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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as stated)
Product
Classification
1 BRU07100001P Augmentin Injection 1.2g
Co-Amoxiclav 1000/200 - Amoxicillin
1g as sodium salt, clavulanic acid
200mg as potassium salt
SmithKline Beecham PLC, Worthing,
West Sussex, UKZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
2 BRU07100002P Augmentin Injection 600mg
Co-Amoxiclav 500/100 - Amoxicillin
500mg as sodium salt, clavulanic acid
100mg as potassium salt
SmithKline Beecham PLC, Worthing,
West Sussex, UKZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
3 BRU08010001PPharmaniaga Aciclovir Tablet
200mgAciclovir 200mg
Pharmaniaga Manufacturing Berhad
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
4 BRU08010002PPharmaniaga Ketoconazole
Tablet 200mgKetoconazole 200mg
Pharmaniaga Manufacturing Berhad
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
5 BRU08010003PPharmaniaga Clarithromycin
Tablet 250mgClarithromycin 250mg
Pharmaniaga Manufacturing Berhad
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
6 BRU08010004PPharmaniaga Fluconazole
150mg CapsulesFluconazole 150mg
Pharmaniaga Manufacturing Berhad
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
7 BRU08010005PPharmaniaga Ciprofloxacin
Tablet 500mgCiprofloxacin 500mg
Pharmaniaga Manufacturing Berhad
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
8 BRU08010009P Meronem Injection 1g Meropenem (as trihydrate) 1g AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
9 BRU08020010P Meronem Injection 500mg Meropenem (as trihydrate) 500mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
10 BRU08020011P Bactroban Cream Mupirocin 2% SmithKline Beecham, Philippines Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
11 BRU08020012PPharmaniaga Cephalexin
Capsule 500mgCephalexin 500mg
Pharmaniaga Manufacturing Berhad
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
12 BRU08020013PPharmaniaga Metronidazole
Tablet 200mg Metronidazole 200mg
Pharmaniaga Manufacturing Berhad
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
13BRU08020016P Anikef Sterile 750mg Cefuroxime 750mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &
Company
06 October 2015 till 05
October 2020
POM
14BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &
Company
06 October 2015 till 05
October 2020
POM
15BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &
Company
06 October 2015 till 05
October 2020
POM
16BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &
Company
06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0317 Page 1 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
17 BRU08020020P
Diprivan 10mg/ml (1%)
Emulsion for Injeciton or
Infusion (20ml Ampoule)
Propofol 10mg/ml (1%) Corden Pharma S.P.A Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
18 BRU08020021P Retrovir Capsule 100mg Zidovudine 100mg SmithKline Beecham Plc, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
19 BRU08020022P Bactroban Ointment Mupirocin 2%GlaxoSmithKline Philippines Inc,
PhilippinesZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
20 BRU08030023P Augmentin Tablet 625mg
Amoxycillin 500mg (as trihydrate);
Clavulanic acid 125mg (as Potassium
Clavulanate)
SmithKline Beecham Plc, Worthing,
UKZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
21 BRU08030024P Augmentin Syrup 228mg/5ml
Amoxycillin 200mg/5ml (as trihydrate);
Clavulanic acid 28.5mg/5ml (as
Potassium Clavulanate)
SmithKline Beecham Plc, Worthing,
UKZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
22 BRU08030025P Augmentin Syrup 457mg/5ml
Amoxycillin 400mg/5ml (as trihydrate);
Clavulanic acid 57mg/5ml (as
Potassium Clavulanate)
SmithKline Beecham Plc, Worthing,
UKZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
23 BRU08030026P Augmentin Tablet 1g
Amoxycillin 875mg (as trihydrate);
Clavulanic acid 125mg (as Potassium
Clavulanate)
SmithKline Beecham Plc, Worthing,
UKZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
24 BRU08030027P Foban Cream Fusidic acid 2%Hoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
25 BRU08030030P Garasent 80mg Injection Gentamicin 40mg/ml (as Sulphate) Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd06 October 2015 till 05
October 2020POM
26 BRU08030031P Retrovir 1% IV Infusion Zidovudine 1% Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
27 BRU08030032P Genta Eye Drop 0.3%w/v Gentamicin (as Sulphate) Duopharma (M) Sdn Bhd, MalaysiaHongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
28 BRU08030034P Zinacef Injection 750mg Cefuroxime (as sodium)GlaxoSmithKline Manufacturing SPA,
Italy.Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
29 BRU08030035P Zinacef Injection 1.5g Cefuroxime (as sodium)GlaxoSmithKline Manufacturing SPA,
Italy.Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
30 BRU08030036P Zinnat Tablet 125mg Cefuroxime (as axetil) Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
31 BRU08030037P Zinnat Tablet 250mg Cefuroxime (as axetil) Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
32 BRU08040039P Solulexin Granules 125mg/5mlCefalexin Monohydrate equivalent to
Cefalexin 125mg/5mlDuopharma (M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
BDMCA/RMP/0317 Page 2 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
33 BRU08040040P Retrovir Syrup Zidovudine 50mg/5ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
34BRU08040041PS1 &
BRU08040041PS2Zeffix Tablet Lamivudine 100mg
Glaxo Wellcome Operations UK Ltd,
UK (S1); GlaxoSmithKline
Pharmaceuticals S.A., Poland (S2)
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
35 BRU08040042P Combivir Tablet Lamivudine 100mg, Zidovudine 300mgGlaxoSmithKline Pharmaceuticals
S.A., PolandZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
36BRU08040043P Zoraxin Syrup Suspension Aciclovir 200mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &
Company
06 October 2015 till 05
October 2020
POM
37 BRU08040046P Genta-Bet Eye Drops
Gentamicin (as Sulphate) 0.3%,
Betamethasone Disodium Phosphate
0.1%
Duopharma (M) Sdn Bhd, MalaysiaHongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
38BRU08040047P Bicafar Sterile 2g (vial) Cefoperazone (as Sodium) 2g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &
Company
06 October 2015 till 05
October 2020
POM
39 BRU08040049PDiflucan IV Infusion 2mg/ml
(50ml)Fluconazole 2mg/ml Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
40 BRU08040050P Sulperazone IM/IV 1gSulbactam (as Sodium) 500mg;
Cefoperazone (as Sodium) 500mgHaupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
41 BRU08040051P Beagenta Cream 0.1% Gentamicin (as Sulphate BP) 0.1%w/wUpha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
42 BRU08040052P Becarin Cream 2% Miconazole Nitrate 2%Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020 GSL
43 BRU08050053PPharmaniaga Aciclovir Tablet
400mgAciclovir 400mg
Pharmaniaga Manufacturing Berhad,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
44 BRU08050054PPharmaniaga Cephalexin
Capsule 250mg
Cephalexin (as Anhydrous) Cephalexin
250mg
Pharmaniaga Manufacturing Berhad,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
45 BRU08050058P Ketozotan Tablet 200mg Ketoconazole 200mg Duopharma (M) Sdn Bhd, MalaysiaHongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
46BRU08050060P Unocef Injection 500mg (Vial) Ceftriaxone (as Sodium) 500mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &
Company
06 October 2015 till 05
October 2020
POM
47BRU08050061P Unocef Injection 1000mg
(Vial)
Ceftriaxone (as Sodium) 1000mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &
Company
06 October 2015 till 05
October 2020
POM
48 BRU08050063P Solulexin Capsule 250mgCephalexin Monohydrate 262.95mg
equivalent to Cephalexin 250mgDuopharma (M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
BDMCA/RMP/0317 Page 3 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
49 BRU08050064P Solulexin Capsule 500mg Cephalexin (as Monohydrate) 500mg Duopharma (M) Sdn Bhd, MalaysiaHongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
50 BRU08050065P Beavate-N Cream
Betamethasone-17-valerate equivalent
to Betamethasone 0.1%w/w;
Neomycin Sulphate 0.5%w/w
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020 POM
51 BRU08050066P Beagenta Eye/ Ear DropsGentamicin Sulphate equivalent to
Gentamicin 0.3%w/wDuopharma (M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
52 BRU08050067P Uphalexin Granules 125Cephalexin Monohydrate 138mg/5ml
equivalent to Cephalexin 125mg/5ml
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
53 BRU08050068P Krisovin Tablet 500 Griseofulvin BP 500mg (micronised)Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
54 BRU08050069P Plaquenil Tablet Hydroxychloroquine Sulphate 200mgSanofi-Aventis, S.A., Riells l Viabrea,
SpainMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
55 BRU08050070P Betacin Eye Ear Drop
Neomycin Sulphate 0.5% w/v;
Betamethasone Sodium Phosphate
0.1%w/v
Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd06 October 2015 till 05
October 2020POM
56 BRU08050071P Foban Ointment Sodium Fusidate BP 2% w/vHoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
57 BRU08050072P Fobancort Cream
Fusidic acid 2%w/w; Betamethasone
Dipropionate 0.064%w/w equivalent
to Betamethasone 0.05%w/w
Hoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
58 BRU08050073P Dezor Cream Ketoconazole 2%w/wHoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
59 BRU08050074P Dezor Shampoo Ketoconazole 2%w/wHoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
60BRU08060075P Genta-Dex Eye Drops Gentamicin 0.3% w/v; Dexamethsone
Phosphate 0.1%w/v
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &
Company
06 October 2015 till 05
October 2020
POM
61BRU08060077P Aecoras Ointment Econazole Nitrate 10mg;
Triamcinolone Acetonide 1mg
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &
Company
06 October 2015 till 05
October 2020
POM
62 BRU08060078P Beapen VK Granules 125mg Phenoxymethypenicillin 125mg/5mlUpha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
63 BRU08060079P Enoxin Tablet 500mg Ciprofloxacin 500mgUpha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
BDMCA/RMP/0317 Page 4 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
64 BRU08060080P Beta Eye/ Ear DropsBetamethasone Sodium Phosphate
0.1%Duopharma (M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
65 BRU08060081P Betagen Eye/ Ear DropsGentamicin 0.3% w/v; Dexamethsone
Phosphate 0.1%w/vDuopharma (M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020 POM
66 BRU08060082P Muprin Ointment Mupirocin 2.0%w/wHoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
67 BRU08060084P Eryson Granules 400Erythromycin ethylsuccinate equiv. to
eryhtromycin 400mg/5ml
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
68 BRU08060085P Neomycin Cream 0.5% Neomycin sulphate 0.5%w/wUpha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
69 BRU08060086P Foban Hydro Cream Fusidic acid 2%; Hydrocortisone 1%Hoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
70 BRU08060087P Foban Hydro OintmentSodium Fusidate 2%; Hydrocortisone
1%
Hoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
71 BRU08060088P Arava Tablet 10mg Leflunomide 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
72 BRU08060089P Arava Tablet 20mg Leflunomide 20mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
73 BRU08070090P Zinnat Suspension 125mg/5mlCefuroxime Axetil equivalent to
Cefuroxime 250mg
Glaxo Wellcome Bernard Castle,
United KingdomZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
74 BRU08070091P Metronol 0.5%w/v Injection Metronidazole 0.5% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah06 October 2015 till 05
October 2020POM
75 BRU08070094P Ecocort CreamEconazole Nitrate 1% w/w;
Triamcinolone Acetonide 0.1% w/w
Hoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
76 BRU08070095P Beprogent OintmentBetamethasone 0.05%; Gentamicin
0.1%
Hoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
77 BRU08070096P Betamox Capsule 250mgAmoxicillin Trihydrate equivalent to
Amoxicillin 250mgDuopharma (M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
78 BRU08070097P Aprovel Tablet 300mg Irbesartan 300mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
79 BRU08070099P Atacand Tablet 8mg Candesartan Cilexetil 8mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
80 BRU08070100P Atacand Tablet 16mg Candesartan Cilexetil 16mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
81 BRU08070101PZovirax Suspension
200mg/5mlAcyclovir 200mg/5ml
GlaxoSmithKline GmbH & Co
GermanyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 5 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
82 BRU08070103P Fortum® Injection 1g Ceftazidime (as Pentahydrate) 1gGlaxoSmithKline Manufacturing SPA,
ItalyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
83 BRU08080104P Beavate Cream 0.1%Betamethasone -17- valerate equiv. to
Betamethasone 0.1%
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020 POM
84 BRU08080106P Candazole Cream Clotrimazole 1.0%Hoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020GSL
85 BRU08080107P Gentamicin Cream Gentamicin (as Sulphate) 0.1%Hoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
86 BRU08080108P Beprogent CreamBetamethasone (as dipropionate)
0.05%, Gentamicin (as sulphate 0.1%)
Hoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
87 BRU08080109P Unasyn Tablet 375mg
Sultamicillin (as tosilate) 375mg
(Ampicillin 250mg & Sulbactam
125mg)
Pfizer Global Supply Japan Inc, Japan Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
88 BRU08080110PZovirax Dispersable Tablet
200mgAciclovir 200mg Glaxo Wellcome, S.A., Spain Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
89 BRU08080111P Valtrex® 500mg Tablet Valciclovir (as HCl) 500mg Glaxo Wellcome SA, Spain Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
90 BRU08080112P Fortum® Injection 2g Ceftazidime (as pentahydrate) 2gGlaxoSmithKline Manufacturing SPA,
ItalyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
91 BRU08080113P Uphalexin Capsule 250 Cephalexin (as monohydrate) 250mgUpha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
92 BRU08080114P Uphalexin Capsule 500 Cephalexin (as monohydrate) 500mgUpha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
93 BRU08080115PVaxcel Cefuroxime 750mg
InjectionCefuroxime (as sodium) 750mg Kotra Pharm (M) Sdn Bhd, Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
94 BRU08080116PVaxcel Ceftriaxone 1g
InjectionCeftriaxone (as sodium) 1g Kotra Pharm (M) Sdn Bhd, Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
95 BRU08080117P Axcel Fusi-Corte CreamFusidic acid 2%, Betamethasone (as 17-
valerate) 0.1%Kotra Pharm (M) Sdn Bhd, Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
96 BRU08090118P Verorab Injection
Inactivated rabies virus (Wistar strain
RABIES PM/WI 38-1503-3M) produced
on VERO cell line, inactivated and
purifed
Sanofi Pasteur, France; Sanofi
Winthrop Industrie (SWI), Le Trait –
France (Diluent)
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
97 BRU08090119P Decocort CreamMiconazole Nitrate 2%w/w;
Hydrocortisone 1% w/w
Hoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
98 BRU08090120P Fobancort Ointment
Sodium Fusidate 2%w/w;
Betamethasone 0.05%w/w (as
Dipropionate 0.064%)
Hoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 6 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
99 BRU08090121P Candacort CreamClotrimazole 1.0% w/w;
Hydrocortisone 1.0%w/w
Hoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
100 BRU08090122P Hepsera Tablet 10mg Adefovir dipivoxil 10mgGlaxosmithKline (Tianjin) Co.Ltd,
ChinaZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
101 BRU08090124PCiprobay® 200 Infusion
SolutionCiprofloxacin (as lactate) 200mg
Bayer Pharma AG, Leverkeusen,
GermanyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
102 BRU08090125P Vaxcel Ceftazidime 2g Ceftazidime (as pentahydrate) 2g Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
103 BRU08090126P Axcel Fusidic Cream Fusidic acid 2% w/w Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
104 BRU08090127P Axcel Fusidic Ointment Sodium Fusidate 2%w/w Kotra Pharm (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
105 BRU08090128P Vaxcel Ceftazidime 1g Ceftazidime (as pentahydrate) 1g Kotra Pharm (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
106 BRU08090129P Axcel Miconazole Cream Miconazole Nitrate 2% w/w Kotra Pharm (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020GSL
107 BRU08090130PCiprobay 100 Infusion Solution
x 50mlCiprofloxacin (as lactate) 100mg
Bayer Pharma AG, Leverkeusen,
GermanyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020P
108 BRU08090132P Aroxin Capsule 250mg Amoxicillin (as trihydrate) 250mg
Agila Specialties Private Limited,
India; Medreich Limited Unit-1,
Bangalore, India
G & H Trading Company06 October 2015 till 05
October 2020POM
109BRU08090133NPS1;
BRU08090133NPS2
Dhamol Suspension
250mg/5mlParacetamol 250mg/5ml
Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta Indonesia (S2)
G & H Trading Company06 October 2015 till 05
October 2020GSL (60ml)
110 BRU08100134P Decozol Cream Miconazole Nitrate 2%w/wHoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020GSL
111BRU08100135P Betamox Capsule 500mg Amoxicillin Trihydrate equivalent to
Amoxicillin 500mg
Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading &
Company
06 October 2015 till 05
October 2020
POM
112 BRU08100136PZovirax Dispersable Tablet
800mgAciclovir 800mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
113 BRU08100137P Neo Deca Eye/Ear Drop
Neomycin Sulphate 0.5%;
Dexamethasone Sodium Phosphate
0.1% w/w
CCM Pharmaceutical Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
114 BRU08100138P Uphalexin Granules 250 Cephalexin (as Monohydrate) 250mgUpha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
115 BRU08100139P Ciprobay® 500 TabletCiprofloxacin (as HCl monohydrate)
500mg
Bayer Pharma AG, Leverkeusen,
GermanyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
116 BRU08100140PAvelox Infusion Solution
0.4g/250mlMoxifloxacin (as Hydrochloride) 400mg
Bayer Pharma AG, Leverkusen,
GermanyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
117 BRU08100141P Avelox 400mg Tablet Moxifloxacin (as Hydrochloride) 400mgBayer Pharma AG, Leverkusen,
GermanyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 7 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
118 BRU08100142P Candazole Lotion Clotrimazole 1%w/wHoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020GSL
119 BRU08100143P Allopurinol 100mg Tablet Allopurinol 100mgDrug Houses of Australia Pte Ltd
G & H Trading Company06 October 2015 till 05
October 2020POM
120BRU08100144PS1;
BRU08100144PS2Bifen Suspension 100mg/5ml Ibuprofen BP 100mg/5ml
Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta Indonesia (S2)G & H Trading Company
06 October 2015 till 05
October 2020P
121 BRU08100145NP Dhamol Tablet 500mg Paracetamol BP 500mgDrug House of Australia Pte Ltd,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020P (1000's)
122 BRU08100146NP Silfazine Cream Silver Sulfadiazine 1%w/wSunward Pharmaceutical Sdn Bhd
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020P
123 BRU08100147P Difenac 50 Tablet Diclofenac Sodium BP 50mgDrug House of Australia Pte Ltd,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020POM
124 BRU08100148P Erythro Ethyl GranulesErythromycin (as ethyl succinate)
200mg/5ml
Drug Houses of Australia Pte. Ltd,
SingaporeG & H Trading Company
06 October 2015 till 05
October 2020POM
125 BRU08110150PAvaxim 160U Suspension for
Injection in a prefilled Syringe
Inactivated Hepatitis A Virus (GBM
strain) 160u/0.5mlSanofi Pasteur France Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
126 BRU08110151P Aprovel 150mg Tablet Irbesartan 150mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
127 BRU08110152P Zovirax IV for Infusion 250mg Aciclovir 250mgGlaxoSmithKline Manufacturing SPA
ItalyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
128 BRU08110153P Axcel Aciclovir Cream 5%w/w Aciclovir 5%w/w Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
129 BRU08110154PAxcel Eryhthromycin ES Tablet
400mg
Erythromycin (as ethyl succinate)
400mgKotra Pharma (M) Sdn Bhd, Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
130 BRU08110155P Axcel Cephalexin-500 Capsule Cephalexin (as monohydrate) 500mg Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
131 BRU08110156PAxcel Eryhthromycin ES-200
Suspension
Erythromycin (as Ethylsuccinate)
200mg/5mlKotra Pharma (M) Sdn Bhd, Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
132 BRU08110157P Soden Tablet 275mg Naproxen Sodium BP 275mgDrug House of Australia Pte Ltd,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020POM
133 BRU08110158NPDhamol Suspension
120mg/5mlParacetamol BP 120mg/5ml
Drug House of Australia Pte Ltd,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020GSL (100mL)
134 BRU08110159P Miconazole Cream 2.0%w/w Miconazole Nitrate 2.0%w/wSunward Pharmaceutical Sdn Bhd
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020GSL
135 BRU08110160P Malarone Tablet Atovaquone 250mg, Proguanil HCl
100mgGlaxoSmithKline Inc Canada Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
136 BRU08110162P Cordarone Tablet 200mg Amiodarone HCl 200mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
137 BRU08110163PCoAprovel 150/12.5mg Film-
coated Tablet
Irbesartan 150mg, Hydrochlorothiazide
12.5mgSanofi Winthrop Industrie, France Medipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
138 BRU08110164P Dhaperazine Tablet 5mg Prochlorperazine (as maleate) 5mgDrug House of Australia Pte Ltd,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 8 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
139BRU08110165P;
BRU08110165PS2Betasone Cream 0.1%w/w
Betamethasone (as 17-valerate)
0.1%w/w
Drug Houses of Australia Pte Ltd; PT
Actavis Indonesia (S2)G & H Trading Company
06 October 2015 till 05
October 2020POM
140 BRU08120166P Ciprobay 250 Tablet Ciprofloxacin (as HCl monohydrate)
250mg
Bayer Pharma AG, Leverkusen,
GermanyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
141 BRU08120167PAxcel Cephalexin 250mg
CaspuleCephalexin (as Monohydrate) 250mg Kotra Pharma (M) Sdn Bhd Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
142 BRU08120168PAxcel Cephalexin 125mg
SuspensionCephalexin (as Monohydrate) 125mg Kotra Pharma (M) Sdn Bhd Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
143 BRU08120169P Cloxacillin Capsule 250 Cloxacillin (as Sodium) 250mgUpha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
144 BRU08120172P Betamox Tablet 125 Amoxicillin (as trihydrate) 125mg Duopharma (M) Sdn Bhd MalaysiaHongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
145 BRU08120173P Ventolin Respirator Solution Salbutamol (as sulphate) 0.5%w/v Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
146 BRU08120174P Dhacopan Syrup 5mg/5mlHyoscine (as butylbromide) BP
5mg/5ml
Drug Houses of Australia Pte Ltd,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020POM
147BRU08120175P;
BRU08120175PS2Phenexpect Syrup
Per 5ml - Diphenhydramine (as HCl)
12.5mg, Ammonium Chloride 135mg
Drug Houses of Australia Pte Ltd,
Singapore; PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company06 October 2015 till 05
October 2020POM
148 BRU08120176P Dhabesol Cream 0.05% Clobetasol (as propionate) 0.05% w/vDrug Houses of Australia Pte Ltd,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020POM
149 BRU08120177P Beprosalic LotionBetamethasone (as dipropionate)
0.05%, Salicylic acid 2.0%
Hoe Pharmaceuticals Sdn Bhd
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
150BRU08120178PS1;
BRU08120178PS2Zenmolin Syrup 2mg/5ml Salbutamol (as sulphate) BP 2mg/5ml
Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company06 October 2015 till 05
October 2020POM
151 BRU08120179P Dhasedyl Syrup
Per 5ml - Promethazine (as HCl)
3.85mg, Epherdrine (as HCl) 6.0mg,
Codeine (as phosphate) 9.0mg
Drug Houses of Australia Pte Ltd,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020POM
152 BRU08120180PZithromax Film-coated Tablet
250mgAzithromycin (as dihydrate) 250mg Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
153 BRU09010181P Unasyn 0.75mg IM/IVAmpicillin (as sodium) 500mg;
Sulbactam (as sodium) 250mgHaupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
154 BRU09010182P Unasyn 3.0g IM/IVAmpicillin (as sodium) 2000mg;
Sulbactam (as sodium) 1000mgHaupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
155 BRU09010183PVaxcel Ceftriaxone-500mg
InjectionCeftriaxone (as sodium) 500mg Kotra Pharma (M) Sdn Bhd Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
156BRU09010184PS1;
BRU09010184PS2 Aroxin granules 125mg/5ml Amoxicillin (as trihydrate) 125mg/5ml
Drug Houses of Australia Pte Ltd,
Singapore (S1); Medreich Limited
Unit-1, India (S2)
G & H Trading Company06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 9 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
157 BRU09010185P Pacofen Tablet
Paracetamol 500mg; Codeine
Phosphate 8mg; Caffeine anhydrous
30mg
Drug Houses of Australia Pte Ltd,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020POM
158 BRU09010186P Plavix Tablet 75mgClopidogrel (as Hydrogen Sulphate)
75mgSanofi Winthrop Industrie, France Medipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
159 BRU09010187PSymbicort Turbuhaler
160/4.5mcg dose
Budenoside 160mcg; Formoterol
fumarate dihydrate 4.5mcgAstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
160 BRU09010188PCoAprovel 300/12.5mg film-
coated tablet
Irbesartan 300mg; Hydrochlorothiazide
12.5mgSanofi Winthrop Industrie, France Medipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
161BRU09010189PS1;
BRU09010189PS2Vasican Syrup 4mg/5ml Bromhexine HCl BP 4mg/5ml
Drug House of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta
Indonesia (S2)
G & H Trading Company06 October 2015 till 05
October 2020POM
162 BRU09010190P Cardium 30 tablet Diltiazem HCl 30mgDrug House of Australia Pte Ltd,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020POM
163BRU09010191PS1 &
BRU09010191PS2Coversyl 8mg tablet Perindopril tert-butylamine 8mg
Les Laboratoires Servier Industrie,
France (S1) & Kotra Pharma (M) Sdn.
Bhd, Malaysia (S2)
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
164 BRU09010192P Dhacopan Tablet Hyoscine (as butylbromide) BP 10mgDrug Houses of Australia Pte Ltd,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020POM
165 BRU09010194PPulmicort turbuhaler
100mcg/doseBudenoside 100mcg AstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
166 BRU09010195P Lantus for Optipen 100iu/ml Insulin glargine 100iu/ml Sanofi Aventis Deutschland, Germany Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
167 BRU09020196P Zovirax Cream 5% Aciclovir 5%w/w Glaxo Wellcome Opertions, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
168 BRU09020197P Zovirax Eye Ointment 3% Aciclovir 3%w/wJubilant HollisterStier General
Partnership, CanadaZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
169 BRU09020198P Adenocor Injection 6mg/2ml Adenosine 6mg/2mlFamar Health Care Services Madrid
S.A.U., Madrid, SpainMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
170BRU09020201NPS1,
BRU09020201NPS2
Dhamol Suspension
500mg/5mlParacetamol BP 500mg/5ml
Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2) G & H Trading Company06 October 2015 till 05
October 2020P (3.8L)
171BRU09020205PS1 &
BRU09020205PS2 Fedac Syrup
Pseudoephedrine 30mg/5ml;
Triprolidine 1.25mg/5ml
Drug House of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta
Indonesia (S2)
G & H Trading Company06 October 2015 till 05
October 2020POM
172 BRU09020206PBricanyl Turbuhaler
0.5mg/doseTerbutaline Sulphate 0.5mg/dose AstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 10 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
173 BRU09020207P Beprosalic OintmentBetamethasone (as Dipropionate
0.064%) 0.05% & Salicylic acid 3% w/w
HOE Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading & Co
06 October 2015 till 05
October 2020POM
174 BRU09020208P Beprogel Topical SolutionBetamethasone (as Dipropionate
0.064%) 0.05% w/w
HOE Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading & Co
06 October 2015 till 05
October 2020POM
175 BRU09020209P Cloderm Scalp Application Clobetasol (as dipropionate) 0.05% w/vHOE Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading & Co
06 October 2015 till 05
October 2020POM
176 BRU09020210P Declovir Cream Acyclovir 5.0% w/wHOE Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading & Co
06 October 2015 till 05
October 2020POM
177 BRU09020211P Lantus 100units/ml for Optiset Insulin Glargine (HOE 901) 100units/mlSanofi-Aventis Deutschland GmbH,
GermanyMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
178 BRU09020212P Glucobay 50 Tablet Acarbose 50mgBayer Pharma AG, Leverkusen,
GermanyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
179 BRU09030213P 3TC Tablet 150mg Lamivudine 150mg Glaxo Wellcome Operaions, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
180 BRU09030214P 3TC Oral Solution 10mg/ml Lamivudine 10mg/ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
181 BRU09030215P Dhatrin TabletSulphamethoxazole BP 400mg;
Trimethoprim BP 80mg
Drug Houses of Australia Pte Ltd,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020POM
182 BRU09030216PCordarone Injection
150mg/3mlAmiodarone 150mg/3ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
183BRU09030217PS1 &
BRU09030217PS2Vastarel MR 35mg Tablet Trimetazidine HCl 35mg
Les Laboratoires Servier Industrie,
France (S1); Kotra Pharma (M) Sdn.
Bhd, Malaysia (S2)
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
184
BRU09030218P0.5gS
&
BRU09030218P0.5gA
Tetavax Suspension for
Injection (Single dose 0.5ml)Purified Tetanus Toxoid Sanofi Pasteur, France Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
185 BRU09030219PCataflam 1.5% Oral Drops
SuspensionDiclofenac Sodium 15mg/ml Novartis Farma SpA, France Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 11 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
186 BRU09030220P Vaxigrip Influenza Vaccine
Strain composition for Influenza
Vaccine complies with the WHO
recommendations and EU
Recommendations for the Northern
Hemisphere 2015/2016 year influenza
season.
Active substance(s):
Split influenza virus, inactivated
containing antigens equivalent to the
following strains per one 0.5ml dose:
• A/California/7/2009 (H1N1)pdm09-
like strain (A/California/7/2009, NYMC
X-179A)
• A/Switzerland/9715293/2013 (H3N2)-
like strain (A/South Australia/55/2014,
IVR-175)
• B/Phuket/3073/2013
Sanofi Pasteur, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
187 BRU09030221PLignocaine HCl BP Injection 1%
(5ml)
Lidocaine HCl (Lignocaine HCl) 1%
(50mg/5ml)Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
188 BRU09030222P Crestor 5mg Tablet Rosuvastatin Calcium 5mg IPR Pharmaceuticals Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
189 BRU09030223P Crestor 20mg Tablet Rosuvastatin Calcium 20mg IPR Pharmaceuticals Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 12 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
190 BRU09030224P Beprosone OintmentBetamethasone (as Dipropionate
0.064%) 0.05% w/w
HOE Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading & Co
06 October 2015 till 05
October 2020POM
191 BRU09030225P Beprosone CreamBetamethasone (as Dipropionate
0.064%) 0.05% w/w
HOE Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading & Co
06 October 2015 till 05
October 2020POM
192 BRU09030226P Benosone-N Cream
Betamethasone (as Valerate 0.12%)
0.1% w/w; Neomycin Sulphate
0.5%w/w
HOE Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading & Co
06 October 2015 till 05
October 2020POM
193 BRU09030227P Pocin H Ear DropNeomycin Sulphate B.P. 3,400 i.u.;
Polymyxin B Sulphate B.P.10,000 i.u;
Hydrocortisone B.P.10mg
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
194 BRU09030228P U-Closone Cream Clobetasone butyrate 0.05%w/wHOE Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading & Co
06 October 2015 till 05
October 2020POM
195 BRU09040229PUnasyn Powder for Oral
Suspension 250mg/5mlSultamicillin (as tosilate) 250mg Pfizer Global Supply Japan, Inc., Japan Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
196 BRU09040230P Axcel Cefuroxime-250 Capsule Cefuroxime (as axetil) 250mg Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
197 BRU09040231P Knowful Capsule 400mg Piracetam 400mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd06 October 2015 till 05
October 2020POM
198
BRU09040232P0.5gV
&
BRU09040232P0.5gS
Stamaril Vaccine
Live attenuated Yellow Fever Virus 17
D-204 strain (per 0.5ml - Not less than
1000 LD50 units of the virus)
Sanofi Pasteur, Campus Merieux &
Sanofi Pasteur, Parc Insutrial
d'Incarville, France
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
199 BRU09040233P Voltaren Suppository 25mg Diclofenac (as Sodium) 25mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
200 BRU09040234P Tidact Capsule 150mg Clindamycin (as hydrochloride) 150mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd06 October 2015 till 05
October 2020POM
201 BRU09040235PVoltaren 75mg/3ml solution
for injectionDiclofenac Sodium 75mg/3ml
Novartis Pharma Stein, ag,
Switzerland; Lek Pharmaceuticals d.d,
Slovenia
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 13 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
202 BRU09040236P Vaxigrip Paediatric Injection
Split influenza virus*, inactivated
containing antigens equivalent to the
following strains per one 0.25ml dose:
A/California/7/2009 (H1N1)pdm09-
derived strain used NYMC X-179A
7.5mcg HA**;
A/Texas/50/2012(H3N2)-derived strain
used NYMC X-223A 7.5mcg HA**;
B/Massachusetts/02/2012 15mcg
HA** Note - *
Propagated in fertilized hens’ egg
from healthy chicken flocks
** haemagglutinin
Sanofi Pasteur, Campus Merieux &
Sanofi Pasteur, Parc Insutrial
d'Incarville, France
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
203 BRU09040237PDepo-Medrol Sterile Aqueous
Suspension 40mg/ml (5ml)
Methylprednisolone Acetate
200mg/5ml
Pfizer Manufacturing Belgium NV,
BelgiumZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
204 BRU09040238P Typhim Vi Vaccine (20 doses)
Per 0.5ml - Purified Vi Capsular
Polysaccharide of Salmonella typhi
(Ty2 strain)
Sanofi Pasteur, Campus Merieux &
Sanofi Pasteur, Parc Insutrial
d'Incarville, France
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
205 BRU09040239PBupivacaine Hydrochloride BP
0.5% w/v injectionBupivacaine hydrochloride BP 0.5%w/v Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
206 BRU09040240P Rhinathiol Capsule 375mg Carbocisteine 375mg Sanofi-aventis Egypt s.a.e., Egypt Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
207 BRU09040241P Celebrex Capsule 200mg Celecoxib 200mgPfizer Pharmaceutical LLC, Vega Baja
Puerto RicoZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
208 BRU09040242P Voltaren® SR Tablet 100mg Diclofenac sodium 100mg Novartis Farma SPA, Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
209 BRU09040243P T3 Mycin GelClindamycin (as phosphate) 1.0% HOE Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading & Co
06 October 2015 till 05
October 2020POM
210 BRU09040244P Cloderm Cream Clobetasone (as butyrate) 0.05%w/wHOE Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading & Co
06 October 2015 till 05
October 2020POM
211 BRU09040245P Bisacodyl Suppositroies Bisacodyl (micronised) 10mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd06 October 2015 till 05
October 2020P
212 BRU09040246P U-Closone Ointment Clobetasol (as propionate) 0.05%w/wHOE Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
213 BRU09040247P Nexium® IV 40mg Esomeprazole (as sodium) 40mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 14 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
214BRU09050248NPS1;
BRU09050248NPS2Dhactulose Syrup Lactulose 67%w/w
Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)G & H Trading Company
06 October 2015 till 05
October 2020
GSL (200mL) &
P(1L)
215 BRU09050249P Vastarel 20mg Tablet Trimetazidine dihydrochloride 20mgLes Laboratoires Servier Industrie,
FranceZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
216 BRU09050250P Coversyl Plus TabletPerindopril tert-butylamine 4mg,
Indapamide 1.25mg
Les Laboratoires Servier Industrie,
FranceZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
217 BRU09050251P Methyldopa Tablet 250mg Methyldopa (as anhydrous) 250mgDrug House of Australia (Asia) Pte Ltd,
SingaporeG & H Trading Company
06 October 2015 till 05
October 2020POM
218 BRU09050252P Glucobay Tablet 100mg Acarbose 100mgBayer Pharma AG, Leverkusen,
GermanyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
219 BRU09050253P Benosone-N Ointment
Betamethasone (as valerate 0.12%
w/w) 0.01%, Neomycin Sulphate
0.50%w/w
HOE Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
220 BRU09050254P Benosone Ointment Betamethasone 0.01% w/wHOE Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
221 BRU09050255P Mycosone Cream
Miconazole nitrate 2% w/w,
Hydrocortisone ( as acetate1.12%) 1%
w/w
Sunward Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
222 BRU09050256P H-Cort Ointment Hydrocortisone 1% w/wHOE Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
223 BRU09050257P T3 Mycin Lotion Clindamycin (as phosphate) 1.0% w/vHOE Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
224 BRU09050258P Lobesol Cream Clobetasol (as propionate) 0.05%w/wSunward Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
225 BRU09060259PVaxcel Cefuroxime 1.5g
InjectionCefuroxime (as sodium) 1.5g Kotra Pharma (M) Sdn Bhd, Malaysia
Medicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
226 BRU09060260P
Tetavax Suspension for
Injection (multidose)
(1 vial of 5mL – 10 doses) Tetanus toxoid 40i.u/0.5ml dose Sanofi Pasteur, Lyon, Pasteur Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
227
BRU09060262P Betamox Tablet 250mg Amoxicillin (as trihydrate) 250mg Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
228 BRU09060263P Voltaren 50mg Tablets Diclofenac Sodium 50mg Novartis Pharma SPA, Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
229 BRU09060264P Voltaren 12.5mg Suppositories Diclofenac Sodium 12.5mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
230 BRU09060265P Voltaren 50mg Suppositories Diclofenac Sodium 50mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
231 BRU09060266P Benosone Cream Betamethasone (as valerate) 0.1%w/wHOE Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 15 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
232 BRU09060267NP Uphamol 250 Syrup Paracetamol 250mg/5mlUpha Pharmaceutical Mfg (M) Sdn
Bhd
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
GSL (60mL)
233 BRU09060268P Betamethasone Cream Betamethasone (as valerate) 0.1%w/wSunward Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
234 BRU09060269P Zorax Cream Aciclovir 5%w/wSunward Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
235 BRU09060270P Nexium mups 20mgEsomeprazole (as magnesium
trihydrate) 20mgAstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
236 BRU09060271P Ebutol-100 Tablet Ethambutol HCl 100mgSunward Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
237 BRU09060272P Neurontin Capsule 300mg Gabapentin 300mgPfizer Pharmaceuticals LLC, Vega Baja
Puerto Rico, USAZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
238 BRU09060274P Relenza® Rotadisks 5mg Zanamivir 5mgGlaxoSmithKline Australia Pty Ltd,
AustraliaZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
239 BRU09070275P Unasyn IM/IV 1.5g
Sulbactam (as sodium 546.4mg)
500mg & Ampicillin (as sodium
1084.6mg) 1000mg
Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
240 BRU09070277P Avaxim 80u Paediatric Inactivated Hepatitis A virus (GBM
strain) 80u per 0.5mlSanofi Pasteur, Lyon, Pasteur Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
241 BRU09070278P Fedac TabletPseudoephedrine HCl 60mg;
Triprolidine HCl 2.5mg
Drug Houses of Australia Pte Ltd,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020POM
242 BRU09070279P Salazopyrin® EN-Tabs Sulfasalazine 500mgKemwell AB, Bjorkgatan 30, SE-751 82
Uppsala, Sweden.Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
243 BRU09070280P Zyloric® 100mg Tablet Allopurinol 100mgGlaxoSmithKline Australia Pty Ltd.,
AustraliaZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
244 BRU09070281P Orrepaste 0.1%w/w Triamcinolone Acetate 0.1%w/wHOE Pharmaceuticals Sdn Bhd,
Malaysia.G & H Trading Company
06 October 2015 till 05
October 2020POM
245 BRU09070282PHydrocortisone Cream 1%
w/wHydrocortisone acetate 1%w/w
Sunward Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
246 BRU09070283P XanaxTM 0.25mg Tablet Alprazolam 0.25mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
247 BRU09070284P Nexium mups 40mgEsomeprazole (as magnesium
trihydrate) 40mgAstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
248 BRU09070286P XanaxTM 0.5mg Tablet Alprazolam 0.5mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
249 BRU09070287P Zolterol S/R Tablet 100mg Diclofenac Sodium 100mgUpha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
250 BRU09070288P Diane-35 TabletCyproterone acetate 2mg;
Ethinylestradiol 0.035mg
Bayer Weimar GmbH und Co. KG,
GermanyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
251 BRU09070289P Amaryl 3mg Tablet Glimepiride Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 16 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
252 BRU09070290P Diamicron Tablet 80mg Gliclazide 80mgLes Laboratoires Servier Industrie,
FranceZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
253 BRU09070291NP Dulcolax Suppository 10mg Bisacodyl 10mg Istituto De Angeli S.r.l., ItalyHongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
254 BRU09070292P Clotrimazole Cream 1% w/w Clotrimazole 1% w/wBeacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020GSL
255 BRU09070293P Mucosolvon® 30mg Tablet Ambroxol hydrochloride 30mgPT Boehringer Ingelheim Indonesia,
Bogor, Indonesia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
256 BRU09080294P Euvax B Vaccine, RecombinantPurified Hepatitis B surface antigen
(HBsAg) 200µg/10mlLG Life Science Ltd, Korea Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
257 BRU09080295PPulmicort® Turbuhaler®
200mcg/dose
Budesonide (micronised) Ph Eur
200mcg/doseAstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
258 BRU09080296PEpilim Intravenous 400mg/
vial Sodium Valproate 400mg
Gruppo Lepetit S.R.L. ItalyMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
259 BRU09080297P Tritace® 5mg Tablet Ramipril 5mg Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
260 BRU09080298P Ebutol-400 Tablet Ethambutol HCl 400mgSunward Pharmaceutical Pte Ltd,
SingaporeG & H Trading Company
06 October 2015 till 05
October 2020POM
261 BRU09080299PBeafemic Suspension
50mg/5mlMefenamic acid 50mg/5mL
Upha Pharmaceuticals Mfg (M) Sdn
Bhd, MalaysiaHongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
262BRU09080300PS1 &
BRU09080300PS2Diamicron MR Tablet 30mg Gliclazide 30mg
Les Laboratoires Servier Industrie,
France (S1) & Kotra Pharma (M) Sdn.
Bhd, Malaysia (S2)
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
263 BRU09080301P Deltasolone Tablet 5mg Prednisolone 5mgSunward Pharmaceutical Pte Ltd,
SingaporeG & H Trading Company
06 October 2015 till 05
October 2020POM
264 BRU09080302P Sunprox-275 Tablet Naproxen Sodium 275mgSunward Pharmaceutical Pte Ltd,
SingaporeG & H Trading Company
06 October 2015 till 05
October 2020POM
265 BRU09080303P Spiriva® 18mcgTiotropium 18mcg (as Bromide
Monohydrate 22.5mcg) Boehringer Ingelheim Pharma GmbH
& Co. KG, Germany
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
266 BRU09080304P Prednisolone 1mg Tablet Prednisolone 1mgBeacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
267 BRU09080305NP Poro Suppository 250mg Paracetamol 250mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United Sdn Bhd06 October 2015 till 05
October 2020P (10 x 10's)
268 BRU09080307P Buscopan Tablet 10mg Hyoscine-N-butylbromideDelpharm Reims S.A.S,France
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
269 BRU09080308PAtrovent N 20µg/ puff
Metered Dose Inhaler
Ipratropium bromide anyhdrous
20mcg (as monohydrate 21mcg)
Boehringer Ingelheim Pharma GmbH
& Co. KG, Germany
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
270 BRU09080309P Fenagesic Capsule 250mg Mefenamic acid 250mgSunward Pharmaceutical Pte Ltd,
SingaporeG & H Trading Company
06 October 2015 till 05
October 2020POM
271 BRU09080311P Carinox CapsulePseudoephedrine sulphate 120mg;
Loratadine 5mg
Upha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020 POM
272 BRU09090312PEuvax B Vaccine, Recombinant
(100µg/5ml)
Purified Hepatitis B surface antigen
(HBsAg) 100µg/5mlLG Life Science Ltd, Korea Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 17 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
273 BRU09090313P Typhim Vi Single Dose
Purified Vi Capsular polysaccharides of
Salmonella typhi (Ty2 strain)
25µg/0.5ml
Sanofi Pasteur, Campus Merieux,
France & Sanofi Pasteur, Parc
industrial d'Incarville, France
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
274 BRU09090314P Crestor 10mg Tablet Rosuvastatin Calcium 10mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
275 BRU09090315P Amaryl 2mg Tablet Glimepride 2mg Sanofi-aventis S.p.A, Italy Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
276 BRU09090316P Lamisil® 250mg Tablet Terbinafine HCl 250mgNovartis Pharmaceuticals UK Limited,
UKZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
277 BRU09090317P Voltaren® SR 75 Tablet Diclofenac Sodium 75mgNovartis Farma S.p.A, Italy
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
278 BRU09090318P Cataflam® 50 Tablet Diclofenac Potassium 50mg Novartis Urunleri, Istanbul Turkey Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
279 BRU09090321PMono-Tildiem SR 200mg
CapsuleDiltiazem HCl 200mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
280 BRU09090322P Actilyse® Treatment-Set
Recombinant Human Tissue-type
Plasminogen Activator (alteplase)
50mg
Boehringer Ingelheim Pharma GmbH
& Co. KG, Germany
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
281 BRU09090324P Trenlin SR Tablet 400mg Pentoxifylline 400mgUpha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
282 BRU09090325NP Paratab Tablet 500mg Paracetamol 500mgSunward Pharmaceutical Pte Ltd,
SingaporeG & H Trading Company
06 October 2015 till 05
October 2020P (100x10's)
283 BRU09090326P Micardis 40mg Tablet Telmisartan 40mgBoehringer Ingelheim Pharma GmbH
& Co. KG, Germany
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
284 BRU09090327PMetalyse Injection
10,000unitsTenecteplase 10,000units (50mg)
Boehringer Ingelheim Pharma GmbH
& Co. KG, Germany
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
285 BRU09090328NP Hemo RidTM TabletMiconised Diosmin 450mg; Micronised
Hesperidine 50mg
Upha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020GSL
286 BRU09090329P Exforge Tablet 5mg/80mgAmlodipine 5mg (as besylate 6.94mg);
Valsartan 80mgNovartis Farmaceutica SA , Spain Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
287 BRU09100330P Imovax Polio Vaccine
Inactivated Polio Virus: Type 1
(40DU/0.5mL), Type 2 (80DU/0.5mL),
Type 3 32DU/0.5mL)
Sanofi Pasteur, Lyon, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
288 BRU09100331P Cloderm Ointment Clobetasol (as propionate) 0.05%w/wHOE Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
289 BRU09100332P H-Cort Cream Hydrocortisone 1%w/wHOE Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
290 BRU09100334P Prelone Syrup 3mg/5ml Prednisolone Sunward Pharmaceutical Sdn Bhd,
Malaysia.G & H Trading Company
06 October 2015 till 05
October 2020POM
291 BRU09100335P Ventolin Nebules 2.5mg/2.5ml Salbutamol Sulphate 2.5mg/2.5mlGlaxoSmithKline Australia Pty Ltd,
AustraliaZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
292 BRU09100336NP Sunquadin Lozenges Dequalinium ChlorideSunward Pharmaceutical Sdn Bhd,
Malaysia.G & H Trading Company
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 18 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
293 BRU09100337P Zoloft Tablet 50mg Sertraline (as hydrochloride) 50mg Pfizer Australia Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
294 BRU09100338NPUphamol 250 Suspension
(Fruity)Paracetamol 250mg/5mL
Upha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
GSL (60mL and
100mL)
295 BRU09100339P XanaxTM 1mg Tablet Alprazolam 1mg Sanico NV Industriezone, Belgium Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
296 BRU09100340P Pontalon Capsule Mefenamic acid 250mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
297 BRU09100342NP Maalox Plus Tablet
Aluminium hydroxide dried gel 200mg,
Magnesium hydroxide 200mg,
Simethicone 26.25mg (correspond to
25mg of polydiemthylsiloxane)
Sanofi-Aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05
October 2020GSL
298 BRU09100343P Neurontin 600mg Tablet Gabapentin 600mgPfizer Pharmaceutical LLC, Puerto
Rico, USAZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
299 BRU09100345P LipitorTM 40mg TabletAtorvastatin (as Calcium 43.38mg-
crystalline) 40mg
Pfizer pharmaceuticals LLC, vega baja
Puerto Rico, USAZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
300 BRU09100346NP Suniton TabletParacetamol 450mg, Orphenadrine
Citrate 35mg
Sunward Pharmaceutical Pte Ltd,
SingaporeG & H Trading Company
06 October 2015 till 05
October 2020POM
301 BRU09100347P SCMC Plus Syrup 250mg/5mLS-carboxy-methylcysteine 250mg/5mL
(Carbocisteine)
Upha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
302 BRU09100348NP Glyprin Dispersible Tablet Aspirin 100mg, Glycine 45mgUpha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
303 BRU09100349P Actonel® 35mg TabletRisedronate sodium 35mg (equivalent
to 32.5mg risedronic acid)Norwich Pharmaceuticals Inc., USA
G&H Trading Company06 October 2015 till 05
October 2020POM
304 BRU09110350P Lantus® Solostar® 100units/ml Insulin Glargine (HOE 901)Sanofi-Aventis Deutschland GmbH,
GermanyMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
305 BRU09110353P Tenoretic Tablet Atenolol 100mg; Chlorthalidone 25mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
306 BRU09110354P LipitorTM 10mg TabletAtorvastatin (as calcium 10.85mg -
crystalline) 10mg
Pfizer pharmaceutical LLC, vega baja
Puerto Rico, USAZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
307 BRU09110357PS2Atrovent Unit Dose Vial (UDV)
250mcg/2ml
Ipratropium bromide anhydrous
250mcg (as monohydrate 261mcg)Laboratoire Unither, France (S2)
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
308 BRU09110358PMicardis Plus 40mg/12.5mg
Tablet
Telmisartan 40mg;
Hydrochlorothiazide 12.5mg
Boehringer Ingelheim Pharma GmbH,
Germany
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
309 BRU09110359P Allavin ExpectorantDiphenhydramine HCl 14mg/5ml;
Ammonium Chloride 135mg/5ml
Upha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020 POM
BDMCA/RMP/0317 Page 19 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
310 BRU09110361NP Uphamol 500 Tablet Paracetamol 500mgUpha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
P (100 x 10's)
311 BRU09110362P Carin Tablet 10mg Loratadine 10mgUpha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020 P
312 BRU09110363PRhinathiol 2% for Children
SyrupCarbocisteine 100mg/5ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
313 BRU09120365P Tienam IV Injection 500mgImipenem (as monohydrate) 500mg &
Cilastatin Sodium 500mgMerck Sharp & Dohme Corp, USA Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
314BRU09120366PS1 &
BRU09120366PS2
Opvero (Oral trivalent
poliomyelitis vaccine)
Each 0.1mL (2 drops) contains: Type1
poliomyelitis virus (LS-c2ab strain) ≥
106.0 CCID50; Type2 poliomyelitis virus
(p712,Ch,2ab strain) ≥ 105.0 CCID50;
Type3 poliomyelitis virus (Leon 12a1b
strain) ≥ 105.8 CCID50;
Sanofi Pasteur, Campus Merieux,
France (S1); Sanofi Pasteur, Parc
industrial d'Incarville, France (S2)
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
315 BRU09120367P Dilantin 100mg Capsule Phenytoin Sodium Pfizer Australia Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
316 BRU09120368P Modalim 100mg Tablet Ciprofibrate 100mg Sanofi Winthrop Limited, UK Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
317 BRU09120369P Oral Aid Lotion
Lignocaine HCl 2.5%; Triamcinolone
Acetonide 0.1%; Chlorhexidine HCl
0.5%
Upha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
318 BRU09120370P Primperan 10mg/2ml Injection Metoclopramide HCl 10mg/2ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
319 BRU09120371P Tritace 10mg Tablet Ramipril 10mg Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
320 BRU09120372P Mono-Tildiem SR 300mg Diltiazem HCl 300mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
321 BRU09120373P Micardis® 80mg Tablet Telmisartan 80mgBoehringer Ingelheim Pharma GmbH,
Germany
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
322 BRU09120374PMicardis Plus 80mg/12.5mg
Tablet
Telmisartan 80mg;
Hydrochlorothiazide 12.5mg
Boehringer Ingelheim Pharma GmbH,
Germany
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
323 BRU09120375P Natrilix® SR Tablet Indapamide 1.5mgLes Laboratoires Servier Industrie,
FranceZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
324 BRU09120376NP Poro Suppository 125mg Paracetamol 125mgY.S.P Industries (M) Sdn Bhd.,
MalaysiaAsterix United (B) Sdn Bhd
06 October 2015 till 05
October 2020
GSL
(1 x 5's); P(10 x
10's)
325 BRU09120377PVascor 40mg Film-coated
TabletSimvastatin 40mg
Upha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
326 BRU09120379PCovastin Film-coated Tablet
10mgSimvastatin 10mg
Xepa-Soul Pattinson (Malaysia) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 20 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
327 BRU09120381PS2Co-Diovan 80/12.5 Film-
coated Tablets
Valsartan 80mg; Hydrochlorothiazide
12.5mgNovartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
328 BRU09120382PRhinathiol® Promethazine
syrup
Carbocisteine 100mg/5ml;
Promethazine HCl 2.5mg/5mlSanofi Winthrop Industrie, France Medipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
329 BRU09120383PMethotrexate Injection BP
1000mg/10mlMethotrexate 1000mg/10ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
