BRUNEI DARUSSALAM MEDICINES CONTROL … Medicinal...brunei darussalam medicines control authority...
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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
No
Product
Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licenceProduct
Classification
1 BRU07100001P Augmentin Injection 1.2g
Co-Amoxiclav 1000/200 - Amoxicillin 1g
as sodium salt, clavulanic acid 200mg as
potassium salt
SmithKline Beecham PLC,
Worthing, West Sussex, UK
Zuellig Pharma 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, UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
3 BRU07100003P Maxipime Injection 1g Cefepime HCl 1gBristol Myers Squibb,
Seromenta Italy
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
4 BRU07100004P Maxipime Injection 500mg Cefepime HCl 500mgBristol Myers Squibb,
Seromenta Italy
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
5 BRU08010001PPharmaniaga Aciclovir Tablet
200mgAciclovir 200mg
Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
6 BRU08010002PPharmaniaga Ketoconazole
Tablet 200mgKetoconazole 200mg
Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
7 BRU08010003PPharmaniaga Clarithromycin
Tablet 250mgClarithromycin 250mg
Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
8 BRU08010004PPharmaniaga Fluconazole
150mg CapsulesFluconazole 150mg
Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
9 BRU08010005PPharmaniaga Ciprofloxacin
Tablet 500mgCiprofloxacin 500mg
Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
10 BRU08010006PPharmaniaga Ciprofloxacin
Tablet 250mgCiprofloxacin 250mg
Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading
Company
06 October 2010 till 05
October 2015POM
11 BRU08010009P Meronem Injection 1g Meropenem (as trihydrate) 1g AstraZeneca UK Ltd, UKZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
12 BRU08020010P Meronem Injection 500mg Meropenem (as trihydrate) 500mg AstraZeneca UK Ltd, UKZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
13 BRU08020011P Bactroban Cream Mupirocin 2% SmithKline Beecham Plc, UKZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 1 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
14 BRU08020012PPharmaniaga Cephalexin
Capsule 500mgCephalexin 500mg
Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
15 BRU08020013PPharmaniaga Metronidazole
Tablet 200mg Metronidazole 200mg
Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading
Company
06 October 2010 till 05
October 2015POM
16 BRU08020014P Baraclude Tablet 1mg Entecavir 1mg Bristol-Myers Squibb, USAZuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
17 BRU08020015P Baraclude Tablet 0.5mg Entecavir 0.5mg Bristol-Myers Squibb, USAZuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
18 BRU08020016P Anikef Sterile 750mg Cefuroxime 750mgDuopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
19 BRU08020017P Bicafar Sterile 1g Cefoperazone 1gDuopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
20 BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5mlDuopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
21 BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5mlDuopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
22 BRU08020020P Diprivan 1%, 20ml Ampoule Propofol 0.1% Corden Pharma S.P.AZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
23 BRU08020021P Retrovir Capsule 100mg Zidovudine 100mg SmithKline Beecham Plc, UKZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
24 BRU08020022P Bactroban Ointment Mupirocin 2%GlaxoSmithKline Philippines
Inc, Philippines
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
25 BRU08030023P Augmentin Tablet 625mg
Amoxycillin 500mg (as trihydrate);
Clavulanic acid 125mg (as Potassium
Clavulanate)
SmithKline Beecham Plc,
Worthing, UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
26 BRU08030024P Augmentin Syrup 228mg/5ml
Amoxycillin 200mg/5ml (as trihydrate);
Clavulanic acid 28.5mg/5ml (as
Potassium Clavulanate)
SmithKline Beecham Plc,
Worthing, UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
27 BRU08030025P Augmentin Syrup 457mg/5ml
Amoxycillin 400mg/5ml (as trihydrate);
Clavulanic acid 57mg/5ml (as Potassium
Clavulanate)
SmithKline Beecham Plc,
Worthing, UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
28 BRU08030026P Augmentin Tablet 1g
Amoxycillin 875mg (as trihydrate);
Clavulanic acid 125mg (as Potassium
Clavulanate)
SmithKline Beecham Plc,
Worthing, UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 2 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
29 BRU08030027P Foban Cream Fusidic acid 2%Hoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
30 BRU08030028P Androxyl Syrup 125mg/5ml Cefadroxil (as monohydrate)Duopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
31 BRU08030029P Androxyl Syrup 250mg/5ml Cefadroxil (as monohydrate)Duopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
32 BRU08030030P Garasent 80mg Injection Gentamicin 40mg/ml (as Sulphate)Duopharma (M) Sdn Bhd,
Malaysia
K-Seri Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
33 BRU08030031P Retrovir 1% IV Infusion Zidovudine 1%Glaxo Operations UK
Limited, UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
34 BRU08030032P Genta Eye Drop 0.3%w/v Gentamicin (as Sulphate)Duopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
35 BRU08030033P Zinacef Injection 250mg Cefuroxime (as sodium)GlaxoSmithKline
Manufacturing SPA, Italy.
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
36 BRU08030034P Zinacef Injection 750mg Cefuroxime (as sodium)GlaxoSmithKline
Manufacturing SPA, Italy.
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
37 BRU08030035P Zinacef Injection 1.5g Cefuroxime (as sodium)GlaxoSmithKline
Manufacturing SPA, Italy.
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
38 BRU08030036P Zinnat Tablet 125mg Cefuroxime (as axetil)Glaxo Operations UK
Limited, UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
39 BRU08030037P Zinnat Tablet 250mg Cefuroxime (as axetil)Glaxo Operations UK
Limited, UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
40 BRU08040039P Solulexin Granules 125mg/5mlCefalexin Monohydrate equivalent to
Cefalexin 125mg/5ml
Duopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
41 BRU08040040P Retrovir Syrup Zidovudine 50mg/5mlGlaxoSmithKline Inc.,
Canada
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
42BRU08040041PS1 &
BRU08040041PS2Zeffix Tablet Lamivudine 100mg
Glaxo Wellcome Operations
UK Ltd, UK (S1);
GlaxoSmithKline
Pharmaceuticals S.A., Poland
(S2)
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
43 BRU08040042P Combivir Tablet Lamivudine 100mg, Zidovudine 300mgGlaxoSmithKline
Pharmaceuticals S.A., Poland
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
44 BRU08040043P Zoraxin Syrup Aciclovir 200mg/5mlDuopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
45 BRU08040044P Trizole TabletSulfamethoxazole 400mg; Trimethoprim
80mg
Duopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
BDMCA/RMP/1215 Page 3 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
46 BRU08040045P Apalin Solution for Injection Amikacin Sulphate 500mgDuopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
47 BRU08040046P Genta-Bet Eye Drops
Gentamicin (as Sulphate) 0.3%,
Betamethasone Disodium Phosphate
0.1%
Duopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
48 BRU08040047P Bicafar Sterile 2g (vial) Cefoperazone (as Sodium) 2gDuopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
49 BRU08040049PDiflucan IV Infusion 2mg/ml
(50ml)Fluconazole 2mg/ml Pfizer PGM, France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
50 BRU08040050P Sulperazone IM/IV 1gSulbactam (as Sodium) 500mg;
Cefoperazone (as Sodium) 500mg
Haupt Pharma Latina S.r.I.,
Italy
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
51 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 2015POM
52 BRU08040052P Becarin Cream 2% Miconazole Nitrate 2%Upha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015GSL
53 BRU08050053PPharmaniaga Aciclovir Tablet
400mgAciclovir 400mg
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
54 BRU08050054PPharmaniaga Cephalexin
Capsule 250mg
Cephalexin (as Anhydrous) Cephalexin
250mg
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
55 BRU08050055P Androxyl Capsule 250mgCefadroxil Monohydrate equivalent to
Cefadroxil 250mg
Duopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
56 BRU08050056P Androxyl Capsule 500mg Cefadroxil (as Monohydrate) 500mgDuopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
57 BRU08050057P Quilaxin Tablet 400mg Pefloxacin Mesylate Dihydrate 400mgDuopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
58 BRU08050058P Ketozotan Tablet 200mg Ketoconazole 200mgDuopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
59 BRU08050060P Unocef Injection 500mg (Vial) Ceftriaxone (as Sodium) 500mgDuopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
60 BRU08050061P Unocef Injection 1000mg (Vial) Ceftriaxone (as Sodium) 1000mgDuopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
61 BRU08050062PGarasent 280mg Injection (2ml
Ampoule)Gentamicin (as Sulphate BP) 280mg
Duopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
62 BRU08050063P Solulexin Capsule 250mgCephalexin Monohydrate 262.95mg
equivalent to Cephalexin 250mg
Duopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
BDMCA/RMP/1215 Page 4 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
63 BRU08050064P Solulexin Capsule 500mg Cephalexin (as Monohydrate) 500mgDuopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
64 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 2010 till 05
October 2015POM
65 BRU08050066P Beagenta Eye/ Ear DropsGentamicin Sulphate equivalent to
Gentamicin 0.3%w/w
Duopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
66 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 2015POM
67 BRU08050068P Krisovin Tablet 500 Griseofulvin BP 500mg (micronised)Upha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
68 BRU08050069P Plaquenil Tablet Hydroxychloroquine Sulphate 200mg Sanofi-Synthelabo Ltd, UK Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
69 BRU08050070P Betacin Eye Ear Drop
Neomycin Sulphate 0.5% w/v;
Betamethasone Sodium Phosphate
0.1%w/v
Duopharma (M)Sdn Bhd,
Malaysia
K-Seri Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
70 BRU08050071P Foban Ointment Sodium Fusidate BP 2% w/vHoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
71 BRU08050072P Fobancort Cream
Fusidic acid 2%w/w; Betamethasone
Dipropionate 0.064%w/w equivalent to
Betamethasone 0.05%w/w
Hoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
72 BRU08050073P Dezor Cream Ketoconazole 2%w/wHoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
73 BRU08050074P Dezor Shampoo Ketoconazole 2%w/wHoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
74 BRU08060075P Genta-Dex Eye DropsGentamicin 0.3% w/v; Dexamethsone
Phosphate 0.1%w/v
Duopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
75 BRU08060077P Aecoras OintmentEconazole Nitrate 10mg; Triamcinolone
Acetonide 1mg
Tai Guk Pharm Co. Ltd.,
Korea
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
76 BRU08060078P Beapen VK Granules 125mg Phenoxymethypenicillin 125mg/5mlUpha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
77 BRU08060079P Enoxin Tablet 500mg Ciprofloxacin 500mgUpha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
BDMCA/RMP/1215 Page 5 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
78 BRU08060080P Beta Eye/ Ear Drops Betamethasone Sodium Phosphate 0.1%Duopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
79 BRU08060081P Betagen Eye/ Ear DropsGentamicin 0.3% w/v; Dexamethsone
Phosphate 0.1%w/v
Duopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
80 BRU08060082P Muprin Ointment Mupirocin 2.0%w/wHoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
81 BRU08060083P Eryson Granules 200Erythromycin ethylsuccinate equiv. to
eryhtromycin 200mg/5ml
Upha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
82 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 2015POM
83 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 2015POM
84 BRU08060086P Foban Hydro Cream Fusidic acid 2%; Hydrocortisone 1%Hoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
85 BRU08060087P Foban Hydro Ointment Sodium Fusidate 2%; Hydrocortisone 1%Hoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
86 BRU08060088P Arava Tablet 10mg Leflunomide 10mgSanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
87 BRU08060089P Arava Tablet 20mg Leflunomide 20mgSanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
88 BRU08070090P Zinnat Suspension 125mg/5mlCefuroxime Axetil equivalent to
Cefuroxime 250mg
Glaxo Wellcome Bernard
Castle, United Kingdom
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
89 BRU08070091P Metronol 0.5%w/v Injection Metronidazole 0.5% w/vAin Medicare Sdn Bhd,
Malaysia
Syarikat Pakatan
Indah
06 October 2015 till 05
October 2020POM
90 BRU08070092P Eryson Tablet 250Erythromycin Stearate BP equivalent to
Eryhthromycin 250mg
Upha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
91 BRU08070093P Neomycin Cream Neomycin sulphate 0.5%w/wHoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2010 till 05
October 2015POM
92 BRU08070094P Ecocort CreamEconazole Nitrate 1% w/w;
Triamcinolone Acetonide 0.1% w/w
Hoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
93 BRU08070095P Beprogent Ointment Betamethasone 0.05%; Gentamicin 0.1%Hoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
94 BRU08070096P Betamox Capsule 250mgAmoxicillin Trihydrate equivalent to
Amoxicillin 250mg
Duopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
BDMCA/RMP/1215 Page 6 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
95 BRU08070097P Aprovel Tablet 300mg Irbesartan 300mgSanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
96 BRU08070099P Atacand Tablet 8mg Candesartan Cilexetil 8mg AstraZeneca AB, SwedenZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
97 BRU08070100P Atacand Tablet 16mg Candesartan Cilexetil 16mg AstraZeneca AB, SwedenZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
98 BRU08070101P Zovirax Suspension 200mg/5ml Acyclovir 200mg/5mlGlaxoSmithKline GmbH & Co
Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
99 BRU08070102P Fortum® Injection 500mg Ceftazidime (as Pentahydrate) 500mgGlaxoSmithKline
Manufacturing SPA, Italy
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
100 BRU08070103P Fortum® Injection 1g Ceftazidime (as Pentahydrate) 1gGlaxoSmithKline
Manufacturing SPA, Italy
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
101 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 2010 till 05
October 2015POM
102 BRU08080106P Candazole Cream Clotrimazole 1.0%Hoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020GSL
103 BRU08080107P Gentamicin Cream Gentamicin (as Sulphate) 0.1%Hoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
104 BRU08080108P Beprogent CreamBetamethasone (as dipropionate) 0.05%,
Gentamicin (as sulphate 0.1%)
Hoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
105 BRU08080109P Unasyn Tablet 375mgSultamicillin (as tosilate) 375mg
(Ampicillin 250mg & Sulbactam 125mg)
Pfizer Global Supply Japan
Inc, Japan
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
106 BRU08080110PZovirax Dispersable Tablet
200mgAciclovir 200mg Glaxo Wellcome, S.A., Spain
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
107 BRU08080111P Valtrex® 500mg Tablet Valciclovir (as HCl) 500mg Glaxo Wellcome SA, SpainZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
108 BRU08080112P Fortum® Injection 2g Ceftazidime (as pentahydrate) 2gGlaxoSmithKline
Manufacturing SPA, Italy
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
109 BRU08080113P Uphalexin Capsule 250 Cephalexin (as monohydrate) 250mgUpha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
110 BRU08080114P Uphalexin Capsule 500 Cephalexin (as monohydrate) 500mgUpha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
111 BRU08080115PVaxcel Cefuroxime 750mg
InjectionCefuroxime (as sodium) 750mg
Kotra Pharm (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 7 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
112 BRU08080116P Vaxcel Ceftriaxone 1g Injection Ceftriaxone (as sodium) 1gKotra Pharm (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
113 BRU08080117P Axcel Fusi-Corte CreamFusidic acid 2%, Betamethasone (as 17-
valerate) 0.1%
Kotra Pharm (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
114 BRU08090118P Verorab Injection
Inactivated rabies virus (Wistar strain
RABIES PM/WI 38-1503-3M) produced
on VERO cell line, inactivated and purifed
Sanofi Pasteur, FranceZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
115 BRU08090119P Decocort CreamMiconazole Nitrate 2%w/w;
Hydrocortisone 1% w/w
Hoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
116 BRU08090120P Fobancort Ointment
Sodium Fusidate 2%w/w;
Betamethasone 0.05%w/w (as
Dipropionate 0.064%)
Hoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
117 BRU08090121P Candacort CreamClotrimazole 1.0% w/w; Hydrocortisone
1.0%w/w
Hoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
118 BRU08090122P Hepsera Tablet 10mg Adefovir dipivoxil 10mgGlaxosmithKline (Tianjin)
Co.Ltd, China
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
119 BRU08090124PCiprobay® 200 Infusion
SolutionCiprofloxacin (as lactate) 200mg
Bayer Pharma AG,
Leverkeusen, Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
120 BRU08090125P Vaxcel Ceftazidime 2g Ceftazidime (as pentahydrate) 2gKotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
121 BRU08090126P Axcel Fusidic Cream Fusidic acid 2% w/wKotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
122 BRU08090127P Axcel Fusidic Ointment Sodium Fusidate 2%w/wKotra Pharm (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
123 BRU08090128P Vaxcel Ceftazidime 1g Ceftazidime (as pentahydrate) 1gKotra Pharm (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
124 BRU08090129P Axcel Miconazole Cream Miconazole Nitrate 2% w/wKotra Pharm (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020GSL
125 BRU08090130PCiprobay 100 Infusion Solution
x 50mlCiprofloxacin (as lactate) 100mg
Bayer Pharma AG,
Leverkeusen, Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020P
126 BRU08090131P Beamoxy Capsule 500 Beamoxy Capsule 500Upha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
127 BRU08090132P Aroxin Capsule 250mg Amoxicillin (as trihydrate) 250mg
Agila Specialties Private
Limited, India; Medreich
Limited Unit-1, Bangalore,
India
G & H Trading
Company
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 8 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
128 BRU08090133NPDhamol Suspension
250mg/5mlParacetamol 250mg/5ml
Drug House of Australia
(Asia) Pte Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020P
129 BRU08100134P Decozol Cream Miconazole Nitrate 2%w/wHoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020GSL
130 BRU08100135P Betamox Capsule 500mgBRU08090127P
Duopharma (M) Sdn Bhd
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
131 BRU08100136PZovirax Dispersable Tablet
800mgAciclovir 800mg Glaxo Wellcome S.A., Spain
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
132 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 2010 till 05
October 2015POM
133 BRU08100138P Uphalexin Granules 250 Cephalexin (as Monohydrate) 250mgUpha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
134 BRU08100139P Ciprobay® 500 TabletCiprofloxacin (as HCl monohydrate)
500mg
Bayer Pharma AG,
Leverkeusen, Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
135 BRU08100140PAvelox Infusion Solution
0.4g/250mlMoxifloxacin (as Hydrochloride) 400mg
Bayer Pharma AG,
Leverkusen, Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
136 BRU08100141P Avelox 400mg Tablet Moxifloxacin (as Hydrochloride) 400mgBayer Pharma AG,
Leverkusen, Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
137 BRU08100142P Candazole Lotion Clotrimazole 1%w/wHoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020GSL
138 BRU08100143P Allopurinol 100mg Tablet Allopurinol 100mgDrug Houses of Australia Pte
Ltd
G & H Trading
Company
06 October 2015 till 05
October 2020POM
139 BRU08100144P Bifen Suspension 100mg/5ml Ibuprofen BP 100mg/5mlDrug Houses of Australia Pte
Ltd
G & H Trading
Company
06 October 2015 till 05
October 2020P
140 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)
141 BRU08100146NP Silfazine Cream Silver Sulfadiazine 1%w/wSunward Pharmaceutical
Sdn Bhd Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020P
142 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
143 BRU08100148P Erythro Ethyl GranulesErythromycin (as ethyl succinate)
200mg/5ml
Drug Houses of Australia
Pte. Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
144 BRU08100149P Eryhthro Tablets 250mg Erythromycin (as stearate) 250mgDrug Houses of Australia
Pte. Ltd, Singapore
G & H Trading
Company
06 October 2010 till 05
October 2015POM
145 BRU08110150PAvaxim 160U Suspension for
Injection in a prefilled Syringe
Inactivated Hepatitis A Virus (GBM
strain) 160u/0.5mlSanofi Pasteur France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 9 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
146 BRU08110151P Aprovel 150mg Tablet Irbesartan 150mgSanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
147 BRU08110152P Zovirax IV for Infusion 250mg Aciclovir 250mgGlaxoSmithKline
Manufacturing SPA Italy
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
148 BRU08110153P Axcel Aciclovir Cream 5%w/w Aciclovir 5%w/wKotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
149 BRU08110154PAxcel Eryhthromycin ES Tablet
400mgErythromycin (as ethyl succinate) 400mg
Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
150 BRU08110155P Axcel Cephalexin-500 Capsule Cephalexin (as monohydrate) 500mgKotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
151 BRU08110156PAxcel Eryhthromycin ES-200
Suspension
Erythromycin (as Ethylsuccinate)
200mg/5ml
Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
152 BRU08110157P Soden Tablet 275mg Naproxen Sodium BP 275mgDrug House of Australia
(Asia) Pte Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
153 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)
154 BRU08110159P Miconazole Cream 2.0%w/w Miconazole Nitrate 2.0%w/wSunward Pharmaceutical
Sdn Bhd Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020GSL
155 BRU08110160P Malarone Tablet Atovaquone 250mg, Proguanil HCl
100mgGlaxoSmithKline Inc Canada
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
156 BRU08110162P Cordarone Tablet 200mg Amiodarone HCl 200mgSanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
157 BRU08110163PCoAprovel 150/12.5mg Film-
coated Tablet
Irbesartan 150mg, Hydrochlorothiazide
12.5mg
Sanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
158 BRU08110164P Dhaperazine Tablet 5mg Prochlorperazine (as maleate) 5mgDrug House of Australia
(Asia) Pte Ltd, Singapore
G & H Trading
Company
06 October 2010 till 05
October 2015POM
159 BRU08110165P Betasone Cream 0.1%w/wBetamethasone (as 17-valerate)
0.1%w/w
Drug Houses of Australia Pte
Ltd
G & H Trading
Company
06 October 2015 till 05
October 2020POM
160 BRU08120166P Ciprobay 250 Tablet Ciprofloxacin (as HCl monohydrate)
250mg
Bayer Pharma AG,
Leverkusen, Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
161 BRU08120167PAxcel Cephalexin 250mg
CaspuleCephalexin (as Monohydrate) 250mg
Kotra Pharma (M) Sdn Bhd
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
162 BRU08120168PAxcel Cephalexin 125mg
SuspensionCephalexin (as Monohydrate) 125mg
Kotra Pharma (M) Sdn Bhd
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
163 BRU08120169P Cloxacillin Capsule 250 Cloxacillin (as Sodium) 250mgUpha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
BDMCA/RMP/1215 Page 10 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
164 BRU08120170P Hydrocrotisone Cream 1% w/w Hydrocortisone acetate BP 1%w/wUpha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
165 BRU08120171P Beamoxy Tablet 250 Amoxicillin (as trihydrate) 250mgUpha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
166 BRU08120172P Betamox Tablet 125 Amoxicillin (as trihydrate) 125mgDuopharma (M) Sdn Bhd
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
167 BRU08120173P Ventolin Respirator Solution Salbutamol (as sulphate) 0.5%w/v Glaxo Operations UK Ltd, UKZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
168 BRU08120174P Dhacopan Syrup 5mg/5ml Hyoscine (as butylbromide) BP 5mg/5mlDrug Houses of Australia Pte
Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
169 BRU08120175P Phenexpect SyrupPer 5ml - Diphenhydramine (as HCl)
