Pertussis toxoid 25µg,

Filamentous haemagglutinin 25µg, Polio

Virus (Inactivated): Type 1 (Mahoney) 40

DU, Type 2 (MEF-1) 8 DU, Type 3 (Saukett)

32 DU, Hepatitis B surface antigen 10 µg,

Haemophilus influenzae tybe b

polysaccharide (Polyribosylribitol

phosphate) . 12µg, conjugated to Tetanus

protein (PRP-T) 22-36µg

Sanofi Pasteur Marcy I’Etoile (MLE),

France; Sanofi Pasteur Val de Reuil,

France; Sanofi Pasteur SPA, Italy

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1597 BRU15011729P Nootropil Solution 20% Piracetam 20g/100ml NextPharma SAS., France Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1598 BRU15011730P Bridion Solution for Injection

100mg/ml

Sugammadex 100mg/ml N.V. Organon, The Netherlands; Organon

(Ireland) Ltd., Ireland; Patheon

Manufacturing Services LLC, USA

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1599 BRU15011731P Serlift Tablets 100mg Setraline hydrochloride 100mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1600 BRU15011732NP Strepsils Soothing Honey &

Lemon

Amylmetacresol 0.6ml; 2,4-Dichlorobenzyl

alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1601 BRU15011733NP Strepsils Max Blackcurrant

Lozenge

Hexylresorcinol 2.4mg Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1602 BRU15011734P Implanon NXT Implant 68mg Etonogestrel N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1603 BRU15011735PS1 &

BRU15011735PS2

Stocrin Tablet 200mg Efavirenz 200mg Merck Sharp & Dohme (Australia) Pte Ltd

Australia; Zhejian Huahai Pharmaceutical

Co. Ltd., China

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1604 BRU15011736PS1 &

BRU15011736PS2

Stocrin Tablet 600mg Efavirenz 600mg Merck Sharp & Dohme (Australia) Pte Ltd

Australia; Zhejian Huahai Pharmaceutical

Co. Ltd., China

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1605 BRU15011737P Magnevist Injection 469mg/ml Each ml contains 0.5mmol gadopentetate

dimeglumine (eqv. to 469.01mg

gadopentetate dimeglumine)

Bayer Pharma AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1606 BRU15011738NP Bactidol Mouthwash Hexetidine 0.1% w/v Interphill Laboratories Inc., Philippines LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1607 BRU15011739P Nicotinell TTS 10 Nicotine 17.5mg (delivers 7mg/24hours) LTS Lohmann Therapie-System AG,

Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

GSL

BDMCA/RMP/1116 Page 95 of 117

Page 96: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1608 BRU15011740P Nicotinell TTS 20 Nicotine 35mg (delivers 14mg/24 hours) LTS Lohmann Therapie-System AG,

Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1609 BRU15011741P Nicotinell TTS 30 Nicotine 52.5mg (delivers 21mg/24 hours) LTS Lohmann Therapie-System AG,

Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1610 BRU15011742NP Natzema Eczema Relief Cream Benzoin tincture 10mg/g; Lavender

Angustifolia Oil 5mg/g; Citrus Sinensis Peel

Oil 5mg/g

Cosmetics Manufacturer (Aust) Pty Ltd,

Australia

Bossom Buddies Enterprise 19 May 2015 till 18 May

2020

GSL

1611 BRU15011743P Pharmaniaga Germacid Cream 2% Fusidic acid 2.0% w/w Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1612 BRU15011744P Extraneal Peritoneal Dialysis

Solution 75g/l (2L Ultrabag)

Each 100ml contains Icodextrin 7.5g,

Sodium Chloride 538mg,

Sodium lactate 448mg, Calcium chloride

dihydrate 25.7mg and Magnesium Chloride

Hexahydrate 5.08mg

Baxter Healthcare SA., Singapore Branch Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1613 BRU15011745P Seladin 250mg tablet Naproxen 250mg Y.S.P Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1614 BRU15011746NP Vitalipid N Adult 1ml contains: Vitamin A 330IU (as retinoyl

palmitate 99mg), Ergocalciferol

0.5mg(»Vitamin D2 20IU), All-rac-a-

Tocopherol 0.91mg(»Vitamin E 1IU),

Phytomenadione (Vitamin K1) 15mg

Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1615 BRU15011747NP Vitalipid N Infant 1ml contains: Vitamin A 230IU (as retinoyl

palmitate 69mg), Ergocalciferol

1.0mg(»Vitamin D2 40IU), All-rac-a-

Tocopherol 0.64mg(»Vitamin E 0.71IU),

Phytomenadione (Vitamin K1) 20mg

Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1616 BRU15011748P Caslot 6.25mg tablet Carvedilol 6.25mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1617 BRU15011749P Caslot 12.5mg tablet Carvedilol 12.5mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1618 BRU15011750NP Prismasol BO Each 1000ml contains (before

reconstitution): Calcium chloride dihydrate

5.145g, Magnesium chloride hexahydrate

2.033g, Lactic acid 5.4g, Sodium chloride

6.45g & Sodium bicarbonate 3.09g

Gambro Dasco S.p.A., Italy Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1619 BRU15021751P Kogenate FS for Injection

1000IU/vial

Antihemophilic factor (recombinant)

sucrose formulated 1000IU

Vetter Pharma-Fertigung GmbH & Co. KG,

Germany; Bayer Pharma AG, Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1620 BRU15021752P Kogenate FS for Injection

500IU/vial

Antihemophilic factor (recombinant)

sucrose formulated 500IU

Bayer Healthcare LLC, United States Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/1116 Page 96 of 117

Page 97: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1621 BRU15021753P Dimenate Syrup 15mg/5ml Dimenhydrinate 15mg/5ml Drug Houses of Australia Private Limited,

Singapore

G & H Trading Company 19 May 2015 till 18 May

2020

POM (3.8L)

1622 BRU15021754P Cernevit Multivitamin Powder for

Injection

Each vial contains: Retinol palmitate

(VitaminA) 3500 IU, Cholecalciferol

(Vitamin D3) 220 IU, DL alpha tocopherol

(Vitamin E) 10.2 mg, Ascorbic acid (Vitamin

C) 125mg, Cocarboxylase tetrahydrate

(Vitamin B1) 5.8mg, Riboflavin sodium

phosphate dehydrate (Vitamin B2) 5.67mg,

Pyridoxine hydrochloride (Vitamin B6)

5.5mg, Cyanocobalamin (Vitamin B12)

0.006mg, Folic acid 0.414mg,

Dexpanthenol 16.15mg, Biotin 0.069mg,

Nicotinamide 46mg

Baxter SA, Belgium Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1623 BRU15021755P Baneocin Ointment Bacitracin Zinc 250IU/1g; Neomycin

Sulphate 5000 IU (5mg)/1g

Merck Kommanditgesellschaft Auf Aktein

& Co., Werk, Austria

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1624 BRU15021756P Ospexin 125mg/5ml granules for

oral suspension

Cephalexin 125mg/5ml Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1625 BRU15021757P Simponi Solution for Injection in

Pre-filled Syringe 50mg/0.5ml

Golimumab 50mg/0.5ml Baxter Pharmaceutical Solutions LLC, USA

(Repacker - Cilag AG, Switzerland)

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1626 BRU15021758P Histac Tablets 150mg Ranitidine Hydrochloride 150mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1627 BRU15021759P Beclazone 100micrograms CFC-

Free Inhaler

Beclomethasone Dipropionate

100micrograms/metered inhalation

Norton Waterford T/A Ivax

Pharmaceuticals Ireland

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1628 BRU15021760PS1 &

BRU15021760PS2

Insulatard 100IU/ml Suspension

for Injection (vial)

1ml of suspension contain 100IU (3.5g) of

insulin

Novo Nordisk A/S, Denmark (S1); Novo

Nordisk Production SAS, France (S2)

Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

POM

1629 BRU15021761P Covapril Tablet 4mg Perindopril Erbumine Upha Pharmaceutical Mfg (M) Sdn Bhd,

Malaysia

K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1630 BRU15021762P Axcel Amlodipine 5mg Tablet Amlodipine Besylate equivalent to

Amlodipine 5mg

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1631 BRU15021763P Neurontin Capsule 400mg Gabapentin 400mg Pfizer Pharmaceuticals LLC., Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1632 BRU15021764P Miostat Intraocular Solution Carbachol 0.1mg/ml Alcon Laboratories Inc., USA Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1633 BRU15021765P NutrIflex Lipid Plus 1 unit consists of Amino Acid Solution;

Glucose Solution; Lipid Emulsion* (For

Detailed Formulation referred to Dossier)

B.Braun Melsungen AG, Germany Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1634 BRU15021766P Neulastim Pre-filled Syringe

6mg/0.6ml

Pegfilgrastim 6mg/0.6ml F-Hoffman-La Roche Ltd., Switzerland Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/1116 Page 97 of 117

Page 98: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1635 BRU15021767P Bacitrecin-N Ointment Bacitracin Zinc 12.5mg (potency)

(Equivalent to Bacitracin Zinc 500 units);

Polymyxin B Sulfate 0.83mg (potency)

(Equivalent to Polymyxin B Sulfate 5,000

units); Neomycin Sulfate 3.5mg (potency)

Y.s.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1636 BRU15021768P Exelon Patch 15 Rivastigmine base 27mg / 15cm2 (In vivo

release rate 13.3mg/24h)

LTS Lohmann Therapie-Systeme AG,

Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1637 BRU15021769P Zellox-II, Double Strength Liquid

Antacid

Per 10ml - Aluminium Hydroxide 800mg;

Magnesium Hydroxide 800mg;

Simethicone 60mg

Hoe Pharmaceuticals Sdn Bhd Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1638 BRU15021770P Bonjela Gel 15g tube Choline Salicylate 8.714% & Cetalkonium

chloride 0.01%

Reckitt Benckiser Healthcare (UK) Ltd., UK Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1639 BRU15021771P Gilenya 0.5mg hard capsule Fingolimod 0.5mg (corresponding to