330 BRU10010384P Zyloric 300mg Tablet Allopurinol 300mgGlaxoSmithKline Australia Pty Ltd.
AustraliaZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
331BRU10010385PS1 &
BRU10010385PS2Coversyl 4mg Tablet Perindopril tert-butylamine 4mg
Les Laboratoires Servier Industrie,
France (S1) & Kotra Pharma (M) Sdn
Bhd., Malaysia
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
332 BRU10010386PS2Atrovent Unit Dose Vial
0.5mg/2ml
Ipratropium bromide (as
monohydrate) 500mcg/2ml
Laboratoires Unither, Amiens cedex,
France (S2)
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
333 BRU10010387P Aspirin EC Tablet 100mg Acetylsalicylic acid 100mgBeacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
334 BRU10010388P Exforge Tablet 5mg/160mgAmlodipine 5mg (as besylate 6.94mg);
Valsartan 160mgNovartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
335 BRU10010389P Taxotere 80mg/2ml VialDocetaxel anhydrous (as trihydrate)
80mg
Sanofi-Aventis Deutschland GmbH,
GermanyMediPharm Sdn Bhd
06 October 2015 till 05
October 2020POM
336
BRU10010390NPS1,
BRU10010390NPS2 &
BRU10010390NPS3
Dulcolax 5mg Tablet Bisacodyl 5mg
Boehringer Ingelheim Korea (S1);
Boehringer Ingelheim France (S2);
Delpharm Reims S.A.S., France (S3)
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
337 BRU10010391PS2 Diovan 80mg Tablet Valsartan 80mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
338 BRU10010392PS2Co-Diovan 160/25 Film-coated
Tablets
Valsartan 160mg; Hydrochlorothiazide
25mgNovartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
339 BRU10010395P Isoket SprayIsosrobide Dinitrate 1.25mg per
actuationSchwarz Pharma Ltd, Ireland Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
340 BRU10010396P Beafemic Capsule 250mg Mefenamic acid 250mgUpha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
341 BRU10010397P Metformin Tablet 500mg Metformin HCl 500mgSunward Pharmaceutical Pte Ltd,
SingaporeG & H Trading Company
06 October 2015 till 05
October 2020POM
342 BRU10010399P Seretide Accuhaler 50/500Salmeterol 50mcg (as Xinafoate),
Fluticasone propionate 500mcgGlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
343 BRU10010401P VentolinTM Tablet 4mg Salbutamol 4mg (as Sulphate 4.8mg) Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
344 BRU10020402PSolu-Medrol Sterile Powder
500mg
Methyprednisolone (as Sodium
succinate) 500mg
Pfizer Manufacturing Belgium N.V.,
BelgiumZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
345 BRU10020404P Imdex 60mg CR Tablet Isosorbide-5-Mononitrate 60mgUpha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
346 BRU10020405P Vascor Tablet 20mg SimvastatinUpha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 21 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
347 BRU10020406PCombivent Unit Dose Vial
500mcg
Per 2.5ml - Ipratropium bromide (as
monohydrate 522mcg) 500mcg;
Salbutamol 2.5mg (as sulphate
3.013mg)
Laboratorie UNITHER , FranceHongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
348 BRU10020408P Guadex Linctus
Per 5ml - Dextromethorphan
Hydrobromide 15mg; Guaifenesin
100mg
Hoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
349 BRU10020409PS2 Diovan® 160mg Tablet Valsartan 160mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
350 BRU10020410PEtoposide 100mg/5ml
InjectionEtoposide 100mg/5ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
351 BRU10020411P Decondine SyrupPer 5ml - Triprolidine HCl 1.25mg;
Pseudoephedrine HCl 30mg
Sunward Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
352 BRU10020412P Seretide Accuhaler 50/100Salmeterol 50mcg (as Xinafoate),
Fluticasone propionate 100mcgGlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
353 BRU10020413P Optizoline eye drops Tetrahydrozoline HCl 0.05%w/wXepa-Soul Pattinson (Malaysia) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
354 BRU10020414P Sunadine Syrup Loratadine 5mg/5mlSunward Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020P
355 BRU10020415P Adalat LA 30 Tablet Nifedipine 30mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
356 BRU10020416P Lipitor 20mg Tablet Atorvastatin (Calcium) 20mgPfizer Pharmaceutical LLC, Puerto
RicoZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
357 BRU10020417PIsosorbide Dinitrate Tablet
10mgIsosorbide Dinitrate BP 10mg
Upha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
POM
358 BRU10020418P Nitroderm TTS® 5 (5mg/24hr) Glyceryl Trinitrate/ nitroglycerin 25mgNovartis Pharma Stein AG,
Switzerland Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
359 BRU10020419P Adalat® LA 20 Tablet Nifedipine 20mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
360 BRU10020421P Xatral XL Tablet 10mg Alfuzosin HCl 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
361 BRU10030423PRhinathiol 5% Adult
Expectorant SyrupCarbocisteine 5g/100ml Unither Liquid Manufacturing, France Medipharm Sdn Bhd
06 October 2015 till 05
October 2020P
362 BRU10030425NP Dulcolax Suppository 5mg Bisacodyl 5mg Instituto De Angeli S.R.L., ItalyHongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
363 BRU10030426P Aromasin 25mg Tablet Exemestane 25mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
364 BRU10030427P Omesec Capsule 20mg Omeprazole 20mgUpha Pharmaceuticals Mfg (M) Sdn
Bhd, MalaysiaK-Seri Pharma Sdn Bhd
06 October 2015 till 05
October 2020POM
365 BRU10030428P Adalat LA 60 Tablet Nifedipine 60mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 22 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
366 BRU10030429P Polarax 2mg Tablet Dexchlorpheniramine maleate 2mgSunward Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
367 BRU10030430P Pharmorubicin CS 50mg/25ml Epirubicin HCl 50mg/2ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
368 BRU10030432P Cisplatin Injection 50mg/50ml Cisplatin USP 50mg/50ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
369 BRU10030433PTerramycin Ophthalmic
Ointment
Per g - Oxytetracycline 5mg; Polymyxin
B 10,000units PT Pfizer (Indonesia), Indonesia Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
370 BRU10030435PAdriamycin CS Injection
50mg/25mlDoxorubicin HCl 50mg/25ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
371 BRU10030436NP Maalox® Plus Suspension
Per 5ml - Aluminium hydroxide 225mg;
Magnesium hydroxide 200mg;
Simethicone USP 25mg
Sanofi Aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05
October 2020GSL
372 BRU10030437P Seretide Evohaler 50
Salmeterol Xinafoate (micronised)
25mcg; Fluticasone Propionate
(micronised) 50mcg
Glaxo Wellcome Production, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
373 BRU10030438P Miacalcic® Ampoules 100IU Calcitonin salmon, synthetic 100IUNovartis Pharma Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
374 BRU10030439P Prozine Syrup 5mg/5ml Promethazine HClSunward Pharmaceutical Sdn Bhd,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
375 BRU10030440P Olmetec Tablet 20mg Olmesartan Medoxomil 20mgDaiichi Sankyo Europe GmbH,
GermanyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
376 BRU10040441P Diflucan Capsule 150mg Fluconazole 150mg Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
377 BRU10040442P Diflucan Capsule 100mg Fluconazole 100mg Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
378 BRU10040443P Diflucan Capsule 50mg Fluconazole 50mg Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
379 BRU10040445P Seretide Accuhaler 50/250Salmeterol (as Xinafoate) 50mcg;
Fluticasone Propionate 250mcgGlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
380 BRU10040447P Ventolin Tablet 2mg Salbutamol (as sulphate) 2mg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
381 BRU10040450P Seretide 125 Evohaler
Salmeterol (as Xinafoate, micronised)
25mcg; Fluticasone Propionate
125mcg
Glaxo Wellcome Production, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
382 BRU10040452P Nitroderm TTS® 10Glyceral trinitrate/ nitroglycerin 50mg
(10mg/24hr)
Novartis Pharma Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
383 BRU10040453P Temodal Capsule 20mg Temozolomide 20mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
384 BRU10040454NP ColimixTM Syrup
Per 5ml - Simethicone (activated
dimethicone) 50mg; dicylcomine HCl
5mg
Xepa-Soul Pattinson (Malaysia) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020GSL
385 BRU10040455P Xepanicol® Eye Drops 0.5% Chloramphenicol 0.5%Xepa-Soul Pattinson (Malaysia) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 23 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
386 BRU10040457P S2Co-Diovan 160/12.5mg
Tablets
Valsartan HCl 160mg;
Hydrochlorothiazide 12.5mgNovartis Pharma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
387 BRU10040459P Atenolol 50mg Tablet Atenolol 50mgSunward Pharmaceutical Pte Ltd.,
SingaporeG & H Trading Company
06 October 2015 till 05
October 2020POM
388 BRU10040460P Bromhexine Tablet 8mg Bromhexine HCl 8mgSunward Pharmaceutical Pte Ltd.,
SingaporeG & H Trading Company
06 October 2015 till 05
October 2020POM
389 BRU10040461PCytarabine® Injection 1000mg
in 10mlCytarabine 1000mg/10ml Pfizer (Perth) Pty, Ltd., Australia Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
390 BRU10040462P Exelon Oral Solution 2mg/mlRivastigmine 2mg/ml (as hydrogen
tartrate)Novartis Pharma S.A.S., France Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
391 BRU10050463PNebido 1000mg/4ml, Solution
for Injection
Testosterone undecanoate
250mg(equiv. to testosterone
157.9mg)
Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
392 BRU10050464NP Mucosolvon Liquid 30mg/5ml Ambroxol Hydrochloride 30mg/5ml Boehringer Ingelheim, FranceHongkiat Trading &
Company
06 October 2015 till 05
October 2020P
393 BRU10050466NPUphamol Suspension 250
(Orange)Paracetamol 250mg/5ml
Upha Pharmaceuticals Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015 (PL
extended to 26 March
2017)
GSL (60mL); P
(3.8L)
394 BRU10050467PTaxotere® 20mg/0.5ml
Concentrate and solvent for
solution for Infusion
Docetaxel 20mg/0.5ml (as trihydrate)Sanofi-Aventis Deutschland GmbH,
GermanyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
395 BRU10050468P
Remicade Powder for
Concentrate for Solution for
Infusion 100mg/vial
Infliximab (cA2 IgG) 100mg/vial Patheon Italia S.p.A, Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
396 BRU10050470P Pristinex Cream 2% w/w Ketoconazole 2%w/wXepa-Soul Pattinson (Malaysia) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
397 BRU10050471PZyvox Infusion Bag
600mg/300mlLinezolid 600mg/300ml Fresenius Kabi Norge As, Norway Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
398 BRU10050472P Panadeine TabletCodeine Phosphate 8mg, Paracetamol
500mgSanofi India Limited, India Medipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
399 BRU10050473P Cervagem Pessary 1mg Gemeprost 1mg Ono Pharmaceutical Co Ltd, Japan Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
400 BRU10050474P Provinace Tablet 4mg Perindopril erbumine 4mgXepa-Soul Pattinson (Malaysia) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
401 BRU10050475P Zyrtec® Oral Solution 1mg/ml Cetrizine diHCl 1mg/ml (0.1%) Aesica Pharmaceuticals S.r.L., Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
402 BRU10050476P Dalacin C Capsule 150mg Clindamycin (as hydrochloride) 150mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
403 BRU10050477P Clozaril® Tablet 100mg Clozapine 100mgNovartis Saglik Gida ve Tarim Urunleri
San. Ve Tic.A.S., Istanbul, TurkeyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 24 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
404 BRU10050478P Telfast® 180mg Tablet Fexofenadine HCl 180mg PT Aventis Pharma, Indonesia Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
405 BRU10050479PCozaar 100mg film-coated
tabletLosartan Potassium 100mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
406 BRU10050480P Dalacin T Topical Solution 1% Clindamycin (as phosphate) 10mg/Ml Zoetis P&U LLC, Kalamazoo, USA Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
407 BRU10060484P Miacalcic 50IU Ampoules Salmon calcitonin, synthetic 50IU/1mlNovartis Pharma Stein AG,
Switzerland.Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
408 BRU10060485P Allersin-F Tablet 4mg Chlorpheniramine maleate 4mgSunward Pharmaceutical Pte. Ltd.,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020P
409 BRU10060486P Daonil Tablet 5mg Glibenclamide 5mg PT Aventis Pharma, Indonesia Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
410 BRU10060487P Asmol SyrupSalbutamol 2mg/5ml (as Sulphate
2.4mg)
Sunward Pharmaceutical Sdn. Bhd.,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
411 BRU10060488P Lescol capsule 40mg Fluvastatin (as the sodium salt) 40mg Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
412 BRU10060489P Lescol XL Tablet 80mg Fluvastatin (as the sodium salt) 80mg Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
413 BRU10060490P Lescol capsule 20mg Fluvastatin (as the sodium salt) 20mg Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
414 BRU10060491P Diatrol Tablet 2mg Loperamide HCl 2mgSunward Pharmaceutical Sdn. Bhd.,
MalaysiaG & H Trading Company
06 October 2015 till 05
October 2020POM
415 BRU10060492P Clozaril® 25mg Tablet Clozapine 25mgNovartis Saglik Gida ve Tarim Urunleri
San. Ve Tic.A.S., Istanbul, TurkeyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
416 BRU10060493P Olmetec 10mg Tablet Olmesartan medoxomil 10mgDaiichi Sankyo Europe GmbH,
GermanyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
417 BRU10060494P Norvasc Tablet 5mg Amlodipine Besylate 5mgPfizer Australia Pty. Ltd., NSW
Australia.Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
418 BRU10060495P Epilim 200mg/5ml Syrup Sodium Valproate 200mg Unither Liquid Manufacturing, France. Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
419 BRU10060496PStilnox 10mg film-coated
tabletZolpidem tartrate 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
420 BRU10060497P Hyosun syrupHyoscine-N-Butylbromide
(Scopolamine Butylbromide) 5mg/5ml
Sunward Pharmaceutical Pte. Ltd.,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020POM
421 BRU10060498P Nalol Tablet 40mg Propranalol HCl 40mgSunward Pharmaceutical Pte. Ltd.,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020POM
422 BRU10060499P Exelon capsule 1.5mgRivastigmine 1.5mg (as hydrogen
tartrate 2.4mg)Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
423 BRU10060500PSyntocinon 10IU solution for
injectionSynthetic Oxytocin 10IU/ml
Novartis Pharma Stein AG,
Switzerland Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
424 BRU10060501P Exelon capsule 6mgRivastigmine 6mg (as hydrogen
tartrate 9.6mg)Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 25 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
425 BRU10060502PZyvox film-coated tablet
600mgLinezolid 600mg
Pfizer Pharmaceuticals LLC, Puerto
Rico, United StatesZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
426 BRU10060504P Sifrol tablet 0.125mg
Pramipexole 0.088mg (eqv. to
Pramipexole dihydrochloride
monohydrate 0.125mg)
Boehringer Ingelheim Pharma GmbH
& Co. Germany
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
427 BRU10060505PMyfortic Gastro-Resistant
tablet 180mg
Mycophenolic Acid 180mg (as Sodium
Salt 192.4mg)
Novartis Pharma Stein AG,
Switzerland Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
428 BRU10070506P Phensedyl Dry Cough LinctusPer 5ml - Promethazine HCl 3.6mg;
Pholcodine 4mg; Ephedrine HCl 7.2mg
Sanofi-Aventis Pakistan Limited,
PakistanMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
429 BRU10070507P Miacalcic® Nasal Spray 200IU Salmon calcitonin, synthetic 200IUDelpharm Huningue S.A.S.,
Switzerland.Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
430 BRU10070508P Norvasc Tablet 10mg Amlodipine Besylate 10mgPfizer Australia Pty. Ltd., NSW
Australia.Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
431 BRU10070509P Pseudorine Tablet 60mg Pseudoephedrine HCl 60mgSunward Pharmaceutical Pte. Ltd.,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020P
432 BRU10070510P Laxodyl Tablet 5mg Bisacodyl 5mgSunward Pharmaceutical Pte. Ltd.,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020
GSL (6's) & P
(60's)
433 BRU10070511P Decondine TabletTripolidine HCl 2.5mg;
Pseudoephedrine HCl 60mg
Sunward Pharmaceutical Pte. Ltd.,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020POM
434 BRU10070512P Metoclopramide Tablet 10mg Metoclopramide HCl 10mgSunward Pharmaceutical Pte. Ltd.,
Singapore G & H Trading Company
06 October 2015 till 05
October 2020POM
435 BRU10070513P Desferal 500mg Desferrioxamine Methane Sulphonate
Novartis Pharma Stein AG,
Switzerland; Wasserburger
Arzneimittelwerk GmbH, Wasserburg
Germany
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
436 BRU10070514P Anafranil® 25mg Tablet Clomipramine HCl 25mg Novartis Farma SpA., Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
437 BRU10070515P Zaricort CreamMiconazole Nitrate 2%w/w;
Hydrocortisone 1%w/w
Xepa-Soul Pattinson (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
438 BRU10070516P Singulair® Tablet 10mg Montelukast (as sodium) 10mgMerck Sharp & Dohme Ltd., United
KingdomZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
439 BRU10070517PSingulair® Chewable Tablet
5mgMontelukast (as sodium) 5mg
Merck Sharp & Dohme Ltd., United
KingdomZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
440 BRU10070518P Lanoxin Injection 0.5mg/2ml Digoxin 0.5mg/2mlGlaxoSmithKline Manufacturing SpA.,
ItalyZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
441 BRU10070519P Zithromax IV 500mg Azithromycin (as dehydrate) 500mgPharmacia & Upjohn Company,
Kalamazoo, USAZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
442 BRU10070520P Exelon® 4.5mg CapsuleRivastigmine 4.5mg (as Rivastigmine
hydrogen tartrate 7.2mg)Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 26 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
443 BRU10070521PEpilim Chrono 500mg Scored
Film-coated Tablet
Sodium valproate 500mg (Sodium
valproate 333mg & Valproic acid
145mg)
Sanofi Winthrop Industries, France Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
444 BRU10070522PRitalin® Modified Release
Capsule 30mgMethylphenidate HCl 30mg Recro Gainsville LLC, USA Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
445 BRU10080523P Exforge 10/160mg FC TabletAmlodipine 10mg (as besylate);
Valsartan 160mg
Novartis Farmaceutica SA, Barbera
del Valles
(Barcelona) SpainZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
446 BRU10080524PZometa Concentrate for
Solution for Infusion 4mg/5ml
Zoledronic Acid (anhydrous) 4mg
corresponding to zoledronic acid
monohydrate 4.264mg
Novartis Pharma Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
447 BRU10080528P Imovane 7.5mg Tablet Zopiclone 7.5mg Aventis International France Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
448 BRU10080529P Nasacort Aqueous Nasal SparyTriamcinolone Acetonide
55mcg/actuationAventis Pharma UK Medipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
449 BRU10080530P Ritalin 10mg Tablet Methylphenidate Hydrochloride 10mg Novartis Pharmaceuticals SA Spain Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
450 BRU10080531P Proctosedyl Suppositories
Chinchocaine 5mg; Framycetin
sulphate 10mg; Hydrocortisone 5mg;
Aesculin 10mg
PT Aventis Pharma, Indonesia Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
451 BRU10080532PProstin VR Paediatric® Sterile
Solution 500mcgAlprostadil 500mcg/ml Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
452 BRU10080533P Lioresal 10mg Tablet Baclofen 10mg Novartis Farma SPA Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
453BRU10080534PS1;
BRU10080534PS2 Fosamax 70mg Tablet
Alendronate sodium 91.37 (as
trihydrate) equivalent to alendronic
acid 70mg
Merck Sharp & Dohme (Italia) SpA,
Italy (S1); Aesica Pharmaceuticals
GmbH, Germany (S2)
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
454BRU10080535PS1;
BRU10080535PS2
Telfast-D Extended Release
TabletFexofenadine hydrochloride 60mg ;
Pseudoephedrine HCl 120mg
Sanofi-Aventis US LLC USA (S1); Sanofi
Winthrop Industrie, France (S2)Medipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
455 BRU10080536P Claforan 1.0g Injection Cefotaxime 1g (as Sodium 1.048g) Patheon UK Ltd, England, UK Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
456 BRU10080538PImmucyst ® BCG
Immnuotherapeutic 81mg/vialBacillus Calmette-Guerin 81mg
Sanofi Pasteur Limited, Toronto,
Ontario, CanadaZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
457 BRU10090539P Singulair Tablet 4mgMontelukast 4mg (as sodium 4.16mg)
Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
458 BRU10090540P Cozaar Tablet 50mg Losartan Potassium 50mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
459 BRU10090541PLanoxin Paediatric/ Geriatric
ElixirDigoxin 0.05mg/mL Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/0317 Page 27 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
460BRU10090542PS1;
BRU10090542PS2 Singulair Oral Granules 4mg
Montelukast Sodium (free acid
equivalent) 4mg
Merck Sharp & Dohme Corp. USA
(S1); DSM Pharmaceuticals, Inc., USA
(S2)
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
461 BRU10090543P Frisium® 10mg Tablet Clobazam 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
462 BRU10090544PS2 Vytorin Tablet 10mg/20mg Ezetimibe 10mg: Simvastatin 20mgMSD International GmbH (Singapore
Branch), Singapore (S2)Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
463 BRU10090545P Zocor 10mg Tablet Simvastatin 10mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
464 BRU10090546P Zocor 40mg Tablet Simvastatin 40mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
465 BRU10090547P Bonefos 800mg Tablet
Disodium Clodronate Tetrahydrate
1000mg equivalent to Disodium
Clodronate (anhydrous) 800mg
Bayer Oy, Finland Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
466 BRU10090548PSuprefact® 1mg/ml Injection
Solution
Buserelin 1.00mg/ml (as acetate
1.05mg)
Aventis-Pharma Deutshland GmbH,
GermanyMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
467 BRU10090549P Livial 2.5mg Tablet Tibolone 2.5mg N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
468 BRU10090550P Ritalin LA 20mg Capsules Methylphenidate Hydrochloride 20mg Recro Gainsville LLC, USA. Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
469 BRU10090551PZoladex LA Depot Injection
10.8mg
Goserelin Acetate equivalent to
Goserelin 10.8mgAstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
470 BRU10090552PHarnal OCAS 400mcg Film-
coated tablet
Tamsulosin (as hydrochloride 400mcg)
367mcg
Astellas Pharma Europe BV, The
NetherlandsZuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
471 BRU10090553P ActifedTM Expectorant (100ml)
Triprolidine hydrochloride
1.25mg/5mL; Pseudoephedrine
hydrochloride 30mg/5mL;
Guaiphenesin 100mg/5mL
Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020P
472 BRU10090554P Proscar® Tablets 5mg Finasteride 5mgMSD International GmbH (Puerto Rico
Branch) LLC., Puerto Rico, USA.Zuellig Pharma (B) Sdn Bhd
06 October 2015 till 05
October 2020POM
473BRU10090555PS1;
BRU10090555PS2 Elomet Cream 0.1% Mometasone Furoate 0.1%
Schering-Plough Labo N.V., Belgium
(S1); PT. Merck Sharp Dohme Pharma
Tbk, Indonesia (S2)
Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05
October 2020POM
474 BRU10100556PMyfortic Gastro-Resistant
tablet 360mgMycophenolic (as sodium) acid 360mg
Novartis Pharma Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
28 October 2015 till 27
October 2020POM
475 BRU10100557P
Intron A* 30 million IU
Solution for Injection,
Multidose Pen
Interferon Alfa-2b 30 million IU Schering-Plough (Brinny) Co., Ireland Zuellig Pharma (B) Sdn Bhd28 October 2015 till 27
October 2020POM
476 BRU10100559P Exelon® Capsule 3mgRivastigmine (as hydrogen tartrate)
3mgNovartis Farmaceutica S.A. Spain Zuellig Pharma (B) Sdn Bhd
28 October 2015 till 27
October 2020POM
BDMCA/RMP/0317 Page 28 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
477 BRU10100560PS2 Arcoxia 60mg Film-coated
tabletEtoricoxib 60mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd
28 October 2015 till 27
October 2020POM
478 BRU10100561P Proctosedyl Ointment
Cinchocaine hydrochloride 0.5%;
Framycetin sulphate 1.0%;
Hydrocortisone 0.5%; Aesculin 1.0%
Patheon UK Ltd., England Medipharm Sdn Bhd28 October 2015 till 27
October 2020POM
479 BRU10100562P Exelon® Patch 10Rivastigmine Base 18mg / 10cm2
(9.5mg/24h)
LTS Lohmann Theraphie-System AG,
GermanyZuellig Pharma (B) Sdn Bhd
28 October 2015 till 27
October 2020POM
480 BRU10100563P Exelon® Patch 5 Rivastigmine base 9mg/5cm2
(4.6mg/24 hours)
LTS Lohmann Theraphie-System AG,
GermanyZuellig Pharma (B) Sdn Bhd
28 October 2015 till 27
October 2020POM
481 BRU10100564PATGAM® Sterile Solution
50mg/mL (5mL amp)
Lymphocyte immune globulin, anti-
thymocyte globulin (equine)
250mg/5mL
Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd28 October 2015 till 27
October 2020POM
482 BRU10100565P Ezetrol 10mg Tablet Ezetimibe 10mg
1) MSD International GmbH (Puerto
Rico Branch) LLC, Puerto Rico; 2) MSD
International GmbH (Singapore
Branch), Singapore
Zuellig Pharma (B) Sdn Bhd28 October 2015 till 27
October 2020POM
483 BRU10100566PS2 Arcoxia 120mg Tablet Etoricoxib 120mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd28 October 2015 till 27
October 2020POM
484 BRU10100567P Sun-Glizide Tablet 80mg Gliclazide 80mgSunward Pharmaceutical Pte Ltd,
Singapore G & H Traidng Company
28 October 2015 till 27
October 2020POM
485 BRU10100568PZithromax Powder For Oral
Suspension 200mg/5ml
Azithromycin (as dihydrate)
200mg/5mlHaupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd
28 October 2015 till 27
October 2020POM
486 BRU10100569PFosamax Plus 70/2800mcg
Tablets
Alendronic (as sodium 91.37) acid
70mg & (Vitamin D3 100,000 IU/g)
Cholecalciferol 2800mcg
MSD Frosst Iberica, Spain Zuellig Pharma (B) Sdn Bhd28 October 2015 till 27
October 2020POM
487 BRU10100571P Arimidex 1mg tablet Anastrozole 1mg AstraZeneca Pharmaceuticals USA Zuellig Pharma (B) Sdn Bhd28 October 2015 till 27
October 2020POM
488 BRU10100572P
Casprin Enteric
Microencapsulated Capsule
100mg
Aspirin 100mgY.S.P. Industries (M) Sdn Bhd,
Malaysia.Asterix United (B) Sdn Bhd
28 October 2015 till 27
October 2020POM
489 BRU10100573P Pontalon Tablet 500mg Mefenamic Acid 500mgY.S.P. Industries (M) Sdn Bhd,
Malaysia.Asterix United (B) Sdn Bhd
28 October 2015 till 27
October 2020POM
490 BRU10100576PAlbutein® Solution for Infusion
25% Albumin (Human) 25% Grifols Biologicals Inc., USA
Hongkiat Trading &
Company
28 October 2015 till 27
October 2020POM
491 BRU10100577P RebetolTM 200mg Capsule Ribavirin 200mgMSD International GmbH (Puerto Rico
Branch) LLC., Puerto Rico, USA.Zuellig Pharma (B) Sdn Bhd
28 October 2015 till 27
October 2020POM
492 BRU10100578P Axol Liquid 3mg/ml Ambroxol Hydrochloride 3mg/mlY.S.P. Industries (M) Sdn Bhd,
Malaysia.Asterix United (B) Sdn Bhd
28 October 2015 till 27
October 2020
P (100ml) &
POM (4L)
493 BRU10100579PS2 Vytorin™ Tablets 10mg/10mg Ezetimibe 10mg; Simvastatin 10mgMSD International GmbH (Singapore
Branch), Singapore (S2) Zuellig Pharma (B) Sdn Bhd
28 October 2015 till 27
October 2020POM
BDMCA/RMP/0317 Page 29 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
494 BRU10110580PIntron A* 18million IU Solution
for Injection, Multidose PenInterferon Alfa-2b 18 million IU Schering-Plough (Brinny) Co., Ireland Zuellig Pharma (B) Sdn Bhd
24 November 2015 till 23
November 2020POM
495BRU10110581PS1;
BRU10110581PS2JanuviaTM Tablet 50mg Sitagliptin (as phosphate) 50mg
Merck Sharp & Dohme (Italia) S.p.A.,
Pavia, Italy (S1); Merck Sharp &
Dohme Ltd, England (S2)
Zuellig Pharma (B) Sdn Bhd24 November 2015 till 23
November 2020POM
496 BRU10110582PS2 Arcoxia® 90mg Tablet Etrocoxib 90mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd24 November 2015 till 23
November 2020POM
497 BRU10110584PZocor 20mg Film-coated
TabletSimvastatin 20mg
Merck Sharp & Dohme Ltd.,
Northumberland, UKZuellig Pharma (B) Sdn Bhd
24 November 2015 till 23
November 2020POM
498 BRU10110585P Sifrol® Tablet 1mg
Pramipexole dihydrochloride
monohydrate 1mg (equivalent to
0.7mg pramipexole)
Boehringer Ingelheim Pharma GmbH
& Co. KG, Germany
Hongkiat Trading &
Company
24 November 2015 till 23
November 2020POM
499 BRU10110587PMetoclopramide Syrup
5mg/5ml
Metoclopramide hydrochloride
5mg/5ml
Sunward Pharmaceutical Pte Ltd,
Singapore G & H Traidng Company
24 November 2015 till 23
November 2020POM
500 BRU10110588NP Suntacid Tablet
Aluminium Hydroxide 250mg,
Magnesium Trisilicate 250mg,
Simethicone 30mg
Sunward Pharmaceutical Pte Ltd,
Singapore G & H Traidng Company
24 November 2015 till 23
November 2020GSL
501 BRU10110590P Zoladex Depot 3.6mg/dose Goserelin (as acetate) 3.6mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd24 November 2015 till 23
November 2020POM
502 BRU10110591PVoren Enteric Coated Tablet
25mgDiclofenac Sodium 25mg
Y.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
24 November 2015 till 23
November 2020POM
503 BRU10110592P Oroxine Tablet 50mcg Levothyroxine Sodium 55.63mcg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd24 November 2015 till 23
November 2020POM
504 BRU10110593PVoren Enteric Coated Tablet
50mgDiclofenac Sodium 50mg
Y.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
24 November 2015 till 23
November 2020POM
505 BRU10110595P Zantac™ Injection 25mg/ml Ranitidine hydrochloride 25mg/mlGlaxoSmithKline Manufacturing
S.p.A., ItalyZuellig Pharma (B) Sdn Bhd
24 November 2015 till 23
November 2020POM
506 BRU10110596PBeconase™ Aqueous Nasal
Spray
Beclomethasone Dipropionate (as
monohydrate)Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd
24 November 2015 till 23
November 2020POM
507 BRU10110597P Campto 40mg/2ml InjectionIrinotecan hydrochloride trihydrate
40mg/2mlPfizer (Perth) Pty Ltd., Australia Zuellig Pharma (B) Sdn Bhd
24 November 2015 till 23
November 2020POM
508BRU10120599PS1;
BRU10120599PS2 JanuviaTM Tablet 25mg Sitagliptin (as phosphate) 25mg
Merck Sharp & Dohme (Italia) S.p.A.,
Pavia, Italy (S1); Merck Sharp &
Dohme Ltd, England
Zuellig Pharma (B) Sdn Bhd29 December 2015 till 28
December 2020POM
509 BRU10120600PRitalin® LA Modified Release
Capsule 40mgMethylphenidate hydrochloride 40mg Recro Gainsville LLC, USA Zuellig Pharma (B) Sdn Bhd
29 December 2015 till 28
December 2020POM
510 BRU10120602POrgalutron Solution for
Injection 0.25mg/0.5mlGanirelix acetate 0.25mg/0.5ml
Vetter Pharma-Fertigung GmbH & Co.
KG, GermanyZuellig Pharma (B) Sdn Bhd
29 December 2015 till 28
December 2020POM
511 BRU10120604P Afrin Nasal Spray 0.05% Oxymetazoline Hydrochloride 0.05%PT. Merck Sharp Dohme Pharma Tbk,
IndonesiaZuellig Pharma (B) Sdn Bhd
29 December 2015 till 28
December 2020P
512 BRU10120605P Clarityne Tablet 10mg Loratadine 10mgPT. Merck Sharp Dohme Pharma Tbk,
IndonesiaZuellig Pharma (B) Sdn Bhd
29 December 2015 till 28
December 2020P
BDMCA/RMP/0317 Page 30 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
513 BRU10120606P Frotin Pessaries Metronidazole 250mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
29 December 2015 till 28
December 2020POM
514 BRU10120607P Allopurinol Tablet 300mg Allopurinol 300mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
29 December 2015 till 28
December 2020POM
515 BRU10120608P Methergin Tablet 0.125mg Methylergometrine maleate 0.125mgNovartis Pharma Produktions GmbH,
GermanyZuellig Pharma (B) Sdn Bhd
29 December 2015 till 28
December 2020POM
516 BRU10120609P Vesicare Tablet 10mg Solifenacin Succinate 10mgAstellas Pharma Europe B.V., The
NetherlandsZuellig Pharma (B) Sdn Bhd
29 December 2015 till 28
December 2020POM
517 BRU10120611P Voren Suppositories 12.5mg Diclofenac Sodium 12.5mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
29 December 2015 till 28
December 2020POM
518 BRU10120612PFlixonase Aqueous Nasal Spray
0.05%
Fluticasone propionate (micronised)
50mcgGlaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd
29 December 2015 till 28
December 2020POM
519BRU10120613PS1;
BRU10120613PS2
Esmeron® Injection 50mg/5ml
(10mg/ml)Rocuronium Bromide 50mg/5ml
N.V. Organon, The Netherlands;
Hameln Pharmaceuticals GmbH,
Germany
Zuellig Pharma (B) Sdn Bhd29 December 2015 till 28
December 2020POM
520 BRU10120614P Clomid Tablet 50mg Clomifene Citrate 50mg Patheon France S.A., France Medipharm Sdn Bhd29 December 2015 till 28
December 2020POM
521 BRU10120615P FlixotideTM EvohalerTM 125mcg Fluticasone propionate 125mcg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd29 December 2015 till 28
December 2020POM
522 BRU10120616PLevitra® film-coated Tablet
5mg
Vardenafil 5mg (as monohydrochloride
trihydrate)Bayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd
29 December 2015 till 28
December 2020POM
523 BRU10120617P IRESSATM Tablet 250mg Gefitinib 250mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd29 December 2015 till 28
December 2020POM
524BRU11010619PS1;
BRU11010619PS2 JanuviaTM Tablet 100mg Sitagliptin (as phosphate) 100mg
Merck Sharp & Dohme (Italia) S.p.A.,
Pavia, Italy (S1); Merck Sharp &
Dohme Ltd, England
Zuellig Pharma (B) Sdn Bhd26 January 2016 till 25
January 2021POM
525 BRU11010621P Femara® 2.5mg Tablet Letrozole 2.5mgNovartis Pharma Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
26 January 2016 till 25
January 2021POM
526 BRU11010623P Allopurinol Tablet 100mg Allopurinol 100mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
26 January 2016 till 25
January 2021POM
527 BRU11010624P Elomet Ointment 0.1%PT. Merck Sharp Dohme Pharma Tbk,
IndonesiaZuellig Pharma (B) Sdn Bhd
26 January 2016 till 25
January 2021POM
528 BRU11010625 Implanon® 68mg ImplantEtonogestrel (Micronised) [Org3236]
68mgN.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd
26 January 2016 till 25
January 2021POM
529 BRU11010626NP Poro Tablet 500mg Paracetamol 500mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
26 January 2016 till 25
January 2021
P (10 x 10's), P
(100x10's &
3,000's)
530 BRU11010627P Tegretol CR 200 Tablet Carbamazapine 200mgNovartis Farma S.p.A., Torree
Annunziata, ItalyZuellig Pharma (B) Sdn Bhd
26 January 2016 till 25
January 2021POM
531 BRU11010628POxy-Nase Paediatric Nasal
Spray 0.025%Oxymetazoline HCl 0.025%
HOE Pharmaceuticals Sdn Bhd,
MalaysiaG&H Trading Company
26 January 2016 till 25
January 2021P
532 BRU11010629P TrandateTM Tablets 100mg Labetalol hyrdochloride 100mgGlaxo Wellcome GmbH & Co.,
GermanyZuellig Pharma (B) Sdn Bhd
26 January 2016 till 25
January 2021POM
BDMCA/RMP/0317 Page 31 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
533 BRU11010631P Tegretol® CR 400 Tablet Carbamazapine 400mgNovartis Farma S.p.A., Torree
Annunziata, ItalyZuellig Pharma (B) Sdn Bhd
26 January 2016 till 25
January 2021POM
534 BRU11010632P Comtan® Tablet 200mg Entacapone 200mg Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd26 January 2016 till 25
January 2021POM
535 BRU11010635P Zantac SyrupTM 150mg/10mlRanitidine (as hydrochloride)
150mg/10mlAspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd
26 January 2016 till 25
January 2021POM
536 BRU11010636NP Bisacodyl Suppositories Bisacodyl 5mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
26 January 2016 till 25
January 2021POM
537 BRU11010637PEngerixTM-B Adult Dose
Vaccine 20mcg/ml
Purified Hepatitis B Surface Antigen
(HBsAg) 20mcg/ml
GlaxoSmithKline Biologicals SA,
Rixensart Belgium; GlaxoSmithKline
Biologicals S.A., Wavre Belgium Zuellig Pharma (B) Sdn Bhd
26 January 2016 till 25
January 2021POM
538
BRU11010638P HavrixTM720 Junior Vaccine Inactivated Hepatitis A virus antigen
(HAV), HM175 strain 720 EL.U
GlaxoSmithKline Biologicals SA,
Rixensart Belgium; GlaxoSmithKline
Biologicals S.A., Wavre Belgium Zuellig Pharma (B) Sdn Bhd
26 January 2016 till 25
January 2021POM
539 BRU11010639P HiberixTM Vaccine
Purified polyribosyl-ribitol-phosphate
capsular polyaccharide (PRP) of
Haemophilus influenza type b (Hib)
10µg covalently bound to 20-40µg
tetanus toxoid
GlaxoSmithKline Biologicals SA,
Belgium; GlaxoSmithKline Biologicals
S.A., Saint-Amand-Les-Eaux
France
Zuellig Pharma (B) Sdn Bhd26 January 2016 till 25
January 2021POM
540 BRU11010640P Microgynon® 30 TabletLevonorgestrel 0.15mg,
Ethinylestradiol 0.03mg
Bayer Weimar GmbH und Co., KG,
GermanyZuellig Pharma (B) Sdn Bhd
26 January 2016 till 25
January 2021POM
541 BRU11010641P Ami-hydrotride TabletAmiloride hydrochloride 5mg &
Hydrochlorthiazide 50mg
Upha Pharmaceutical Mfg (M) Sdn
Bhd., Malaysia
Hongkiat Trading &
Company
26 January 2011 till 25
January 2016 (PL
extended to 26 March
2017)
POM
542 BRU11010642P Virless Tablets 200mg Acyclovir 200mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
26 January 2016 till 25
January 2021POM
543 BRU11020643P Dalacin C 300mg Capsule Clindamycin (as Hydrochloride) 300mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd24 February 2016 till 23
February 2021POM
544 BRU11020644P Tegretol® 200mg Tablet Carbamazepine 200mg Novartis Pharma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd24 February 2016 till 23
February 2021POM
545 BRU11020645P OroxineTM Tablet 100mcgLevothyroxine (as sodium) anhydrous
100mcgAspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd
24 February 2016 till 23
February 2021POM
546 BRU11020646P ActifedTM Syrup
Triprolidine Hydrochloride BP
1.25mg/5ml; Pseudoephedrine
hydrochloride BP 30mg/5ml
Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd24 February 2016 till 23
February 2021
P (60ml &
100ml)
547 BRU11020647P Tegretol® 2% Syrup Carbamazepine 100mg/5ml Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd24 February 2016 till 23
February 2021POM
548 BRU11020648PGlivec® 100mg Film-coated
TabletImatinib (as mesylate) 100mg
Novartis Pharma Produktions GmbH,
GermanyZuellig Pharma (B) Sdn Bhd
24 February 2016 till 23
February 2021POM
BDMCA/RMP/0317 Page 32 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
549 BRU11020649PSandostatin® Ampoules
0.05mg/mlOctreotide (as acetate) 0.05mg/ml
Novartis Pharma Stein AG.,
SwitzerlandZuellig Pharma (B) Sdn Bhd
24 February 2016 till 23
February 2021POM
550 BRU11020650PLevitra® film-coated Tablet
20mg
Vardenafil (as monochloride
trihydrate) 20mgBayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd
24 February 2016 till 23
February 2021POM
551 BRU11020652PUrosin® Film-coated Tablet
50mgAtenolol 50mg
Y.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
24 February 2016 till 23
February 2021POM
552 BRU11020653PIbuprofen Film-coated Tablet
400mgIbuprofen 400mg
Y.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
24 February 2016 till 23
February 2021P
553 BRU11020654P Promethazine Syrup 5mg/5ml Promethazine HCl 5mg/5mlDrug House of Australia Pte Ltd.,
SingaporeG & H Trading Company
24 February 2016 till 23
February 2021POM
554 BRU11020655P Voren GelDiclofenac Sodium 10mg/g (as
Diclofenac Acid Diethylamine)
Y.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
24 February 2016 till 23
February 2021GSL
555 BRU11020656PAtacor 20mg Film-coated
TabletsAtorvastatin (as Calcium) 20mg Actavis hf., Iceland K-Seri Pharma Sdn Bhd
24 February 2016 till 23
February 2021POM
556 BRU11020657P Dermosol Cream Clobetasol (as propionate) 0.5%w/wY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
24 February 2016 till 23
February 2021POM
557 BRU11020658P Zendhin 150 Tablet Ranitidine (as hydrochloride) 150mgDrug House of Australia (Asia) Pte
Ltd., SingaporeG & H Trading Company
24 February 2016 till 23
February 2021POM
558 BRU11030660P Oxy-nase® Nasal Spray 0.05% Oxymetazoline HCl 0.05%HOE Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
26 March 2016 till 25
March 2021P
559 BRU11030661PPrimperan® 10mg
SuppositoriesMetoclopramide 10mg
Unither Liquid Manufacturing,
France.Medipharm Sdn Bhd
26 March 2016 till 25
March 2021POM
560 BRU11030662PFucon Film Coated Tablet
10mgHysocine-n-butylbromide 10mg
Y.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
26 March 2016 till 25
March 2021POM
561 BRU11030663P Betamethasone Tablet 0.5mg Betamethasone 0.5mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
26 March 2016 till 25
March 2021POM
562 BRU11030664P Trivastal® Retard 50 Tablet Piribedil 50mgLes Laboratoires Servier Industrie,
FranceZuellig Pharma (B) Sdn Bhd
26 March 2016 till 25
March 2021POM
563 BRU11030667P Clarinase Syrup 5mg/5mlPer 5ml: Loratadine 5mg,
Pseudoephedrine Sulphate 60mg
Sanofi Aventis Argentina S.A.,
ArgentinaZuellig Pharma (B) Sdn Bhd
26 March 2016 till 25
March 2021P
564 BRU11030668P
Vivaxim Suspension and
Solution for Suspension for
Injection
Inactivated Hepatitis A Virus, GBM
strain 160 antigen units
Sanofi Pasteur, Parc industriel
d'Incarville, FranceZuellig Pharma (B) Sdn Bhd
26 March 2016 till 25
March 2021POM
565BRU11030669PS1;
BRU11030669PS2
Caelyx 2mg/ml Concentrate
for InfusionDoxorubicin HCl 2mg/ml
Alza Corporation, USA (S1);
GlaxoSmithKline Manufacturing
S.P.A., Italy (S2)
Zuellig Pharma (B) Sdn Bhd26 March 2016 till 25
March 2021POM
BDMCA/RMP/0317 Page 33 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
566 BRU11030670P Alkeran Tablet 2mg Melphalan 2mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd26 March 2016 till 25
March 2021POM
567 BRU11030671P Hyzaar Forte Tablet 100/25mgLosartan potassium 100mg,
Hydrochlorothiazide 25mgMerck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd
26 March 2016 till 25
March 2021POM
568 BRU11030672P Avodart Soft Capsules 0.5mg Dutasteride 0.5mgGlaxoSmithKline Pharmaceuticals
S.A., PolandZuellig Pharma (B) Sdn Bhd
26 March 2016 till 25
March 2021POM
569 BRU11030673PTopistin® Solution for IV
Infusion 200mg/100ml
Ciprofloxacin (as lactate)
200mg/100ml
Elpen Pharmaceutical Co., Inc.,
Greece.G & H Trading Company
26 March 2016 till 25
March 2021POM
570 BRU11030674P Arixtra Injection 2.5mg/0.5ml Fondporinux sodium 2.5mg/0.5ml Glaxo Wellcome Production, France Zuellig Pharma (B) Sdn Bhd26 March 2016 till 25
March 2021POM
571 BRU11040675PPuregon® 600iu/0.72ml
Solution for Injection
Recombinant follicle-stimulating
hormone (FSH) (follitrophin beta) [Org
32489] 600iu/0.72ml
Vetter Pharma-Fertigung GmbH & Co.
KG., Mooswiesen, Revensburg,
Germany and Vetter Pharma-
Fertigung GmbH & Co. KG.,
Schutzenstrasse, Ravensburg,
Germany
Zuellig Pharma (B) Sdn Bhd30 April 2016 till 29 April
2021POM
572BRU11040676PS1;
BRU11040676PS2 Tazocin EF 4.5g
Piperacillin (asmonohydrate) 4g;
Tazobactam (as sodium) 0.5g
Wyeth Lederle S.r.I, Catania, Italy
(S1); Pfizer Biotech Corporation,
Hsinchu Plant, Taiwan-Republic of
China (S2)
Zuellig Pharma (B) Sdn Bhd30 April 2016 till 29 April
2021POM
573 BRU11040677PVaxigrip Suspension for
Injection
Split influenza virus*, inactivated
containing antigens equivalent to the
following strains per one 0.5ml dose:
A/California/7/2009 (H1N1)pdm09-
derived strain used NYMC X-179A)
15mcg HA**; A/Texas/50/2012(H3N2)-
derived strain used NYMC X-223A
15mcg HA**; B/Massachusetts/2/2012-
derived strain used NYMC BX-51B
15mcg HA** Note - *
Propagated in fertilized hens’ egg
from healthy chicken flocks
** haemagglutinin
Sanofi Pasteur, Lyon, France Zuellig Pharma (B) Sdn Bhd30 April 2016 till 29 April
2021POM
574 BRU11040678PEuvax B Adult Vaccine
RecombinantPurified HBs-Ag 20mcg LG Life Science Ltd., Korea Zuellig Pharma (B) Sdn Bhd
30 April 2016 till 29 April
2021POM
575 BRU11040679PTrandateTM Injection 5mg/ml x
5mlLabetalol HCl 25mg/5ml
Hsinchu Plant of UBI Pharma Inc.,
TaiwanZuellig Pharma (B) Sdn Bhd
30 April 2016 till 29 April
2021POM
BDMCA/RMP/0317 Page 34 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
576 BRU11040680PS2 Puregon® 50IU/0.5ml Solution
for Injection
Follitrophin Beta (recombinant follicale-
stimulating hormone (FSH) 50IU/0.5mlN.V.Organon, The Netherlands (S2) Zuellig Pharma (B) Sdn Bhd
30 April 2016 till 29 April
2021POM
577 BRU11040681P Oxy-Nase Nasal Drops 0.05% Oxymetazolin Hydrochloride 0.05%w/vHOE Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
30 April 2016 till 29 April
2021P
578 BRU11040682P Sunolut Tablet 5mg Norethisterone 5mgSunward Pharmaceutical Pte Ltd.,
SingaporeG & H Trading Company
30 April 2016 till 29 April
2021POM
579 BRU11040683PSandostatin® LAR® Injection
10mgOctreotide 10mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd
30 April 2016 till 29 April
2021POM
580 BRU11040684PVfend TM Film-Coated Tablets
200mgVoriconazole 200mg Pfizer Italia S.R.L, Italy Zuellig Pharma (B) Sdn Bhd
30 April 2016 till 29 April
2021POM
581 BRU11040685P Voren Suppositories 25mg Diclofenac Sodium 25mgY.S.P Industries (M) Sdn Bhd.,
MalaysiaAsterix United (B) Sdn Bhd
30 April 2016 till 29 April
2021POM
582 BRU11040687PMultaq 400mg Film-coated
Tablet
Dronedarone 400mg (equiv.
Dronedarone HCl 426mg)Sanofi Winthrop Industrie, France Medipharm Sdn Bhd
30 April 2016 till 29 April
2021POM
583 BRU11040688P Stablon Coated Tablet 12.5mg Tianeptine (as sodium) 12.5mgLes Laboratoires Servier Industrie,
FranceZuellig Pharma (B) Sdn Bhd
30 April 2016 till 29 April
2021POM
584 BRU11040689P Shinoxol Tablet 30mg Ambroxol HCl 30mgY.S.P Industries (M) Sdn Bhd.,
MalaysiaAsterix United (B) Sdn Bhd
30 April 2016 till 29 April
2021POM
585 BRU11040690PEngerixTM-B Paediatric Vaccine
10mcg/0.5mlPurified HBs-Ag 10mcg
GlaxoSmithKline Biologicals SA.,
Rixensart Belgium; GlaxoSmithKline
Biologicals S.A., Wavre
Belgium
Zuellig Pharma (B) Sdn Bhd30 April 2016 till 29 April
2021POM
586 BRU11040691P Elosone Cream Mometasone Furoate 0.1%w/wHOE Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
30 April 2016 till 29 April
2021POM
587 BRU11040693P Cinna Tablet 25mg Cinnarizine 25mgY.S.P Industries (M) Sdn Bhd.,
MalaysiaAsterix United (B) Sdn Bhd
30 April 2016 till 29 April
2021POM
588 BRU11040694PStalevo® 100/25/200mg Film-
coated Tablet
Levodopa 100mg; Carbidopa 25mg;
Entacapone 200mgOrion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd
30 April 2016 till 29 April
2021POM
589 BRU11040695PRevoladeTM Film-coated Tablet
25mg
Eltrombopag 25mg [as free acid] (as
olamine)
Glaxo Operations UK Ltd (trading as
Glaxo Wellcome Operations), UKZuellig Pharma (B) Sdn Bhd
30 April 2016 till 29 April
2021POM
590 BRU11040696PCoversyl® Film-coated Tablet
10mg
Perindopril arginine 20mg (equiv to
perindopril 6.790mg)
Les Laboratoires Servier Industrie,
FranceZuellig Pharma (B) Sdn Bhd
30 April 2016 till 29 April
2021POM
591 BRU11040697PAtorvastatin Winthrop® 20mg
Film-coated Tablet
Atorvastatin 20mg (as calcium
20.68mg) Zentiva k.s., Prague, Czech Republic Medipharm Sdn Bhd
30 April 2016 till 29 April
2021POM
592 BRU11040698P SeroxatTM CR Tablet 12.5mgParoxetine 12.5mg (as Paroxetine HCl
hemihydrate) GlaxoSmithKline Inc., Ontario, Canada Zuellig Pharma (B) Sdn Bhd
30 April 2016 till 29 April
2021POM
593 BRU11050699P Avamys® Nasal Spray Fluticasone furoate (micronised)
27.5µg /spray
Glaxo Operations UK Ltd, United
KingdomZuellig Pharma (B) Sdn Bhd
25 May 2016 till 24 May
2021POM
BDMCA/RMP/0317 Page 35 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
594 BRU11050700P Tetraxim Vaccine
Purified diphteria toxoid ≥ 30IU;
purified tetanus toxoid ≥ 40IU;
Bordetella pertusis antigens: Adsorbed
purified pertusis toxoid 25µg,
Adsorbed purified filamentous
haemagglutinin 25µg ; Inactivated
poliomyelitis virus: Type 1 40 D units,
Type 2 8 Dunits, Type 3 32 Dunits.
Sanofi Pasteur, Campus Merieux,
France; Sanofi Pasteur, Parc industriel
d'Incarville, France
Zuellig Pharma (B) Sdn Bhd25 May 2016 till 24 May
2021POM
595 BRU11050701P Depo-Provera Vial 150mg/3ml Medroxyprogesterone acetate 150mgPfizer Manufacturing Belgium N.V.,
BelgiumZuellig Pharma (B) Sdn Bhd
25 May 2016 till 24 May
2021POM
596 BRU11050702P Benzhexol Tablet 2mg Benzhexol HCl 2mgSunward Pharmaceutical Pte Ltd.,
SingaporeG & H Trading Company
25 May 2016 till 24 May
2021POM
597 BRU11050703PLevitra Film-coated Tablets
10mg
Vardenafil (as monohydrochloride
trihydrate) 10mgBayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd
25 May 2016 till 24 May
2021POM
598 BRU11050704PVentolin Solution for
Intravenous Infusion 5mg/5mlSalbutamol (as sulphate) 5mg/5ml
GlaxoSmithKline Pharmaceutical
S.p.A., ItalyZuellig Pharma (B) Sdn Bhd
25 May 2016 till 24 May
2021POM
599 BRU11050705NP Upha B6 10 Tablet Pyridoxine HCl 10mgUpha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
25 May 2011 till 24 May
2016 (PL extended to 26
March 2017)
P (5 x 50's)
600 BRU11050706PZofran Injection Flexi-Amp
AmpoulesOndansetron HCl Dihydrate 8mg/4ml
GlaxoSmithKline Australia Pty Ltd.m
AustraliaZuellig Pharma (B) Sdn Bhd
25 May 2016 till 24 May
2021POM
601 BRU11050707PCaverject 20mcg Powder and
solvent for injectionAlprostadil 20µg
Pfizer Manufacturing Belgium N.V.,
BelgiumZuellig Pharma (B) Sdn Bhd
25 May 2016 till 24 May
2021POM
602 BRU11050708NP Essentiale Forte N Capsule
Phospholipids fatty mass 392mg
(equivalent to 300mg phospholipids
from soya beans containing 76% of (3-
sn-phosphatidyl) choline)
A. Nattermann & Cie. GmbH.,
GermanyMedipharm Sdn Bhd
25 May 2016 till 24 May
2021GSL (50's)
603 BRU11050710P Coveram Tablets 5mg/5mg
Perindopril arginine 5mg (equiv. to
perindopril 3.395mg); Amlodipine 5mg
(as besilate 6.935mg)
Servier (Ireland) Industries Ltd.,
IrelandZuellig Pharma (B) Sdn Bhd
25 May 2016 till 24 May
2021POM
604 BRU11050712PTracrium Injection
25mg/2.5mlAtracurium besylate 25mg/2.5ml
GlaxoSmithKline Manufactuirng
S.p.A., ItalyZuellig Pharma (B) Sdn Bhd
25 May 2016 till 24 May
2021POM
605 BRU11060714P Zantac 150mg Tablet Ranitidine 150mg (as HCl 168mg)GlaxoSmithKline (Tianjin) Co. Ltd., PR
ChinaZuellig Pharma (B) Sdn Bhd
02 July 2016 till 01 July
2021POM
606 BRU11060715POxy-Nase Paediatric Nasal
Drop 0.025%w/vOxymetazoline HCl 0.025%
HOE Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
02 July 2016 till 01 July
2021POM
607 BRU11060716PVfend 50mg film-coated
TabletVoriconazole 50mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd
02 July 2016 till 01 July
2021POM
608 BRU11060717P Protaxos 2g Strontium Ranelate 2632mgLes Laboratoires Servier Industrie,
FranceZuellig Pharma (B) Sdn Bhd
02 July 2016 till 01 July
2021POM
BDMCA/RMP/0317 Page 36 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
609 BRU11060718P MyleranTM Tablets 2mg Busulphan 2mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd02 July 2016 till 01 July
2021POM
610 BRU11060719PAmlodipine Winthrop Tablet
5mgAmlodipine (as besilate)
Unichem Laboratories Limited, Goa,
IndiaMedipharm Sdn Bhd
02 July 2016 till 01 July
2021POM
611 BRU11060720P Virless Tablet 800mg Acyclovir 800mgY.S.P. Industries (M) Sdn Bhd.,
MalaysiaAsterix United (B) Sdn Bhd
02 July 2016 till 01 July
2021POM
612 BRU11060721PAtorvastatin Winthrop® 40mg
Tablet
Atorvastatin 40mg (as Calcium
41.36mg) Zentiva k.s., Czech Republic Medipharm Sdn Bhd
02 July 2016 till 01 July
2021POM
613 BRU11060722P Propecia 1mg Tablet Finasteride 1mgMerck Sharp & Dohme, Puerto Rico,
USAZuellig Pharma (B) Sdn Bhd
02 July 2016 till 01 July
2021POM
614 BRU11060723PSeroquel XR Extended-Release
Tablets 50mg
Quetiapine 50mg (as fumarate
57.560mg)AstraZeneca Pharmaeuticals LP, USA Zuellig Pharma (B) Sdn Bhd
02 July 2016 till 01 July
2021POM
615 BRU11070724P Vesicare® 5mg Tablet Solifenacin Succinate 5mgAstella Pharma Europe B.V., The
NetherlandsZuellig Pharma (B) Sdn Bhd
27 July 2016 till 26 July
2021POM
616 BRU11070727P SW Bena-Expectorant
Per 5ml: Diphenhydramine HCl 10mg,
Ammonium Chloride 102mg, Sodium
Citrate 46mg
Sunward Pharmaceutical Pte Ltd.,
SingaporeG&H Trading Company
27 July 2016 till 26 July
2021POM
617 BRU11070729P Priorix TM
Composition of Priorix™ per dose
(0.5ml): Live attenuated measles virus
(Schwarz strain) ≥103.0 CCID50, Live
attenuated mumps virus (RIT4385
strain) ≥103.7 CCID50, Live attenuated
rubella virus (Wistar RA 27/3 strain)
≥103.0 CCID50
GlaxoSmithKline Biologicals s.a.,
Belgium; FIDIA Farmaceutici S.p.a.,
Italy
Zuellig Pharma (B) Sdn Bhd27 July 2016 till 26 July
2021POM
618 BRU11070730PMirena® Intrauterine System
20mcg/24hrLevonorgestrel 52mg Bayer Oy, Finland Zuellig Pharma (B) Sdn Bhd
27 July 2016 till 26 July
2021POM
619 BRU11070731PAmlodipine Winthrop® 10mg
TabletAmlodipine 10mg (as besilate)
Unichem Laboratories Limited, Goa,
IndiaMedipharm Sdn Bhd
27 July 2016 till 26 July
2021POM
620BRU11070732PS1;
BRU11070732PS2Zoral 400 Tablet 400mg Acyclovir USP 400mg
Drug House of Australia Pte Ltd.,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indoensia (S2)
G & H Trading Company27 July 2016 till 26 July
2021POM
621 BRU11070733P ZofranTM Injection 4mg/2mlOndansetron 4mg/5ml (as HCl
dihydrate)
GlaxoSmithKline Australia Pty Ltd.,
AustraliaZuellig Pharma (B) Sdn Bhd
27 July 2016 till 26 July
2021POM
622 BRU11070734PSyntometrine® Injection
5IU/ml AmpouleOxytocin 5IU/ml
Novartis Pharma Steing AG.,
SwitzerlandMedipharm Sdn Bhd
27 July 2016 till 26 July
2021POM
623 BRU11070735P Elosone Ointment 0.1%w/w Mometasone furoate 0.1% w/wHOE Pharmaceuticals Sdn Bhd.,
MalaysiaG & H Trading Company
27 July 2016 till 26 July
2021POM
BDMCA/RMP/0317 Page 37 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
624 BRU11070736P Coveram 5/10mg Tablet
Perindopril arginine 5mg (equiv. to
3.395mg perindopril) and amlodipine
10mg (as besilate 13.870mg)
Servier (Ireland) Industries Ltd,
IrelandZuellig Pharma (B) Sdn Bhd
27 July 2016 till 26 July
2021POM
625 BRU11070737P ZofranTM Tablets 8mg Ondansetron 8mg (as HCl dihydrate) Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd27 July 2016 till 26 July
2021POM
626BRU11070738PS1;
BRU11070738PS2 Diamicron® MR 60mg Tablet Gliclazide 60mg
Les Laboratoires Servier Industrie,
France (S1); Kotra Pharma (M) Sdn.