12.5mg, Ammonium Chloride 135mg
Drug Houses of Australia Pte
Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
170 BRU08120176P Dhabesol Cream 0.05% Clobetasol (as propionate) 0.05% w/vDrug House of Australia
(Asia) Pte Ltd, Singapore
G & H Trading
Company
06 October 2010 till 05
October 2015POM
171 BRU08120177P Beprosalic LotionBetamethasone (as dipropionate) 0.05%,
Salicylic acid 2.0%
Hoe Pharmaceuticals Sdn
Bhd Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
172 BRU08120178P Zenmolin Syrup 2mg/5ml Salbutamol (as sulphate) BP 2mg/5mlDrug Houses of Australia Pte
Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
173 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
174 BRU08120180PZithromax Film-coated Tablet
250mgAzithromycin (as dihydrate) 250mg
Haupt Pharma Latina S.r.l,
Italy
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
175 BRU09010181P Unasyn 0.75mg IM/IVAmpicillin (as sodium) 500mg; Sulbactam
(as sodium) 250mg
Haupt Pharma Latina S.r.l,
Italy
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
176 BRU09010182P Unasyn 3.0g IM/IVAmpicillin (as sodium) 2000mg;
Sulbactam (as sodium) 1000mg
Haupt Pharma Latina S.r.l,
Italy
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
177 BRU09010183PVaxcel Ceftriaxone-500mg
InjectionCeftriaxone (as sodium) 500mg
Kotra Pharma (M) Sdn Bhd
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
178BRU09010184PS1;
BRU09010184PS2 Aroxin granules 125mg/5ml Amoxicillin (as trihydrate) 125mg/5ml
Drug Houses of Australia Pte
Ltd, Singapore (S1);
Medreich Limited Unit-1,
India (S2)
G & H Trading
Company
06 October 2015 till 05
October 2020POM
179 BRU09010185P Pacofen TabletParacetamol 500mg; Codeine Phosphate
8mg; Caffeine anhydrous 30mg
Drug House of Australia
(Asia) Pte Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 11 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
180 BRU09010186P Plavix Tablet 75mgClopidogrel (as Hydrogen Sulphate)
75mg
Sanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
181 BRU09010187PSymbicort Turbuhaler
160/4.5mcg dose
Budenoside 160mcg; Formoterol
fumarate dihydrate 4.5mcg
AstraZeneca AB, Sodertalje,
Sweden
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
182 BRU09010188PCoAprovel 300/12.5mg film-
coated tablet
Irbesartan 300mg; Hydrochlorothiazide
12.5mg
Sanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
183 BRU09010189P Vasican Syrup 4mg/5ml Bromhexine HCl BP 4mg/5mlDrug House of Australia Pte
Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
184 BRU09010190P Cardium 30 tablet Diltiazem HCl 30mgDrug House of Australia
(Asia) Pte Ltd, Singapore
G & H Trading
Company
06 October 2010 till 05
October 2015POM
185BRU09010191PS1 &
BRU09010191PS2Coversyl 8mg tablet Perindopril tert-butylamine 8mg
Les Laboratoires Servier
Industrie, France (S1) &
Kotra Pharma (M) Sdn. Bhd,
Malaysia (S2)
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
186 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
187 BRU09010193P Fleming Tablet 1g
Amoxicillin (as trihydrate) 875mg;
Clavulanic acid (as Potassium
Clavulanate) 125mg
Medreich Limited IndiaAsterix United (B)
Sdn Bhd
06 October 2010 till 05
October 2015POM
188 BRU09010194PPulmicort turbuhaler
100mcg/doseBudenoside 100mcg
AstraZeneca AB, Sodertalje,
Sweden
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
189 BRU09010195P Lantus for Optipen 100iu/ml Insulin glargine 100iu/mlSanofi Aventis Deutschland,
GermanyMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
190 BRU09020196P Zovirax Cream 5% Aciclovir 5%w/wGlaxo Wellcome Opertions,
UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
191 BRU09020197P Zovirax Eye Ointment 3% Aciclovir 3%w/wJubilant HollisterStier
General Partnership, Canada
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
192 BRU09020198P Adenocor Injection 6mg/2ml Adenosine 6mg/2ml
Famar Health Care Services
Madrid S.A.U., Madrid,
Spain
Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
193 BRU09020199P Dhatrin Paediatric Suspension Trimethoprim BP 40mg/5ml;
Sulphamethoxazole BP 200mg/5ml
Drug Houses of Australia Pte
Ltd, Singapore
G & H Trading
Company
06 October 2010 till 05
October 2015POM
194 BRU09020200P Amedin 10 Tablet Amlodipine BP (as besilate) 10mg Medreich Limited IndiaAsterix United (B)
Sdn Bhd
06 October 2010 till 05
October 2015POM
195 BRU09020201NPDhamol Suspension
500mg/5mlParacetamol BP 500mg/5ml
Drug Houses of Australia Pte
Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020P
196 BRU09020202P Amedin 5 Tablet Amlodipine BP (as besilate) 5mg Medreich Limited IndiaAsterix United (B)
Sdn Bhd
06 October 2010 till 05
October 2015POM
BDMCA/RMP/1215 Page 12 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
197 BRU09020203P Fleming Tablet 625mg
Amoxicillin (as trihydrate) 500mg;
Clavulanic acid (as Potassium
Clavulanate) 125mg
Medreich Limited IndiaAsterix United (B)
Sdn Bhd
06 October 2010 till 05
October 2015POM
198 BRU09020204P Beamoxy Tablet 500 Amoxicillin (as trihydrate 575mg) 500mgUpha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
199 BRU09020205P Fedac SyrupPseudoephedrine 30mg/5ml; Triprolidine
1.25mg/5ml
Drug House of Australia
(Asia) Pte Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
200 BRU09020206PBricanyl Turbuhaler
0.5mg/doseTerbutaline Sulphate 0.5mg/dose
AstraZeneca AB, Sodertalje,
Sweden
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
201 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
202 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
203 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
204 BRU09020210P Declovir Cream Acyclovir 5.0% w/wHOE Pharmaceutical Sdn
Bhd, MalaysiaG & H Trading & Co
06 October 2015 till 05
October 2020POM
205 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
206 BRU09020212P Glucobay 50 Tablet Acarbose 50mgBayer Pharma AG,
Leverkusen, Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
207 BRU09030213P 3TC Tablet 150mg Lamivudine 150mgGlaxo Wellcome Operaions,
UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
208 BRU09030214P 3TC Oral Solution 10mg/ml Lamivudine 10mg/mlGlaxoSmithKline Inc.,
Canada
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
209 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
210 BRU09030216PCordarone Injection
150mg/3mlAmiodarone 150mg/3ml
Sanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
211BRU09030217PS1 &
BRU09030217PS2Vastarel MR 35mg Tablet Trimetazidine HCl 35mg
Les Laboratoires Servier
Industrie, France (S1); Kotra
Pharma (M) Sdn. Bhd,
Malaysia (S2)
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 13 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
212
BRU09030218P0.5g
S &
BRU09030218P0.5g
A
Tetavax Suspension for
Injection (Single dose 0.5ml)Purified Tetanus Toxoid Sanofi Pasteur, France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
213 BRU09030219PCataflam 1.5% Oral Drops
SuspensionDiclofenac Sodium 15mg/ml Novartis Farma SpA, France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
214 BRU09030220P Vaxigrip Influenza Vaccine
Split influenza virus*, inactivated
containing antigens equivalent to the
following strains per one 0.5ml dose:
A/California/07/2009 NYMC X-179A
(H1N1) 15 mcg HA **;
A/South Australia/55/2014 IVR 175
(H3N2)15 mcg HA **;
B/Phuket/3073/2013(Yamagata lineage)
15 mcg HA **; B/Brisbane/60/2008
(Victoria lineage) 15 mcg HA ** (SH2015)
Note - * Propagated in fertilized hens’
egg from healthy chicken flocks
** haemagglutinin
Sanofi Pasteur, FranceZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
215 BRU09030221PLignocaine HCl BP Injection 1%
(5ml)
Lidocaine HCl (Lignocaine HCl) 1%
(50mg/5ml)
Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
216 BRU09030222P Crestor 5mg Tablet Rosuvastatin Calcium 5mgIPR Pharmaceuticals Inc.,
Puerto Rico
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
217 BRU09030223P Crestor 20mg Tablet Rosuvastatin Calcium 20mgIPR Pharmaceuticals Inc.,
Puerto Rico
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
218 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
219 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
220 BRU09030226P Benosone-N CreamBetamethasone (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
221 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 2010 till 05
October 2015POM
BDMCA/RMP/1215 Page 14 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
222 BRU09030228P U-Closone Cream Clobetasone butyrate 0.05%w/wHOE Pharmaceutical Sdn
Bhd, MalaysiaG & H Trading & Co
06 October 2015 till 05
October 2020POM
223 BRU09040229PUnasyn Powder for Oral
Suspension 250mg/5mlSultamicillin (as tosilate) 250mg
Pfizer Global Supply Japan,
Inc., Japan
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
224 BRU09040230P Axcel Cefuroxime-250 Capsule Cefuroxime (as axetil) 250mgKotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
225 BRU09040231P Knowful Capsule 400mg Piracetam 400mgYSP Industries (M) Sdn Bhd,
Malaysia
Asterix United (B)
Sdn Bhd
06 October 2015 till 05
October 2020POM
226
BRU09040232P0.5g
V &
BRU09040232P0.5g
S
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 Sdn
Bhd
06 October 2015 till 05
October 2020POM
227 BRU09040233P Voltaren Suppository 25mg Diclofenac (as Sodium) 25mgDelpharm Huningue S.A.S.,
France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
228 BRU09040234P Tidact Capsule 150mg Clindamycin (as hydrochloride) 150mgYSP Industries (M) Sdn Bhd,
Malaysia
Asterix United (B)
Sdn Bhd
06 October 2015 till 05
October 2020POM
229 BRU09040235PVoltaren 75mg/3ml solution
for injectionDiclofenac Sodium 75mg/3ml
Novartis Pharma Stein, ag,
Switzerland; Lek
Pharmaceuticals d.d,
Slovenia
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
230 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 Sdn
Bhd
06 October 2015 till 05
October 2020POM
231 BRU09040237PDepo-Medrol Sterile Aqueous
Suspension 40mg/ml (5ml)Methylprednisolone Acetate 200mg/5ml
Pfizer Manufacturing
Belgium NV, Belgium
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 15 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
232 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 Sdn
Bhd
06 October 2015 till 05
October 2020POM
233 BRU09040239PBupivacaine Hydrochloride BP
0.5% w/v injectionBupivacaine hydrochloride BP 0.5%w/v
Pfizer (Perth) Pty Ltd,
Australia
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
234 BRU09040240P Rhinathiol Capsule 375mg Carbocisteine 375mgSanofi-aventis Egypt s.a.e.,
EgyptMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
235 BRU09040241P Celebrex Capsule 200mg Celecoxib 200mgPfizer Pharmaceutical LLC,
Vega Baja Puerto Rico
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
236 BRU09040242P Voltaren® SR Tablet 100mg Diclofenac sodium 100mg Novartis Farma SPA, ItalyZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
237 BRU09040243P T3 Mycin GelClindamycin (as phosphate) 1.0% HOE Pharmaceutical Sdn
Bhd, MalaysiaG & H Trading & Co
06 October 2015 till 05
October 2020POM
238 BRU09040244P Cloderm Cream Clobetasone (as butyrate) 0.05%w/wHOE Pharmaceutical Sdn
Bhd, MalaysiaG & H Trading & Co
06 October 2015 till 05
October 2020POM
239 BRU09040245P Bisacodyl Suppositroies Bisacodyl (micronised) 10mgYSP Industries (M) Sdn Bhd,
Malaysia
Asterix United (B)
Sdn Bhd
06 October 2015 till 05
October 2020P
240 BRU09040246P U-Closone Ointment Clobetasol (as propionate) 0.05%w/wHOE Pharmaceutical Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
241 BRU09040247P Nexium® IV 40mg Esomeprazole (as sodium) 40mg AstraZeneca AB, SwedenG & H Trading
Company
06 October 2015 till 05
October 2020POM
242 BRU09050248NP Dhactulose Syrup Lactulose 67%w/wDrug Houses of Australia Pte
Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020
GSL (200mL)
& P(1L)
243 BRU09050249P Vastarel 20mg Tablet Trimetazidine dihydrochloride 20mgLes Laboratoires Servier
Industrie, France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
244 BRU09050250P Coversyl Plus TabletPerindopril tert-butylamine 4mg,
Indapamide 1.25mg
Les Laboratoires Servier
Industrie, France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
245 BRU09050251P Methyldopa Tablet 250mg Methyldopa (as anhydrous) 250mgDrug House of Australia
(Asia) Pte Ltd, Singapore
G & H Trading
Company
06 October 2010 till 05
October 2015POM
246 BRU09050252P Glucobay Tablet 100mg Acarbose 100mgBayer Pharma AG,
Leverkusen, Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
247 BRU09050253P Benosone-N OintmentBetamethasone (as valerate 0.12% w/w)
0.01%, Neomycin Sulphate 0.50%w/w
HOE Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
248 BRU09050254P Benosone Ointment Betamethasone 0.01% w/wHOE Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 16 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
249 BRU09050255P Mycosone Cream
Miconazole nitrate 2% w/w,
Hydrocortisone ( as acetate1.12%) 1%
w/w
Sunward Pharmaceutical
Sdn Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
250 BRU09050256P H-Cort Ointment Hydrocortisone 1% w/wHOE Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
251 BRU09050257P T3 Mycin Lotion Clindamycin (as phosphate) 1.0% w/vHOE Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
252 BRU09050258P Lobesol Cream Clobetasol (as propionate) 0.05%w/wSunward Pharmaceutical
Sdn Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
253 BRU09060259PVaxcel Cefuroxime 1.5g
InjectionCefuroxime (as sodium) 1.5g
Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05
October 2020POM
254 BRU09060260PTetavax Suspension for
InjectionTetanus toxoid 40i.u/0.5ml dose
Sanofi Pasteur, Lyon,
Pasteur
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
255 BRU09060261P Beamoxy Capsule 250 Amoxycillin (as trihydrate) 250mgUpha Pharmaceutical Mfg
(M) Sdn Bhd
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
256 BRU09060262P Betamox Tablet 250mg Amoxicillin (as trihydrate) 250mgDuopharma (M) Sdn Bhd
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
257 BRU09060263P Voltaren 50mg Tablets Diclofenac Sodium 50mg Novartis Pharma SPA, ItalyZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
258 BRU09060264P Voltaren 12.5mg Suppositories Diclofenac Sodium 12.5mgDelpharm Huningue S.A.S.,
France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
259 BRU09060265P Voltaren 50mg Suppositories Diclofenac Sodium 50mgDelpharm Huningue S.A.S.,
France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
260 BRU09060266P Benosone Cream Betamethasone (as valerate) 0.1%w/wHOE Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
261 BRU09060267NP Uphamol 250 Syrup Paracetamol 250mg/5mlUpha Pharmaceutical Mfg
(M) Sdn Bhd
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015GSL (60mL)
262 BRU09060268P Betamethasone Cream Betamethasone (as valerate) 0.1%w/wSunward Pharmaceutical
Sdn Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
263 BRU09060269P Zorax Cream Aciclovir 5%w/wSunward Pharmaceutical
Sdn Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
264 BRU09060270P Nexium mups 20mgEsomeprazole (as magnesium trihydrate)
20mgAstraZeneca AB, Sweden
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
265 BRU09060271P Ebutol-100 Tablet Ethambutol HCl 100mgSunward Pharmaceutical
Sdn Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
266 BRU09060272P Neurontin Capsule 300mg Gabapentin 300mg Pfizer Pharmaceuticals LLC,
Vega Baja Puerto Rico, USA
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 17 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
267 BRU09060274P Relenza® Rotadisks 5mg Zanamivir 5mgGlaxoSmithKline Australia
Pty Ltd, Australia
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
268 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 Sdn
Bhd
06 October 2015 till 05
October 2020POM
269 BRU09070276PFleming Oral Suspension
228.5mg/5ml
Amoxicillin (as trihydrate) 200mg/5ml;
Clavulanic acid (as Potassium
clavulanate) 28.5mg/5ml
Medreich Limited,
Bengalore, India
Asterix United (B)
Sdn Bhd
06 October 2010 till 05
October 2015POM
270 BRU09070277P Avaxim 80u Paediatric Inactivated Hepatitis A virus (GBM strain)
80u per 0.5ml
Sanofi Pasteur, Lyon,
Pasteur
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
271 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
272 BRU09070279P Salazopyrin® EN-Tabs Sulfasalazine 500mgKemwell AB, Bjorkgatan 30,
SE-751 82 Uppsala, Sweden.
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
273 BRU09070280P Zyloric® 100mg Tablet Allopurinol 100mg GlaxoSmithKline Australia
Pty Ltd., Australia
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
274 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
275 BRU09070282P Hydrocortisone Cream 1% w/w Hydrocortisone acetate 1%w/wSunward Pharmaceutical
Sdn Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
276 BRU09070283P XanaxTM 0.25mg Tablet Alprazolam 0.25mg Sanico N.V., BelgiumZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
277 BRU09070284P Nexium mups 40mgEsomeprazole (as magnesium trihydrate)
40mgAstraZeneca AB, Sweden
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
278 BRU09070286P XanaxTM 0.5mg Tablet Alprazolam 0.5mg Sanico N.V., BelgiumZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
279 BRU09070287P Zolterol S/R Tablet 100mg Diclofenac Sodium 100mgUpha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
280 BRU09070288P Diane-35 TabletCyproterone acetate 2mg;
Ethinylestradiol 0.035mg
Bayer Weimar GmbH und
Co. KG, Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
281 BRU09070289P Amaryl 3mg Tablet Glimepiride Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
282 BRU09070290P Diamicron Tablet 80mg Gliclazide 80mgLes Laboratoires Servier
Industrie, France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 18 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
283 BRU09070291NP Dulcolax Suppository 10mg Bisacodyl 10mg Istituto De Angeli S.r.l., ItalyHongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
284 BRU09070292P Clotrimazole Cream 1% w/w Clotrimazole 1% w/wBeacons Pharmaceuticals
Pte Ltd, Singapore
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015GSL
285 BRU09070293P Mucosolvon® 30mg Tablet Ambroxol hydrochloride 30mg Delpharm Reims,FranceHongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
286 BRU09080294P Euvax B Vaccine, RecombinantPurified Hepatitis B surface antigen
(HBsAg) 200µg/10mlLG Life Science Ltd, Korea
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
287 BRU09080295PPulmicort® Turbuhaler®
200mcg/dose
Budesonide (micronised) Ph Eur
200mcg/doseAstraZeneca AB, Sweden
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
288 BRU09080296P Epilim Intravenous 400mg/ vial Sodium Valproate 400mgGruppo Lepetit S.R.L. Italy
Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
289 BRU09080297P Tritace® 5mg Tablet Ramipril 5mg Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
290 BRU09080298P Ebutol-400 Tablet Ethambutol HCl 400mgSunward Pharmaceutical Pte
Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
291 BRU09080299PBeafemic Suspension
50mg/5mlMefenamic acid 50mg/5mL Upha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
292BRU09080300PS1 &
BRU09080300PS2Diamicron MR Tablet 30mg Gliclazide 30mg
Les Laboratoires Servier
Industrie, France (S1) &
Kotra Pharma (M) Sdn. Bhd,
Malaysia (S2)
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
293 BRU09080301P Deltasolone Tablet 5mg Prednisolone 5mgSunward Pharmaceutical Pte
Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
294 BRU09080302P Sunprox-275 Tablet Naproxen Sodium 275mgSunward Pharmaceutical Pte
Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
295 BRU09080303P Spiriva® 18mcg Tiotropium 18mcg (as Bromide
Monohydrate 22.5mcg)
Boehringer Ingelheim
Pharma GmbH & Co. KG,
Germany
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
296 BRU09080304P Prednisolone 1mg Tablet Prednisolone 1mgBeacons Pharmaceuticals
Pte Ltd, Singapore
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
297 BRU09080305NP Poro Suppository 250mg Paracetamol 250mgYSP Industries (M) Sdn Bhd,
Malaysia
Asterix United Sdn
Bhd
06 October 2015 till 05
October 2020GSL
298 BRU09080306P Strimox-250 Capsule Amoxicillin (as trihydrate) 250mg Strides Arcolab Ltd., IndiaG & H Trading
Company
06 October 2010 till 05
October 2015POM
299 BRU09080307P Buscopan Tablet 10mg Hyoscine-N-butylbromideDelpharm Reims
S.A.S,France
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 19 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
300 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
301 BRU09080309P Fenagesic Capsule 250mg Mefenamic acid 250mgSunward Pharmaceutical Pte
Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
302 BRU09080311P Carinox CapsulePseudoephedrine sulphate 120mg;
Loratadine 5mg
Upha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
303 BRU09090312PEuvax B Vaccine, Recombinant
(100µg/5ml)
Purified Hepatitis B surface antigen
(HBsAg) 100µg/5mlLG Life Science Ltd, Korea
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
304 BRU09090313P Typhim Vi Single DosePurified 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 Sdn
Bhd
06 October 2015 till 05
October 2020POM
305 BRU09090314P Crestor 10mg Tablet Rosuvastatin Calcium 10mg AstraZeneca UK Ltd, UKZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
306 BRU09090315P Amaryl 2mg Tablet Glimepride 2mg Sanofi-aventis S.p.A, Italy Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
307 BRU09090316P Lamisil® 250mg Tablet Terbinafine HCl 250mgNovartis Pharmaceuticals UK
Limited, UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
308 BRU09090317P Voltaren® SR 75 Tablet Diclofenac Sodium 75mgNovartis Farma S.p.A, Italy
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
309 BRU09090318P Cataflam® 50 Tablet Diclofenac Potassium 50mgNovartis Urunleri, Istanbul
Turkey
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
310 BRU09090319PTETRAct-HIB (Act-HIB-
D.T.COQ/D.T.P) Vaccine
Act-HIB (Powder) - Haemophilus
influenza type b polysacharride
conjugated with tetanus protein 10µg;
D.T.COQ/D.T.P (Suspension) - purified
diphteria toxoid not less than 30iu,
purified tetanus toxoid not less than
60iu, Bordetella pertusis not less than
4iu
Sanofi Pasteur, Campus
Merieux, France; Sanofi
Pasteur, Parc industrial
d'Incarville, France & Sanofi
Pasteur, Gruppo Lepeptit,
France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
311 BRU09090320P Zyrtec-D TabletCetirizine Dihydrochloride 5mg;
Pseudoephedrine HCl 120mgUCB Farchim SA, Switzerland
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
312 BRU09090321PMono-Tildiem SR 200mg
CapsuleDiltiazem HCl 200mg
Sanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 20 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
313 BRU09090322P Actilyse® Treatment-SetRecombinant Human Tissue-type
Plasminogen Activator (alteplase) 50mg
Boehringer Ingelheim
Pharma GmbH & Co. KG,
Germany
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
314 BRU09090323P Zoraxin Tablet 400mg Aciclovir 400mgDuopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
315 BRU09090324P Trenlin SR Tablet 400mg Pentoxifylline 400mgUpha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
316 BRU09090325NP Paratab Tablet 500mg Paracetamol 500mgSunward Pharmaceutical Pte
Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020P (100x10's)
317 BRU09090326P Micardis 40mg Tablet Telmisartan 40mg
Boehringer Ingelheim
Pharma GmbH & Co. KG,
Germany
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
318 BRU09090327P Metalyse Injection 10,000units Tenecteplase 10,000units (50mg)
Boehringer Ingelheim
Pharma GmbH & Co. KG,
Germany
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
319 BRU09090328NP Hemo RidTM TabletMiconised Diosmin 450mg; Micronised
Hesperidine 50mg
Upha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015GSL
320 BRU09090329P Exforge Tablet 5mg/80mgAmlodipine 5mg (as besylate 6.94mg);
Valsartan 80mg
Novartis Farmaceutica SA ,
Spain
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
321 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, FranceZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
322 BRU09100331P Cloderm Ointment Clobetasol (as propionate) 0.05%w/wHOE Pharmaceutical Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
323 BRU09100332P H-Cort Cream Hydrocortisone 1%w/wHOE Pharmaceutical Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
324 BRU09100333P Pneumo 23 Vaccine
Polysaccharides of Streptococcus
pneumoniae serotypes (1, 2, 3, 4, 5, 6B,
7F, 8, 9N, 9V,10A, 11A, 12F, 14, 15B, 17F,
18C, 19A, 19F, 20, 22F, 23F, 33F)
Sanofi Pasteur, Mercy
I'Etoile, France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
325 BRU09100334P Prelone Syrup 3mg/5ml Prednisolone Sunward Pharmaceutical
Sdn Bhd, Malaysia.