0.56mg Fingolimod Hydrochloride)

Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1640 BRU15021772P Presolin 150 tablet Irbesartan 150mg Unison Laboratories Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1641 BRU15021773P Presolin 300 tablet Irbesartan 300mg Unison Laboratories Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1642 BRU15021774P Tracidol Injection 50mg/ml Tramadol Hydrochloride 50mg/ml Y.S.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1643 BRU15021775P Hurix Skin Ointment 5%w/w Benzoic acid 5%; Sulphur 25; Salicyllic acid

5%; Camphor 3%; Menthol 1% w/w

Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May

2020

GSL

1644 BRU15021776P Apo-Risperidone 2mg tablet Risperidone 2mg Apotex Inc, Canada Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1645 BRU15021777P Apo-Megestrol 160mg tablet Megestrol acetate 160mg Apotex Inc, Canada Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1646 BRU15021778P Olapine 5mg FCT Megestrol acetate 160mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1647 BRU15021779P Trajenta Duo 2.5mg/500mg FCT

tablet

Linagliptin 2.5mg; Metformin

hydrochloride 500mg

Boehringer Ingelheim GmbH and Co. KG.,

Germany

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1648 BRU15021780P Trajenta Duo 2.5mg/850mg FCT Linagliptin 2.5mg; Metformin

hydrochloride 850mg

Boehringer Ingelheim GmbH and Co. KG.,

Germany

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1649 BRU15021781P Trajenta Duo 2.5mg/1000mg film-

coated tablets

Linagliptin 2.5mg; Metformin

hydrochloride 1000mg

Boehringer Ingelheim GmbH and Co. KG.,

Germany

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1650 BRU15021782P Humalog 100u/ml (Catridge) Insulin Lispro 100 units/ml Lillly France, France Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1651 BRU15021783P Acustop Cataplasma Flurbiprofen 40mg Green Cross Corporation, Korea Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1652 BRU15021784P Toviaz 4mg prolonged-release

tablet

Fesoterodine fumarate equivalent to

3.1mg fesoterodine

Aesica Pharmaceuticals GmbH, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1653 BRU15021785P Toviaz 8mg prolonged-release

tablet

Fesoterodine fumarate equivalent to

6.2mg fesoterodine

Aesica Pharmaceuticals GmbH, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/1116 Page 98 of 117

Page 99: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1654 BRU15021786P Giotrif 20mg film-coated tablets

(Afatinib 20mg)

Afatinib (as dimaleate) 20mg Boehringer Ingelheim GmbH and Co. KG.,

Germany

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1655 BRU15021787P Giotrif 30mg film-coated tablets

(Afatinib 20mg)

Afatinib (as dimaleate) 30mg Boehringer Ingelheim GmbH and Co. KG.,

Germany

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1656 BRU15021788P Giotrif 40mg film-coated tablets

(Afatinib 20mg)

Afatinib (as dimaleate) 40mg Boehringer Ingelheim GmbH and Co. KG.,

Germany

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1657 BRU15021789P Giotrif 50mg film-coated tablets

(Afatinib 20mg)

Afatinib (as dimaleate) 50mg Boehringer Ingelheim GmbH and Co. KG.,

Germany

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1658 BRU15021790P Mikostat oral suspension 30ml

(Nystatin 100,000 IU/ml)

Nystatin 100,000 IU/ml Gulf Pharmaceutical Industries (Julphar),

United Arab Emirates

K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1659 BRU15021791P Losartan Winthrop 50mg tablet Losartan Potassium 50mg Zentiva, a.as., Slovak Republic Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

POM

1660 BRU15021792P Losartan Winthrop 100mg tablet Losartan Potassium 100mg Zentiva, a.as., Slovak Republic Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

POM

1661 BRU15021793P SMOFlipid 20% Emulsion for

Infusion

1000ml contain: Soya-bean oil, refined 60

g, Medium-chain triglycerides 60 g, Olive

oil, refined 50 g, Fish oil, rich in omega-2-

acids 30 g

Fresenius Kabi Austria GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1662 BRU15021794NP Aminoven 10% Isoleucine 5.00g/L; Leucine 7.4g/L; Lysine

acetate= Lysine 9.31g/L; Methionine

4.3g/L; Phenylalanine 5.1g/L; Threonine

4.4g/L; Tryptophan 2.0 g/L; Valine 6.2 g/L;

Arginine 12.0g/L; Histidine 3.0 g/L, Alanine

14.0 g/L, Glycine 11.0 g/L; Proline 11.2 g/L;

Serine 6.5g/L; Tyrosine 0.4g/L; Taurine

1.0g/L.

Fresenius Kabi Austria GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1663 BRU15021795P Ceflour CFT 250mg Cefuroxime (as Cefuroxime Axetil) 250mg Yung Shin Pharmaceutical Ind. Co. Ltd.,

Republic of China

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1664 BRU15021796P Montelair 10mg film-coated

tablet

Montelukast (as Montelukast Sodium)

10mg

Hovid Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1665 BRU15021797P Amlibon 10mg tablet Amlodipine (as Amlodipine Besilate) 10mg Lek Pharmaceuticals D.D., Solvenia Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1666 BRU15021798NP Dianeal Low Calcium (2.5MEq/L)

Peritoneal Dialysis Solution with

4.25% Dextrose (2L Ultrabag)

Each 100ml contains: Dextrose Hydrous

4.25g; Sodium Chloride 538mg; Sodium

Lactate 448mg; Calcium Chloride dihydrate

18.3mg; and Magnesium Chloride

Hexhydrate 5.08mg

Baxter Healthcare SA., Singapore Branch Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/1116 Page 99 of 117

Page 100: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1667 BRU15021799NP Dianeal Low Calcium (2.5MEq/L)

Peritoneal Dialysis Solution 2.5%

Dextrose (2L Ultrabag and 2.5L

Ultrabag)

Each 100ml contains: Dextrose Hydrous

2.5g; Sodium Chloride 538mg; Sodium

Lactate 448mg; Calcium Chloride dihydrate

18.3mg; and Magnesium Chloride

Hexhydrate 5.08mg

Baxter Healthcare SA., Singapore Branch Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1668 BRU15021800NP Dianeal Low Calcium (2.5MEq/L)

Peritoneal Dialysis Solution 1.5%

Dextrose (2L Ultrabag and 2.5L

Ultrabag)

Each 100ml contains: Dextrose Hydrous

1.5g; Sodium Chloride 538mg; Sodium

Lactate 448mg; Calcium Chloride dihydrate

18.3mg; and Magnesium Chloride

Hexhydrate 5.08mg

Baxter Healthcare SA., Singapore Branch Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1669 BRU15021801NP Calactate 300mg tab Calcium Lactate pentahydrate 300mg Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1670 BRU15021802P Xylid 250mg tab Cefuroxime Axetil 250mg Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1671 BRU15021803P Colospan 10mg sugar coated

tablet

Hyoscine Butylbromide 10mg Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1672 BRU15021804P Caslot 25mg tablet Carvedilol 25mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1673 BRU15021805P Serenata 50mg Tablet Sertraline hydrochloride 56mg equivalent

to Sertraline 50mg

Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1674 BRU15021806P Gammaplex 5% w/v 2.5g Human Immunoglobulin G 2.5g/50ml Bio Product Lab, UK Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

POM

1675 BRU15021807P Gammaplex 5% w/v 5g Human Immunoglobulin G 5g/100ml Bio Product Lab, UK Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

POM

1676 BRU15021808P Gammaplex 5% w/v 10g Human Immunoglobulin G 10g/200ml Bio Product Lab, UK Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

POM

1677 BRU15031809P Moxiclav Forte Dry Powder for

Oral Suspension 312.5mg/5ml

Amoxicillin (as trihydrate) 250mg &

Clavulanic acid 62.5mg

Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May

2020

POM

1678 BRU15031810P Moxiclav 625mg Tablets Amoxicllin trihydrate (574mg) 500mg;

clavulanate potassium microcrystalline

cellulose (297.8mg) eq. to clavulanic acid

125mg

Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May

2020

POM

1679 BRU15031811P Zemplar Injection Paricalcitol 5mcg/ml Hospira S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1680 BRU15031812P Lamotrix 100mg Tablets Lamotrigine 100mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May

2020

POM

1681 BRU15031813P Lamotrix 50mg Tablets Lamotrigine 50mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/1116 Page 100 of 117

Page 101: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1682 BRU15031814P NimenrixTM (Meningococcal

polysaccharide serogroups A,C,W-

135, Y) Vaccine

MenAAH-TT-conjugate (Mean TT/PS ratio:3)

5mcg PSA~15mcg TT, MenCAH-TT-conjugate

(Mean TT/PS ratio:3) 5mcg PSC~15mcg TT,

MenW-TT-conjugate (Mean TT/PS

ratio:1.5) 5mcg PSW~7.5mcg TT, MenY-TT-

conjugate (Mean TT/PS ratio:1.3) 5mcg

PSY~6.5mcg TT

Glaxosmithkline Biologicals s.a., Rixensart,

Belgium; GlaxoSmithKline Biologicals,

Branch of SmithKline Beecham Pharma

GmbH & Co. KG., Dresden

Germany (diluent Ampoule); Delpharm

Tours, Chambray-lès-Tours

France (Diluent ampoule);

GlaxoSmithKline Biologicals SA, Rixensart

Belgium (diluent PFS); Catalent Belgium

SA, Brussels, Belgium (diluent PFS);

GlaxoSmithKline Biologicals S.A. , Wavre

Belgium (Additional facility for

formulation)

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1683 BRU15031815P Cialis 2.5mg Tablet Tadalafil 2.5mg Lily del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1684 BRU15031816P Cialis 5mg Tablet Tadalafil 5mg Lily del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1685 BRU15031817P Cialis 20mg Tablet Tadalafil 20mg Lily del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1686 BRU15031818NP Tempol Tablet 500mg Paracetamol Tablet 500mg Duopharma (M) Sdn. Bhd., Malaysia Hongkiat Trading & Company 19 May 2015 till 18 May

2020

P (50 x 10’s)

1687 BRU15031819P Placta Film-coated Tablets 75mg Clopidogrel (as bisulphate) 75mg Actavis Ltd., Malta G&H Trading Company 19 May 2015 till 18 May

2020

POM

1688 BRU15031820P SmofKabiven Peripheral Emulsion

for Infusion

1 unit consists of Amino Acid Solution;

Glucose Solution; Lipid Emulsion (For

detailed formulation referred to dossier)

Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1689 BRU15031821P Ometec capsule 20mg Omeprazole 20mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May

2020

POM

1690 BRU15031822P Elantan® long sustained-release

capsule

Isosorbide-5-mononitrate 50mg GlaxoSmithKline Pharmaceuticals Sdn.