Bhd, Malaysia (S2)
Zuellig Pharma (B) Sdn Bhd27 July 2016 till 26 July
2021POM
627 BRU11070739P Fedac DM Linctus
Per 5ml: Triprolidine HCl 12.5mg,
Pesudoephedrine HCl 30mg,
Dextrometorphan HBr 10mg
Drug House of Australia Pte Ltd.,
SingaporeG & H Trading Company
27 July 2016 till 26 July
2021POM
628 BRU11070740P Tracrium Injection 50mg/5ml Atracurium Besylate 50mg/5mlGlaxoSmithKline Manufacturing
S.p.A., Parma, ItalyZuellig Pharma (B) Sdn Bhd
27 July 2016 till 26 July
2021POM
629 BRU11070741P Coralan® Tablet 2.5mg Ivabradine 7.5mg (as HCl 8.085mg)Les Laboratoires Servier Industrie,
FranceZuellig Pharma (B) Sdn Bhd
27 July 2016 till 26 July
2021POM
630 BRU11080742PAclasta 5mg/10ml Solution for
Infusion
Zolendranic acid (anhydrous) 5mg (as
zolendranic acid monohydrate 5.33mg)
Novartis Pharma Stein AG.,
SwitzerlandZuellig Pharma (B) Sdn Bhd
25 August 2016 till 24
August 2021POM
631 BRU11080743P Lanoxin Tablet 250mcg Digoxin 250mcg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd25 August 2016 till 24
August 2021POM
632 BRU11080744P Lanoxin PG Tablet 0.0625mg Digoxin 0.0625mg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd25 August 2016 till 24
August 2021POM
633 BRU11080745PGlivec® 400mg Film-coated
TabletImatinib (as mesylate) 400mg
Novartis Pharma Stein AG.,
SwitzerlandZuellig Pharma (B) Sdn Bhd
25 August 2016 till 24
August 2021POM
634 BRU11080746PStalevo 50/12.5/200mg film-
coated tablet
Levodopa 50mg, Carbidopa 12.5mg,
Entacapone 200mgOrion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd
25 August 2016 till 24
August 2021POM
635
BRU11080747PS1,
BRU11080747PS2,
BRU11080747PS3
Pentaxim Vaccine
Composition of final container per
dose (0.5ml): TETRAXIM - Purified
diphteria toxoid ≥ 30 I.U; Purified
tetanus toxoid ≥40 I.U; Adsorbed
purified pertusis toxoid 25µg;
Inactivated poliomyeltis virus type1 40
DU, type 2 8DU, type 3 32 DU; Act-HIB -
Polysaccharide of Haemophilus
influenza type b conjugated to tetanus
protein 10µg
Sanofi Pasteur, Campus Merieux,
Marcy I'Etoile, France (S1); Sanofi
Pasteur, Parc Industriel d'Incarville,
France (S2); Sanofi Pasteur, Gruppo
Lepeptit, Angani, Italy (S3)
Zuellig Pharma (B) Sdn Bhd25 August 2016 till 24
August 2021POM
636 BRU11080748P Campto 100mg/5ml Injection Irinotecan hydrochloride trihydrate Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd25 August 2016 till 24
August 2021POM
637 BRU11080749P Econazine CreamEconazole nitrate 1% w/w,
Triamcinolone actonide 0.1% w/w
Y.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
25 August 2016 till 24
August 2021POM
BDMCA/RMP/0317 Page 38 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
638 BRU11080750PFrotin Film Coated 200mg
Tablet Metronidazole 200mg
Y.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
25 August 2016 till 24
August 2021POM
639 BRU11080751PUrosin Film Coated Tablet
100mgAtenolol 100mg
Y.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
25 August 2016 till 24
August 2021POM
640 BRU11080752P TwinrixTM Vaccine
Hepatitis A virus antigen 720 ELISA
units; r-DNA hepatitis B virus surface
antigen (HBsAg)* 20µg
*Thiomersal-free HBsAg purified bulk
GlaxoSmithKline Biologicals SA,
BelgiumZuellig Pharma (B) Sdn Bhd
25 August 2016 till 24
August 2021POM
641 BRU11080753P Fukole Capsule 150mg Fluconazole 150mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
25 August 2016 till 24
August 2021POM
642 BRU11080754P CoAprovel Tablet 300/25mgIrbesartan 300mg, Hydrochlorothiazide
25mgSanofi Winthrop Industrie, France Medipharm Sdn Bhd
25 August 2016 till 24
August 2021POM
643 BRU11080755P SeroxatTM CR Tablet 25mgParoxetine 25mg(as Paroxetine
hydrochloride hemihydrate)GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd
25 August 2016 till 24
August 2021POM
644 BRU11080757P Orphenadol® TabletOrphenadrine Citrate 50mg,
Paracetamol 325mg
Y.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
25 August 2016 till 24
August 2021POM
645 BRU11080758P Loramide Capsule 2mg Loperamide HCl 2mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
25 August 2016 till 24
August 2021POM
646 BRU11080759P VOREN Suppositories 50mg Diclofenac Sodium 50mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
25 August 2016 till 24
August 2021POM
647 BRU11080760P Decan Tablet 0.75mg Dexamethasone 0.75mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
25 August 2016 till 24
August 2021POM
648 BRU11090762P Properazine Tablet 5mg Prochlorperazine maleate 5mgSunward Pharmaceutical Pte Ltd,
SingaporeG & H Trading Company
27 September 2016 till 26
September 2021POM
649 BRU11090763P Infanrix HexaTM
Composition of reconstiitiuted DTPa-
HBV-IPV+Hib Vaccine per dose (0.5ml):
Diphteria toxoid min. 30 I.U; Tetanus
toxoid min. 40 I.U; Pertusis toxoid (PT)
25µg; Filamentous haemagglutinin
(FHA), adsorbed 25µg; Pertactin,
adsorbed 8µg; r-DNA Hepatitis B
surface antigen (HBsAg purified) 10µg;
Inactivated poliomyeltis virus type I 40
DU, Inactivated poliomyeltis virus type
II 8DU, Inactivated poliomyeltis virus
type III 32 DU;Conjugate of
Haemophilus influenza type b capsular
polysaccharide (PRP) and tetanus
toxoid 10µg PRP and ~25µg T
GlaxoSmithKline Biologicals SA,
Rixensart Belgium; GlaxoSmithKline
Biologicals S.A., Saint-Amand-Les-
Eaux
France; GlaxoSmithKline Biologicals
S.A., Wavre
Belgium;
Zuellig Pharma (B) Sdn Bhd27 September 2016 till 26
September 2021POM
BDMCA/RMP/0317 Page 39 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
650 BRU11090764P
Eloxatin 5mg/ml Concentrate
for Solution for Infusion
(10ml)
Oxaliplatin 50mg/10mlSanofi-Aventis Deutschland GmbH,
GermanyMedipharm Sdn Bhd
27 September 2016 till 26
September 2021POM
651 BRU11090765P
Eloxatin 5mg/ml Concentrate
for Solution for Infusion
(20ml)
Oxaliplatin 100mg/20mlSanofi-Aventis Deutschland GmbH,
GermanyMedipharm Sdn Bhd
27 September 2016 till 26
September 2021POM
652 BRU11090766P InfanrixTM-IPV Vaccine
Composition per dose (0.5ml):
Diphteria toxoid (DT), adsorbed min.
30 I.U; Tetanus toxoid (TT), adsorbed
min. 40 I.U; Pertusis toxoid (PT),
adsorbed 25µg; Filamentous
haemagglutinin (FHA), adsorbed 25µg;
Pertactin, adsorbed 8µg; Inactivated
poliomyeltis virus type I 40 DU,
Inactivated poliomyeltis virus type II
8DU, Inactivated poliomyeltis virus
type III 32 DU
GlaxoSmithKline Biologicals SA,
BelgiumZuellig Pharma (B) Sdn Bhd
27 September 2016 till 26
September 2021POM
653 BRU11090767PSandimmun Neoral® Oral
Solution 100mg/mlCiclosporin A 100mg/ml Novartis Pharma S.A.S., France Zuellig Pharma (B) Sdn Bhd
27 September 2016 till 26
September 2021POM
654 BRU11090768P Hyzaar® Tablet 50/12.5mgLosartan Potassium 50mg,
Hydrochlorothiazide 12.5mg
Merck Sharp & Dohme,
Northumberland, UKZuellig Pharma (B) Sdn Bhd
27 September 2016 till 26
September 2021POM
655 BRU11090769PHyzaar® Plus Tablet
100/12.5mg
Losartan Potassium 100mg,
Hydrochlorothiazide 12.5mg
Merck Sharp & Dohme,
Northumberland, UKZuellig Pharma (B) Sdn Bhd
27 September 2016 till 26
September 2021POM
656 BRU11090770PFlebogamma 5% DIF Solution
for Infusion (100mL)
Human Normal Immunoglobulin
50mg/mlInstituo Grifols S.A., Barcelona, Spain
Hongkiat Trading &
Company
27 September 2016 till 26
September 2021POM
657 BRU11090771P Seroquel XR Tablets 200mg Quetiapine (as fumarate) 200mg AstraZeneca Pharmaeuticals LP, USA Zuellig Pharma (B) Sdn Bhd27 September 2016 till 26
September 2021POM
658 BRU11090772PDiabetamin Film-coated
Tablet 500mgMetformin HCl 500mg Hovid Bhd, Perak, Malaysia G & H Trading Company
27 September 2016 till 26
September 2021POM
659 BRU11090773P Tidact Gel 1%Clindamycin 10mg/g (as phosphate
11.9mg/g)
Y.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
27 September 2016 till 26
September 2021POM
660 BRU11090774P Daunoblastina Injection 20mg Daunoribicin Hydrochloride 20mg Actavis S.p.A., Italy Zuellig Pharma (B) Sdn Bhd27 September 2016 till 26
September 2021POM
661 BRU11090775P Fucon Capsule 10mg Hyoscine-N-butylbromide 10mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
27 September 2016 till 26
September 2021POM
662 BRU11090776P Virless Cream Acyclovir 50mg/gY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
27 September 2016 till 26
September 2021POM
663 BRU11090777P Solian® 100mg Scored Tablet Amisulpiride 100mg Sanofi Winthrop Industrie, France MediPharm Sdn Bhd27 September 2016 till 26
September 2021POM
664 BRU11090778P Hovasc Tablet 5mg Amlodipine 5mg (as besilate 6.90mg) Hovid Bhd, Malaysia G & H Trading Company27 September 2016 till 26
September 2021POM
BDMCA/RMP/0317 Page 40 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
665 BRU11100779P Pariet® Tablet 20mg Sodium Rabeprazole 20mgBushu Pharmaceuticals Ltd, Japan. ,
JapanMediPharm Sdn Bhd
31 October 2016 till 30
October 2021POM
666 BRU11100780P Pariet® Tablet 10mg Sodium Rabeprazole 10mgBushu Pharmaceuticals Ltd, Japan. ,
JapanMediPharm Sdn Bhd
31 October 2016 till 30
October 2021POM
667 BRU11100781PS2Puregon® 100IU/0.5ml
Solution for Injection
Follitropin beta (recombinant follicle-
stimulating hormone - FSH)
100IU/0.5ml
N.V. Organon, The Netherlands (S2) Zuellig Pharma (B) Sdn Bhd31 October 2016 till 30
October 2021POM
668 BRU11100782P Gardasil Vaccine
HPV Type 6 L1 protein 20mcg/0.5ml;
HPV Type 11 L1 protein 40mcg/0.5ml;
HPV Type 16 L1 protein 40mcg/0.5ml;
HPV Type 18 L1 protein 20mcg/0.5ml
Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd31 October 2016 till 30
October 2021POM
669 BRU11100783P
TypherixTM Vi Polysccharide
Typhoid Vaccine 25mcg/0.5ml
Vi Polysaccaharide of Salmonella Typhi
GlaxoSmithKline Biologicals SA,
Rixensart Belgium; GlaxoSmithKline
Biologicals S.A., Wavre Belgium;
Sächsisches Serumwerk Dresden
Branch of SmithKline Beecham
Pharma GmbH & Co. K.G., Dresden
Germany; GlaxoSmithKline
Biologicals, Saint Amand Les Eaux
France
Zuellig Pharma (B) Sdn Bhd31 October 2016 till 30
October 2021POM
670 BRU11100784PSandostatin® ampoules
0.1mg/mlOctreotide (as acetate) 0.1mg/ml
Novartis Pharma Stein A.G.,
SwitzerlandZuellig Pharma (B) Sdn Bhd
31 October 2016 till 30
October 2021POM
671 BRU11100785PAtorvastatin Winthrop® 10mg
film-coated Tablets
Atorvastatin 10mg (as calsium
10.34mg)Zentiva k.s., Czech Republic MediPharm Sdn Bhd
31 October 2016 till 30
October 2021POM
672 BRU11100786PStalevo® 150/37.5/200mg
Film-coated Tablet
Levodopa 150mg; Carbidopa 37.5mg;
Entacapone 200mgOrion Corporation Fermion, Finland Zuellig Pharma (B) Sdn Bhd
31 October 2016 till 30
October 2021POM
673 BRU11100787P Coveram Tablet 10mg/5mg
Perindopril arginine 10mg (eqv. To
Perindopril 6.790mg); Amlodipine 5mg
(as besilate 6.935mg)
Servier (Ireland) Industries Ltd.,
IrelandZuellig Pharma (B) Sdn Bhd
31 October 2016 till 30
October 2021POM
674 BRU11100788PCoversyl® Fim-coated Tablet
5mg
Perindopril arginine 5mg (eqv.
Perindopril 3.395mg)
Les Laboratoires Servier Industrie,
Gidy, FranceZuellig Pharma (B) Sdn Bhd
31 October 2016 till 30
October 2021POM
675 BRU11100789P Myonal 50mg Tablet Eperisone Hydrochloride 50mgEisai Co., Ltd, Saitama Prefecture,
JapanMediPharm Sdn Bhd
31 October 2016 till 30
October 2021POM
BDMCA/RMP/0317 Page 41 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
676
BRU11100790P VarilrixTM Live attenuated varicella virus (OKA
strain)
GlaxoSmithKline Biologicals SA,
Rixensart, Belgium (Manufacturer of
finished product); GlaxoSmithKline
Biologicals SA, Rixensart, Belgium
(Manufacturing site for Water for
Injection (WFI) diluents in syringe and
ampoule); Delpharm Tours, Chambray-
lès-Tours, France (Manufacturing site
for Water for Injection (WFI) diluents
in ampoules); GlaxoSmithKline
Biologicals S.A., Wavre, Belgium
& GlaxoSmithKline Biologicals, Saint-
Amand-Les-Eaux, France & Centre de
Recherche et de Nouvelles
Applications (CRNA) SA, Belgium
(Manufacturing site for final
packaging operations)
Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30
October 2021
POM
677 BRU11100791P Coveram Tablet 10mg/10mg
Perindopril arginine 10mg (eqv. To
Perindopril 6.790mg); Amlodipine
10mg (as besilate 13.870mg)
Servier (Ireland) Industries Ltd.,
IrelandZuellig Pharma (B) Sdn Bhd
31 October 2016 till 30
October 2021POM
678 BRU11100792PVoker Film Coated Tablet
20mgFamotidine 20mg
Y.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
31 October 2016 till 30
October 2021POM
679 BRU11100793P Solian® 400mg Scored Tablet Amisulpride 400mg Sanofi Winthrop Industrie, France MediPharm Sdn Bhd31 October 2016 till 30
October 2021POM
680 BRU11100794PClarityn-D 12HR EXTENDED
RELEASE TABLET 5mg/120mg
Loratadine 5mg, Pseudoephedrine
sulphate 120mgSchering Plough Labo N.V., Belgium Zuellig Pharma (B) Sdn Bhd
31 October 2016 till 30
October 2021POM
681 BRU11100795P Euthyrox® Tablet 25mcg Levothyroxine sodium 25mcg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd31 October 2016 till 30
October 2021POM
682 BRU11100796P Concor® 2.5mg Tablet Bisoprolol hemifumarate 2.5mg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd31 October 2016 till 30
October 2021POM
BDMCA/RMP/0317 Page 42 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
683 BRU11110797P OnglyzaTM Tablet 2.5mgSaxagliptin 2.5mg (as HCl anhydrous
2.79mg)
Bristol-Myers Squibb Company,
Indiana, USAZuellig Pharma (B) Sdn Bhd
24 November 2016 till 23
November 2021POM
684 BRU11110798P OnglyzaTM Tablet 5mgSaxagliptin 5mg (as HCl anhydrous
5.58mg)
Bristol-Myers Squibb Company,
Indiana, USAZuellig Pharma (B) Sdn Bhd
24 November 2016 till 23
November 2021POM
685 BRU11110799PSandostatin® LAR® Injection
20mgOctreotide (as acetate) 20mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd
24 November 2016 till 23
November 2021POM
686 BRU11110800PSandostatin® LAR® Injection
30mgOctreotide (as acetate) 30mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd
24 November 2016 till 23
November 2021POM
687 BRU11110802P GardasilTM Vaccine (Syringe)
Per 0.5ml dose - HPV Type 6 L1 protein
20mcg; HPV Type 11 L1 protein 40mcg;
HPV Type 16 L1 protein 40mcg; HPV
Type 18 L1 protein 20mcg
Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd24 November 2016 till 23
November 2021POM
688 BRU11110803PNexavar® 200mg Film-coated
TabletsSorafenib Tosylate 200mg
Bayer Pharma AG., Leverkusen,
Germany; Bayer Healthcare
Manufacturing S.r.l., Italy
Zuellig Pharma (B) Sdn Bhd24 November 2016 till 23
November 2021POM
689 BRU11110804PPEG Intron CLEARCLICK for
Injection 150mcg/0.5ml
Recombinant interferon alfa-2b
150mcg (pegylated to monoethoxy
polyethylene glycol)
MSD International GmbH (Singapore
Branch), Singapore SingaporeZuellig Pharma (B) Sdn Bhd
24 November 2016 till 23
November 2021POM
690 BRU11110805PPEG Intron CLEARCLICK for
Injection 120mcg/0.5ml
Recombinant interferon alfa-2b
120mcg (pegylated to monoethoxy
polyethylene glycol)
Schering-Plough Ltd., Singapore Zuellig Pharma (B) Sdn Bhd24 November 2016 till 23
November 2021POM
691 BRU11110806PPEG Intron CLEARCLICK for
Injection 100mcg/0.5ml
Recombinant interferon alfa-2b
100mcg (pegylated to monoethoxy
polyethylene glycol)
MSD International GmbH (Singapore
Branch), Singapore SingaporeZuellig Pharma (B) Sdn Bhd
24 November 2016 till 23
November 2021POM
BDMCA/RMP/0317 Page 43 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
692 BRU11110807PPEG Intron CLEARCLICK for
Injection 80mcg/0.5ml
Recombinant interferon alfa-2b 80mcg
(pegylated to monoethoxy
polyethylene glycol)
MSD International GmbH (Singapore
Branch), Singapore SingaporeZuellig Pharma (B) Sdn Bhd
24 November 2016 till 23
November 2021POM
693 BRU11110808PPEG Intron CLEARCLICK for
Injection 50mcg/0.5ml
Recombinant interferon alfa-2b 50mcg
(pegylated to monoethoxy
polyethylene glycol)
MSD International GmbH (Singapore
Branch), Singapore SingaporeZuellig Pharma (B) Sdn Bhd
24 November 2016 till 23
November 2021POM
694 BRU11110809PDalacin CTM Sterile Solution
150mg/ml x 2ml ampouleClindamycin Phosphate 300mg
Pfizer Manufacturing Belgium N.V.,
Puurs, BelgiumZuellig Pharma (B) Sdn Bhd
24 November 2016 till 23
November 2021POM
695 BRU11110812P Euthyrox® Tablet 100mcg Levothyroxine sodium 100mcg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd24 November 2016 till 23
November 2021POM
696 BRU11110813PKetipinor Film-coated Tablet
200mg
Quetiapine 200mg (as fumarate
230.36mg)Orion Corporation, Espoo, Finland
Hongkiat Trading &
Company
24 November 2011 till 23
November 2016 (PL
extended to 26 March
2017)
POM
697 BRU11110814P Prednisolone Tablet 5mg Prednisolone 5mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
24 November 2016 till 23
November 2021POM
698 BRU11110815P Granocyte® 34 InjectionLenograstim (rHug-CSF) 33.6 million IU
(equiv. to 263 mcg)/ vialSanofi Winthrop Industrie, France MediPharm Sdn Bhd
24 November 2016 till 23
November 2021POM
699 BRU11120816PEuvax B Pediatric Vaccine
Recombinant (10mcg/0.5ml)Purified HBs-Ag 10mcg/0.5ml LG Life Science Ltd., Korea Zuellig Pharma (B) Sdn Bhd
22 December 2016 till 21
December 2021POM
700 BRU11120817PPuregon® 300IU/0.36 ml
Solution for Injection
Recombinant follicle-stimulating
hormone (FSH) (follitrophin beta) [Org
32489] 600iu/0.72ml
Vetter Pharm-Fertigung GmbH & Co.
KG., Schutzenstrasse, Ravensburg,
Germany: Vetter Pharm-Fertigung
GmbH & Co. KG., Mooswiesen,
Ravensburg, Germany; Vetter
Pharma-Fertigung GmbH & Co. KG,
Eisenbahnstrasse, Langenargen,
Germany and Vetter Pharma-
Fertigung GmbH & Co. KG,
Holbeinstrassee, Ravensburg
Germany
Zuellig Pharma (B) Sdn Bhd22 December 2016 till 21
December 2021POM
701 BRU11120818P Clarityn Syrup Loratadine 1mg/mlPT. Merck Sharp Dohme Pharma Tbk,
IndonesiaZuellig Pharma (B) Sdn Bhd
22 December 2016 till 21
December 2021P
BDMCA/RMP/0317 Page 44 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
702 BRU11120819P SynflorixTM Vaccine
1 dose (0.5ml) contains: Pneumococcal
polysaccharide serotype 11,2 - 1mcg,
Pneumococcal polysaccharide serotype
41,2 - 3mcg, Pneumococcal
polysaccharide serotype 51,2 - 1mcg,
Pneumococcal polysaccharide serotype
6B1,2 - 1mcg, Pneumococcal
polysaccharide serotype 7F1,2 - 1mcg,
Pneumococcal polysaccharide serotype
9V1,2 - 1mcg, Pneumococcal
polysaccharide serotype 141,2 - 1mcg,
Pneumococcal polysaccharide
serotype18C1,3 - 3mcg, Pneumococcal
polysaccharide serotype 19F1,4 - 3mcg,
Pneumococcal polysaccharide serotype
23F1,2 - 1mcg
GlaxoSmithKline Biologicals SA,
Rixensart Belgium; Glaxo SmithKline
Biologicals SA, Saint-Amand-Les-Eaux
France
Zuellig Pharma (B) Sdn Bhd22 December 2016 till 21
December 2021POM
703 BRU11120820P VentolinTM EvohalerTM Salbutamol (as sulphate 120.5mcg)
100mcgGlaxo Wellcome S.A., Burgos, Spain Zuellig Pharma (B) Sdn Bhd
22 December 2016 till 21
December 2021POM
704 BRU11120821PMencevaxTM ACWY Vaccine (1
Dose)
Per 0.5ml : Meningococcal purified
polysaccharides of: Serogroup A -
50mcg, Serogroup C - 50mcg
Serogroup W135 - 50mcg Serogroup
W135 - 50mcg Serogroup Y - 50mcg
GlaxoSmithKline Biologicals SA,
Rixensart BelgiumZuellig Pharma (B) Sdn Bhd
22 December 2016 till 21
December 2021POM
705 BRU11120822PRevoladeTM Film-coated
Tablets 50mg
Eltrombopag olamine (eq. to
Eltrombopag 50mg as Eltrombopag
free acid)
Glaxo Operations UK Ltd (trading as
Glaxo Wellcome Operations) United
Kingdom
Zuellig Pharma (B) Sdn Bhd22 December 2016 till 21
December 2021POM
706 BRU11120823P Coversyl® Plus 5mgPerindopril arginine 5mg (as besilate
3.395mg); Indapamide 1.25mg
Les Laboratoires Servier Industrie,
FranceZuellig Pharma (B) Sdn Bhd
22 December 2016 till 21
December 2021POM
707 BRU11120824P Yasmin® Film-coated TabletsDrospirenone 3mg, Ethinylestradiol
0.03mg
Bayer Weimar GmbH und Co. KG
(WEIMAR PLANT), GermanyZuellig Pharma (B) Sdn Bhd
22 December 2016 till 21
December 2021POM
708 BRU11120826NP Arcalion® 200mg Tablet Sulbutiamine 200mgLes Laboratoires Servier Industrie,
FranceZuellig Pharma (B) Sdn Bhd
22 December 2016 till 21
December 2021GSL
709 BRU11120827PMethycobal Injection
500mcg/mlMecobalamin 500mcg Bushu Pharmaceuticals Ltd, Japan MediPharm Sdn Bhd
22 December 2016 till 21
December 2021POM
BDMCA/RMP/0317 Page 45 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
710 BRU11120828PFlebogamma® 5% DIF Solution
for Infusion (200ml)
Human Normal Immunoglobulin
10g/200mL (50mg/ml)Instituto Grifols, S.A., Spain Hongkiat Trading
22 December 2016 till 21
December 2021POM
711 BRU11120829NP Shintamet film coated Tablet Cimetidine 400mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
22 December 2016 till 21
December 2021POM
712 BRU11120830P Dermafin cream 1% Terbinafine Hydrochloride 1%w/wY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
22 December 2016 till 21
December 2021GSL
713 BRU11120831P Pontalon Tablet 250mg Mefenamic Acid 250mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
22 December 2016 till 21
December 2021POM
714 BRU11120832P Clopivid Tablet 75mgClopidogrel 75mg (as hydrogen
sulphate 97.90mg)Hovid Bhd, Malaysia G & H Trading Company
22 December 2016 till 21
December 2021POM
715 BRU11120833PShincort Injection “Yung Shin”
10mg/mlTriamcinolone Acetonide 50mg/5ml
Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan ROCAsterix United (B) Sdn Bhd
22 December 2016 till 21
December 2021POM
716 BRU11120834P Hovasc Tablet 10mg Amlodipine 10mg (as Besylate 13.8mg) Hovid Bhd, Malaysia G & H Trading Company22 December 2016 till 21
December 2021POM
717 BRU11120835P Indomen Capsule 25mg Indomethacin 25mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd 22 December 2016 till 21
December 2021POM
718 BRU11120836P Clomiphene Tablet 50mg Clomiphene citrate 50mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd 22 December 2016 till 21
December 2021POM
719 BRU11120837PPrimacor® 10mg/10ml
InjectionMilrinone 10mg/10ml (as lactate) Sanofi Winhtrop Industrie, France MediPharm Sdn Bhd
22 December 2016 till 21
December 2021POM
720 BRU11120838NPChamps D-Worms 6 Chewable
Tablet (Chocolate)Albendazole 200mg
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
22 December 2011 till 21
December 2016 (PL
extended to 26 March
2017)
GSL (2's)
721 BRU11120839PEpilim® 200 Enteric Coated
TabletsSodium Valproate 200mg
Sanofi-Synthelabo Ltd., United
KingdomMediPharm Sdn Bhd
22 December 2016 till 21
December 2021POM
BDMCA/RMP/0317 Page 46 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
722 BRU12010840PInfanrixTM-IPV+Hib Vaccine
(DTPa-IPV+Hib)
1 dose (0.5ml) contains: Diphteria
toxoid (DT) Min 30 I.U.; Tetanus toxoid
(TT) Min 40 I.U.; Pertussis toxoid (PT)
Min 25mcg; Filamentous
haemagglutinin (FHA) 25mcg; Pertactin
(69Kda Outer membrance protein)
8mcg; Inactivated Polio Virus Type 1
(Mahoney seed) 40DU; Inactivated
Polio Virus Type 2 (MEF-1 seed) 8DU;
Inactivated Polio Virus Type 3 (Saukett
seed) 32DU; Conjugate of purified
capsular polysaccharide (10mcg) of
Haemophilus influenza type b
covalently bound to approximately
30mcg to 50 mcg tetanus toxoid
GlaxoSmithKline Biologicals SA,
Rixensart Belgium; GlaxoSmithkline
Biologicals S.A., France
Zuellig Pharma (B) Sdn Bhd01 February 2017 till 31
January 2022POM
723 BRU12010841P Cardura XLTM tablet 4mg Doxazosin Mesylate 4mgPfizer Pharmaceuticals LLC, Puerto
Rico, USAZuellig Pharma (B) Sdn Bhd
01 February 2017 till 31
January 2022POM
724 BRU12010842PValdoxan® 25mg film-coated
tabletAgomelatine 25mg
Les Laboratoires Servier Industrie,
FranceZuellig Pharma (B) Sdn Bhd
01 February 2017 till 31
January 2022POM
725 BRU12010843P Zofran Tablet 4mgOndansetron (as Hydrochloride
Dihydrate) 4mgAspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd
01 February 2017 till 31
January 2022POM
726 BRU12010844PFlebogamma® 5% DIF Solution
for Infusion (50ml)
Human Normal Immunoglobulin
2.5g/50mL (50mg/ml)Instituto Grifols, S.A., Spain Hongkiat Trading & Co
01 February 2017 till 31
January 2022POM
727 BRU12010845P Coralan® Tablet 5mgIvabradine 5mg eq. to 5.39mg
ivabradine hydrochloride
Les Laboratoires Servier Industrie,
FranceZuellig Pharma (B) Sdn Bhd
01 February 2017 till 31
January 2022POM
728 BRU12010846P Seroquel XR tablets 300mg Quetiapine (as fumarate) 300mg Astrazeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd01 February 2017 till 31
January 2022POM
729 BRU12010847P Seroquel XR tablets 400mg Quetiapine (as fumarate) 400mg Astrazeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd01 February 2017 till 31
January 2022POM
730 BRU12010848P Chemix tabletTrimethoprim 80mg, Sulfamethoxazole
400mg
Y.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
01 February 2012 till 31
January 2017POM
731 BRU12010850P Enapril tablet 10mg Enalapril maleate 10mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
01 February 2017 till 31
January 2022POM
732 BRU12010851NP Princi-B Fort® tablet
Thiamin mononitrate 250mg,
Pyridoxine hydrochloride 250mg &
Cyanocobalamin 1mg
Olic (Thailand) Ltd, Thailand MediPharm Sdn Bhd01 February 2017 till 31
January 2022P
733 BRU12010852P Antifungal Cream 2% Miconazole Nitrate 20mg/g (2% w/w)Y.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
01 February 2017 till 31
January 2022GSL
734 BRU12010853P Concor® 5mg tabletBisoprolol hemifumarate 5mg
Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd01 February 2017 till 31
January 2022POM
BDMCA/RMP/0317 Page 47 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
735 BRU12010854PKetipinor film-coated tablet
100mg
Quetiapine (as fumarate 115.13mg)
100mgOrion Corporation, Finland Hongkiat Trading & Co
01 February 2012 till 31
January 2017 (PL
extended to 26 March
2017)
POM
736 BRU12010855P Euthyrox® Tablet 50mgLevothyroxine sodium 50mcg
Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd01 February 2017 till 31
January 2022POM
737 BRU12010856NPPanadol Suspension
250mg/5mlParacetamol 250mg/5ml Smithkline Beecham, Philippines
Kingston Beverage &
Creamery Sdn Bhd
01 February 2012 till 31
January 2017
GSL
(60ml/120ml)
738 BRU12010857P Targocid® Injection 200mg Teicoplanin 200mg/3ml (200mg/vial) Gruppo Lepetit S.r.I., Italy MediPharm Sdn Bhd01 February 2017 till 31
January 2022POM
739 BRU12020858P Sebivo™ Tablet 600mg Telbivudine 600mgNovartis Pharma Stein AG.,
SwitzerlandZuellig Pharma (B) Sdn Bhd
1 March 2017 till 28
February 2022 POM
740 BRU12020859PEsonide Nasal Spray
100mcg/dose
Budesonide 2mg/ml equivalent to
100mcg/doseKleva S.A., Greece G & H Trading Company
29 February 2012 till 28
February 2017 POM
741 BRU12020860P Yucomy Tablet 200mg Ketoconazole 200mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
1 March 2017 till 28
February 2022 POM
742 BRU12020861PThyrozol® 20mg Film-coated
TabletsThiamazole 20mg Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd
1 March 2017 till 28
February 2022 POM
743 BRU12020862PKetipinor Film-coated Tablet
25mg
Quetiapine (as fumarate 28.78mg)
25mgOrion Corporation, Finland Hongkiat Trading & Co
29 February 2012 till 28
February 2017 (PL
extended to 26 March
2017)
POM
744 BRU12020863P
Taxotere 20mg/1ml
concentrate for solution for
infusion
Docetaxel (as trihydrate) 20mg/mlSanofi-Aventis Deutschland GmbH,
GermanyMediPharm Sdn Bhd
29 February 2012 till 28
February 2017 POM
745 BRU12020864P Zanidip® Tablet 10mgLercanidipine Hydrochloride 10mg (eq.
to 9.4mg Lercanidipine)
Recordati Industria Chimica &
Farmaceutica S.p.A, ItalyHongkiat Trading & Co
1 March 2017 till 28
February 2022 POM
746BRU12020865PS1 &
BRU12020865PS2Nifedipine LA Tablet 30mg Nifedipine 30mg
Valpharma International S.p.A, Italy
(S1); Valpharma S.A, Italy (S2)G & H Trading Company
1 March 2017 till 28
February 2022 POM
747 BRU12020866P
Apidra® Solostar®
100units/ml, Solution for
Injection in a Pre-filled Pen
Insulin Glulisine 100units/mlSanofi-Aventis Deutschland GmbH,
GermanyMediPharm Sdn Bhd
1 March 2017 till 28
February 2022 POM
748 BRU12020867P Zavedos CS Injection vials Idarubicin hydrochloride 1mg/ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd1 March 2017 till 28
February 2022 POM
749 BRU12020868P Betnovate™ Cream
Betamethasone 0.1%w/w (as
Betamethasone 17-Valerate BP 0.122%
w/w)
Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd1 March 2017 till 28
February 2022 POM
750 BRU12020869P Dermovate™ Cream Clobetasol (as propionate) 0.05% w/w Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd1 March 2017 till 28
February 2022 POM
751 BRU12020870P Lyrica™ 150mg Capsules Pregabalin 150mg Pfizer Manufacturing Deutshland
GmbH, GermanyZuellig Pharma (B) Sdn Bhd
1 March 2017 till 28
February 2022 POM
BDMCA/RMP/0317 Page 48 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
752 BRU12030871NP Panadol® Menstrual CapletParacetamol 500mg & Pamabrom
25mg
Sterling Drug (Malaya) Sdn Bhd.,
Malaysia
Kingston Beverage &
Creamery Sdn Bhd
30 March 2012 till 29
March 2017 P (12 x 10's)
753 BRU12030872NP Panadol® Pain Relief Patch
Glycol Salicylate 1.5%w/w, L-Menthol
1.0% w/w, DL-Camphor 0.5%w/w, DL-
A-Tocopherol Acetate 0.3%w/w
Teh Seng Pharmaceutical Mfg Co.,
Ltd., Taiwan, ROC
Kingston Beverage &
Creamery Sdn Bhd
30 March 2012 till 29
March 2017 GSL
754 BRU12030873P LacipilTM Tablet 4mg Lacipidine 4mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd30 March 2017 till 29
March 2022 POM
755 BRU12030874P BrilintaTM 90mg F/C Tablet Ticagrelor 90mg AstraZeneca AB., Sweden Zuellig Pharma (B) Sdn Bhd30 March 2017 till 29
March 2022 POM
756 BRU12030875P DetrusitolTM SR Capsule 4mgTolterodine L-Tartrate 4mg (equivalent
to Tolterodine 2.74mg)Catalent Pharma Solutions LLC, USA Zuellig Pharma (B) Sdn Bhd
30 March 2017 till 29
March 2022 POM
757 BRU12030876NPEllgy Corns & Warts
Treatment SolutionSalicylic acid 17%w/v
HOE Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
30 March 2017 till 29
March 2022 P
758 BRU12030877PPuregon® 900IU/1.08ml
Solution for Injection
Follitropin Beta (Recombinant follicle-
stimulating hormone FSH) [Org 32489]
Vetter Pharma-Fertigung GmbH & Co.
KG., Schutzenstrasse, Ravensburg,
Germany; Vetter Pharma-Fertigung
GmbH & Co. KG., Mooswiesn2,
Ravensburg, Germany; Vetter Pharma-
Fertigung GmbH & Co. KG.,
Eisenbahnstrasse, Langenargen,
Germany; Vetter Pharma-Fertigung
GmbH & Co. KG., Holbeinstrasse,
Ravensburg, Germany
Zuellig Pharma (B) Sdn Bhd30 March 2017 till 29
March 2022 POM
759 BRU12030879PMethotrexate Injection BP
50mg in 2mlMethotrexate 50mg/2ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd
30 March 2017 till 29
March 2022 POM
760 BRU12030880NP Aqua Cream
Emulsifying Wax 8% w/w, White Soft
Paraffin 12%w/w, Liquid Paraffin
8%w/w
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
30 March 2012 till 29
March 2017 GSL
761 BRU12030881P CelebrexTM 400mg Capsule Celecoxib 400mgPfizer Pharmaceuticals LLC., vega Baja
Puerto Rico, USAZuellig Pharma (B) Sdn Bhd
30 March 2017 till 29
March 2022 POM
762 BRU12030882PCancidas Powder for Injection
50mg/vialCaspofungin (as acetate) 50mg/vial
Laboratoires Merck Sharp & Dohme
Chibret, FranceZuellig Pharma (B) Sdn Bhd
30 March 2017 till 29
March 2022 POM
763 BRU12030883P Axcel Dextrozine Syrup
Dextromethorphan Hydrobromide
15mg/5ml; Promethazine HCl
3.6mg/5ml
Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd
30 March 2017 till 29
March 2022 POM
764 BRU12040884PDilantin Steri Vials 250mg in
5mlPhenytoin Sodium 250mg/5ml Actavis Italy S.p.A., Italy Zuellig Pharma (B) Sdn Bhd
30 April 2017 till 29 April
2022 POM
765 BRU12040885P
Jevtana® 60mg Concentrate
and Solvent for Solution for
Infusion
Cabazitaxel 60mg/1.5mlSanofi-Aventis Deutschland GmbH,
GermanyMedipharm Sdn Bhd
30 April 2012 till 29 April
2017 POM
BDMCA/RMP/0317 Page 49 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
766 BRU12040886P HycamtinTM Hard Capsule 1mg Topotecan 1mg (as hydrochloride) GlaxoSmithKline Manufacturing
S.p.A., Parma, ItalyZuellig Pharma (B) Sdn Bhd
30 April 2017 till 29 April
2022POM
767 BRU12040887NPPanadol Suspension
120mg/5mlParacetamol 120mg/5ml
SmithKline Beecham, Cainta Rizal,
Philippines
Kingston Beverage &
Creamey Sdn Bhd
30 April 2012 till 29 April
2017
GSL
(60ml & 120ml)
768 BRU12040888PCancidas Powder for Injection
70mg/vialCaspofungin (as acetate) 70mg/vial
Laboratoires Merck Sharp & Dohme
Chibret, FranceZuellig Pharma (B) Sdn Bhd
30 April 2017 till 29 April
2022 POM
769BRU12040889PS1 &
BRU12040889PS2
Nasonex Aqueous Nasal Spray
0.05%
Mometasone furorate monohydrate,
micronized 0.05%
Schering-Plough Labo N.V., Belgium
(S1) & MSD International GmbH
(Singapore Branch), Singapore (S2)
Zuellig Pharma (B) Sdn Bhd30 April 2017 till 29 April
2022 POM
770 BRU12040891P Axcel Diprodin ElixirDiphenhydramine HCl 12.5mg/5ml;
Ephedrine HCl 6mg/5mlKotra Pharma (M) Sdn Bhd, Malaysia
Medicorp Sdn Bhd30 April 2017 till 29 April
2022POM
771 BRU12040892NPAxcel Paracetamol-120 Syrup
(Cherry)Paracetamol 120mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia
Medicorp Sdn Bhd 30 April 2017 till 29 April
2022
GSL (60ml &
100ml)
772 BRU12040893P Axcel Clobetasol 0.05% Cream Clobetasol propionate 0.05%w/w Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 30 April 2017 till 29 April
2022POM
773 BRU12040894P Axcel Tridine SyrupTriprolidine HCl 1.25mg/5ml;
Pseudoephedrine HCl 30mg/5mlKotra Pharma (M) Sdn Bhd, Malaysia
Medicorp Sdn Bhd 30 April 2017 till 29 April
2022POM
774 BRU12040895PAxcel Lignocaine Sterile Gel
2%w/w
Lignocaine HCl (Equiv. to anhydrous
HCl) 2g/100gKotra Pharma (M) Sdn Bhd, Malaysia
Medicorp Sdn Bhd 30 April 2017 till 29 April
2022POM
775 BRU12040896PNiquitin 21mg Transdermal
Patch
Nicotine 114mg (delivers 21mg/24
hours)ALZA Corporation, California, USA Zuellig Pharma (B) Sdn Bhd
30 April 2012 till 29 April
2017 P
776 BRU12050897P VfendTM IV 200mg Voriconazole 200mgPharmacia & Upjohn Company, USA
(Repacker - Pfizer PGM, France)Zuellig Pharma (B) Sdn Bhd
24 May 2017 till 23 May
2022 POM
777 BRU12050898PLamictal Dispersible Tablet
5mgLamotrigine 5mg
GlaxoSmithKline Pharmaceuticals SA.,
Poznan, Poland (Repacker -
GlaxoSmithKline Australia Pty Ltd.,
ViCtoria, Australia)
Zuellig Pharma (B) Sdn Bhd24 May 2017 till 23 May
2022 POM
778 BRU12050899PHycamtinTM Hard Capsule
0.25mgTopotecan 0.25mg (as hydrochloride)
GlaxoSmithKline Manufacturing
S.p.A., Parma, ItalyZuellig Pharma (B) Sdn Bhd
24 May 2017 till 23 May
2022POM
779 BRU12050900P AeriusTM Syrup 0.5mg/ml Desloratadine 0.5mg/ml Schering-Plough Labo N.V., Belgium Zuellig Pharma (B) Sdn Bhd24 May 2017 till 23 May
2022POM
780 BRU12050901NP Flamazine Cream 1% w/w Silver Sulfadiazine 1.0%w/wRecipharm Parets S.L., Barcelona,
SpainMc Quipp Technisell
Marketing Sdn Bhd
24 May 2017 till 23 May
2022P
781 BRU12050902P AeriusTM Tablets 5mg Desloratadine 5mg Schering-Plough Labo N.V., Belgium Zuellig Pharma (B) Sdn Bhd24 May 2017 till 23 May
2022POM
BDMCA/RMP/0317 Page 50 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
782 BRU12050903NP Panadol® ActiFast Caplets Paracetamol 500mg
GlaxoSmithKline Dungravan Ltd,
Ireland (Repacker - Sterling Drug
(Malaya) Sdn Bhd., Malaysia
Kingston Beverage &
Creamery Sdn Bhd
24 May 2012 till 23 May
2017
P ( 48's; 80's (8
tabs per blister)
per box)
783 BRU12050904PVaxcel Heparin Sodium
Injection 5000 IU/ml x 5ml
Heparin Sodium (Bovine mucosa)
25,000/5mlKotra Pharma (M) Sdn Bhd, Malaysia
Medicorp Sdn Bhd 24 May 2017 till 23 May
2022POM
784 BRU12050905PPregnyl® 5000IU Powder and
Solvent for Injection
Heparin Sodium (Bovine mucosa)
25,000/5mlMerck & Co. Inc., USA Zuellig Pharma (B) Sdn Bhd
24 May 2017 till 23 May
2022POM
785 BRU12050906PNiquitin 7mg Transdermal
PatchNicotine 36mg/cm2 (delivers 7mg/24
hours)ALZA Corporation, California, USA Zuellig Pharma (B) Sdn Bhd
24 May 2012 till 23 May
2017 P
786 BRU12050907NPEye Mo Moist Eye Lubricant
(Eye Drops)
Hydroxypropyl Methycellulose
0.3%w/v
GlaxoSmithKline (Tianjin) Co Ltd.,
China
Kingston Beverage &
Creamery Sdn Bhd
24 May 2012 till 23 May
2017 GSL
787 BRU12060908P Methycobal Tablets 500mcg Mecobalamin JP 0.5mg Bushu Pharmaceuticals Ltd, Japan Medipharm Sdn Bhd30 June 2017 till 29 June
2022 POM
788 BRU12060909P LyricaTM 75mg Capsules Pregabalin 75mgPfizer Manufacturing Deutschland
GmbH, Freiburg, GermanyZuellig Pharma (B) Sdn Bhd
30 June 2017 till 29 June
2022 POM
789 BRU12060910NPPanadol® Soluble Tablet
500mgParacetamol 500mg
GlaxoSmithKline Australia Pty Ltd,
Ermington, NSW, Australia
Kingston Beverage &
Creamery Sdn Bhd
30 June 2012 till 29 June
2017
GSL
(20's) & P (144's)
790 BRU12060911NPPanadol For Children Tablets
120mgParacetamol 120mg
Sterling Drug (Malaya) Sdn Bhd.,
Selangor, Malaysia
Kingston Beverage &
Creamery Sdn Bhd
30 June 2012 till 29 June
2017
P (24's &
144's)
791 BRU12060912PCanesten GYN 1 Day Therapy
Vaginal Tablet 0.5gClotrimazole 500mg
Bayer Pharma AG, Leverkusen,
GermanyZuellig Pharma (B) Sdn Bhd
30 June 2017 till 29 June
2022 POM
792 BRU12060913P Casodex Tablet 50mg Bicalutamide 50mgCorden Pharma GmbH, Plankstadt,
GermanyZuellig Pharma (B) Sdn Bhd
30 June 2017 till 29 June
2022 POM
793 BRU12060914NP ENO Mint Fruit Salt
Sodium Bicarbonate Coarse 1.483g
(34.49%w/w); Sodium Bicarbonate
Fine 0.495g (11.51%w/w); Citric Acid
Anhydrous 1.860g (43.26%w/w);
Sodium Carbonate Anhydrous 0.43g
(10.0%w/w)
Sterling Drug (Malaya) Sdn Bhd.,
Selangor, Malaysia
Kingston Beverage &
Creamery Sdn Bhd
30 June 2012 till 29 June
2017 GSL (48's)
794 BRU12060915NP Drapolene Cream
Cetrimide 0.2%w/w; Benzalkonium
Chloride Solution 0.02%w/w (equiv. to
Benzalkonium Chloride 0.01%w/w)
GlaxoSmithKline Pharmacuetical SA,
Poznan, Poland
Kingston Beverage &
Creamery Sdn Bhd
30 June 2012 till 29 June
2017 GSL (55g)
795 BRU12060916P Rhewlin Gel 1%w/wDiclofenac Diethylamine equiv. to
Diclofenac Sodium 1%w/w
Beacons Pharmaceutical Pte Ltd,
Singapore
Hongkiat Trading &
Company
30 June 2012 till 29 June
2017 GSL
796 BRU12060917P Efexor® XR 37.5mg Capsule Venlafaxine Hydrochloride 37.5mgPfizer Ireland Pharmacueticals,
Kildare, Republic of IrelandZuellig Pharma (B) Sdn Bhd
30 June 2017 till 29 June
2022 POM
BDMCA/RMP/0317 Page 51 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
797 BRU12070918PBeclomet Nasal Aqua
50mcg/dose Nasal Spray
Beclomethasone dipropionate
50mcg/doseOrion Corporation, Kuopio, Finland
Hongkiat Trading &
Company
30 July 2012 till 29 July
2017 POM
798 BRU12070919PPanadol CF Cold and Flu
Caplets
Paracetamol 500mg; Pseudoephedrine
HCl 30mg; Chlorpheniramine 2mg
Sterling Drug (Malaya) Sdn Bhd.,
Selangor, MalaysiaZuellig Pharma (B) Sdn Bhd
30 July 2017 till 29 July
2022 P (10's)
799 BRU12070920NPPanadol® Biconvex Film-
coated Tablet 500mgParacetamol 500mg
Sterling Drug (Malaya) Sdn Bhd.,
Selangor, Malaysia
Kingston Beverage &
Creamery Sdn Bhd
30 July 2012 till 29 July
2017
P (50's, 3
x 10's & 15 x
10's)
800 BRU12070921NP ENO Ginger Fruit Salt
Sodium Bicarbonate Coarse 1.462g
(34.002%w/w); Sodium Bicarbonate
Fine 0.487g (11.316%w/w); Citric Acid
Anhydrous 1.834g (42.640%w/w);
Sodium Carbonate Anhydrous 0.425g
(9.892%w/w)
Sterling Drug (Malaya) Sdn Bhd.,
Selangor, Malaysia
Kingston Beverage &
Creamery Sdn Bhd
30 July 2012 till 29 July
2017 GSL
801 BRU12070922NP ENO Fruit Salt
Sodium Bicarbonate Coarse 1.489g
(34.63%w/w); Sodium Bicarbonate
Fine 0.496 (11.54%w/w); Citric Acid
Anhydrous 1.873g (43.58%w/w);
Sodium Carbonate Anhydrous 0.43g
(10.00%w/w)
Sterling Drug (Malaya) Sdn Bhd.,
Selangor, Malaysia
Kingston Beverage &
Creamery Sdn Bhd
30 July 2012 till 29 July
2017 GSL
802 BRU12070923PCoversyl Plus 10mg/2.5mg
Tablet
Perindopril arginine 10mg (equiv. to
6.79mg perindopril); Indapamide
2.5mg
Servier (Ireland) Industries Ltd,
IrelandZuellig Pharma (B) Sdn Bhd
30 July 2017 till 29 July
2022POM
803 BRU12070924P RotarixTM oral SuspensionHuman rotavirus RIX4414 strain, not
less than 106.0 CCID50
GlaxoSmithKline Biological SA,
BelgiumZuellig Pharma (B) Sdn Bhd
30 July 2017 till 29 July
2022POM
804 BRU12070925P CutivateTM CreamFluticasone propionate (micronised)
0.05%w/wGlaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd
30 July 2017 till 29 July
2022POM
805 BRU12070926NP Bepanthen® Ointment Dexpanthenol 5%w/wGP Genzech Produktions GmbH,
GermanyZuellig Pharma (B) Sdn Bhd
30 July 2017 till 29 July
2022GSL
806 BRU12070927P Axcel Hydrocortisone Cream Hydrocortisone (micronised) 1% w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 July 2017 till 29 July
2022POM
807 BRU12070928PSevoflurane Inhalation
Anaesthetic Liquid 100%Sevoflurane 100% (1ml/ml)
Baxter Healthcare Corporation,
Puerto Rico, USA Zuellig Pharma (B) Sdn Bhd
30 July 2017 till 29 July
2022POM
808 BRU12080929PNiquitin 14mg Transdermal
PatchNicotine 78mg (14mg/24hrs) Alza Corporation, California, USA Zuellig Pharma (B) Sdn Bhd
29 August 2012 till 28
August 2017 P
809 BRU12080930NPDequadin® Lozenges (Citrus
Flavour)Dequalinium Chloride 0.25mg
Sterling Drug (Malaya) Sdn Bhd.,
Selangor, Malaysia
Kingston Beverage &
Creamery Sdn Bhd
29 August 2012 till 28
August 2017
GSL (6x4's &
24's)
810 BRU12080931P Rilutek Tablets 50mg Riluzole 50mgSanofi Winthrop Industrie, Cedex,
FranceMedipharm Sdn Bhd
29 August 2017 till 28
August 2022 POM
BDMCA/RMP/0317 Page 52 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
811 BRU12080932P Efexor XR 75mg Capsule Venlafaxine (as HCl) 75mgPfizer Ireland Pharmaceuticals,
Kildare, Republic of IrelandZuellig Pharma (B) Sdn Bhd
29 August 2017 till 28
August 2022 POM
812 BRU12090933PXarelto® Film-coated Tablet
10mgRivaroxaban 10mg
Bayer Pharma AG, Leverkusen,
GermanyZuellig Pharma (B) Sdn Bhd
27 September 2017 till 26
September 2022 POM
813 BRU12090934P Nif-Ten Capsule Atenolol 50mg; Nifedipine 20mgCorden Pharma GmbH, Plankstadt,
GermanyZuellig Pharma (B) Sdn Bhd
27 September 2017 till 26
September 2022 POM
814 BRU12090937PTelfast 6mg/ml Oral
SuspensionFexofenadine Hydrochloride 6mg/ml
Sanofi-Aventis Farmceutica Ltd, Vila
Areiao Suzano-SP-BrasilMedipharm Sdn Bhd
27 September 2017 till 26
September 2022 POM
815 BRU12090938PGlucophage® XR 750mg
Extended Release TabletMetformin HCl 750mg
Merck KGaA, Germany; Merck Sante
SAS, Semoy, FranceZuellig Pharma (B) Sdn Bhd
27 September 2017 till 26
September 2022 POM
816 BRU12090939P Glucophage® Tablet 500mg Metformin HCl 500mg Merck Sante SAS, Semoy, France Zuellig Pharma (B) Sdn Bhd27 September 2017 till 26
September 2022 POM
817 BRU12100940NP Dermoplex Calamine CreamCalamine (Fine) 4.00%; Zinc Oxide
3.00% w/w
Upha Pharmaceutical Mfg (M) Sdn
Bhd
Hongkiat Trading &
Company
31 October 2012 till 30
October 2017 GSL
818 BRU12100941PFragminTM Solution for
Injection 5,000IU (anti-
Xa)/0.2ml
Dalteparin Sodium 5,000IU (anti-
Xa)/0.2ml
Vetter Pharma-Fertigung GmbH &
Co., GermanyZuellig Pharma (B) Sdn Bhd
31 October 2017 till 30
October 2022 POM
819 BRU12100942PProstin E2TM Vaginal Tablet
3mgDinoprostone 3mg Sanico N.V., Turnhout, Belgium Zuellig Pharma (B) Sdn Bhd
31 October 2017 till 30
October 2022 POM
820 BRU12100943NP
Dianeal Low Calcium
(2.5mEq/L) Peritoneal Dialysis
Solution with 2.5% Dextrose
Dextrose 2.5g; Sodium Chloride
538mg; Sodium Lactate 448mg;
Calcium Chloride dihydrate 18.3mg;
Magnesium Chloride Hexhydrate
5.08mg
Baxter Healthcare SA, Singapore Medipharm Sdn Bhd31 October 2017 till 30
October 2022 POM
821 BRU12100944NPPotassium Chloride Tablet
600mg (Slow release)Potassium Chloride 600mg
Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading &
Company
31 October 2012 till 30
October 2017 POM
822 BRU12100945NP Anucare SuppositoriesZinc Oxide 300mg; Balsam Peru 50mg;
Benzyl Benzoate 33mg
Y.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
31 October 2012 till 30
October 2017 GSL
823 BRU12100946P Salbu-Air CFC Free InhalerSalbutamol Sulphate (micronised)
100mcg per actuation
Laboratorio Aldo-Union S.A.,
BarcelonaG & H Trading Company
31 October 2012 till 30
October 2017 POM
824 BRU12100947PIlliadin Nasal Decongestant
Solution 0.01%Oxymetazoline Hydrochloride 0.01% Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd
31 October 2012 till 30
October 2017 P
825 BRU12100948PRenvela (Sevelamer
Carbonate) Tablet 800mgSevelamer Carbonate 800mg Genzyme Ireland Limited, Ireland Medipharm Sdn Bhd
31 October 2012 till 30
October 2017 POM
826 BRU12100949P Lyrica Capsules 50mg Pregabalin 50mgPfizer Manufacturing Deutschland
GmbH, Freiburg, GermanyZuellig Pharma (B) Sdn Bhd
31 October 2017 till 30
October 2022 POM
827 BRU12100950P QvarTM 100 InhalerBeclomethasone dipropionate 100mcg
per inhalation3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd
31 October 2017 till 30
October 2021 POM
BDMCA/RMP/0317 Page 53 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
828 BRU12100951P Prograf Capsule 0.5mg Tacrolimus 0.5mg Astellas Ireland Ltd, Ireland Zuellig Pharma (B) Sdn Bhd31 October 2017 till 30
October 2021 POM
829 BRU12110952P Panadol C TabletParacetamol 500mg; Pseudoephedrine
Hydrochloride 30mg
Sterling Drug (Malaya) Sdn Bhd,
MalaysiaZuellig Pharma (B) Sdn Bhd
27 November 2012 till 26
November 2017 P (10's)
830 BRU12110953PFragminTM Solution for
Injection 2,500IU (anti-
Xa)/0.2ml, Single dose syringe
Dalteparin Sodium 2,500IU (anti-
Xa)/0.2ml
Vetter Pharma-Fertigung GmbH &
Co., GermanyZuellig Pharma (B) Sdn Bhd
27 November 2017 till 26
November 2022 POM
831 BRU12110954P Efexor XR 150mg Capsule Venlafaxine (as Hydrochloride) 150mgPfizer Ireland Pharmaceuticals,
Kildare, Republic of IrelandZuellig Pharma (B) Sdn Bhd
27 November 2017 till 26
November 2022 POM
832 BRU12110955PEprex® 4000 Prefilled Syringe
4000IU/0.4mlEpoetin alfa 4,000IU/0.4ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd
27 November 2017 till 26
November 2022 POM
833 BRU121109561P Topamax® 50 Tablets Topiramate 50mg Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd27 November 2017 till 26
November 2022 POM
834 BRU12110956NP Vitamin C 100mg Tablet Ascorbic Acid 100mgBeacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading &
Company
27 November 2012 till 26
November 2017 GSL
835BRU12110957PS1;
BRU12110957PS2
Actrapid® 100IU/ml Solution
for InjectionInsulin Human (rDNA) 100iu/ml
Novo Nordisk A/S, Denmark (S1);
Novo Nordisk Production SAS, France
(S2)
Medipharm Sdn Bhd27 November 2017 till 26
November 2022 POM
836 BRU12110958P Tretinon Cream 0.05% Tretinoin (Retinoic acid) 0.5mg/gY.S.P. Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
27 November 2017 till 26
November 2022 POM
837 BRU12110959PEprex® 2000 Prefilled Syringe
2000IU/0.5mlEpoetin alfa 2,000IU/0.5ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd
27 November 2017 till 26
November 2022 POM
838 BRU12110960NP Daflon 500mg Tablet Diosmin 450mg; Hesperidin 50mgLes Laboratories Servier Industrie,
FranceZuellig Pharma (B) Sdn Bhd
27 November 2017 till 26
November 2022 GSL
839 BRU12110962P Tenol-100 Atenolol 100mgSunward Pharmaceutical Pte Ltd,
SingaporeG & H Trading Company
27 November 2017 till 26
November 2022 POM
840 BRU12110963NP Polysilic III Suspension
Per 5ml contains Dried Aluminium
Hydroxide Gel 400mg; Magnesium
Trisilicate light 400mg; Simethicone
30mg
Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading &
Company
27 November 2012 till 26
November 2017
GSL (200ml);
GSL (3.8L)
841 BRU12110964PExjade 125mg Dispersible
TabletsDeferasirox 125mg
Novartis Pharmas Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
27 November 2017 till 26
November 2022 POM
842 BRU12110965PExjade 500mg Dispersible
TabletsDeferasirox 500mg
Novartis Pharmas Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
27 November 2017 till 26
November 2022 POM
843 BRU12110966NP Dhamotil TabletsDiphenoxylate HCl BP 2.5mg; Atropine
Sulphate 0.025mg
Drug Houses of Australia Pte Ltd.,
SingaporeG & H Trading Company
27 November 2012 till 26
November 2017 POM
BDMCA/RMP/0317 Page 54 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
844 BRU12120967PCervarixTM Vaccine (Prefilled
Syringe)
1 dose (0.5ml) contains: Human
Papillomavirus type 16 L1 protein
20mcg; Human Papillomavirus type 18
L1 protein 20mcg; 3-O-desacyl-4'-
monophosphoryl lipid A (MPL) 50mcg;
adsorbed on aluminium hydroxide,
hydrated (Al(OH)3) 0.5mcg Al3+
GlaxoSmithKine Biologicals S.A.,
Rixensart, BelgiumZuellig Pharma (B) Sdn Bhd
27 November 2017 till 26
November 2022 POM
845 BRU12120968NP
Dianeal Low Calcium
(2.5mEq/L) Peritoneal Dialysis
Sodium with 4.25% Dextrose
Per 100ml contains Calcium Chloride
18.3mg; Dextrose hydrous 4.25g;
Magnesium Chloride 5.08mg; Sodium
Chloride 538mg; Sdoium Lactate
448mg
Baxter Healthcare SA, Singapore Zuellig Pharma (B) Sdn Bhd27 November 2017 till 26
November 2022 POM
846 BRU12120969NP ENO Orange
Each 4.3g contains Citric Acid
Anhydrous 1.851g; Sodium
Bicarbonate Coarse 1.478g; Sodium
Bicarbonate Fine 0.492; Sodium
Carbonate Anhydrous 0.43g
Sterling Drug (Malaya) Sdn Bhd.,
Malaysia
Kingston Beverage &
Creamery Sdn Bhd
27 December 2012 till 26
December 2017 GSL
847 BRU12120970PClementin Film Coated Tablet
625mg
Amoxicillin (as Trihydrate) 500mg;
Clavulanic Acid (as Potassium Salt)
125mg
Yung Shin Pharmaceutical Ind. Co.