G & H Trading
Company
06 October 2015 till 05
October 2020POM
326 BRU09100335P Ventolin Nebules 2.5mg/2.5ml Salbutamol Sulphate 2.5mg/2.5ml GlaxoSmithKline Australia
Pty Ltd, Australia
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 21 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
327 BRU09100336NP Sunquadin Lozenges Dequalinium ChlorideSunward Pharmaceutical
Sdn Bhd, Malaysia.
G & H Trading
Company
06 October 2015 till 05
October 2020POM
328 BRU09100337P Zoloft Tablet 50mg Sertraline (as hydrochloride) 50mgPfizer Australia Pty Ltd,
Australia
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
329 BRU09100338NPUphamol 250 Suspension
(Fruity)Paracetamol 250mg/5mL
Upha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
330 BRU09100339P XanaxTM 1mg Tablet Alprazolam 1mgSanico NV Industriezone,
Belgium
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
331 BRU09100340P Pontalon Capsule Mefenamic acid 250mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
06 October 2015 till 05
October 2020POM
332 BRU09100341P Clexane 6000 Anti-Xa IU/0.6mL Enoxaprin Sodium (Porcine in origin)Aventis Intercontinental,
France
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
333 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
334 BRU09100343P Neurontin 600mg Tablet GabapentinPfizer Pharmaceutical LLC,
Puerto Rico, USA
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
335 BRU09100345P LipitorTM 40mg TabletAtorvastatin (as Calcium 43.38mg-
crystalline) 40mg
Pfizer pharmaceuticals LLC,
vega baja Puerto Rico, USA
G & H Trading
Company
06 October 2015 till 05
October 2020POM
336 BRU09100346NP Suniton TabletParacetamol 450mg, Orphenadrine
Citrate 35mg
Sunward Pharmaceutical Pte
Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
337 BRU09100347P SCMC Plus Syrup 250mg/5mLS-carboxy-methylcysteine 250mg/5mL
(Carbocisteine)
Upha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
338 BRU09100348NP Glyprin Dispersible Tablet Aspirin 100mg, Glycine 45mgUpha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
339 BRU09100349P Actonel® 35mg TabletRisedronate sodium 35mg (equivalent to
32.5mg risedronic acid)Norwich Pharmaceuticals
Inc., USAMedipharm Sdn Bhd
06 October 2010 till 05
October 2015POM
340 BRU09110350P Lantus® Solostar® 100units/ml Insulin Glargine (HOE 901)Sanofi-Aventis Deutschland
GmbH, GermanyMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
341 BRU09110353P Tenoretic Tablet Atenolol 100mg; Chlorthalidone 25mg AstraZeneca UK Ltd, UKZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 22 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
342 BRU09110354P LipitorTM 10mg TabletAtorvastatin (as calcium 10.85mg -
crystalline) 10mg
Pfizer pharmaceutical LLC,
vega baja Puerto Rico, USA
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
343 BRU09110355P RotarixTM Vaccine
1 reconstituted dose (1ml) contains live
attenuated human rotavirus RIX4414
strain not less than 106.0 CCID50
GlaxoSmithKline Biologicals
SA, Belgium
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
344 BRU09110356PClexane 4000 Anti-Xa IU/0.4mL
(40mg/0.4ml)
Enoxaprin Sodium 40mg/0.4ml (Porcine
in origin)
Aventis Intercontinental,
France
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
345 BRU09110357PAtrovent Unit Dose Vial (UDV)
250mcg/2ml
Ipratropium bromide anhydrous 250mcg
(as monohydrate 261mcg)Laboratoire Unither, France
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
346 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
347 BRU09110359P Allavin ExpectorantDiphenhydramine HCl 14mg/5ml;
Ammonium Chloride 135mg/5ml
Upha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
348 BRU09110360P Nitrocine Ampoules 0.1% Nitroglycerin 1mg/10mlJenahexal Pharma GmbH,
Germany
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
349 BRU09110361P Uphamol 500 Tablet Paracetamol 500mgUpha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
350 BRU09110362P Carin Tablet 10mg Loratadine 10mgUpha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015
P
351 BRU09110363PRhinathiol 2% for Children
SyrupCarbocisteine 100mg/5ml
Sanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
352 BRU09110364PArepanrixTM H1N1 Pandemic
Influenza Vaccine
After mixing 1 dose (0.5ml) contains:
Split influenza virus, inactivated,
containing antigen* equivalent to:
A/California/7/2009 (H1N1)v-like virus
3.75mcg** (Note:* propagated in egg;
** haemagglutinin .) Adjuvant:ASO3 -
Squalene 10.69mg; DL-α-tocopherol
11.86mg & polysorbate 80 4.86mg
Antigen - ID Biomedical
Corporation of Quebec,
GlaxoSmithKline Biologicals
North America, Quebec,
Canada.
Adjuvant - GlaxoSmithKline
Biologicals SA, Rixensart,
Belgium
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
353 BRU09120365P Tienam IV Injection 500mgImipenem (as monohydrate) 500mg &
Cilastatin Sodium 500mg
Merck Sharp & Dohme Corp,
USA
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 23 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
354BRU09120366PS1 &
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 Sdn
Bhd
06 October 2015 till 05
October 2020POM
355 BRU09120367P Dilantin 100mg Capsule Phenytoin SodiumPfizer Australia Pty Limited,
Australia
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
356 BRU09120368P Modalim 100mg Tablet Ciprofibrate 100mg Sanofi Winthrop Limited, UK Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
357 BRU09120369P Oral Aid LotionLignocaine HCl 2.5%; Triamcinolone
Acetonide 0.1%; Chlorhexidine HCl 0.5%
Upha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
358 BRU09120370P Primperan 10mg/2ml Injection Metoclopramide HCl 10mg/2mlSanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
359 BRU09120371P Tritace 10mg Tablet Ramipril 10mg Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
360 BRU09120372P Mono-Tildiem SR 300mg Diltiazem HCl 300mgSanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
361 BRU09120373P Micardis® 80mg Tablet Telmisartan 80mgBoehringer Ingelheim
Pharma GmbH, Germany
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
362 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
363 BRU09120375P Natrilix® SR Tablet Indapamide 1.5mgLes Laboratoires Servier
Industrie, France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
364 BRU09120376NP Poro Suppository 125mg Paracetamol 125mgY.S.P Industries (M) Sdn
Bhd., Malaysia
Asterix United (B)
Sdn Bhd
06 October 2015 till 05
October 2020POM
365 BRU09120377PVascor 40mg Film-coated
TabletSimvastatin 40mg
Upha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
366 BRU09120378P Chloramine Tablet 4mg Chlorpheniramine maleate 4mgUpha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015P
367 BRU09120379PCovastin Film-coated Tablet
10mgSimvastatin 10mg
Xepa-Soul Pattinson
(Malaysia) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
368 BRU09120380P Metformin Tablet 500 Metformin HCl 500mgUpha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
BDMCA/RMP/1215 Page 24 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
369BRU09120381PS1 &
BRU09120381PS2
Co-Diovan 80/12.5 Film-coated
Tablets
Valsartan 80mg; Hydrochlorothiazide
12.5mg
Novartis Pharma Stein AG,
Switzerland (S1); Novartis
Farma S.p.A., Italy (S2)
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
370 BRU09120382PRhinathiol® Promethazine
syrup
Carbocisteine 100mg/5ml; Promethazine
HCl 2.5mg/5ml
Sanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
371 BRU09120383PMethotrexate Injection BP
1000mg/10mlMethotrexate 1000mg/10ml
Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
372 BRU10010384P Zyloric 300mg Tablet Allopurinol 300mgGlaxoSmithKline Australia
Pty Ltd. Australia
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
373BRU10010385PS1 &
BRU10010385PS2Coversyl 4mg Tablet Perindopril tert-butylamine 4mg
Les Laboratoires Servier
Industrie, France (S1) &
Kotra Pharma (M) Sdn Bhd.,
Malaysia
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
374 BRU10010386PAtrovent Unit Dose Vial
0.5mg/2ml
Ipratropium bromide (as monohydrate)
500mcg/2ml
Laboratoires Unither,
Amiens cedex, France
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
375 BRU10010387P Aspirin EC Tablet 100mg Acetylsalicylic acid 100mgBeacons Pharmaceuticals
Pte Ltd, Singapore
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
376 BRU10010388P Exforge Tablet 5mg/160mgAmlodipine 5mg (as besylate 6.94mg);
Valsartan 160mg
Novartis Farmaceutica SA,
Spain
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
377 BRU10010389P Taxotere 80mg/2ml VialDocetaxel anhydrous (as trihydrate)
80mg
Sanofi-Aventis Deutschland
GmbH, GermanyMediPharm Sdn Bhd
06 October 2015 till 05
October 2020POM
378
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
379BRU10010391PS1 &
BRU10010391PS2Diovan 80mg Tablet Valsartan 80mg
Novartis Pharma Stein AG,
Switzerland (S1); Novartis
Farma S.A., Spain (S2)
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
380BRU10010392PS1 &
BRU10010392PS2
Co-Diovan 160/25 Film-coated
Tablets
Valsartan 160mg; Hydrochlorothiazide
25mg
Novartis Pharma Stein AG,
Switzerland (S1); Novartis
Farma S.p.A., Italy (S2)
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 25 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
381 BRU10010393P Chloramine 4 Syrup Chlorpheniramine maleate BP 4mg/5mlUpha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015P
382 BRU10010394PIsoket 0.1% Solution for
InjectionIsosrobide Dinitrate 0.1%
Jenahexal Pharma GmbH,
Germany
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
383 BRU10010395P Isoket SprayIsosrobide Dinitrate 1.25mg per
actuationSchwarz Pharma Ltd, Ireland
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
384 BRU10010396P Beafemic Capsule 250mg Mefenamic acid 250mgUpha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
385 BRU10010397P Metformin Tablet 500mg Metformin HCl 500mgSunward Pharmaceutical Pte
Ltd, Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
386 BRU10010399P Seretide Accuhaler 50/500Salmeterol 50mcg (as Xinafoate),
Fluticasone propionate 500mcgGlaxoSmithKline LLC, USA
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
387 BRU10010400P Cisplatin Injection 10mg/10ml Cisplatin 10mg/10mlPfizer (Perth) Pty Limited,
Australia
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
388 BRU10010401P VentolinTM Tablet 4mg Salbutamol 4mg (as Sulphate 4.8mg) Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
389 BRU10020402PSolu-Medrol Sterile Powder
500mg
Methyprednisolone (as Sodium
succinate) 500mg
Pfizer Manufacturing
Belgium N.V., Belgium
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
390 BRU10020403P Losec 40mg IV Injection Omeprazole (as sodium) 40mg AstraZencea AB, SwedenZuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
391 BRU10020404P Imdex 60mg CR Tablet Isosorbide-5-Mononitrate 60mgUpha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
392 BRU10020405P Vascor Tablet 20mg SimvastatinUpha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
393 BRU10020406PCombivent Unit Dose Vial
500mcg
Per 2.5ml - Ipratropium bromide (as
monohydrate 522mcg) 500mcg;
Salbutamol 2.5mg (as sulphate 3.013mg)
Boehringer Ingelheim
Limited, United Kingdom
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
394 BRU10020407P Perinace Tablet 4mg Perindopril erbumine 4mgUpha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
395 BRU10020408P Guadex LinctusPer 5ml - Dextromethorphan
Hydrobromide 15mg; Guaifenesin 100mg
Hoe Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 26 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
396BRU10020409PS1 &
BRU10020409PS2 Diovan® 160mg Tablet Valsartan 160mg
Novartis Pharma Stein AG,
Switzerland (S1); Novartis
Farma S.A., Spain (S2)
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
397 BRU10020410P Etoposide 100mg/5ml Injection Etoposide 100mg/5mlPfizer (Perth) Pty Limited,
Australia
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
398 BRU10020411P Decondine SyrupPer 5ml - Triprolidine HCl 1.25mg;
Pseudoephedrine HCl 30mg
Sunward Pharmaceutical
Sdn Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
399 BRU10020412P Seretide Accuhaler 50/100Salmeterol 50mcg (as Xinafoate),
Fluticasone propionate 100mcgGlaxoSmithKline LLC, USA
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
400 BRU10020413P Optizoline eye drops Tetrahydrozoline HCl 0.05%w/w
Xepa-Soul Pattinson
(Malaysia) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
401 BRU10020414P Sunadine Syrup Loratadine 5mg/5mlSunward Pharmaceutical
Sdn Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020P
402 BRU10020415P Adalat LA 30 Tablet Nifedipine 30mg Bayer Pharma AG, GermanyZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
403 BRU10020416P Lipitor 20mg Tablet Atorvastatin (Calcium) 20mgPfizer Pharmaceutical LLC,
Puerto Rico
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
404 BRU10020417PIsosorbide Dinitrate Tablet
10mgIsosorbide Dinitrate BP 10mg
Upha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
405 BRU10020418P Nitroderm TTS® 5 (5mg/24hr) Glyceryl Trinitrate/ nitroglycerin 25mgNovartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
406 BRU10020419P Adalat® LA 20 Tablet Nifedipine 20mg Bayer Pharma AG, GermanyZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
407 BRU10020421P Xatral XL Tablet 10mg Alfuzosin HCl 10mgSanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
408 BRU10030422P Beten 50mg Tablet Atenolol 50mgUpha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
409 BRU10030423PRhinathiol 5% Adult
Expectorant SyrupCarbocisteine 5g/100ml
Unither Liquid
Manufacturing, FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020P
410 BRU10030425NP Dulcolax Suppository 5mg Bisacodyl 5mgInstituto De Angeli S.R.L.,
Italy
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
411 BRU10030426P Aromasin 25mg Tablet Exemestane 25mg Pfizer Italia S.R.L., ItalyZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 27 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
412 BRU10030427P Omesec Capsule 20mg Omeprazole 20mgUpha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
K-Seri Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
413 BRU10030428P Adalat LA 60 Tablet Nifedipine 60mg Bayer Pharma AG, GermanyZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
414 BRU10030429P Polarax 2mg Tablet Dexchlorpheniramine maleate 2mgSunward Pharmaceutical
Sdn Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
415 BRU10030430P Pharmorubicin CS 50mg/25ml Epirubicin HCl 50mg/2mlPfizer (Perth) Pty Limited,
Australia
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
416 BRU10030431P Deco Expectorant
Per 5ml - Guaifenesin/ Guaicol Glycerol
Ether USP 100mg; Tripolidine HCl
1.25mg; Pseudoephedrine HCl 30mg
HOE Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
06 October 2010 till 05
October 2015P
417 BRU10030432P Cisplatin Injection 50mg/50ml Cisplatin USP 50mg/50mlPfizer (Perth) Pty Limited,
Australia
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
418 BRU10030433PTerramycin Ophthalmic
Ointment
Per g - Oxytetracycline 5mg; Polymyxin B
10,000units
PT Pfizer (Indonesia),
Indonesia
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
419 BRU10030435PAdriamycin CS Injection
50mg/25mlDoxorubicin HCl 50mg/25ml
Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
420 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
421 BRU10030437P Seretide Evohaler 50
Salmeterol Xinafoate (micronised)
25mcg; Fluticasone Propionate
(micronised) 50mcg
Glaxo Wellcome Production,
France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
422 BRU10030438P Miacalcic® Ampoules 100IU Calcitonin salmon, synthetic 100IUNovartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
423 BRU10030439P Prozine Syrup 5mg/5ml Promethazine HClSunward Pharmaceutical
Sdn Bhd, Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
424 BRU10030440P Olmetec Tablet 20mg Olmesartan Medoxomil 20mgDaiichi Sankyo Europe
GmbH, Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
425 BRU10040441P Diflucan Capsule 150mg Fluconazole 150mg Pfizer PGM, FranceZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
426 BRU10040442P Diflucan Capsule 100mg Fluconazole 100mg Pfizer PGM, FranceZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
427 BRU10040443P Diflucan Capsule 50mg Fluconazole 50mg Pfizer PGM, FranceZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 28 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
428 BRU10040444NP Cartril-S 500mg Capsule
Glucosamine HCl 472.5mg equivalent to
Glucosamine content in Glucosamine
Sulphate 500mg
Upha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015
GSL
429 BRU10040445P Seretide Accuhaler 50/250Salmeterol (as Xinafoate) 50mcg;
Fluticasone Propionate 250mcgGlaxoSmithKline LLC, USA
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
430 BRU10040447P Ventolin Tablet 2mg Salbutamol (as sulphate) 2mgAspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
431 BRU10040448PZyrtec® Film-coated Tablet
10mgCetrizine HCl 10mg
UCB Farchim S.A.,
Switzerland
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
432 BRU10040450P Seretide 125 EvohalerSalmeterol (as Xinafoate, micronised)
25mcg; Fluticasone Propionate 125mcg
Glaxo Wellcome Production,
France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
433 BRU10040452P Nitroderm TTS® 10Glyceral trinitrate/ nitroglycerin 50mg
(10mg/24hr)
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
434 BRU10040453P Temodal Capsule 20mg Temozolomide 20mg Orion Corporation, FinlandZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
435 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
436 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
437BRU10040457PS1 &
BRU10040457P S2Co-Diovan 160/12.5mg Tablets
Valsartan HCl 160mg;
Hydrochlorothiazide 12.5mg
Novartis Pharma Stein AG,
Switzerland (S1); Novartis
Pharma S.p.A., Italy (S2)
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
438 BRU10040458P Zyrtec® Oral Drops 10mg/ml Cetrizine diHCl 10mg/mlAesica Pharmaceuticals
S.r.L., Italy
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
439 BRU10040459P Atenolol 50mg Tablet Atenolol 50mgSunward Pharmaceutical Pte
Ltd., Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
440 BRU10040460P Bromhexine Tablet 8mg Bromhexine HCl 8mgSunward Pharmaceutical Pte
Ltd., Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
441 BRU10040461PCytarabine® Injection 1000mg
in 10mlCytarabine 1000mg/10ml
Pfizer (Perth) Pty, Ltd.,
Australia
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
442 BRU10040462P Exelon Oral Solution 2mg/mlRivastigmine 2mg/ml (as hydrogen
tartrate)
Novartis Pharma S.A.S.,
France
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
443 BRU10050463PNebido 1000mg/4ml, Solution
for Injection
Testosterone undecanoate 250mg(equiv.
to testosterone 157.9mg)Bayer Pharma AG, Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 29 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
444 BRU10050464NP Mucosolvon Liquid 30mg/5ml Ambroxol Hydrochloride 30mg/5mlBoehringer Ingelheim,
France
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020P
445 BRU10050466NPUphamol Suspension 250
(Orange)Paracetamol 250mg/5ml
Upha Pharmaceuticals Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
06 October 2010 till 05
October 2015POM
446 BRU10050467PTaxotere® 20mg/0.5ml
Concentrate and solvent for
solution for Infusion
Docetaxel 20mg/0.5ml (as trihydrate)Sanofi-Aventis Deutschland
GmbH, Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
447 BRU10050468P
Remicade Powder for
Concentrate for Solution for
Infusion 100mg/vial
Infliximab (cA2 IgG) 100mg/vial Patheon Italia S.p.A, ItalyZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
448 BRU10050470P Pristinex Cream 2% w/w Ketoconazole 2%w/w
Xepa-Soul Pattinson
(Malaysia) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
449 BRU10050471PZyvox Infusion Bag
600mg/300mlLinezolid 600mg/300ml
Fresenius Kabi Norge As,
Norway
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
450 BRU10050472P Panadeine TabletCodeine Phosphate 8mg, Paracetamol
500mgSanofi India Limited, India
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
451 BRU10050473P Cervagem Pessary 1mg Gemeprost 1mgOno Pharmaceutical Co Ltd,
JapanMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
452 BRU10050474P Provinace Tablet 4mg Perindopril erbumine 4mg
Xepa-Soul Pattinson
(Malaysia) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company
06 October 2015 till 05
October 2020POM
453 BRU10050475P Zyrtec® Oral Solution 1mg/ml Cetrizine diHCl 1mg/ml (0.1%)Aesica Pharmaceuticals
S.r.L., Italy
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
454 BRU10050476P Dalacin C Capsule 150mg Clindamycin (as hydrochloride) 150mg Pfizer PGM, FranceZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
455 BRU10050477P Clozaril® Tablet 100mg Clozapine 100mg
Novartis Saglik Gida ve
Tarim Urunleri San. Ve
Tic.A.S., Istanbul, Turkey
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
456 BRU10050478P Telfast® 180mg Tablet Fexofenadine HCl 180mgPT Aventis Pharma,
IndonesiaMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
457 BRU10050479PCozaar 100mg film-coated
tabletLosartan Potassium 100mg
Merck Sharp & Dohme Ltd
UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
458 BRU10050480P Dalacin T Topical Solution 1% Clindamycin (as phosphate) 10mg/MlZoetis P&U LLC, Kalamazoo,
USA
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
459 BRU10050482PIlomedin Infusion Solution
50mcg/0.5ml
Illoprost 50mcg/0.5mL (as Illoprost
trometamol 67mcg/0.5mL)Berlimed SA Spain
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
BDMCA/RMP/1215 Page 30 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
460 BRU10060483P Starlix Tablet Nateglinide 120mgNovartis Farma S.p.A., Torre
Annunziata, Italy
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
461 BRU10060484P Miacalcic 50IU Ampoules Salmon calcitonin, synthetic 50IU/1mlNovartis Pharma Stein AG,
Switzerland.