Bhd., Malaysia

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1691 BRU15031823P ADVATE 500IU Powder and

Solvent for Solution for Injection

Octocog alfa (recombinant human

coagulation factor VIII)

Baxter BioScience Manufacturing Sàrl,

Switzerland

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1692 BRU15031824NP Livovid Forte Capsule Lecithin soya bean (300mg phosphatidyl

choline) 858.0mg, Thiamine hydrochloride

(4.7mg vitamin B1) 6mg, Riboflavin 6mg,

Pyridoxine hydrochloride (4.93mg of

vitamin B6) 6mg, Cyanocobalamin

0.006mg, Nicotinamide 30mg, dl-alpha-

tocopherol acetate 6IU

Hovid Bhd., Malaysia G&H Trading Company 19 May 2015 till 18 May

2020

GSL

BDMCA/RMP/1116 Page 101 of 117

Page 102: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1693 BRU15031825P Saizen® Liquid 12mg (8mg/ml) Somatropin 12mg/1.5ml (recombinant

human growth hormone)

Merck Serono S.p.A., Italy G&H Trading Company 19 May 2015 till 18 May

2020

POM

1694 BRU15031826P Saizen® Liquid 6mg (5.83mg/ml) Somatropin 6mg/1.03ml (recombinant

human growth hormone)

Merck Serono S.p.A., Italy G&H Trading Company 19 May 2015 till 18 May

2020

POM

1695 BRU15031827P Torpezil Tablets 10mg Donepezil hydrochloride 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May

2020

POM

1696 BRU15031828P Torpezil Tablets 5mg Donepezil hydrochloride 5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May

2020

POM

1697 BRU15031829NP BrevoxylTM 4% cream Hydrous Benzoyl Peroxide (eq. to benzoyl

peroxide 4%)

Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1698 BRU15031830NP Gaviscon Liquid Sachet Each 10ml contains: Sodium alginate

500mg, Sodium bicarbonate 267mg and

Calcium carbonate 160mg

Reckitt Benckiser Healthcare (UK) Ltd., UK Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1699 BRU15031831NP Fisherman’s Friend Sugar-Free

Apple & Cinnamon Lozenges

Menthol 4.025mg IDS Manufacturing Sdn. Bhd., Malaysia Kingston Beverage & Creamery

Sdn. Bhd.

19 May 2015 till 18 May

2020

GSL

1700 BRU15031832NP Fisherman’s Friend Sugar-Free

Mandarin & Ginger Lozenges

Menthol 4.6mg IDS Manufacturing Sdn. Bhd., Malaysia Kingston Beverage & Creamery

Sdn. Bhd.

19 May 2015 till 18 May

2020

GSL

1701 BRU15031833NP Fisherman’s Friend Sugar-Free

Lemon Lozenges

Menthol 4.6mg IDS Manufacturing Sdn. Bhd., Malaysia Kingston Beverage & Creamery

Sdn. Bhd.

19 May 2015 till 18 May

2020

GSL

1702 BRU15041834P Rotaqor 20mg film-coated tablet Atorvastatin Calcium 20mg Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1703 BRU15041835P Jakavi 20mg tablet Ruxolitinib (as phosphate 26.40mg) 20mg Novartis Pharma Stein, AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1704 BRU15041836P Jakavi 15mg tablet Ruxolitinib (as phosphate 19.8mg) 15mg Novartis Pharma Stein, AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1705 BRU15041837P Jakavi 5mg tablet Ruxolitinib (as phosphate 6.6mg) 5mg Novartis Pharma Stein, AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1706 BRU15041838P Rocephin for Injection 250mg IM Ceftriaxone sodium (eq. to ceftriaxone

250mg/vial)

F.Hoffman-La Roche Ltd., France Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1707 BRU15041839P Archifar 500mg powder for

injection/infusion

Meropenem (as trihydrate) 500mg Medochemie Ltd, Cyprus Hong Kiat Trading & Co. 19 May 2015 till 18 May

2020

POM

1708 BRU15041840P Ciproflo 2mg/ml solution for IV

infusion

Ciprofloxacin 2mg/ml (as hydrochloride) Sin Guan Chem. Ind. Co. Ltd., Republic of

China

K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May

2020

POM

1709 BRU15041841P Omezole 20mg capsule Omeprazole 20mg Hovid Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1710 BRU15041842P B-Mycin cream Betamethasone dipropionate 0.643mg (eq.

to 0.5mg betamethasone); Gentamicin

Sulfate 1mg (potency)

Y.S.P. Industries (M) Sdn. Bhd., Malaysia Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1711 BRU15041843P Mucodin syrup 250mg/5ml Carbocysteine 250mg/5ml Sunward Pharmaceutical Sdn. Bhd.,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

P

BDMCA/RMP/1116 Page 102 of 117

Page 103: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1712 BRU15041844P Pharmaniaga Loratadine tablet

10mg

Loratadine 10mg Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

P

1713 BRU15041845P Curam 1000mg tablet Amoxycillin 875 (as trihydrate); clavulanic

acid 125mg (as potassium clavulanate)

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1714 BRU15041846P Vancotex Injection 500mg Vancomycin (as hydrochloride) 500mg Fisiopharma S.r.L., Italy K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May

2020

POM

1715 BRU15041847P Sunadine tablet 10mg Loratadine 10mg Sunward Pharmaceutical Sdn. Bhd.,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

P

1716 BRU15041848NP Soluvit N Powder for Solution for

Infusion

Thiamine mononitrate 3.1mg

(corresponding to vitamin B1 2.5mg);

Riboflavine sodium phosphate 4.9mg

(corresponding to vitamin B2

3.6mg);Nicotinamide 40mg; Pyridoxine

Sino Swed Pharmaceutical Corp. Ltd.,

China

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1717 BRU15041849NP Folic acid 5mg tablet Folic acid 5mg Sunward Pharmaceutical Sdn. Bhd.,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

P

1718 BRU15041850P Estelle-35 tablet Cyproterone acetate 2mg; Ethinylestradiol

0.03mg

Douglas Manufacturing Limited, New

Zealand

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1719 BRU15041851NP Cetomacragol emulsifying

ointment

Cetomacragol emulsifying wax 30% w/w;

liquid paraffin 20%; white soft paraffin

50%

Hovid Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1720 BRU15041852PS1/

BRU15041852PS2

Glucophage® XR 1000mg

Extended-release tablet

Metformin (as hydrochloride 1000mg)

780mg

1. Merck Sante SAS, France;

2. Merck KGaA, Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1721 BRU15041853P Duofilm Liquid Salicylic acid 16.7% w/w; lactic acid 16.7% Stiefel Labs (Ireland) Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

P

1722 BRU15041854NP Voluven Solution for Infusion 6% Per 1000ml: Poly (O-2-hydroxyethyl) starch

60.0g; sodium chloride 9.00g

Frensius Kabi Deutschland GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1723 BRU15041855NP Iris eye drops Hydroxypropyl methylcellulose 3mg;

dextran 70 1mg

Sam Chun Dang Pharm Co Ltd, South

Korea

Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1724 BRU15041856P Onzapin film-coated tablet 5mg Olanzapine 5mg Actavis Ltd., Malta G & H Trading Company 19 May 2015 till 18 May

2020

POM

1725 BRU15041857P Onzapin film-coated tablet 10mg Olanzapine 10mg Actavis Ltd., Malta G & H Trading Company 19 May 2015 till 18 May

2020

POM

1726 BRU15041858NP Fisherman’s friend aniseed

lozenges

Menthol 5.75mg Lofthouse of Fleetwood Limited, UK Kingston Beverage & Creamery

Sdn Bhd

19 May 2015 till 18 May

2020

GSL

1727 BRU15041859NP Fisherman’s Friend Sugar Free

Mint Lozenges

Menthol 3.45mg Lofthouse of Fleetwood Limited, UK Kingston Beverage & Creamery

Sdn Bhd

19 May 2015 till 18 May

2020

GSL

1728 BRU15041860NP Fisherman’s Friend Sugar Free

Cherry Lozenges With Menthol

6.9mg

Menthol 6.9mg Lofthouse of Fleetwood Limited, UK Kingston Beverage & Creamery

Sdn Bhd

19 May 2015 till 18 May

2020

GSL

1729 BRU15041861NP ChlorHex 5% Concentrate

Solution

Chlorhexidine gluconate 5% w/v;

isopropylaocohol 3.15% w/v

Pahang Pharmacy Sdn Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1730 BRU15041862P Salmax CR tablet 4mg Salbutamol sulphate 4mg Upha Pharmaceuticals Sdn Bhd, Malaysia Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/1116 Page 103 of 117

Page 104: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1731 BRU15051863NP SP Pharma Paracetamol Tablets

500mg

Paracetamol 500mg Simpor Pharma Sendirian Berhad, Brunei

Darussalam

Simpor Pharma Sendirian

Berhad

19 May 2015 till 18 May

2020

P (200’s)

1732 BRU15051864NP Addamel™ N Concentrate for

Infusion

1 mL contains: Chromic chloride 6 H2O 5.33

µg; Copper chloride 2 H2O 340 µg; Ferric

chloride 6 H2O 540 µg; Manganese

chloride 4 H2O 99 µg; Potassium iodide

16.6 µg; Sodium fluoride 210 µg; Sodium

molybdate 2 H2O 4.85 µg; Sodium selenite

anhydrous 6.90 µg; Zinc chloride 1.36 mg

Fresenius Kabi Norge AS, Norway Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1733 BRU15051865NP Dettol Moisturing Formula