Ltd., Taichung, TaiwanAsterix United (B) Sdn Bhd
27 December 2012 till 26
December 2017 POM
848 BRU12120971PSurvanta® Beractant
Intratracheal SuspensionBeractant (as phospholipids) 25mg/ml AbbVie Inc., USA Zuellig Pharma (B) Sdn Bhd
27 December 2017 till 26
December 2022POM
849 BRU12120972PHumira Solution for Injection
40mg/0.8mlAdalimumab 40mg/0.8ml
Vetter-Pharma-Fertigung GmbH &
Co., KG, Ravensburg, GermanyZuellig Pharma (B) Sdn Bhd
27 December 2017 till 26
December 2022POM
850 BRU12120973P ZyrprexaTM Tablet 10mg Olanzapine 10mgLily del Caribe Inc, Puerto Rico, USA &
Lilly S.A., Madrid, SpainZuellig Pharma (B) Sdn Bhd
27 December 2017 till 26
December 2022POM
851 BRU12120974PSutentTM Hard Capsules
12.5mgSunitinib 12.5mg (as Malate) Pfizer Italia S.r.l., Ascoli Piceno, Italy Zuellig Pharma (B) Sdn Bhd
27 December 2017 till 26
December 2022 POM
852 BRU12120975P
Stelara Solution for Injection
in pre-filled syringe
45mg/0.5ml
Ustekinumab 45mg/0.5mlBaxter Pharmaceutical Solutions LLC,
Blommington, United StatesZuellig Pharma (B) Sdn Bhd
27 December 2017 till 26
December 2022 POM
853 BRU12120976P Viagra 50mg Tablet Sildenafil 50mg (as Citrate) Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd27 December 2017 till 26
December 2022 POM
854 BRU12120977P Viagra 100mg Tablet Sildenafil 100mg (as Citrate) Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd27 December 2017 till 26
December 2022 POM
855 BRU12120978PAerrane (Isoflurane USP)
Inhalation LiquidIsoflurane USP 100%
Baxter Healthcare Corporation,
Puerto Rico, USAZuellig Pharma (B) Sdn Bhd
27 December 2017 till 26
December 2022 POM
856 BRU12120979PKogenate FS for Injection
250IU/vial
Antihaemophilic Factor (recombinant)
sucrose formulated 250IUBayer Healthcare LLC., United States Zuellig Pharma (B) Sdn Bhd
27 December 2017 till 26
December 2022 POM
BDMCA/RMP/0317 Page 55 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
857 BRU12120980P Potcit MixturePer 5ml contains Potassium Citrate 1g;
Citric acid anhydrous 200mg
Beacons Pharmaceutical Pte Ltd.,
Singapore
Hongkiat Trading &
Company
27 December 2012 till 26
December 2017 POM
858 BRU12120981P Garbose Tablet 100mg Acarbose 100mgY.S.P Industries (M) Sdn Bhd.,
Selangor Darul Ehsan, MalaysiaAsterix United (B) Sdn Bhd
27 December 2012 till 26
December 2017 POM
859 BRU13010982PKombiglyzeTM XR Tablet
5/1000mg
Saxagliptin HCl 5mg (as anhydrous
5.58mg); Metformin Hydrochloride
1000mg
AstraZeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd26 January 2013 till 25
January 2018 POM
860 BRU13010983PKombiglyzeTM XR Tablet
5/500mg
Saxagliptin HCl 5mg (as anhydrous
5.58mg); Metformin Hydrochloride
500mg
AstraZeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd26 January 2013 till 25
January 2018 POM
861 BRU13010984PKombiglyzeTM XR Tablet
2.5/1000mg
Saxagliptin HCl 2.5mg (as anhydrous
2.79mg); Metformin Hydrochloride
1000mg
AstraZeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd26 January 2013 till 25
January 2018 POM
862 BRU13010985P Zanidip® 20mg Tablet Lercanidipine HCl 20mgRecordati Industria Chimica &
Farmaceutica S.p.A., Milan, ItalyHongkiat Trading & Co
26 January 2018 till 25
January 2023 POM
863 BRU13010986NP Eye Mo Eye Drops
Boric acid 12.98mg/ml (1.298% w/v);
Sodium Borate (equivalent to)
2.04mg/ml (0.204%w/v)
GlaxoSmithKline (Tianjin) Co. Ltd.,
China
Kingston Beverage &
Creamery Sdn Bhd
26 January 2013 till 25
January 2018 GSL
864 BRU13010987P Pontalon Tablet 500mg Mefenamic Acid 500mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd26 January 2013 till 25
January 2018 POM
865 BRU13010988P Co-Trimexazole SuspensionPer 5ml - Sulphamethoxazole BP
200mg; Trimethoprim 40mg
Beacons Pharmaceuticals Pte Ltd,
SingaporeHongkiat Trading & CO
26 January 2013 till 25
January 2018 POM
866 BRU13010989P Opticrom® Eye Drops 2% w/v Sodium Cromoglycate BP 2% w/v Sanofi Winthrop Industrie, France Medipharm Sdn Bhd26 January 2013 till 25
January 2018 P
867 BRU13010990NPPanamol Paed. Suspension
120mg/5mlParacetamol 120mg/5ml
Beacons Pharmaceuticals Pte ltd,
SingaporeHongkiat Trading & Co
26 January 2013 till 25
January 2018 P (3.8L)
868 BRU13010991PHumulin 30/70 Injection
100iu/ml (vial)
Human Insulin 100IU/ml (recombinant)
- 30% Soluble insulin & 70% Isophane
Insulin
Eli Lilly and Co., USA Zuellig Pharma (B) Sdn Bhd26 January 2018 till 25
January 2023 POM
869 BRU13010993PFML® Liquifilm Sterile
Opthalmic Solution 0.1%Fluorometholone 0.1%w/v
Allergan Pharmaceuticals Ireland,
IrelandMedipharm Sdn Bhd
26 January 2018 till 25
January 2023 POM
870 BRU13010994NPLacri-Lube S.O.P. Lubricants
Eye Ointment
Liquid Paraffin (Mineral Oil)
42.5%w/w; Soft White Paraffin (White
Petrolatum) 56.8% w/w
Allergan Sales LLC, United States Medipharm Sdn Bhd26 January 2013 till 25
January 2018 GSL
871 BRU13010995P Daivonex® Ointment Calcipotriol 50mcg/g (0.005% w/w)LEO Laboratories Ltd (LEO Pharma),
IrelandZuellig Pharma (B) Sdn Bhd
26 January 2018 till 25
January 2023 POM
872 BRU13010996P Seretide Evohaler 25/125mcg
Per actuation - Fluticasone propionate
125mcg; Salmetarol 25mcg (as
xinafoate)
Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd26 January 2018 till 25
January 2023 POM
873 BRU13010997P Glucophage® Tablet 850mgMetformin HCl 850mg (~Metformin
662.9mg)Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd
26 January 2018 till 25
January 2023 POM
BDMCA/RMP/0317 Page 56 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
874 BRU13010998P Revlimid® Capsules 5mg Lenalidomide 5mg
Penn Pharmaceutical Services
Limited, UK & Celgene International
Sarl, Switzerland
Zuellig Pharma (B) Sdn Bhd26 January 2018 till 25
January 2023 POM
875 BRU13010999NP Infusol® NS Sodium Chloride 0.9% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah26 January 2013 till 25
January 2018 GSL
876 BRU13011000P Inpanol Tablets 10mg Propranolol BP 10mgDrug Houses of Australia Private
Limited, SingaporeG & H Trading Company
26 January 2013 till 25
January 2018 POM
877 BRU13011001P Ciloxan Eyedrops Per ml - Ciprofloxacin HCl 3mg (as
Ciprofloxacin HCl monohydrate 3.5%)S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co
26 January 2013 till 25
January 2018 POM
878 BRU13011002P One-Alpha® Capsule 1mcgAlfacalcidol 1mcg (1α-Hydroxy-vitamin
D3)
Leo Pharmaceutical Products Ltd., A/S
(Leo Pharma), DenmarkZuellig Pharma (B) Sdn Bhd
26 January 2013 till 25
January 2018 POM
879 BRU13011003PNimotop Infusion Solution
0.02%Nimodipine 0.01g/50ml
Bayer Schering Pharma AG,
Leverkeusen, GermanyZuellig Pharma (B) Sdn Bhd
26 January 2013 till 25
January 2018 POM
880 BRU13011004PGemzar 200mg Powder for
Solution for InfusionGemcitabine 200mg (as HCl) Eli Lilly and Company, Indiana, USA Zuellig Pharma (B) Sdn Bhd
26 January 2013 till 25
January 2018 POM
881 BRU13011005P ZyprexaTM 5mg Tablet Olanzapine 5mgLilly del Caribe Inc., Puerto Rico, USA
& Lilly, S.A., SpainZuellig Pharma (B) Sdn Bhd
26 January 2018 till 25
January 2023 POM
882 BRU13021006PCanesten GYN Vaginal Tablet
100mg - 3 day therapyClotrimazole 100mg
Bayer Consumer AG, Basel,
SwitzerlandZuellig Pharma (B) Sdn Bhd
26 February 2013 till 25
February 2018 POM
883 BRU13021008PPrevenar 13 Suspension for
Injection
Per 0.5ml - Pneumococcal
Polysaccharide Serotype 1, 3, 4, 5, 6A,
7F, 9V, 14, 18C, 19A, 19F, 23F -
2.2mcg; Pneumococcal Polysaccharide
Serotype 6B - 4.4mcg
Pfizer Ireland Pharmaceuticals,
Dublin, IrelandZuellig Pharma (B) Sdn Bhd
26 February 2013 till 25
February 2018 POM
884 BRU13021009PHemabate Sterile Solution
250mcg/ml
Carboprost (as tromethamine)
250mcg/mlPharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd
26 February 2013 till 25
February 2018 POM
885BRU13021010PS1;
BRU13021010PS2
Humulin® 30/70 Injection
100iu/ml (catridge)
Human Insulin 100IU/ml (recombinant)
- 30% Soluble insulin & 70% Isophane
Insulin
Eli Lilly and Company, Indiana, USA
(S1); Eli Lily Italia S.p.A., Sesto
Fiorentino,
(FI) Italy (S2)
Zuellig Pharma (B) Sdn Bhd26 February 2018 till 25
February 2023 GSL
886 BRU13021011PExtraneal Peritoneal Dialysis
Solution 75g/L
Per 100ml: Icodextrin 7.5g; Sodium
Chloride 538mg; Sodium Lactate
448mg; Calcium Chloride 25.7mg;
Magnesium Chloride 5.08mg
Baxter Healthcare SA, Singapore Medipharm Sdn Bhd26 February 2018 till 25
February 2023 POM
887 BRU13021012P Afinitor Tablet 10mg Everolimus 10mgNovartis Pharma Stein AG, Stein,
SwitzerlandZuellig Pharma (B) Sdn Bhd
26 February 2013 till 25
February 2018 POM
888 BRU13021013P Ketovid Cream 2% Ketoconazole 2.0% w/w Hovid Bhd, Perak, Malaysia G & H Trading Company26 February 2013 till 25
February 2018 POM
889 BRU13021014P Progynova® Tablet 2mg Estradiol Valerate 2mgDelpharm Lille SAS, Lys Les Lannoy,
FrancZuellig Pharma (B) Sdn Bhd
26 February 2013 till 25
February 2018 POM
BDMCA/RMP/0317 Page 57 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
890 BRU13021015P Azopt Eye Drops, Suspension Brinzolamide 10mg/ml (1.0%w/w) S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co26 February 2013 till 25
February 2018 POM
891 BRU13021016P Rhewlin SR Tablet Diclofenac Sodium 100mgBeacons Pharmaceutical Pte Ltd,
SingaporeHongkiat Trading & Co
26 February 2013 till 25
February 2018 POM
892 BRU13021017PHydrogen Peroxide Solution
6%
Hydrogen Peroxide 6% w/v (equivalent
to 20 volumes of oxygen)
Xepa-Soul Pattinson (Malaysia) Sdn
Bhd, MalaysiaHongkiat Trading & Co
26 February 2013 till 25
February 2018 P
893 BRU13021018P Inpanol Tablets 40mg Propranolol BP 40mgDrug Houses of Australia Private
Limited, SingaporeG & H Trading Company
26 February 2013 till 25
February 2018 POM
894 BRU13021019PStilamin 3000 for Injection
3mg/ampouleSomatostatin (as acetate) 3mg
Merck Serono SA, Aubonne,
SwitzerlandG&H Trading Company
26 February 2018 till 25
February 2023 POM
895 BRU13021020P Loradine Syrup 1mg/ml Loratadine 1mg/mlY.S.P Industries (M) Sdn Bhd, Selangor
Darul Ehsan, MalaysiaAsterix United (B) Sdn Bhd
26 February 2013 till 25
February 2018 P
896 BRU13021021P Decozol Oral Gel 2% w/w Miconazole 2% w/wHOE Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
26 February 2013 till 25
February 2018 GSL
897 BRU13021022P Rasitol Injection 20mg/2ml Furosemide 20mg/2mlYung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan, ROCAsterix United (B) Sdn Bhd
26 February 2013 till 25
February 2018 POM
898 BRU13021023P Fusate-250 Tablet Sodium fusidate 250mgNoripharma Sdn Bhd, Selangor Darul
Ehsan, MalaysiaK-Seri Pharma Sdn Bhd
26 February 2013 till 25
February 2018 POM
899 BRU13021024P Premarin Vaginal Cream Conjugated Oestrogen (CE) 0.625mg/g Pfizer Canada Inc., Canada Zuellig Pharma (B) Sdn Bhd26 February 2013 till 25
February 2018 POM
900 BRU13021025NP Dhalgesic Rub 15% w/wMethyl salicylate 15% w/w; Menthol
5% w/w; Camphor (racemic) 2% w/w
Drug Houses of Australia Private
Limited, SingaporeG & H Trading Company
26 February 2013 till 25
February 2018 GSL
901 BRU13021026PKaletra Film-coated Tablet
200mg/50mgLopinavir 200mg; Ritonavir 50mg
AbbVie Deutschland GmbH & Co. KG,
GermanyZuellig Pharma (B) Sdn Bhd
26 February 2013 till 25
February 2018 POM
902 BRU13021027P Sustanon 250
Per 1ml - Testosterone decanoate
100mg; Testosterone
phenylpropionate 60mg; Testosterone
isocaproate 60mg; Testosterone
propionate 30mg [Equivalent to
Testosterone 176mg/ml]
Merck Sharp & Dohme, the
NetherlandsZuellig Pharma (B) Sdn Bhd
26 February 2013 till 25
February 2018 POM
903 BRU13021028P Holoxan for Injection Ifosfamide 1g Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd26 February 2018 till 25
February 2023 POM
904 BRU13031029NP Panadol Extend Tablet Paracetamol 665mgGlaxoSmithKline Australia Pty Ltd,
Australia
Kingston Beverage &
Creamery Sdn Bhd
28 March 2013 till 27
March 2018 P (8 x 6's)
905 BRU13031030P Canesten Cream 1% w/w Clotrimazole 1% w/w Encube Ethicals Private Ltd, India Zuellig Pharma (B) Sdn Bhd28 March 2018 till 27
March 2023 GSL
906 BRU13031032PPantaprazole Winthrop 20mg
Tablet
Pantoprazole (as sodium
sesquihydrate) 20mgSanofi-Aventis S.P.Z.O.O., Poland Medipharm Sdn Bhd
28 March 2013 till 27
March 2018 POM
907BRU13031033PS1;
BRU13031033PS2Metoclopramide Tablet 10mg
Metoclopramide HCl BP (equivalent to
Metoclopramide HCl anhydrous 10mg)
Drug House of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company28 March 2013 till 27
March 2018 POM
BDMCA/RMP/0317 Page 58 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
908 BRU13031034P Loperamil Tablet 2mg Loperamide 2mgDrug House of Australia Pte Ltd,
SingaporeG & H Trading Company
28 March 2013 till 27
March 2018 POM
909 BRU13031035P Hydralazine Tablet 50mg Hydralazine HCl 50mgBeacons Pharmaceuticals Pte Ltd,
SingaporeHongkiat Trading & Co
28 March 2013 till 27
March 2018 POM
910 BRU13031036P Dhacort Cream 1%w/wHydrocortisone acetate BP
(micronised) 1% w/w
Drug Houses of Australia Private
Limited, SingaporeG & H Trading Company
28 March 2013 till 27
March 2018 POM
911 BRU13031037P Tracidol Capsule 50mg Tramadol HCl 50mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd28 March 2013 till 27
March 2018 POM
912 BRU13031038PSolcoseryl Dental Adhesive
Paste
Per g - Solcoseryl CMC 2.125mg;
Polidocanol 10mg
Legacy Pharmaceuticals Switzreland
GmbH, SwitzerlandZuellig Pharma (B) Sdn Bhd
28 March 2018 till 27
March 2023 POM
913 BRU13031039NP Infusol® S3 Sodium Chloride 3% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah28 March 2013 till 27
March 2018 POM
914 BRU13031040P Indapamide SR Tablet 1.5mg Indapamide 1.5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd28 March 2013 till 27
March 2018 POM
915 BRU13031041P Dhatifen Syrup 1mg/5mlKetotifen (as hydrogen fumarate)
1mg/5ml
Drug Houses of Australia Private
Limited, SingaporeG & H Trading Company
28 March 2013 till 27
March 2018 POM
916 BRU13031042P Inox Capsule 100mg Itraconazole 100mg Hovid Bhd, Malaysia G & H Trading Company28 March 2013 till 27
March 2018 POM
917 BRU13031043P Doxycap capsule 100mg Anhydrous Doxycycline 100mg Hovid Bhd, Malaysia G & H Trading Company28 March 2013 till 27
March 2018 POM
918 BRU13031044P Zenmolin tablet 2mg Salbutamol (as sulphate) 2mgDrug Houses of Australia Private
Limited, SingaporeG & H Trading Company
28 March 2013 till 27
March 2018 POM
919 BRU13031045PRecormon Pre-filled Syringe
2000IU/0.3mlErythropoetin Beta 2,000iu/0.3ml Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd
28 March 2013 till 27
March 2018 POM
920 BRU13031046P Leukeran Tablet 2mg Chlorambucil 2mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd28 March 2013 till 27
March 2018 POM
921 BRU13031047PRecormon Pre-filled Syringe
4000IU/0.3mlErythropoetin Beta 4,000iu/0.3ml Roche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd
28 March 2013 till 27
March 2018 POM
922 BRU13031049PSaizen for Injection
3.33mg/vialSomatropin 3.33mg (10 IU) Merck Serono S.A., Switzerland G & H Trading Company
28 March 2013 till 27
March 2018 POM
923 BRU13031050P Isentress 400mg TabletRaltegravir 400mg (as potassium
434.4mg)
MSD Technology Singapore Pte Ltd.,
SingaporeZuellig Pharma (B) Sdn Bhd
28 March 2018 till 27
March 2023 POM
924 BRU13041051P
Taxotere 80mg/4ml
Concentrate for Solution for
Infusion
Docetaxel trihydrate 80mg/4mlSanofi-Aventis Deutschland GmbH,
GermanyMedipharm Sdn Bhd
30 April 2013 till 29 April
2018 POM
925 BRU13041052PFosamax Plus Tablet
70mg/5600IU
Alendronic Acid 70mg (as Sodium
91.37mg); Colecalciferol 140mcg
(5,600IU)
MSD Frosst Iberica, S.A., Madrid,
SpainZuellig Pharma (B) Sdn Bhd
30 April 2018 till 29 April
2023 POM
926 BRU13041053PGlucovance Tablet
500mg/2.5mg
Metformin HCl 500mg, Glibenclamide
2.5mgMerck Sante SAS, Semoy, France Zuellig Pharma (B) Sdn Bhd
30 April 2013 till 29 April
2018 POM
927BRU13041054PS1 &
BRU13041054PS2
Rebif ® Pre-filled Syringe
22mcg/0.5ml
Interferon beta-1a 22mcg (6MIU) /
0.5ml
Merck Serono S.p.A., Modugno, Italy
(S1); Merck Serono S.A., Aubonne,
Switzerland (S2)
G & H Trading Company30 April 2013 till 29 April
2018 POM
BDMCA/RMP/0317 Page 59 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
928 BRU13041055P Alpranax Tablet 0.5mg Alprazolam 0.5mg Y.S.P Industries (M) Sdn Bhd Malaysia K-Seri Pharma Sdn Bhd30 April 2013 till 29 April
2018 POM
929 BRU13041056NP Liquid Paraffin Liquid Paraffin 100%w/wBeacons Pharmaceuticals, Pte ltd,
SingaporeHongkiat Trading & Co
30 April 2013 till 29 April
2018 GSL
930 BRU13041058PPegasys Pre-filled Syringe
180mcg/0.5mlPeginterferon alfa-2a 180mcg/0.5ml
F Hoffman-La Roche Ltd, Switzerland;
Roche Diagnostic GmbH, Germany; F
Hoffman-La Roche Ltd,
Betriebsstandort Kaiseraugst
(Parenterals), Switzerland
Hongkiat Trading & Co30 April 2013 till 29 April
2018 POM
931 BRU13041059P Borymycin Capsule 50mg Minocycline HCl 50mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd30 April 2013 till 29 April
2018 POM
932 BRU13041060P Kytril Tablet 1mg Granisetron 1mg (as HCl) Roche S.p.A., Italy Hongkiat Trading & Co30 April 2013 till 29 April
2018 POM
933 BRU13041061PVenofer® Solution for
Injection 100mg/5ml
Iron (III) [as Iron (III)-hydroxide
sucrose complex] 100mg/5ml
IDT Biologika GmbH, Germany; BIPSO
GmbH, GermanyHongkiat Trading & Co
30 April 2013 till 29 April
2018 POM
934 BRU13041062NP Calamine cream Calamine 4%w/w; Zinc Oxide 3% w/wBeacons Pharmaceuticals, Pte ltd,
SingaporeHongkiat Trading & Co
30 April 2013 till 29 April
2018 GSL
935 BRU13041063P Apuzin tablet 25mg Captopril 25mgY.S.P. Industries (M) Sdn Bhd
MalaysiaAsterix United (B) Sdn Bhd
30 April 2013 till 29 April
2018 POM
936 BRU13041064PLezpain film-coated tablet
135mgMebeverine HCl 135mg
Y.S.P. Industries (M) Sdn Bhd
MalaysiaAsterix United (B) Sdn Bhd
30 April 2013 till 29 April
2018 POM
937 BRU13041065P Copegus Tablet 200mg Ribavarin 200mgHoffman-La Roche Inc., USA; Patheon
Inc., Ontario, CanadaHongkiat Trading & Co
30 April 2013 till 29 April
2018 POM
938 BRU13041066P Celexin 250 Film-coated Tablet Cephalexin 250mg (as monohydrate) Hovid Bhd, Malaysia K-Seri Pharma Sdn Bhd30 April 2013 till 29 April
2018 POM
939 BRU13041067NP White Soft Paraffin White Soft Paraffin Sasaol Wax GmbH, Germany Hongkiat Trading & Co30 April 2013 till 29 April
2018 GSL
940 BRU13041068NP Calamine Lotion 15% w/v Calamine 15%w/vBeacons Pharmaceuticals, Pte ltd,
SingaporeHongkiat Trading & Co
30 April 2013 till 29 April
2018 GSL
941 BRU13061069PVotrient™ Film-coated tablets
200mgPazopanib (as hydrochloride) 200mg
Glaxo Operations UK Ltd,
Hertfordshire, UKZuellig Pharma (B) Sdn Bhd
04 June 2013 till 03 June
2018 POM
942
BRU13061070PS1;
BRU13061070PS2;
BRU13061070PS3
NovoMix® 30 FlexPen®
Suspension for Injection 100
U/ml
1ml contains 100u of Soluble Insulin
aspart 30% and Protamine-crystallised
Insulin aspart 70%
Novo Nordisk Producao Farmaceutica
do Brasil Ltda., Brazil (S1); Novo
Nordisk A/S, Bagsværd, Denmark (S2);
Novo Nordisk Production SAS, France
(S3)
Medipharm Sdn Bhd04 June 2013 till 03 June
2018 POM
943 BRU13061071P Duphaston Tablet 10mg Dydrogesterone 10mgAbbott Biologicals B.V., The
NetherlandsZuellig Pharma (B) Sdn Bhd
04 June 2013 till 03 June
2018 POM
BDMCA/RMP/0317 Page 60 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
944 BRU13061072NP Nutravit™ Syrup
Per 5ml - Riboflavine 1.46mg; Calcium
Pantothenate 3.25mg; Ascorbic Acid
17.5mg; Vitamin A 4000iu; Vitamin D
400iu; Nicotinamide 10.00mg; Lysine
HCl/ Monochloride 100.00mg;
Thiamine HCl/ Vit. B1 2.00mg;
Cynocobalamine/ Vit B12 1.5mcg;
Pyridoxine HCl/Vit B6 2.00mg
Hovid Bhd, Malaysia G & H Trading Company04 June 2013 till 03 June
2018 GSL
945 BRU13061073P Prednisolone Tablet 20mg Prednisolone 20mgBeacons Pharmaceuticals, Pte ltd,
SingaporeHongkiat Trading & Co
04 June 2013 till 03 June
2018 POM
946 BRU13061074P Kytril For Infusion 3mg/3ml Granisetron 3mg (as HCl 3.36mg) Cenexi SAS, France Hongkiat Trading & Co04 June 2013 till 03 June
2018 POM
947 BRU13061075P Minison Tablet 1mg Prazosin 1mg (as HCl 1.095mg)Y.S.P. Industries (M) Sdn Bhd
MalaysiaAsterix United (B) Sdn Bhd
04 June 2013 till 03 June
2018 POM
948 BRU13061076P Xeloda™ Tablets 500mg Capecatibine 500mg Productos Roche S.A. de C.V, Mexico Zuellig Pharma (B) Sdn Bhd04 June 2013 till 03 June
2018 POM
949 BRU13061077PChloramphenicol Eye
OintmentChloramphenicol 10mg/g KRKA d.d., Slovenia K-Seri Pharma Sdn Bhd
04 June 2013 till 03 June
2018 POM
950 BRU13061078NP Zentel Tablet 200mg Albendazole 200mg Tianjin SKF Labs Ltd, Tianjin, ChinaKingston Beverage &
Creamery Sdn Bhd
04 June 2013 till 03 June
2018 GSL (2's)
951 BRU13061079NP Maltofer® Syrup Iron (III) [as Iron (III)-hydroxide-
polymaltose complex] 10mg/ml
Vifor S.A., Switzerland & Vifor
(International) Inc., SwitzerlandMedipharm Sdn Bhd
04 June 2013 till 03 June
2018 GSL
952 BRU13061080P Noriday® Tablet Norethisterone 0.35mgPiramal Healthcare UK Limited,
United KingdomZuellig Pharma (B) Sdn Bhd
04 June 2013 till 03 June
2018 POM
953 BRU13061081PKeppra 250mg Film-coated
TabletLevetiracetam 250mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd
04 June 2013 till 03 June
2018 POM
954 BRU13061082PKeppra 500mg Film-coated
TabletLevetiracetam 500mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd
04 June 2013 till 03 June
2018 POM
955
BRU13061083PS1,
BRU13061083PS2,BRU
13061083PS3,
BRU13061083PS4
Avastin Concentrate For
Solution For Infusion
400mg/16ml
Bevacizumab 400mg/16ml
Genentech Inc., USA (S1); F-Hoffman-
La Roche Ltd, Basel, Switzerland (S2);
Roche Diagnostics GmbH, Manheim,
Germany (S3); F Hoffmann-La Roche
Ltd, Kaiseraugst, Switzerland (S4)
Hongkiat Trading & Co04 June 2013 till 03 June
2018 POM
956 BRU13061084P Xeloda Tablet 150mg Capecatibine 150mg Productos Roche S.A. de C.V, Mexico Zuellig Pharma (B) Sdn Bhd04 June 2013 till 03 June
2018 POM
957 BRU13061085PUripax Film-coated Tablet
200mgFlavoxate HCl 200mg
Y.S.P. Industries (M) Sdn Bhd
MalaysiaAsterix United (B) Sdn Bhd
04 June 2013 till 03 June
2018 POM
958 BRU13061086PAtorvas Tablets 10mg
Atorvastatin (as calcium) 10mgRanbaxy (Malaysia) Sdn. Bhd.,
MalaysiaG & H Trading Company
04 June 2013 till 03 June
2018 POM
959 BRU13061087PElonva Solution for Injection
150mcg/0.5mlCorifollitrophin alfa 150mcg/0.5ml
Vetter Pharma-Fertigung GmbH & Co.
KG, GermanyZuellig Pharma (B) Sdn Bhd
27 June 2013 till 26 June
2018 POM
BDMCA/RMP/0317 Page 61 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
960 BRU13061088P Maxitrol Eye Ointment
Per g: Neomycin Sulfate 3,500 IU;
Polymyxin B Sulfate 6,000IU;
Dexamethasone 0.1%
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co27 June 2013 till 26 June
2018 POM
961 BRU13061089P Maxidex® Eye Ointment Dexamethasone 0.1% w/w S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co27 June 2013 till 26 June
2018 POM
962 BRU13061090NPCiproxol (Ciprofloxacin) 0.2%
w/v Intravenous Infusion BPCiprofloxacin 0.2% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah
27 June 2013 till 26 June
2018 POM
963 BRU13061091NPInfusol® W Intravenous
Infusion BPWater for Injection BP Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah
27 June 2013 till 26 June
2018 GSL
964 BRU13061092P Isoket Ampoule 10mg/10ml Isosorbide Dinitrate 10mg/10ml (0.1%) EVER Pharma Jena GmbH, Germany Zuellig Pharma (B) Sdn Bhd27 June 2013 till 26 June
2018 POM
965 BRU13061093P Invoril tablets 10mg Enalapril maleate 10mgRanbaxy (Malaysia) Sdn. Bhd.,
MalaysiaG & H Trading Company
27 June 2013 till 26 June
2018 POM
966 BRU13061094PPharmaniaga Simvastatin
tablet 10mgSimvastatin 10mg
Pharmaniaga Manufacturing Berhad,
MalaysiaG & H Trading Company
27 June 2013 till 26 June
2018 POM
967 BRU13061095P Vitamin B1 Tablet Thiamine HCl 10mgBeacons Pharmaceuticals, Pte ltd,
SingaporeHongkiat Trading & Co
27 June 2013 till 26 June
2018 POM
968 BRU13061096P Invoril tablets 20mg Enalapril maleate 20mgRanbaxy (Malaysia) Sdn. Bhd.,
MalaysiaG & H Trading Company
27 June 2013 till 26 June
2018 POM
969 BRU13061097P Seldron Cleaning Lotion Selenium Sulphide USP 2.5% w/v ICM Pharma Pte Ltd, SingaporeMc Quipp Technisell
Marketing Sdn Bhd
27 June 2013 till 26 June
2018 p
970 BRU13071098NP Cortal for Children Tablet Acetaminophen (Paracetamol) 80mgSterling Drug (Malaya) Sdn Bhd,
Malaysia
Kingston Beverage &
Creamery Sdn Bhd
30 July 2013 till 29 July
2018
P
12 x 12's (144's)
971 BRU13071099PChampix 1mg film-coated
tabletVarenicline Tartrate 1mg
Pfizer Manufacturing Deutschland
GmbH, GermanyZuellig Pharma (B) Sdn Bhd
30 July 2013 till 29 July
2018 POM
972 BRU13071100P Iodosorb Ointment Cardexomar Iodine (eq. to Iodine 0.9%)Perstorp Speciality Chemicals,
Sweden
Mc Quipp Technisell
Marketing Sdn Bhd
30 July 2013 till 29 July
2018 POM
973 BRU13071101PGlucophage XR 500mg
Extended Release TabletMetformin HCl 500mg Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd
30 July 2013 till 29 July
2018 POM
974 BRU13071102P Victrelis Capsule 200mg Boceprevir 200mgSchering-Plough (Singapore) Pte Ltd,
SingaporeZuellig Pharma (B) Sdn Bhd
30 July 2013 till 29 July
2018 POM
975 BRU13071103P Axcel Cefaclor-250 Capsule Cefaclor (as monohydrate) 250mg Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd
30 July 2013 till 29 July
2018 POM
976 BRU13071104P
Gonal-F Powder and Solvent
for Solution for Injection 75IU
(5.5mcg)/ vial
Follitrophin Alfa 75 IU ( 5.5mcg)Merck Serono S.p.A., Bari (MSB), Italy;
Merck Serono S.A. (MSA), SwizerlandG & H Trading Company
30 July 2013 till 29 July
2018 POM
977 BRU13071105P Lignocaine Injection 2% x 5ml Lignocaine Hydrochloride 20mg/ml Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd30 July 2013 till 29 July
2018 POM
978 BRU13071106PPred Mild® Sterile Ophthalmic
Suspension 0.12%Prednisolone acetate 0.12% w/v
Allergen Pharmaceuticals Ireland,
Wesport, IrelandMedipharm Sdn Bhd
30 July 2013 till 29 July
2018 POM
BDMCA/RMP/0317 Page 62 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
979 BRU13071107P Tamiflu Capsules 75mg Oseltamivir 75mg
Cenexi SAS, France; Catalent Germany
Schorndorf GmbH, Germany; Roche
S.p.A., Italy
Zuellig Pharma (B) Sdn Bhd30 July 2013 till 29 July
2018 POM
980 BRU13071108P Revlimid® Capsules 25mg Lenalidomide 25mg
Penn Pharmaceutical Services
Limited, UK & Celgene International
Sarl, Switzerland
Zuellig Pharma (B) Sdn Bhd30 July 2013 till 29 July
2018 POM
981 BRU13071109P Revlimid® Capsules 15mg Lenalidomide 15mg
Penn Pharmaceutical Services
Limited, UK & Celgene International
Sarl, Switzerland
Zuellig Pharma (B) Sdn Bhd30 July 2013 till 29 July
2018 POM
982 BRU13071110P Solcoseryl Eye Gel Solcoseryl 120 Concentrate 8.3mg/gLegacy Pharmaceuticals Switzreland
GmbH, SwitzerlandZuellig Pharma (B) Sdn Bhd
30 July 2018 till 29 July
2023POM
983 BRU13071111P Micosten-H CreamMiconazole Nitrate 2%;
Hydrocortisone 1%Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd
30 July 2013 till 29 July
2018 POM
984 BRU13071112PPharmaniaga Labetalol Tablet
100mgLabetalol Hydrochloride 100mg
Pharmaniaga Manufacturing Berhad,
MalaysiaG & H Trading Company
30 July 2013 till 29 July
2018 POM
985 BRU13071113P Hydralazine Tablet 10mg Hydralazine Hydrochloride 10mgDrug Houses of Australia Private
Limited, SingaporeG & H Trading Company
30 July 2013 till 29 July
2018 POM
986 BRU13071114PSandimmun Neoral Capsule
25mgCiclosporin A 25mg
R.P. Scherer GmbH & Co. KG.,
GermanyZuellig Pharma (B) Sdn Bhd
30 July 2013 till 29 July
2018 POM
987 BRU13081115P Champix 0.5mg & 1mg TabletVarenicline Tartrate 0.5mg &
Varenicline Tartrate 1mg
Pfizer Manufacturing Deutschland
GmbH, GermanyZuellig Pharma (B) Sdn Bhd
27 August 2013 till 26
August 2018 POM
988 BRU13081116P Daktarin Oral Gel 2% Miconzaole 2% Janssen Pharmaceutical NV, Belgium Zuellig Pharma (B) Sdn Bhd27 August 2013 till 26
August 2018 P
989 BRU13081117P Dhasedyl DM Syrup
Per 5ml - Dextromethorphan HBr
10mg; Promethazine HCl 3.6mg/
Ephedrine HCl 6mg
Drug House of Australia (Asia) Pte Ltd,
SingaporeG & H Trading Company
27 August 2013 till 26
August 2018 POM
990 BRU13081118P Daivonex® Cream Calcipotriol 50mcg/g (0.0005% w/w)LEO Laboratories Ltd (LEO Pharma),
IrelandZuellig Pharma (B) Sdn Bhd
27 August 2013 till 26
August 2018 POM
991BRU13081119PS1;
BRU13081119PS2 Zoral Cream Acyclovir USP 5% w/w
Drug Houses of Australia Private
Limited, Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)G & H Trading Company
27 August 2013 till 26
August 2018 POM
992 BRU13081120PEnbrel® 25mg solution for
injection in pre-filled syringeEtanercept 25mg/0.5ml
Pfizer Ireland Pharmaceuticals,
IrelandZuellig Pharma (B) Sdn Bhd
27 August 2013 till 26
August 2018 POM
993 BRU13081121P Xenical Capsule 120mg Orlistat 120mg Roche SpA, Italy Zuellig Pharma (B) Sdn Bhd27 August 2013 till 26
August 2018 POM
994 BRU13081122P Requip® Tablet 1mg Ropinirole (as Hydrochloride) 1mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd27 August 2013 till 26
August 2018 POM
995 BRU13081123P Minazol Powder 2% Miconzaole Nitrate 2% w/wBiosis Pharmaceuticals Sdn Bhd.,
MalaysiaK-Seri Pharma Sdn Bhd
27 August 2013 till 26
August 2018 P
996 BRU13081124P Heparinol 5000IU/ml Heparin Sodium (bovine) 5,000IU/ml Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah27 August 2013 till 26
August 2018 POM
BDMCA/RMP/0317 Page 63 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
997 BRU13081125PPharmaniaga Pyrazinamide
Tablet 500mgPyrazinamide 500mg
Pharmaniaga Manufacturing Berhad,
MalaysiaG & H Trading Company
27 August 2013 till 26
August 2018 POM
998 BRU13081126P Sathrocin ES Tablet 400mgErythromycin (as ethylsuccinate)
400mg
Pharmaniaga Manufacturing Berhad,
MalaysiaG & H Trading Company
27 August 2013 till 26
August 2018 POM
999 BRU13081127P Ketovid Shampoo 2% w/v Ketoconazole (micronised) 2% w/w Hovid Bhd, Malaysia G & H Trading Company27 August 2013 till 26
August 2018 POM
1000 BRU13081128P Maxitrol Eye Drops
Per 1ml - Dexamethasone 0.1%;
Neomycin Sulphate 3,500IU; Polymyxin
B Sulphate 6,000 IU
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co27 August 2013 till 26
August 2018 POM
1001 BRU13091129P VentolinTM Syrup 2mg/5ml Salbutamol Sulphate (as sulphate)
5mg/5mlSmithKlineBeecham, Rizal, Philippines Zuellig Pharma (B) Sdn Bhd
28 September 2013 till 27
September 2018 POM
1002 BRU13091130PErbitux® 5mg/ml Solution for
InfusionCetuximab 5mg/ml
Boehringer Ingelheim, Germany &
Merck KGaA, Germany (1 Artwork)Zuellig Pharma (B) Sdn Bhd
28 September 2013 till 27
September 2018 POM
1003 BRU13091132NP Beafort Syrup
Each 5ml contains: Thiamine HCl 5mg;
Riboflavin 2.5mg; Pyridoxine HCl 2mg;
Cyanocobalamin 5mcg; Nicotinamide
20mg; Calcium Panthothenate 1.5mg
Beacons Pharmaceuticals, Pte ltd,
SingaporeHongkiat Trading & Co
28 September 2013 till 27
September 2018 GSL
1004 BRU13091133PClexane 4000/0.4ml Anti XA
Pre-filled Syringe
Enoxaprin sodium 4,000 anti-Xa
IU/0.4ml equivalent to 40mg/0.4mlSanofi Winthrop Industrie, France Medipharm Sdn Bhd
28 September 2013 till 27
September 2018 POM
1005 BRU13091134PPantaprazole Winthrop 40mg
Tablet
Pantoprazole (as sodium
Sesquihydate) 40mgSanofi-Aventis S.P.Z.O.O., Poland Medipharm Sdn Bhd
28 September 2013 till 27
September 2018 POM
1006 BRU13091135P Iodosorb PowderCadexomer 99.1% w/w, with Iodine
0.9%w/w
Perstorp Speciality Chemicals AB,
Sweden
Mc Quipp Technisell
Marketing Sdn Bhd
28 September 2013 till 27
September 2018 P
1007 BRU13091136P Anlodin Tablet 10mg Amlodipine (as besylate) 10mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd28 September 2013 till 27
September 2018 POM
1008 BRU13091137P Effient Tablet 5mg Prasugrel HCl 5mg Eli Lilly & Co., USA Zuellig Pharma (B) Sdn Bhd28 September 2013 till 27
September 2018 POM
1009 BRU13091138PClexane 6000/0.6ml Anti-Xa
IU Pre-filled Syringe
Enoxaprin sodium 6,000 anti-Xa
IU/0.6ml equivalent to 60mg/0.6mlSanofi Winthrop Industrie, France Medipharm Sdn Bhd
28 September 2013 till 27
September 2018 POM
1010 BRU13091139PSimvastatin Winthrop 40mg
TabletSimvastatin 40mg Sanofi Aventis S.p.z.o.o, Poland Medipharm Sdn Bhd
28 September 2013 till 27
September 2018 POM
1011 BRU13091140P Camazol Tablet 5mg Carbimazole 5mgXepa-Soul Pattinson (M) Sdn Bhd
MalaysiaHongkiat Trading & Co
28 September 2013 till 27
September 2018 POM
1012 BRU13091141P Pulin Injection 10mg/2ml Metoclopramide HCl 10mg/2mlYung Shin Pharmaceutical Ind. Co.
Ltd., TaiwanAsterix United (B) Sdn Bhd
28 September 2013 till 27
September 2018 POM
1013 BRU13091142NP Sulbutiamine 200 capsule Sulbutiamine 200mg Pahang Pharmacy Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd28 September 2013 till 27
September 2018 GSL
BDMCA/RMP/0317 Page 64 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1014 BRU13091143P VelcadeTM 3.5mg for Injection Bortezomib 3.5mg
Pierre Fabree Medicament Productio
(PFMP), France & BSP
Pharmaceuticals Srl (BSP), Latina, Italy
- (1 artwork)
Zuellig Pharma (B) Sdn Bhd28 September 2013 till 27
September 2018 POM
1015 BRU13091144P Bezamidin Tablet 200mg Bezafibrate 200mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd28 September 2013 till 27
September 2018 POM
1016 BRU13091145NP A-Bite Cream Crotamiton 10%w/wHOE Pharmaceuticals Sdn Bhd
MalaysiaG & H Trading Company
28 September 2013 till 27
September 2018 GSL
1017 BRU13091146P Tipidin Tablet 250mg Ticolopidine HCl BP 250mgDrug Houses of Australia Private
Limited, SingaporeG & H Trading Company
28 September 2013 till 27
September 2018 POM
1018 BRU13091147P Gynera Tablets Ethinylestradiol 0.03mg; Gestodene
0.075mg
Schering do Brasil Quimica e
Farmaceutica Ltda., Sao Paulo, BrazilZuellig Pharma (B) Sdn Bhd
28 September 2013 till 27
September 2018 POM
1019 BRU13101148P Eumovate™ Cream Clobetasone 17-butyrate 0.05% w/w Glaxo Wellcome Opration, UK Zuellig Pharma (B) Sdn Bhd31 October 2013 till 31
October 2018 POM
1020 BRU13101149PErycin Film Coated Tablet
250mgErythromycin (as stearate) 250mg
Y.S.P. Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
31 October 2013 till 31
October 2018 POM
1021 BRU13101151NP ENO Fruit Salt Lemon
Per 4.3g - Sodium Bicarbonate Coarse
1.468g (34.16%w/w); Sodium
Bicarbonate Fine 0.489g (11.39%w/w);
Citric Acid Anhydrous 1.853g
(43.10%w/w); Sodium Carbonate
Anhydrous 0.43g (10.0%w/w)
Sterling Drug (Malaya) Sdn Bhd,
Malaysia
Kingston Beverage &
Creamery Sdn Bhd
31 October 2013 till 31
October 2018 GSL
1022 BRU13101152P Hycamtin™ Injection 1MG Topotecan (as HCl) 1mgGlaxoSmithKline Manufacturing
S.p.A., Parma, ItalyZuellig Pharma (B) Sdn Bhd
31 October 2013 till 31
October 2018 POM
1023 BRU13101153P
Clexane 2000 anti-Xa IU/0.2ml
(Pre-filled Syringe for
Injection)
Enoxaparin Sodium 2,000 anti-Xa
IU/0.2ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd
31 October 2013 till 31
October 2018 POM
1024 BRU13101154PAxcel Mefenamic Acid
SuspensionMefenamic Acid 125mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd
31 October 2013 till 31
October 2018 POM
1025 BRU13101155P
Ovidrel Solution for Injection
250mcg/0.5ml in Pre-filled
Syringe
Choriogonadotropin alfa
250mcg/0.5ml
Merck Serono S.p.A., Italy & Merck
Serono S.A., SwitzerlandG & H Trading Company
31 October 2013 till 31
October 2018 POM
1026 BRU13101156PSandimmun Neoral Capsule
100mgCiclosporin 100mg
R.P Scherer GmbH & Co, Baden,
GermanyZuellig Pharma (B) Sdn Bhd
31 October 2013 till 31
October 2018 POM
1027 BRU13101157P Tobrex Eye Ointment Tobramycin 0.3% (3mg/g) S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co31 October 2013 till 31
October 2018 POM
1028 BRU13101158P Endoxan Tablet 50mgCyclophosphamide anhydrous (as
monohydrate) 50mg
Prasfarma S.L., Manlleu/Barcelona,
Spain; Haupt Pharma Amareg GmBH,
Germany
Zuellig Pharma (B) Sdn Bhd31 October 2013 till 31
October 2018 POM
1029 BRU13101159P CEF-4® Injection 500mg Ceftazidime (as pentahydrate) 500mgSiam Bheasach Co. Ltd., Bangkok,
ThailandK-Seri Pharma Sdn Bhd
31 October 2013 till 31
October 2018 POM
BDMCA/RMP/0317 Page 65 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1030 BRU13101160P Premarin Tablet 0.625mg Conjugated Estrogens 0.625mgPfizer Ireland Pharmaceuticals,
Kildare, IrelandZuellig Pharma (B) Sdn Bhd
31 October 2013 till 31
October 2018 POM
1031BRU13101161PS1;
BRU13101161PS2Revlimid capsules 10mg Lenalidomide 10mg
Penn Pharmaceutical Services, Gwent,
UK (S1) & Celgene International Sarl,
Boudry, Switzerlnd (S2)
Zuellig Pharma (B) Sdn Bhd31 October 2013 till 31
October 2018 POM
1032 BRU13101162PPharmaniaga Cephalexin
Suspension 125mg Cephalexin (as anhydrous) 125mg/5ml
Pharmaniaga Manufacturing Berhad,
MalaysiaG & H Trading Company
31 October 2013 till 31
October 2018 POM
1033 BRU13101163P Tolbutamide Tablets 500mg Tolbutamide 500mgDrug Houses Australia Pte Ltd.,
SingaporeG & H Trading Company
31 October 2013 till 31
October 2018 POM
1034 BRU13101164PIsopto Homatropine 2% Sterile
Ophthalmic Solution (
Homatropine Hydrobromide 2%
(20.0mg/ml)S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co
31 October 2013 till 31
October 2018 POM
1035 BRU13101165NPLactacyd Feminine Hygiene
Liquid
Per 100ml - Lactic Acid 1g; Atomised
Lactoserum (spray dried) 0.93g
Sanofi Synthelabo Vietnam, Ho Chi
Minh City, Viet NamMedipharm Sdn Bhd
31 October 2013 till 31
October 2018 GSL
1036 BRU13121166P SCMC Syrup 125mg/5ml S-Carboxymethyl-cysteine 125mg/5mlUpha Pharmaceutical Mfg (M) Sdn
Bhd, MalaysiaHongkiat Trading & Co
02 December 2013 till 01
December 2018 P
1037 BRU13121167PCopastin Film Coated Tablets
10mgCloperastine Hydrochloride 10mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd
02 December 2013 till 01
December 2018 P
1038 BRU13121168P Ucort CreamPer g – Urea 100mg; Hydrocortisone
acetate 10mgY.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd
02 December 2013 till 01
December 2018 P
1039 BRU13121169PPradaxa® Hard Capsules
150mg
Dabigatran etexilate 150mg (as
mesilate 172.95g)
Boehringer Ingelheim Pharma GmbH
&Co, Ingelheim am Rhein, GermanyHongkiat Trading & Co
02 December 2013 till 01
December 2018 POM
1040 BRU13121170PPradaxa® Hard Capsules
110mg
Dabigatran etexilate 110mg (as
mesilate 126.83g)
Boehringer Ingelheim Pharma GmbH
& Co., KG, GermanyHongkiat Trading & Co
02 December 2013 till 01
December 2018 POM
1041 BRU13121171P Amoxicillin Capsule 250mg Amoxicillin Trihydrate 250mgYung Shin Pharmaceutical Ind. Co.
Ltd., TaiwanAsterix United (B) Sdn Bhd
02 December 2013 till 01
December 2018 POM
1042 BRU13121172NP
Dianeal Low Calcium
(2.5mEq/L) Peritoneal Dialysis
Solution with 1.5% Dextrose
Each 100ml contains: Calcium
Choloride 18.3mg; Dextrose hydrous
1.5g; Magnesium Chloride 5.08mg;
Sodium Chloride 538mg; Sodium
Lactate 448mg
Baxter Healthcare SA, Singapore Medipharm Sdn Bhd02 December 2013 till 01
December 2018 POM
1043 BRU13121173NPRefresh Tears Lubricant Eye
Drops 0.5%
Carboxymethylcellulose Sodium 0.5%
w/vAllergan Sales LLC, USA Medipharm Sdn Bhd
02 December 2013 till 01
December 2018 GSL
1044 BRU13121174P Temodal Capsules 100mg Temozolomide 100mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd02 December 2013 till 01
December 2018 POM
1045BRU13121176PS1 &
BRU13121176PS2 Dhasolone Tablet 5mg Prednisolone BP (micronized) 5mg
Drug Houses of Australia Private
Limited, Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)G & H Trading Company
02 December 2013 till 01
December 2018 POM
BDMCA/RMP/0317 Page 66 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1046 BRU13121177PCyclogyl® 1% Sterile
Ophthalmic Solution (T)Cyclopentolate Hydrochloride 1% S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co
02 December 2013 till 01
December 2018 POM
1047 BRU13121178P Betawin Tablet 50mg (T) Metoprolol Tartrate 50mg Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Co02 December 2013 till 01
December 2018 POM
1048 BRU13121179P Imigran FD Tablets 50mg Sumatriptan 50mg ( as succinate) Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd30 December 2013 till 29
December 2018 POM
1049 BRU13121180PGlucovance Tablet
500mg/5mg
Metformin HCl 500mg; Glibenclamide
5mgMerck Sante SAS, France Zuellig Pharma (B) Sdn Bhd
30 December 2013 till 29
December 2018 POM
1050 BRU13121181P
Priorix-Tetra Powder and
Diluent for Solution for
Injection
Composition of Priorix™ per dose
(0.5ml): Live attenuated measles virus
(Schwarz strain) ≥103.0 CCID50, Live
attenuated mumps virus (RIT4385
strain) ≥103.7 CCID50, Live attenuated
rubella virus (Wistar RA 27/3 strain)
≥103.0 CCID50, Live attenuated Varicella
Virus (OKA strain) ≥103.3 PFU
Glaxosmithkline Biologicals S.A.,
BelgiumZuellig Pharma (B) Sdn Bhd
30 December 2013 till 29
December 2018 POM
1051 BRU13121182P Hycamtin Injection 4mg Topotecan (as Hydrochloride) 4mgGlaxoSmithKline Manufacturing
S.p.A., ItalyZuellig Pharma (B) Sdn Bhd
30 December 2013 till 29
December 2018 POM
1052 BRU13121183P Anarex TabletsParacetamol 450mg; Orphenadrine
citrate 35mg
Beacons Pharmaceuticals, Pte ltd,
SingaporeHongkiat Trading & Co
30 December 2013 till 29
December 2018 POM
1053 BRU13121184PAtarax Film-Coated Tablet
25mgHydroxyzine Hydrochloride 25mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd
30 December 2013 till 29
December 2018 POM
1054BRU13121185PS1;
BRU13121185PS2Propylthiouracil Tablets 50mg Propylthiouracil 50mg
Drug Houses of Australia Pte Ltd.,
Singapore (S1); PT Actavis Indonesia,
Jakarta, Indonesia (S2)
G & H Trading Company30 December 2013 till 29
December 2018 POM
1055 BRU13121186P Xyzal Oral Drops 5mg/mlPer mL - Levocetitrizine Hydrochloride
5mg
Aesica Pharmaceuticals S.r.L Pianezza,
ItalyZuellig Pharma (B) Sdn Bhd
30 December 2013 till 29
December 2018 POM
1056 BRU13121187NP10% Glucose Intravenous
Infusion B.P.