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
462 BRU10060485P Allersin-F Tablet 4mg Chlorpheniramine maleate 4mgSunward Pharmaceutical
Pte. Ltd., Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020P
463 BRU10060486P Daonil Tablet 5mg Glibenclamide 5mgPT Aventis Pharma,
IndonesiaMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
464 BRU10060487P Asmol Syrup Salbutamol 2mg/5ml (as Sulphate 2.4mg) Sunward Pharmaceutical
Sdn. Bhd., Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
465 BRU10060488P Lescol capsule 40mg Fluvastatin (as the sodium salt) 40mgNovartis Farmaceutica S.A.,
Spain
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
466 BRU10060489P Lescol XL Tablet 80mg Fluvastatin (as the sodium salt) 80mgNovartis Farmaceutica S.A.,
Spain
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
467 BRU10060490P Lescol capsule 20mg Fluvastatin (as the sodium salt) 20mgNovartis Farmaceutica S.A.,
Spain
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
468 BRU10060491P Diatrol Tablet 2mg Loperamide HCl 2mgSunward Pharmaceutical
Sdn. Bhd., Malaysia
G & H Trading
Company
06 October 2015 till 05
October 2020POM
469 BRU10060492P Clozaril® 25mg Tablet Clozapine 25mg
Novartis Saglik Gida ve
Tarim Urunleri San. Ve
Tic.A.S., Istanbul, Turkey
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
470 BRU10060493P Olmetec 10mg Tablet Olmesartan medoxomil 10mgDaiichi Sankyo Europe
GmbH, Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
471 BRU10060494P Norvasc Tablet 5mg Amlodipine Besylate 5mgPfizer Australia Pty. Ltd.,
NSW Australia.
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
472 BRU10060495P Epilim 200mg/5ml Syrup Sodium Valproate 200mgUnither Liquid
Manufacturing, France.Medipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
473 BRU10060496P Stilnox 10mg film-coated tablet Zolpidem tartrate 10mgSanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
474 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
475 BRU10060498P Nalol Tablet 40mg Propranalol HCl 40mgSunward Pharmaceutical
Pte. Ltd., Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
476 BRU10060499P Exelon capsule 1.5mgRivastigmine 1.5mg (as hydrogen tartrate
2.4mg)
Novartis Farmaceutica S.A.,
Spain
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
477 BRU10060500PSyntocinon 10IU solution for
injectionSynthetic Oxytocin 10IU/ml
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 31 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
478 BRU10060501P Exelon capsule 6mgRivastigmine 6mg (as hydrogen tartrate
9.6mg)
Novartis Farmaceutica S.A.,
Spain
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
479 BRU10060502PZyvox film-coated tablet
600mgLinezolid 600mg
Pfizer Pharmaceuticals LLC,
Puerto Rico, United States
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
480 BRU10060503P Zocor 5mg film-coated tablet SimvastatinMerck Sharp & Dohme Ltd.,
United Kingdom
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
481 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
482 BRU10060505PMyfortic Gastro-Resistant
tablet 180mg
Mycophenolic Acid 180mg (as Sodium
Salt 192.4mg)
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
483 BRU10070506P Phensedyl Dry Cough LinctusPer 5ml - Promethazine HCl 3.6mg;
Pholcodine 4mg; Ephedrine HCl 7.2mg
Sanofi-Aventis Pakistan
Limited, Pakistan
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
484 BRU10070507P Miacalcic® Nasal Spray 200IU Salmon calcitonin, synthetic 200IUDelpharm Huningue S.A.S.,
Switzerland.
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
485 BRU10070508P Norvasc Tablet 10mg Amlodipine Besylate 10mgPfizer Australia Pty. Ltd.,
NSW Australia.
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
486 BRU10070509P Pseudorine Tablet 60mg Pseudoephedrine HCl 60mgSunward Pharmaceutical
Pte. Ltd., Singapore G & H Trading Company
06 October 2015 till 05
October 2020P
487 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)
488 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
489 BRU10070512P Metoclopramide Tablet 10mg Metoclopramide HCl 10mgSunward Pharmaceutical
Pte. Ltd., Singapore
G & H Trading
Company
06 October 2015 till 05
October 2020POM
490 BRU10070513P Desferal 500mg Desferrioxamine Methane SulphonateNovartis Pharma Stein AG,
Switzerland.
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
491 BRU10070514P Anafranil® 25mg Tablet Clomipramine HCl 25mg Novartis Farma SpA., ItalyZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
492 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
493 BRU10070516P Singulair® Tablet 10mg Montelukast (as sodium) 10mgMerck Sharp & Dohme Ltd.,
United Kingdom
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
494 BRU10070517PSingulair® Chewable Tablet
5mgMontelukast (as sodium) 5mg
Merck Sharp & Dohme Ltd.,
United Kingdom
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
495 BRU10070518P Lanoxin Injection 0.5mg/2ml Digoxin 0.5mg/2mlGlaxoSmithKline
Manufacturing SpA., Italy
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 32 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
496 BRU10070519P Zithromax IV 500mg Azithromycin (as dehydrate) 500mgPharmacia & Upjohn
Company, Kalamazoo, USA
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
497 BRU10070520P Exelon® 4.5mg CapsuleRivastigmine 4.5mg (as Rivastigmine
hydrogen tartrate 7.2mg)
Novartis Farmaceutica S.A.,
Spain
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
498 BRU10070521PEpilim Chrono 500mg Scored
Film-coated Tablet
Sodium valproate 500mg (Sodium
valproate 333mg & Valproic acid 145mg)
Sanofi Winthrop Industries,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
499 BRU10070522PRitalin® Modified Release
Capsule 30mgMethylphenidate HCl 30mg
Elan Holdings Inc., United
States
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
500 BRU10080523P Exforge 10/160mg FC TabletAmlodipine 10mg (as besylate);
Valsartan 160mg
Novartis Pharma Stein AG
Switzerland
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
501 BRU10080524PZometa Concentrate for
Solution for Infusion 4mg/5ml
Zoledronic Acid (anhydrous) 4mg
corresponding to zoledronic acid
monohydrate 4.264mg
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
502 BRU10080527P Mediaxal Tablet 150mg Benfluorex Hydrochloride 150mgLes Laboratoires Servier
Industrie France
Zuellig Pharma Sdn
Bhd
06 October 2010 till 05
October 2015POM
503 BRU10080528P Imovane 7.5mg Tablet Zopiclone 7.5mg Aventis International France Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
504 BRU10080529P Nasacort Aqueous Nasal SparyTriamcinolone Acetonide
55mcg/actuationAventis Pharma UK Medipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
505 BRU10080530P Ritalin 10mg Tablet Methylphenidate Hydrochloride 10mgNovartis Pharmaceuticals SA
Spain
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
506 BRU10080531P Proctosedyl Suppositories
Chinchocaine 5mg; Framycetin sulphate
10mg; Hydrocortisone 5mg; Aesculin
10mg
PT Aventis Pharma,
IndonesiaMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
507 BRU10080532PProstin VR Paediatric® Sterile
Solution 500mcgAlprostadil 500mcg/ml
Pharmacia & Upjohn
Company, USA
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
508 BRU10080533P Lioresal 10mg Tablet Baclofen 10mg Novartis Farma SPA ItalyZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
509BRU10080534PS1;
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 Sdn
Bhd
06 October 2015 till 05
October 2020POM
510BRU10080535PS1;
BRU10080535PS2
Telfast-D Extended Release
TabletFexofenadine hydrochloride 60mg ;
Pseudoephedrine HCl 120mg
Sanofi-Aventis US LLC USA
(S1); Sanofi Winthrop
Industrie, France (S2)
Medipharm Sdn Bhd06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 33 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
511 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
512 BRU10080538PImmucyst ® BCG
Immnuotherapeutic 81mg/vialBacillus Calmette-Guerin 81mg
Sanofi Pasteur Limited,
Toronto, Ontario, Canada
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
513 BRU10090539P Singulair Tablet 4mgMontelukast 4mg (as sodium 4.16mg)
Merck Sharp & Dohme Ltd
UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
514 BRU10090540P Cozaar Tablet 50mg Losartan Potassium 50mgMerck Sharp & Dohme Ltd
UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
515 BRU10090541PLanoxin Paediatric/ Geriatric
ElixirDigoxin 0.05mg/mL
Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
516BRU10090542PS1;
BRU10090542PS2 Singulair Oral Granules 4mg
Montelukast Sodium (free acid
equivalent) 4mg
Merck Sharp & Dohme Corp.
USA (S1); DSM
Pharmaceuticals, Inc., USA
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
517 BRU10090543P Frisium® 10mg Tablet Clobazam 10mgSanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
518 BRU10090544P Vytorin Tablet 10mg/20mg Ezetimibe 10mg: Simvastatin 20mg
Merck Sharp & Dohme
(Italia) SpA, Italy & MSD
International GmbH
(Singapore Branch),
Singapore
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
519 BRU10090545P Zocor 10mg Tablet Simvastatin 10mgMerck Sharp & Dohme Ltd.,
UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
520 BRU10090546P Zocor 40mg Tablet Simvastatin 40mgMerck Sharp & Dohme Ltd.,
UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
521 BRU10090547P Bonefos 800mg Tablet
Disodium Clodronate Tetrahydrate
1000mg equivalent to Disodium
Clodronate (anhydrous) 800mg
Bayer Oy, FinlandZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
522 BRU10090548PSuprefact® 1mg/ml Injection
SolutionBuserelin 1.00mg/ml (as acetate 1.05mg)
Aventis-Pharma Deutshland
GmbH, GermanyMedipharm Sdn Bhd
06 October 2015 till 05
October 2020POM
523 BRU10090549P Livial 2.5mg Tablet Tibolone 2.5mgN.V. Organon, The
Netherlands
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
524 BRU10090550P Ritalin LA 20mg Capsules Methylphenidate Hydrochloride 20mg Elan Holdings Inc., USAZuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
525 BRU10090551PZoladex LA Depot Injection
10.8mg
Goserelin Acetate equivalent to
Goserelin 10.8mgAstraZeneca UK Ltd, UK
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
BDMCA/RMP/1215 Page 34 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
526 BRU10090552PHarnal OCAS 400mcg Film-
coated tablet
Tamsulosin (as hydrochloride 400mcg)
367mcg
Astellas Pharma Europe BV,
The Netherlands
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
527 BRU10090553P ActifedTM Expectorant (100ml)
Triprolidine hydrochloride 1.25mg/5mL;
Pseudoephedrine hydrochloride
30mg/5mL; Guaiphenesin 100mg/5mL
Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020P
528 BRU10090554P Proscar® Tablets 5mg Finasteride 5mg
MSD International GmbH
(Puerto Rico Branch) LLC.,
Puerto Rico, USA.
Zuellig Pharma Sdn
Bhd
06 October 2015 till 05
October 2020POM
529BRU10090555PS1;
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 Sdn
Bhd
06 October 2015 till 05
October 2020POM
530 BRU10100556PMyfortic Gastro-Resistant
tablet 360mgMycophenolic (as sodium) acid 360mg
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
28 October 2015 till 27
October 2020POM
531 BRU10100557PIntron A* 30 million IU Solution
for Injection, Multidose PenInterferon Alfa-2b 30 million IU
Schering-Plough (Brinny)
Co., Ireland
Zuellig Pharma Sdn
Bhd
28 October 2015 till 27
October 2020POM
532 BRU10100558PGyno-Trosyd Vaginal Tablet
100mgTioconazole 100mg
Heinrich Mack Nachf, Pfizer
Inc., Heinrich Mack Nachf
GmbH & Co KG, Heinrich
Mack Strasse 35, 89257,
Illertissen, Germany.
Zuellig Pharma Sdn
Bhd
28 October 2010 till 27
October 2015POM
533 BRU10100559P Exelon® Capsule 3mg Rivastigmine (as hydrogen tartrate) 3mgNovartis Farmaceutica S.A.
Spain
Zuellig Pharma Sdn
Bhd
28 October 2015 till 27
October 2020POM
534BRU10100560PS1;
BRU10100560PS2
Arcoxia 60mg Film-coated
tabletEtoricoxib 60mg
Merck Sharp & Dohme
Corp., USA (S1)and Frosst
Iberica S.A., Spain (S2)
Zuellig Pharma Sdn
Bhd
28 October 2015 till 27
October 2020POM
535 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
536 BRU10100562P Exelon® Patch 10Rivastigmine Base 18mg / 10cm2
(9.5mg/24h)
LTS Lohmann Theraphie-
System AG, Germany
Zuellig Pharma Sdn
Bhd
28 October 2015 till 27
October 2020POM
537 BRU10100563P Exelon® Patch 5 Rivastigmine base 9mg/5cm2 (4.6mg/24
hours)
LTS Lohmann Theraphie-
System AG, Germany
Zuellig Pharma Sdn
Bhd
28 October 2015 till 27
October 2020POM
BDMCA/RMP/1215 Page 35 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
538 BRU10100564PATGAM® Sterile Solution
50mg/mL (5mL amp)
Lymphocyte immune globulin, anti-
thymocyte globulin (equine) 250mg/5mL
Pharmacia & Upjohn
Company, USA
Zuellig Pharma Sdn
Bhd
28 October 2015 till 27
October 2020POM
539 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 Sdn
Bhd
28 October 2015 till 27
October 2020POM
540BRU10100566PS1;
BRU10100566PS2 Arcoxia 120mg Tablet Etoricoxib 120mg
Merck Sharp & Dohme
Corp., USA (S1)and Frosst
Iberica S.A., Spain (S2)
Zuellig Pharma Sdn
Bhd
28 October 2015 till 27
October 2020POM
541 BRU10100567P Sun-Glizide Tablet 80mg Gliclazide 80mgSunward Pharmaceutical Pte
Ltd, Singapore
G & H Traidng
Company
28 October 2015 till 27
October 2020POM
542 BRU10100568PZithromax Powder For Oral
Suspension 200mg/5mlAzithromycin (as dihydrate) 200mg/5ml
Haupt Pharma Latina S.r.I.,
Italy
Zuellig Pharma Sdn
Bhd
28 October 2015 till 27
October 2020POM
543 BRU10100569PFosamax Plus 70/2800mcg
Tablets
Alendronic (as sodium 91.37) acid 70mg
& (Vitamin D3 100,000 IU/g)
Cholecalciferol 2800mcg
MSD Frosst Iberica, SpainZuellig Pharma Sdn
Bhd
28 October 2015 till 27
October 2020POM
544 BRU10100571P Arimidex 1mg tablet Anastrozole 1mgAstraZeneca
Pharmaceuticals USA
Zuellig Pharma Sdn
Bhd
28 October 2015 till 27
October 2020POM
545 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
546 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
547BRU10100575PS1 &
BRU10100575PS2Renitec® 10mg Tablet Enalapril maleate 10mg
(S1) Merck Sharp & Dohme
Ltd., United Kingdom; (S2)
Merck Sharp & Dohme
(Australia), Australia
Zuellig Pharma Sdn
Bhd
28 October 2015 till 27
October 2020POM
548 BRU10100576PAlbutein® Solution for Infusion
25% Albumin (Human) 25% Grifols Biologicals Inc., USA
Hongkiat Trading &
Company
28 October 2015 till 27
October 2020POM
549 BRU10100577P RebetolTM 200mg Capsule Ribavirin 200mg
MSD International GmbH
(Puerto Rico Branch) LLC.,
Puerto Rico, USA.