Antiseptic Cream

Triclosan 0.3%; Chloroxylenol 0.3%; Edetic

acid 0.2%

Reckitt Benckiser Healthcare (UK) Ltd., UK Syarikat Aliaa Sdn Bhd 28 July 2015 till 27 July 2020 GSL

1734 BRU15051866P Dophilin Tablets 2mg Doxazosin (as mesylate) 2mg Taiwan Biotech Co. Ltd., Taiwan R.O.C. K-Seri Pharma Sdn Bhd 28 July 2015 till 27 July 2020 POM

1735 BRU15051867NP Kabiven Peripheral Emulsion for

Infusion

1000ml of the mixture contain: Purified

soybean oil 35g; Glucose (anhydrous) 68g;

Alanine 3.3g; Arginine 2.4g; Aspartic acid

0.71g; Phenylalanine 1.6g; Glutamic acid

1.2g; Glycine 1.6g; Histidine 1.4g;

Isoleucine 1.2g; Leucine 1.6g; Lysine 1.9g;

Methionine 1.2g; Proline 1.4g; Serine

0.94g; Threonine 1.2g; Tryptophan 0.40g;

Tyrosine 0.05g; Valine 1.5g; Sodium

glycerophosphate (anhydrous) 1.0g;

Calcium chloride 0.15g; Potassium chloride

1.2g; Magnesium sulphate 0.33g; Sodium

acetate 1.0g

Fresenius Kabi AB, Uppsala, Sweden Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1736 BRU15051868NP Kabiven Emulsion for Infusion Fresenius Kabi AB, Uppsala, Sweden Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1737 BRU15051869P Dopatab M250 Tablet Methyldopa 250mg Hovid Bhd., Malaysia G & H Trading Company 28 July 2015 till 27 July 2020 POM

1738 BRU15051870P Fenagesic Tablet 250mg Mefenamic acid 250mg Sunward Pharmaceutical Pte Ltd.,

Singapore

G & H Trading Company 28 July 2015 till 27 July 2020 POM

1739 BRU15051871P Metta SR Tablets 500mg Metformin Hydrochloride USP 500mg Torrent Pharmaceuticals Ltd., Indrad,

India

K-Seri Pharma Sdn Bhd 28 July 2015 till 27 July 2020 POM

1740 BRU15051872P Diamitex Tablet 80mg Gliclazide 80mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 28 July 2015 till 27 July 2020 POM

1741 BRU15051873NP Calamine Lotion Calamine BP 15% w/v Royce Pharma Manufacturing Sdn Bhd,

Malaysia

SWL Biomed Sales & Services 28 July 2015 till 27 July 2020 GSL

1742 BRU15051874NP Fisherman’s Friend Original

Lozenges

Menthol 10.35mg; Eucalyptus oil 1.73mg Lofthouse of Fleetwood Limited, UK Kingston beverage & Creamary

Sdn Bhd

28 July 2015 till 27 July 2020 GSL

BDMCA/RMP/1116 Page 104 of 117

Page 105: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1743 BRU15051875NP Fisherman’s Friend Mint Lozenges Menthol 4.6mg; Peppermint oil 11.270mg Lofthouse of Fleetwood Limited, UK Kingston beverage & Creamary

Sdn Bhd

28 July 2015 till 27 July 2020 GSL

1744 BRU15051876NP Fisherman’s Friend Sugar Free

Original Lozenges

Menthol 9.2mg IDS Manufacturing Sdn Bhd, Malaysia Kingston beverage & Creamary

Sdn Bhd

28 July 2015 till 27 July 2020 GSL

1745 BRU15051877P Progyluton Tablet Estradiol Valerate (in brown tablet) 2mg;

Estradiol Valerate (in white tablet) 2mg;

Norgestrel (in brown tablet) 0.5mg

Bayer Weimar GmbH und Co. KG.,

Germany

Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1746 BRU15051878P Loratyn-10 Loratadine 10mg Hovid Bhd., Malaysia G & H Trading Company 28 July 2015 till 27 July 2020 POM (100's); P

(20's)

1747 BRU15051879P Candazole V Single Dose Cream

10% w/w

Clotrimazole 10% w/w HOE Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Company 28 July 2015 till 27 July 2020 POM

1748 BRU15052038P GPO-L-OneTM 500mg Tablet Deferiprone 500mg The Government Pharmaceutical

Organization (GPO), Thailand

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1749 BRU15061880P Keppra® Oral Solution 100mg/ml Levetiracetam 10mg/ml NextPharma SAS., France Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1750 BRU15061881P Norditrophin Nordilet Inejction

5mg/1.5ml Pre-filled Pen,

Solution for Injection

Somatropin (rDNA) 3.3mg/ml Nove Nordisk A/A, Denmark Medipharm Sdn Bhd 28 July 2015 till 27 July 2020 POM

1751 BRU15061882P Aceprin 10mg tablet Aspirin 100mg Hovid Bhd, Malaysia G & H Trading Company 28 July 2015 till 27 July 2020 POM

1752 BRU15061883P Povidone Iodine solution 10%

w/v

Povidone Iodine 10% w/v Royce Pharma Manufacturing Sdn. Bhd.,

Malaysia

SWL Biomed Sales & Services 28 July 2015 till 27 July 2020 GSL

1753 BRU15061884P Pharmaniaga Cephalexin

Suspension 250mg

Cephalexin (as Cephalexin Anhydrous)

250mg/5mL

Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 28 July 2015 till 27 July 2020 POM

1754 BRU15061885P Zorax Suspension 200mg/5ml Aciclovir 200mg/5ml Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 28 July 2015 till 27 July 2020 POM

1755 BRU15061886P Ganaton 50mg tablet Itopride hydrochloride 50mg Abbott Japan Co. Ltd., Japan Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1756 BRU15061887P PVP Iodine Solution Povidone-Iodine 10% w/v (equivalent to

1% available Iodine)

Dynapharm (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd 28 July 2015 till 27 July 2020 GSL

1757 BRU15061888P Herceptin Powder for Injection

440mg/vial

Trastuzumab 440mg Genentech Inc., California, USA;

Genentech Inc., Oregon, USA

Medicare 28 July 2015 till 27 July 2020 POM

1758 BRU15061889P Azoren 20mg/5mg Film-Coated

Tablet

Olmesartan medoxomil 20mg and

Amlodipine (as amlodipine

besylate) 5mg

Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1759 BRU15061890P Azoren 40mg/10mg Film-Coated

Tablet

Olmesartan medoxomil 40mg and

Amlodipine (as amlodipine

besylate) 10mg

Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1760 BRU15061891P Azoren 40mg/5mg Film-Coated

Tablet

Olmesartan medoxomil 40mg and

Amlodipine (as amlodipine

besylate) 5mg

Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

BDMCA/RMP/1116 Page 105 of 117

Page 106: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1761 BRU15061892P Perindosyl 4mg Tablet Perindopril tert-butylamine 4mg (eqv. to

3.338mg perindopril)

Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1762 BRU15061893NP Mentholatum Deep Heating Rub Methyl Salicylate 12.7% & Menthol 5.8% The Mentholatum Co., Inc., USA Hamitan Marketing 28 July 2015 till 27 July 2020 GSL

1763 BRU15061894NP Oxy Cover Cream Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam) Co. Ltd.,

Vietnam

Hamitan Marketing 28 July 2015 till 27 July 2020 GSL

1764 BRU15061895NP Oxy Acne Wash Triclosan 0.30% Rohto-Mentholatum (Vietnam) Co. Ltd.,

Vietnam

Hamitan Marketing 28 July 2015 till 27 July 2020 GSL

1765 BRU15061896NP Hocodin Lozenge 250mcg Dequalinium chloride 250mcg Winwa Medical Sdn. Bhd., Malaysia Medicorp Sdn. Bhd. 28 July 2015 till 27 July 2020 GSL

1766 BRU15061897NP Gaviscon Advance Peppermint Sodium alginate 500mg/5ml

Potassium bicarbonate 100mg/5ml

Reckitt Benckiser Healthcare (UK) Ltd., UK Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 GSL

1767 BRU15071898P Celluvisc Lubricating Eye Drops

1%

Carboxymethylcellulose sodium 1% Allergan Sales, LLC, USA Medipharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL

1768 BRU15071899P Cavumox 625mg Tablet Amoxicillin (as trihydrate) 500mg;

Clavulanic acid (as potassium salt) 125mg

Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1769 BRU15071900NP Gaviscon Liquid Per 10ml - Sodium alginate 500mg; Sodium

bicarbonate 267mg; Calcium carbonate

160mg

Reckitt Benckiser Healthcare (UK) Ltd, UK Syarikat Aliaa Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL

1770 BRU15071901P Zapine 100mg Tablet Clozapine100mg Taiwan Biotech Co. Ltd, Taiwan G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM

1771 BRU15071902P Alendronate Sandoz 70mg FCT Alendronic acid 70mg Lek Pharmaceuticals D.D., Ljubljana Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1772 BRU15071903NP Chlorhex 4% antiseptic solution Chlorhexidine gluconate 4% Pahang Pharmacy Sdn Bhd., Malaysia G & H Trading Company 09 Dec 2015 till 08 Dec 2020 GSL

1773 BRU15071904P Resolor Film-coated Tablet 2mg Prucalopride succinate 2.642mg eqv

Prucalopride 2mg

Janssen-Cilag S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1774 BRU15071905P Proglutrol 500 Extended Release

Tablets

Metformin Hydrochloride 500mg Inventia Healthcare Pvt. Ltd., India Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1775 BRU15071906NP Gaviscon Double Action Liquid Per 10ml - Sodium Alginate 500mg; Sodium

Bicarbonate 213mg; Calcium Carbonate

325mg

Reckitt Benckiser Healthcare (UK) Ltd, UK Syarikat Aliaa Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL

1776 BRU15071907NP Gaviscon Double Action Tablet Sodium Alginate 250mg; Sodium

Bicarbonate 106.5mg; Calcium Carbonate

187.5mg

Reckitt Benckiser Healthcare (UK) Ltd, UK Syarikat Aliaa Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL

1777 BRU15071908P Daivobet Gel Calcipotriol (as monohydrate) 50mcg/g &

betamethasone (as dipropionate) 0.5mg/g

LEO Laboratories Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1778 BRU15071909NP Oxy 10 Lotion Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam) Co. Ltd.,

Vietnam

Hamitan Marketing 09 Dec 2015 till 08 Dec 2020 GSL

1779 BRU15071910NP Oxy 5 Lotion Benzoyl peroxide 5% w/w Rohto-Mentholatum (Vietnam) Co. Ltd.,

Vietnam

Hamitan Marketing 09 Dec 2015 till 08 Dec 2020 GSL

BDMCA/RMP/1116 Page 106 of 117

Page 107: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1780 BRU15071911P Hydrogen Peroxide Solution (6%) Hydrogen Peroxide 6% w/v (equivalent to

20 volumes of available oxygen)

The Government Pharmaceutical

Organization, Thailand

SWL Biomed Sales & Services 09 Dec 2015 till 08 Dec 2020 P

1781 BRU15071912P Keppra Film-coated Tablet

1000mg

Levetiracetam 1000mg UCB Pharma SA, Belgium Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1782 BRU15081913NP Zentel Suspension 400mg/10ml Albendazole 400mg/10ml Smithkline Beecham, Philippines Kingston Beverage & Creamery

Sdn Bhd

09 Dec 2015 till 08 Dec 2020 GSL (1's x 10ml)

1783 BRU15081914P Xalacom Eye Drops 1ml contains latanoprost 50 micrograms

and timolol maleate 6.8mg (eq to 5mg

timolol)

Pfizer Manufacturing Belgium NV,

Belgium

Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1784 BRU15081915P Dormicum Tablet 15mg Midazolam Maleate 20.40mg eqv. to

Midazolam 15mg

Productos Roche S.A. de C.V. Via Isidro

Fabela Nte., Edo de Mexico.

Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1785 BRU15081916P Unihepa 5000IU/ml Injection (5ml

vial)

Heparin sodium 5000IU/ml Duopharma (M) Sdn Bhd., Malaysia K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1786 BRU15081917P Olmetec 40 Tablet Olmesartan Medoxomil 40mg Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1787 BRU15081918P Olanzapine Orodispersible

Tablets 5mg

Olanzapine 5mg Jubilant Life Sciences Ltd., India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1788 BRU15081919P Olanzapine Orodispersible

Tablets 10mg

Olanzapine 10mg Jubilant Life Sciences Ltd., India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1789 BRU15081920P Metrogyl Injection 5mg/ml Metronidazole 500mg/100mL Unique Pharmaceutical Laboratories,

India

K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1790 BRU15081921P Pharmaniaga Dermapro Ointment

0.05% w/w

Clobetasol propionate 0.05% w/w Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM

1791 BRU15081922P Olmetec Plus 40/12.5mg Film-

Coated Tablet

Olmesartan Medoxomil 40mg;

Hydrochlorothiazide 12.5mg

Daiichi Sankyo Europe GmbH, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1792 BRU15081923P Risperdal Tablet 1mg Risperidone 1mg Janssen Cilag SPA, Italy Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1793 BRU15081924P Risperdal Tablet 2mg Risperidone 2mg Janssen Cilag SPA, Italy Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1794 BRU15081925P Apo-Clopidogrel Tablet 75mg Clopidogrel (as bisulfate) 75mg Apotex Inc. Canada, Canada Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1795 BRU15081926NP Win-Aqueous Cream Emulsifying Wax 8%w/w; Liquid Paraffin

5% w/w; White Soft Paraffin 13% w/w

Winwa Medical Sdn Bhd., Pulau Pinang,

Malaysia

Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL

1796 BRU15091927P Axcel Piroxicam-10 Capsule Piroxicam 10mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1797 BRU15091928P Acular Ophthalmic Solution 0.5% Ketorolac Trometamol 0.50% w/v Allergan Pharmaceuticals Ireland, Ireland MediPharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1798 BRU15091929P Dilantin capsule 30mg Phenytoin Sodium 30mg Pfizer Australia Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1799 BRU15091930P Zymar® (gatifloxacin opthalmic

solution) 0.3%

Gatifloxacin 0.3% Allergan Sales, United States MediPharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

BDMCA/RMP/1116 Page 107 of 117

Page 108: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1800 BRU15091931P Klerimed 500mg Film-Coated

Tablets

Clarithromycin 515mg (equivalent to

anhydrous clarithromycin 500mg)

1. Medochmie Ltd (Factory AZ), Cyprus

2. Medochmie Ltd (Central Factory),

Cyprus

Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM

1801 BRU15091932P Gadovist Injection 1.0mmol/ml

Prefilled syringe 5.0ml

Gadobutrol pure 604.72mg & Calcium

sodium butrol 0.513mg

Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1802 BRU15091933P Gadovist Injection 1.0mmol/ml Gadobutrol pure 604.72mg & Calcium

sodium butrol 0.513mg

Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1803 BRU15091934P Neostigmine Methysulphate –

Fresenius 2.5mg/1ml (Ampoules)

Neostigmine methylsulphate 2.5mg/ml Fresenius Kabi Manufacturing SA (Pty)

Ltd., Republic of South Africa.

K-Seri Pharma Sdn. Bhd. 09 Dec 2015 till 08 Dec 2020 POM

1804 BRU15091935P Cardiprin 100 Tablet Aspirin 100mg Reckitt Benckiser Healthcare (UK),United

Kingdom

Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1805 BRU15091936P Calact 300mg Tablets Calcium Lactate USP Eq. to Calcium Lactate

Pentahydrate 300mg.

Elemental Calcium 39mg (from Calcium

lactate pentahydrate 300mg).

Unique Pharmaceutical Laboratories (A

Division of J.B. Chemicals &

Pharmaceuticals Limited), India.

K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1806 BRU15091937P Guafensin Syrup 20mg/ml Guaifenesin 20mg/ml Y.S.P. Industries (M) Sdn. Bhd., Malaysia Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1807 BRU15091938P Storvas C Tablets 10mg Atorvastatin 10mg as Atorvastatin Calcium

Trihydrate

Ranbaxy (Malaysia) Sdn. Bhd., Malaysia G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM

1808 BRU15091939NP Zinc Cream Zinc Oxide 32% w/w HOE Pharmaceuticals Sdn. Bhd., Malaysia G & H Trading Company 09 Dec 2015 till 08 Dec 2020 GSL

1809 BRU15091940P Pirimat Injection 10mg/ml (1ml

ampoule)

Chlorpheniramine Maleate 10mg/m Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM

1810 BRU15091941P Irprestan Tablet 150mg Irbesartan 150mg Actavis ehf, Iceland G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM

1811 BRU15091942P Irprestan Tablet 300mg Irbesartan 300mg Actavis ehf, Iceland G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM

1812 BRU15091943P Heparinol® 10 Sterile Heparinised

Saline Injection

Heparin Sodium (Bovine) 10 IU/ml Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 09 Dec 2015 till 08 Dec 2020 POM

1813 BRU15091944P Fucid Ointment 2% w/w Sodium Fusidate (Micronised) 20mg/g (2%

w/w)

Noripharma Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1814 BRU15091945P Actemra Concentrate for Solution

for Infusion 20mg/ml

Tocilizumab 20mg/ml Chugai Pharma Manufacturing Co., Ltd,

Japan

Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM

1815 BRU15091946P Axcel Bromhexine (Children) Elixir Bromhexine Hydrochloride 4mg Kotra Pharma (M) Sdn Bhd., Malaysia Medicorp Sdn Bhd. 09 Dec 2015 till 08 Dec 2020 POM

1816 BRU15101947P Cetyrol 10mg Film-coated Tablet Cetirizine dihydrochloride 10mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

BDMCA/RMP/1116 Page 108 of 117

Page 109: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1817 BRU15101948P Archifar 1g Powder for Solution

for Injection/Infusion

Meropenem (as trihydrate) 1g Medochemie Ltd., Cyprus Hongkiat Trading & Co 09 Dec 2015 till 08 Dec 2020 POM

1818 BRU15101949P Antismine Syrup 2mg/5ml Chlorpheniramine maleate 2mg/5ml Winwa Medical Sdn Bhd., Malaysia Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 P

1819 BRU15101950P Respidon 2mg Tablets Risperidone 2mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1820 BRU15101951P Respidon 1mg Tablets Risperidone 1mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1821 BRU15101952NP Flexjoint 1500mg Powder Crystalline glucosamine sulphate 1884mg

(equivalent to glucosamine sulphate

1500mg)

Winwa Medical Sdn Bhd., Malaysia Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL

1822 BRU15101953NP Colin Cough Syrup 100mg Guaiphenesin 100mg/5ml Winwa Medical Sdn Bhd., Malaysia Yuh Hua Trading Company 09 Dec 2015 till 08 Dec 2020 GSL

1823 BRU15101954P Tystatin Oral Suspension Nystatin BP 100,000 units T.O. Chemicals (1979) Co. Ltd., Thailand Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1824 BRU15101955P Ezede Tablet 10mg Loratadine 10mg Xepa-Soul Pattinson (M) Sdn Bhd.,

Malaysia

Hongkiat Trading & Co 09 Dec 2015 till 08 Dec 2020 P

1825 BRU15101956P Pred Forte Sterile Ophthalmic

Suspension 1%

Prednisolone acetate 1% w/v Allergan Pharmaceuticals Ireland, Mayo,

Ireland

Medipharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1826 BRU15111957P Stivarga Tablet 40mg Regorafenib

(40mg Regorafenib equivalent to 41.49mg

Regorafenib monohydrate)