Glucose monohydrate (as equiv. to
anhydrous glucose) 10%B Braun Industries Sdn Bhd, Malaysia Hongkiat Trading & Co
30 December 2013 till 29
December 2018 POM
1057 BRU13121188PDaivonex Scalp Solution
50mcg/mlCalcipotriol 50mcg/ml
Leo Pharmaceutical Products Ltd., A/S
(Leo Pharma), DenmarkZuellig Pharma (B) Sdn Bhd
30 December 2013 till 29
December 2018 POM
1058 BRU13121189PHeparinised Saline Injection
10iu/ml (5ml)
Heparin Sodium (Bovine Mucosa)
10i.u./mlB Braun Industries Sdn Bhd, Malaysia Hongkiat Trading & Co
30 December 2013 till 29
December 2018 POM
1059 BRU13121190P Rescuvolin Tablet 15mgCalcium Folinate (equiv. to Folinic Acid)
15mg
Teva Pharmaceutical Works Pte Ltd
Co., Debrecen Site, HungaryK-Seri Pharma Sdn Bhd
30 December 2013 till 29
December 2018 POM
1060 BRU13121191PQuinax Sterile Ophthalmic
Solution
Sodium Dihydroazapentacene
Polysulfonate 0.15mg/mlS.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co
30 December 2013 till 29
December 2018 POM
1061 BRU13121192PNutriflex Lipid Peri Emulsion
for Infusion
1 unit consists of Amino Acid Solution;
Glucose Solution; Lipid Emulsion (For
Detailed Formulation referred to
Dossier)
B Braun Industries Sdn Bhd, Malaysia Hongkiat Trading & Co30 December 2013 till 29
December 2018 POM
BDMCA/RMP/0317 Page 67 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1062BRU14011193PS1 &
BRU14011193PS2
Alimta 500mg Powder for
Solution for InfusionPemetrexed (as Pemetrexed disodium)
500mg/vial
Eli Lilly and Company, USA (S1); Lilly
France, France (S2)Zuellig Pharma (B) Sdn Bhd
28 January 2014 till 27
January 2019POM
1063BRU14011194P
Gemzar 1G Powder for
Solution for InfusionGemcitabine 1000mg (as gemcitabine
hydrochloride)
Eli Lilly and Company, USAZuellig Pharma (B) Sdn Bhd
28 January 2014 till 27
January 2019POM
1064 BRU14011196P Largo Tablets 100mgChlorpromazine HCl 100mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading &
Company
28 January 2014 till 27
January 2019POM
1065 BRU14011197NP Axcel Eviline Forte Suspension
Each 5ml contains: Magnesium
Hydroxide 400mg, Aluminium
Hydroxide 400mg and Simethicone
40mg
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd,
Malaysia
28 January 2014 till 27
January 2019 GSL
1066 BRU14011198NP Bepanthen® First Aid CreamDexpanthenol 5%w/w; Chlorhexidine
hydrochloride 0.5% w/w
GP Grenzach Produktions GmbH,
Germany Zuellig Pharma (B) Sdn Bhd28 January 2014 till 27
January 2019 GSL
1067 BRU14011199NPDextrose 5% and Sodium
Chloride 0.9% Injection USP
Dextrose 5%; Sodium Chloride 0.9% Baxter Healthcare Corporation, USAZuellig Pharma (B) Sdn Bhd
28 January 2014 till 27
January 2019 POM
1068 BRU14011200NP Macgel® Tablet
Magnesium Hydroxide 200mg;
Aluminium Hydroxide Gel Dried
200mg; Dimethylpolysiloxane 25mg
Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 28 January 2014 till 27
January 2019 GSL
1069 BRU14011201PPrefrin Liquifilm Eye Drops
0.12%Phenylephrine Hydrochloride 0.12% Allergan Sales, LLC., USA MediPharm Sdn Bhd 28 January 2014 till 27
January 2019P
1070 BRU14011202NPRefresh Liquigel Lubricant Eye
Drops 1%Carboxymethylcellulose Sodium 1%
w/v
Allergan Sales, LLC., USA MediPharm Sdn Bhd 28 January 2014 till 27
January 2019GSL
1071 BRU14011203P Betaserc 24mg TabletBetahistine dihydrochloride 24mg Abbott Healthcare SAS, France
Zuellig Pharma (B) Sdn Bhd28 January 2014 till 27
January 2019POM
1072BRU14011204PS1;
BRU14011204PS2
Humalog Mix50 100 units/ml
Kwikpen
Insulin Lispro * 100U/ml (equivalent to
3.5mg) * in the proportion of 50%
insulin lispro solution and 50% insulin
lispro protamine suspension (rDNA
origin)
Lilly France S.A.S., France (S1); Eli Lilly
Italia S.p.A., Sesto Fiorentino, (FI)
Italy (S2)
(repacker - Eli Lilly And Company,
USA) & Eli Lilly Italia S.p.A., Sesto
Fiorentino, (FI) Italy;
Zuellig Pharma (B) Sdn Bhd
28 January 2014 till 27
January 2019
POM
1073 BRU14011205NP Panamol Tablet 500mgParacetamol 500mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading &
Company
28 January 2014 till 27
January 2019GSL (100 x 10's)
1074 BRU14011206PSeretide™ Evohaler™
25/50mcgFluticasone propionate 50mcg;
Salmeterol (as xinafoate) 25mcg
Glaxo Wellcome S.A., SpainZuellig Pharma (B) Sdn Bhd
28 January 2014 till 27
January 2019POM
1075BRU14011207PS1;
BRU14011207PS2 Tobrex® Eye Drops Solution
Tobramycin 0.3% (3mg/ml) S.A. Alcon-Couvreur N.V., Belgium
(S1); Alcon Singapore Manufacturing
Pte Ltd, Singapore (S2)
Hongkiat Trading &
Company
28 January 2014 till 27
January 2019 POM
BDMCA/RMP/0317 Page 68 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1076 BRU14011208P PNEUMOVAX 23
Pneumococcal Polysaccharide Danish
Types 1,2,3,4,5,6B, 7F,8,9N,9V, 10A,
11A, 12F, 14, 15B, 17F, 18C, 19A, 19F,
20, 22F, 23F, 33F. Each 0.5ml dose
contains 25µg of each polysaccharide
type
Merck Sharp & Dohme Corp, USA
Zuellig Pharma (B) Sdn Bhd
28 January 2014 till 27
January 2019
POM
1077 BRU14011209PNEUPOGEN PRE-FILLED
SYRINGE 30MU/0.5ML
Filgrastim 30mu/0.5ml F.Hoffmann-La Roche Ltd, Kaiseraugst
Switzerland
Medipharm Sdn Bhd 28 January 2014 till 27
January 2019 POM
1078 BRU14011210P Axcel Famotidine-20 CapsuleFamotidine 20mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd,
Malaysia
28 January 2014 till 27
January 2019POM
1079BRU14011211NPS1;
BRU14011207PS2
Tears Naturale II Eye Drops
Solution
Dextran 70 0.1% (1mg/ml);
Hypromellose 0.3% (3mg/ml)
S.A. Alcon-Couvreur N.V., Belgium
(S1); Alcon Singapore Manufacturing
Pte Ltd, Singapore (S2)
Hongkiat Trading &
Company
28 January 2014 till 27
January 2019 GSL
1080 BRU14011212PAxcel Chlorpheniramine-4
SyrupChlorpheniramine Maleate 4mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd,
Malaysia
28 January 2014 till 27
January 2019P
1081 BRU14011213PImojev Japanese Encephalitis
vaccine (live, attenuated) MD
Live, attenuated, recombinant
Japanese Encephalitis virus 4.0 - 5.8 log
PFU*/dose (0.5ml) *Plaque Forming
Unit
Government Pharmaceutical
Organization - Meriux Biological
Products Co., Ltd., ThailandZuellig Pharma (B) Sdn Bhd
28 January 2014 till 27
January 2019 POM
1082BRU14021214P Panaflex Extra Gel Diclofenac Sodium 10mg/1gm United Biomedical Inc., Asia, Taiwan
Zuellig Pharma (B) Sdn Bhd27 February 2014 till 26
February 2019
P
1083
BRU14021215P Havrix 1440 Vaccine Inactivated Hepatitis A virus antigen
(HAV), HM175 strain 1440 ELISA Units
(EL.U.)/ml
GlaxoSmithKline Biologicals SA,
Rixensart Belgium; GlaxoSmithKline
Biologicals S.A., Wavre Belgium Zuellig Pharma (B) Sdn Bhd
27 February 2014 till 26
February 2019
POM
1084BRU14021216P Co-Plavix® 75/100 film-coated
tablets
Clopidogrel (as hydrogen sulphate)
75mg; Acetylsalicylic acid 100mg
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 27 February 2014 till 26
February 2019
POM
1085BRU14021217P VotrientTM Film-coated tablets
400mg
Pazopanib (as hydrochloride) 400mg Glaxo Operations UK Limited, UKZuellig Pharma (B) Sdn Bhd
27 February 2014 till 26
February 2019
POM
1086BRU14021218P Motilium tablets 10mg Domperidone 10mg Janssen Pharmaceutica NV, Belgium
Zuellig Pharma (B) Sdn Bhd27 February 2014 till 26
February 2019
POM
1087
BRU14021219PS1;
BRU14021219PS2;
BRU14021219PS3
Novorapid® Flexpen®
100IU/ml
1ml of solution contains 100U insulin
aspart (r-DNA) (equivalent to 3.5mg)
Nordisk Producao Farmaceutica do
Brasil Ltda., Brazil (S1); Novo Nordisk
A/S, Denmark (S2); Novo Nordisk
Production SAS, France (S3)
Medipharm Sdn Bhd 27 February 2014 till 26
February 2019
POM
1088BRU14021220P Omelon Enteric
Microencapsulated capsule
20mg
Omeprazole 20mg Y.S.P. Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
BDMCA/RMP/0317 Page 69 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1089BRU14021221NP Lactacyd® liquid Lactic acid (1g/100ml) and atomized
lactoserum (0.9g/100ml)
Sanofi Synthelabo Vietnam, Ho Chi
Minh City, Viet Nam
Medipharm Sdn Bhd 27 February 2014 till 26
February 2019
GSL
1090
BRU14021222P Invega® Sustenna Prolonged
Release Suspension for
Intramuscular Injection
25mg/0.25ml
0.25ml of solution contains
Paliperidone (as palmitate 39mg)
25mg
Janssen Pharmaceutica NV, Belgium
Zuellig Pharma (B) Sdn Bhd
27 February 2014 till 26
February 2019
POM
1091
BRU14021223P Invega® Sustenna Prolonged
Release Suspension for
Intramuscular Injection
50mg/0.5ml
0.5ml of solution contains Paliperidone
(as palmitate 78mg) 50mg
Janssen Pharmaceutica NV, Belgium
Zuellig Pharma (B) Sdn Bhd
27 February 2014 till 26
February 2019
POM
1092
BRU14021224P Invega® Sustenna Prolonged
Release Suspension for
Intramuscular Injection
75mg/0.75ml
0.75ml of solution contains
Paliperidone (as palmitate 117mg)
75mg
Janssen Pharmaceutica NV, Belgium
Zuellig Pharma (B) Sdn Bhd
27 February 2014 till 26
February 2019
POM
1093
BRU14021225P Invega® Sustenna Prolonged
Release Suspension for
Intramuscular Injection
100mg/1.0ml
1.0ml of solution contains Paliperidone
(as palmitate 156mg) 100mg
Janssen Pharmaceutica NV, Belgium
Zuellig Pharma (B) Sdn Bhd
27 February 2014 till 26
February 2019
POM
1094BRU14021226P Simvastatin Winthrop 20mg
tablet
Simvastatin 20mg Sanofi-Aventis S.P.Z.O.O., Poland Medipharm Sdn Bhd 27 February 2014 till 26
February 2019
POM
1095
BRU14021227P LumiganTM (Bitamoprost
Ophthalmic Solution) 0.03%
Bimatoprost 0.03% w/v Allergan Sales, LLC, USA Medipharm Sdn Bhd 27 February 2014 till 26
February 2019
POM
1096BRU14021228NP Refresh Plus Lubricating Eye
Drops 0.5%
Carboxymethylcellulose Sodium 0.5% Allergan Sales, LLC, USA Medipharm Sdn Bhd 27 February 2014 till 26
February 2019
POM
1097
BRU14021229P NovoSeven® Powder and
Solvent for Solution for
Injection 2mg
Eptacog Alfa (Activated) 2mg/vial
(corresponds to 100 KIU/vial), 1mg/ml
after reconstitution.
1 KIU equals 1000 IU (International
Units)
eptacog alfa (activated) is recombinant
coagulation factor VIIa (rFVIIa) with a
molecular mass of approximately
50,000 Dalton produced in baby
hamster kidney cells (BHK Cells) by
recombinant DNA technology.
Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 27 February 2014 till 26
February 2019
POM
BDMCA/RMP/0317 Page 70 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1098BRU14021230NP Axcel Eviline Tablet Aluminium Hydroxide 200mg,
Magnesium Hydroxide 200mg,
Simethicone 20mg
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26
February 2019
GSL
1099BRU14021231P Axcel Loratadine syrup Loratadine 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26
February 2019
P
1100BRU14021232P Cymbalta Capsule 30mg Duloxetine (as hydrochloride) 30mg Eli Lilly and Company, Indiana, USA;
Lilly del Caribe, Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd27 February 2014 till 26
February 2019
POM
1101BRU14021233P TykerbTM tablets 250mg Lapatinib 250mg (as ditosylate
monohydrate)
Glaxo Wellcome Operations, UKZuellig Pharma (B) Sdn Bhd
27 February 2014 till 26
February 2019
POM
1102BRU14021234P Axcel Mefenamic Acid
Capsules
Mefenamic acid 250mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26
February 2019
POM
1103BRU14021235P Dostinex tablet 0.5mg Cabergoline 0.5mg Pfizer Italia S.r.I, Italy
Zuellig Pharma (B) Sdn Bhd27 February 2014 till 26
February 2019
POM
1104BRU14021236NP Lactated Ringer’s Injection
USP4
Sodium Chloride 6g/L; Sodium Lactate
3.1g/L; Potassium Chloride 0.3g/L;
Calcium Chloride 0.2g/L
Baxter Healthcare Corporation, USAZuellig Pharma (B) Sdn Bhd
27 February 2014 till 26
February 2019
GSL
1105BRU14021237P Imuran 50mg tablet Azathioprine 50mg Excella GmbH, Germany
Zuellig Pharma (B) Sdn Bhd27 February 2014 till 26
February 2019
POM
1106
BRU14021238NP Axcel Dicyclomine-S Syrup Per 5mL: Dicyclomine hydrochloride
5mg and Simethicone 50mg
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26
February 2019
GSL
1107BRU14021239P Humulin R Injection 100IU/ml Regular Human Insulin (recombinant
DNA origin) Biosynthetic
Eli Lilly an Company, USAZuellig Pharma (B) Sdn Bhd
27 February 2014 till 26
February 2019
POM
1108BRU14021240NP 5% Dextrose and 0.45%
Sodium Chloride Injection,
USP
Dextrose 5%; Sodium Chloride 0.45% Baxter Healthcare Corporation, USAZuellig Pharma (B) Sdn Bhd
27 February 2014 till 26
February 2019
GSL
1109BRU14021241P Giona Easyhaler 200mcg/dose
Inhalation Powder
Budesonide 200mcg Orion Corporation, Finland Hongkiat Trading & Co 27 February 2014 till 26
February 2019
POM
1110BRU14021242P Amoxicillin Capsule 500mg Amoxicillin Trihydrate 500mg Yung Shin Pharmaceutical Ind. Co.,
Taiwan
Asterix United (B) Sdn Bhd 27 February 2014 till 26
February 2019
POM
1111BRU14021243NP Neurobion tablet Thiamine disulfide 100mg; Pyridoxine
hydroxide 200mg & Cyanocobalamin
200mcg
Merck KGaA & Co, AustriaZuellig Pharma (B) Sdn Bhd
27 February 2014 till 26
February 2019
P
BDMCA/RMP/0317 Page 71 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1112BRU14021244P Omeprazole for Injection
(Lyophilised) 40mg/vial
Omeprazole 40mg/vial Gland Pharma Limited, India K-Seri Pharma Sdn Bhd 27 February 2014 till 26
February 2019
POM
1113BRU14021245P Keppra Concentrate for
solution for (infusion) /
intravenous
Levetiracetam 500mg/5ml Patheon Italia S.p.A., ItalyZuellig Pharma (B) Sdn Bhd
27 February 2014 till 26
February 2019
POM
1114
BRU14021246P Imojev Japanese Encephalitis
Vaccine (live, attenuated)
Live, attenuated, recombinant
Japanese Encephalitis virus 4.0 - 5.8 log
PFU*/ dose (0.5ml) * Plaque Forming
Unit
Government Pharmaceutical
organization-Meriux Biological
Products Co., Ltd., ThailandZuellig Pharma (B) Sdn Bhd
27 February 2014 till 26
February 2019
POM
1115BRU14021247P Pradaxa® Hard Capsules 75mg Dabigatran etexilate 75mg (as mesilate
86.48mg)
Boehringer Ingelheim Pharma GmbH
& Co., KG, GermanyHongkiat Trading & Co 27 February 2014 till 26
February 2019
POM
1116BRU14021248P Axcel Flemin Expectorant Diphenhydramine HCl 12.5mg/5ml;
Ammonium Chloride 130mg/5ml
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2014 till 26
February 2019
POM
1117BRU14031249P Tygacil 50mg Lyophilised
Powder for Intravenous
Infusion
Tigecycline 50mg Wyeth Lederle S.r.L, ItalyZuellig Pharma (B) Sdn Bhd
27 March 2014 till 26
March 2019
POM
1118
BRU14031250PS1;
BRU14031250PS2;
BRU14031250PS3
Levemir Flexpen 100IU/ml Insulin Detemir 100U/ml (equivalent to
14.2mg
Novo Nordisk A/S, Bagsværd,
Denmark (S1); Novo Nordisk
Producao Farmaceutica do Brasil
Ltda., Brazil (S2); Novo Nordisk
Production SAS, France (S3)
MediPharm Sdn Bhd 27 March 2014 till 26
March 2019
POM
1119BRU14031251P Stalevo 75/18.75/200mg Film-
coated Tablet
Levodopa 75mg; Carbidopa 18.75mg;
Entacapone 200mg
Orion Corporation, FinlandZuellig Pharma (B) Sdn Bhd
27 March 2014 till 26
March 2019
POM
1120BRU14031252P Stalevo 200/50/200mg Film-
coated Tablet
Levodopa 200mg; Carbidopa 50mg;
Entacapone 200mg
Orion Corporation, FinlandZuellig Pharma (B) Sdn Bhd
27 March 2014 till 26
March 2019
POM
1121BRU14031253P Humulin N Injection 100iu/vial Insulin (Human) Isophane 100iu/ml Eli Lilly and Company, USA
Zuellig Pharma (B) Sdn Bhd27 March 2014 till 26
March 2019
POM
1122
BRU14031254NP Nutrineal PD-4 with 1.1%
Amino Acid Solution
Each 1000ml contains L-Serine 0.510g;
L-Isoleucine 0.850g; L-Leucine 1.020g;
L-Lysine (as Hydrochloride) 0.955g; L-
Methionine 0.850g; L-Phenylalanine
0.570g; L-Threonine 0.646g; L-
Tryptophan 0.270g; L-Valine 1.393g; L-
Alanine 0.951g; L-Arginine 1.071g;
Glycine 0.510g; L-Histidine 0.714g; L-
Proline 0.595g; L-Tyrosine 0.300g;
Sodium Chloride 5.380g; Calcium
Chloride Dihydrate 0.184g;
Magnesium Chloride Hexahydrate
0.051g; Sodium Lactate 4.48g
Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 27 March 2014 till 26
March 2019
POM
BDMCA/RMP/0317 Page 72 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1123BRU14031255P Effient™ Tablet 10mg Prasugrel (as hydrochloride) 10mg Eli Lilly and Company, USA
Zuellig Pharma (B) Sdn Bhd27 March 2014 till 26
March 2019
POM
1124BRU14031256P Gonal-F 300IU/0.5ml solution
for injection in a pre-filled pen
Each pen (0.5ml) contains 300IU
follitropin alfa (eq. to 22 micrograms)
Merck Serono S.p.A, Italy G&H Trading Company 27 March 2014 till 26
March 2019
POM
1125
BRU14031257P Gonal-F 900IU/1.5ml Solution
for Injection in a pre-filled pen
Each pen (1.5ml) contains 900IU
follitropin alfa (eq. to 66 micrograms).
Each ml of solution contains 600IU
follitropin alfa (equivalent to 44
micrograms)
Merck Serono S.p.A, Italy G&H Trading Company 27 March 2014 till 26
March 2019
POM
1126BRU14031258P Volibris 5mg Film-coated
TabletAmbrisentan 5mg Patheon Inc., Ontario, USA Zuellig Pharma (B) Sdn Bhd
27 March 2014 till 26
March 2019
POM
1127BRU14031259P Volibris 10mg Film-coated
TabletAmbrisentan 10mg Patheon Inc., Ontario, USA Zuellig Pharma (B) Sdn Bhd
27 March 2014 till 26
March 2019
POM
1128BRU14031260P Atarax™ Syrup 2mg/ml
Hydroxyzine hydrochloride 2mg/ml NextPharma SAS, France Zuellig Pharma (B) Sdn Bhd27 March 2014 till 26
March 2019
POM
1129BRU14031261P Prograf Capsule 1mg
Tacrolimus 1mg Astellas Ireland Ltd, Ireland Zuellig Pharma (B) Sdn Bhd27 March 2014 till 26
March 2019
POM
1130BRU14031262P Loperamil Syrup 1mg/5ml
Loperamide HCl 1mg/5mlDrug Houses of Australia Pte Ltd,
SingaporeG&H Trading Company
27 March 2014 till 26
March 2019
POM
1131BRU14031263P;
BRU14031263PS2
Patanol® Eye Drops, Solution
0.1% Olopatadine (as HCl) 0.1%
S.A. Alcon-Couvreur N.V., Belgium;
Alcon Singapore Manufacturing Pte.
Ltd., Singapore (S2)
Hongkiat Trading &
Company
27 March 2014 till 26
March 2019
POM
1132
BRU14031264PS1;
BRU14031264PS2
Travatan® Eye Drops
40mcg/ml Travoprost 40mcg/ml
S.A. Alcon-Couvreur N.V., Belgium
(S1); Alcon Singapore Manufacturing
Pte Ltd, Singapore (S2)
Hongkiat Trading &
Company
27 March 2014 till 26
March 2019
POM
1133BRU14031265P;
BRU14031265PS2
Chlorpheniramine tablet 4mgChlorpheniramine Maleate 4mg
Drug Houses of Australia Pte Ltd,
Singapore; PT Actavis Indonesia,
Indonesia (S2)
G&H Trading Company 27 March 2014 till 26
March 2019
POM
1134BRU14031266P Allertyn Tablet 10mg
Loratadine (micronized) 10mgDrug Houses of Australia Pte Ltd,
SingaporeG&H Trading Company
27 March 2014 till 26
March 2019
P
BDMCA/RMP/0317 Page 73 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1135
BRU14031267P Motilium Suspension 1mg/ml
Domperidone 1mg/ml Janssen Pharmaceutica NV, Belgium Zuellig Pharma (B) Sdn Bhd
27 March 2014 till 26
March 2019
POM
1136BRU14031268P Elonva Solution for Injection
100mcg/0.5mlCorifollitropin alfa 100mcg/0.5ml
Vetter Pharma-Fertigung GmbH & Co.
KG, GermanyZuellig Pharma (B) Sdn Bhd
27 March 2014 till 26
March 2019
POM
BDMCA/RMP/0317 Page 74 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1137
BRU14031269P Menveo Powder & Solution
for Solution for Injection
One dose (0.5ml of the reconstituted
vaccine) contains:
Originally contained in the powder:
Meninggococcal group A
oligosaccharide 10micrograms
(Conjugated to Corynebacterium
diphtheria CRM197 protein 16.7 to
33.3 micrograms)
Originally contained in the solution:
Meninggococcal group C
oligosaccharide 5micrograms
(Conjugated to Corynebacterium
diphtheria CRM197 protein…..7.1 to
12.5 micrograms); Meninggococcal
group W135 oligosaccharide
5micrograms
(Conjugated to Corynebacterium
diphtheria CRM197 protein 3.3 to 8.3
micrograms); Meninggococcal group Y
oligosaccharide 5micrograms
(Conjugated to Corynebacterium
diphtheria CRM197 protein….5.6 to
10.0. micrograms)
Novartis Vaccines and Diagnostics
GmbH, Germany; Novartis Vaccines
and Diagnostics S.r.I, Italy
Zuellig Pharma (B) Sdn Bhd
27 March 2014 till 26
March 2019
POM
1138BRU14031270P Enbrel® 50mg solution for
Injection in a pre-filled syringe Etanercept 50.0mg/1.0mlPfizer Ireland Pharmaceuticals,
IrelandZuellig Pharma (B) Sdn Bhd
27 March 2014 till 26
March 2019
POM
1139BRU14031272P Seretide Evohaler dose-
counter 25/250mcgSalmeterol 25mcg (as the xinafoate)
and Fluticasone Propionate 250mcgGlaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd
27 March 2014 till 26
March 2019
POM
1140
BRU14031273PS1;
BRU14031273PS2
Galvus Met 50/500mg Film-
coated TabletVildagliptin 50mg; Metformin HCl
500mg(corresponding to 390mg
Metformin)
Novartis Pharma Stein AG,
Switzerland (S1); Novartis Pharma
Produktions GmbH, Germany (S2)
Zuellig Pharma (B) Sdn Bhd
27 March 2014 till 26
March 2019
POM
1141
BRU14031274PS1;
BRU14031274PS2
Galvus Met 50/1000mg Film-
coated TabletVildagliptin 50mg; Metformin HCl
1000mg(corresponding to 780mg
Metformin)
Novartis Pharma Stein AG,
Switzerland (S1); Novartis Pharma
Produktions GmbH, Germany (S2)
Zuellig Pharma (B) Sdn Bhd
27 March 2014 till 26
March 2019
POM
1142
BRU14031275PS1;
BRU14031275PS2
Galvus Met 50/850mg Film-
coated TabletVildagliptin 50mg; Metformin HCl
850mg(corresponding to 660mg
Metformin)
Novartis Pharma Stein AG,
Switzerland (S1); Novartis Pharma
Produktions GmbH, Germany (S2)
Zuellig Pharma (B) Sdn Bhd
27 March 2014 till 26
March 2019
POM
BDMCA/RMP/0317 Page 75 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1143BRU14031276P Galvus 50mg Tablet
Vildagliptin 50mg Novartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd27 March 2014 till 26
March 2019
POM
1144
BRU14031277P Duac Once Daily Gel Clindamycin 1% w/w (as Clindamycin
phosphate); Benzoyl Peroxide 5% w/w
(as hydrous Benzoyl Peroxide)
Glaxo Wellcome UK Operations, UK
Zuellig Pharma (B) Sdn Bhd
27 March 2014 till 26
March 2019
POM
1145
BRU14031278P Conazole Cream Miconazole nitrate 2.0% w/w;
Betamethasone 0.1% w/w (as
valerate); Gentamicin (as sulphate)
0.1% w/w
Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 27 March 2014 till 26
March 2019
POM
1146BRU14031279NP Axcel Paracetamol-250 Syrup
(Orange)
Paracetamol 250mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 March 2014 till 26
March 2019
GSL (60 mL &
100 mL)
1147BRU14031280P Lamictal Dispersible/Chewable
Tablet 25mg
Lamotrigine 25mg GlaxoSmithKline Pharmaceutical SA,
Poland Zuellig Pharma (B) Sdn Bhd27 March 2014 till 26
March 2019
POM
1148BRU14031281P Panaco Tablets Paracetamol 500mg; Codeine
Phosphate 9mg
Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading &
Company
27 March 2014 till 26
March 2019
POM
1149BRU14031282P Voren Injection ‘Yung Shin’
(Diclofenac)
Diclofenac Sodium 75mg/3ml Yung Shin Pharmaceutical Ind,
Taiwan, R.O.C.
Asterix United (B) Sdn Bhd 27 March 2014 till 26
March 2019
POM
1150BRU14031283P Dhasolone Syrup 3mg/5ml Prednisolone 3mg/5ml Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 27 March 2014 till 26
March 2019
POM
1151BRU14031284P Xalatan Eyedrops Latanoprost 0.005% w/v Pfizer Manufacturing Belgium NV,
BelgiumZuellig Pharma (B) Sdn Bhd
27 March 2014 till 26
March 2019
POM
1152
BRU14041285P Giona Easyhaler®
100mcg/dose Inhalation
Powder
Budesonide 100mcg/dose Orion Corporation, Finland Hongkiat Trading &
Company
26 April 2014 till 25 April
2019
POM
1153BRU14041286P Axcel Nasatab Tablet Paracetamol 500mg; Chlorpheniramine
Maleate 4mg; Pseudoephedrine HCl
60mg
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 26 April 2014 till 25 April
2019
P (10 x 10's)
1154BRU14041287P XareltoTM Film-coated tablet
15mg
Rivaroxaban 15mg Bayer Pharma AG, GermanyZuellig Pharma (B) Sdn Bhd
26 April 2014 till 25 April
2019
POM
1155BRU14041288P XareltoTM Film-coated tablet
20mg
Rivaroxaban 20mg Bayer Pharma AG, GermanyZuellig Pharma (B) Sdn Bhd
26 April 2014 till 25 April
2019
POM
1156BRU14041289P Metformin 500 Tablet 500mg Metformin HCl BP 500mg Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
POM
1157BRU14041290NP Liquifilm TearsTM Ocular
Lubricant 1.4%
Polyvinyl Alcohol 1.4% Allergan Pharmaceuticals Ireland,
Ireland
Medipharm Sdn Bhd 26 April 2014 till 25 April
2019
GSL
1158BRU14041291NP Sodium Chloride Injection USP
0.9% in Mini-Bag Plus
Container
Sodium Chloride 0.9% Baxter Healthcare Corporation, USAZuellig Pharma (B) Sdn Bhd
26 April 2014 till 25 April
2019
GSL
1159BRU14041292PS1&
BRU14041292PS2
Rasilez® Film-coated Tablet
300mg
Aliskiren (as hemifumarate) 300mg Novartis Pharma Stein AG,
Switzerland (S1); Novartis Farma
S.p.A., Italy (S2)
Zuellig Pharma (B) Sdn Bhd26 April 2014 till 25 April
2019
POM
BDMCA/RMP/0317 Page 76 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1160BRU14041293P Endoxan® Injection 200mg/vial Cyclophosphamide monohydrate
213.8mg (eq. to anhydrous
Cyclophosphamide 200mg)
Baxter Oncology GmbH, GermanyZuellig Pharma (B) Sdn Bhd
26 April 2014 till 25 April
2019
POM
1161BRU14041294P Certican Tablet 0.25mg Everolimus 0.25mg Novartis Pharma Stein, AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
26 April 2014 till 25 April
2019
POM
1162BRU14041295P Certican Tablet 0.75mg Everolimus 0.75mg Novartis Pharma Stein, AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
26 April 2014 till 25 April
2019
POM
1163BRU14041296P Shincort IM Injection “Yung
Shin” 5ml vial
Triamcinolone acetonide 40mg/ml Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan, R.O.C.
Asterix United (B) Sdn Bhd 26 April 2014 till 25 April
2019
POM
1164
BRU14041297PS1;
BRU14041297PS2
DuoTrav Eye Drops, Solution Travoprost 40mcg/ml; Timolol 5mg/ml
(as timolol maleate)
S.A. Alcon-Couvreur N.V., Belgium
(S1); Alcon Singapore Manufacturing
Pte Ltd, Singapore (S2)
Hongkiat Trading &
Company
26 April 2014 till 25 April
2019
POM
1165BRU14041298P Chlormine Syrup 4mg/5ml Chlorpheniramine Maleate 4mg/5ml Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
P
1166BRU14041299P Hypernol 100 Tablets 100mg Atenolol 100mg Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
POM
1167BRU14041300P Hypernol Tablets 50mg Atenolol 50mg Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
POM
1168BRU14041301P DermovateTM Ointment Clobetasol Propionate 0.05% w/w Glaxo Wellcome Operations, UK
Zuellig Pharma (B) Sdn Bhd26 April 2014 till 25 April
2019
POM
1169BRU14041302P Tasigna Capsule 150mg Nilotinib (as hydrochloride,
monohydrate) 150mg
Novartis Pharma Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
26 April 2014 till 25 April
2019
POM
1170BRU14041303P Tasigna Capsule 200mg Nilotinib (as hydrochloride,
monohydrate) 200mg
Novartis Pharma Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
26 April 2014 till 25 April
2019
POM
1171BRU14041304NP Infusol NSD5 Sodium Chloride 9g/L; Dextrose
anhydrous 50g/L
Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 April 2014 till 25 April
2019
POM
1172BRU14041305NP Lactul Solution 670mg/ml Lactulose 670mg/ml Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 26 April 2014 till 25 April
2019
GSL
1173BRU14041306P Kytril for Infusion 1mg/ml Granisetron 1mg (equivalent to
Granisetron hydrochloride 1.12mg)
Cenexi SAS, France Hongkiat Trading &
Company
26 April 2014 till 25 April
2019
POM
1174BRU14041307P Alimta 100mg Powder for
Solution for Infusion
Pemetrexed (as Pemetrexed disodium)
100mg/vial
Eli Lilly and Company, USAZuellig Pharma (B) Sdn Bhd
26 April 2014 till 25 April
2019
POM
1175BRU14041308P Decofam Cough Syrup Per 5mL contains Ephedrine HCl 4mg;
Guaiphenesin 50mg & Ammonium
Chloride 80mg
Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
P
1176BRU14041309NP RinsCap W (Sterile Water for
Injection BP)
Water for Injection BP Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 April 2014 till 25 April
2019
GSL
1177
BRU14041310PS1;
BRU14041310PS2
Famotin Tablet 40mg Famotidine 40mg Drug Houses of Australia Pte Ltd,
Singapore (S1); PT Actavis Indonesia,
Jakarta,Indonesia (S2)
G&H Trading Company 26 April 2014 till 25 April
2019
POM
BDMCA/RMP/0317 Page 77 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1178BRU14041311P Paradrine Tablet Paracetamol 500mg; Pseudoephedrine
HCl BP 20mg; Chlorpheniramine
Maleate BP 2mg
Drug Houses of Australia Pte Ltd,
Singapore
G&H Trading Company 26 April 2014 till 25 April
2019
P (10 x 10 x 10's)
1179BRU14041312P One-Alpha® 0.25mcg Capsule Alfacalcidol 0.25mcg Leo Pharmaceutical Products Ltd., A/S
(Leo Pharma), DenmarkZuellig Pharma (B) Sdn Bhd
26 April 2014 till 25 April
2019
POM
1180BRU14041313P Ibuprofen Suspension
20mg/ml
Ibuprofen 20mg/ml Y.S.P. Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 26 April 2014 till 25 April
2019
P
1181BRU14041314NP Sodium Chloride Injection
0.9%, USP
Sodium Chloride 0.9% Baxter Healthcare Corporation, USAZuellig Pharma (B) Sdn Bhd
26 April 2014 till 25 April
2019
GSL
1182BRU14041315P Rivadem 3mg Capsule Rivastigmine (as hydrogen tartrate)
3mg
Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 26 April 2014 till 25 April
2019
POM
1183BRU14041316P Rivadem 1.5mg Capsule Rivastigmine (as hydrogen tartrate)
1.5mg
Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 26 April 2014 till 25 April
2019
POM
1184BRU14041317P Rozidal Tablet 1mg Risperidone 1mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G&H Trading Company 26 April 2014 till 25 April
2019
POM
1185BRU14071318PS1 &
BRU14071318PS2
Rebif ® 44 Pre-filled Syringe
44mcg/0.5ml
Interferon-beta-1a (12MIU)
44mcg/0.5mlMerck Serono S.p.A., Italy G & H Trading Company
02 July 2014 till 01 July
2019POM
1186BRU14071319PS1 &
BRU14071319PS2Mixtard® 30 100IU/ml
Insulin Human, rDNA ( as Isophane
Insulin) 70%, Insulin Human, rDNA (as
soluble insulin) 30%
Novo Nordisk A/S, Bagsvaerd,
Denmark (S1); Novo Nordisk
Productions SAS, France (S2)
Medipharm Sdn Bhd02 July 2014 till 01 July
2019POM
1187 BRU14071320P Protopic Ointment 0.03% Tacrolimus 0.3mg/g (0.03%) Astellas Pharma Tech Co., Ltd., Japan Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July
2019POM
1188 BRU14071321P Beathorphan Elixir 15mg/5ml Dextromethorphan HBr 15mg/5mlBeacons Pharmaceuticals, Pte ltd,
SingaporeHongkiat Trading & Co
02 July 2014 till 01 July
2019POM
1189 BRU14071322P Nootropil 1200mg Tablet Piracetam 1200mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July
2019POM
1190 BRU14071323P Nootropil 800mg Tablet Piracetam 800mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July
2019POM
1191 BRU14071324PLuvox® Film-coated Tablets
50mgFluvoxamine maleate 50mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd
02 July 2014 till 01 July
2019POM
1192 BRU14071325PLuvox® Film-coated Tablets
100mgFluvoxamine maleate 100mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd
02 July 2014 till 01 July
2019POM
1193 BRU14071326P TobraDex® Eye OintmentTobramycin 0.3%, Dexamethasone
0.1%S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co
02 July 2014 till 01 July
2019POM
BDMCA/RMP/0317 Page 78 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1194 BRU14071327PAgrippalTM S1, Suspension for
Injection in pre-filled syringe
Per 0.5ml dose: Split influenza virus*,
inactivated, containing antigens
equivalent to the following strains:
A/California/07/2009 (H1N1) pdm09–
like strain -15μg HA**
(A/California/07/2009, NYMC X-181);
A/Texas/50/2012 (H3N2) – like strain
15μg HA**, A/Texas/50/2012, NYMC X-
223-; B/Massachusetts/2/2012– like
strain 15μgHA** B/Florida/4/2006
wild type.
Novartis Vaccines and Diagnostic
S.r.L., ItalyZuellig Pharma (B) Sdn Bhd
02 July 2014 till 01 July
2019POM
1195 BRU14071328P Lanvis® Tablet 40mg Thioguanin 40mg Excella GmbH, Germany Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July
2019POM
1196 BRU14071329NP Axcel Papain Tablet
Papain Pure equiv. to proteolytic
enzymes from carica papaya 10,000
USP Units
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd02 July 2014 till 01 July
2019GSL
1197BRU14071330PS1;
BRU14071330PS2Humalog Kwikpen 100units/ml Insulin Lispro 100units/ml
Lilly France S.A.S., France (S1); Eli Lilly
Italia S.p.A., Sesto Fiorentino, (FI)
Italy (S2)
(repacker - Eli Lilly And Company,
USA) & Eli Lilly Italia S.p.A., Sesto
Fiorentino, (FI) Italy;
Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July
2019POM
1198 BRU14071331PShincort IM Injection "Yung
Shin" 40mg/ml ampoulesTriamcinolone acetonide 40mg
Yung Shin Pharmaceutical Ind. Co.
Ltd., TaiwanAsterix United (B) Sdn Bhd
02 July 2014 till 01 July
2019POM
1199 BRU14071332PEmend IV Powder For Solution
for Infusion 150mg
Fosaprepitant 150mg (as fosaprepitant
dimeglumine)DSM Pharmaceuticals Inc., USA Zuellig Pharma (B) Sdn Bhd
02 July 2014 till 01 July
2019POM
1200BRU14071333PS1;
BRU14071333PS2Zytiga Tablets 250mg Abiraterone acetate 250mg
Patheon Inc. Canada (S1); Patheon
S.A.S. (Patheon-France), France (S2)Zuellig Pharma (B) Sdn Bhd
02 July 2014 till 01 July
2019POM
1201 BRU14071334P Axcel Cefaclor-500 Capsule Cefaclor 500mg (as monohydrate) Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd02 July 2014 till 01 July
2019POM
1202 BRU14071335P Anlodin Tablet 5mg Amlodipine 5mg (as Besylate 6.93mg) Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd02 July 2014 till 01 July
2019POM
1203 BRU14071336P Aldara Cream 5%w/w Imiquimod 5% w/w 3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July
2019POM
1204 BRU14071337P Premarin Tablet 0.3mg Conjugated estrogens 0.3mgPfizer Ireland Pharmaceuticals,
IrelandZuellig Pharma (B) Sdn Bhd
02 July 2014 till 01 July
2019POM
BDMCA/RMP/0317 Page 79 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1205BRU14071338PS1;
BRU14071338PS2Regro Lotion 5% Minoxidil USP 5% w/v
Drug Houses of Australia Private
Limited, Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)
G & H Trading Company02 July 2014 till 01 July
2019P
1206BRU14071339PS1;
BRU14071339PS2Regro Lotion 3% Minoxidil USP 3% w/v
Drug Houses of Australia Private
Limited, Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)
G & H Trading Company02 July 2014 till 01 July
2019P
1207 BRU14071340NP Dequalinium Lozenges Dequalinium Chloride 0.25mgDrug Houses of Australia Private
Limited, SingaporeG & H Trading Company
02 July 2014 till 01 July
2019GSL
1208 BRU14071341P DHA-Ketozole Tablet 200mg Ketoconazole 200mgDrug Houses of Australia Private
Limited, SingaporeG & H Trading Company
02 July 2014 till 01 July
2019POM
1209 BRU14071342PAxcel Ibuprofen Paediatric
SyrupIbuprofen 100mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd
02 July 2014 till 01 July
2019P
1210 BRU14071343P Pharynx LozengesCetylpyridinium Chloride 1.50mg,
Benzocaine 3.33mg
Drug Houses of Australia Private
Limited, SingaporeG & H Trading Company
02 July 2014 till 01 July
2019GSL
1211 BRU14071344P Bislan Tablet 8mg Bromhexine Hydrochloride 8mgY.S.P. Industries (M) Sdn Bhd
MalaysiaAsterix United (B) Sdn Bhd
02 July 2014 till 01 July
2019POM
1212 BRU14071345P Tren Capsules 250mg Tranexamic Acid 250mgY.S.P. Industries (M) Sdn Bhd
MalaysiaAsterix United (B) Sdn Bhd
02 July 2014 till 01 July
2019POM
1213 BRU14071346P Hydrocort Cream Hydrocortisone acetate 10mg/g (1%
w/w)
Y.S.P. Industries (M) Sdn Bhd
MalaysiaAsterix United (B) Sdn Bhd
02 July 2014 till 01 July
2019POM
1214 BRU14071347P Invoril Tablet 5mg Enalapril Maleate 5mgRanbaxy (Malaysia) Sdn. Bhd.,
MalaysiaG & H Trading Company
02 July 2014 till 01 July
2019POM
1215 BRU14071348PAtropine Sulphate 1mg/1ml
InjectionAtropine Sulphate 1mg/ml
Pharmaniaga Manufacturing Berhad,
MalaysiaG & H Trading Company
02 July 2014 till 01 July
2019POM
1216BRU14071349P;
BRU14071349PS2Dhacodine Syrup 15mg/5ml Pholocodine 15mg/5ml
Drug Houses of Australia Private
Limited, Singapore; ICM PHARMA PTE
LTD, Singapore (S2)
G & H Trading Company02 July 2014 till 01 July
2019POM
1217 BRU14071350P Roaccutane Capsules 20mg Isotretinion 20mg R P Scherer GmbH & Co KG., Germany Hongkiat Trading & Co02 July 2014 till 01 July
2019POM
1218 BRU14071351P Roaccutane Capsule 10mg Isotretinion 10mgR.P. Scherer GmbH & Co. KG.,
GermanyHongkiat Trading & Co
02 July 2014 till 01 July
2019POM
1219 BRU14071352P Ipolipid 600mg Tablets Gemfibrozil 600mg Medochemie Ltd., Cyprus Hongkiat Trading & Co02 July 2014 till 01 July
2019POM
1220 BRU14071353PSalbutamol Injection
0.5mg/ml
Salbutamol Sulphate 0.5mg/ml
(equivalent to salbutamol base)
Yung Shin Pharmaceutical Ind., Co.