Zuellig Pharma Sdn
Bhd
28 October 2015 till 27
October 2020POM
550 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)
BDMCA/RMP/1215 Page 36 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
551BRU10100579PS1 &
BRU10100579PS1Vytorin™ Tablets 10mg/10mg Ezetimibe 10mg; Simvastatin 10mg
Merck Sharp & Dohme
(Italia) S.p.A., Italy (S1);
MSD International GmbH
(Singapore Branch),
Singapore (S2)
Zuellig Pharma Sdn
Bhd
28 October 2015 till 27
October 2020POM
552 BRU10110580PIntron A* 18million IU Solution
for Injection, Multidose PenInterferon Alfa-2b 18 million IU
Schering-Plough (Brinny)
Co., Ireland
Zuellig Pharma Sdn
Bhd
24 November 2015 till
23 November 2020POM
553BRU10110581PS1;
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 Sdn
Bhd
24 November 2015 till
23 November 2020POM
554BRU10110582PS1;
BRU10110582PS2 Arcoxia® 90mg Tablet Etrocoxib 90mg
Merck Sharp & Dohme
Corp., USA (S1)and Frosst
Iberica S.A., Spain (S2)
Zuellig Pharma Sdn
Bhd
24 November 2015 till
23 November 2020POM
555BRU10110583PS1 &
BRU10110583PS2Renitec® 20mg Tablet Enalapril maleate 20mg
(S1) Merck Sharp & Dohme
Ltd., United Kingdom; (S2)
Merck Sharp & Dohme
(Australia), Australia
Zuellig Pharma Sdn
Bhd
24 November 2015 till
23 November 2020POM
556 BRU10110584P Zocor 20mg Film-coated Tablet Simvastatin 20mgMerck Sharp & Dohme Ltd.,
Northumberland, UK
Zuellig Pharma Sdn
Bhd
24 November 2015 till
23 November 2020POM
557 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
558 BRU10110587PMetoclopramide Syrup
5mg/5mlMetoclopramide hydrochloride 5mg/5ml
Sunward Pharmaceutical Pte
Ltd, Singapore
G & H Traidng
Company
24 November 2015 till
23 November 2020POM
559 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
560 BRU10110589P Fosamax® Tablet 10mg Alendronic (as sodium 13.05) acid 10mg Merck & Co Inc., USAZuellig Pharma Sdn
Bhd
24 November 2010 till
23 November 2015POM
561 BRU10110590P Zoladex Depot 3.6mg/dose Goserelin (as acetate) 3.6mg AstraZeneca UK Ltd., UKZuellig Pharma Sdn
Bhd
24 November 2015 till
23 November 2020POM
BDMCA/RMP/1215 Page 37 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
562 BRU10110591PVoren Enteric Coated Tablet
25mgDiclofenac Sodium 25mg
Y.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
24 November 2015 till
23 November 2020POM
563 BRU10110592P Oroxine Tablet 50mcg Levothyroxine Sodium 55.63mcg Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma Sdn
Bhd
24 November 2015 till
23 November 2020POM
564 BRU10110593PVoren Enteric Coated Tablet
50mgDiclofenac Sodium 50mg
Y.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
24 November 2015 till
23 November 2020POM
565BRU10110594PS1 &
BRU10110594PS2Vytorin™ Tablets 10mg/80mg Ezetimibe 10mg; Simvastatin 80mg
Merck Sharp & Dohme
(Italia) S.p.A., Italy (S1) ;
MSD International GmbH
(Singapore Branch),
Singapore (S2)
Zuellig Pharma Sdn
Bhd
24 November 2010 till
23 November 2015POM
566 BRU10110595P Zantac™ Injection 25mg/ml Ranitidine hydrochloride 25mg/mlGlaxoSmithKline
Manufacturing S.p.A., Italy
Zuellig Pharma Sdn
Bhd
24 November 2015 till
23 November 2020POM
567 BRU10110596PBeconase™ Aqueous Nasal
Spray
Beclomethasone Dipropionate (as
monohydrate)Glaxo Wellcome S.A., Spain
Zuellig Pharma Sdn
Bhd
24 November 2015 till
23 November 2020POM
568 BRU10110597P Campto 40mg/2ml InjectionIrinotecan hydrochloride trihydrate
40mg/2ml
Pfizer (Perth) Pty Ltd.,
Australia
Zuellig Pharma Sdn
Bhd
24 November 2015 till
23 November 2020POM
569BRU10120599PS1;
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 Sdn
Bhd
29 December 2015 till
28 December 2020POM
570 BRU10120600PRitalin® LA Modified Release
Capsule 40mgMethylphenidate hydrochloride 40mg
Elan Holdings Inc., United
States
Zuellig Pharma Sdn
Bhd
29 December 2015 till
28 December 2020POM
571 BRU10120601P Mercilon TabletDesogestrel 0.15mg & Ethinylestradiol
0.02mg
Organon (Ireland) Ltd.,
Irelnad
Zuellig Pharma Sdn
Bhd
29 December 2010 till
28 December 2015POM
572 BRU10120602POrgalutron Solution for
Injection 0.25mg/0.5mlGanirelix acetate 0.25mg/0.5ml
Vetter Pharma-Fertigung
GmbH & Co. KG, Germany
Zuellig Pharma Sdn
Bhd
29 December 2015 till
28 December 2020POM
BDMCA/RMP/1215 Page 38 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
573BRU10120603PS1 &
BRU10120603PS2Renitec® Tablet 5mg Enalapril maleate 5mg
(S1) Merck Sharp & Dohme
Ltd., United Kingdom; (S2)
Merck Sharp & Dohme
(Australia), Australia
Zuellig Pharma Sdn
Bhd
29 December 2015 till
28 December 2020POM
574 BRU10120604P Afrin Nasal Spray 0.05% Oxymetazoline Hydrochloride 0.05%PT. Merck Sharp Dohme
Pharma Tbk, Indonesia
Zuellig Pharma Sdn
Bhd
29 December 2015 till
28 December 2020P
575 BRU10120605P Clarityne Tablet 10mg Loratadine 10mgPT. Merck Sharp Dohme
Pharma Tbk, Indonesia
Zuellig Pharma Sdn
Bhd
29 December 2015 till
28 December 2020P
576 BRU10120606P Frotin Pessaries Metronidazole 250mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
29 December 2015 till
28 December 2020POM
577 BRU10120607P Allopurinol Tablet 300mg Allopurinol 300mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
29 December 2015 till
28 December 2020POM
578 BRU10120608P Methergin Tablet 0.125mg Methylergometrine maleate 0.125mg
Novartis Pharma
Produktions GmbH,
Germany
Zuellig Pharma Sdn
Bhd
29 December 2015 till
28 December 2020POM
579 BRU10120609P Vesicare Tablet 10mg Solifenacin Succinate 10mgAstellas Pharma Europe
B.V., The Netherlands
Zuellig Pharma Sdn
Bhd
29 December 2015 till
28 December 2020POM
580 BRU10120611P Voren Suppositories 12.5mg Diclofenac Sodium 12.5mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
29 December 2015 till
28 December 2020POM
581 BRU10120612PFlixonase Aqueous Nasal Spray
0.05%
Fluticasone propionate (micronised)
50mcgGlaxo Wellcome S.A., Spain
Zuellig Pharma Sdn
Bhd
29 December 2015 till
28 December 2020POM
582BRU10120613PS1;
BRU10120613PS2
Esmeron® Injection 50mg/5ml
(10mg/ml)Rocuronium Bromide 50mg/5ml
N.V. Organon, The
Netherlands; Hameln
Pharmaceuticals GmbH,
Germany
Zuellig Pharma Sdn
Bhd
29 December 2015 till
28 December 2020POM
583 BRU10120614P Clomid Tablet 50mg Clomifene Citrate 50mg Patheon France S.A., France Medipharm Sdn Bhd29 December 2015 till
28 December 2020POM
584 BRU10120615P FlixotideTM EvohalerTM 125mcg Fluticasone propionate 125mcg Glaxo Wellcome S.A., SpainZuellig Pharma Sdn
Bhd
29 December 2015 till
28 December 2020POM
BDMCA/RMP/1215 Page 39 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
585 BRU10120616P LEVITRA® Film-coated TabletVardenafil 5mg (as monohydrochloride
trihydrate)Bayer Pharma AG., Germany
Zuellig Pharma Sdn
Bhd
29 December 2015 till
28 December 2020POM
586 BRU10120617P IRESSATM Tablet 250mg Gefitinib 250mg AstraZeneca UK Ltd., UKZuellig Pharma Sdn
Bhd
29 December 2015 till
28 December 2020POM
587BRU11010619PS1;
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 Sdn
Bhd
26 January 2016 till 25
January 2021POM
588 BRU11010621P Femara® 2.5mg Tablet Letrozole 2.5mgNovartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
26 January 2011 till 25
January 2016POM
589 BRU11010622P Bonefos® 400mg CapsulesAnhydrous Disodium Clodronate (as
tetrahydrate 500mg) 400mgBayer Oy, Finland
Zuellig Pharma Sdn
Bhd
26 January 2011 till 25
January 2016POM
590 BRU11010623P Allopurinol Tablet 100mg Allopurinol 100mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
26 January 2011 till 25
January 2016POM
591 BRU11010624P Elomet Ointment 0.1% Mometasone Furoate (as anhydrous)PT. Merck Sharp Dohme
Pharma Tbk, Indonesia
Zuellig Pharma Sdn
Bhd
26 January 2016 till 25
January 2021POM
592 BRU11010625 Implanon® 68mg ImplantEtonogestrel (Micronised) [Org3236]
68mg
N.V. Organon, The
Netherlands
Zuellig Pharma Sdn
Bhd
26 January 2016 till 25
January 2021POM
593 BRU11010626NP Poro Tablet 500mg Paracetamol 500mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
26 January 2011 till 25
January 2016
GSL (10 x
10's), P
(100x10's &
3,000's)
594 BRU11010627P Tegretol CR 200 Tablet Carbamazapine 200mgNovartis Farma S.p.A.,
Torree Annunziata, Italy
Zuellig Pharma Sdn
Bhd
26 January 2016 till 25
January 2021POM
595 BRU11010628POxy-Nase Paediatric Nasal
Spray 0.025%Oxymetazoline HCl 0.025%
HOE Pharmaceuticals Sdn
Bhd, Malaysia
G&H Trading
Company
26 January 2016 till 25
January 2021P
596 BRU11010629P TrandateTM Tablets 100mg Labetalol hyrdochloride 100mgGlaxo Wellcome GmbH &
Co., Germany
Zuellig Pharma Sdn
Bhd
26 January 2016 till 25
January 2021POM
597 BRU11010631P Tegretol® CR 400 Tablet Carbamazapine 400mgNovartis Farma S.p.A.,
Torree Annunziata, Italy
Zuellig Pharma Sdn
Bhd
26 January 2016 till 25
January 2021POM
598 BRU11010632P Comtan® Tablet 200mg Entacapone 200mgOrion Corporation, Espoo,
Finland
Zuellig Pharma Sdn
Bhd
26 January 2016 till 25
January 2021POM
599 BRU11010633P DF118 Tablet DihydrocodeineGlaxoSmithKline South
Africa (Pty) Ltd., South Africa
Zuellig Pharma Sdn
Bhd
26 January 2016 till 25
January 2021POM
600 BRU11010635P Zantac SyrupTM 150mg/10mlRanitidine (as hydrochloride)
150mg/10ml
Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma Sdn
Bhd
26 January 2016 till 25
January 2021POM
BDMCA/RMP/1215 Page 40 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
601 BRU11010636NP Bisacodyl Suppositories Bisacodyl 5mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
26 January 2011 till 25
January 2016POM
602 BRU11010637PEngerixTM-B Adult Dose
Vaccine 20mcg/ml
Purified Hepatitis B Surface Antigen
(HBsAg) 20mcg/ml
GlaxoSmithKline Biologicals
SA, Belgium
Zuellig Pharma Sdn
Bhd
26 January 2016 till 25
January 2021POM
603 BRU11010638P HavrixTM720 Junior VaccineInactivated Hepatitis A virus antigen
(HAV), HM175 strain 720 EL.U
GlaxoSmithKline Biologicals
SA, Belgium
Zuellig Pharma Sdn
Bhd
26 January 2016 till 25
January 2021POM
604 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
Zuellig Pharma Sdn
Bhd
26 January 2016 till 25
January 2021POM
605 BRU11010640P Microgynon® 30 TabletLevonorgestrel 0.15mg, Ethinylestradiol
0.03mg
Bayer Weimar GmbH und
Co., KG, Germany
Zuellig Pharma Sdn
Bhd
26 January 2016 till 25
January 2021POM
606 BRU11010641P Ami-hydrotride TabletAmiloride hydrochloride 5mg &
Hydrochlorthiazide 50mg
Upha Pharmaceutical Mfg
(M) Sdn Bhd., Malaysia
Hongkiat Trading &
Company
26 January 2011 till 25
January 2016POM
607 BRU11010642P Virless Tablets 200mg Acyclovir 200mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
26 January 2011 till 25
January 2016POM
608 BRU11020643P Dalacin C 300mg Capsule Clindamycin (as Hydrochloride) 300mg Pfizer PGM, FranceZuellig Pharma Sdn
Bhd
24 February 2016 till
23 February 2021POM
609 BRU11020644P Tegretol® 200mg Tablet Carbamazepine 200mg Novartis Pharma S.p.A., ItalyZuellig Pharma Sdn
Bhd
24 February 2016 till
23 February 2021POM
610 BRU11020645P OroxineTM Tablet 100mcgLevothyroxine (as sodium) anhydrous
100mcg
Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma Sdn
Bhd
24 February 2016 till
23 February 2021POM
611 BRU11020646P ActifedTM Syrup
Triprolidine Hydrochloride BP
1.25mg/5ml; Pseudoephedrine
hydrochloride BP 30mg/5ml
Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma Sdn
Bhd
24 February 2016 till
23 February 2021
P (60ml &
100ml)
612 BRU11020647P Tegretol® 2% Syrup Carbamazepine 100mg/5mlDelpharm Huningue S.A.S.,
France
Zuellig Pharma Sdn
Bhd
24 February 2016 till
23 February 2021POM
613 BRU11020648PGlivec® 100mg Film-coated
TabletImatinib (as mesylate) 100mg
Novartis Pharma
Produktions GmbH,
Germany
Zuellig Pharma Sdn
Bhd
24 February 2016 till
23 February 2021POM
614 BRU11020649PSandostatin® Ampoules
0.05mg/mlOctreotide (as acetate) 0.05mg/ml
Novartis Pharma Stein AG.,
Switzerland
Zuellig Pharma Sdn
Bhd
24 February 2016 till
23 February 2021POM
BDMCA/RMP/1215 Page 41 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
615 BRU11020650PLevitra® film-coated Tablet
20mg
Vardenafil (as monochloride trihydrate)
20mgBayer Pharma AG., Germany
Zuellig Pharma Sdn
Bhd
24 February 2016 till
23 February 2021POM
616 BRU11020651PFormoxol I.V. Injection "Yung
Shin"Paclitaxel 6mg/ml
Yung Shin Pharmaceutical
Ind. Co. Ltd., Taiwan
Asterix United (B)
Sdn Bhd
24 February 2011 till
23 February 2016POM
617 BRU11020652PUrosin® Film-coated Tablet
50mgAtenolol 50mg
Y.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
24 February 2011 till
23 February 2016POM
618 BRU11020653PIbuprofen Film-coated Tablet
400mgIbuprofen 400mg
Y.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
24 February 2011 till
23 February 2016P
619 BRU11020654P Promethazine Syrup 5mg/5ml Promethazine HCl 5mg/5mlDrug House of Australia Pte
Ltd., Singapore
G & H Trading
Company
24 February 2011 till
23 February 2016POM
620 BRU11020655P Voren GelDiclofenac Sodium 10mg/g (as Diclofenac
Acid Diethylamine)
Y.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
24 February 2011 till
23 February 2016GSL
621 BRU11020656PAtacor 20mg Film-coated
TabletsAtorvastatin (as Calcium) 20mg Actavis hf., Iceland
K-Seri Pharma Sdn
Bhd
24 February 2011 till
23 February 2016POM
622 BRU11020657P Dermosol Cream Clobetasol (as propionate) 0.5%w/wY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
24 February 2011 till
23 February 2016POM
623 BRU11020658P Zendhin 150 Tablet Ranitidine (as hydrochloride) 150mgDrug House of Australia
(Asia) Pte Ltd., Singapore
G & H Trading
Company
24 February 2011 till
23 February 2016POM
624BRU11030659PS1 &
BRU11030659PS2Vytorin Tablet 10mg/40mg Ezetimibe 10mg, Simvastatin 40mg
MSD International gmbH
(Singapore Branch),
Singapore (S1); Merck Sharp
& Dohme (Italia) S.p.A., Italy
(S2)
Zuellig Pharma Sdn
Bhd
26 March 2016 till 25
March 2021POM
625 BRU11030660P Oxy-nase® Nasal Spray 0.05% Oxymetazoline HCl 0.05%HOE Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
26 March 2016 till 25
March 2021P
626 BRU11030661PPrimperan® 10mg
SuppositoriesMetoclopramide 10mg
Unither Liquid
Manufacturing, France.
Zuellig Pharma Sdn
Bhd
26 March 2011 till 25
March 2016POM
627 BRU11030662PFucon Film Coated Tablet
10mgHysocine-n-butylbromide 10mg
Y.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
26 March 2011 till 25
March 2016POM
BDMCA/RMP/1215 Page 42 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
628 BRU11030663P Betamethasone Tablet 0.5mg Betamethasone 0.5mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
26 March 2011 till 25
March 2016POM
629 BRU11030664P Trivastal® Retard 50 Tablet Piribedil 50mgLes Laboratoires Servier
Industrie, France
Zuellig Pharma Sdn
Bhd
26 March 2016 till 25
March 2021POM
630 BRU11030667P Clarinase Syrup 5mg/5mlPer 5ml: Loratadine 5mg,
Pseudoephedrine Sulphate 60mg
Sanofi Aventis Argentina
S.A., Argentina
Zuellig Pharma Sdn
Bhd
26 March 2016 till 25
March 2021P
631 BRU11030668P
Vivaxim Suspension and
Solution for Suspension for
Injection
Inactivated Hepatitis A Virus, GBM strain
160 antigen units
Sanofi Pasteur, Parc
industriel d'Incarville, France
Zuellig Pharma Sdn
Bhd
26 March 2016 till 25
March 2021POM
632BRU11030669PS1;
BRU11030669PS2
Caelyx 2mg/ml Concentrate for
InfusionDoxorubicin HCl 2mg/ml
Alza Corporation, USA (S1);
GlaxoSmithKline
Manufacturing S.P.A., Italy
(S2)
Zuellig Pharma Sdn
Bhd
26 March 2016 till 25
March 2021POM
633 BRU11030670P Alkeran Tablet 2mg Melphalan 2mg Excella GmbH, GermanyZuellig Pharma Sdn
Bhd
26 March 2016 till 25
March 2021POM
634 BRU11030671P Hyzaar Forte Tablet 100/25mgLosartan potassium 100mg,
Hydrochlorothiazide 25mg
Merck Sharp & Dohme Ltd.,
UK
Zuellig Pharma Sdn
Bhd
26 March 2016 till 25
March 2021POM
635 BRU11030672P Avodart Soft Capsules 0.5mg Dutasteride 0.5mgGlaxoSmithKline
Pharmaceuticals S.A., Poland
Zuellig Pharma Sdn
Bhd
26 March 2016 till 25
March 2021POM
636 BRU11030673PTopistin® Solution for IV
Infusion 200mg/100mlCiprofloxacin (as lactate) 200mg/100ml
Elpen Pharmaceutical Co.,
Inc., Greece.
G & H Trading
Company
26 March 2011 till 25
March 2016POM
637 BRU11030674P Arixtra Injection 2.5mg/0.5ml Fondporinux sodium 2.5mg/0.5mlGlaxo Wellcome Production,
France
Zuellig Pharma Sdn
Bhd
26 March 2016 till 25
March 2021POM
638 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 Sdn
Bhd
30 April 2016 till 29
April 2021POM
639BRU11040676PS1;
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 Sdn
Bhd
30 April 2016 till 29
April 2021POM
BDMCA/RMP/1215 Page 43 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
640 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, FranceZuellig Pharma Sdn
Bhd
30 April 2016 till 29
April 2021POM
641 BRU11040678PEuvax B Adult Vaccine
RecombinantPurified HBs-Ag 20mcg LG Life Science Ltd., Korea
Zuellig Pharma Sdn
Bhd
30 April 2016 till 29
April 2021POM
642 BRU11040679PTrandateTM Injection 5mg/ml x
5mlLabetalol HCl 25mg/5ml
United Biomedical Inc (UBI)
Asia Ltd., Taiwan
Zuellig Pharma Sdn
Bhd
30 April 2016 till 29
April 2021POM
643BRU11040680PS1 &
BRU11040680PS2 Puregon® 50IU/0.5ml Solution
for Injection
Follitrophin Beta (recombinant follicale-
stimulating hormone (FSH) 50IU/0.5ml
Organon (Ireland) Ltd.,
Dublin, Ireland (S1);
N.V.Organon, The
Netherlands (S2)
Zuellig Pharma Sdn
Bhd
30 April 2016 till 29
April 2021POM
644 BRU11040681P Oxy-Nase Nasal Drops 0.05% Oxymetazolin Hydrochloride 0.05%w/vHOE Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
30 April 2016 till 29
April 2021P
645 BRU11040682P Sunolut Tablet 5mg Norethisterone 5mgSunward Pharmaceutical Pte
Ltd., Singapore
G & H Trading
Company
30 April 2016 till 29
April 2021POM
646 BRU11040683PSandostatin® LAR® Injection
10mgOctreotide 10mg Biochemie GmbH, Austria
Zuellig Pharma Sdn
Bhd
30 April 2016 till 29
April 2021POM
647 BRU11040684PVfend TM Film-Coated Tablets
200mgVoriconazole 200mg Pfizer Italia S.R.L, Italy
Zuellig Pharma Sdn
Bhd
30 April 2016 till 29
April 2021POM
648 BRU11040685P Voren Suppositories 25mg Diclofenac Sodium 25mgY.S.P Industries (M) Sdn
Bhd., Malaysia
Asterix United (B)
Sdn Bhd
30 April 2011 till 29
April 2016POM
649 BRU11040687PMultaq 400mg Film-coated
Tablet
Dronedarone 400mg (equiv.
Dronedarone HCl 426mg)
Sanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
30 April 2011 till 29
April 2016POM
650 BRU11040688P Stablon Coated Tablet 12.5mg Tianeptine (as sodium) 12.5mgLes Laboratoires Servier
Industrie, France
Zuellig Pharma Sdn
Bhd
30 April 2016 till 29
April 2021POM
BDMCA/RMP/1215 Page 44 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
651 BRU11040689P Shinoxol Tablet 30mg Ambroxol HCl 30mgY.S.P Industries (M) Sdn
Bhd., Malaysia
Asterix United (B)
Sdn Bhd
30 April 2011 till 29
April 2016POM
652 BRU11040690PEngerixTM-B Paediatric Vaccine
10mcg/0.5mlPurified HBs-Ag 10mcg
GlaxoSmithKline Biologicals
SA., Belgium
Zuellig Pharma Sdn
Bhd
30 April 2016 till 29
April 2021POM
653 BRU11040691P Elosone Cream Mometasone Furoate 0.1%w/wHOE Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
30 April 2016 till 29
April 2021POM
654 BRU11040692P Fedac Compound Linctus
Per 5ml- Triprolidine HCl BP 1.25mg;
Pseudoephedrine HCl BP 30mg; Codeine
Phosphate BP 10mg
Drug House of Australia Pte
Ltd., Singapore
G & H Trading
Company
30 April 2011 till 29
April 2016POM
655 BRU11040693P Cinna Tablet 25mg Cinnarizine 25mgY.S.P Industries (M) Sdn
Bhd., Malaysia
Asterix United (B)
Sdn Bhd
30 April 2011 till 29
April 2016POM
656 BRU11040694PStalevo® 100/25/200mg Film-
coated Tablet
Levodopa 100mg; Carbidopa 25mg;
Entacapone 200mg
Orion Corporation, Espoo,
Finland
Zuellig Pharma Sdn
Bhd
30 April 2016 till 29
April 2021POM
657 BRU11040695PRevoladeTM Film-coated Tablet
25mg
Eltrombopag 25mg [as free acid] (as
olamine)
Glaxo Operations UK Ltd
(trading as Glaxo Wellcome
Operations), UK
Zuellig Pharma Sdn
Bhd
30 April 2016 till 29
April 2021POM
658 BRU11040696PCoversyl® Film-coated Tablet
10mg
Perindopril arginine 20mg (equiv to
perindopril 6.790mg)
Les Laboratoires Servier
Industrie, France
Zuellig Pharma Sdn
Bhd
30 April 2016 till 29
April 2021POM
659 BRU11040697PAtorvastatin Winthrop® 20mg
Film-coated TabletAtorvastatin 20mg (as calcium 20.68mg)
Zentiva k.s., Prague, Czech
RepublicMedipharm Sdn Bhd
30 April 2011 till 29
April 2016POM
660 BRU11040698P SeroxatTM CR Tablet 12.5mgParoxetine 12.5mg (as Paroxetine HCl
hemihydrate)
GlaxoSmithKline Inc.,
Ontario, Canada
Zuellig Pharma Sdn
Bhd
30 April 2016 till 29
April 2021POM
661 BRU11050699P Avamys® Nasal Spray Fluticasone furoate (micronised) 27.5µg
/spray
Glaxo Operations UK Ltd,
United Kingdom
Zuellig Pharma Sdn
Bhd
25 May 2016 till 24
May 2021POM
662 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 Sdn
Bhd
25 May 2016 till 24
May 2021POM
663 BRU11050701P Depo-Provera Vial 150mg/3ml Medroxyprogesterone acetate 150mgPfizer Manufacturing
Belgium N.V., Belgium
Zuellig Pharma Sdn
Bhd
25 May 2016 till 24
May 2021POM
664 BRU11050702P Benzhexol Tablet 2mg Benzhexol HCl 2mgSunward Pharmaceutical Pte
Ltd., Singapore
G & H Trading
Company
25 May 2016 till 24
May 2021POM
BDMCA/RMP/1215 Page 45 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
665 BRU11050703PLevitra Film-coated Tablets
10mg
Vardenafil (as monohydrochloride
trihydrate) 10mgBayer Pharma AG., Germany
Zuellig Pharma Sdn
Bhd
25 May 2016 till 24
May 2021POM
666 BRU11050704PVentolin Solution for
Intravenous Infusion 5mg/5mlSalbutamol (as sulphate) 5mg/5ml
GlaxoSmithKline
Pharmaceutical S.p.A., Italy
Zuellig Pharma Sdn
Bhd
25 May 2016 till 24
May 2021POM
667 BRU11050705NP Upha B6 10 Tablet Pyridoxine HCl 10mgUpha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Company
25 May 2011 till 24
May 2016P (5 x 50's)
668 BRU11050706PZofran Injection Flexi-Amp
AmpoulesOndansetron HCl Dihydrate 8mg/4ml
GlaxoSmithKline Australia
Pty Ltd.m Australia
Zuellig Pharma Sdn
Bhd
25 May 2016 till 24
May 2021POM
669 BRU11050707PCaverject 20mcg Powder and
solvent for injectionAlprostadil 20µg
Pfizer Manufacturing
Belgium N.V., Belgium
Zuellig Pharma Sdn
Bhd
25 May 2016 till 24
May 2021POM
670 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 2011 till 24
May 2016GSL (50's)
671 BRU11050709P Diosper Film-coated Tablets Diosmin 450mg. Hesperidin 50mgKleva S.A. Pharmaceutical,
Greece
G & H Trading
Company
25 May 2011 till 24
May 2016
GSL (3 x 10's)
P (50 x 10's)
672 BRU11050710P Coveram Tablets 5mg/5mg
Perindopril arginine 5mg (equiv. to
perindopril 3.395mg); Amlodipine 5mg
(as besilate 6.935mg)