Bayer Pharma AG, Germany. Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1827 BRU15111958P A Scabs Lotion Permethrin 5.0% w/v HOE Pharmaceuticals Sdn. Bhd., Malaysia G & H Trading Company 09 Dec 2015 till 08 Dec 2020 GSL

1828 BRU15111959P Insugen-N (NPH) Insulin Injection, Isophane Ph. Eur. (Human

Insulin rDNA origin) 100IU/ml

Biocon Limited, India Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM

1829 BRU15111960P Tetradox Capsules 100mg Doxycycline Hydrochloride/Hcylate eq to

Doxycycline 100mg

Ranbaxy (Malaysia) Sdn Bhd, Malaysia G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM

1830 BRU15111961NP Infusol® NS (Ampoule) Sodium chloride 0.9%w/v AIN Medicare Sdn. Bhd., Malaysia Syarikat Pakatan Indah 09 Dec 2015 till 08 Dec 2020 GSL

1831 BRU15111962NP Infusol W (Sterilised Water for

Injection BP)

Water for injection BP AIN Medicare Sdn. Bhd., Malaysia Syarikat Pakatan Indah 09 Dec 2015 till 08 Dec 2020 GSL

1832 BRU15111963P Elan Forte Cream Tolnaftate 10mg/g; Chlorhexidine HCl

2mg/g

Y.S.P. Industries (M) Sdn. Bhd.,Malaysia Asterix United (B) Sdn Bhd. 09 Dec 2015 till 08 Dec 2020 GSL

1833 BRU15111964P Valparin XR 500mg Tablet i) Sodium Valproate 333mg

ii) Valproic Acid 145mg

(Both together correspond to sodium

valproate 500mg)

Torrent Pharmaceuticals Limited, India K-Seri Pharma Sdn Bhd., 09 Dec 2015 till 08 Dec 2020 POM

1834 BRU15111965P Axcel Betamethasone Cream Betamethasone 17-Valerate (micronized)

equivalent to Betamethasone 0.1% w/w

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1835 BRU15111966P Freederm Gel Terbinafine HCl 1%w/w Winwa Medical Sdn Bhd., Malaysia Yuh Hua Trading Company 09 Dec 2015 till 08 Dec 2020 GSL

BDMCA/RMP/1116 Page 109 of 117

Page 110: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1836 BRU15111967P Cough-En Linctus Dextromethorphan Hydrobromide

15mg/5ml;

Tripolidine Hydrochloride 1.25mg/5ml;

Pseudoephedrine Hydrochloride 30mg/5ml

Xepa-Soul Pattinson (Malaysia) Sdn. Bhd.,

Malaysia

Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM

1837 BRU15111968PT Atehexal Comp Mite Tablet Atenolol 50mg; Chlorthalidone 12.5mg Salutas Pharma GmbH, Federal Republic

of Germany

Medicorp 09 Dec 2015 till 28 April 2019 POM

1838 BRU15111969PT Hurricaine Topical Anaesthetic

Gel – Original Wild Cherry

Benzocaine 20% Dental Technologies Inc. , United States L S Kai Care 09 Dec 2015 till 16 Feb 2018 POM

1839 BRU15111970PT Duocaine Cream 5% w/w Lidocaine 2.5% w/w; Prilocaine 2.5% w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia G & H Trading Co 09 Dec 2015 till 14 Jan 2019 POM

1840 BRU15111971PT SOLIRIS Concentrate for Solution

for Infusion 300mg

Eculizumab 300mg DSM Pharmaceuticals Inc, USA Medipharm Sdn Bhd 09 Dec 2015 till 23/11/2018 POM

1841 BRU15121972PS1 &

BRU15121972PS2

Varivax (refrigerated) Varicella Virus Vaccine Live (Oka / Merck)

1350PFU / 0.5ml

Merck Sharp & Dohme Corp.,

Pennsylvania USA (S1)

ii) Merck Sharp and Dohme Corp., North

Carolina, US (S2)

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1842 BRU15121973P SW-Dexasone Tablet Dexamethasone 0.5mg Sunward Pharmaceutical Sdn Bhd.,

Singapore

G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

1843 BRU15121974P Paracetamol Codeine Tablet Paracetamol 500mg and Codeine

Phosphate 8mg

Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

1844 BRU15121975NP Mentholatum Deep Heat Sport

Pain Relief Spray

Methyl Nicotinate 16mg/g; Glycol

Salicylate 50mg/g; Methyl Salicylate

10mg/g; Ethyl salicylate 50mg/g

Ensign Labs Pty. Ltd., Australia Hamitan Marketing 21 Jun 2016 till 20 Jun 2021 GSL

1845 BRU15121976NP Mentholatum Deep Cold Ice Gel

Therapy

Menthol 20g/g Mentholatum Australia Pty. Ltd., Australia Hamitan Marketing 21 Jun 2016 till 20 Jun 2021 GSL

1846 BRU15121977NP Axcel Urea Cream Urea 10% w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1847 BRU15121978P Axcel Clomiphene Tablet Clomiphene Citrate 50mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1848 BRU15121979P Medocef 1g Powder for Solution

for Injection or Infusion

Cefoperazone (as sodium) 1g Medochemie Ltd., Cyprus Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1849 BRU15121980NP Dexxon Lozenges Dequalinium Chloride 0.25mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1850 BRU15121981P Oragel Pain Relief Choline Salicylate 9% w/w &

Cetylpyridinium Chloride 0.05% w/w

Winwa Medical Sdn. Bhd., Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1851 BRU16011982NP 0.9% Sodium Chloride Solution,

USP

Sodium Chloride USP 0.9% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

BDMCA/RMP/1116 Page 110 of 117

Page 111: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1852 BRU16011983P Amlibon 5mg Tablet Amlodipine (as Amlodipine Besilate) 5mg Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1853 BRU16011984P Ospexin 250mg/5ml Granules for

Oral Suspension

Cephalexin 250mg/5ml Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1854 BRU16011985P Azukon MR 30mg Tablet Gliclazide 30mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1855 BRU16011986P Espran 10mg Tablet Escitalopram (as Oxalate) 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1856 BRU16011987P Zenalb 20% Human albumin 20%w/v Bio Product Lab, UK Medipharm Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1857 BRU16011988P Lestric Tablets 20mg Lovastatin 20mg Ranbaxy (Malaysia) Sdn Bhd., Malaysia G&H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

1858 BRU16011989P Potassium Chloride 10% w/v

Injection

Potassium Chloride 10% w/v Pharmaniaga Manufacturing Berhad,

Malaysia

G&H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

1859 BRU16011990P Gastografin Solution 1ml contains Sodium amidotrizoate 0.1g

and Meglumine amidotrizoate 0.66g

Belimed SA, Spain Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1860 BRU16011991P Rabotide Capsule 20mg (as

enteric coated pellets)

Rabeprazole Sodium 20mg Inventia Healthcare Pvt Ltd., India Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1861 BRU16011992P Pharmaniaga Gliclazide Tablet

80mg

Gliclazide 80mg Pharmaniaga Manufacturing Berhad,

Malaysia

G&H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

1862 BRU16011993NP Betadine Antiseptic Ointment Povidone-Iodine 10% w/w Pt. Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1863 BRU16011994NP Betadine Feminine Wash with

Douching Apparatus 10% w/v

Povidone-Iodine 10% w/v Pt. Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1864 BRU16011995NP Betadine Feminine Wash Povidone-Iodine 10% w/v Pt. Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1865 BRU16011996NP Coxan Tablets 500mg Paracetamol 500mg Prime Pharmaceuticals Sdn Bhd., Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1866 BRU16011997P Soluwax Ear Drops Docusate sodium 0.5% w/v Hoe Pharmaceuticals Sdn Bhd., Malaysia G&H Trading Company 21 Jun 2016 till 20 Jun 2021 GSL

1867 BRU1602070P Sifrol Extended Release 1.5mg

tablet

Pramipexole

Dihydrochloride

Monohydrate 1.5mg

(eqv. to 1.05mg

pramipexole free base)

Boehringer Ingelheim Pharma gmbH &

Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM

1868 BRU16021998P Insugen-R (NPH) Insulin Injection, Soluble Ph. Eur. (Insulin,

Human of recombinant DNA origin) 100

IU/ml

Biocon Limited, India Hongkiat Trading & Co 21 Jun 2016 till 20 Jun 2021 POM

1869 BRU16021999P Levetiracetam tablet 500mg Levetiracetam 500mg Jubilant Generics, Limited, India Axterix United (B) Sdn. Bhd 21 Jun 2016 till 20 Jun 2021 POM

1870 BRU16022000P Glimicron 80mg tablet Gliclazide 80mg HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun 2021 POM

BDMCA/RMP/1116 Page 111 of 117

Page 112: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1871 BRU16022001NP Liquid Paraffin Liquid Paraffin BP 100% HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun 2021 GSL

1872 BRU16022002NP Noxworm Suspension (chocolate)

400mg

Albendazole 200mg/5mL Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL

1873 BRU16022003P Mircera pre-filled syringe

100mcg/0.3ml

Methoxy polyethylene glycol-epoetin beta

100mcg/0.3ml

Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1874 BRU16022004P Glucodex tablet Gliclazide 80mg PT Dexa Medica, Indonesia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1875 BRU16022005P Rocaltrol capsule 0.5mcg Calcitriol 0.5mcg Catalent Germany Eberbach GmbH,

Germany for F.Hoffmann-La Roche Ltd.,

Switzerland

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM

1876 BRU16022006P Rocaltrol capsule 0.25mcg Calcitriol 0.25mcg Catalent Germany Eberbach GmbH,

Germany for F.Hoffmann-La Roche Ltd.,

Switzerland

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM

1877 BRU16022007P Adezio Oral Suspension Cetirizine Hydrochloride 1mg/ml Xepa-Soul Pattinson (Malaysia) Sdn

Bhd,

Malaysia

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 P

1878 BRU16022008P Zarin cream Miconazole nitrate 2%w/w Xepa-Soul Pattinson (Malaysia) Sdn

Bhd,

Malaysia

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 GSL

1879 BRU16022009P Jumex (Selegiline HCl) tablet 5mg Selegiline Hydrochloride 5mg Chinoin Pharmaceutical and Chemical

Works Co. Ltd., Hungary.