Ltd., Taichong, TaiwanAsterix United (B) Sdn Bhd
02 July 2014 till 01 July
2019POM
1221BRU14071354PS1;
BRU14071354PS2Glipizide Tablet 5mg Glipizide 5mg
Drug Houses of Australia Private
Limited, Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)
G & H Trading Company02 July 2014 till 01 July
2019POM
1222 BRU14071355PAxcel Dexchlorpheniramine
TabletDexchlorpheniramine 2mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd
02 July 2014 till 01 July
2019POM
BDMCA/RMP/0317 Page 80 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1223BRU14071356P;
BRU14071356PS2Phenexpect CD Syrup
Per 5 ml - Diphenhydramine HCl BP
12.5mg; Ammonium Chloride BP
135mg; Codeine Phosphate BP 5.7mg
Drug Houses of Australia Private
Limited, Singapore; ICM PHARMA PTE
LTD, Singapore (S2)
G & H Trading Company02 July 2014 till 01 July
2019POM
1224 BRU14071357PQuinine Sulphate Tablet
300mgQuinine Sulphate BP 300mg
Beacons Pharmaceuticals, Pte ltd,
SingaporeHongkiat Trading & Co
02 July 2014 till 01 July
2019POM
1225 BRU14071358NP20% Glucose Intravenous
Infusion BPGlucose (as monohydrate) 20%
B. Braun Medical Industries Sdn Bhd
MalaysiaHongkiat Trading & Co
02 July 2014 till 01 July
2019POM
1226 BRU14071359PPharmaniaga Spironolactone
Tablet 25mgSpironolactone 25mg
Pharmaniaga Manufacturing Berhad,
MalaysiaG & H Trading Company
02 July 2014 till 01 July
2019POM
1227 BRU14071360PMaxidex Sterile Opthalmic
SuspensionDexamethasone 0.1% ( 1mg/ml) S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co
02 July 2014 till 01 July
2019POM
1228 BRU14071361P Heparinol 1000IU/ml Heparin sodium (bovine) BP 1000IU/ml Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah02 July 2014 till 01 July
2019POM
1229 BRU14071362PAlphagan Ophthalmic Solution
0.2%
Brimonidine tartrate (anhydrous basis)
2mg/ml
Allergan Pharmaceuticals Ireland,
IrelandMedipharm Sdn Bhd
02 July 2014 till 01 July
2019POM
1230 BRU14071363P Dormicum Injection 15mg/3ml Midazolam 15mg/3ml Cenexi SAS, France Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July
2019POM
1231 BRU14071364P Dormicum Injection 5mg/5ml Midazolam 5mg/5ml Cenexi SAS, France Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July
2019POM
1232 BRU14071365NP
0.18% sodium Chloride and
4.3% Glucose Intravenous
Infusion
0.18% Sodium Chloride 0.18%; Glucose
4.3%
B.Braun Medical Industries Sdn Bhd.,
MalaysiaHongkiat Trading & Co
02 July 2014 till 01 July
2019POM
1233BRU14071366PS1 &
BRU14071366PS2
Rasilez Film-coated Tablet
150mgAliskiren 150mg (as Hemifumarate)
Novartis Pharma Stein AG,
Switzerland & Novartis Farma S.p.A.,
Italy
Zuellig Pharma (B) Sdn Bhd02 July 2014 till 01 July
2019POM
1234 BRU14071367P
Invega Sustenna Prolonged
Release Suspension for IM
Injection 150mg/1.5ml
Paliperidone 150mg/1.5ml (as
palmitate 234mg)Janssen Pharmaceutical NV, Belgium Zuellig Pharma (B) Sdn Bhd
02 July 2014 till 01 July
2019POM
1235 BRU14071368PYondelis® Powder for Injection
1mg/vial Trabectedin 0.05mg/ml Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1236 BRU14071369PTrajenta film-coated tablet
5mgLinagliptin 5mg Boehringer Ingelhein Roxane Inc., USA
Hongkiat Trading &
Company
24 July 2014 till 23 July
2019POM
1237 BRU14071370P
Novoseven® 1mg Powder and
Solvent for Solution for
Injection
Eptacog alfa (activated) 1mg/ml
(corresponds to 50KIU/vial) - 1mg/ml
after reconstitution
Novo Nordisk A/S, Denmark Medipharm Sdn Bhd24 July 2014 till 23 July
2019POM
1238 BRU14071371P
NovoSeven 5mg/vial, Powder
and Solvent for Solution for
Injection
Eptacog alfa (activated) 5mg/vial
(corresponds to 250KIU/vial) - 1mg/ml
after reconstitution
Novo Nordisk A/S, Denmark Medipharm Sdn Bhd24 July 2014 till 23 July
2019POM
1239BRU14071372PS1 &
BRU14071372PS2
Invega® Extended-Release
Tablet 9mg
Paliperidone 9mg [Layer 1 - 2.7mg;
Layer 2 - 6.3mg]
ALZA Corporation, USA (S1); Janssen
Cilag Manufacturing L.L.C., Puerto
Rico (S2)
Zuellig Pharma (B) Sdn Bhd24 July 2014 till 23 July
2019POM
BDMCA/RMP/0317 Page 81 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1240BRU14071373PS1 &
BRU14071373PS2
Invega® Extended-Release
Tablet 3mg
Paliperidone 3mg [Layer 1 - 0.9mg;
Layer 2 - 2.1mg]
ALZA Corporation, USA (S1); Janssen
Cilag Manufacturing L.L.C., Puerto
Rico (S2)
Zuellig Pharma (B) Sdn Bhd24 July 2014 till 23 July
2019POM
1241BRU14071374PS1 &
BRU14071374PS2
Invega® Extended-Release
Tablet 6mg
Paliperidone 6mg [Layer 1 - 1.8mg;
Layer 2 - 4.2mg]
ALZA Corporation, USA (S1); Janssen
Cilag Manufacturing L.L.C., Puerto
Rico (S2)
Zuellig Pharma (B) Sdn Bhd24 July 2014 till 23 July
2019POM
1242 BRU14071375PLucentis 10mg/ml Solution for
InjectionRanibizumab 10mg/ml
Novartis Pharma Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1243 BRU14071376P
Onbrez Breezhaler 150mcg
Inhalation Powder, Hard
Capsule
Indacterol 150mcg (as maleate
194mcg)
Novartis Pharma Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1244 BRU14071377P
Onebrez Breezhaler 300mcg
Inhalation Powder Hard
Capsule
Indacterol 300mcg (as maleate
389mcg)
Novartis Pharma Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1245 BRU14071378PRequip PD 24hr Prolong
Release Tablet 2mgRopinirole 2mg (as Hydrochloride) Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1246 BRU14071379PDifflam Anti-Inflammatory
Lozenges (with Anti-bacterial)
Benzydamine Hydrochloride 3mg;
Cetylpyridinium Chloride 1.33mg
Unique Pharmaceutical Laboratories,
IndiaZuellig Pharma (B) Sdn Bhd
24 July 2014 till 23 July
2019GSL
1247 BRU14071380PVfend Powder For Oral
Suspension 40mg/mlVoriconazole 40mg/ml Pfizer PGM, France Zuellig Pharma (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1248 BRU14071381P
Norditropin® Nordilet®
Solution for Injection
10mg/1.5ml
Somatropin (biosynthetic human
growth hormone) 10mg/1.5mlNovo Nordisk A/S, Denmark Medipharm Sdn Bhd
24 July 2014 till 23 July
2019POM
1249 BRU14071382PAlphagan P Ophthalmic
Solution 0.15%Brimonidine tartrate 0.15% Allergan Sales LLC, USA Medipharm Sdn Bhd
24 July 2014 till 23 July
2019POM
1250 BRU14071383PMapenem® IV Injection
500mgMeropenem 500mg (as trihydrate) Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd
24 July 2014 till 23 July
2019POM
1251 BRU14071384PCuram Powder for oral
Suspension 312.5mg/5ml
Amoxycillin 250mg (as trihydrate);
Clavulanic Acid 62.5mg (as potassium
salt)
Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd24 July 2014 till 23 July
2019POM
1252 BRU14071385P Topamax® 25 Tablet 25mg Topiramate 25mg CILAG AG, Switzerland Zuellig Pharma (B) Sdn Bhd24 July 2014 till 23 July
2019POM
1253 BRU14071386P Tussils 5 Lozenge 5mgDextromethorphan Hydrobromide
5mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd24 July 2014 till 23 July
2019POM
1254 BRU14071387P Kivexa Tablets 600mg/300mgAbacavir 600mg (as sulfate);
Lamivudine 300mgGlaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1255 BRU14071388PLucrin® depot 3.75mg
InjectionLeuproprelin acetate 3.75mg
Takeda Pharmaceutical Company
Limited, JapanZuellig Pharma (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1256 BRU14071389PLucrin® depot 11.25mg
InjectionLeuproprelin acetate 11.25mg
Takeda Pharmaceutical Company
Limited, Japan Zuellig Pharma (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1257 BRU14071390P Axcel Diclofenac-50 Tablet Diclofenac Sodium 50mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd24 July 2014 till 23 July
2019POM
BDMCA/RMP/0317 Page 82 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1258 BRU14071391P Lamictal Tablet 50mg Lamotrigine 50mgGlaxosmithkline Pharmaceuticals SA,
PolandZuellig Pharma (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1259 BRU14071392PInfasurf® (Calfactant)
Intrathecal Suspension
Per ml - Phospholipids 35mg (including
26mg phosphatidycholine of which
16mg is disaturated
phosphatidycholine) and 0.7mg
protein (incuding 0.26mg of SP-
B0Calfactant [Calf lung Surfactant
Extract -CLSE]
ONY Inc., USA K-Seri Pharma24 July 2014 till 23 July
2019POM
1260 BRU14071393NP Kaolin & Pectin MixturePer 5ml - Kaolin Light BP 1g; Pectin
50mg
Drug Houses of Australia Private
Limited, SingaporeG & H Trading Company
24 July 2014 till 23 July
2019P
1261 BRU14071394PDuodart 0.5mg/0.4mg
CapsulesDutasteride 0.5mg; Tamsulosin 0.4mg
Catalent Germany Schorndorf GmbH,
GermanyZuellig Pharma (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1262 BRU14071395PAxcel Metronidazole-400
TabletMetronidazole 400mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd
24 July 2014 till 23 July
2019POM
1263 BRU14071396P Cefazolin Sandoz 1g Vial Cefazolin 1g Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd24 July 2014 till 23 July
2019POM
1264
BRU14071397PS1 &
BRU14071397PS2 &
BRU14071397PS3
MABTHERA Concentrate for
Solution for Infusion
500mg/50ml
Rituximab 500mg/50ml
Genetech Inc., USA (S1); F. Hoffmann-
LA Roche Ltd, Switzerland (S2); and
Roche Diagnostics GmbH, Germany
(S3)
Zuellig Pharma (B) Sdn Bhd24 July 2014 till 23 July
2019POM
1265 BRU14071398P Lamitor 100mg Tablet Lamotrigine 100mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd24 July 2014 till 23 July
2019POM
1266 BRU14071399PVigamox® Ophthalmic
Solution 0.5% Moxifloxacin 0.5% (as hydrochloride) Alcon Laboratories, Inc., USA Hongkiat Trading & Co
24 July 2014 till 23 July
2019POM
1267 BRU14071400P Cementin Tablet 200mg Cimetidene 200mgDrug Houses of Australia Pte Ltd,
SingaporeG & H Trading Company
24 July 2014 till 23 July
2019POM
1268BRU14071401PS1 &
BRU14071401PS2Voltaren Emulgel 1%
Diclofenac diethylamine 1.16g/100g
(equivalent to 1g of diclofenac sodium)
Novartis Pharma Produktions GmbH,
Germany (S1 for pack size 50g) &
Novartis Consumer Health SA,
Switzerland (S2 for pack size 20g)
Zuellig Pharma (B) Sdn Bhd24 July 2014 till 23 July
2019GSL
1269 BRU14071402PImexa Film-Coated Tablet
250mgAzithromycin 250mg (as dihydrate)
Xepa-Soul Pattinson (M) Sdn Bhd
MalaysiaHongkiat Trading & Co
24 July 2014 till 23 July
2019POM
1270 BRU14071403P Cymbalta Capsule 60mg Duloxetine 60mg (as hydrochloride)Eli Lilly and Co., USA & Lilly del Caibe
Inc, Puerto RicoZuellig Pharma (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1271 BRU14071404P Beanamine Expectorant Per 5ml - Diphenhydramine BP 10mg;
Ammonium Chloride BP 120mg)
Beacons Pharmaceuticals, Pte ltd,
SingaporeHongkiat Trading & Co
24 July 2014 till 23 July
2019POM
1272 BRU14071405P Setrof Tablet 50mg Sertraline 50mg Hovid Bhd, Malaysia G & H Trading Company24 July 2014 till 23 July
2019POM
1273 BRU14071406P Dimenate Tablet 50mg Dimenhydrinate BP 50mgDrug Houses of Australia Private
Limited, SingaporeG & H Trading Company
24 July 2014 till 23 July
2019
POM (5 x 20 x
10's; 1000's)
BDMCA/RMP/0317 Page 83 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1274 BRU14071407P Dhatifen Tablet 1mgKetotifen 1mg (as hydrogen fumarate
1.38mg)
Drug Houses of Australia Private
Limited, SingaporeG & H Trading Company
24 July 2014 till 23 July
2019POM
1275 BRU14071408P Melashine Cream 4% Hydroquinone 40mg/gY.S.P. Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1276 BRU14071409P Asumalife Syrup 1.38mg/5mlPer 5ml - Ketotifen 1mg (as hydrogen
fumarate 1.38mg)
Y.S.P. Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1277 BRU14071410P Lovastin Tablet 20mg Lovastatin 20mgY.S.P. Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1278 BRU14071411P Requip tablet 0.25mg Ropinirole 0.25mg (as Hydrochloride) Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd24 July 2014 till 23 July
2019POM
1279 BRU14071412NP Zoben Tablet 200mg Albendazole 200mgPharmaniaga Manufacturing Berhad,
MalaysiaG & H Trading Company
24 July 2014 till 23 July
2019P (10 x 10's)
1280 BRU14071413P Clamentin Injection 600mg
Amoxycillin 500mg (as sodium);
Clavulanic Acid 0.1g (as Clavulanate
potassium)
Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan, R.O.C.Asterix United (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1281 BRU14071414P Garbose Tablet 50mg Acarbose 50mgY.S.P. Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd
24 July 2014 till 23 July
2019POM
1282 BRU14071415P Dexamethasone 4mg Tablet Dexamethasone 4mgBeacons Pharmaceuticals, Pte ltd,
SingaporeHongkiat Trading & Co
24 July 2014 till 23 July
2019POM
1283BRU14081416PS1;
BRU14081416PS2Sevorane Inhalation Liquid Sevoflurane 100%v/v
Aesica Queensborough Ltd, UK (S1);
Abbvie S.R.L, Italy (S2)Zuellig Pharma (B) Sdn Bhd
30 August 2014 till 29
August 2019POM
1284 BRU14081417P Emend Tri-Pack CapsuleEach capsule either contains
Aprepitant 80mg or 125mgMerck Sharp & Dohme Corp. Australia Zuellig Pharma (B) Sdn Bhd
30 August 2014 till 29
August 2019POM
1285 BRU14081418P Protopic Ointment 0.1%Tacrolimus (as Tacrolimus
monohydrate) 0.1% Astellas Pharma Tech Co., Ltd., Japan Zuellig Pharma (B) Sdn Bhd
30 August 2014 till 29
August 2019POM
1286BRU14081419PS1 &
BRU14081419PS2
Exforge HCT 10/160/12.5mg
Film-coated tablet
Amlodipine 10mg (as besylate);
Valsartan 160mg; Hydrochlorothiazide
12.5mg
Novartis Pharma Stein AG,
Switzerland (S1) & Novartis
Farmaceutica SA, Barcelona, Spain
(S2)
Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
1287BRU14081420PS1 &
BRU14081420PS2
Exforge HCT 10/160/25mg
Film-coated tablet
Amlodipine 10mg (as besylate);
Valsartan 160mg; Hydrochlorothiazide
25mg
Novartis Pharma Stein AG,
Switzerland (S1) & Novartis
Farmaceutica SA, Barcelona, Spain
(S2)
Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
1288BRU14081421PS1 &
BRU14081421PS2
Exforge HCT 5/160/12.5mg
Film-coated tablet
Amlodipine 5mg (as besylate);
Valsartan 160mg; Hydrochlorothiazide
12.5mg
Novartis Pharma Stein AG,
Switzerland (S1) & Novartis
Farmaceutica SA, Barcelona, Spain
(S2)
Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
1289BRU14081422PS1 &
BRU14081422PS2
Exforge HCT 5/160/25mg Film-
coated tablet
Amlodipine 5mg (as besylate);
Valsartan 160mg; Hydrochlorothiazide
25mg
Novartis Pharma Stein AG,
Switzerland (S1) & Novartis
Farmaceutica SA, Barcelona, Spain
(S2)
Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
BDMCA/RMP/0317 Page 84 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1290BRU14081423PS1 &
BRU14081423PS2
Exforge HCT 10/320/25mg
Film-coated tablet
Amlodipine 10mg (as besylate);
Valsartan 320mg; Hydrochlorothiazide
25mg
Novartis Pharma Stein AG,
Switzerland (S1) & Novartis
Farmaceutica SA, Barcelona, Spain
(S2)
Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
1291 BRU14081424PLuveris for Injection 75IU/Vial
(Revised Formula)
Lutropin alfa 75IU (Recombinant
Human Lutenising Hormone)Merck Serono SA., Switzerland G & H Trading Company
30 August 2014 till 29
August 2019POM
1292 BRU14081425PLipanthyl Penta 145 Film-
Coated tabletFenofibrate 145mg Recipharm Fontaine, France Zuellig Pharma (B) Sdn Bhd
30 August 2014 till 29
August 2019POM
1293 BRU14081426P Dexamethasone Tablet 0.5mg Dexamethasone 0.5mgBeacons Pharmaceuticals, Pte ltd,
SingaporeHongkiat Trading & Co
30 August 2014 till 29
August 2019POM
1294 BRU14081427P FlixotideTM Evohaler 50mcg Fluticasone Propionate 50mcg GlaxoWellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
1295BRU14081428PS1
BRU14081428PS2JanumetTM Tablet
50mg/850mg
Sitagliptin 50mg (as phosphate);
Metformin HCl 850mg
Patheon Puerto Rico, Inc., Manati, PR
00674, Puerto Rico (S1) & Aesica
Queensborough Limited, UK (S2)
Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
1296BRU14081429PS1
BRU14081429PS2JanumetTM Tablet
50mg/500mg
Sitagliptin 50mg (as phosphate);
Metformin HCl 500mg
Patheon Puerto Rico, Inc., Manati, PR
00674, Puerto Rico (S1) & Aesica
Queensborough Limited, UK (S2)
Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
1297BRU14081430PS1
BRU14081430PS2JanumetTM Tablet
50mg/1000mg
Sitagliptin 50mg (as phosphate);
Metformin HCl 1000mg
Patheon Puerto Rico Inc., Manati,
Puerto Rico (S1) & Aesica
Queensborough Limited, UK (S2)
Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
1298 BRU14081431P Napan Capsules 250mg Mefenamic Acid 250mgDrug Houses of Australia Private
Limited, SingaporeG & H Trading Company
30 August 2014 till 29
August 2019POM
1299
BRU14081432PS1 &
BRU14081432PS2 &
BRU14081432PS3
Mabthera Concentrate for
Solution for Infusion
100mg/10ml
Rituximab 100mg/10ml
Genetech Inc., USA; F Hoffmann-LA
Roche Ltd, Switzerland; Roche
Diagnostics GmbH, Germany
Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
1300 BRU14081433P EraxisTM 100mg for Injection Anidulafungin 100mg/vial Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
1301 BRU14081434P Moxiclav 1G Tablet
Amoxycillin 875mg (as sodium);
Clavulanic Acid 125mg (as Clavulanate
potassium)
Medochemie Ltd., Cyprus Hongkiat Trading & Co30 August 2014 till 29
August 2019POM
1302 BRU14081435P Lisdene 10mg tablet Lisinopril 10mg (as dihydrate) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
1303 BRU14081436P Dilatrend Tablet 25mg Carvedilol 25mg Roche S.p.A., Italy Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
1304 BRU14081437P Dilatrend Tablet 12.5mg Carvedilol 12.5mg Roche S.p.A., Italy Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
1305 BRU14081438P Dilatrend Tablet 6.25mg Carvedilol 6.25mg Roche S.p.A., Italy Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
BDMCA/RMP/0317 Page 85 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1306 BRU14081439P Carzepin 200mg Tablet Carbamazepine 200mg Hovid Bhd, Malaysia G & H Trading Company30 August 2014 till 29
August 2019POM
1307 BRU14081440PNaphcon-A Sterile Ophthalmic
Solution
Naphazoline Hydrochloride 0025%;
Pheniramine maleate 0.3%S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co
30 August 2014 till 29
August 2019P
1308 BRU14081441P Lamictal 100mg Tablet Lamotrigine 100mgGlaxosmithkline Pharmaceuticals SA,
PolandZuellig Pharma (B) Sdn Bhd
30 August 2014 till 29
August 2019POM
1309 BRU14081442P Axcel Loratadine Tablet Loratadine 10mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 August 2014 till 29
August 2019P
1310 BRU14081443NP Neuroxel Tablet
Thiamine Mononitrate 100mg;
Pyridoxine HCl 200mg; Cynocobalamin
200mcg
Drug Houses of Australia Private
Limited, SingaporeG & H Trading Company
30 August 2014 till 29
August 2019P
1311 BRU14081444P Rhiniramine SR Tablet 6mg Dexhlorpheniramine Maleate 6mgDrug Houses of Australia Private
Limited, SingaporeG & H Trading Company
30 August 2014 till 29
August 2019POM
1312 BRU14081445P
Buventhol Easyhaler
100mcg/dose inhalation
powder
Salbutamol sulphate
100mcg/actuation (delivered dose
90mcg/actuation)
Orion Corporation, Finland Hongkiat Trading & Co30 August 2014 till 29
August 2019POM
1313 BRU14081446P
Buventhol Easyhaler
200mcg/dose inhalation
powder
Salbutamol sulphate
300mcg/actuation (delivered dose
180mcg/actuation)
Orion Corporation, Finland Hongkiat Trading & Co30 August 2014 till 29
August 2019POM
1314 BRU14081447P Axcel Cefaclor-125 Suspension Cefaclor 125mg (as monohydrate) Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 August 2014 till 29
August 2019POM
1315 BRU14081448P Dextramine Tablet 2mg Dexchlorpheniramine 2mgBiosis Pharmaceuticals Sdn Bhd.,
MalaysiaK-Seri Pharma Sdn Bhd
30 August 2014 till 29
August 2019POM
1316 BRU14081449PMircera Pre-filled Syringe
75mcg/0.3ml
Methoxy polyethylene glycol-epoetin
Beta 75mcg/0.3mlRoche Diagnostics GmbH, Germany Zuellig Pharma (B) Sdn Bhd
30 August 2014 till 29
August 2019POM
1317 BRU14081450P Creobic (New Formula) Cream Clotrimazole 1%w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 August 2014 till 29
August 2019GSL
1318 BRU14081451P Axcel Cetirizine Syrup Cetirizine Dihydrochloride 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 August 2014 till 29
August 2019P
1319 BRU14081452P Tinacort CreamMiconazole nitrate 2%w/w;
Hydrocortisone 1.0% w/wHovid Bhd, Malaysia G & H Trading Company
30 August 2014 till 29
August 2019POM
1320 BRU14081453P Sunex Cough Syrup
Per 5ml - Diphenhydramine HCl 14mg;
Ammonium chloride 135mg; Sodium/
Trisodium citrate 57.5mg
Sunward Pharmaceutical Sdn Bhd
MalaysiaG & H Trading Company
30 August 2014 till 29
August 2019POM
1321 BRU14081454P Loxof Tablets 500mg Levofloxacin 500mgRanbaxy (Malaysia) Sdn. Bhd.,
MalaysiaG & H Trading Company
30 August 2014 till 29
August 2019POM
1322 BRU14081455PProluton Depot 250mg
InjectionHydroxyprogesterone Caproate 250mg
Bayer Pharma AG, Leverkeusen,
GermanyZuellig Pharma (B) Sdn Bhd
30 August 2014 till 29
August 2019POM
1323 BRU14081456P Nurofen for Children Ibuprofen 100mg/5ml
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019P
1324 BRU14081457P Axcel Sabutamol Syrup Salbutamol 2mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 August 2014 till 29
August 2019POM
BDMCA/RMP/0317 Page 86 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1325 BRU14081458P Doxymycin Capsule 100mg Doxycycline Hydrochloride 100mgY.S.P. Industries (M) Sdn Bhd
MalaysiaAsterix United (B) Sdn Bhd
30 August 2014 till 29
August 2019POM
1326 BRU14081459PClamentin Powder for Syrup
31.25mg/ml
Per ml - Amoxycillin 25mg (as
trihydrate); Clavulanic acid 6.25mg (as
potassium salt)
Yung Shin Pharmaceutical Ind. Co.,
Ltd, Taiwan, R.O.C.Asterix United (B) Sdn Bhd
30 August 2014 till 29
August 2019POM
1327 BRU14081460PClarimycin Film Coated Tablet
500mgClarithromycin 500mg
Y.S.P. Industries (M) Sdn Bhd
MalaysiaAsterix United (B) Sdn Bhd
30 August 2014 till 29
August 2019POM
1328 BRU14081461NP Mentar ShampooCoal Tar solution 9% v/v; Menthol 1%
w/w
HOE Pharmaceuticals Sdn Bhd
MalaysiaG & H Trading Company
30 August 2014 till 29
August 2019GSL
1329 BRU14081462NP Menzza CreamMethyl Salicylate 25%w/w; Menthol
5%w/w
Hoe Pharmaceuticals Sdn Bhd
MalaysiaG & H Trading Company
30 August 2014 till 29
August 2019GSL
1330 BRU14081463P Difnal OD Tablet 100mgMethyl Salicylate 25%w/w; Menthol
5%w/w
Ranbaxy (Malaysia) Sdn. Bhd.,
MalaysiaG & H Trading Company
30 August 2014 till 29
August 2019POM
1331BRU14081464PS1;
BRU14081464PS2
Humulin N Injection 100IU/ml
(Catridges)
Human Insulin 100IU/ml (recombinant
DNA oigin)
Lilly France SAS, France (S1); Eli Lily
Italia S.p.A., Sesto Fiorentino,
(FI) Italy (S2)Zuellig Pharma (B) Sdn Bhd
30 August 2014 till 29
August 2019POM
1332 BRU14081465NP Bayer Aspirin Tablet 500mg Aspirin 500mg (Acetylsalicylic acid)
PT Bayer Indonesia,
Indonesia Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019GSL
1333 BRU14081466P Doridone Tablet 10mg Domperidone 10mgDrug Houses of Australia Private
Limited, SingaporeG & H Trading Company
30 August 2014 till 29
August 2019POM
1334 BRU14081467PTobradex® Eye Drops
Suspension
Tobramycin 0.3%; Dexamethasone
0.1%S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co
30 August 2014 till 29
August 2019POM
1335 BRU14081468NPFerrous Fumarate Tablet
200mg
Ferrous fumarate 200mg (equivalent
to 65mg of elemental iron)
Drug Houses of Australia Private
Limited, SingaporeG & H Trading Company
30 August 2014 till 29
August 2019GSL
1336 BRU14081469P Tamoxifen 20mg Tablet Tamoxifen 20mg (as citrate 30.4mg)Teva Pharmaceutical Industries Ltd,
IsraelK-Seri Pharma Sdn Bhd
30 August 2014 till 29
August 2019POM
1337 BRU14081470PRotaqor 10mg film-coated
tabletAtorvastatin 10mg (as calcium) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd
30 August 2014 till 29
August 2019POM
1338BRU14081471P;
BRU14081471PS2Zoral 200 tablet 200mg Acyclovir USP 200mg
Drug Houses of Australia Private
Limited, Singapore; PT Actavis
Indonesia, Indonesia (S2)
G & H Trading Company30 August 2014 till 29
August 2019POM
1339 BRU14081472P Vamlo Tablets 5mg Amlodipine 5mg (as besilate)Ranbaxy (Malaysia) Sdn. Bhd.,
MalaysiaG & H Trading Company
30 August 2014 till 29
August 2019POM
1340 BRU14081473P Clofenac SR Tablet Diclofenac Sodium 100mg Hovid Bhd, Malaysia G & H Trading Company30 August 2014 till 29
August 2019POM
1341 BRU14081474P Strepsils Max Plus Lozenges
2,4 Dichlorobenzyl alcohol 1.2mg;
amymetacresol 0.6mg; Lignocaine
Hydrochloride 10mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019GSL
1342 BRU14081475P Cera-Scalp OintmentCoal Tar solution 12% w/w; Salicylic
acid 2%; Sulphur 4% w/w
HOE Pharmaceuticals Sdn Bhd
MalaysiaG & H Trading Company
30 August 2014 till 29
August 2019GSL
BDMCA/RMP/0317 Page 87 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1343 BRU14081476P Lisdene 20mg Tablet Lisinopril 20mg (as dihydrate) Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd30 August 2014 till 29
August 2019POM
1344BRU14091477P Suprane Inhalation Liquid
100%
Desflurane 100% Baxter Healthcare Corporation, USAZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1345BRU14091478P Buclizine Tablet 25mg Buclizine 25mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 September 2014 till 29
September 2019
P
1346BRU14091479PS1;
BRU14091479PS2
Cetrotide Injection 0.25mg Cetrotrelix 0.25mg (as Acetate) Baxter Oncology GmbH, Germany
(S1); Pierre Fabre Medicament
Production, France (S2)
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1347BRU14091480P Mivacron Injection 10mg/5ml Mivacurium Chloride 10mg/5ml GlaxoSmithKline Manufacturing
S.p.A., ItalyZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1348BRU14091481P Xolair Powder and Solvent for
Solution for Injection
Omalizumab 150mg Novartis Pharma Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1349BRU14091482P Frusemide Tablet 40mg Furosemide 40mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1350BRU14091483P Penegesic 50 Capsule Tramadol HCl 50mg Hovid Bhd, Malaysia G & H Trading Company 30 September 2014 till 29
September 2019
POM
1351BRU14091486P Crinone Progestrone Vaginal
Gel 8%
Progestrone 8% Fleet Laboratories Ltd, United
Kingdom
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1352BRU14091487NP Pinetarsol Gel Tar 1.6% EGO Pharmaceuticals Pty Ltd.,
AustraliaZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
GSL
1353BRU14091488P Defungo (Vaginal Tablet 0.1g) Clotrimazole 0.1g Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 30 September 2014 till 29
September 2019
POM
1354BRU14091489P Magrilan 20mg capsules Fluoxetine 20mg (as Hydrochloride) Medochemie Ltd., Cyprus Hongkiat Trading & Co 30 September 2014 till 29
September 2019
POM
1355BRU14091490P Trileptal 600mg Film-coated
Tablets
Oxcarbazepine 600mg Novartis Farma S.p.A., ItalyZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1356BRU14091491P Binozyt 500mg film-coated
tablet
Azithromycin 500mg (as monohydrate) Novartis (Bangladesh) Ltd.,
BangladeshZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1357BRU14091492P Nurofen 400 Caplet Ibuprofen 400mg Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd30 September 2014 till 29
September 2019
P
1358BRU14091493P Recormon Pre-filled Syringe
30,000Iu/0.6ml
Epoetin beta 30,000 IU/0.6ml Roche Diagnostics GmbH, GermanyZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1359BRU14091494P Eprex® 10000 Prefilled
Syringes 10,000iu/1ml
Epoetin alfa 10,000 IU/ml Cilag AG, SwitzerlandZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1360BRU14091495P Metformin Tablet 250mg Metformin Hydrochloride 250mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1361
BRU14091496PS1;
BRU14091496PS2
Hydrochlorothiazide Tablet
50mg
Hydrochlorothiazide BP 50mg Drug Houses of Australia Private
Limited, Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)
G & H Trading Company 30 September 2014 till 29
September 2019
POM
BDMCA/RMP/0317 Page 88 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1362
BRU14091497PS1;
BRU14091497PS2
Famotin Tablet 20mg Famotidine USP 20mg Drug Houses of Australia Private
Limited, Singapore (S1); PT Actavis
Indonesia, Jakarta, Indonesia (S2)
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1363BRU14091498P Difenac Tablet 25mg Diclofenac (as Sodium) 25mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1364BRU14091501P Yucomy cream Ketoconazole 20g/g Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1365BRU14091502P Loradine Tablet 10mg Loratadine 10mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
p
1366BRU14091503P Rasitol Tablet 40mg Furosemide 40mg YSP Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1367BRU14091504P Betoptic S Eye Drops Betaxolol 2.5mg/ml (as Hydrochloride
2.8mg)
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 30 September 2014 till 29
September 2019
POM
1368BRU14091505P Nurofen Caplet 200mg Ibuprofen 200mg Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Zuellig Pharma (B) Sdn Bhd30 September 2014 till 29
September 2019
p
1369BRU14091506P Rhiniramine Syrup 2mg/5ml Dexchlorpheniramine maleate BP
2mg/5ml
Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1370BRU14091507P Afinitor 2.5mg Tablet Everolimus 2.5mg Novartis Pharma Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1371BRU14091508P Glucagen® 1mg Powder and
Solvent for Solution for
Injection
Glucagon 1mg (as hydrochloride) Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 30 September 2014 till 29
September 2019
POM
1372BRU14091509P Chloramine Syrup 4mg/5ml Chlorpheniramine maleate 4mg/5ml Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 30 September 2014 till 29
September 2019
p
1373BRU14091510P Difnal-K Tablet 50mg Diclofenac Potassium 50mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 30 September 2014 till 29
September 2019
POM
1374BRU14091511NP 0.9% Sodium Chloride
Injection, B.P. (10ml)
Sodium Chloride 0.9% B. Braun Medical Industries Sdn Bhd
Malaysia
Hongkiat Trading & Co 30 September 2014 till 29
September 2019
GSL
1375
BRU14091512NP Compound Sodium Lactate
Intravenous Infusion B.P.
(Hartmann's Solution)
Per 1000ml contains: Sodium Chloride
6g; Sodium Lactate solution 6.24g
(50% w/w); Potassium Chloride 0.40g;
Calcium Chloride dehydrate 0.27g
B. Braun Medical Industries Sdn Bhd
Malaysia
Hongkiat Trading & Co 30 September 2014 till 29
September 2019
POM
1376BRU14091513P HBVaxPro® 5mcg/0.5ml
Injection
Hepatitis B surface Antigen
5mcg/0.5ml
Merck Sharp & Dohme Corp., West
Point, Pensylvania, USAZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1377BRU14091514P HBVaxPro® 10mcg/1.0ml
Injection
Hepatitis B surface Antigen
10mcg/1.0ml
Merck Sharp & Dohme Corp., West
Point, Pensylvania, USAZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1378BRU14091515P HBvaxPro® 40mcg/1.0ml
Injection
Hepatitis B surface Antigen
40mcg/1.0ml
Merck Sharp & Dohme Corp., USAZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1379BRU14091516P Emthexate 2.5mg Tablet Methotrexate 2.5mg (as disodium) Teva Czech Industries S.R.O., Czech
Republic
K-Seri Pharma Sdn Bhd 30 September 2014 till 29
September 2019
POM
BDMCA/RMP/0317 Page 89 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1380BRU14091517P Stalevo 125/31.25/200mg film-
coated tablet
Levodopa 125mg, Carbidopa 31.25mg,
Entacapone 200mg
Baxter Bioscience Manufacturing Sarl,
SwitzerlandZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1381BRU14091518P Axcel Dextromethorphan-30
Syrup
Dextromethorphan Hydrobromide
30mg/5ml
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 30 September 2014 till 29
September 2019
POM
1382BRU14091519P Afinitor 5mg Tablet Everolimus 5mg Novartis Pharma Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1383
BRU14091520P Renacid K8 Each 1 Litre contains: Sodium Chloride
161.43g, Potassium Chloride 5.49g,
Calcium Chloride 2H2O 6.77g,
Magnesium Chloride 6H2O 3.74g,
Glacial acetic acid 8.85g
Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 30 September 2014 till 29
September 2019
POM
1384BRU14091521P Ospexin 500mg Film-coated
Tablets
Cefalexin 500mg (as monohydrate) Sandoz GmbH, AustriaZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1385BRU14091522PS1 &
BRU14091522PS2
Androcur Tablet 50mg Cyproterone acetate 50mg Delpharm Lille SAS, FranceZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1386BRU14091523NP Poviderm Ointment Povidone Iodine 10% w/w Hoe Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 30 September 2014 till 29
September 2019
GSL
1387BRU14091524P Melaquin Cream 4% w/w Hydroquinone 40mg/g Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
P
1388BRU14091525P Calumid 50mg Film-coated Bicalutamide 50mg Gedeon Richter Plc., Hungary K-Seri Pharma Sdn Bhd 30 September 2014 till 29
September 2019
POM
1389BRU14091526P Glucomet Tablet 500mg Metformin Hydrochloride 500mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1390BRU14091527P Quemox Tablet 500mg Mebendazole 500mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
P
1391BRU14091528P Campto 300mg/15ml Injection Irinotecan Hydrochloride Trihydrate
300mg/15ml
Pfizer (Perth) Pty Ltd, AustraliaZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1392BRU14091529NP Strepsils Cool Lozenges Each lozenge contains: Amymetacresol
0.6mg, 2,4-Dichlorobezyl alcohol
1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 30 September 2014 till 29
September 2019
GSL
1393BRU14091530NP Strepsils Sugar Free Lemon
Lozenges
Each lozenge contains: Amymetacresol
0.6mg, 2,4-Dichlorobezyl alcohol
1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 30 September 2014 till 29
September 2019
GSL
1394BRU14091531P Nordette 21 Tablet Levonogestrel 150mcg, Ethinyl
estradiol 30mcg
Haupt Pharma Munster GmbH.,
GermanyZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1395
BRU14091532P Primocal Solution Per Litre: Sodium 140mmol,
Magnesium 0.5mmol, Lactate 3mmol,
Bicarbonate 32mmol, Chloride
106mmol
Gambro Dasco S.p.A., Italy Medicorp Sdn Bhd 30 September 2014 till 29
September 2019
POM
1396BRU14091533P Ansures Extended Release
Tablet 500mg
Metformin Hydrochloride 500mg Siu Guan Chem, Ind. Co. Ltd., Taiwan G & H Trading Company 30 September 2014 till 29
September 2019
POM
BDMCA/RMP/0317 Page 90 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1397BRU14091534P Deplatt Tablet 75mg Clopidogrel 75mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 30 September 2014 till 29
September 2019
POM
1398
BRU14091535NP Livolin Forte Softgel Capsules Per Capsule: Lecithin [PC 35%]
857.13mg (equivalent to
Phosphatidylcholine 300mg), Di-alpha-
tocopheryl acetate 10mg, Thiamine
mononitrate 10mg, Riboflavin 6mg,
Pyridoxine hydrochloride 10mg,
Vitamin B12 0.1% WS 15mg
(equivalent to Vitamin B12 0.015mg),
Nicotinamide 30mg.
Mega Lifesciences Public Company
Limited, Thailand
Hongkiat Trading & Co 30 September 2014 till 29
September 2019
GSL
1399BRU14091536NP Pharmaniaga Aqueous Cream White Soft Paraffin 15%, Emulsifying
Wax 9%, Liquid Paraffin 6%
Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 30 September 2014 till 29
September 2019
GSL
1400BRU14091537P Synagis 100mg Powder and
Solvent for Solution for
Injection
Palivizumab 100mg Boehringer Ingelheim Pharma KG,
Germany Zuellig Pharma (B) Sdn Bhd30 September 2014 till 29
September 2019
POM
1401BRU14091538P Clamentin Injection 1.2g Amoxicillin 1g (as sodium), Clavulanic
acid 0.2g (as clavulanate potassium)
Yung Shin Phamaceutical Ind. Co Ltd,
Taiwan, ROC
Asterix United (B) Sdn Bhd 30 September 2014 till 29
September 2019
POM
1402
BRU14091539P ZmaxTM Extended-Release
Granules for Oral Suspension
2g
Azithromycin 2g (as dihydrate) Pfizer Pharmaceuticals LLC Vega Baja,
Puerto Rico Zuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1403BRU14091540P Eturion 10mg Film Coated
Tablet
Atorvastatin 10mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceuticals LLC, Puerto
RicoZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1404BRU14091541P Eturion 20mg Film Coated
Tablet
Atorvastatin 20mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceuticals LLC, Puerto
Rico, USAZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1405BRU14091542P Eturion 40mg Film Coated
Tablet
Atorvastatin 40mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceutical LLC, Puerto
Rico, USAZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1406BRU14091543P Eturion 80mg Film Coated
Tablet
Atorvastatin 80mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceuticals LLC, Puerto
Rico, USAZuellig Pharma (B) Sdn Bhd
30 September 2014 till 29
September 2019
POM
1407BRU14111544P (vial) EYLEA Solution for Injection
(vial)
Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc., New
York, USAZuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
POM
1408BRU14111545P EYLEA Solution for Injection
(pre-filled syringe)
Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc., New
York, USA Zuellig Pharma (B) Sdn Bhd01 November 2014 till 31
October 2019
POM
1409BRU14111546P Binocrit Solution for Injection
2000 IU/ml in Pre-filled
Syringe
Epoetin Alfa 2,000 IU/ml IDT Biologika GmbH, GermanyZuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
POM
1410BRU14111547P Binocrit Solution for Injection
4000 IU/0.4ml in Pre-filled
Syringe
Epoetin Alfa 4,000IU/0.4ml IDT Biologika GmbH, GermanyZuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
POM
BDMCA/RMP/0317 Page 91 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1411BRU14111548P Nootropil Infusion 12g/60ml Piracetam 12g/60ml Aesica Pharmaceuticals SRL., Italy
Zuellig Pharma (B) Sdn Bhd01 November 2014 till 31
October 2019
POM
1412BRU14111549P Nootropil Injection 1g/5ml Piracetam 1g/5ml UCB Pharma S.P.A., Italy
Zuellig Pharma (B) Sdn Bhd01 November 2014 till 31
October 2019
POM
1413BRU14111550P Advagraf Prolonged Release
Hard Capsule 0.5mg
Tacrolimus 0.5mg (as monohydrate) Astellas Ireland Co Ltd., IrelandZuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
POM
1414BRU14111551P Advagraf Prolonged Release
Hard Capsule 1mg
Tacrolimus 1mg (as monohydrate) Astellas Ireland Co Ltd., IrelandZuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
POM
1415BRU14111552P Advagraf Prolonged Release
Hard Capsule 5mg
Tacrolimus 5mg (as monohydrate) Astellas Ireland Co Ltd., IrelandZuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
POM
1416BRU14111553P Dynastat Powder and Solvent
for Solution for Injection 40mg
Parecoxib (as Sodium) 40mg Pharmacia & Upjohn Company, USAZuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
POM
1417BRU14111554P Invanz Powder for Injection
1g/vial
Ertapenem 1g (as Sodium 1.046g) Laboratories Merck Sharp & Dohme-
Chibret, FranceZuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
POM
1418
BRU14111555PS1;
BRU14111555PS2
Humalog Mix25 100 units/ml
Kwikpen
Insulin Lispro 100IU/ml [In the
proportion of 25% Insulin Lisporo &
75% Insulin Lispro Protamine
Suspension (rDNA origin)
Lilly France S.A.S., France (S1); Eli Lilly
Italia S.p.A., Sesto Fiorentino, (FI)
Italy (S2)
(repacker - Eli Lilly And Company,
USA) & Eli Lilly Italia S.p.A., Sesto
Fiorentino, (FI) Italy;
Zuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
POM
1419BRU14111556P Brozil Capsule 300mg Gemfibrozil 300mg YSP Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1420BRU14111557NP Menzza Ice Gel Menthol 4% w/w Hoe Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 01 November 2014 till 31
October 2019
GSL
1421BRU14111558P Trileptal Film-coated Tablets
300mg
Oxcarbazepine 300mg Novartis Pharma S.p.A., ItalyZuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
POM
1422BRU14111559NP Alka Seltzer Lemon Acetylsalicylic Acid 324mg; Sodium
Bicarbonate 1.737g; Citric Acid
(anhydrous) 1.223g.
Bayer de Mexico SA De CV, MexicoZuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
GSL
1423BRU14111560P Voren Plus Gel Diclofenac sodium 10mg/g (1%w/w) Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 01 November 2014 till 31
October 2019
GSL
1424BRU14111561NP Strepsils Original Lozenges Amylmetacresol 0.6mg; 2,4-
Dichlorobenzyl Alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 01 November 2014 till 31
October 2019
GSL
1425
BRU14111562NP Strepsils Orange with Vitamin
C Lozenges
Amylmetacresol 0.6mg; 2,4-
Dichlorobenzyl Alcohol 1.2mg;
Ascorbic Acid 33.5mg; Sodium
Ascorbate 74.9mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 01 November 2014 till 31
October 2019
GSL
1426BRU14111563P Loette 21 Tablet Levonorgetsrel 100mcg;
ethinylestradiol 20mcg
Haupt Pharma Munster GmbH.,
GermanyZuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
POM
1427BRU14111564P Axcel Promethazine-5 Syrup Promethazine Hydrochloride 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 01 November 2014 till 31
October 2019
POM
BDMCA/RMP/0317 Page 92 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1428BRU14111565P NIMBEXTM Injection 2mg/ml
(5ml)
Cisatracurium Besylate 10mg/5ml GLaxoSmithKline Manufacturing
S.p.A., ItalyZuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
POM
1429BRU14111566P Aggrastat Concentrate for
Infusion 0.25mg/ml
Tirofibon 0.25mg/ml (as hydrochloride
monohydrate 0.281mg/ml)
DSM Pharmaceuticals Inc., USA &
Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd01 November 2014 till 31
October 2019
POM
1430BRU14111567P Promezine Syrup 1mg/ml Promethazine Hydrochloride 1mg/ml Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1431BRU14111568P Cephanmycin Capsules 500mg Cephalexin 500mg Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan
Asterix United (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1432BRU14111569P Ferinject® 50mg Iron/ml
solution for Injection/Infusion
Iron 50mg/ml (as ferric
carboxymaltose)
BIPSO GmbH, Germany K-Seri Pharma Sdn Bhd 01 November 2014 till 31
October 2019
POM
1433BRU14111570P Olmetec Plus 20/12.5mg Film-
coated Tablet
Olmesartan Medoxomil 20mg;
Hydrochlorothiazide 12.5mg
Daiichi Sankyo Europe GmbH,
GermanyZuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
POM
1434BRU14111571P Norfox 400 Tablet Norfloxacin 400mg The United Drug (1996) Co. Ltd.,
Thailand
K-Seri Pharma Sdn Bhd 01 November 2014 till 31
October 2019
POM
1435
BRU14111572P Rotateq® Rotavirus Vaccine,
Live, Oral, Pentavalent
Human-bovine Rotavirus G1 ≥ 2.2 x
106IU; Human-bovine Rotavirus G2 ≥
2.8 x 106IU; Human-bovine Rotavirus
G3 ≥ 2.2 x 106IU; Human-bovine
Rotavirus G4 ≥ 2.0 x 106IU; Human-
bovine Rotavirus P1 ≥ 2.3 x 106IU
Merck Sharp & Dohme Corp., USA
Zuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
POM
1436BRU14111573P Eliquis Film-coated Tablets
2.5mg
Apixaban 2.5mg Bristol-Myers Squibb Manufacturing
Company, Puerto Rico, USA Zuellig Pharma (B) Sdn Bhd01 November 2014 till 31
October 2019
POM
1437BRU14111574P Tren Injection 100mg/ml Tranexamic Acid 100mg/ml Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan
Asterix United (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
1438BRU14111575P Ryzodeg Flex Touch 100
units/ml
Per 1 ml: Insulin Degludec 70%; Insulin
Aspart 30%
Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 01 November 2014 till 31
October 2019
POM
1439BRU14111576NP Folic Acid Tablets 5mg Folic Acid BP 5mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 01 November 2014 till 31
October 2019
GSL
1440BRU14111577NP Dettol Antiseptic Germicide
Liquid
Parachlorometaxylenol 4.8%w/v Pt. Reckitt Benckiser Indonesia Syarikat Aliaa Sdn Bhd 01 November 2014 till 31
October 2019
GSL
1441BRU14111578P Tolanz Tablet 5mg Olanzapine 5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 01 November 2014 till 31
October 2019
POM
1442BRU14111579P Tolanz Tablet 10mg Olanzapine 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 01 November 2014 till 31
October 2019
POM
1443BRU14111580P Somin Tablet 2mg Dexchlorpheniramine Maleate 2mg Y.S.P Industries (M) Sdn. Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 01 November 2014 till 31
October 2019
POM
BDMCA/RMP/0317 Page 93 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1444
BRU14111581P Vaminolact Solution Per 100ml: L-Alanine 6.3 g; L-Arginine
4.1g; L-Aspartic Acid 4.1g; L-Cysteine /
L-Cystine 1g; L-Glutamic Acid 7.1g;
Glycine (Amino Acetic Acid) 2.1g; L-
Histidine 2.1g; L-Isoleucine3.1g; L-
Leucine 7g; L-Lysine 5.6g; L-Methionine
1.3g; L-Phenylalanine 2.7g; L-Proline
5.6g; L-Serine 3.8g; Taurine 300mg; L-
Threonine 3.6g; L-Tryptophan 1.4g; L-
Tyrosine 500mg; L-Valine 3.6g
Fresenius Kabi Austria GmbH, Austria
Zuellig Pharma (B) Sdn Bhd
01 November 2014 till 31
October 2019
P
1445BRU14111582P Covinace Tablet 4mg Perindopril Ter-butylamine 4mg Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 01 November 2014 till 31
October 2019
POM
1446
BRU14111583NP Oralite Natural Oral
Rehydration Salts
Per 4.92g sachet: Glucose anhydrous
3.24g; Sodium Chloride 0.624g;
Trisodium citrate dihydrate 0.696g;
Potassium Chloride 0.36g
Royce Pharma Manufacturing Sdn.
Bhd., Malaysia
SWL Biomed Sales &
Services
01 November 2014 till 31
October 2019
GSL
1447BRU14111584NP Panamol Forte Suspension
250mg/5ml
Paracetamol 250mg/5ml Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 01 November 2014 till 31
October 2019
P (3.8L)
1448
BRU14111585PS1,
BRU14111585PS2,
BRU14111585PS3,
BRU14111585PS4
Avastin 100mg/4ml Bevacizumab 25mg/ml (Humanised
anti-VEGF monoclonal antibody)
Genentech Inc., USA (S1); F-Hoffman-
La Roche Ltd, Basel, Switzerland (S2);
Roche Diagnostics GmbH, Manheim,
Germany (S3); F Hoffmann-La Roche
Ltd, Kaiseraugst, Switzerland (S4)
Hongkiat Trading & Co 01 November 2014 till 31
October 2019
POM
1449BRU14111586P Zyvox 20mg/ml Granules For
Oral Suspension
Linezolid 100mg/5ml Pfizer Pharmaceuticals LLC, USAZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1450BRU14111587P Axcel Cimetidine-400 Tablet Cimetidine 400mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1451
BRU14111588PS1;
BRU14111588PS2
Humulin R Injection 100IU/ml
(Catridges)
Human Insulin (Recombinant DNA
origin) 100IU/ml
Lilly France SAS, France (S1); Eli Lily
Italia S.p.A., Sesto Fiorentino,
(FI) Italy (S2)Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1452BRU14111589P Resolor film-coated tablet
1mg
Prucalopride 1mg (as succinate
1.321mg)
Janssen-Cilag SpA., ItalyZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1453BRU14111590NP Maltofer Fol Chewable Tablet Iron (III) 100mg (as hydroxide-
polymaltose Complex); Folic acid
0.35mg
Vifor S.A., Switzerland & Iberfar-
Industria Farmacetutica S.A.,
Barcelona, Portugal
Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1454BRU14111591P Pristiq 50mg Extended-
Release Tablets
Desvenlafaxine 50mg (as succinate
75.87mg)
Pfizer Ireland Pharmaceuticals,
IrelandZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
BDMCA/RMP/0317 Page 94 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1455BRU14111592P ElIquis 5mg Film-coated Tablet Apixaban 5mg Bristol-Myers Squibb Manufacturing
Company, Puerto Rico, USA Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020
POM
1456BRU14111593P Pulin Film-coated Tablet 10mg Metoclopramide HCl 10mg ( as Mono
HCl 10.5mg)
Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1457BRU14111594P Rocephin for Injection 1g IV Ceftriaxone 1g F.Hoffmann-La Roche Ltd., Basel,
SwitzerlandZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1458BRU14111595P Advate 250 IU Powder and
Solvent for Solution for
Injection
Octocog alfa (recombinant human
coagulation factor VIII) 250 IU
Baxalta Manufacturing Sarl,
Switzerland Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020
POM
1459BRU14111596P Glibenclamide Tablet 5mg Glibenclamide 5mg Drug Houses of Australia Private
Limited, Singapore
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1460BRU14111597NP 0.45% Sodium Chloride and
5% Dextrose Intravenous
Infusion B.P
Per 1L - Sodium Chloride 4.5g; Glucose
anhdyrous 50g (as monohydrate 55g)
B.Braun Medical Industries Sdn Bhd.,
Malaysia
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1461
BRU14111598P Gonal-F 1050IU/1.75ml
(77mcg/1.75ml) Powder and
Solution for Injection
Per Pen (1.75ml) - Follitropin Alfa
1050IU (equivalent 77mcg) [Per ml of
solution contains 600IU Follitropin alfa
~ 44mcg]
Merck Serono S.p.A., Italy & Merck
Serono S.A., Switzerland
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1462BRU14111599P Cardiol Tablet 6.25mg Carvedilol 6.25mg Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1463BRU14111600P Cardiol Tablet 25mg Carvedilol 25mg Yung Shin Pharmaceutical Ind. Co.
Ltd., Taiwan
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1464BRU14111601NP T3 Pimple Gel Rescorcinol 2% w/w HOE Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1465
BRU14111602NP BSS® (Balanced Salt Solution)
Sterile Irrigation Solution
Per 1L - Sodium Chloride 6.4g;
Potassium Chloride 0.75g; Calcium
Chloride, dehydrate 0.48; Magnesium
Chloride, hexahydrate 0.3; Sodium
Citrate, dehydrate 1.7; Sodium
acetate, trihydrate 3.9
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 19 May 2015 till 18 May
2020
GSL
1466BRU14111603P Domper Tablet 10mg Domperidone 10mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1467BRU14111604NP Davmorid film-coated Tablet Diosmin 450mg; Hesperidin 50mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1468BRU14111605P Zimmex Tablet 10mg Simvastatin 10mg Silom Medical Co. Ltd., Thailand Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1469BRU14111606NP Strepsils Warm Lozenges Amymetacresol 0.6mg; 2,4-
Dichlorobenzyl Alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1470BRU14111607NP Sodium Bicarbonate 8.4% w/v
Injection (10ml glass ampoule)
Sodium Bicarbonate 8.4%w/v
(84mg/ml)
Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/0317 Page 95 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1471BRU14111608P Binozyt 200mg/5ml Powder
for Oral Suspension
Azithromycin 200mg Sandoz S.R.L., RomaniaZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1472
BRU14111609NP Renacid K4 Per Litre - Sodium Chloride BP 161.43g;
Potassium Chloride BP 5.49g; Calcium
Chloride 2H2O BP 9.75g; Magnesium
Chloride 6H2O BP 3.74g; Gacial Acetic
Acid BP 8.85g
Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 19 May 2015 till 18 May
2020
POM
1473BRU14111610NP Renacarb K2 Per Litre - Sodium Chloride BP 30.5g;
Sodium Bicarbonate BP 66.0g
Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 19 May 2015 till 18 May
2020
POM
1474BRU14111611P Kogrel 75mg Film Coated
Tablet
Clopidogrel 75mg (as bisulfate
97.875mg)
Sandoz Private Limited, Mumbai,
IndiaZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1475BRU14111612P Chloramine Tablet 4mg Chlorpheniramine maleate 4mg Beacons Pharmaceuticals, Pte ltd,
Singapore
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
P
1476BRU14111613NP Tolnaderm Cream 1% Tolnaftate 1% w/w HOE Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1477BRU14111614P Medoflucon Capsule 50mg Fluconazole 50mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1478BRU14111615P Curam 156.25mg/5ml Powder
for Oral Suspension
Per 5ml - Amoxycillin 125mg (as
trihydrate); Clavulanic acid 31.25mg
Sandoz GmbH, AustriaZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1479BRU14111617P Nospan Tablet 30mg Dextromethorphan Hydrobromide
30mg
Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1480BRU14111618NP Strepsils Extra Strong Lozenge Amymetacresol 0.6mg; 2,4-
Dichlorobenzyl Alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1481BRU14111619P Crixan Tablet 250mg Clarithromycin 250mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1482BRU14111620P Storvas Tablet 20mg Atorvastatin 20mg (as calcium) Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1483BRU14111621P Brozil Film coated Tablet
600mg
Gemfibrozil 600mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1484BRU14111622NP Panadol Extra Tablets Paracetamol 500mg; Caffeine 65mg Sterling Drug (Malaya) Sdn Bhd,
Malaysia
Kingston Beverage &
Creamery Sdn Bhd
19 May 2015 till 18 May
2020
GSL (2 x 6's)
1485BRU14111623P Botox (Botulinium Toxin, Type
A) Injection 100units/vial
Clostridium Botulinum Toxin Type A
Purified Neurotoxin Complex
100Units/vial
Allergan Pharmaceuticals Ireland,
Ireland
Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
1486BRU14111624P Botox (Botulinium Toxin, Type
A) Injection 50units/vial
Clostridium Botulinum Toxin Type A
Purified Neurotoxin Complex
50Units/vial
Allergan Pharmaceuticals Ireland,
Ireland
Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/0317 Page 96 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1487BRU14111625P Botox (Botulinium Toxin, Type
A) Injection 200units/vial
Clostridium Botulinum Toxin Type A
Purified Neurotoxin Complex
200Units/vial
Allergan Pharmaceuticals Ireland,
Ireland
Medipharm Sdn Bhd 19 May 2015 till 18 May
2020
POM
1488BRU14111626P Lovir Tablets 200mg Acyclovir 200mg Ranbaxy (Malaysia) Sdn. Bhd.,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1489BRU14111627P Cellcept Tablet 500mg Mycophenolate mofetil 500mg Roche S.p.A., Italy Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1490BRU14111628NP 0.45% Sodium Chloride
Intravenous Infusion B.P
Sodium Chloride 0.45% B.Braun Medical Industries Sdn Bhd.,
Malaysia
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
P
1491BRU14111629P Xorimax 500mg Coated Tablet Cefuroxime 500mg (as axetil) PenCef Pharma GmbH, Germany
Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020
POM
1492BRU14111630P Xorimax 250mg Coated Tablet Cefuroxime 250mg (as axetil) PenCef Pharma GmbH, Germany
Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020
POM
1493
BRU14111631P Peditrace Concentrate for
Solution for Infusion
Per 1ml - Zinc Chloride 521mcg;
Copper Chloride 2H2O 53.7mcg;
Manganese Chloride 4H2O 3.60mcg;
Sodium Selenite anhydrous 4.38mcg;
Sodium Fluoride 126mcg; Potassium
Iodide 1.31mcg
Fresenius Kabo Nolge AS, Norway
Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1494BRU14111632P Axcel Orlistat 120 Tablet Orlistat 120mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1495BRU14111633P Pharmaniaga Salbutamol
Respirator Solution 0.5%w/v
Salbutamol 0.5%w/v (as sulphate) Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1496BRU14111634P Epimate 50mg Tablet Topiramate 50mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1497BRU14111635NP Aqueous Cream Emulsifying wax 9.0%w/w; White Soft
Paraffin 15% w/w; Liquid Paraffin 6.0%
w/w
Hoe Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1498BRU14111636P Melomet Cream 0.1% w/w Mometasone Furoate 0.1% w/w Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1499BRU14111637NP Poro Suspension 250mg/5ml Paracetamol 250mg/5ml Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
GSL ( 60 mL &
100 mL)
1500BRU14111638P Primovists 0.25mmol/ml
solution for injection
Gadoxetic acid, Sodium 0.25mmol/ml Bayer Pharma AG, Leverkeusen,
GermanyZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1501BRU14111639P Servidipine 30mg Film-coated
Tablets
Nifedipine 30mg Lek Pharmaceuticals D.D., SloveniaZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1502BRU14111640P Servidipine 60mg Film-coated
Tablets
Nifedipine 60mg Lek Pharmaceuticals D.D., SloveniaZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1503BRU14111641NP Hoemal Oral Suspension Paracetamol 250mg/5ml (5%) Hoe Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
GSL (60mL)
BDMCA/RMP/0317 Page 97 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1504BRU14111642P Manace Injection 5mg/ml
(Haloperidol 5mg/ml)
Haloperidol 5mg/ml Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1505BRU14111643NP Woodward's Gripe Water
(Alcohol Free)
Per 5ml - Terpeneless Dill Seed Oil
2.3mg; Sodium Bicarbonate 52.5mg
IDS Manufacturing Sdn Bhd, Malaysia Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1506BRU14111644P Buston Injection 20mg/ml Hyoscine-N-butylbromide 20mg/ml Siu Guan Chem, Ind. Co. Ltd., Taiwan G & H Trading Company 19 May 2015 till 18 May
2020
POM
1507BRU14111645NP Tolnaderm lotion 1.0%w/v Tolnaftate 1% w/w Hoe Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1508
BRU14111646NP Oralite Orange Oral
Rehydration Salts
Per 4.95g - Glucose anhydrous 3.24g;
Sodium Chloride 0.624g; Trisodium
citrate dihydrate 0.696g; Potassium
Chloride 0.36g
Royce Pharma Manufacturing Sdn.
Bhd., Malaysia
SWL Biomed Sales &
Services
19 May 2015 till 18 May
2020
GSL
1509BRU14111647P Vesyca Film Coated Tablet
150mg
Ranitidine 150mg (as hydrochloride) Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1510BRU14111648P Pharmaniaga Cetirizine 10mg
tablet
Cetirizine 10mg (as hydrochloride) Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
P
1511BRU14111649P Hovid Lipiduce-20 Tablet Atorvastatin 20mg (as calcium) Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
1512BRU14111650P Invokana Film-coated Tablet
100mg
Canagliflozin 100mg (as hemihydrate) Janssen-Cilag SpAZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1513BRU14111651P Axcel Chlorpheniramine-2
Syrup
Chlorpheniramine maleate 2mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
P
1514BRU14111652P Binozyt Film-Coated Tablet
250mg
Azithromycin 250mg (as monohydrate) Novartis (Bangladesh) Ltd.,
BangladeshZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1515BRU14111653P Asmol 2 tablet Salbutamol 2mg (as sulphate) Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1516BRU14111654NP Paracetamol Kabi Solution for
infusion 10mg/ml
Paracetamol 10mg/ml i) Fresenius Kabi Germany AB ii)
Fresenius Kabi AustriaZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1517BRU14111655P Risperdal Solution 1mg/ml Risperidone 1mg/ml Janssen Pharmaceutical NV, Belgium
Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020
POM
1518BRU14111656P Visudyne Injection Verteprofin 15mg Par Sterile Products LLC, United
StatesZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1519 BRU14121661P Kastipron Tablet 375mgS-Carboxymethylcysteine 375mg Y.S.P. Industries (M) Sdn Bhd
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1520 BRU14121662P Ipolipid Capsules 300mgGemfibrozil 300mg Medochemic Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1521 BRU14121663PCuram 625mg Film-coated
TabletAmoxicillin 500mg; Clavulanic acid as
potassium salt 125mg
Sandoz GmbH, AustriaZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1522 BRU14121664P Vesyca Injection 25mg/mlRanitidine (as hydrochloride) 25mg/ml Yung Shin Pharmaceutical Ind. Co.,
Ltd, Taiwan, R.O.C.
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1523 BRU14121666P Amoxicap 500 CapsuleAmoxicillin (as trihydrate 574mg)
500mg
Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/0317 Page 98 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1524 BRU14121667NP Wintosal Cream Methyl salicylate 15.0% w/w; Menthol
2.3% w/w and Cmaphor 4.0% w/w
Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1525 BRU14121668NP50% Glucose Intravenous
Infusion B.P.
Glucose monohydrate (550.00g) eq. to
anhydrous glucose 500.0g/1000ml
B.Braun Medical Industries Sdn Bhd.,
Malaysia
Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1526 BRU14121669P Visanne 2mg TabletDienogest 2mg Bayer Weimar GmbH und. Co. KG.,
Dobereinesrtr. 20, D-99427, Weimar,
Germany
Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020
POM
1527 BRU14121670P Medoflucon Capsule 150mgFluconazole 150mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1528 BRU14121671P Topamax 100 Tablets 100mgTopiramate 100mg Cilag AG, Switzerland
Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020
POM
1529 BRU14121672NPDuratears Ocular Lubricant
Ointment
Mineral Oil 30.0mg/g, Anhydrous liquid
lanolin 30.0mg/g and white petrolatum
q.s. ad 1g
S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 19 May 2015 till 18 May
2020
GSL
1530 BRU14121673PEprex® 40,000 Prefilled
Syringes 40,000iu/1ml
Epoetin alfa 40,000IU/ml Vetter Pharma-Fertigung GmbH & Co.
KG, Germany; Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020
POM
1531 BRU14121674P Milosec Capsule 20mgOmeprazole 20mg The United Drug (1966) Co. Ltd.,
Thailand
Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1532 BRU14121675P Ziagen Oral SolutionAbacavir (as Abacavir Sulfate) 20mg/ml GlaxoSmithKline Inc., Canada
Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020
POM
1533 BRU14121676P Minulet 21 TabletGestodene 75mcg; ethinylestradiol
30mcg
Haupt Pharma Munster GmbH.,
GermanyZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1534 BRU14121677PPataday Olopatadine
Ophthalmic Solution 0.2%
Olopatadine hydrochloride 2.22mg (eq.
to Olopatadine 2mg (0.2%)
Alcon Laboratories, Inc., USA Hongkiat Trading & Co 19 May 2015 till 18 May
2020
POM
1535 BRU14121678P Provironum Tablet 25mgMesterolone 25mg Schering Do Brasil Quimica e
Farmaceutica Ltda., San Paulo-SP,
Brazil
Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020
POM
1536 BRU14121681NPStrepsils Strawberry Sugar
Free ChildrenAmylmetacresol 0.6mg; 2.4-
Dichlorobenzyl Alcohol 1.2mg
Reckitt Benckiser Healthcare
International Limited, UK
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1537 BRU14121682PAxcel Sodium Fusidate 250
TabletSodium Fusidate (Micronized) 250mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1538 BRU14121683P Pencor 1mg tabletDoxazosin Mesylate (eq. to Doxazosin
1mg)
Unison Laboratories Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1539 BRU14121684P Pencor 2mg tabletDoxazosin Mesylate (eq. to Doxazosin
2mg)
Unison Laboratories Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1540 BRU14121685P Pencor 4 TabletDoxazosin Mesylate (eq. to Doxazosin
4mg)
Unison Laboratories Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1541 BRU14121686P Decan Injection 2mg/mlDexamethasone Sodium Phosphate
2.2mg (eq. to Dexamethasone
Phosphate 2mg)
Yung Shin Pharmaceutical Ind. Co.,
Ltd, Taiwan, R.O.C.