Servier (Ireland) Industries
Ltd., Ireland
Zuellig Pharma Sdn
Bhd
25 May 2016 till 24
May 2021POM
673 BRU11050711P Penrazol Capsule 20mg Omeprazole 20mgElpen Pharmaceutical Co.
Inc., Greece
G & H Trading
Company
25 May 2011 till 24
May 2016POM
674 BRU11050712P Tracrium Injection 25mg/2.5ml Atracurium besylate 25mg/2.5mlGlaxoSmithKline
Manufactuirng S.p.A., Italy
Zuellig Pharma Sdn
Bhd
25 May 2016 till 24
May 2021POM
675 BRU11050713P Aricept Tablet 10mgDonepezil HCl 10mg (equiv. Donepezil
free base 9.12mg)Eisai Taiwan Inc., Taiwan Medipharm Sdn Bhd
25 May 2011 till 24
May 2016POM
676 BRU11060714P Zantac 150mg Tablet Ranitidine 150mg (as HCl 168mg)GlaxoSmithKline (Tianjin) Co.
Ltd., PR China
Zuellig Pharma Sdn
Bhd
02 July 2016 till 01 July
2021POM
677 BRU11060715POxy-Nase Paediatric Nasal
Drop 0.025%w/vOxymetazoline HCl 0.025%
HOE Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
02 July 2016 till 01 July
2021POM
678 BRU11060716P Vfend 50mg film-coated Tablet Voriconazole 50mg Pfizer Italia S.R.L., ItalyZuellig Pharma Sdn
Bhd
02 July 2016 till 01 July
2021POM
679 BRU11060717P Protaxos 2g Strontium Ranelate 2632mgLes Laboratoires Servier
Industrie, France
Zuellig Pharma Sdn
Bhd
02 July 2016 till 01 July
2021POM
680 BRU11060718P MyleranTM Tablets 2mg Busulphan 2mg Excella GmbH, GermanyZuellig Pharma Sdn
Bhd
02 July 2016 till 01 July
2021POM
BDMCA/RMP/1215 Page 46 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
681 BRU11060719PAmlodipine Winthrop Tablet
5mgAmlodipine (as besilate)
Unichem Laboratories
Limited, Goa, IndiaMedipharm Sdn Bhd
02 July 2011 till 01 July
2016POM
682 BRU11060720P Virless Tablet 800mg Acyclovir 800mgY.S.P. Industries (M) Sdn
Bhd., Malaysia
Asterix United (B)
Sdn Bhd
02 July 2011 till 01 July
2016POM
683 BRU11060721PAtorvastatin Winthrop® 40mg
TabletAtorvastatin 40mg (as Calcium 41.36mg) Zentiva k.s., Czech Republic Medipharm Sdn Bhd
02 July 2011 till 01 July
2016POM
684 BRU11060722P Propecia 1mg Tablet Finasteride 1mgMerck Sharp & Dohme,
Puerto Rico, USA
Zuellig Pharma Sdn
Bhd
02 July 2016 till 01 July
2021POM
685 BRU11060723PSeroquel XR Extended-Release
Tablets 50mg
Quetiapine 50mg (as fumarate
57.560mg)
AstraZeneca Pharmaeuticals
LP, USA
Zuellig Pharma Sdn
Bhd
02 July 2016 till 01 July
2021POM
686 BRU11070724P Vesicare® 5mg Tablet Solifenacin Succinate 5mgAstella Pharma Europe B.V.,
The Netherlands
Zuellig Pharma Sdn
Bhd
27 July 2011 till 26 July
2016POM
687 BRU11070725P InfanrixTM Hib
Diphteria toxoid min. 30IU, Tetanus
toxoid min. 40IU, Pertussis toxoid (PT)
25mcg, Conjugate Haemophilus
influenzae type b capsular
polysaccharide 10mcg coupled to 20 to
40mcg tetanus toxoid
GlaxoSmithKline Biologicals
s.a., Belgium
Zuellig Pharma Sdn
Bhd
27 July 2011 till 26 July
2016POM
688 BRU11070726PInfanrixTM Suspension for
Injection
Diphteria toxoid min. 30IU, Tetanus
toxoid min. 40IU, Pertussis toxoid (PT)
25mcg
GlaxoSmithKline Biologicals
s.a., Belgium
Zuellig Pharma Sdn
Bhd
27 July 2011 till 26 July
2016POM
689 BRU11070727P SW Bena-Expectorant
Per 5ml: Diphenhydramine HCl 10mg,
Ammonium Chloride 102mg, Sodium
Citrate 46mg
Sunward Pharmaceutical Pte
Ltd., Singapore
Zuellig Pharma Sdn
Bhd
27 July 2011 till 26 July
2016POM
690 BRU11070728P
Fluarix Inactivated Split
Infuenza Vaccine (2014
Northern Hemisphere)
Purified, inactivated influenza virus of
the following strains:A/California/7/2009
(H1N1) pdm09-like strain [variant
A/Christchurch/16/2010 (NIB-74xp)]
15mcgHA; A/Texas/50/2012 (H3N2)-like
strain [variant A/Texas/50/2012 (NYMC X-
223A)] 15mcg HA;
B/Massachusetts/02/2012-like strain
[variant B/Massachusetts/02/2012
(NYMC BX-51B)] 15mcg HA
GlaxoSmithKline Biologicals
s.a., Dresden, Germany
Zuellig Pharma Sdn
Bhd
27 July 2011 till 26 July
2016POM
BDMCA/RMP/1215 Page 47 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
691 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 Sdn
Bhd
27 July 2016 till 26 July
2021POM
692 BRU11070730PMirena® Intrauterine System
20mcg/24hrLevonorgestrel 52mg Bayer Oy, Finland
Zuellig Pharma Sdn
Bhd
27 July 2016 till 26 July
2021POM
693 BRU11070731PAmlodipine Winthrop® 10mg
TabletAmlodipine 10mg (as besilate)
Unichem Laboratories
Limited, Goa, IndiaMedipharm Sdn Bhd
27 July 2011 till 26 July
2016POM
694 BRU11070732P Zoral 400 Tablet 400mg Acyclovir USP 400mgDrug House of Australia Pte
Ltd., Singapore
G & H Trading
Company
27 July 2011 till 26 July
2016POM
695 BRU11070733P ZofranTM Injection 4mg/2ml Ondansetron 4mg/5ml (as HCl dihydrate) GlaxoSmithKline Australia
Pty Ltd., Australia
Zuellig Pharma Sdn
Bhd
27 July 2016 till 26 July
2021POM
696 BRU11070734PSyntometrine® Injection
5IU/ml AmpouleOxytocin 5IU/ml
Novartis Pharma Steing AG.,
SwitzerlandMedipharm Sdn Bhd
27 July 2011 till 26 July
2016POM
697 BRU11070735P Elosone Ointment 0.1%w/w Mometasone furoate 0.1% w/wHOE Pharmaceuticals Sdn
Bhd., Malaysia
G & H Trading
Company
27 July 2016 till 26 July
2021POM
698 BRU11070736P Coveram 5/10mg Tablet
Perindopril arginine 5mg (equiv. to
3.395mg perindopril) and amlodipine
10mg (as besilate 13.870mg)
Servier (Ireland) Industries
Ltd, Ireland
Zuellig Pharma Sdn
Bhd
27 July 2016 till 26 July
2021POM
699 BRU11070737P ZofranTM Tablets 8mg Ondansetron 8mg (as HCl dihydrate) Aspen Bad Oldesloe GmbH,
Germany
Zuellig Pharma Sdn
Bhd
27 July 2016 till 26 July
2021POM
700BRU11070738PS1;
BRU11070738PS2 Diamicron® MR 60mg Tablet Gliclazide 60mg
Les Laboratoires Servier
Industrie, France (S1); Kotra
Pharma (M) Sdn. Bhd,
Malaysia (S2)
Zuellig Pharma Sdn
Bhd
27 July 2016 till 26 July
2021POM
701 BRU11070739P Fedac DM Linctus
Per 5ml: Triprolidine HCl 12.5mg,
Pesudoephedrine HCl 30mg,
Dextrometorphan HBr 10mg
Drug House of Australia Pte
Ltd., Singapore
G & H Trading
Company
27 July 2011 till 26 July
2016POM
702 BRU11070740P Tracrium Injection 50mg/5ml Atracurium Besylate 50mg/5ml
GlaxoSmithKline
Manufacturing S.p.A.,
Parma, Italy
Zuellig Pharma Sdn
Bhd
27 July 2016 till 26 July
2021POM
703 BRU11070741P Coralan® Tablet 2.5mg Ivabradine 7.5mg (as HCl 8.085mg)Les Laboratoires Servier
Industrie, France
Zuellig Pharma Sdn
Bhd
27 July 2016 till 26 July
2021POM
BDMCA/RMP/1215 Page 48 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
704 BRU11080742PAclasta 5mg/10ml Solution for
Infusion
Zolendranic acid (anhydrous) 5mg (as
zolendranic acid monohydrate 5.33mg)
Novartis Pharma Stein AG.,
Switzerland
Zuellig Pharma Sdn
Bhd
25 August 2016 till 24
August 2021POM
705 BRU11080743P Lanoxin Tablet 250mcg Digoxin 250mcgGlaxoSmithKline Australia
Pty Ltd., Australia
Zuellig Pharma Sdn
Bhd
25 August 2011 till 24
August 2016POM
706 BRU11080744P Lanoxin PG Tablet 0.0625mg Digoxin 0.0625mgGlaxoSmithKline Australia
Pty Ltd., Australia
Zuellig Pharma Sdn
Bhd
25 August 2011 till 24
August 2016POM
707 BRU11080745PGlivec® 400mg Film-coated
TabletImatinib (as mesylate) 400mg
Novartis Pharma Stein AG.,
Switzerland
Zuellig Pharma Sdn
Bhd
25 August 2016 till 24
August 2021POM
708 BRU11080746PStalevo 50/12.5/200mg film-
coated tablet
Levodopa 50mg, Carbidopa 12.5mg,
Entacapone 200mg
Orion Corporation, Espoo,
Finland
Zuellig Pharma Sdn
Bhd
25 August 2016 till 24
August 2021POM
709
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 Sdn
Bhd
25 August 2016 till 24
August 2021POM
710 BRU11080748P Campto 100mg/5ml Injection Irinotecan hydrochloride trihydratePfizer (Perth) Pty Ltd,
Australia
Zuellig Pharma Sdn
Bhd
25 August 2016 till 24
August 2021POM
711 BRU11080749P Econazine CreamEconazole nitrate 1% w/w,
Triamcinolone actonide 0.1% w/w
Y.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
25 August 2011 till 24
August 2016POM
712 BRU11080750PFrotin Film Coated 200mg
Tablet Metronidazole 200mg
Y.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
25 August 2011 till 24
August 2016POM
713 BRU11080751PUrosin Film Coated Tablet
100mgAtenolol 100mg
Y.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
25 August 2011 till 24
August 2016POM
714 BRU11080752P TwinrixTM Vaccine
Hepatitis A virus antigen 720 ELISA units;
r-DNA hepatitis B virus surface antigen
(HBsAg)* 20µg *Thiomersal-free
HBsAg purified bulk
GlaxoSmithKline Biologicals
SA, Belgium
Zuellig Pharma Sdn
Bhd
25 August 2016 till 24
August 2021POM
715 BRU11080753P Fukole Capsule 150mg Fluconazole 150mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
25 August 2011 till 24
August 2016POM
716 BRU11080754P CoAprovel Tablet 300/25mgIrbesartan 300mg, Hydrochlorothiazide
25mg
Sanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
25 August 2011 till 24
August 2016POM
BDMCA/RMP/1215 Page 49 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
717 BRU11080755P SeroxatTM CR Tablet 25mgParoxetine 25mg(as Paroxetine
hydrochloride hemihydrate)
GlaxoSmithKline Inc.,
Canada
Zuellig Pharma Sdn
Bhd
25 August 2016 till 24
August 2021POM
718 BRU11080757P Orphenadol® TabletOrphenadrine Citrate 50mg, Paracetamol
325mg
Y.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
25 August 2011 till 24
August 2016POM
719 BRU11080758P Loramide Capsule 2mg Loperamide HCl 2mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
25 August 2011 till 24
August 2016POM
720 BRU11080759P VOREN Suppositories 50mg Diclofenac Sodium 50mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
25 August 2011 till 24
August 2016POM
721 BRU11080760P Decan Tablet 0.75mg Dexamethasone 0.75mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
25 August 2011 till 24
August 2016POM
722 BRU11090762P Properazine Tablet 5mg Prochlorperazine maleate 5mgSunward Pharmaceutical Pte
Ltd, Singapore
G & H Trading
Company
27 September 2011 till
26 September 2016POM
723 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, Belgium
Zuellig Pharma Sdn
Bhd
27 September 2011 till
26 September 2016POM
724 BRU11090764PEloxatin 5mg/ml Concentrate
for Solution for Infusion (10ml)Oxaliplatin 50mg/10ml
Sanofi-Aventis Deutschland
GmbH, GermanyMedipharm Sdn Bhd
27 September 2011 till
26 September 2016POM
725 BRU11090765PEloxatin 5mg/ml Concentrate
for Solution for Infusion (20ml)Oxaliplatin 100mg/20ml
Sanofi-Aventis Deutschland
GmbH, GermanyMedipharm Sdn Bhd
27 September 2011 till
26 September 2016POM
BDMCA/RMP/1215 Page 50 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
726 BRU11090766P InfanrixTM-IPV Vaccine
Composition per dose (0.5ml): Diphteria
toxoid (DT), adsorbed min. 30 I.U;
Tetanus toxoid (TT), adsorbed min. 40
I.U; Pertusis toxoid (PT), adsorbed 25µg;
Filamentous haemagglutinin (FHA),
adsorbed 25µg; Pertactin, adsorbed 8µg;
Inactivated poliomyeltis virus type I 40
DU, Inactivated poliomyeltis virus type II
8DU, Inactivated poliomyeltis virus type
III 32 DU
GlaxoSmithKline Biologicals
SA, Belgium
Zuellig Pharma Sdn
Bhd
27 September 2011 till
26 September 2016POM
727 BRU11090767PSandimmun Neoral® Oral
Solution 100mg/mlCiclosporin A 100mg/ml
Novartis Pharma S.A.S.,
France
Zuellig Pharma Sdn
Bhd
27 September 2016 till
26 September 2021POM
728 BRU11090768P Hyzaar® Tablet 50/12.5mgLosartan Potassium 50mg,
Hydrochlorothiazide 12.5mg
Merck Sharp & Dohme,
Northumberland, UK
Zuellig Pharma Sdn
Bhd
27 September 2016 till
26 September 2021POM
729 BRU11090769PHyzaar® Plus Tablet
100/12.5mg
Losartan Potassium 100mg,
Hydrochlorothiazide 12.5mg
Merck Sharp & Dohme,
Northumberland, UK
Zuellig Pharma Sdn
Bhd
27 September 2016 till
26 September 2021POM
730 BRU11090770PFlebogamma 5% DIF Solution
for Infusion (100mL)
Human Normal Immunoglobulin
50mg/ml
Instituo Grifols S.A.,
Barcelona, Spain
Hongkiat Trading &
Company
27 September 2011 till
26 September 2016POM
731 BRU11090771P Seroquel XR Tablets 200mg Quetiapine (as fumarate) 200mgAstraZeneca Pharmaeuticals
LP, USA
Zuellig Pharma Sdn
Bhd
27 September 2011 till
26 September 2016POM
732 BRU11090772PDiabetamin Film-coated Tablet
500mgMetformin HCl 500mg Hovid Bhd, Perak, Malaysia
G & H Trading
Company
27 September 2011 till
26 September 2016POM
733 BRU11090773P Tidact Gel 1%Clindamycin 10mg/g (as phosphate
11.9mg/g)
Y.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
27 September 2011 till
26 September 2016POM
734 BRU11090774P Daunoblastina Injection 20mg Daunoribicin Hydrochloride 20mg Actavis S.p.A., ItalyZuellig Pharma Sdn
Bhd
27 September 2016 till
26 September 2021POM
735 BRU11090775P Fucon Capsule 10mg Hyoscine-N-butylbromide 10mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
27 September 2011 till
26 September 2016POM
BDMCA/RMP/1215 Page 51 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
736 BRU11090776P Virless Cream Acyclovir 50mg/gY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
27 September 2011 till
26 September 2016POM
737 BRU11090777P Solian® 100mg Scored Tablet Amisulpiride 100mgSanofi Winthrop Industrie,
FranceMediPharm Sdn Bhd
27 September 2011 till
26 September 2016POM
738 BRU11090778P Hovasc Tablet 5mg Amlodipine 5mg (as besilate 6.90mg) Hovid Bhd, MalaysiaG & H Trading
Company
27 September 2011 till
26 September 2016POM
739 BRU11100779P Pariet® Tablet 20mg Sodium Rabeprazole 20mgEisai Co., Ltd, Saitama
Prefecture, JapanMediPharm Sdn Bhd
31 October 2011 till 30
October 2016POM
740 BRU11100780P Pariet® Tablet 10mg Sodium Rabeprazole 10mgEisai Co., Ltd, Saitama
Prefecture, JapanMediPharm Sdn Bhd
31 October 2011 till 30
October 2016POM
741BRU11100781PS1 &
BRU11100781PS2
Puregon® 100IU/0.5ml
Solution for Injection
Follitropin beta (recombinant follicle-
stimulating hormone - FSH) 100IU/0.5ml
Organon (Ireland) Ltd.,
Dublin, Ireland (S1) & N.V.
Organon, The Netherlands
(S2)
Zuellig Pharma Sdn
Bhd
31 October 2016 till 30
October 2021POM
742 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 Sdn
Bhd
31 October 2016 till 30
October 2021POM
743 BRU11100783PTypherixTM Vi Polysccharide
Typhoid Vaccine 25mcg/0.5ml Vi Polysaccaharide of Salmonella TyphiGlaxoSmithKline Biologicals
SA, Belgium
Zuellig Pharma Sdn
Bhd
31 October 2011 till 30
October 2016POM
744 BRU11100784PSandostatin® ampoules
0.1mg/mlOctreotide (as acetate) 0.1mg/ml
Novartis Pharma Stein A.G.,
Switzerland
Zuellig Pharma Sdn
Bhd
31 October 2016 till 30
October 2021POM
745 BRU11100785PAtorvastatin Winthrop® 10mg
film-coated TabletsAtorvastatin 10mg (as calsium 10.34mg) Zentiva k.s., Czech Republic MediPharm Sdn Bhd
31 October 2011 till 30
October 2016POM
746 BRU11100786PStalevo® 150/37.5/200mg Film-
coated Tablet
Levodopa 150mg; Carbidopa 37.5mg;
Entacapone 200mg
Orion Corporation Fermion,
Finland
Zuellig Pharma Sdn
Bhd
31 October 2016 till 30
October 2021POM
747 BRU11100787P Coveram Tablet 10mg/5mg
Perindopril arginine 10mg (eqv. To
Perindopril 6.790mg); Amlodipine 5mg
(as besilate 6.935mg)
Servier (Ireland) Industries
Ltd., Ireland
Zuellig Pharma Sdn
Bhd
31 October 2016 till 30
October 2021POM
748 BRU11100788PCoversyl® Fim-coated Tablet
5mg
Perindopril arginine 5mg (eqv.