MediPharm Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1880 BRU16022010P Bena

®

Expectorant

Diphenhydramine hydrochloride

14mg/5ml and ammonium

chloride 135mg/5ml

Xepa-Soul Pattinson (Malaysia) Sdn

Bhd,

Malaysia

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM

1881 BRU16022011P Pantor 20 Pantoprazole (as sodium

sesquihydrate) 20mg

Torrent Pharmaceuticals Limited, India K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1882 BRU16022012P Pantor 40 Pantoprazole (as sodium

sesquihydrate) 40mg

Torrent Pharmaceuticals Limited, India K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1883 BRU16032013P Ceritec Film Coated Tablet 10mg Cetirizine Hydrochloride 10mg Y.S.P. Industries (M) Sdn. Bhd., Malaysia. Asterix United (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 P

1884 BRU16032014P Tinazol Cream 2% (15g) Miconazole nitrate 2% w/w Hovid Bhd, Malaysia. G & H Trading Company 21 Jun 2016 till 20 Jun 2021 GSL

1885 BRU16032015PS1 &

BRU16032015PS2

M-M-R II® Vaccine Live, attenuated virus derived from

Edmonston B strain of measles - 3.0 log

TCID50, Live attenuated Jeryl LynnTM strain

of mumps - 4.1 log TCID50, Live, attenuated

Wistar RA 27/3 strain of rubella - 3.0 log

TCID50

1. Merck Sharp & Dohme Corp.,

Pennsylvania, USA,

2. Merck Sharp & Dohme Corp., North

Carolina, U.S.A

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1886 BRU16032016P Insugen-30/70 (Biphasic) Insulin Injection, Biphasic Isophane Ph. Eur.

(Insulin, Human recombinant DNA origin)

100 IU/ml

Biocon Limited, India Hongkiat Trading & Co. 21 Jun 2016 till 20 Jun 2021 POM

1887 BRU16032017P Natrixam 1.5mg/10mg modified-

release tablet

Indapamide 1.5mg & Amlodipine 10mg (as

besilate)

Les Laboratories Servier Industrie, France Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

BDMCA/RMP/1116 Page 112 of 117

Page 113: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1888 BRU16032018P Natrixam 1.5mg/5mg modified-

release tablet

Indapamide 1.5mg & Amlodipine 5mg (as

besilate)

Les Laboratories Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1889 BRU16032019P Levetiracetam 250mg tablet Levetiracetam 250mg Jubilant Generics Limited, India Asterix United (B)Sdn Bhd., 21 Jun 2016 till 20 Jun 2021 POM

1890 BRU16032020NP Mifuko Ointment Zinc Oxide 6% (w/w) and Salicylic acid 5%

(w/w)

Winwa Medical Sdn Bhd, Malaysia. Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL

1891 BRU16032021P Primodil 5 Tablet Amlodipine Besilate 6.94mg (equivalent to

Amlodipine 5mg)

Medley Pharmaceuticals Ltd, India Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1892 BRU16032022P Oxair Film Coated Tablet 10mg Montelukast Sodium 10.4mg (equivalent to

Montelukast 10mg)

Y.S.P. Industries (M) Sdn Bhd., Malaysia Asterix United (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1893 BRU16032023NP Bacidin Antiseptic Cream 1% w/w Chlorhexidine Gluconate 1% w/w Xepa-soul Pattinson (Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 GSL

1894 BRU16032024P Axcel Oxymetazoline 0.05% Nasal

Spray

Oxymetazoline Hydrochloride 0.05% w/v Kotra Pharma (M) Sdn Bhd., Malaysia. Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 P

1895 BRU16042025P Romesec 20mg Capsules Omeprazole USP 20mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia. G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

1896 BRU16042026NP Migrate Q10 Coenzyme Q10………….100mg;

Lycopene………………….... 5mg; L-

Arginine…………….…..100mg;

Zinc Sulphate monohydrate (eq to

Elemental zinc)..22.5mg;

Piperine………………………..5mg; Sodium

selenite (eq to Elemental selenium)

….70mcg

Goodman Pharmaceuticals, India. MediBiotech 21 Jun 2016 till 20 Jun 2021 GSL

1897 BRU16042027NP Potassium Chloride Injectable

Solution 10%

Potassium chloride 1g / 10ml DEMO SA Pharmaceutical Industry,

Greece.

Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1898 BRU16042028P Oratane 20mg Capsules Isotretinoin 20mg Swiss Caps AG, Switzerland, Contract Mfg.

for Douglas Pharmaceuticals Limited, New

Zealand.

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1899 BRU16042029P Oratane 10mg Capsules Isotretinoin 10mg Swiss Caps AG, Switzerland, Contract Mfg.

for Douglas Pharmaceuticals Limited, New

Zealand.

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1900 BRU16042030NP Osteoactiv 3 in 1 Joint Formula

Powder

Glucosamine Hydrochloride 1000mg,

Methylsulfonylmethane 1000mg,

Chondroitin Sulphate Sodium 880.4mg

(equivalent to 800mg chondroitin)

Winwa Medical Sdn. Bhd., Malaysia. Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1901 BRU16042031NP Osteoactiv 3 in 1 Joint Formula

Tablet

Glucosamine Hydrochloride 250mg,

Methylsulfonylmethane 250mg,

Chondroitin Sulphate Sodium 220mg

(equivalent to 200mg chondroitin)

Winwa Medical Sdn. Bhd., Malaysia. Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

BDMCA/RMP/1116 Page 113 of 117

Page 114: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1902 BRU16042032P Sedilix-DM Linctus Dextromethorphan (as Hydrobromide)

15mg/5mL; Pseudoephedrine (as

Hydrochloride) 30mg/5mL; Promethazine

(as Hydrochloride) 3.125mg/5mL

Xepa-Soul Pattinson (M) Sdn Bhd,

Malaysia.

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM

1903 BRU16042033P Aloxi Solution for Injection

50mcg/ml

Palonosetron Hydrochloride 56 mcg eqv to

Palonosetron 50 mcg (0.050 mg)

Pierre-Fabre Medicament Production,

France.

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1904 BRU16042034P Taver Tablet 200mg Carbamazepine 200mg Medochemie Ltd., Cyprus. Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1905 BRU16042035NP Axcel B Complex Tablet Vitamin B1 10mg; Vitamin B2 3mg;

Vitamin B6 1mg; Cyanocobalamine 5mcg;

Calcium Pantothenate 1mg; Nicotinamide

25mg

Kotra Pharma (M) Sdn Bhd, Malaysia. Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1906 BRU16042036P Pharmaniaga Allopurinol Tablet

300mg

Allopurinol 300mg Pharmaniaga Manufacturing Berhad,

Malaysia.

G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

1907 BRU16042037NP Povidin Solution 10% Povidone-Iodine 10% w/v (equivalent to

1% of Available Iodine)

Xepa-soul Pattinson (Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 GSL

1908 BRU16052039NP Noxworm Chewtab Albendazole 200mg Winwa Medical Sdn. Bhd., Malaysia Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL

1909 BRU16052040P Betadine® Antiseptic Solution Povidone-Iodine 10% w/v PT Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1910 BRU16052041P Zoratadine Syrup 5mg/5ml Loratadine 5mg/5ml HOE Pharmaceuticals Sdn. Bhd., Malaysia G&H Trading Company 21 Jun 2016 till 20 Jun 2021 P

1911 BRU16052042P Axcel Oxymetazoline 0.025%

Nasal Drop

Oxymetazoline hydrochloride 0.025% w/v Kotra Pharma (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 P

1912 BRU16052043P Axcel Dextromethorphan-15

Syrup

Dextromethorphan hydrobromide

15mg/5ml

Kotra Pharma (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1913 BRU16052044P Zometa Solution for Infusion

4mg/100ml

Zoledronic Acid (anhydrous) 4mg/100ml

corresponding to 4.264mg Zoledronic Acid

Monohydrate

Novartis Pharma Stein AG, Switzerland Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1914 BRU16052045P Novomin Tablet 50mg Dimenhydrinate 50mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd,

Malaysia.

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM

1915 BRU16062046P Valzaar 80mg Tablets Valsartan 80mg Torrent Pharmaceuticals Ltd, India K-Seri Pharma Sdn. Bhd 08 November 2016 till 07

November 2021

POM

1916 BRU16062047P Valzaar 160mg Tablets Valsartan 160mg Torrent Pharmaceuticals Ltd, India K-Seri Pharma Sdn. Bhd 08 November 2016 till 07

November 2021

POM

1917 BRU16062048P Tozaar 50mg tablet Losartan potassium 50mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 08 November 2016 till 07

November 2021

POM

1918 BRU16062049P Seebri Breezhaler 50mcg

Inhalation Powder Hard Capsules

Glycopyrronium bromide 63mcg

(corresponding to 50 mcg Glycopyrronium)

Novartis Pharma Stein AG., Switzerland Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM

BDMCA/RMP/1116 Page 114 of 117

Page 115: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1919 BRU16062050P Neotigason Capsule 10mg Acitretin 10mg Patheon Inc., Canada G & H Trading Company 08 November 2016 till 07

November 2021

POM

1920 BRU16062051P Neotigason Capsule 25mg Acitretin 25mg Patheon Inc., Canada G & H Trading Company 08 November 2016 till 07

November 2021

POM

1921 BRU16062052P Tidact Injection 150mg/ml Clindamycin (as phosphate) 150mg/ml Yung Shin Pharmaceutical Ind. Co. Ltd.,

Republic of China

Asterix United (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM

1922 BRU16062053P APO-Risperidone Tablets 1mg Risperidone 1mg Apotex Inc, Canada Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

1923 BRU16062054P Betmiga Prolonged-Release

Tablets 25mg

Mirabegron 25mg Astellas Pharma Technologies Inc., US Medipharm Sdn Bhd 08 November 2016 till 07

November 2021

POM

1924 BRU16062055P Betmiga Prolonged-Release

Tablets 50mg

Mirabegron 50mg Astellas Pharma Technologies Inc., US Medipharm Sdn Bhd 08 November 2016 till 07

November 2021

POM

1925 BRU16062056P Axcel Mometasone 0.1% Cream Mometasone furoate (micronised) 0.1%

w/w

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

1926 BRU16072057P Dipeptiven Infusion 200mg/ml N(2)-L-Alanyl-L-glutamine 200mg/ml Frensius Kabi Austria GmbH, Austria Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM

1927 BRU16072058P Noxafl 100mg tablet Posaconazole 100mg N.V Organon, Netherlan Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM

1928 BRU16072059P Onegaba 300mg capsules Gabapentin 300mg Aurobindo Pharma Limited (Unit III),

India

K-Seri Pharma Sdn Bhd 08 November 2016 till 07

November 2021

POM

1929 BRU16072060P Pethidine-Hameln Solution for

Injection 50mg/ml

Pethidine Hydrochloride

50mg/ml

Hameln Pharmaceuticals GmbH, Langes

Feld 13, 31789 Ham

eln, Germany

Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

1930 BRU16072061P Axcel Clobetasol 0.05 Ointment Clobetasol Propionate (micronized) 0.05%

w/w

Kotra Pharma (M) Sdn Bhd.,

Malaysia.

Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

1931 BRU16072062P Prednisolone syrup 5mg/5ml Each 5ml contains:

Prednisolone (as salt of

prednisolone) 5mg

Beacons Pharmaceutical Pte Ltd,

Singapore

Hong Kiat Trading & Co 08 November 2016 till 07

November 2021

POM

1932 BRU16082063NP Zenalb 4.5%, Human Albumin

Solution 4.5%

Human Albumin Solution 4.5% Bio Products Laboratory Limited, UK MediPharm Sdn Bhd 08 November 2016 till 07

November 2021

POM

1933 BRU16082064P Axcel Lamivudine 100mg Tablet Lamivudine 100mg Kotra Pharma (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

1934 BRU16082065P Calpo Suspension Mebendazole 100mg/5ml Winwa Medical Sdn. Bhd., Malaysia Yuh Hua Trading Company 08 November 2016 till 07

November 2021

GSL

1935 BRU16082066NP Alphanate® 250IU Factor VII 250IU and von Willebrand Factor

>400IU/1000IU Factor VII

Grifols Bilogicals Inc., USA Hongkiat Trading & Company 08 November 2016 till 07

November 2021

POM

1936 BRU16082067P Anoro Ellipta 62.5/25 micrograms

inhalation powder, pre-dispensed

Each pre-dispensed dose contains 62.5

micrograms umeclidinium (equivalent to

74.2 micrograms of umeclidinium bromide)

and 25 micrograms vilanterol (as

trifenatate)

Glaxo Operations UK Ltd (trading as Glaxo

Wellcome Operations), UK

Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM

1937 BRU16082068NP RINS® NS Sodium Chloride 0.9%

w/v Irrigation Solution BP

Sodium Chloride 0.9% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 08 November 2016 till 07

November 2021

GSL

BDMCA/RMP/1116 Page 115 of 117

Page 116: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1938 BRU16092069P Sifrol Extended Release 0.375mg

tablet

Pramipexole

Dihydrochloride

Monohydrate 0.375mg

(eq

v.

to 0.26mg

pramipexole free base)

Boehringer Ingelheim Pharma gmbH &

Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM

1939 BRU16092071NP Mentholatum Deep Heating Rub

Extra Strength Cream

Methyl Salicylate 30%; Menthol

8%

The Mentholatum Co., USA. Hamitan Marketng, Brunei

Darussalam

08 November 2016 till 07

November 2021

GSL

1940 BRU16092072P GlobalVacc Al-Shifa HIB Each dose of 0.5ml contains:

Purified Capsular Polysaccharide Hib

(PRP) –10mcg

(Hib Polysaccharide) (PRP) Tetanus Toxoid

(carrier protein) –19 to 33mcg

Serum Institute India Ltd., India Bruvac Pharma Sdn Bhd,

Brunei Darussalam

08 November 2016 till 07

November 2021

POM

1941 BRU16092073P Adrenaline (Epinephrine)

Injection 1:1000

Adrenaline (Epinephrine) as acid

tartrate

Mc Carthys Laboratories Ltd., UK Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

1942 BRU16092074P Axcel Mometasone 0.1%

Ointment Mometasone Furoate

(micronised) 0.1% w/w

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

1943 BRU16092075P Amphotret for Injection U.S.P.

50mg

Amphotericin B U.S.P. 50mg Bharat Serums And Vaccines Ltd, India K-Seri Pharma Sdn Bhd 08 November 2016 till 07

November 2021

POM

1944 BRU16092076NP Alumag Plus Tablet Per tablet:

Aluminium Hydroxide Dried Gel 250mg;

Magnesium Trisilicate Light 250mg;

Simethicone

30mg

Beacons Pharmaceuticals Pte Ltd,

Singapore

HongKiat Trading Co 08 November 2016 till 07

November 2021

POM

1945 BRU16102077PT Olanzapine Genmark 10mg Tablet Olanzapine 10mg Glenmark Pharmaceuticals Europe

Limited, United Kingdom

Hongkiat Trading & Company 08 November 2016 till 23

Nov 2018

POM (2 X 14's)

1946 BRU16102078PT Olanzapine Genmark 5mg Tablet Olanzapine 5mg Glenmark Pharmaceuticals Europe

Limited, United Kingdom

Hongkiat Trading & Company 08 November 2016 till 14

Jan 2019

POM (2 X 14's)

1947 BRU16102079PT Baxter Chlorhexidine Acetate

0.1% w/v Antiseptic Solution

Chlorhexidine (as

Acetate)

Baxter Healthcare Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 26

Jan 2019

GSL (100ml)

1948 BRU16102080P Magurol 2mg tablet Doxazosin mesilate eq. to

doxazosin base 2

mg

Medochemie Ltd Central Factory, Cyprus Medicorp Sdn. Bhd 08 November 2016 till 07

November 2021

POM (2 x 10’s and

100 x 10’s)

1949 BRU16102081P Magurol 2mg tablet Doxazosin mesilate eq. to

doxazosin base 4

mg

Medochemie Ltd Central Factory, Cyprus Medicorp Sdn. Bhd 08 November 2016 till 07

November 2021

POM (2 x 10’s and

100 x 10’s)

1950 BRU16102082P Xyzal Film-coated tablet 5mg Levocetirizine dihydrochloride

5mg

UCB Farchim SA, Switzerland Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM (50's)

BDMCA/RMP/1116 Page 116 of 117

Page 117: BRUNEI DARUSSALAM MEDICINES CONTROL … Documents/Importation of Medicines/Registered...BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED NOVEMBER 2016)

1951 BRU16102083P Xolair 75mg powder for solution

for injection

Omalizumab 75mg.

Reconstituted Xolair contains

125mg/ml of omalizumab (75mg

in

0.6ml)

Novartis Corporation (Malaysia) Sdn.

Bhd., Malaysia

Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM (1 vial of

powder & 1

ampoule of

solvent 2ml/ pack)

1952 BRU16102084P Bilaxten 20mg tablet Bilastine 20mg A.Menarini Manufacturing Logistic and

Services S.r.l., Italy

Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM (1X 4's; 1X

10's; 2X10's; 3x

10'S; 4 x 10'S and

5 x10's)1953 BRU16102085P Loxin Injection (5ml amp)

(Dopamine HCl)

Dopamine hydrochloride Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 08 November 2016 till 07

November 2021

POM (10's)

1954 BRU16102086P Mycamine 50mg/vial Powder for

Solution for Infusion

Micafungin (as sodium)

50mg/via

Astellas Pharma Tech Co., Ltd., Japan MediPharm Sdn Bhd, Brunei

Darussalam

08 November 2016 till 07

November 2021

POM (1’s x

10ml/vial and

10’s x 10ml/vial)

1955 BRU16102087P Vaxcel Fluconazole 2mg/ml IV

Infusion

Fluconazole 2mg/ml Kotra Pharma (M) Sdn. Bhd.,Malaysia Medicorp Sdn Bhd, Malaysia 08 November 2016 till 07

November 2021

POM (50ml/vial)

1956 BRU16102088P Sellon Shampoo Selenium sulfide 2.5% w/v Unison Laboratories Co., Ltd., Thailand K-Seri Pharma Sdn Bhd, 08 November 2016 till 07

November 2021

POM (120ml)

1957 BRU16102089NP Daily-vite multivitamin syrup for

children

Each 5mL contains:

Vitamin A: 2,000 IU

Vitamin D :400 IU

Vitamin B1 (Thiamine HCl): 1.5 mg

Vitamin B2 (Riboflavin): 1.2 mg

Vitamin B6 (Pyridoxine HCl): 1.0 mg

Vitamin B12 (cyanocobalamin): 3.0 mcg

Niacinamide: 10mg

Vitamin C (Ascorbic Acid): 50 mg

L-Lysine Monohydrochloride: 37.5 mg

Dynapharm (M) Sdn Bhd, Malaysia Medicorp Sdn. Bhd 08 November 2016 till 07

November 2021

GSL (100ml)

1958 BRU16102090NP Ubat Batok Cap Kaki Tiga

(Solution)

Guaifenesin 100mg/5ml Syarikat Wen Ken Drug Sdn Bhd, ,

Malaysia

Syarikat Rajamas Bersama 08 November 2016 till 07

November 2021

GSL (60ml, 120ml)

1959 BRU16102091P Vaxcel Lignocaine 1% Injection Lignocaine Hydrochloride

1% (50mg/5ml)

Kotra Pharma (M) Sdn. Bhd.,Malaysia Medicorp Sdn. Bhd 08 November 2016 till 07

November 2021

POM (5 X 10's)

BDMCA/RMP/1116 Page 117 of 117