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
BDMCA/RMP/0317 Page 99 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1542 BRU14121687P Primodil-10 TabletAmlodipine Besilate 13.87mg (eq. to
Amlodipine 10mg)
Medley Pharmaceuticals Limited,
India
Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1543 BRU14121688P Cuvarlix Capsule 120mgOrlistat 120mg Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1544 BRU14121689NP Calcium Lactate 300mg tabletCalcium lactate 300mg Drug Houses of Australia Pte Ltd.,
Singapore
G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1545 BRU14121690P Seladin 500mg tabletNaproxen 500mg Y.S.P. Industries (M) Sdn Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1546 BRU14121691P Driminate 50mg SuppositoryDimenhydrinate 50mg Y.S.P. Industries (M) Sdn Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
P (10 x 10's)
1547 BRU14121692NPHurix's Panau Salap &Gatal-
Gatal Kecil
Zinc oxide 5% w/w; Menthol 1% w/w;
Salicylic Acid/2-Hydroxybenzoic acid
5% w/w & Camphor 3% w/w
Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May
2020
GSL
1548 BRU14121693NPHurix Corn Rid Solution 5%
w/wlactic Acid 5% w/v; Salicylic Acid 17%
w/v
Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May
2020
GSL
1549 BRU14121694NP Hurix Corn Solution 17%Salicylic Acid 0.17g(17%w/v) Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May
2020
GSL
1550 BRU14121695P Axcel Fungicort CreamMiconazole nitrate 2%w/w;
Hydrocortisone 1% w/w
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May
2020
POM
1551 BRU14121696P Methacid 25mg tabletIndomethacin 25mg Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 19 May 2015 till 18 May
2020
POM
1552 BRU14121697NPDettol Antiseptic Wound
Wash Spraybenzalkonium chloride 0.198% Reckitt Benckiser Healthcare (UK)
Ltd., UK
Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1553 BRU14121698PEdurant Film-Coated 25mg
tabletRilpivirine (as hydrochloride) 25mg Janssen-Cilag S.p.A., Italy
Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020
POM
1554 BRU14121699P Invokana 300mg FCTCanagliflozin 300mg (as hemihydrate) Janssen Ortho, LLC, Puerto Rico
Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020
POM
1555 BRU14121700P Amlodipine Tablet 10mgAmlodipine Tablet 10mg Jubilant Generics, Limited, India Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1556 BRU14121701P Borymycin Capsule 100mgMinocycline HCl 100mg Y.S.P., Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 19 May 2015 till 18 May
2020
POM
1557 BRU14121702NP Septi-Sol SolutionChlorhexidine Gluconate 20% Solution -
0.5% w/v; Ethanol 94% - 77% v/v
Pahang Pharmacy Sdn Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May
2020
GSL
1558 BRU14121703PAtoris Film-coated Tablet
20mgAtorvastatin (as calcium) 20mg KRKA, d.d., Slovenia K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May
2020
POM
1559 BRU14121704NPNutrilite Glucosamine HCl
Capsule 375mgGlucosamine HCl 375mg Pharmaniaga Manufacturing Berhad,
Malaysia
Amway Sdn Bhd 19 May 2015 till 18 May
2020
GSL
1560 BRU14121705P
Ultibro Breezhaler 110/50 mcg
Inhalation Powder Hard
Capsule
Indacaterol (as maleate) 110mcg (143
mcg); Glycopyrronium (as bromide)
50mcg (63 mcg)
Novartis Pharma Stein AG,
Switzerland Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020
POM
1561 BRU15011706PZyprexa Zydis
OrodispersibleTablet 5mgOlanzapine micronized 5mg Catalent UK Swindon Zydis Ltd, UK Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
BDMCA/RMP/0317 Page 100 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1562 BRU15011707PZyprexa Zydis
OrodispersibleTablet 10mgOlanzapine micronized 10mg Catalent UK Swindon Zydis Ltd, UK Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020 POM
1563 BRU15011709P Klacid MR 500mg Tablet Clarithromycin 500mg Aesica Queensborough Ltd, UK Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020POM
1564 BRU15011710P Klerimed 250mg FC Tablets Clarithromycin 250mg (as anhydrous) Medochemie Ltd., Cyprus Hongkiat Trading & Co19 May 2015 till 18 May
2020POM
1565 BRU15011711P DiSuf-B CreamFusidic acid (micronized) 2.0% w/w &
Betamethasone 0.1%w/w (as valerate)Hovid Bhd, Malaysia G & H Trading Company
19 May 2015 till 18 May
2020 POM
1566 BRU15011712NP Dhalumag Suspension
Per 5ml - Magnesium trisilicate BP
500mg, Dried Aluminium Hydroxide BP
250mg
Drug Houses of Australia Private
Limited, SingaporeG & H Trading Company
19 May 2015 till 18 May
2020 GSL
1567 BRU15011713PBinoclar® 500mg Film-coated
TabletsClarithromycin 500mg Novartis Bangladesh Ltd, Bangladesh Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1568 BRU15011714POspamox 250mcg/5ml
granules for suspension
Amoxicillin 250mg (as trihydrate
287mg) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1569 BRU15011715P Ospamox 250mg CapsuleAmoxicillin 250mg (as trihydrate
287mg) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1570 BRU15011716POspamox 500mg Film-coated
Tablet
Amoxicillin 500mg (as trihydrate
574mg)Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1571 BRU15011717P
Salofalk® 500mg Gastro-
Resistant Prolonged-Release
Granules
Mesalazine 500mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd19 May 2015 till 18 May
2020 POM
1572 BRU15011718P
Salofalk® 1000mg Gastro-
Resistant Prolonged-Release
Granules
Mesalazine 1000mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd19 May 2015 till 18 May
2020 POM
1573 BRU15011719P Vaqta® Vaccine 50U/mlHepatitis A Virus, Purified, Inactivated
50U/mlMerck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1574 BRU15011720P Vaqta® Vaccine 25U/0.5mlHepatitis A Virus, Purified, Inactivated
25U/0.5mlMerck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1575 BRU15011721P
Salofalk® 3000mg Gastro-
Resistant Prolonged-Release
Granules
Mesalazine 3g Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd19 May 2015 till 18 May
2020 POM
1576 BRU15011722P T3 Ada Gel 0.1% Adapalene 0.1%Hoe Pharmaceuticals Sdn Bhd
MalaysiaG & H Trading Company
19 May 2015 till 18 May
2020POM
1577 BRU15011723PClarimycin Film Coated Tablet
250mgClarithromycin 250mg
Y.S.P. Industries (M) Sdn Bhd
MalaysiaAsterix United (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1578 BRU15011724P Forteo Injection 20mcg/80mcl
Each ml contains 250mcg of
Teriparatide (recombinant of human
parathyroid hormone (1-34) [rhPTH (1-
34)])
Lilly France SAS, France Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020 POM
1579 BRU15011725PTorisel Concentrate for
Injection 25mg/mlTemsirolimus 25mg/ml
Pierre Fabre Medicament Production
(PFMP), FranceZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
BDMCA/RMP/0317 Page 101 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1580 BRU15011726PUrsofalk 500mg Film-coated
TabletsUrsodeoxycholic acid 500mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd
19 May 2015 till 18 May
2020POM
1581 BRU15011727P Bactigen Eye Drops 0.3%Gentamicin 0.3% (as Gentamicin
Sulphate)FDC Limited, India K-Seri Pharma Sdn Bhd
19 May 2015 till 18 May
2020POM
1582 BRU15011728PHexaxim Suspension for
Injection
Per dose (0.5ml):
Dipththeria toxoid 30 Lf (≥ 20IU),
Tetanus toxoid 10 Lf (≥ 40IU),
Bordetella pertussis antigens: Pertussis
toxoid 25µg, Filamentous
haemagglutinin 25µg, Polio Virus
(Inactivated): Type 1 (Mahoney) 40
DU, Type 2 (MEF-1) 8 DU, Type 3
(Saukett) 32 DU, Hepatitis B surface
antigen 10 µg, Haemophilus influenzae
tybe b polysaccharide
(Polyribosylribitol phosphate) . 12µg,
conjugated to Tetanus protein (PRP-T)
22-36µg
Sanofi Pasteur Marcy I’Etoile (MLE),
France; Sanofi Pasteur Val de Reuil,
France; Sanofi Pasteur SPA, Italy
Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1583 BRU15011730PBridion Solution for Injection
100mg/mlSugammadex 100mg/ml
N.V. Organon, The Netherlands;
Organon (Ireland) Ltd., Ireland;
Patheon Manufacturing Services LLC,
USA
Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020 POM
1584 BRU15011731P Serlift Tablets 100mg Setraline hydrochloride 100mgRanbaxy (Malaysia) Sdn. Bhd.,
MalaysiaG & H Trading Company
19 May 2015 till 18 May
2020POM
1585 BRU15011732NPStrepsils Soothing Honey &
Lemon
Amylmetacresol 0.6ml; 2,4-
Dichlorobenzyl alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd19 May 2015 till 18 May
2020 GSL
1586 BRU15011733NPStrepsils Max Blackcurrant
LozengeHexylresorcinol 2.4mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand) Limited,
Thailand
Syarikat Aliaa Sdn Bhd19 May 2015 till 18 May
2020 GSL
1587 BRU15011734P Implanon NXT Implant 68mg Etonogestrel N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020POM
1588BRU15011735PS1 &
BRU15011735PS2Stocrin Tablet 200mg Efavirenz 200mg
Merck Sharp & Dohme (Australia) Pte
Ltd Australia; Zhejian Huahai
Pharmaceutical Co. Ltd., China
Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020 POM
1589BRU15011736PS1 &
BRU15011736PS2Stocrin Tablet 600mg Efavirenz 600mg
Merck Sharp & Dohme (Australia) Pte
Ltd Australia; Zhejian Huahai
Pharmaceutical Co. Ltd., China
Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020 POM
1590 BRU15011737P Magnevist Injection 469mg/ml
Each ml contains 0.5mmol
gadopentetate dimeglumine (eqv. to
469.01mg gadopentetate
dimeglumine)
Bayer Pharma AG, Leverkeusen,
GermanyZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020 POM
BDMCA/RMP/0317 Page 102 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1591 BRU15011738NP Bactidol Mouthwash Hexetidine 0.1% w/vInterphill Laboratories Inc.,
PhilippinesLF Asia (Borneo) Sdn Bhd
19 May 2015 till 18 May
2020GSL
1592 BRU15011739P Nicotinell TTS 10 Nicotine 17.5mg (delivers
7mg/24hours)
LTS Lohmann Therapie-System AG,
Germany Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020GSL
1593 BRU15011740P Nicotinell TTS 20 Nicotine 35mg (delivers 14mg/24
hours)
LTS Lohmann Therapie-System AG,
GermanyZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020GSL
1594 BRU15011741P Nicotinell TTS 30 Nicotine 52.5mg (delivers 21mg/24
hours)
LTS Lohmann Therapie-System AG,
GermanyZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020GSL
1595 BRU15011742NP Natzema Eczema Relief Cream
Benzoin tincture 10mg/g; Lavender
Angustifolia Oil 5mg/g; Citrus Sinensis
Peel Oil 5mg/g
Cosmetics Manufacturer (Aust) Pty
Ltd, AustraliaBossom Buddies Enterprise
19 May 2015 till 18 May
2020 GSL
1596 BRU15011743PPharmaniaga Germacid Cream
2%Fusidic acid 2.0% w/w
Pharmaniaga Manufacturing Berhad,
MalaysiaG & H Trading Company
19 May 2015 till 18 May
2020POM
1597 BRU15011744PExtraneal Peritoneal Dialysis
Solution 75g/l (2L Ultrabag)
Each 100ml contains Icodextrin 7.5g,
Sodium Chloride 538mg,
Sodium lactate 448mg, Calcium
chloride dihydrate 25.7mg and
Magnesium Chloride Hexahydrate
5.08mg
Baxter Healthcare SA., Singapore
BranchZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1598 BRU15011745P Seladin 250mg tablet Naproxen 250mgY.S.P Industries (M) Sdn Bhd.,
MalaysiaAsterix United (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1599 BRU15011746NP Vitalipid N Adult
1ml contains: Vitamin A 330IU (as
retinoyl palmitate 99mg),
Ergocalciferol 0.5mg(»Vitamin D2
20IU), All-rac-a-Tocopherol
0.91mg(»Vitamin E 1IU),
Phytomenadione (Vitamin K1) 15mg
Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1600 BRU15011747NP Vitalipid N Infant
1ml contains: Vitamin A 230IU (as
retinoyl palmitate 69mg),
Ergocalciferol 1.0mg(»Vitamin D2
40IU), All-rac-a-Tocopherol
0.64mg(»Vitamin E 0.71IU),
Phytomenadione (Vitamin K1) 20mg
Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1601 BRU15011748P Caslot 6.25mg tablet Carvedilol 6.25mgRanbaxy (Malaysia) Sdn. Bhd.,
MalaysiaG & H Trading Company
19 May 2015 till 18 May
2020POM
1602 BRU15011749P Caslot 12.5mg tablet Carvedilol 12.5mgRanbaxy (Malaysia) Sdn. Bhd.,
MalaysiaG & H Trading Company
19 May 2015 till 18 May
2020POM
BDMCA/RMP/0317 Page 103 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1603 BRU15011750NP Prismasol BO
Each 1000ml contains (before
reconstitution): Calcium chloride
dihydrate 5.145g, Magnesium chloride
hexahydrate 2.033g, Lactic acid 5.4g,
Sodium chloride 6.45g & Sodium
bicarbonate 3.09g
Gambro Dasco S.p.A., Italy Medicorp Sdn Bhd
19 May 2015 till 18 May
2020
POM
1604 BRU15021751PKogenate FS for Injection
1000IU/vial
Antihemophilic factor (recombinant)
sucrose formulated 1000IU
Vetter Pharma-Fertigung GmbH & Co.
KG, Germany; Bayer Pharma AG,
Germany
Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020 POM
1605 BRU15021752PKogenate FS for Injection
500IU/vial
Antihemophilic factor (recombinant)
sucrose formulated 500IUBayer Healthcare LLC, United States Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020 POM
1606 BRU15021753P Dimenate Syrup 15mg/5ml Dimenhydrinate 15mg/5mlDrug Houses of Australia Private
Limited, SingaporeG & H Trading Company
19 May 2015 till 18 May
2020POM (3.8L)
1607 BRU15021754PCernevit Multivitamin Powder
for Injection
Each vial contains: Retinol palmitate
(VitaminA) 3500 IU, Cholecalciferol
(Vitamin D3) 220 IU, DL alpha
tocopherol (Vitamin E) 10.2 mg,
Ascorbic acid (Vitamin C) 125mg,
Cocarboxylase tetrahydrate (Vitamin
B1) 5.8mg, Riboflavin sodium
phosphate dehydrate (Vitamin B2)
5.67mg, Pyridoxine hydrochloride
(Vitamin B6) 5.5mg, Cyanocobalamin
(Vitamin B12) 0.006mg, Folic acid
0.414mg, Dexpanthenol 16.15mg,
Biotin 0.069mg, Nicotinamide 46mg
Baxter SA, Belgium Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1608 BRU15021755P Baneocin OintmentBacitracin Zinc 250IU/1g; Neomycin
Sulphate 5000 IU (5mg)/1g
Merck Kommanditgesellschaft Auf
Aktein & Co., Werk, AustriaZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020 POM
1609 BRU15021756POspexin 125mg/5ml granules
for oral suspensionCephalexin 125mg/5ml Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020 POM
1610 BRU15021757P
Simponi Solution for Injection
in Pre-filled Syringe
50mg/0.5ml
Golimumab 50mg/0.5ml
Baxter Pharmaceutical Solutions LLC,
USA (Repacker - Cilag AG,
Switzerland)
Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020 POM
1611 BRU15021758P Histac Tablets 150mg Ranitidine Hydrochloride 150mgRanbaxy (Malaysia) Sdn. Bhd.,
MalaysiaG & H Trading Company
19 May 2015 till 18 May
2020POM
1612 BRU15021759PBeclazone 100micrograms CFC-
Free Inhaler
Beclomethasone Dipropionate
100micrograms/metered inhalation
Norton Waterford T/A Ivax
Pharmaceuticals IrelandG & H Trading Company
19 May 2015 till 18 May
2020 POM
BDMCA/RMP/0317 Page 104 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1613BRU15021760PS1 &
BRU15021760PS2
Insulatard 100IU/ml
Suspension for Injection (vial)
1ml of suspension contain 100IU (3.5g)
of insulin
Novo Nordisk A/S, Denmark (S1);
Novo Nordisk Production SAS, France
(S2)
Medipharm Sdn Bhd19 May 2015 till 18 May
2020 POM
1614 BRU15021761P Covapril Tablet 4mg Perindopril ErbumineUpha Pharmaceutical Mfg (M) Sdn
Bhd, MalaysiaK-Seri Pharma Sdn Bhd
19 May 2015 till 18 May
2020POM
1615 BRU15021762P Axcel Amlodipine 5mg TabletAmlodipine Besylate equivalent to
Amlodipine 5mgKotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd
19 May 2015 till 18 May
2020POM
1616 BRU15021763P Neurontin Capsule 400mg Gabapentin 400mgPfizer Pharmaceuticals LLC., Puerto
RicoZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1617 BRU15021764P Miostat Intraocular Solution Carbachol 0.1mg/ml Alcon Laboratories Inc., USA Hongkiat Trading & Co19 May 2015 till 18 May
2020POM
1618 BRU15021765P NutrIflex Lipid Plus
1 unit consists of Amino Acid Solution;
Glucose Solution; Lipid Emulsion* (For
Detailed Formulation referred to
Dossier)
B.Braun Melsungen AG, Germany Hongkiat Trading & Co
19 May 2015 till 18 May
2020 POM
1619 BRU15021766PNeulastim Pre-filled Syringe
6mg/0.6mlPegfilgrastim 6mg/0.6ml F-Hoffman-La Roche Ltd., Switzerland Medipharm Sdn Bhd
19 May 2015 till 18 May
2020POM
1620 BRU15021767P Bacitrecin-N Ointment
Bacitracin Zinc 12.5mg (potency)
(Equivalent to Bacitracin Zinc 500
units); Polymyxin B Sulfate 0.83mg
(potency) (Equivalent to Polymyxin B
Sulfate 5,000 units); Neomycin Sulfate
3.5mg (potency)
Y.s.P. Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1621 BRU15021768P Exelon Patch 15Rivastigmine base 27mg / 15cm2 (In
vivo release rate 13.3mg/24h)
LTS Lohmann Therapie-Systeme AG,
GermanyZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1622 BRU15021769PZellox-II, Double Strength
Liquid Antacid
Per 10ml - Aluminium Hydroxide
800mg; Magnesium Hydroxide 800mg;
Simethicone 60mg
Hoe Pharmaceuticals Sdn Bhd
MalaysiaG & H Trading Company
19 May 2015 till 18 May
2020 GSL
1623 BRU15021770P Bonjela Gel 15g tubeCholine Salicylate 8.714% &
Cetalkonium chloride 0.01%
Reckitt Benckiser Healthcare (UK)
Ltd., UKSyarikat Aliaa Sdn Bhd
19 May 2015 till 18 May
2020GSL
1624 BRU15021771P Gilenya 0.5mg hard capsuleFingolimod 0.5mg (corresponding to
0.56mg Fingolimod Hydrochloride)
Novartis Pharma Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020 POM
1625 BRU15021772P Presolin 150 tablet Irbesartan 150mg Unison Laboratories Co. Ltd., Thailand K-Seri Pharma Sdn Bhd19 May 2015 till 18 May
2020POM
1626 BRU15021773P Presolin 300 tablet Irbesartan 300mg Unison Laboratories Co. Ltd., Thailand K-Seri Pharma Sdn Bhd19 May 2015 till 18 May
2020POM
1627 BRU15021774P Tracidol Injection 50mg/ml Tramadol Hydrochloride 50mg/mlY.S.P. Industries (M) Sdn Bhd
MalaysiaAsterix United (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1628 BRU15021775P Hurix Skin Ointment 5%w/w
Benzoic acid 5%; Sulphur 25; Salicyllic
acid 5%; Camphor 3%; Menthol 1%
w/w
Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May
2020 GSL
BDMCA/RMP/0317 Page 105 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1629 BRU15021776P Apo-Risperidone 2mg tablet Risperidone 2mg Apotex Inc, Canada Medicorp Sdn Bhd19 May 2015 till 18 May
2020POM
1630 BRU15021777P Apo-Megestrol 160mg tablet Megestrol acetate 160mg Apotex Inc, Canada Medicorp Sdn Bhd19 May 2015 till 18 May
2020POM
1631 BRU15021778P Olapine 5mg FCT Megestrol acetate 160mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020POM
1632 BRU15021779PTrajenta Duo 2.5mg/500mg
FCT tablet
Linagliptin 2.5mg; Metformin
hydrochloride 500mg
Boehringer Ingelheim GmbH and Co.
KG., GermanyHongkiat Trading & Co
19 May 2015 till 18 May
2020POM
1633 BRU15021780PTrajenta Duo 2.5mg/850mg
FCT
Linagliptin 2.5mg; Metformin
hydrochloride 850mg
Boehringer Ingelheim GmbH and Co.
KG., GermanyHongkiat Trading & Co
19 May 2015 till 18 May
2020POM
1634 BRU15021781PTrajenta Duo 2.5mg/1000mg
film-coated tablets
Linagliptin 2.5mg; Metformin
hydrochloride 1000mg
Boehringer Ingelheim GmbH and Co.
KG., GermanyHongkiat Trading & Co
19 May 2015 till 18 May
2020 POM
1635BRU15021782P;
BRU15021782PS2Humalog 100u/ml (Catridge) Insulin Lispro 100 units/ml
Lillly France, France; Eli Lilly Italia
S.p.A., Fiorentino, (FI) Italy (S2)Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020 POM
1636 BRU15021783P Acustop Cataplasma Flurbiprofen 40mg Green Cross Corporation, Korea Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020POM
1637 BRU15021784PToviaz 4mg prolonged-release
tablet
Fesoterodine fumarate equivalent to
3.1mg fesoterodine
Aesica Pharmaceuticals GmbH,
GermanyZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1638 BRU15021785PToviaz 8mg prolonged-release
tablet
Fesoterodine fumarate equivalent to
6.2mg fesoterodine
Aesica Pharmaceuticals GmbH,
GermanyZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1639 BRU15021786PGiotrif 20mg film-coated
tablets (Afatinib 20mg)Afatinib (as dimaleate) 20mg
Boehringer Ingelheim GmbH and Co.
KG., GermanyHongkiat Trading & Co
19 May 2015 till 18 May
2020POM
1640 BRU15021787PGiotrif 30mg film-coated
tablets (Afatinib 20mg)Afatinib (as dimaleate) 30mg
Boehringer Ingelheim GmbH and Co.
KG., GermanyHongkiat Trading & Co
19 May 2015 till 18 May
2020POM
1641 BRU15021788PGiotrif 40mg film-coated
tablets (Afatinib 20mg)Afatinib (as dimaleate) 40mg
Boehringer Ingelheim GmbH and Co.
KG., GermanyHongkiat Trading & Co
19 May 2015 till 18 May
2020POM
1642 BRU15021789PGiotrif 50mg film-coated
tablets (Afatinib 20mg)Afatinib (as dimaleate) 50mg
Boehringer Ingelheim GmbH and Co.
KG., GermanyHongkiat Trading & Co
19 May 2015 till 18 May
2020POM
1643 BRU15021790PMikostat oral suspension 30ml
(Nystatin 100,000 IU/ml)Nystatin 100,000 IU/ml
Gulf Pharmaceutical Industries
(Julphar), United Arab EmiratesK-Seri Pharma Sdn Bhd
19 May 2015 till 18 May
2020 POM
1644 BRU15021791PLosartan Winthrop 50mg
tabletLosartan Potassium 50mg Zentiva, a.as., Slovak Republic Medipharm Sdn Bhd
19 May 2015 till 18 May
2020POM
1645 BRU15021792PLosartan Winthrop 100mg
tabletLosartan Potassium 100mg Zentiva, a.as., Slovak Republic Medipharm Sdn Bhd
19 May 2015 till 18 May
2020POM
1646 BRU15021793PSMOFlipid 20% Emulsion for
Infusion
1000ml contain: Soya-bean oil, refined
60 g, Medium-chain triglycerides 60 g,
Olive oil, refined 50 g, Fish oil, rich in
omega-2- acids 30 g
Fresenius Kabi Austria GmbH, Austria Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
BDMCA/RMP/0317 Page 106 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1647 BRU15021794NP Aminoven 10%
Isoleucine 5.00g/L; Leucine 7.4g/L;
Lysine acetate= Lysine 9.31g/L;
Methionine 4.3g/L; Phenylalanine
5.1g/L; Threonine 4.4g/L; Tryptophan
2.0 g/L; Valine 6.2 g/L; Arginine
12.0g/L; Histidine 3.0 g/L, Alanine 14.0
g/L, Glycine 11.0 g/L; Proline 11.2 g/L;
Serine 6.5g/L; Tyrosine 0.4g/L; Taurine
1.0g/L.
Fresenius Kabi Austria GmbH, Austria Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1648 BRU15021795P Ceflour CFT 250mgCefuroxime (as Cefuroxime Axetil)
250mg
Yung Shin Pharmaceutical Ind. Co.
Ltd., Republic of ChinaAsterix United (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1649 BRU15021796PMontelair 10mg film-coated
tablet
Montelukast (as Montelukast Sodium)
10mgHovid Bhd., Malaysia G & H Trading Company
19 May 2015 till 18 May
2020POM
1650 BRU15021797P Amlibon 10mg tablet Amlodipine (as Amlodipine Besilate)
10mgLek Pharmaceuticals D.D., Solvenia Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1651 BRU15021798NP
Dianeal Low Calcium
(2.5MEq/L) Peritoneal Dialysis
Solution with 4.25% Dextrose
(2L Ultrabag)
Each 100ml contains: Dextrose
Hydrous 4.25g; Sodium Chloride
538mg; Sodium Lactate 448mg;
Calcium Chloride dihydrate 18.3mg;
and Magnesium Chloride Hexhydrate
5.08mg
Baxter Healthcare SA., Singapore
BranchZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1652 BRU15021799NP
Dianeal Low Calcium
(2.5MEq/L) Peritoneal Dialysis
Solution 2.5% Dextrose (2L
Ultrabag and 2.5L Ultrabag)
Each 100ml contains: Dextrose
Hydrous 2.5g; Sodium Chloride 538mg;
Sodium Lactate 448mg; Calcium
Chloride dihydrate 18.3mg; and
Magnesium Chloride Hexhydrate
5.08mg
Baxter Healthcare SA., Singapore
BranchZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1653 BRU15021800NP
Dianeal Low Calcium
(2.5MEq/L) Peritoneal Dialysis
Solution 1.5% Dextrose (2L
Ultrabag and 2.5L Ultrabag)
Each 100ml contains: Dextrose
Hydrous 1.5g; Sodium Chloride 538mg;
Sodium Lactate 448mg; Calcium
Chloride dihydrate 18.3mg; and
Magnesium Chloride Hexhydrate
5.08mg
Baxter Healthcare SA., Singapore
BranchZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1654 BRU15021801NP Calactate 300mg tab Calcium Lactate pentahydrate 300mg Hovid Bhd, Malaysia G & H Trading Company19 May 2015 till 18 May
2020GSL
1655 BRU15021802P Xylid 250mg tab Cefuroxime Axetil 250mgPharmaniaga Manufacturing Berhad,
MalaysiaG & H Trading Company
19 May 2015 till 18 May
2020POM
1656 BRU15021803PColospan 10mg sugar coated
tabletHyoscine Butylbromide 10mg Hovid Bhd, Malaysia G & H Trading Company
19 May 2015 till 18 May
2020POM
1657 BRU15021804P Caslot 25mg tablet Carvedilol 25mgRanbaxy (Malaysia) Sdn. Bhd.,
MalaysiaG & H Trading Company
19 May 2015 till 18 May
2020POM
1658 BRU15021805P Serenata 50mg TabletSertraline hydrochloride 56mg
equivalent to Sertraline 50mgTorrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd
19 May 2015 till 18 May
2020POM
BDMCA/RMP/0317 Page 107 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1659 BRU15021806P Gammaplex 5% w/v 2.5g Human Immunoglobulin G 2.5g/50ml Bio Product Lab, UK Medipharm Sdn Bhd19 May 2015 till 18 May
2020POM
1660 BRU15021807P Gammaplex 5% w/v 5g Human Immunoglobulin G 5g/100ml Bio Product Lab, UK Medipharm Sdn Bhd19 May 2015 till 18 May
2020POM
1661 BRU15021808P Gammaplex 5% w/v 10g Human Immunoglobulin G 10g/200ml Bio Product Lab, UK Medipharm Sdn Bhd19 May 2015 till 18 May
2020POM
1662 BRU15031809PMoxiclav Forte Dry Powder for
Oral Suspension 312.5mg/5ml
Amoxicillin (as trihydrate) 250mg &
Clavulanic acid 62.5mgMedochemie Ltd., Cyprus
Hongkiat Trading &
Company
19 May 2015 till 18 May
2020 POM
1663 BRU15031810P Moxiclav 625mg Tablets
Amoxicllin trihydrate (574mg) 500mg;
clavulanate potassium microcrystalline
cellulose (297.8mg) eq. to clavulanic
acid 125mg
Medochemie Ltd., CyprusHongkiat Trading &
Company
19 May 2015 till 18 May
2020POM
1664 BRU15031811P Zemplar Injection Paricalcitol 5mcg/ml Hospira S.p.A., Italy Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020POM
1665 BRU15031812P Lamotrix 100mg Tablets Lamotrigine 100mg Medochemie Ltd., CyprusHongkiat Trading &
Company19 May 2015 till 18 May
2020POM
1666 BRU15031813P Lamotrix 50mg Tablets Lamotrigine 50mg Medochemie Ltd., CyprusHongkiat Trading &
Company19 May 2015 till 18 May
2020POM
1667 BRU15031814PNimenrixTM (Meningococcal
polysaccharide serogroups
A,C,W-135, Y) Vaccine
MenAAH-TT-conjugate (Mean TT/PS
ratio:3) 5mcg PSA~15mcg TT, MenCAH-
TT-conjugate (Mean TT/PS ratio:3)
5mcg PSC~15mcg TT, MenW-TT-
conjugate (Mean TT/PS ratio:1.5) 5mcg
PSW~7.5mcg TT, MenY-TT-conjugate
(Mean TT/PS ratio:1.3) 5mcg
PSY~6.5mcg TT
Glaxosmithkline Biologicals s.a.,
Rixensart, Belgium; GlaxoSmithKline
Biologicals, Branch of SmithKline
Beecham Pharma GmbH & Co. KG.,
Dresden
Germany (diluent Ampoule);
Delpharm Tours, Chambray-lès-Tours
France (Diluent ampoule);
GlaxoSmithKline Biologicals SA,
Rixensart Belgium (diluent PFS);
Catalent Belgium SA, Brussels,
Belgium (diluent PFS);
GlaxoSmithKline Biologicals S.A. ,
Wavre Belgium (Additional facility for
formulation)
Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1668 BRU15031815P Cialis 2.5mg Tablet Tadalafil 2.5mg Lily del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020POM
1669 BRU15031816P Cialis 5mg Tablet Tadalafil 5mg Lily del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
BDMCA/RMP/0317 Page 108 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1670 BRU15031817P Cialis 20mg Tablet Tadalafil 20mg Lily del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020POM
1671 BRU15031818NP Tempol Tablet 500mg Paracetamol Tablet 500mg Duopharma (M) Sdn. Bhd., MalaysiaHongkiat Trading &
Company19 May 2015 till 18 May
2020P (50 x 10’s)
1672 BRU15031819PPlacta Film-coated Tablets
75mgClopidogrel (as bisulphate) 75mg Actavis Ltd., Malta G&H Trading Company
19 May 2015 till 18 May
2020POM
1673 BRU15031820PSmofKabiven Peripheral
Emulsion for Infusion
1 unit consists of Amino Acid Solution;
Glucose Solution; Lipid Emulsion (For
detailed formulation referred to
dossier)
Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020 POM
1674 BRU15031821P Ometec capsule 20mg Omeprazole 20mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn. Bhd.19 May 2015 till 18 May
2020POM
1675 BRU15031823P
ADVATE 500IU Powder and
Solvent for Solution for
Injection
Octocog alfa (recombinant human
coagulation factor VIII)
Baxalta Manufacturing Sarl,
Switzerland Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020 POM
1676 BRU15031824NP Livovid Forte Capsule
Lecithin soya bean (300mg
phosphatidyl choline) 858.0mg,
Thiamine hydrochloride (4.7mg
vitamin B1) 6mg, Riboflavin 6mg,
Pyridoxine hydrochloride (4.93mg of
vitamin B6) 6mg, Cyanocobalamin
0.006mg, Nicotinamide 30mg, dl-alpha-
tocopherol acetate 6IU
Hovid Bhd., Malaysia G&H Trading Company
19 May 2015 till 18 May
2020
GSL
1677 BRU15031825P Saizen® Liquid 12mg (8mg/ml)Somatropin 12mg/1.5ml (recombinant
human growth hormone)Merck Serono S.p.A., Italy G&H Trading Company
19 May 2015 till 18 May
2020 POM
1678 BRU15031826PSaizen® Liquid 6mg
(5.83mg/ml)
Somatropin 6mg/1.03ml (recombinant
human growth hormone)Merck Serono S.p.A., Italy G&H Trading Company
19 May 2015 till 18 May
2020 POM
1679 BRU15031827P Torpezil Tablets 10mg Donepezil hydrochloride 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn. Bhd.19 May 2015 till 18 May
2020POM
1680 BRU15031828P Torpezil Tablets 5mg Donepezil hydrochloride 5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn. Bhd.19 May 2015 till 18 May
2020POM
1681 BRU15031829NP BrevoxylTM 4% creamHydrous Benzoyl Peroxide (eq. to
benzoyl peroxide 4%)Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020GSL
1682 BRU15031830NP Gaviscon Liquid Sachet
Each 10ml contains: Sodium alginate
500mg, Sodium bicarbonate 267mg
and Calcium carbonate 160mg
Reckitt Benckiser Healthcare (UK)
Ltd., UKSyarikat Aliaa Sdn Bhd
19 May 2015 till 18 May
2020 GSL
1683 BRU15031831NPFisherman’s Friend Sugar-Free
Apple & Cinnamon LozengesMenthol 4.025mg
IDS Manufacturing Sdn. Bhd.,
Malaysia
Kingston Beverage &
Creamery Sdn. Bhd.
19 May 2015 till 18 May
2020 GSL
BDMCA/RMP/0317 Page 109 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1684 BRU15031832NPFisherman’s Friend Sugar-Free
Mandarin & Ginger LozengesMenthol 4.6mg
IDS Manufacturing Sdn. Bhd.,
Malaysia
Kingston Beverage &
Creamery Sdn. Bhd.
19 May 2015 till 18 May
2020 GSL
1685 BRU15031833NPFisherman’s Friend Sugar-Free
Lemon LozengesMenthol 4.6mg
IDS Manufacturing Sdn. Bhd.,
Malaysia
Kingston Beverage &
Creamery Sdn. Bhd.19 May 2015 till 18 May
2020GSL
1686 BRU15041834PRotaqor 20mg film-coated
tabletAtorvastatin Calcium 20mg Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1687 BRU15041835P Jakavi 20mg tabletRuxolitinib (as phosphate 26.40mg)
20mg
Novartis Pharma Stein, AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1688 BRU15041836P Jakavi 15mg tabletRuxolitinib (as phosphate 19.8mg)
15mg
Novartis Pharma Stein, AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1689 BRU15041837P Jakavi 5mg tablet Ruxolitinib (as phosphate 6.6mg) 5mgNovartis Pharma Stein, AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1690 BRU15041838PRocephin for Injection 250mg
IM
Ceftriaxone sodium (eq. to ceftriaxone
250mg/vial)F.Hoffman-La Roche Ltd., France Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1691 BRU15041839PArchifar 500mg powder for
injection/infusionMeropenem (as trihydrate) 500mg Medochemie Ltd, Cyprus Hong Kiat Trading & Co.
19 May 2015 till 18 May
2020POM
1692 BRU15041840PCiproflo 2mg/ml solution for
IV infusion
Ciprofloxacin 2mg/ml (as
hydrochloride)
Sin Guan Chem. Ind. Co. Ltd., Republic
of ChinaK-Seri Pharma Sdn. Bhd.
19 May 2015 till 18 May
2020POM
1693 BRU15041841P Omezole 20mg capsule Omeprazole 20mg Hovid Bhd., Malaysia G & H Trading Company19 May 2015 till 18 May
2020POM
1694 BRU15041842P B-Mycin cream
Betamethasone dipropionate 0.643mg
(eq. to 0.5mg betamethasone);
Gentamicin Sulfate 1mg (potency)
Y.S.P. Industries (M) Sdn. Bhd.,
MalaysiaAsterix United (B) Sdn Bhd
19 May 2015 till 18 May
2020 POM
1695 BRU15041843P Mucodin syrup 250mg/5ml Carbocysteine 250mg/5mlSunward Pharmaceutical Sdn. Bhd.,
MalaysiaG & H Trading Company
19 May 2015 till 18 May
2020P
1696 BRU15041844PPharmaniaga Loratadine
tablet 10mgLoratadine 10mg
Pharmaniaga Manufacturing Berhad,
MalaysiaG & H Trading Company
19 May 2015 till 18 May
2020
P
1697 BRU15041845P Curam 1000mg tablet
Amoxycillin 875 (as trihydrate);
clavulanic acid 125mg (as potassium
clavulanate)
Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May
2020 POM
1698 BRU15041846P Vancotex Injection 500mg Vancomycin (as hydrochloride) 500mg Fisiopharma S.r.L., Italy K-Seri Pharma Sdn. Bhd.19 May 2015 till 18 May
2020POM
1699 BRU15041847P Sunadine tablet 10mg Loratadine 10mgSunward Pharmaceutical Sdn. Bhd.,
MalaysiaG & H Trading Company
19 May 2015 till 18 May
2020
P
BDMCA/RMP/0317 Page 110 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1700 BRU15041848NPSoluvit N Powder for Solution
for Infusion
Thiamine mononitrate 3.1mg
(corresponding to vitamin B1 2.5mg);
Riboflavine sodium phosphate 4.9mg
(corresponding to vitamin B2
3.6mg);Nicotinamide 40mg; Pyridoxine
hydrochloride 4.9mg (corresponding to
vitamin B6 4.0mg); Sodium
panthothenate 16.5mg (corresponding
to pantothenic acid 15.0mg); Sodium
ascorbate 113mg (corresponding to
Vitamin C 100mg); Biotin 60mcg; Folic
acid 0.40mg; cyanocobalamin 5.0mcg
Sino Swed Pharmaceutical Corp. Ltd.,
ChinaZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020
POM
1701 BRU15041849NP Folic acid 5mg tablet Folic acid 5mgSunward Pharmaceutical Sdn. Bhd.,
MalaysiaG & H Trading Company
19 May 2015 till 18 May
2020P
1702 BRU15041850P Estelle-35 tabletCyproterone acetate 2mg;
Ethinylestradiol 0.03mg
Douglas Manufacturing Limited, New
ZealandG & H Trading Company
19 May 2015 till 18 May
2020POM
1703 BRU15041851NPCetomacragol emulsifying
ointment
Cetomacragol emulsifying wax 30%
w/w; liquid paraffin 20%; white soft
paraffin 50%
Hovid Bhd., Malaysia G & H Trading Company19 May 2015 till 18 May
2020 GSL
1704BRU15041852PS1/
BRU15041852PS2
Glucophage® XR 1000mg
Extended-release tablet
Metformin (as hydrochloride 1000mg)
780mg
1. Merck Sante SAS, France;
2. Merck KGaA, GermanyZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020POM
1705 BRU15041853P Duofilm LiquidSalicylic acid 16.7% w/w; lactic acid
16.7%Stiefel Labs (Ireland) Ltd., Ireland Zuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020P
1706 BRU15041854NPVoluven Solution for Infusion
6%
Per 1000ml: Poly (O-2-hydroxyethyl)
starch 60.0g; sodium chloride 9.00g
Frensius Kabi Deutschland GmbH,
GermanyZuellig Pharma (B) Sdn Bhd
19 May 2015 till 18 May
2020 POM
1707 BRU15041855NP Iris eye dropsHydroxypropyl methylcellulose 3mg;
dextran 70 1mg
Sam Chun Dang Pharm Co Ltd, South
KoreaMedipharm Sdn Bhd
19 May 2015 till 18 May
2020GSL
1708 BRU15041856POnzapin film-coated tablet
5mgOlanzapine 5mg Actavis Ltd., Malta G & H Trading Company
19 May 2015 till 18 May
2020POM
1709 BRU15041857POnzapin film-coated tablet
10mgOlanzapine 10mg Actavis Ltd., Malta G & H Trading Company
19 May 2015 till 18 May
2020POM
1710 BRU15041858NPFisherman’s friend aniseed
lozengesMenthol 5.75mg Lofthouse of Fleetwood Limited, UK
Kingston Beverage &
Creamery Sdn Bhd19 May 2015 till 18 May
2020GSL
1711 BRU15041859NPFisherman’s Friend Sugar Free
Mint LozengesMenthol 3.45mg Lofthouse of Fleetwood Limited, UK
Kingston Beverage &
Creamery Sdn Bhd19 May 2015 till 18 May
2020GSL
1712 BRU15041860NP
Fisherman’s Friend Sugar Free
Cherry Lozenges With
Menthol 6.9mg
Menthol 6.9mg Lofthouse of Fleetwood Limited, UKKingston Beverage &
Creamery Sdn Bhd
19 May 2015 till 18 May
2020 GSL
BDMCA/RMP/0317 Page 111 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1713 BRU15041861NPChlorHex 5% Concentrate
Solution
Chlorhexidine gluconate 5% w/v;
isopropylaocohol 3.15% w/vPahang Pharmacy Sdn Bhd, Malaysia G & H Trading Company
19 May 2015 till 18 May
2020 GSL
1714 BRU15041862P Salmax CR tablet 4mg Salbutamol sulphate 4mgUpha Pharmaceuticals Sdn Bhd,
MalaysiaHongkiat Trading & Co
19 May 2015 till 18 May
2020POM
1715BRU15051863NP SP Pharma Paracetamol
Tablets 500mg
Paracetamol 500mg Simpor Pharma Sendirian Berhad,
Brunei Darussalam
Simpor Pharma Sendirian
Berhad19 May 2015 till 18 May
2020 P (200’s)
1716
BRU15051864NP Addamel™ N Concentrate for
Infusion
1 mL contains: Chromic chloride 6 H2O
5.33 µg; Copper chloride 2 H2O 340
µg; Ferric chloride 6 H2O 540 µg;
Manganese chloride 4 H2O 99 µg;
Potassium iodide 16.6 µg; Sodium
Fresenius Kabi Norge AS, Norway Zuellig Pharma (B) Sdn Bhd28 July 2015 till 27 July
2020
POM
1717BRU15051865NP
Dettol Moisturing Formula
Antiseptic Cream
Triclosan 0.3%; Chloroxylenol 0.3%;
Edetic acid 0.2%
Reckitt Benckiser Healthcare (UK)
Ltd., UKSyarikat Aliaa Sdn Bhd
28 July 2015 till 27 July
2020 GSL
1718BRU15051866P
Dophilin Tablets 2mg Doxazosin (as mesylate) 2mgTaiwan Biotech Co. Ltd., Taiwan
R.O.C.K-Seri Pharma Sdn Bhd
28 July 2015 till 27 July
2020 POM
1719
BRU15051867NP Kabiven Peripheral Emulsion
for Infusion 1000ml of the mixture contain:
Purified soybean oil 35g; Glucose
(anhydrous) 68g; Alanine 3.3g;
Arginine 2.4g; Aspartic acid 0.71g;
Phenylalanine 1.6g; Glutamic acid 1.2g;
Glycine 1.6g; Histidine 1.4g; Isoleucine
1.2g; Leucine 1.6g; Lysine 1.9g;
Methionine 1.2g; Proline 1.4g; Serine
0.94g; Threonine 1.2g; Tryptophan
0.40g; Tyrosine 0.05g; Valine 1.5g;
Sodium glycerophosphate (anhydrous)
1.0g; Calcium chloride 0.15g;
Potassium chloride 1.2g; Magnesium
sulphate 0.33g; Sodium acetate 1.0g
Fresenius Kabi AB, Uppsala, Sweden Zuellig Pharma (B) Sdn Bhd28 July 2015 till 27 July
2020
POM
BDMCA/RMP/0317 Page 112 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1720
BRU15051868NP Kabiven Emulsion for Infusion1000ml of the mixture contain:
Purified soybean oil 39g; Glucose
(anhydrous) 97g; Alanine 4.7g;
Arginine 3.3g; Aspartic acid 0.99g;
Phenylalanine 2.3g; Glutamic acid 1.6g;
Glycine 2.3g; Histidine 2.0g; Isoleucine
1.6g; Leucine 2.3g; Lysine 2.6g;
Methionine 1.6g; Proline 2.0g; Serine
1.3g; Threonine 1.6g; Tryptophan
0.56g; Tyrosine 0.07g; Valine 2.1g;
Sodium glycerophosphate (anhydrous)
1.5g; Calcium chloride 0.22g;
Potassium chloride 1.7g; Magnesium
sulphate 0.47g; Sodium acetate 1.4g
Fresenius Kabi AB, Uppsala, Sweden Zuellig Pharma (B) Sdn Bhd28 July 2015 till 27 July
2020
POM
1721BRU15051869P
Dopatab M250 Tablet Methyldopa 250mg Hovid Bhd., Malaysia G & H Trading Company28 July 2015 till 27 July
2020POM
1722BRU15051870P
Fenagesic Tablet 250mg Mefenamic acid 250mgSunward Pharmaceutical Pte Ltd.,
SingaporeG & H Trading Company
28 July 2015 till 27 July
2020POM
1723BRU15051871P
Metta SR Tablets 500mg Metformin Hydrochloride USP 500mgTorrent Pharmaceuticals Ltd., Indrad,
IndiaK-Seri Pharma Sdn Bhd
28 July 2015 till 27 July
2020POM
1724BRU15051872P
Diamitex Tablet 80mg Gliclazide 80mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd28 July 2015 till 27 July
2020POM
1725BRU15051873NP
Calamine Lotion Calamine BP 15% w/vRoyce Pharma Manufacturing Sdn
Bhd, Malaysia
SWL Biomed Sales &
Services
28 July 2015 till 27 July
2020 GSL
1726BRU15051874NP
Fisherman’s Friend Original
Lozenges
Menthol 10.35mg; Eucalyptus oil
1.73mgLofthouse of Fleetwood Limited, UK
Kingston beverage &
Creamary Sdn Bhd
28 July 2015 till 27 July
2020 GSL
1727BRU15051875NP
Fisherman’s Friend Mint
Lozenges
Menthol 4.6mg; Peppermint oil
11.270mgLofthouse of Fleetwood Limited, UK
Kingston beverage &
Creamary Sdn Bhd
28 July 2015 till 27 July
2020 GSL
1728BRU15051876NP
Fisherman’s Friend Sugar Free
Original LozengesMenthol 9.2mg IDS Manufacturing Sdn Bhd, Malaysia
Kingston beverage &
Creamary Sdn Bhd
28 July 2015 till 27 July
2020 GSL
1729
BRU15051877P
Progyluton Tablet
Estradiol Valerate (in brown tablet)
2mg; Estradiol Valerate (in white
tablet) 2mg; Norgestrel (in brown
tablet) 0.5mg
Bayer Weimar GmbH und Co. KG.,
GermanyZuellig Pharma (B) Sdn Bhd
28 July 2015 till 27 July
2020POM
1730BRU15051878P
Loratyn-10 Loratadine 10mg Hovid Bhd., Malaysia G & H Trading Company28 July 2015 till 27 July
2020POM (100's); P
(20's)
1731BRU15051879P
Candazole V Single Dose
Cream 10% w/wClotrimazole 10% w/w
HOE Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Company
28 July 2015 till 27 July
2020 POM
1732BRU15061880P Keppra® Oral Solution
100mg/ml
Levetiracetam 10mg/ml NextPharma SAS., FranceZuellig Pharma (B) Sdn Bhd
28 July 2015 till 27 July
2020
POM
BDMCA/RMP/0317 Page 113 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1733
BRU15061881P Norditrophin Nordilet
Inejction 5mg/1.5ml Pre-filled
Pen, Solution for Injection
Somatropin (rDNA) 3.3mg/ml Nove Nordisk A/A, Denmark Medipharm Sdn Bhd 28 July 2015 till 27 July
2020
POM
1734BRU15061882P Aceprin 10mg tablet Aspirin 100mg Hovid Bhd, Malaysia G & H Trading Company 28 July 2015 till 27 July
2020
POM
1735BRU15061883NP Povidone Iodine solution 10%
w/v
Povidone Iodine 10% w/v Royce Pharma Manufacturing Sdn.
Bhd., Malaysia
SWL Biomed Sales &
Services
28 July 2015 till 27 July
2020
GSL
1736BRU15061884P Pharmaniaga Cephalexin
Suspension 250mg
Cephalexin (as Cephalexin Anhydrous)
250mg/5mL
Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 28 July 2015 till 27 July
2020
POM
1737BRU15061885P Zorax Suspension 200mg/5ml Aciclovir 200mg/5ml Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 28 July 2015 till 27 July
2020
POM
1738BRU15061886P Ganaton 50mg tablet Itopride hydrochloride 50mg Abbott Japan Co. Ltd., Japan
Zuellig Pharma (B) Sdn Bhd28 July 2015 till 27 July
2020
POM
1739BRU15061887NP PVP Iodine Solution Povidone-Iodine 10% w/v (equivalent
to 1% available Iodine)
Dynapharm (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd 28 July 2015 till 27 July
2020
GSL
1740BRU15061888P Herceptin Powder for
Injection 440mg/vial
Trastuzumab 440mg Genentech Inc., California, USA;
Genentech Inc., Oregon, USA
Medicare 28 July 2015 till 27 July
2020
POM
1741BRU15061889P Azoren 20mg/5mg Film-
Coated Tablet
Olmesartan medoxomil 20mg and
Amlodipine (as amlodipine
besylate) 5mg
Daiichi Sankyo Europe GmbH,
Germany Zuellig Pharma (B) Sdn Bhd28 July 2015 till 27 July
2020
POM
1742BRU15061890P Azoren 40mg/10mg Film-
Coated Tablet
Olmesartan medoxomil 40mg and
Amlodipine (as amlodipine
besylate) 10mg
Daiichi Sankyo Europe GmbH,
Germany Zuellig Pharma (B) Sdn Bhd28 July 2015 till 27 July
2020
POM
1743BRU15061891P Azoren 40mg/5mg Film-
Coated Tablet
Olmesartan medoxomil 40mg and
Amlodipine (as amlodipine
besylate) 5mg
Daiichi Sankyo Europe GmbH,
Germany Zuellig Pharma (B) Sdn Bhd28 July 2015 till 27 July
2020
POM
1744BRU15061892P Perindosyl 4mg Tablet Perindopril tert-butylamine 4mg (eqv.
to 3.338mg perindopril)
Lek Pharmaceuticals DD., SloveniaZuellig Pharma (B) Sdn Bhd
28 July 2015 till 27 July
2020
POM
1745BRU15061893NP Mentholatum Deep Heating
Rub
Methyl Salicylate 12.7% & Menthol
5.8%
The Mentholatum Co., Inc., USA Hamitan Marketing 28 July 2015 till 27 July
2020
GSL
1746BRU15061894NP Oxy Cover Cream Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam) Co.
Ltd., Vietnam
Hamitan Marketing 28 July 2015 till 27 July
2020
GSL
1747BRU15061895NP Oxy Acne Wash Triclosan 0.30% Rohto-Mentholatum (Vietnam) Co.
Ltd., Vietnam
Hamitan Marketing 28 July 2015 till 27 July
2020
GSL
1748BRU15061896NP Hocodin Lozenge 250mcg Dequalinium chloride 250mcg Winwa Medical Sdn. Bhd., Malaysia Medicorp Sdn. Bhd. 28 July 2015 till 27 July
2020
GSL
1749
BRU15061897NP Gaviscon Advance Peppermint Sodium alginate 500mg/5ml
Potassium bicarbonate 100mg/5ml
Reckitt Benckiser Healthcare (UK)
Ltd., UK Zuellig Pharma (B) Sdn Bhd
28 July 2015 till 27 July
2020
GSL
BDMCA/RMP/0317 Page 114 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1750BRU15071898P Celluvisc Lubricating Eye
Drops 1%
Carboxymethylcellulose sodium 1% Allergan Sales, LLC, USA Medipharm Sdn Bhd 09 Dec 2015 till 08 Dec
2020
GSL
1751BRU15071899P Cavumox 625mg Tablet Amoxicillin (as trihydrate) 500mg;
Clavulanic acid (as potassium salt)
125mg
Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec
2020
POM
1752BRU15071900NP Gaviscon Liquid Per 10ml - Sodium alginate 500mg;
Sodium bicarbonate 267mg; Calcium
carbonate 160mg
Reckitt Benckiser Healthcare (UK) Ltd,
UK Syarikat Aliaa Sdn Bhd09 Dec 2015 till 08 Dec
2020
GSL
1753BRU15071901P Zapine 100mg Tablet Clozapine100mg Taiwan Biotech Co. Ltd, Taiwan G & H Trading Company 09 Dec 2015 till 08 Dec
2020
POM
1754BRU15071902P Alendronate Sandoz 70mg FCT Alendronic acid 70mg Lek Pharmaceuticals D.D., Ljubljana
Zuellig Pharma (B) Sdn Bhd09 Dec 2015 till 08 Dec
2020
POM
1755BRU15071903NP Chlorhex 4% antiseptic
solution
Chlorhexidine gluconate 4% Pahang Pharmacy Sdn Bhd., Malaysia G & H Trading Company 09 Dec 2015 till 08 Dec
2020
GSL
1756BRU15071904P Resolor Film-coated Tablet
2mg
Prucalopride succinate 2.642mg eqv
Prucalopride 2mg
Janssen-Cilag S.p.A., ItalyZuellig Pharma (B) Sdn Bhd
09 Dec 2015 till 08 Dec
2020
POM
1757BRU15071905P Proglutrol 500 Extended
Release Tablets
Metformin Hydrochloride 500mg Inventia Healthcare Pvt. Ltd., India Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec
2020
POM
1758BRU15071906NP Gaviscon Double Action Liquid Per 10ml - Sodium Alginate 500mg;
Sodium Bicarbonate 213mg; Calcium
Carbonate 325mg
Reckitt Benckiser Healthcare (UK) Ltd,
UK Syarikat Aliaa Sdn Bhd09 Dec 2015 till 08 Dec
2020
GSL
1759BRU15071907NP Gaviscon Double Action Tablet Sodium Alginate 250mg; Sodium
Bicarbonate 106.5mg; Calcium
Carbonate 187.5mg
Reckitt Benckiser Healthcare (UK) Ltd,
UK Syarikat Aliaa Sdn Bhd09 Dec 2015 till 08 Dec
2020
GSL
1760BRU15071908P Daivobet Gel Calcipotriol (as monohydrate) 50mcg/g
& betamethasone (as dipropionate)
0.5mg/g
LEO Laboratories Ltd., IrelandZuellig Pharma (B) Sdn Bhd
09 Dec 2015 till 08 Dec
2020
POM
1761BRU15071909NP Oxy 10 Lotion Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam) Co.
Ltd., Vietnam
Hamitan Marketing 09 Dec 2015 till 08 Dec
2020
GSL
1762BRU15071910NP Oxy 5 Lotion Benzoyl peroxide 5% w/w Rohto-Mentholatum (Vietnam) Co.
Ltd., Vietnam
Hamitan Marketing 09 Dec 2015 till 08 Dec
2020
GSL
1763BRU15071911P Hydrogen Peroxide Solution
(6%)
Hydrogen Peroxide 6% w/v (equivalent
to 20 volumes of available oxygen)
The Government Pharmaceutical
Organization, Thailand
SWL Biomed Sales &
Services
09 Dec 2015 till 08 Dec
2020
P
1764BRU15071912P Keppra Film-coated Tablet
1000mg
Levetiracetam 1000mg UCB Pharma SA, BelgiumZuellig Pharma (B) Sdn Bhd
09 Dec 2015 till 08 Dec
2020
POM
1765BRU15081913NP Zentel Suspension
400mg/10ml
Albendazole 400mg/10ml Smithkline Beecham, Philippines Kingston Beverage &
Creamery Sdn Bhd
09 Dec 2015 till 08 Dec
2020
GSL (1's x 10ml)
1766BRU15081914P Xalacom Eye Drops 1ml contains latanoprost 50
micrograms and timolol maleate
6.8mg (eq to 5mg timolol)
Pfizer Manufacturing Belgium NV,
Belgium Zuellig Pharma (B) Sdn Bhd09 Dec 2015 till 08 Dec
2020
POM
1767BRU15081915P Dormicum Tablet 15mg Midazolam Maleate 20.40mg eqv. to
Midazolam 15mg
Productos Roche S.A. de C.V. Via
Isidro Fabela Nte., Edo de Mexico.Zuellig Pharma (B) Sdn Bhd
09 Dec 2015 till 08 Dec
2020
POM
BDMCA/RMP/0317 Page 115 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1768BRU15081916P Unihepa 5000IU/ml Injection
(5ml vial)
Heparin sodium 5000IU/ml Duopharma (M) Sdn Bhd., Malaysia K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec
2020
POM
1769BRU15081917P Olmetec 40 Tablet Olmesartan Medoxomil 40mg Daiichi Sankyo Europe GmbH,
GermanyZuellig Pharma (B) Sdn Bhd
09 Dec 2015 till 08 Dec
2020
POM
1770BRU15081918P Olanzapine Orodispersible
Tablets 5mg
Olanzapine 5mg Jubilant Life Sciences Ltd., India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec
2020
POM
1771BRU15081919P Olanzapine Orodispersible
Tablets 10mg
Olanzapine 10mg Jubilant Life Sciences Ltd., India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec
2020
POM
1772BRU15081920P Metrogyl Injection 5mg/ml Metronidazole 500mg/100mL Unique Pharmaceutical Laboratories,
India
K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec
2020
POM
1773BRU15081921P Pharmaniaga Dermapro
Ointment 0.05% w/w
Clobetasol propionate 0.05% w/w Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 09 Dec 2015 till 08 Dec
2020
POM
1774BRU15081922P Olmetec Plus 40/12.5mg Film-
Coated Tablet
Olmesartan Medoxomil 40mg;
Hydrochlorothiazide 12.5mg
Daiichi Sankyo Europe GmbH,
GermanyZuellig Pharma (B) Sdn Bhd
09 Dec 2015 till 08 Dec
2020
POM
1775BRU15081923P Risperdal Tablet 1mg Risperidone 1mg Janssen Cilag SPA, Italy
Zuellig Pharma (B) Sdn Bhd09 Dec 2015 till 08 Dec
2020
POM
1776BRU15081924P Risperdal Tablet 2mg Risperidone 2mg Janssen Cilag SPA, Italy
Zuellig Pharma (B) Sdn Bhd09 Dec 2015 till 08 Dec
2020
POM
1777BRU15081925P Apo-Clopidogrel Tablet 75mg Clopidogrel (as bisulfate) 75mg Apotex Inc. Canada, Canada Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec
2020
POM
1778
BRU15081926NP Win-Aqueous Cream Emulsifying Wax 8%w/w; Liquid
Paraffin 5% w/w; White Soft
Paraffin 13% w/w
Winwa Medical Sdn Bhd., Pulau
Pinang, Malaysia
Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec
2020
GSL
1779 BRU15091927P Axcel Piroxicam-10 Capsule Piroxicam 10mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd09 Dec 2015 till 08 Dec
2020POM
1780 BRU15091928PAcular Ophthalmic Solution
0.5%Ketorolac Trometamol 0.50% w/v
Allergan Pharmaceuticals Ireland,
IrelandMediPharm Sdn Bhd
09 Dec 2015 till 08 Dec
2020POM
1781 BRU15091929P Dilantin capsule 30mg Phenytoin Sodium 30mg Pfizer Australia Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd09 Dec 2015 till 08 Dec
2020POM
1782 BRU15091930PZymar® (gatifloxacin
opthalmic solution) 0.3%Gatifloxacin 0.3% Allergan Sales, United States MediPharm Sdn Bhd
09 Dec 2015 till 08 Dec
2020POM
1783 BRU15091931PKlerimed 500mg Film-Coated
Tablets
Clarithromycin 515mg (equivalent to
anhydrous clarithromycin 500mg)
1. Medochmie Ltd (Factory AZ),
Cyprus
2. Medochmie Ltd (Central Factory),
Cyprus
Hongkiat Trading &
Company
09 Dec 2015 till 08 Dec
2020POM
1784 BRU15091932P
Gadovist Injection
1.0mmol/ml Prefilled syringe
5.0ml
Gadobutrol pure 604.72mg & Calcium
sodium butrol 0.513mgBayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd
09 Dec 2015 till 08 Dec
2020 POM
1785 BRU15091933PGadovist Injection
1.0mmol/ml
Gadobutrol pure 604.72mg & Calcium
sodium butrol 0.513mgBayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd
09 Dec 2015 till 08 Dec
2020POM
BDMCA/RMP/0317 Page 116 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1786 BRU15091934P
Neostigmine Methysulphate –
Fresenius 2.5mg/1ml
(Ampoules)
Neostigmine methylsulphate 2.5mg/mlFresenius Kabi Manufacturing SA (Pty)
Ltd., Republic of South Africa.K-Seri Pharma Sdn. Bhd.
09 Dec 2015 till 08 Dec
2020 POM
1787 BRU15091935P Cardiprin 100 Tablet Aspirin 100mgReckitt Benckiser Healthcare
(UK),United KingdomZuellig Pharma (B) Sdn Bhd
09 Dec 2015 till 08 Dec
2020POM
1788 BRU15091936P Calact 300mg Tablets
Calcium Lactate USP Eq. to Calcium
Lactate Pentahydrate 300mg.
Elemental Calcium 39mg (from
Calcium lactate pentahydrate 300mg).
Unique Pharmaceutical Laboratories
(A Division of J.B. Chemicals &
Pharmaceuticals Limited), India.
K-Seri Pharma Sdn Bhd
09 Dec 2015 till 08 Dec
2020
POM
1789 BRU15091937P Guafensin Syrup 20mg/ml Guaifenesin 20mg/mlY.S.P. Industries (M) Sdn. Bhd.,
MalaysiaAsterix United (B) Sdn Bhd
09 Dec 2015 till 08 Dec
2020POM
1790 BRU15091938P Storvas C Tablets 10mgAtorvastatin 10mg as Atorvastatin
Calcium Trihydrate
Ranbaxy (Malaysia) Sdn. Bhd.,
MalaysiaG & H Trading Company
09 Dec 2015 till 08 Dec
2020POM
1791 BRU15091939NP Zinc Cream Zinc Oxide 32% w/wHOE Pharmaceuticals Sdn. Bhd.,
MalaysiaG & H Trading Company
09 Dec 2015 till 08 Dec
2020GSL
1792 BRU15091940PPirimat Injection 10mg/ml
(1ml ampoule)Chlorpheniramine Maleate 10mg/m Duopharma (M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company09 Dec 2015 till 08 Dec
2020POM
1793 BRU15091941P Irprestan Tablet 150mg Irbesartan 150mg Actavis ehf, Iceland G & H Trading Company09 Dec 2015 till 08 Dec
2020POM
1794 BRU15091942P Irprestan Tablet 300mg Irbesartan 300mg Actavis ehf, Iceland G & H Trading Company09 Dec 2015 till 08 Dec
2020POM
1795 BRU15091943PHeparinol® 10 Sterile
Heparinised Saline InjectionHeparin Sodium (Bovine) 10 IU/ml Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah
09 Dec 2015 till 08 Dec
2020 POM
1796 BRU15091944P Fucid Ointment 2% w/wSodium Fusidate (Micronised) 20mg/g
(2% w/w)Noripharma Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd
09 Dec 2015 till 08 Dec
2020POM
1797 BRU15091945PActemra Concentrate for
Solution for Infusion 20mg/mlTocilizumab 20mg/ml
Chugai Pharma Manufacturing Co.,
Ltd, Japan
Hongkiat Trading &
Company
09 Dec 2015 till 08 Dec
2020 POM
1798 BRU15091946PAxcel Bromhexine (Children)
ElixirBromhexine Hydrochloride 4mg Kotra Pharma (M) Sdn Bhd., Malaysia Medicorp Sdn Bhd.