Perindopril 3.395mg)
Les Laboratoires Servier
Industrie, Gidy, France
Zuellig Pharma Sdn
Bhd
31 October 2016 till 30
October 2021POM
749 BRU11100789P Myonal 50mg Tablet Eperisone Hydrochloride 50mgEisai Co., Ltd, Saitama
Prefecture, JapanMediPharm Sdn Bhd
31 October 2011 till 30
October 2016POM
750 BRU11100790P VarilrixTM Live attenuated varicella virus (OKA
strain)
GlaxoSmithKline Biologicals
SA, Belgium
Zuellig Pharma Sdn
Bhd
31 October 2011 till 30
October 2016POM
BDMCA/RMP/1215 Page 52 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
751 BRU11100791P Coveram Tablet 10mg/10mg
Perindopril arginine 10mg (eqv. To
Perindopril 6.790mg); Amlodipine 10mg
(as besilate 13.870mg)
Servier (Ireland) Industries
Ltd., Ireland
Zuellig Pharma Sdn
Bhd
31 October 2016 till 30
October 2021POM
752 BRU11100792P Voker Film Coated Tablet 20mg Famotidine 20mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
31 October 2011 till 30
October 2016POM
753 BRU11100793P Solian® 400mg Scored Tablet Amisulpride 400mgSanofi Winthrop Industrie,
FranceMediPharm Sdn Bhd
31 October 2011 till 30
October 2016POM
754 BRU11100794PClarityn-D 12HR EXTENDED
RELEASE TABLET 5mg/120mg
Loratadine 5mg, Pseudoephedrine
sulphate 120mg
Schering Plough Labo N.V.,
Belgium
Zuellig Pharma Sdn
Bhd
31 October 2016 till 30
October 2021POM
755 BRU11100795P Euthyrox® Tablet 25mcg Levothyroxine sodium 25mcgMerck KGaA., Darmstadt,
Germany
Zuellig Pharma Sdn
Bhd
31 October 2011 till 30
October 2016POM
756 BRU11100796P Concor® 2.5mg Tablet Bisoprolol hemifumarate 2.5mgMerck KGaA., Darmstadt,
Germany
Zuellig Pharma Sdn
Bhd
31 October 2011 till 30
October 2016POM
757 BRU11110797P OnglyzaTM Tablet 2.5mgSaxagliptin 2.5mg (as HCl anhydrous
2.79mg)
Bristol-Myers Squibb
Company, Indiana, USA
Zuellig Pharma Sdn
Bhd
24 November 2011 till
23 November 2016POM
758 BRU11110798P OnglyzaTM Tablet 5mgSaxagliptin 5mg (as HCl anhydrous
5.58mg)
Bristol-Myers Squibb
Company, Indiana, USA
Zuellig Pharma Sdn
Bhd
24 November 2011 till
23 November 2016POM
759 BRU11110799PSandostatin® LAR® Injection
20mgOctreotide (as acetate) 20mg Sandoz GmbH, Austria
Zuellig Pharma Sdn
Bhd
24 November 2016 till
23 November 2021POM
760 BRU11110800PSandostatin® LAR® Injection
30mgOctreotide (as acetate) 30mg Sandoz GmbH, Austria
Zuellig Pharma Sdn
Bhd
24 November 2016 till
23 November 2021POM
761 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 Sdn
Bhd
24 November 2016 till
23 November 2021POM
762 BRU11110803PNexavar® 200mg Film-coated
TabletsSorafenib Tosylate 200mg
Bayer Pharma AG.,
Leverkusen, Germany; Bayer
Healthcare Manufacturing
S.r.l., Italy
Zuellig Pharma Sdn
Bhd
24 November 2011 till
23 November 2016POM
763 BRU11110804PPEG Intron CLEARCLICK for
Injection 150mcg/0.5ml
Recombinant interferon alfa-2b 150mcg
(pegylated to monoethoxy polyethylene
glycol)
MSD International GmbH
(Singapore Branch),
Singapore Singapore
Zuellig Pharma Sdn
Bhd
24 November 2016 till
23 November 2021POM
BDMCA/RMP/1215 Page 53 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
764 BRU11110805PPEG Intron CLEARCLICK for
Injection 120mcg/0.5ml
Recombinant interferon alfa-2b 120mcg
(pegylated to monoethoxy polyethylene
glycol)
Schering-Plough Ltd.,
Singapore
Zuellig Pharma Sdn
Bhd
24 November 2016 till
23 November 2021POM
765 BRU11110806PPEG Intron CLEARCLICK for
Injection 100mcg/0.5ml
Recombinant interferon alfa-2b 100mcg
(pegylated to monoethoxy polyethylene
glycol)
Schering-Plough Ltd.,
Singapore
Zuellig Pharma Sdn
Bhd
24 November 2016 till
23 November 2021POM
766 BRU11110807PPEG Intron CLEARCLICK for
Injection 80mcg/0.5ml
Recombinant interferon alfa-2b 80mcg
(pegylated to monoethoxy polyethylene
glycol)
MSD International GmbH
(Singapore Branch),
Singapore Singapore
Zuellig Pharma Sdn
Bhd
24 November 2016 till
23 November 2021POM
767 BRU11110808PPEG Intron CLEARCLICK for
Injection 50mcg/0.5ml
Recombinant interferon alfa-2b 50mcg
(pegylated to monoethoxy polyethylene
glycol)
MSD International GmbH
(Singapore Branch),
Singapore Singapore
Zuellig Pharma Sdn
Bhd
24 November 2016 till
23 November 2021POM
768 BRU11110809PDalacin CTM Sterile Solution
150mg/ml x 2ml ampouleClindamycin Phosphate 300mg
Pfizer Manufacturing
Belgium N.V., Puurs,
Belgium
Zuellig Pharma Sdn
Bhd
24 November 2016 till
23 November 2021POM
769 BRU11110810P LeukeranTM Tablet 2mg Chlorambucil 2mgExcella GmbH., Feucht,
Germany
Zuellig Pharma Sdn
Bhd
24 November 2011 till
23 November 2016POM
770 BRU11110811P Aricept® Tablet 5mgDonepezil HCl 5mg (equiv. to Donepezil
free base 4.56mg)
Eisai Taiwan Inc., Tainan
Hsien, TaiwanMediPharm Sdn Bhd
24 November 2011 till
23 November 2016POM
771 BRU11110812P Euthyrox® Tablet 100mcg Levothyroxine sodium 100mcgMerck KGaA., Darmstadt,
Germany
Zuellig Pharma Sdn
Bhd
24 November 2011 till
23 November 2016POM
772 BRU11110813PKetipinor Film-coated Tablet
200mg
Quetiapine 200mg (as fumarate
230.36mg)
Orion Corporation, Espoo,
Finland
Hongkiat Trading &
Company
24 November 2011 till
23 November 2016POM
773 BRU11110814P Prednisolone Tablet 5mg Prednisolone 5mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
24 November 2011 till
23 November 2016POM
774 BRU11110815P Granocyte® 34 InjectionLenograstim (rHug-CSF) 33.6 million IU
(equiv. to 263 mcg)/ vial
Sanofi Winthrop Industrie,
FranceMediPharm Sdn Bhd
24 November 2011 till
23 November 2016POM
775 BRU11120816PEuvax B Pediatric Vaccine
Recombinant (10mcg/0.5ml)Purified HBs-Ag 10mcg/0.5ml LG Life Science Ltd., Korea
Zuellig Pharma Sdn
Bhd
22 December 2016 till
21 December 2021POM
BDMCA/RMP/1215 Page 54 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
776 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,
Zuellig Pharma Sdn
Bhd
22 December 2016 till
21 December 2021POM
777 BRU11120818P Clarityn Syrup Loratadine 1mg/mlPT. Merck Sharp Dohme
Pharma Tbk, Indonesia
Zuellig Pharma Sdn
Bhd
22 December 2016 till
21 December 2021P
778 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
Zuellig Pharma Sdn
Bhd
22 December 2011 till
21 December 2016POM
779 BRU11120820P VentolinTM EvohalerTM Salbutamol (as sulphate 120.5mcg)
100mcg
Glaxo Wellcome S.A.,
Burgos, Spain
Zuellig Pharma Sdn
Bhd
22 December 2011 till
21 December 2016POM
BDMCA/RMP/1215 Page 55 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
780 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 Belgium
Zuellig Pharma Sdn
Bhd
22 December 2011 till
21 December 2016POM
781 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 Sdn
Bhd
22 December 2011 till
21 December 2016POM
782 BRU11120823P Coversyl® Plus 5mgPerindopril arginine 5mg (as besilate
3.395mg); Indapamide 1.25mg
Les Laboratoires Servier
Industrie, France
Zuellig Pharma Sdn
Bhd
22 December 2011 till
21 December 2016POM
783 BRU11120824P Yasmin® Film-coated TabletsDrospirenone 3mg, Ethinylestradiol
0.03mg
Bayer Weimar GmbH und
Co. KG (WEIMAR PLANT),
Germany
Zuellig Pharma Sdn
Bhd
22 December 2011 till
21 December 2016POM
784 BRU11120826NP Arcalion® 200mg Tablet Sulbutiamine 200mgLes Laboratoires Servier
Industrie, France
Zuellig Pharma Sdn
Bhd
22 December 2016 till
21 December 2021GSL
785 BRU11120827PMethycobal Injection
500mcg/mlMecobalamin 500mcg Eisai Co., Ltd, Japan MediPharm Sdn Bhd
22 December 2011 till
21 December 2016POM
786 BRU11120828PFlebogamma® 5% DIF Solution
for Infusion (200ml)
Human Normal Immunoglobulin
10g/200mL (50mg/ml)Instituto Grifols, S.A., Spain Hongkiat Trading
22 December 2011 till
21 December 2016POM
787 BRU11120829NP Shintamet film coated Tablet Cimetidine 400mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
22 December 2011 till
21 December 2016POM
788 BRU11120830P Dermafin cream 1% Terbinafine Hydrochloride 1%w/wY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
22 December 2011 till
21 December 2016GSL
789 BRU11120831P Pontalon Tablet 250mg Mefenamic Acid 250mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
22 December 2011 till
21 December 2016POM
790 BRU11120832P Clopivid Tablet 75mgClopidogrel 75mg (as hydrogen sulphate
97.90mg)Hovid Bhd, Malaysia
G & H Trading
Company
22 December 2011 till
21 December 2016POM
791 BRU11120833PShincort Injection “Yung Shin”
10mg/mlTriamcinolone Acetonide 50mg/5ml
Yung Shin Pharmaceutical
Ind. Co. Ltd., Taiwan ROC
Asterix United (B)
Sdn Bhd
22 December 2011 till
21 December 2016POM
BDMCA/RMP/1215 Page 56 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
792 BRU11120834P Hovasc Tablet 10mg Amlodipine 10mg (as Besylate 13.8mg) Hovid Bhd, MalaysiaG & H Trading
Company
22 December 2011 till
21 December 2016POM
793 BRU11120835P Indomen Capsule 25mg Indomethacin 25mgY.S.P Industries (M) Sdn
Bhd, Malaysia
G & H Trading
Company
22 December 2011 till
21 December 2016POM
794 BRU11120836P Clomiphene Tablet 50mg Clomiphene citrate 50mgY.S.P Industries (M) Sdn
Bhd, Malaysia
G & H Trading
Company22 December 2011 till
21 December 2016POM
795 BRU11120837PPrimacort® 10mg/10ml
InjectionMilrinone 10mg/10ml (as lactate)
Sanofi Winhtrop Industrie,
FranceMediPharm Sdn Bhd
22 December 2011 till
21 December 2016POM
796 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 2016GSL
797 BRU11120839PEpilim® 200 Enteric Coated
TabletsSodium Valproate 200mg
Sanofi-Synthelabo Ltd.,
United KingdomMediPharm Sdn Bhd
22 December 2011 till
21 December 2016POM
798 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 Sdn
Bhd
01 February 2012 till
31 January 2017POM
799 BRU12010841P Cardura XLTM tablet 4mg Doxazosin Mesylate 4mgPfizer Pharmaceuticals LLC,
Puerto Rico, USA
Zuellig Pharma Sdn
Bhd
01 February 2012 till
31 January 2017POM
800 BRU12010842PValdoxan® 25mg film-coated
tabletAgomelatine 25mg
Les Laboratoires Servier
Industrie, France
Zuellig Pharma Sdn
Bhd
01 February 2012 till
31 January 2017POM
BDMCA/RMP/1215 Page 57 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
801 BRU12010843P Zofran Tablet 4mgOndansetron (as Hydrochloride
Dihydrate) 4mg
Glaxo Wellcome GmbH &
Co., Germany
Zuellig Pharma Sdn
Bhd
01 February 2012 till
31 January 2017POM
802 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 2012 till
31 January 2017POM
803 BRU12010845P Coralan® Tablet 5mgIvabradine 5mg eq. to 5.39mg ivabradine
hydrochloride
Les Laboratoires Servier
Industrie, France
Zuellig Pharma Sdn
Bhd
01 February 2012 till
31 January 2017POM
804 BRU12010846P Seroquel XR tablets 300mg Quetiapine (as fumarate) 300mgAstrazeneca
Pharmaceuticals LP, USA
Zuellig Pharma Sdn
Bhd
01 February 2012 till
31 January 2017POM
805 BRU12010847P Seroquel XR tablets 400mg Quetiapine (as fumarate) 400mgAstrazeneca
Pharmaceuticals LP, USA
Zuellig Pharma Sdn
Bhd
01 February 2012 till
31 January 2017POM
806 BRU12010848P Chemix tabletTrimethoprim 80mg, Sulfamethoxazole
400mg
Y.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
01 February 2012 till
31 January 2017POM
807 BRU12010849P Sofradex ear/eye drops
Dexamethasone (as sodium
metasulphobenzoate) 0.05%w/v,
Framycetin sulphate 0.5% w/v,
Gramicidin 0.005% w/v
Patheon UK, UK MediPharm Sdn Bhd01 February 2012 till
31 January 2017POM
808 BRU12010850P Enapril tablet 10mg Enalapril maleate 10mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
01 February 2012 till
31 January 2017POM
809 BRU12010851NP Princi-B Fort® tablet
Thiamin mononitrate 250mg, Pyridoxine
hydrochloride 250mg & Cyanocobalamin
1mg
Olic (Thailand) Ltd, Thailand MediPharm Sdn Bhd01 February 2012 till
31 January 2017P
810 BRU12010852P Antifungal Cream 2% Miconazole Nitrate 20mg/g (2% w/w)Y.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
01 February 2012 till
31 January 2017GSL
811 BRU12010853P Concor® 5mg tabletBisoprolol hemifumarate 5mg
Merck KGaA, GermanyZuellig Pharma Sdn
Bhd
01 February 2012 till
31 January 2017POM
812 BRU12010854PKetipinor film-coated tablet
100mg
Quetiapine (as fumarate 115.13mg)
100mgOrion Corporation, Finland
Hongkiat Trading &
Co
01 February 2012 till
31 January 2017POM
813 BRU12010855P Euthyrox® Tablet 50mgLevothyroxine sodium 50mcg
Merck KGaA, GermanyZuellig Pharma Sdn
Bhd
01 February 2012 till
31 January 2017POM
814 BRU12010856NPPanadol Suspension
250mg/5mlParacetamol 250mg/5ml
Smithkline Beecham,
Philippines
Kingston Beverage &
Creamery Sdn Bhd
01 February 2012 till
31 January 2017
60ml/120ml -
P
815 BRU12010857P Targocid® Injection 200mg Teicoplanin 200mg/3ml (200mg/vial) Gruppo Lepetit S.r.I., ItalyAsterix United (B)
Sdn Bhd
01 February 2012 till
31 January 2017POM
816 BRU12020858P Sebivo™ Tablet 600mg Telbivudine 600mgNovartis Pharma Stein AG.,
Switzerland
Zuellig Pharma Sdn
Bhd
29 February 2012 till
28 February 2017 POM
BDMCA/RMP/1215 Page 58 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
817 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
818 BRU12020860P Yucomy Tablet 200mg Ketoconazole 200mgY.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
29 February 2012 till
28 February 2017 POM
819 BRU12020861PThyrozol® 20mg Film-coated
TabletsThiamazole 20mg Merck KGaA, Germany
Zuellig Pharma Sdn
Bhd
29 February 2012 till
28 February 2017 POM
820 BRU12020862PKetipinor Film-coated Tablet
25mgQuetiapine (as fumarate 28.78mg) 25mg Orion Corporation, Finland
Hongkiat Trading &
Co
29 February 2012 till
28 February 2017 POM
821 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
822 BRU12020864P Zanidip® Tablet 10mgLercanidipine Hydrochloride 10mg (eq.
to 9.4mg Lercanidipine)
Recordati Industria Chimica
& Farmaceutica S.p.A, Italy
Hongkiat Trading &
Co
29 February 2012 till
28 February 2017 POM
823BRU12020865PS1 &
BRU12020865PS2Nifedipine LA Tablet 30mg Nifedipine 30mg
Valpharma International
S.p.A, Italy (S1); Valpharma
S.A, Italy (S2)
G & H Trading
Company
29 February 2012 till
28 February 2017 POM
824 BRU12020866P
Apidra® Solostar® 100units/ml,
Solution for Injection in a Pre-
filled Pen
Insulin Glulisine 100units/mlSanofi-Aventis Deutschland
GmbH, GermanyMediPharm Sdn Bhd
29 February 2012 till
28 February 2017 POM
825 BRU12020867P Zavedos CS Injection vials Idarubicin hydrochloride 1mg/mlPfizer (Perth) Pty Limited,
Australia
Zuellig Pharma Sdn
Bhd
29 February 2012 till
28 February 2017 POM
826 BRU12020868P Betnovate™ Cream
Betamethasone 0.1%w/w (as
Betamethasone 17-Valerate BP 0.122%
w/w)
Glaxo Wellcome Operations,
UK
Zuellig Pharma Sdn
Bhd
29 February 2012 till
28 February 2017 POM
827 BRU12020869P Dermovate™ Cream Clobetasol (as propionate) 0.05% w/wGlaxo Wellcome Operations,
UK
Zuellig Pharma Sdn
Bhd
29 February 2012 till
28 February 2017 POM
828 BRU12020870P Lyrica™ 150mg Capsules Pregabalin 150mg Pfizer Manufacturing
Deutshland GmbH, Germany
Zuellig Pharma Sdn
Bhd
29 February 2012 till
28 February 2017 POM
829 BRU12030871NP Panadol® Menstrual Caplet Paracetamol 500mg & Pamabrom 25mgSterling Drug (Malaya) Sdn
Bhd., Malaysia
Kingston Beverage &
Creamery Sdn Bhd
30 March 2012 till 29
March 2017
GSL
(12 x 10's)
BDMCA/RMP/1215 Page 59 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
830 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
831 BRU12030873P LacipilTM Tablet 4mg Lacipidine 4mg Glaxo Wellcome S.A., SpainZuellig Pharma Sdn
Bhd
30 March 2012 till 29
March 2017 POM
832 BRU12030874P BrilintaTM 90mg F/C Tablet Ticagrelor 90mg AstraZeneca AB., SwedenZuellig Pharma Sdn
Bhd
30 March 2012 till 29
March 2017 POM
833 BRU12030875P DetrusitolTM SR Capsule 4mgTolterodine L-Tartrate 4mg (equivalent
to Tolterodine 2.74mg)Pfizer Inc., USA
Zuellig Pharma Sdn
Bhd
30 March 2012 till 29
March 2017 POM
834 BRU12030876NPEllgy Corns & Warts Treatment
SolutionSalicylic acid 17%w/v
HOE Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
30 March 2012 till 29
March 2017 P
835 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 Sdn
Bhd
30 March 2012 till 29
March 2017 POM
836 BRU12030879PMethotrexate Injection BP
50mg in 2mlMethotrexate 50mg/2ml
Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma Sdn
Bhd
30 March 2012 till 29
March 2017 POM
837 BRU12030880NP Aqua CreamEmulsifying 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
838 BRU12030881P CelebrexTM 400mg Capsule Celecoxib 400mgPfizer Pharmaceuticals LLC.,
vega Baja Puerto Rico, USA
Zuellig Pharma Sdn
Bhd
30 March 2012 till 29
March 2017 POM
839 BRU12030882PCancidas Powder for Injection
50mg/vialCaspofungin (as acetate) 50mg/vial
Laboratoires Merck Sharp &
Dohme Chibret, France
Zuellig Pharma Sdn
Bhd
30 March 2012 till 29
March 2017 POM
BDMCA/RMP/1215 Page 60 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
840 BRU12030883P Axcel Dextrozine SyrupDextromethorphan Hydrobromide
15mg/5ml; Promethazine HCl 3.6mg/5ml
Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd30 March 2012 till 29
March 2017 POM
841 BRU12040884PDilantin Steri Vials 250mg in
5mlPhenytoin Sodium 250mg/5ml Actavis Italy S.p.A., Italy
Zuellig Pharma Sdn
Bhd
30 April 2012 till 29
April 2017 POM
842 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
843 BRU12040886P HycamtinTM Hard Capsule 1mg Topotecan 1mg (as hydrochloride)
GlaxoSmithKline
Manufacturing S.p.A.,
Parma, Italy
Zuellig Pharma Sdn
Bhd
30 April 2012 till 29
April 2017 POM
844 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)
845 BRU12040888PCancidas Powder for Injection
70mg/vialCaspofungin (as acetate) 70mg/vial
Laboratoires Merck Sharp &
Dohme Chibret, France
Zuellig Pharma Sdn
Bhd
30 April 2012 till 29
April 2017 POM
846BRU12040889PS1 &
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 Sdn
Bhd
30 April 2012 till 29
April 2017 POM
847BRU12040890PS1 &
BRU12040890PS2Cerazette® Tablet 75mcg Desogestrel 75mcg
N.V.Organon, The
Netherlands (S1) & Organon
Ireland Limited, Ireland (S2)
Zuellig Pharma Sdn
Bhd
30 April 2012 till 29
April 2017 POM
848 BRU12040891P Axcel Diprodin ElixirDiphenhydramine HCl 12.5mg/5ml;
Ephedrine HCl 6mg/5ml
Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 30 April 2012 till 29
April 2017 POM
849 BRU12040892NPAxcel Paracetamol-120 Syrup
(Cherry)Paracetamol 120mg/5ml
Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 30 April 2012 till 29
April 2017 POM
850 BRU12040893P Axcel Clobetasol 0.05% Cream Clobetasol propionate 0.05%w/wKotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 30 April 2012 till 29
April 2017 POM
851 BRU12040894P Axcel Tridine SyrupTriprolidine HCl 1.25mg/5ml;
Pseudoephedrine HCl 30mg/5ml
Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 30 April 2012 till 29
April 2017 POM
852 BRU12040895PAxcel Lignocaine Sterile Gel
2%w/w
Lignocaine HCl (Equiv. to anhydrous HCl)
2g/100g
Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 30 April 2012 till 29
April 2017 POM
853 BRU12040896PNiquitin 21mg Transdermal