09 Dec 2015 till 08 Dec
2020POM
1799 BRU15101947PCetyrol 10mg Film-coated
TabletCetirizine dihydrochloride 10mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd
09 Dec 2015 till 08 Dec
2020POM
1800 BRU15101948PArchifar 1g Powder for
Solution for Injection/InfusionMeropenem (as trihydrate) 1g Medochemie Ltd., Cyprus Hongkiat Trading & Co
09 Dec 2015 till 08 Dec
2020 POM
1801 BRU15101949P Antismine Syrup 2mg/5ml Chlorpheniramine maleate 2mg/5ml Winwa Medical Sdn Bhd., Malaysia Medicorp Sdn Bhd09 Dec 2015 till 08 Dec
2020P
1802 BRU15101950P Respidon 2mg Tablets Risperidone 2mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd09 Dec 2015 till 08 Dec
2020POM
BDMCA/RMP/0317 Page 117 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1803 BRU15101951P Respidon 1mg Tablets Risperidone 1mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd09 Dec 2015 till 08 Dec
2020POM
1804 BRU15101952NP Flexjoint 1500mg Powder
Crystalline glucosamine sulphate
1884mg (equivalent to glucosamine
sulphate 1500mg)
Winwa Medical Sdn Bhd., Malaysia Medicorp Sdn Bhd09 Dec 2015 till 08 Dec
2020 GSL
1805 BRU15101953NP Colin Cough Syrup 100mg Guaiphenesin 100mg/5ml Winwa Medical Sdn Bhd., Malaysia Yuh Hua Trading Company09 Dec 2015 till 08 Dec
2020GSL
1806 BRU15101954P Tystatin Oral Suspension Nystatin BP 100,000 unitsT.O. Chemicals (1979) Co. Ltd.,
ThailandMedicorp Sdn Bhd
09 Dec 2015 till 08 Dec
2020POM
1807 BRU15101955P Ezede Tablet 10mg Loratadine 10mgXepa-Soul Pattinson (M) Sdn Bhd.,
MalaysiaHongkiat Trading & Co
09 Dec 2015 till 08 Dec
2020P
1808 BRU15101956PPred Forte Sterile Ophthalmic
Suspension 1%Prednisolone acetate 1% w/v
Allergan Pharmaceuticals Ireland,
Mayo, IrelandMedipharm Sdn Bhd
09 Dec 2015 till 08 Dec
2020 POM
1809 BRU15111957P Stivarga Tablet 40mg
Regorafenib
(40mg Regorafenib equivalent to
41.49mg Regorafenib monohydrate)
Bayer Pharma AG, Germany. Zuellig Pharma (B) Sdn Bhd
09 Dec 2015 till 08 Dec
2020 POM
1810 BRU15111958P A Scabs Lotion Permethrin 5.0% w/vHOE Pharmaceuticals Sdn. Bhd.,
MalaysiaG & H Trading Company
09 Dec 2015 till 08 Dec
2020GSL
1811 BRU15111959P Insugen-N (NPH)Insulin Injection, Isophane Ph. Eur.
(Human Insulin rDNA origin) 100IU/mlBiocon Limited, India
Hongkiat Trading &
Company
09 Dec 2015 till 08 Dec
2020 POM
1812 BRU15111960P Tetradox Capsules 100mgDoxycycline Hydrochloride/Hcylate eq
to Doxycycline 100mgRanbaxy (Malaysia) Sdn Bhd, Malaysia G & H Trading Company
09 Dec 2015 till 08 Dec
2020 POM
1813 BRU15111961NP Infusol® NS (Ampoule) Sodium chloride 0.9%w/v AIN Medicare Sdn. Bhd., Malaysia Syarikat Pakatan Indah09 Dec 2015 till 08 Dec
2020GSL
1814 BRU15111962NPInfusol W (Sterilised Water for
Injection BP)Water for injection BP AIN Medicare Sdn. Bhd., Malaysia Syarikat Pakatan Indah
09 Dec 2015 till 08 Dec
2020GSL
1815 BRU15111963P Elan Forte CreamTolnaftate 10mg/g; Chlorhexidine HCl
2mg/g
Y.S.P. Industries (M) Sdn.
Bhd.,MalaysiaAsterix United (B) Sdn Bhd.
09 Dec 2015 till 08 Dec
2020GSL
1816 BRU15111964P Valparin XR 500mg Tablet
i) Sodium Valproate 333mg
ii) Valproic Acid 145mg
(Both together correspond to sodium
valproate 500mg)
Torrent Pharmaceuticals Limited,
IndiaK-Seri Pharma Sdn Bhd.,
09 Dec 2015 till 08 Dec
2020 POM
1817 BRU15111965P Axcel Betamethasone Cream
Betamethasone 17-Valerate
(micronized) equivalent to
Betamethasone 0.1% w/w
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd09 Dec 2015 till 08 Dec
2020 POM
1818 BRU15111966P Freederm Gel Terbinafine HCl 1%w/w Winwa Medical Sdn Bhd., Malaysia Yuh Hua Trading Company 09 Dec 2015 till 08 Dec
2020GSL
BDMCA/RMP/0317 Page 118 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1819 BRU15111967P Cough-En Linctus
Dextromethorphan Hydrobromide
15mg/5ml;
Tripolidine Hydrochloride 1.25mg/5ml;
Pseudoephedrine Hydrochloride
30mg/5ml
Xepa-Soul Pattinson (Malaysia) Sdn.
Bhd., Malaysia
Hongkiat Trading &
Company
09 Dec 2015 till 08 Dec
2020
POM
1820 BRU15111968PT Atehexal Comp Mite Tablet Atenolol 50mg; Chlorthalidone 12.5mgSalutas Pharma GmbH, Federal
Republic of Germany Medicorp
09 Dec 2015 till 28 April
2019POM
1821 BRU15111969PTHurricaine Topical Anaesthetic
Gel – Original Wild CherryBenzocaine 20%
Dental Technologies Inc. , United
States L S Kai Care09 Dec 2015 till 16 Feb
2018POM
1822 BRU15111970PT Duocaine Cream 5% w/wLidocaine 2.5% w/w; Prilocaine 2.5%
w/wHoe Pharmaceuticals Sdn Bhd,
MalaysiaG & H Trading Co
09 Dec 2015 till 14 Jan
2019POM
1823 BRU15111971PTSOLIRIS Concentrate for
Solution for Infusion 300mgEculizumab 300mg
DSM Pharmaceuticals Inc, USAMedipharm Sdn Bhd
09 December 2015 till 23
November 2018POM
1824
BRU15121972PS1 &
BRU15121972PS2
Varivax (refrigerated) Varicella Virus Vaccine Live (Oka /
Merck) 1350PFU / 0.5ml
Merck Sharp & Dohme Corp.,
Pennsylvania USA (S1)
ii) Merck Sharp and Dohme Corp.,
North Carolina, US (S2)
Zuellig Pharma (B) Sdn Bhd
21 Jun 2016 till 20 Jun
2021
POM
1825BRU15121973P SW-Dexasone Tablet Dexamethasone 0.5mg Sunward Pharmaceutical Sdn Bhd.,
Singapore
G & H Trading Company 21 Jun 2016 till 20 Jun
2021
POM
1826BRU15121974P Paracetamol Codeine Tablet Paracetamol 500mg and Codeine
Phosphate 8mg
Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 21 Jun 2016 till 20 Jun
2021
POM
1827
BRU15121975NP Mentholatum Deep Heat
Sport Pain Relief Spray
Methyl Nicotinate 16mg/g; Glycol
Salicylate 50mg/g; Methyl Salicylate
10mg/g; Ethyl salicylate 50mg/g
Ensign Labs Pty. Ltd., Australia Hamitan Marketing 21 Jun 2016 till 20 Jun
2021
GSL
1828BRU15121976NP Mentholatum Deep Cold Ice
Gel Therapy
Menthol 20g/g Mentholatum Australia Pty. Ltd.,
Australia
Hamitan Marketing 21 Jun 2016 till 20 Jun
2021
GSL
1829BRU15121977NP Axcel Urea Cream Urea 10% w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun
2021
GSL
1830BRU15121978P Axcel Clomiphene Tablet Clomiphene Citrate 50mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun
2021
POM
1831BRU15121979P Medocef 1g Powder for
Solution for Injection or
Infusion
Cefoperazone (as sodium) 1g Medochemie Ltd., Cyprus Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun
2021
POM
1832BRU15121980NP Dexxon Lozenges Dequalinium Chloride 0.25mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun
2021
GSL
1833BRU15121981P Oragel Pain Relief Choline Salicylate 9% w/w &
Cetylpyridinium Chloride 0.05% w/w
Winwa Medical Sdn. Bhd., Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun
2021
GSL
BDMCA/RMP/0317 Page 119 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1834 BRU16011982NP0.9% Sodium Chloride
Injection, USPSodium Chloride USP 0.9% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd
21 Jun 2016 till 20 Jun
2021GSL
1835 BRU16011983P Amlibon 5mg TabletAmlodipine (as Amlodipine Besilate)
5mgLek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd
21 Jun 2016 till 20 Jun
2021POM
1836 BRU16011984POspexin 250mg/5ml Granules
for Oral SuspensionCephalexin 250mg/5ml Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd
21 Jun 2016 till 20 Jun
2021 POM
1837 BRU16011985P Azukon MR 30mg Tablet Gliclazide 30mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd21 Jun 2016 till 20 Jun
2021POM
1838 BRU16011986P Espran 10mg Tablet Escitalopram (as Oxalate) 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd21 Jun 2016 till 20 Jun
2021POM
1839 BRU16011987P Zenalb 20% Human albumin 20%w/v Bio Product Lab, UK Medipharm Sdn Bhd21 Jun 2016 till 20 Jun
2021POM
1840 BRU16011988P Lestric Tablets 20mg Lovastatin 20mgRanbaxy (Malaysia) Sdn Bhd.,
MalaysiaG&H Trading Company
21 Jun 2016 till 20 Jun
2021POM
1841 BRU16011989PPotassium Chloride 10% w/v
InjectionPotassium Chloride 10% w/v
Pharmaniaga Manufacturing Berhad,
MalaysiaG&H Trading Company
21 Jun 2016 till 20 Jun
2021POM
1842 BRU16011990P Gastografin Solution
1ml contains Sodium amidotrizoate
0.1g and Meglumine amidotrizoate
0.66g
Belimed SA, Spain Zuellig Pharma (B) Sdn Bhd21 Jun 2016 till 20 Jun
2021 POM
1843 BRU16011991PRabotide Capsule 20mg (as
enteric coated pellets)Rabeprazole Sodium 20mg Inventia Healthcare Pvt Ltd., India Medicorp Sdn Bhd
21 Jun 2016 till 20 Jun
2021POM
1844 BRU16011992PPharmaniaga Gliclazide Tablet
80mgGliclazide 80mg
Pharmaniaga Manufacturing Berhad,
MalaysiaG&H Trading Company
21 Jun 2016 till 20 Jun
2021POM
1845 BRU16011993NP Betadine Antiseptic Ointment Povidone-Iodine 10% w/w Pt. Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd21 Jun 2016 till 20 Jun
2021GSL
1846 BRU16011994NPBetadine Feminine Wash with
Douching Apparatus 10% w/vPovidone-Iodine 10% w/v Pt. Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd
21 Jun 2016 till 20 Jun
2021 GSL
1847 BRU16011995NP Betadine Feminine Wash Povidone-Iodine 10% w/v Pt. Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd21 Jun 2016 till 20 Jun
2021GSL
1848 BRU16011996NP Coxan Tablets 500mg Paracetamol 500mgPrime Pharmaceuticals Sdn Bhd.,
MalaysiaMedicorp Sdn Bhd
21 Jun 2016 till 20 Jun
2021GSL (10 x 10’s)
1849 BRU16011997P Soluwax Ear Drops Docusate sodium 0.5% w/vHoe Pharmaceuticals Sdn Bhd.,
MalaysiaG&H Trading Company
21 Jun 2016 till 20 Jun
2021GSL
1850BRU16021998P Insugen-R (NPH) Insulin Injection, Soluble Ph. Eur.
(Insulin, Human of recombinant DNA
origin) 100 IU/ml
Biocon Limited, India Hongkiat Trading & Co 21 Jun 2016 till 20 Jun
2021
POM
1851BRU16021999P Levetiracetam tablet 500mg Levetiracetam 500mg Jubilant Generics, Limited, India Axterix United (B) Sdn. Bhd 21 Jun 2016 till 20 Jun
2021
POM
1852BRU16022000P Glimicron 80mg tablet Gliclazide 80mg HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun
2021
POM
1853BRU16022001NP Liquid Paraffin Liquid Paraffin BP 100% HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun
2021
GSL
BDMCA/RMP/0317 Page 120 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1854BRU16022002NP Noxworm Suspension
(chocolate) 400mg
Albendazole 200mg/5mL Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 21 Jun 2016 till 20 Jun
2021
GSL
1855BRU16022003P Mircera pre-filled syringe
100mcg/0.3ml
Methoxy polyethylene glycol-epoetin
beta 100mcg/0.3ml
Roche Diagnostics GmbH, GermanyZuellig Pharma (B) Sdn Bhd
21 Jun 2016 till 20 Jun
2021
POM
1856BRU16022004P Glucodex tablet Gliclazide 80mg PT Dexa Medica, Indonesia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun
2021
POM
1857BRU16022005P Rocaltrol capsule 0.5mcg Calcitriol 0.5mcg Catalent Germany Eberbach GmbH,
Germany for F.Hoffmann-La Roche
Ltd., Switzerland
Hongkiat Trading &
Company
21 Jun 2016 till 20 Jun
2021
POM
1858BRU16022006P Rocaltrol capsule 0.25mcg Calcitriol 0.25mcg Catalent Germany Eberbach GmbH,
Germany for F.Hoffmann-La Roche
Ltd., Switzerland
Hongkiat Trading &
Company
21 Jun 2016 till 20 Jun
2021
POM
1859BRU16022007P Adezio Oral Suspension Cetirizine Hydrochloride 1mg/ml Xepa-Soul Pattinson (Malaysia) Sdn
Bhd,
Malaysia
Hongkiat Trading &
Company
21 Jun 2016 till 20 Jun
2021
P
1860BRU16022008P Zarin cream Miconazole nitrate 2%w/w Xepa-Soul Pattinson (Malaysia) Sdn
Bhd,
Malaysia
Hongkiat Trading &
Company
21 Jun 2016 till 20 Jun
2021
GSL
1861BRU16022009P Jumex (Selegiline HCl) tablet
5mg
Selegiline Hydrochloride 5mg Chinoin Pharmaceutical and Chemical
Works Co. Ltd., Hungary.
MediPharm Sdn Bhd 21 Jun 2016 till 20 Jun
2021
POM
1862BRU16022010P Bena
®
Expectorant
Diphenhydramine hydrochloride
14mg/5ml and ammonium
chloride 135mg/5ml
Xepa-Soul Pattinson (Malaysia) Sdn
Bhd,
Malaysia
Hongkiat Trading &
Company
21 Jun 2016 till 20 Jun
2021
POM
1863BRU16022011P
Pantor 20Pantoprazole (as sodium
sesquihydrate) 20mg
Torrent Pharmaceuticals Limited,
India
K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun
2021
POM
1864BRU16022012P Pantor 40 Pantoprazole (as sodium
sesquihydrate) 40mg
Torrent Pharmaceuticals Limited,
India
K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun
2021
POM
1865BRU16032013P Ceritec Film Coated Tablet
10mgCetirizine Hydrochloride 10mg
Y.S.P. Industries (M) Sdn. Bhd.,
Malaysia.Asterix United (B) Sdn Bhd
21 Jun 2016 till 20 Jun
2021P
1866BRU16032014P
Tinazol Cream 2% (15g) Miconazole nitrate 2% w/w Hovid Bhd, Malaysia. G & H Trading Company21 Jun 2016 till 20 Jun
2021GSL
1867
BRU16032015PS1 &
BRU16032015PS2
M-M-R II® Vaccine
Live, attenuated virus derived from
Edmonston B strain of measles - 3.0
log TCID50, Live attenuated Jeryl LynnTM
strain of mumps - 4.1 log TCID50, Live,
attenuated Wistar RA 27/3 strain of
rubella - 3.0 log TCID50
1. Merck Sharp & Dohme Corp.,
Pennsylvania, USA,
2. Merck Sharp & Dohme Corp., North
Carolina, U.S.A Zuellig Pharma (B) Sdn Bhd
21 Jun 2016 till 20 Jun
2021
POM
1868
BRU16032016P
Insugen-30/70 (Biphasic)
Insulin Injection, Biphasic Isophane Ph.
Eur. (Insulin, Human recombinant
DNA origin) 100 IU/ml
Biocon Limited, India Hongkiat Trading & Co.
21 Jun 2016 till 20 Jun
2021 POM
BDMCA/RMP/0317 Page 121 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1869BRU16032017P Natrixam 1.5mg/10mg
modified-release tablet
Indapamide 1.5mg & Amlodipine 10mg
(as besilate)
Les Laboratories Servier Industrie,
FranceZuellig Pharma (B) Sdn Bhd
21 Jun 2016 till 20 Jun
2021POM
1870
BRU16032018PNatrixam 1.5mg/5mg
modified-release tablet
Indapamide 1.5mg & Amlodipine 5mg
(as besilate)
Les Laboratories Servier Industrie,
France Zuellig Pharma (B) Sdn Bhd
21 Jun 2016 till 20 Jun
2021 POM
1871BRU16032019P
Levetiracetam 250mg tablet Levetiracetam 250mg Jubilant Generics Limited, India Asterix United (B)Sdn Bhd.,21 Jun 2016 till 20 Jun
2021POM
1872BRU16032020NP
Mifuko OintmentZinc Oxide 6% (w/w) and Salicylic acid
5% (w/w)Winwa Medical Sdn Bhd, Malaysia. Yuh Hua Trading Company
21 Jun 2016 till 20 Jun
2021GSL
1873BRU16032021P
Primodil 5 Tablet Amlodipine Besilate 6.94mg
(equivalent to Amlodipine 5mg)Medley Pharmaceuticals Ltd, India Medicorp Sdn Bhd
21 Jun 2016 till 20 Jun
2021POM
1874BRU16032022P Oxair Film Coated Tablet
10mg
Montelukast Sodium 10.4mg
(equivalent to Montelukast 10mg)
Y.S.P. Industries (M) Sdn Bhd.,
MalaysiaAsterix United (B) Sdn Bhd
21 Jun 2016 till 20 Jun
2021POM
1875BRU16032023NP Bacidin Antiseptic Cream 1%
w/wChlorhexidine Gluconate 1% w/w
Xepa-soul Pattinson (Malaysia) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company21 Jun 2016 till 20 Jun
2021GSL
1876BRU16032024P Axcel Oxymetazoline 0.05%
Nasal Spray
Oxymetazoline Hydrochloride 0.05%
w/vKotra Pharma (M) Sdn Bhd., Malaysia. Medicorp Sdn Bhd
21 Jun 2016 till 20 Jun
2021P
1877 BRU16042025P Romesec 20mg Capsules Omeprazole USP 20mgRanbaxy (Malaysia) Sdn. Bhd.,
Malaysia.G & H Trading Company
21 Jun 2016 till 20 Jun
2021POM
1878
BRU16042026NP
Migrate Q10
Coenzyme Q10………….100mg;
Lycopene………………….... 5mg; L-
Arginine…………….…..100mg;
Zinc Sulphate monohydrate (eq to
Elemental zinc)..22.5mg;
Piperine………………………..5mg; Sodium
selenite (eq to Elemental selenium)
….70mcg
Goodman Pharmaceuticals, India. MediBiotech
21 Jun 2016 till 20 Jun
2021
GSL
1879 BRU16042027NPPotassium Chloride Injectable
Solution 10%Potassium chloride 1g / 10ml
DEMO SA Pharmaceutical Industry,
Greece. Medicorp Sdn Bhd
21 Jun 2016 till 20 Jun
2021POM
1880 BRU16042028P Oratane 20mg Capsules Isotretinoin 20mg
Swiss Caps AG, Switzerland, Contract
Mfg. for Douglas Pharmaceuticals
Limited, New Zealand.
K-Seri Pharma Sdn Bhd
21 Jun 2016 till 20 Jun
2021 POM
1881 BRU16042029P Oratane 10mg Capsules Isotretinoin 10mg
Swiss Caps AG, Switzerland, Contract
Mfg. for Douglas Pharmaceuticals
Limited, New Zealand.
K-Seri Pharma Sdn Bhd
21 Jun 2016 till 20 Jun
2021 POM
1882 BRU16042030NPOsteoactiv 3 in 1 Joint
Formula Powder
Glucosamine Hydrochloride 1000mg,
Methylsulfonylmethane 1000mg,
Chondroitin Sulphate Sodium 880.4mg
(equivalent to 800mg chondroitin)
Winwa Medical Sdn. Bhd., Malaysia. Medicorp Sdn Bhd
21 Jun 2016 till 20 Jun
2021GSL
BDMCA/RMP/0317 Page 122 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1883 BRU16042031NPOsteoactiv 3 in 1 Joint
Formula Tablet
Glucosamine Hydrochloride 250mg,
Methylsulfonylmethane 250mg,
Chondroitin Sulphate Sodium 220mg
(equivalent to 200mg chondroitin)
Winwa Medical Sdn. Bhd., Malaysia. Medicorp Sdn Bhd
21 Jun 2016 till 20 Jun
2021GSL
1884 BRU16042032P Sedilix-DM Linctus
Dextromethorphan (as Hydrobromide)
15mg/5mL; Pseudoephedrine (as
Hydrochloride) 30mg/5mL;
Promethazine (as Hydrochloride)
3.125mg/5mL
Xepa-Soul Pattinson (M) Sdn Bhd,
Malaysia.
Hongkiat Trading &
Company
21 Jun 2016 till 20 Jun
2021
POM
1885 BRU16042033PAloxi Solution for Injection
50mcg/ml
Palonosetron Hydrochloride 56 mcg
eqv to Palonosetron 50 mcg (0.050
mg)
Pierre-Fabre Medicament Production,
France.Zuellig Pharma (B) Sdn Bhd
21 Jun 2016 till 20 Jun
2021 POM
1886 BRU16042034P Taver Tablet 200mg Carbamazepine 200mg Medochemie Ltd., Cyprus. Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun
2021POM
1887 BRU16042035NP Axcel B Complex Tablet
Vitamin B1 10mg; Vitamin B2 3mg;
Vitamin B6 1mg; Cyanocobalamine
5mcg; Calcium Pantothenate 1mg;
Nicotinamide 25mg
Kotra Pharma (M) Sdn Bhd, Malaysia. Medicorp Sdn Bhd
21 Jun 2016 till 20 Jun
2021 GSL
1888 BRU16042036PPharmaniaga Allopurinol
Tablet 300mgAllopurinol 300mg
Pharmaniaga Manufacturing Berhad,
Malaysia.G & H Trading Company
21 Jun 2016 till 20 Jun
2021POM
1889 BRU16042037NP Povidin Solution 10%Povidone-Iodine 10% w/v (equivalent
to 1% of Available Iodine)
Xepa-soul Pattinson (Malaysia) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company
21 Jun 2016 till 20 Jun
2021 GSL
1890 BRU16052038P GPO-L-OneTM 500mg Tablet Deferiprone 500mgThe Government Pharmaceutical
Organization (GPO), ThailandK-Seri Pharma Sdn Bhd
21 Jun 2016 till 20 Jun
2021POM
1891 BRU16052039NP Noxworm Chewtab Albendazole 200mg Winwa Medical Sdn. Bhd., Malaysia Yuh Hua Trading Company21 Jun 2016 till 20 Jun
2021GSL
1892 BRU16052040NP Betadine® Antiseptic Solution Povidone-Iodine 10% w/v PT Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd21 Jun 2016 till 20 Jun
2021GSL
1893 BRU16052041P Zoratadine Syrup 5mg/5ml Loratadine 5mg/5mlHOE Pharmaceuticals Sdn. Bhd.,
MalaysiaG&H Trading Company
21 Jun 2016 till 20 Jun
2021P
1894 BRU16052042PAxcel Oxymetazoline 0.025%
Nasal Drop
Oxymetazoline hydrochloride 0.025%
w/vKotra Pharma (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd
21 Jun 2016 till 20 Jun
2021P
1895 BRU16052043PAxcel Dextromethorphan-15
Syrup
Dextromethorphan hydrobromide
15mg/5mlKotra Pharma (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd
21 Jun 2016 till 20 Jun
2021POM
1896 BRU16052044PZometa Solution for Infusion
4mg/100ml
Zoledronic Acid (anhydrous)
4mg/100ml corresponding to 4.264mg
Zoledronic Acid Monohydrate
Novartis Pharma Stein AG,
SwitzerlandZuellig Pharma (B) Sdn Bhd
21 Jun 2016 till 20 Jun
2021 POM
1897 BRU16052045P Novomin Tablet 50mg Dimenhydrinate 50mgXepa-Soul Pattinson (Malaysia) Sdn
Bhd, Malaysia.
Hongkiat Trading &
Company21 Jun 2016 till 20 Jun
2021POM
BDMCA/RMP/0317 Page 123 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1898 BRU16062046P Valzaar 80mg Tablets Valsartan 80mg Torrent Pharmaceuticals Ltd, India K-Seri Pharma Sdn. Bhd08 November 2016 till 07
November 2021POM
1899BRU16062047P
Valzaar 160mg Tablets Valsartan 160mg Torrent Pharmaceuticals Ltd, India K-Seri Pharma Sdn. Bhd08 November 2016 till 07
November 2021POM
1900 BRU16062048P Tozaar 50mg tablet Losartan potassium 50mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd08 November 2016 till 07
November 2021POM
1901 BRU16062049P
Seebri Breezhaler 50mcg
Inhalation Powder Hard
Capsules
Glycopyrronium bromide 63mcg
(corresponding to 50 mcg
Glycopyrronium)
Novartis Pharma Stein AG.,
SwitzerlandZuellig Pharma (B) Sdn Bhd
08 November 2016 till 07
November 2021POM
1902 BRU16062050P Neotigason Capsule 10mg Acitretin 10mg Patheon Inc., Canada G & H Trading Company08 November 2016 till 07
November 2021POM
1903 BRU16062051P Neotigason Capsule 25mg Acitretin 25mg Patheon Inc., Canada G & H Trading Company08 November 2016 till 07
November 2021POM
1904 BRU16062052P Tidact Injection 150mg/ml Clindamycin (as phosphate) 150mg/mlYung Shin Pharmaceutical Ind. Co.
Ltd., Republic of ChinaAsterix United (B) Sdn Bhd
08 November 2016 till 07
November 2021POM
1905 BRU16062053P APO-Risperidone Tablets 1mg Risperidone 1mg Apotex Inc, Canada Medicorp Sdn Bhd08 November 2016 till 07
November 2021POM
1906 BRU16062054PBetmiga Prolonged-Release
Tablets 25mgMirabegron 25mg Astellas Pharma Technologies Inc., US Medipharm Sdn Bhd
08 November 2016 till 07
November 2021POM
1907 BRU16062055PBetmiga Prolonged-Release
Tablets 50mgMirabegron 50mg Astellas Pharma Technologies Inc., US Medipharm Sdn Bhd
08 November 2016 till 07
November 2021POM
1908 BRU16062056PAxcel Mometasone 0.1%
Cream
Mometasone furoate (micronised)
0.1% w/wKotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd
08 November 2016 till 07
November 2021POM
1909BRU16072057P Dipeptiven Infusion 200mg/ml N(2)-L-Alanyl-L-glutamine 200mg/ml Frensius Kabi Austria GmbH, Austria
Zuellig Pharma (B) Sdn Bhd08 November 2016 till 07
November 2021POM
1910BRU16072058P Noxafl 100mg tablet Posaconazole 100mg N.V Organon, Netherlan
Zuellig Pharma (B) Sdn Bhd08 November 2016 till 07
November 2021POM
1911BRU16072059P Onegaba 300mg capsules Gabapentin 300mg Aurobindo Pharma Limited (Unit
III), India
K-Seri Pharma Sdn Bhd 08 November 2016 till 07
November 2021POM
1912BRU16072060P Pethidine-Hameln Solution for
Injection 50mg/ml
Pethidine Hydrochloride
50mg/ml
Hameln Pharmaceuticals GmbH,
Langes Feld 13, 31789 Ham
eln, Germany
Medicorp Sdn Bhd08 November 2016 till 07
November 2021
POM
1913BRU16072061P Axcel Clobetasol 0.05
Ointment
Clobetasol Propionate (micronized)
0.05% w/w
Kotra Pharma (M) Sdn Bhd.,
Malaysia.
Medicorp Sdn Bhd 08 November 2016 till 07
November 2021POM
1914BRU16072062P Prednisolone syrup 5mg/5ml Each 5ml contains:
Prednisolone (as salt of
prednisolone) 5mg
Beacons Pharmaceutical Pte Ltd,
Singapore
Hong Kiat Trading & Co08 November 2016 till 07
November 2021
POM
1915 BRU16082063NPZenalb 4.5%, Human Albumin
Solution 4.5%Human Albumin Solution 4.5% Bio Products Laboratory Limited, UK MediPharm Sdn Bhd
08 November 2016 till 07
November 2021POM
1916 BRU16082064PAxcel Lamivudine 100mg
TabletLamivudine 100mg Kotra Pharma (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd
08 November 2016 till 07
November 2021POM
1917 BRU16082065P Calpo Suspension Mebendazole 100mg/5ml Winwa Medical Sdn. Bhd., Malaysia Yuh Hua Trading Company08 November 2016 till 07
November 2021GSL
BDMCA/RMP/0317 Page 124 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1918 BRU16082066NP Alphanate® 250IUFactor VII 250IU and von Willebrand
Factor >400IU/1000IU Factor VIIGrifols Bilogicals Inc., USA
Hongkiat Trading &
Company
08 November 2016 till 07
November 2021POM
1919 BRU16082067P
Anoro Ellipta 62.5/25
micrograms inhalation
powder, pre-dispensed
Each pre-dispensed dose contains 62.5
micrograms umeclidinium (equivalent
to 74.2 micrograms of umeclidinium
bromide) and 25 micrograms vilanterol
(as trifenatate)
Glaxo Operations UK Ltd (trading as
Glaxo Wellcome Operations), UKZuellig Pharma (B) Sdn Bhd
08 November 2016 till 07
November 2021POM
1920 BRU16082068NP
RINS® NS Sodium Chloride
0.9% w/v Irrigation Solution
BP
Sodium Chloride 0.9% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah08 November 2016 till 07
November 2021GSL
1921
BRU16092069P Sifrol Extended Release
0.375mg tablet
Pramipexole
Dihydrochloride
Monohydrate 0.375mg
(eq
v.
to 0.26mg
pramipexole free base)
Boehringer Ingelheim Pharma gmbH
& Co. KG, Germany
Hongkiat Trading &
Company
08 November 2016 till 07
November 2021
POM
1922
BRU16092070P Sifrol Extended Release 1.5mg
tablet
Pramipexole
Dihydrochloride
Monohydrate 1.5mg
(eqv. to 1.05mg
pramipexole free base)
Boehringer Ingelheim Pharma gmbH
& Co. KG, Germany Hongkiat Trading &
Company
08 November 2016 till 07
November 2021
POM
1923BRU16092071NP Mentholatum Deep Heating
Rub Extra Strength Cream
Methyl Salicylate 30%; Menthol
8%
The Mentholatum Co., USA. Hamitan Marketng, Brunei
Darussalam
08 November 2016 till 07
November 2021GSL
1924
BRU16092072P GlobalVacc Al-Shifa HIB Each dose of 0.5ml contains:
Purified Capsular Polysaccharide Hib
(PRP) –10mcg
(Hib Polysaccharide) (PRP) Tetanus
Toxoid (carrier protein) –19 to 33mcg
Serum Institute India Ltd., India Bruvac Pharma Sdn Bhd
08 November 2016 till 07
November 2021
POM
1925BRU16092073P Adrenaline (Epinephrine)
Injection 1:1000
Adrenaline (Epinephrine) as acid
tartrate
Mc Carthys Laboratories Ltd., UK Medicorp Sdn Bhd 08 November 2016 till 07
November 2021POM
1926BRU16092074P Axcel Mometasone 0.1%
Ointment Mometasone Furoate
(micronised) 0.1% w/w
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd08 November 2016 till 07
November 2021
POM
1927BRU16092075P Amphotret for Injection U.S.P.
50mg
Amphotericin B U.S.P. 50mg Bharat Serums And Vaccines Ltd,
India
K-Seri Pharma Sdn Bhd 08 November 2016 till 07
November 2021POM
BDMCA/RMP/0317 Page 125 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1928
BRU16092076NP Alumag Plus Tablet Per tablet:
Aluminium Hydroxide Dried Gel
250mg; Magnesium Trisilicate Light
250mg; Simethicone
30mg
Beacons Pharmaceuticals Pte Ltd,
Singapore
HongKiat Trading Co 08 November 2016 till 07
November 2021
GSL
1929BRU16102077PT Olanzapine Genmark 10mg
Tablet
Olanzapine 10mg Glenmark Pharmaceuticals Europe
Limited, United Kingdom
Hongkiat Trading &
Company
08 November 2016 till 23
Nov 2018
POM
1930BRU16102078PT Olanzapine Genmark 5mg
Tablet
Olanzapine 5mg Glenmark Pharmaceuticals Europe
Limited, United Kingdom
Hongkiat Trading &
Company
08 November 2016 till 14
Jan 2019
POM
1931BRU16102079PT Baxter Chlorhexidine Acetate
0.1% w/v Antiseptic Solution
Chlorhexidine (as
Acetate)
Baxter Healthcare Pty Ltd, AustraliaZuellig Pharma (B) Sdn Bhd
08 November 2016 till 26
Jan 2019
GSL
1932BRU16102080P Magurol 2mg tablet Doxazosin mesilate eq. to
doxazosin base 2
mg
Medochemie Ltd Central Factory,
Cyprus
Medicorp Sdn. Bhd 08 November 2016 till 07
November 2021
POM
1933BRU16102081P Magurol 4mg tablet Doxazosin mesilate eq. to
doxazosin base 4
mg
Medochemie Ltd Central Factory,
Cyprus
Medicorp Sdn. Bhd 08 November 2016 till 07
November 2021
POM
1934BRU16102082P Xyzal Film-coated tablet 5mg Levocetirizine dihydrochloride
5mg
UCB Farchim SA, SwitzerlandZuellig Pharma (B) Sdn Bhd
08 November 2016 till 07
November 2021
POM
1935
BRU16102083P Xolair 75mg powder for
solution for injection
Omalizumab 75mg.
Reconstituted Xolair contains
125mg/ml of omalizumab (75mg
in
0.6ml)
Novartis Corporation (Malaysia) Sdn.
Bhd., MalaysiaZuellig Pharma (B) Sdn Bhd
08 November 2016 till 07
November 2021
POM
1936BRU16102084P Bilaxten 20mg tablet Bilastine 20mg A.Menarini Manufacturing Logistic
and Services S.r.l., ItalyZuellig Pharma (B) Sdn Bhd
08 November 2016 till 07
November 2021
POM
1937BRU16102085P Loxin Injection (5ml amp)
(Dopamine HCl)
Dopamine hydrochloride Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &
Company
08 November 2016 till 07
November 2021
POM
1938BRU16102086P Mycamine 50mg/vial Powder
for Solution for Infusion
Micafungin (as sodium)
50mg/via
Astellas Pharma Tech Co., Ltd., Japan MediPharm Sdn Bhd 08 November 2016 till 07
November 2021
POM
1939BRU16102087P Vaxcel Fluconazole 2mg/ml IV
Infusion
Fluconazole 2mg/ml Kotra Pharma (M) Sdn. Bhd.,Malaysia Medicorp Sdn Bhd 08 November 2016 till 07
November 2021
POM
1940BRU16102088P Sellon Shampoo Selenium sulfide 2.5% w/v Unison Laboratories Co., Ltd.,
Thailand
K-Seri Pharma Sdn Bhd 08 November 2016 till 07
November 2021
P
BDMCA/RMP/0317 Page 126 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1941
BRU16102089NP Daily-vite multivitamin syrup
for children
Each 5mL contains:
Vitamin A: 2,000 IU
Vitamin D :400 IU
Vitamin B1 (Thiamine HCl): 1.5 mg
Vitamin B2 (Riboflavin): 1.2 mg
Vitamin B6 (Pyridoxine HCl): 1.0 mg
Vitamin B12 (cyanocobalamin): 3.0
mcg
Niacinamide: 10mg
Vitamin C (Ascorbic Acid): 50 mg
L-Lysine Monohydrochloride: 37.5 mg
Dynapharm (M) Sdn Bhd, Malaysia Medicorp Sdn. Bhd 08 November 2016 till 07
November 2021
GSL
1942BRU16102090NP Ubat Batok Cap Kaki Tiga
(Solution)
Guaifenesin 100mg/5ml Syarikat Wen Ken Drug Sdn Bhd, ,
Malaysia
Syarikat Rajamas Bersama 08 November 2016 till 07
November 2021
GSL
1943BRU16102091P Vaxcel Lignocaine 1% Injection Lignocaine Hydrochloride
1% (50mg/5ml)
Kotra Pharma (M) Sdn. Bhd.,Malaysia Medicorp Sdn. Bhd 08 November 2016 till 07
November 2021
POM
1944 BRU16112092PRisperidone Orally
Disintegrating Tablet 3mgRisperidone 3.0mg Jubilant Generics Ltd, India Asterix United (B) Sdn Bhd
21 March 2017 till
20 March 2022POM
1945 BRU16112093PRisperidone Orally
Disintegrating Tablet 2mgRisperidone 2.0mg Jubilant Generics Ltd, India Asterix United (B) Sdn Bhd
21 March 2017 till
20 March 2022POM
1946 BRU16112094P Goutnor 0.5mg tablet Colchicine 0.5mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn. Bhd.21 March 2017 till
20 March 2022POM
1947 BRU16112095P Salbutamol Syrup 2mg/5ml Salbutamol sulphate 2mg/5mlY.S.P. Industries (M) Sdn. Bhd.,
MalaysiaAsterix United (B) Sdn Bhd.
21 March 2017 till
20 March 2022POM
1948 BRU16112096POspexin 1000mg Film-coated
TabletCephalexin 1000mg Sandoz GmBH, Austria Zuellig Pharma Sdn Bhd.
21 March 2017 till
20 March 2022POM
1949 BRU16112097NP Noflux Tablet 90mg Lysozyme chloride 90mgY.S.P Industries (M) Sdn Bhd,
MalaysiaAsterix United (B) Sdn Bhd.
21 March 2017 till
20 March 2022GSL
1950 BRU16112098NP Calamine Lotion with MentholCalamine powder 15% w/v, zinc oxide
5% w/v and menthol 0.4% w/v
Beacons Pharmaceuticals Pte Ltd.,
Singapore
Hongkiat Trading &
Company
21 March 2017 till
20 March 2022 GSL
1951 BRU16112099PToujeo 300 units/ml Solution
For Injection In Pre-Filled Pen
Insulin glargine 300units/ml
(10.91mg/ml)
Sanofi-Aventis Deutschland GmbH,
GermanyMediPharm Sdn Bhd.
21 March 2017 till
20 March 2022 POM
1952 BRU16112100PApo-Levocarb Tablet
100mg/25mgLevodopa 100mg; Carbidopa 25mg Apotex Inc., Canada Medicorp Sdn Bhd,
21 March 2017 till
20 March 2022POM
1953 BRU16112101PExviera 250mg Film Coated
Tablets
Dasabuvir (as sodium monohydrate)
250mgAbbVie Ireland NL B.V, Ireland Zuellig Pharma Sdn Bhd
21 March 2017 till
20 March 2022POM
1954 BRU16112102NPWhite Balsem, Three Legs
Brand
Methyl salicylate 18% w/w, Menthol
9% w/w and Camphor 5% w/w
Syarikat Wen Ken Drug Sdn Bhd,
MalaysiaSyarikat Rajamas Bersama
21 March 2017 till
20 March 2022 GSL
1955 BRU16112103NPTinea Skin Solution, Three
Legs Brand
Salicylic acid 5% w/v and Benzoic acid
2% w/v
Syarikat Wen Ken Drug Sdn Bhd,
MalaysiaSyarikat Rajamas Bersama
21 March 2017 till
20 March 2022GSL
BDMCA/RMP/0317 Page 127 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1956 BRU16112104NP Three Legs Yellow Lotion Acriflavine 0.1%w/vSyarikat Wen Ken Drug Sdn Bhd,
MalaysiaSyarikat Rajamas Bersama
21 March 2017 till
20 March 2022GSL
1957 BRU16112105PFurosemide-hameln 10mg/ml
InjectionFurosemide 10mg/ml
Hameln Pharmaceuticals
GmbH,Germany Medicorp Sdn Bhd
21 March 2017 till
20 March 2022POM
1958 BRU16112106NPTolnaftate Cream Three Legs
BrandTolnaftate 1% w/v
Syarikat Wen Ken Drug Sdn Bhd,
MalaysiaSyarikat Rajamas Bersama
21 March 2017 till
20 March 2022GSL
1959 BRU16112107NPUbat Serbuk Cap Kaki Tiga
600mg/sac
Acetylsalicylic acid (Aspirin) 600mg /
sachet
Syarikat Wen Ken Drug Sdn Bhd,
MalaysiaSyarikat Rajamas Bersama
21 March 2017 till
20 March 2022GSL
1960 BRU16112108P Denkan (1) Injection
i) Lignocaine HCl monohydrate eq. to
Lignocaine HCl Anhydrous 20mg
(2%w/v)
ii) Epinephrine Acid Tartrate eq. to
Epinephrine 0.01mg (1:100 000)
Duopharma (M) Sdn Bhd., Malaysia. K-Seri Pharma Sdn Bhd.
21 March 2017 till
20 March 2022
POM
1961 BRU16112109NP
5% Dextrose in 0.9% Sodium
Chloride Solution for
Intravenous Infusion
Each 100ml contains: Dextrose
monohydrate 5.00g and Sodium
Chloride 900mg
Euro-Med Laboratories Phil., Inc.,
Philippines Medicorp Sdn Bhd,
21 March 2017 till
20 March 2022 POM
1962 BRU16112110P Zylovaa Tablet 100mg Losartan potassium 100mgXepa-Soul Pattinson (Malaysia) Sdn
Bhd, Malaysia
Hongkiat Trading &
Company21 March 2017 till
20 March 2022POM
1963 BRU16122111P Ceflour Injection 0.75g Cefuroxime Sodium 0.75gYung Shin Pharmaceutical Ind. Co.
Ind., Republic of ChinaK-Seri Pharma Sdn. Bhd.
21 March 2017 till
20 March 2022POM
1964 BRU16122112P Ziagen Tablets 300mg Abacavir 300mg (as abacavir sulphate)GlaxoSmithKline Pharmaceuticals
S.A., PolandZuellig Pharma (B) Sdn Bhd
21 March 2017 till
20 March 2022POM
1965 BRU16122113P Apo-Alendronate 70mg tabletAlendronate Sodium Trihydrate eq to
Alendronic acid 70mgApotex Inc. Canada MediPharm Sdn Bhd
21 March 2017 till
20 March 2022POM
1966 BRU16122114PTensiber Film Coated Tablet
300mgIrbesartan 300mg Lek Pharmaceuticals d.d., Slovenia Medicorp Sdn. Bhd
21 March 2017 till
20 March 2022POM
1967 BRU16122115P Cala-My Lotion Calamine 15% w/v, Zinc Oxide 5% w/vHOE Pharmaceuticals Sdn. Bhd.,
MalaysiaG & H Trading Company
21 March 2017 till
20 March 2022GSL
1968 BRU16122116P Apo-Quetiapine 25mg TabletQuetiapine Fumarate equivalent to
25mg QuetiapineApotex Inc, Canada MediPharm Sdn Bhd
21 March 2017 till
20 March 2022POM
1969 BRU16122117P Apo-Quetiapine 100mg TabletQuetiapine Fumarate equivalent to
100mg QuetiapineApotex Inc, Canada MediPharm Sdn Bhd
21 March 2017 till
20 March 2022POM
1970 BRU16122118P Apo-Quetiapine 200mg TabletQuetiapine Fumarate equivalent to
200mg QuetiapineApotex Inc, Canada MediPharm Sdn Bhd
21 March 2017 till
20 March 2022POM
1971 BRU16122119NP Actimax 500 tablet Paracetamol 500mg Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company21 March 2017 till
20 March 2022GSL (10’s x 15,
10’s x 50 )
1972 BRU16122120NPBetadine® Dry Powder Spray
2.5%Povidone –Iodine 2.5%
Mundipharma Pharmaceuticals
Limited, CyprusZuellig Pharma (B) Sdn. Bhd.
21 March 2017 till
20 March 2022GSL
1973 BRU16122121P Flanil Analgesic Cream
Methyl Salicylate 10.20% w/w,
Menthol 5.44% w/w and
Eugenol1.36% w/w
Biolab Company Ltd., Thailand Hongkiat Trading & Co.21 March 2017 till
20 March 2022 GSL
BDMCA/RMP/0317 Page 128 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1974 BRU16122122NPBetadine® Antiseptic Skin
Cleanser 7.5% w/vPovidone-Iodine 7.5% w/v PT Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn. Bhd.
21 March 2017 till
20 March 2022GSL
1975 BRU16122123POxynorm Sterile Solution for
Injection or Infusion 10mg/mL
Oxycodone hydrochloride 10mg/ml
(equivalent to 9 mg/ml Oxycodone)Hamol Ltd, United Kingdom Zuellig Pharma (B) Sdn. Bhd.
21 March 2017 till
20 March 2022 POM
1976 BRU16122124P Ferriprox 500mg Tablet Deferiprone 500mg Apotex Inc., Canada Medicare21 March 2017 till
20 March 2022POM
1977 BRU16122125P Vaxcel Lignocaine 2% Injection Lignocaine Hydrochloride 2%
(200mg/10ml) Kotra Pharma (M) Sdn. Bhd.,Malaysia Medicorp Sdn. Bhd
21 March 2017 till
20 March 2022POM
1978 BRU16122126POxynorm Oral Solution
5mg/5mL
Each 5ml contains oxycodone base
4.5mg as oxycodone hydrochloride
5mg
Mundipharma Pharmaceuticals
Limited, CyprusZuellig Pharma (B) Sdn. Bhd.
21 March 2017 till
20 March 2022 POM
1979 BRU16122127PShintamet Film Coated Tablet
200mgCimetidine 200mg
Y.S.P. Industries (M) Sdn. Bhd.,
MalaysiaAsterix United (B) Sdn. Bhd.
21 March 2017 till
20 March 2022POM
1980
BRU17012128P Zaltrap™
Concentrate for Solution for
Infusion 25mg/ml (4ml
vial)
Aflibercept 25mg/ml Sanofi-Aventis Deutschland GmbH,
Germany
Medipharm Sdn Bhd 21 March 2017 till
20 March 2022
POM
1981
BRU17012129P Zaltrap™
Concentrate for Solution for
Infusion 25mg/ml (8ml
vial)
Aflibercept 25mg/ml Sanofi-Aventis Deutschland GmbH,
Germany
Medipharm Sdn Bhd 21 March 2017 till
20 March 2022
POM
1982BRU17012130PS1&
BRU17012130PS2
Tarceva Tablet 100mg Erlotinib 100mg (i) Kremers Urban Pharmaceuticals
inc., USA; (ii) Roche SpA, Italy
Hongkiat Trading & Co 21 March 2017 till
20 March 2022
POM
1983BRU17012131PS1 &
BRU17012131PS2
Tarceva Tablet 150mg Erlotinib 150mg (i) Kremers Urban Pharmaceuticals
inc., USA; (ii) Roche SpA, Italy
Hongkiat Trading & Co 21 March 2017 till
20 March 2022
POM
1984BRU17012132P Apo-Gliclazide 30mr MR
tablet
Gliclazide 30mg Apotex Inc. Canada Medicorp Sdn. Bhd 21 March 2017 till
20 March 2022
POM
1985BRU17012133P Glitrol Controlled Release
Capsules 30mg
Gliclazide
30mg
Inventia Healthcare Pte Ltd, India Medicorp Sdn. Bhd 21 March 2017 till
20 March 2022
POM
1986BRU17012134NP Orregel Choline salicylate 8.70% w/w; and
Cetylpyridinium Chloride
0.10% w/w
HOE Pharmaceuticals Sdn. Bhd.,
Malaysia
G & H Trading Company 21 March 2017 till
20 March 2022
GSL
1987
BRU17012135P Gaviscon peppermint tablets Sodium alginate 250mg
Sodium bicarbonate 133.5mg
Calcium carbonate 80mg
Reckitt Benckiser Healthcare (UK)
Limited, Dansom Lane, East Yo
rkshire, Hull HU8
7DS, United Kingdom
Syarikat Aliaa Sdn Bhd 21 March 2017 till
20 March 2022
GSL
1988BRU17012136NP Senokot tablet Sennoside B 7.5mg Reckitt Benckiser Healthcare (UK)
Ltd., UK
Zuellig Pharma Sdn Bhd 21 March 2017 till
20 March 2022
GSL
1989BRU17012137P Tussidex Forte Linctus Dextromethorphan hydrobromide
15mg/5ml
Xepa-Soul Pattinson (Malaysia) Sdn
Bhd, Malaysia
Hong Kiat Tradin
g Co
21 March 2017 till
20 March 2022
POM
BDMCA/RMP/0317 Page 129 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
1990BRU17012138P Floctil 250mg Capsule Azithromycin dihydrate eq. to
Azithromycin 250mg
Unison Laboratories Co. Ltd, Thailand Hong Kiat Tradin
g Co
21 March 2017 till
20 March 2022
POM
1991BRU17012139P Selegos 5mg Tablet Selegiline
Hydrochloride 5mg
Medochemie Ltd., Cyprus Hong Kiat Tradin
g Co
21 March 2017 till
20 March 2022
POM
1992BRU17012140P
Timolol-POS 0.5% Eye DropTimolol maleate 6.84mg/ml Ursapharm Arzneimittel GmbH,
Germany
Medicorp Sdn. Bhd 21 March 2017 till
20 March 2022
POM
1993BRU17012141P
Metformin Tablet 500mgMetformin Hydrochloride 500mg Dynapharm (M) Sdn Bhd., Malaysia Medicorp Sdn. Bhd 21 March 2017 till
20 March 2022
POM
1994BRU17012142P Axcel Cinnarizine Tablet Cinnarizine 25mg Kotra Pharma (M) Sdn. Bhd.,Malaysia Medicorp Sdn. Bhd 21 March 2017 till
20 March 2022
POM
1995BRU17012143NP
UO Cream 100mg/g (10%)
Carbonyldiamide (Urea)
100mg/g (10%)
Y.S.P. Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd, 21 March 2017 till
20 March 2022
GSL
1996
BRU17012144NP Axcel Vitalic Tablet Vitamin B1 (Thiamine) 100mg
Vitamin B6 (Pyridoxine) 200mg
Vitamin B12 (Cyanocobalamine)
200mcg
Kotra Pharma (M) Sdn. Bhd.,Malaysia Medicorp Sdn. Bhd 21 March 2017 till
20 March 2022
P
1997BRU17012145P Iqnyde Tablet 50mg Sildenafil Citrate 70.25mg
equivalent to Sildenafil 50mg
Pharmaniaga Manufacturing Berhad,
Malaysia
G & H Trading Company 21 March 2017 till
20 March 2022
POM
1998 BRU17022146P Azarga Eye Drops SuspensionBrinzolamide 10mg/ml
Timolol maleate 5mg/mlS.A. Alcon, Couvreur N.V., Belgium
Hongkiat Trading &
Company21 March 2017 till
20 March 2022POM
1999 BRU17022147PPharmaniaga Dermasole
Cream 0.1% w/wBetamethasone 17-valerate 0.1% w/w
Pharmaniaga Manufacturing Berhad,
MalaysiaG&H Trading Co
21 March 2017 till
20 March 2022POM
2000 BRU17022148PJardiance 10mg Film-coated
TabletEmpagliflozin 10mg
Boehringer Ingelheim Pharma GmbH
& Co. KG, Germany
Hongkiat Trading &
Company21 March 2017 till
20 March 2022POM
2001 BRU17022149PJardiance 25mg Film-coated
TabletEmpagliflozin 25mg
Boehringer Ingelheim Pharma GmbH
& Co. KG, Germany
Hongkiat Trading &
Company21 March 2017 till
20 March 2022POM
2002 BRU17022150PMeraparon 1000mg Powder
for Solution for Injection
Meropenem Trihydrate equivalent to
1000mg Anhydrous MeropenemSandoz Private Limited, India Zuellig Pharma Sdn Bhd
21 March 2017 till
20 March 2022 POM
2003 BRU17022151PMeraparon 500mg Powder for
Solution for Injection
Meropenem Trihydrate equivalent to
500mg Anhydrous MeropenemSandoz Private Limited, India Zuellig Pharma Sdn Bhd
21 March 2017 till
20 March 2022POM
2004 BRU17022152P Glumet DC Tablet 500mg Metformin hydrochloride 500mgPharmaniaga Manufacturing Berhad,
MalaysiaG&H Trading Co
21 March 2017 till
20 March 2022POM
2005 BRU17022153PTargin Prolonged Release
Tablets 5mg/2.5mg
Each tablet contains:
4.5mg of oxycodone as 5mg
oxycodone hydrochloride
2.25mg of naloxone as 2.5mg naloxone
hydrochloride.
Bard Pharmaceuticals Limited, UK Zuellig Pharma Sdn Bhd
21 March 2017 till
20 March 2022POM
2006 BRU17022154PTargin Prolonged Release
Tablets 10mg/5mg
Each tablet contains:
9mg of oxycodone as 10mg oxycodone
hydrochloride
4.5mg of naloxone as 5mg naloxone
hydrochloride.
Bard Pharmaceuticals Limited, UK Zuellig Pharma Sdn Bhd
21 March 2017 till
20 March 2022POM
BDMCA/RMP/0317 Page 130 of 131
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2017)
2007 BRU17022155PTargin Prolonged Release
Tablets 20mg/10mg
Each tablet contains:
18mg of oxycodone as 20mg
oxycodone hydrochloride
9mg of naloxone as 10mg naloxone
hydrochloride.
Bard Pharmaceuticals Limited, UK Zuellig Pharma Sdn Bhd
21 March 2017 till
20 March 2022POM
2008 BRU17022156PTargin Prolonged Release
Tablets 40mg/20mg
Each tablet contains:
36mg of oxycodone as 40mg
oxycodone hydrochloride
18mg of naloxone as 20mg naloxone
hydrochloride.
Bard Pharmaceuticals Limited, UK Zuellig Pharma Sdn Bhd
21 March 2017 till
20 March 2022
POM
2009 BRU17022157P Pristine Shampoo 2% w/w Ketoconazole 2% w/wXepa-Soul Pattinson (Malaysia) Sdn
Bhd
Hongkiat Trading &
Company21 March 2017 till
20 March 2022POM
2010 BRU17022158NPEffervescent Mouthwash
Tablets
Thymol EP 0.77mg;
Menthol EP 1.87mg JL Bragg Ltd, UKHongkiat Trading &
Company
21 March 2017 till
20 March 2022 GSL
2011 BRU17022159P Salmol Expectorant
Each 5ml contains:
Salbutamol Sulfate equivalent to
Salbutamol 1.0 mg;
Guaiphenesin 50.0 mg
Biolab Co., Ltd, ThailandHongkiat Trading &
Company
21 March 2017 till
20 March 2022 POM
2012 BRU17022160P Acnotin 10 Capsule Isotretinoin 10mgMega Lifesceinces Public Company
Limited, ThailandG&H Trading Co
21 March 2017 till
20 March 2022POM
2013 BRU17022161P Acnotin 20 Capsule Isotretinoin 20mgMega Lifesceinces Public Company
Limited, ThailandG&H Trading Co
21 March 2017 till
20 March 2022POM
2014 BRU17022162P Ketobid Shampoo Ketoconazole 2% w/vSM Pharmaceuticals Sdn Bhd,
MalaysiaG&H Trading Co
21 March 2017 till
20 March 2022POM
2015 BRU17022163P Axcel Glucosamine-500 Tablet
Crystalline Glucosamine Sulphate
Potassium Chloride 665mg equivalent
to Glucosamine Sulphate 500mg
Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd
21 March 2017 till
20 March 2022 GSL
2016 BRU17022164P Cef-4 1G Injection Ceftazidime (as pentahydrate) 1g Siam Bheasach Co., Ltd., Thailand K-Seri Pharma Sdn Bhd21 March 2017 till
20 March 2022POM
BDMCA/RMP/0317 Page 131 of 131