Patch
Nicotine 114mg (delivers 21mg/24
hours)
ALZA Corporation,
California, USA
Zuellig Pharma Sdn
Bhd
30 April 2012 till 29
April 2017 P
BDMCA/RMP/1215 Page 61 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
854 BRU12050897P VfendTM IV 200mg Voriconazole 200mg
Pharmacia & Upjohn
Company, USA (Repacker -
Pfizer PGM, France)
Zuellig Pharma Sdn
Bhd
24 May 2012 till 23
May 2017 POM
855 BRU12050898PLamictal Dispersible Tablet
5mgLamotrigine 5mg
GlaxoSmithKline
Pharmaceuticals SA.,
Poznan, Poland (Repacker -
GlaxoSmithKline Australia
Pty Ltd., ViCtoria, Australia)
Zuellig Pharma Sdn
Bhd
24 May 2012 till 23
May 2017 POM
856 BRU12050899PHycamtinTM Hard Capsule
0.25mgTopotecan 0.25mg (as hydrochloride)
GlaxoSmithKline
Manufacturing S.p.A.,
Parma, Italy
Zuellig Pharma Sdn
Bhd
24 May 2012 till 23
May 2017 POM
857 BRU12050900P AeriusTM Syrup 0.5mg/ml Desloratadine 0.5mg/mlSchering-Plough Labo N.V.,
Belgium
Zuellig Pharma Sdn
Bhd
24 May 2012 till 23
May 2017 POM
858 BRU12050901NP Flamazine Cream 1% w/w Silver Sulfadiazine 1.0%w/wRecipharm Parets S.L.,
Barcelona, Spain
Mc Quipp Technisell
Marketing Sdn Bhd24 May 2012 till 23
May 2017 P
859 BRU12050902P AeriusTM Tablets 5mg Desloratadine 5mgSchering-Plough Labo N.V.,
Belgium
Zuellig Pharma Sdn
Bhd
24 May 2012 till 23
May 2017 POM
860 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 GSL
861 BRU12050904PVaxcel Heparin Sodium
Injection 5000 IU/ml x 5ml
Heparin Sodium (Bovine mucosa)
25,000/5ml
Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd 24 May 2012 till 23
May 2017 POM
862 BRU12050905PPregnyl® 5000IU Powder and
Solvent for Injection
Human Chorionic Gonadotrophin
5,000IU/ampouleMerck & Co. Inc., USA
Zuellig Pharma Sdn
Bhd
24 May 2012 till 23
May 2017 POM
863 BRU12050906PNiquitin 7mg Transdermal
PatchNicotine 36mg/cm2 (delivers 7mg/24
hours)
ALZA Corporation,
California, USA
Zuellig Pharma Sdn
Bhd
24 May 2012 till 23
May 2017 P
864 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
865 BRU12060908P Methycobal Tablets 500mcg Mecobalamin JP 0.5mgEisai Co. Ltd., Saitama
Perfecture, JapanMedipharm Sdn Bhd
30 June 2012 till 29
June 2017 POM
866 BRU12060909P LyricaTM 75mg Capsules Pregabalin 75mg
Pfizer Manufacturing
Deutschland GmbH,
Freiburg, Germany
Zuellig Pharma Sdn
Bhd
30 June 2012 till 29
June 2017 POM
BDMCA/RMP/1215 Page 62 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
867 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 & 144's)
868 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
GSL
(24's & 144's)
869 BRU12060912PCanesten GYN 1 Day Therapy
Vaginal Tablet 0.5gClotrimazole 500mg
Bayer Pharma AG,
Leverkusen, Germany
Zuellig Pharma Sdn
Bhd
30 June 2012 till 29
June 2017 POM
870 BRU12060913P Casodex Tablet 50mg Bicalutamide 50mgCorden Pharma GmbH,
Plankstadt, Germany
Zuellig Pharma Sdn
Bhd
30 June 2012 till 29
June 2017 POM
871 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)
872 BRU12060915P Drapolene Cream
Cetrimide 0.2%w/w; Benzalkonium
Chloride Solution 0.02%w/w (equiv. to
Benzalkonium Chloride 0.01%w/w)
GlaxoSmithKline
Pharmacuetical SA, Poznan,
Poland
Kingston Beverage &
Creamery Sdn Bhd
30 June 2012 till 29
June 2017 GSL (55g)
873 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
874 BRU12060917P Efexor® XR 37.5mg Capsule Venlafaxine Hydrochloride 37.5mg
Pfizer Ireland
Pharmacueticals, Kildare,
Republic of Ireland
Zuellig Pharma Sdn
Bhd
30 June 2012 till 29
June 2017 POM
875 BRU12070918PBeclomet Nasal Aqua
50mcg/dose Nasal Spray
Beclomethasone dipropionate
50mcg/dose
Orion Corporation, Kuopio,
Finland
Hongkiat Trading &
Company
30 July 2012 till 29 July
2017 POM
876 BRU12070919PPanadol CF Cold and Flu
Caplets
Paracetamol 500mg; Pseudoephedrine
HCl 30mg; Chlorpheniramine 2mg
Sterling Drug (Malaya) Sdn
Bhd., Selangor, Malaysia
Zuellig Pharma Sdn
Bhd
30 July 2012 till 29 July
2017 POM
877 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
GSL
(50's, 3 x 10's
& 15 x 10's)
BDMCA/RMP/1215 Page 63 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
878 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
879 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
880 BRU12070923PCoversyl Plus 10mg/2.5mg
Tablet
Perindopril arginine 10mg (equiv. to
6.79mg perindopril); Indapamide 2.5mg
Servier (Ireland) Industries
Ltd, Ireland
Zuellig Pharma Sdn
Bhd
30 July 2012 till 29 July
2017 POM
881 BRU12070924P RotarixTM oral SuspensionHuman rotavirus RIX4414 strain, not less
than 106.0 CCID50
GlaxoSmithKline Biological
SA, Belgium
Zuellig Pharma Sdn
Bhd
30 July 2012 till 29 July
2017 POM
882 BRU12070925P CutivateTM CreamFluticasone propionate (micronised)
0.05%w/w
Glaxo Wellcome Operations,
UK
Zuellig Pharma Sdn
Bhd
30 July 2012 till 29 July
2017 POM
883 BRU12070926NP Bepanthen® Ointment Dexpanthenol 5%w/wGP Genzech Produktions
GmbH, Germany
Zuellig Pharma Sdn
Bhd
30 July 2012 till 29 July
2017 GSL
884 BRU12070927P Axcel Hydrocortisone Cream Hydrocortisone (micronised) 1% w/wKotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
30 July 2012 till 29 July
2017 POM
885 BRU12070928PSevoflurane Inhalation
Anaesthetic Liquid 100%Sevoflurane 100% (1ml/ml)
Baxter Healthcare Of Puerto
rico, USA
Zuellig Pharma Sdn
Bhd
30 July 2012 till 29 July
2017 POM
886 BRU12080929PNiquitin 14mg Transdermal
PatchNicotine 78mg (14mg/24hrs)
Alza Corporation, California,
USA
Zuellig Pharma Sdn
Bhd
29 August 2012 till 28
August 2017 P
887 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)
888 BRU12080931P Rilutek Tablets 50mg Riluzole 50mgSanofi Winthrop Industrie,
Cedex, FranceMedipharm Sdn Bhd
29 August 2012 till 28
August 2017 POM
889 BRU12080932P Efexor XR 75mg Capsule Venlafaxine (as HCl) 75mg
Pfizer Ireland
Pharmaceuticals, Kildare,
Republic of Ireland
Zuellig Pharma Sdn
Bhd
29 August 2012 till 28
August 2017 POM
890 BRU12090933PXarelto® Film-coated Tablet
10mgRivaroxaban 10mg
Bayer Pharma AG,
Leverkusen, Germany
Zuellig Pharma Sdn
Bhd
27 September 2012 till
26 September 2017 POM
BDMCA/RMP/1215 Page 64 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
891 BRU12090934P Nif-Ten Capsule Atenolol 50mh; Nifedipine 20mgCorden Pharma GmbH,
Plankstadt, Germany
Zuellig Pharma Sdn
Bhd
27 September 2012 till
26 September 2017 POM
892 BRU12090935P PrepandrixTM Vaccine
Purified antigen fractions of inactivated
split virions A/Indonesia/05/2005
(H5N1)/PR8-IBCDC-RG2 - 0.375mcg
haemagglutinin/dose
GlaxoSmithKline Biologicals,
Zirkusstrabe, Germany
Zuellig Pharma Sdn
Bhd
27 September 2012 till
26 September 2017 POM
893 BRU12090937PTelfast 6mg/ml Oral
SuspensionFexofenadine Hydrochloride 6mg/ml
Sanofi-Aventis Farmceutica
Ltd, Vila Areiao Suzano-SP-
Brasil
Medipharm Sdn Bhd27 September 2012 till
26 September 2017 POM
894 BRU12090938PGlucophage® XR 750mg
Extended Release TabletMetformin HCl 750mg
Merck KGaA, Germany;
Merck Sante SAS, Semoy,
France
Zuellig Pharma Sdn
Bhd
27 September 2012 till
26 September 2017 POM
895 BRU12090939P Glucophage® Tablet 500mg Metformin HCl 500mgMerck Sante SAS, Semoy,
France
Zuellig Pharma Sdn
Bhd
27 September 2012 till
26 September 2017 POM
896 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
897 BRU12100941PFragminTM Solution for
Injection 5,000IU (anti-
Xa)/0.2ml
Dalteparin Sodium 5,000IU (anti-
Xa)/0.2ml
Vetter Pharma-Fertigung
GmbH & Co., Germany
Zuellig Pharma Sdn
Bhd
31 October 2012 till 30
October 2017 POM
898 BRU12100942PProstin E2TM Vaginal Tablet
3mgDinoprostone 3mg
Sanico N.V., Turnhout,
Belgium
Zuellig Pharma Sdn
Bhd
31 October 2012 till 30
October 2017 POM
899 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,
SingaporeMedipharm Sdn Bhd
31 October 2012 till 30
October 2017 POM
900 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
901 BRU12100945NP Anucare SuppositoriesZinc Oxide 300mg; Balsam Peru 50mg;
Benzyl Benzoate 33mg
Y.S.P Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
31 October 2012 till 30
October 2017 GSL
902 BRU12100946P Salbu-Air CFC Free InhalerSalbutamol Sulphate (micronised)
100mcg per actuation
Laboratorio Aldo-Union S.A.,
Barcelona
G & H Trading
Company
31 October 2012 till 30
October 2017 POM
903 BRU12100947PIlliadin Nasal Decongestant
Solution 0.01%Oxymetazoline Hydrochloride 0.01% Merck KGaA, Germany
Zuellig Pharma Sdn
Bhd
31 October 2012 till 30
October 2017 P
904 BRU12100948PRenvela (Sevelamer
Carbonate) Tablet 800mgSevelamer Carbonate 800mg
Genzyme Ireland Limited,
IrelandMedipharm Sdn Bhd
31 October 2012 till 30
October 2017 POM
BDMCA/RMP/1215 Page 65 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
905 BRU12100949P Lyrica Capsules 50mg Pregabalin 50mg
Pfizer Manufacturing
Deutschland GmbH,
Freiburg, Germany
Zuellig Pharma Sdn
Bhd
31 October 2012 till 30
October 2017 POM
906 BRU12100950P QvarTM 100 InhalerBeclomethasone dipropionate 100mcg
per inhalation
3M Health Care Limited,
England
Zuellig Pharma Sdn
Bhd
31 October 2012 till 30
October 2017 POM
907 BRU12100951P Prograf Capsule 0.5mg Tacrolimus 0.5mg Astellas Ireland Ltd, IrelandZuellig Pharma Sdn
Bhd
31 October 2012 till 30
October 2017 POM
908 BRU12110952P Panadol C TabletParacetamol 500mg; Pseudoephedrine
Hydrochloride 30mg
Sterling Drug (Malaya) Sdn
Bhd, Malaysia
Zuellig Pharma Sdn
Bhd
27 November 2012 till
26 November 2017 P
909 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., Germany
Zuellig Pharma Sdn
Bhd
27 November 2012 till
26 November 2017 POM
910 BRU12110954P Efexor XR 150mg Capsule Venlafaxine (as Hydrochloride) 150mg
Pfizer Ireland
Pharmaceuticals, Kildare,
Republic of Ireland
Zuellig Pharma Sdn
Bhd
27 November 2012 till
26 November 2017 POM
911 BRU12110955PEprex® 4000 Prefilled Syringe
4000IU/0.4mlEpoetin alfa 4,000IU/0.4ml Cilag AG, Switzerland
Zuellig Pharma Sdn
Bhd
27 November 2012 till
26 November 2017 POM
912 BRU12110956NP Vitamin C 100mg Tablet Ascorbic Acid 100mgBeacons Pharmaceuticals
Pte Ltd, Singapore
Hongkiat Trading &
Company
27 November 2012 till
26 November 2017 GSL
913BRU12110957PS1;
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 2012 till
26 November 2017 POM
914 BRU12110958P Tretino Cream 0.05% Tretionoin (Retinoic acid) 0.5mg/gY.S.P. Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
27 November 2012 till
26 November 2017 POM
915 BRU12110959PEprex® 2000 Prefilled Syringe
2000IU/0.5mlEpoetin alfa 2,000IU/0.5ml Cilag AG, Switzerland
Zuellig Pharma Sdn
Bhd
27 November 2012 till
26 November 2017 POM
916 BRU12110960NP Daflon 500mg Tablet Diosmin 450mg; Hesperidin 50mgLes Laboratories Servier
Industrie, France
Zuellig Pharma Sdn
Bhd
27 November 2012 till
26 November 2017 GSL
917 BRU121109561P Topamax® 50 Tablets Topiramate 50mg Cilag AG, SwitzerlandZuellig Pharma Sdn
Bhd
27 November 2012 till
26 November 2017 POM
BDMCA/RMP/1215 Page 66 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
918 BRU12110962P Tenol-100 Atenolol 100mgSunward Pharmaceutical Pte
Ltd, Singapore
G & H Trading
Company
27 November 2012 till
26 November 2017 POM
919 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)
920 BRU12110964PExjade 125mg Dispersible
TabletsDeferasirox 125mg
Novartis Pharmas Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
27 November 2012 till
26 November 2017 POM
921 BRU12110965PExjade 500mg Dispersible
TabletsDeferasirox 500mg
Novartis Pharmas Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
27 November 2012 till
26 November 2017 POM
922 BRU12110966NP Dhamotil TabletsDiphenoxylate HCl BP 2.5mg; Atropine
Sulphate 0.025mg
Drug Houses of Australia Pte
Ltd., Singapore
G & H Trading
Company
27 November 2012 till
26 November 2017 POM
923 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, Belgium
Zuellig Pharma Sdn
Bhd
27 December 2012 till
26 December 2017 POM
924 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 Asia,
Singapore
Zuellig Pharma Sdn
Bhd
27 December 2012 till
26 December 2017 POM
925 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
926 BRU12120970PClementin Film Coated Tablet
625mg
Amoxicillin (as Trihydrate) 500mg;
Clavulanic Acid (as Potassium Salt)
125mg
Yung Shin Pharmaceutical
Ind. Co. Ltd., Taichung,
Taiwan
Asterix United (B)
Sdn Bhd
27 December 2012 till
26 December 2017 POM
BDMCA/RMP/1215 Page 67 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
927 BRU12120971PSurvanta® Beractant
Intratracheal SuspensionBeractant (as phospholipids) 25mg/ml Abbott Lab., Illinois, USA
Zuellig Pharma Sdn
Bhd
27 December 2012 till
26 December 2017 POM
928 BRU12120972PHumira Solution for Injection
40mg/0.8mlAdalimumab 40mg/0.8ml
Vetter-Pharma-Fertigung
GmbH & Co., KG,
Ravensburg, Germany
Zuellig Pharma Sdn
Bhd
27 December 2012 till
26 December 2017 POM
929 BRU12120973P ZyrprexaTM Tablet 10mg Olanzapine 10mg
Lily del Caribe Inc, Puerto
Rico, USA & Lilly S.A.,
Madrid, Spain
Zuellig Pharma Sdn
Bhd
27 December 2012 till
26 December 2017 POM
930 BRU12120974PSutentTM Hard Capsules
12.5mgSunitinib 12.5mg (as Malate)
Pfizer Italia S.r.l., Ascoli
Piceno, Italy
Zuellig Pharma Sdn
Bhd
27 December 2012 till
26 December 2017 POM
931 BRU12120975PStelara Solution for Injection in
pre-filled syringe 45mg/0.5mlUstekinumab 45mg/0.5ml
Baxter Pharmaceutical
Solutions LLC, Blommington,
United States
Zuellig Pharma Sdn
Bhd
27 December 2012 till
26 December 2017 POM
932 BRU12120976P Viagara 50mg Tablet Sildenafil 50mg (as Citrate)Pfizer Australia Pty Limited,
West Ryde, Australia
Zuellig Pharma Sdn
Bhd
27 December 2012 till
26 December 2017 POM
933 BRU12120977P Viagara 100mg Tablet Sildenafil 100mg (as Citrate)Pfizer Australia Pty Limited,
West Ryde, Australia
Zuellig Pharma Sdn
Bhd
27 December 2012 till
26 December 2017 POM
934 BRU12120978PAerrane (Isoflurane USP)
Inhalation LiquidIsoflurane USP 100%
Baxter Healthcare of Puerto
Rico, USA
Zuellig Pharma Sdn
Bhd
27 December 2012 till
26 December 2017 POM
935 BRU12120979PKogenate FS for Injection
250IU/vial
Antihaemophilic Factor (recombinant)
sucrose formulated 250IU
Bayer Healthcare LLC.,
United States
Zuellig Pharma Sdn
Bhd
27 December 2012 till
26 December 2017 POM
936 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
937 BRU12120981P Garbose Tablet 100mg Acarbose 100mg
Y.S.P Industries (M) Sdn
Bhd., Selangor Darul Ehsan,
Malaysia
Asterix United (B)
Sdn Bhd
27 December 2012 till
26 December 2017 POM
938 BRU13010982PKombiglyzeTM XR Tablet
5/1000mg
Saxagliptin HCl 5mg (as anhydrous
5.58mg); Metformin Hydrochloride
1000mg
Bristol Myers Squibb
Company USA
Zuellig Pharma Sdn
Bhd
26 January 2013 till 25
January 2018 POM
BDMCA/RMP/1215 Page 68 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
939 BRU13010983PKombiglyzeTM XR Tablet
5/500mg
Saxagliptin HCl 5mg (as anhydrous
5.58mg); Metformin Hydrochloride
500mg
Bristol Myers Squibb
Company USA
Zuellig Pharma Sdn
Bhd
26 January 2013 till 25
January 2018 POM
940 BRU13010984PKombiglyzeTM XR Tablet
2.5/1000mg
Saxagliptin HCl 2.5mg (as anhydrous
2.79mg); Metformin Hydrochloride
1000mg
Bristol Myers Squibb
Company USA
Zuellig Pharma Sdn
Bhd
26 January 2013 till 25
January 2018 POM
941 BRU13010985P Zanidip® 20mg Tablet Lercanidipine HCl 20mg
Recordati Industria Chimica
& Farmaceutica S.p.A.,
Milan, Italy
Hongkiat Trading &
Co
26 January 2013 till 25
January 2018 POM
942 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
943 BRU13010987P Pontalon Tablet 500mg Mefenamic Acid 500mgY.S.P Industries (M) Sdn Bhd
Malaysia
Asterix United (B)
Sdn Bhd
26 January 2013 till 25
January 2018 POM
944 BRU13010988P Co-Trimexazole SuspensionPer 5ml - Sulphamethoxazole BP 200mg;
Trimethoprim 40mg
Y.S.P Industries (M) Sdn Bhd
Malaysia
Asterix United (B)
Sdn Bhd
26 January 2013 till 25
January 2018 POM
945 BRU13010989P Opticrom® Eye Drops 2% w/v Sodium Cromoglycate BP 2% w/vSanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
26 January 2013 till 25
January 2018 P
946 BRU13010990NPPanamol Paed. Suspension
120mg/5mlParacetamol 120mg/5ml
Beacons Pharmaceuticals
Pte ltd, Singapore
Hongkiat Trading &
Co
26 January 2013 till 25
January 2018 POM
947 BRU13010991PHumulin 30/70 Injection
100iu/ml (vial)
Human Insulin 100IU/ml (recombinant) -
30% Soluble insulin & 70% Isophane
Insulin
Eli Lilly and Co., USAZuellig Pharma Sdn
Bhd
26 January 2013 till 25
January 2018 POM
948 BRU13010993PFML® Liquifilm Sterile
Opthalmic Solution 0.1%Fluorometholone 0.1%w/v
Allergan Pharmaceuticals
Ireland, IrelandMedipharm Sdn Bhd
26 January 2013 till 25
January 2018 POM
949 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
StatesMedipharm Sdn Bhd
26 January 2013 till 25
January 2018 GSL
950 BRU13010995P Daivonex® Ointment Calcipotriol 50mcg/g (0.005% w/w)LEO Laboratories Ltd (LEO
Pharma), Ireland
Zuellig Pharma Sdn
Bhd
26 January 2013 till 25
January 2018 POM
951 BRU13010996P Seretide Evohaler 25/125mcgPer actuation - Fluticasone propionate
125mcg; Salmetarol 25mcg (as xinafoate)Glaxo Wellcome SA Spain
Zuellig Pharma Sdn
Bhd
26 January 2013 till 25
January 2018 POM
952 BRU13010997P Glucophage® Tablet 850mgMetformin HCl 850mg (~Metformin
662.9mg)Merck Sante SAS, France
Zuellig Pharma Sdn
Bhd
26 January 2013 till 25
January 2018 POM
953 BRU13010998P Revlimid® Capsules 5mg Lenalidomide 5mg
Penn Pharmaceutical
Services Limited, UK &
Celgene International Sarl,
Switzerland
Zuellig Pharma Sdn
Bhd
26 January 2013 till 25
January 2018 POM
BDMCA/RMP/1215 Page 69 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
954 BRU13010999NP Infusol® NS Sodium Chloride 0.9% w/vAin Medicare Sdn Bhd
Malaysia
Syarikat Pakatan
Indah
26 January 2013 till 25
January 2018 GSL
955 BRU13011000P Inpanol Tablets 10mg Propranolol BP 10mgDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
26 January 2013 till 25
January 2018 POM
956 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
957 BRU13011002P One-Alpha® Capsule 1mcgAlfacalcidol 1mcg (1α-Hydroxy-vitamin
D3)
Leo Pharmaceutical
Products Ltd., A/S (Leo
Pharma), Denmark
Zuellig Pharma Sdn
Bhd
26 January 2013 till 25
January 2018 POM
958 BRU13011003PNimotop Infusion Solution
0.02%Nimodipine 0.01g/50ml
Bayer Schering Pharma AG,
Leverkeusen, Germany
Zuellig Pharma Sdn
Bhd
26 January 2013 till 25
January 2018 POM
959 BRU13011004PGemzar 200mg Powder for
Solution for InfusionGemcitabine 200mg (as HCl)
Eli Lilly and Company,
Indiana, USA
Zuellig Pharma Sdn
Bhd
26 January 2013 till 25
January 2018 POM
960 BRU13011005P ZyprexaTM 5mg Tablet Olanzapine 5mgLilly del Caribe Inc., Puerto
Rico, USA
Zuellig Pharma Sdn
Bhd
26 January 2013 till 25
January 2018 POM
961 BRU13021006PCanesten GYN Vaginal Tablet
100mg - 3 day therapyClotrimazole 100mg
Bayer Consumer AG, Basel,
Switzerland
Zuellig Pharma Sdn
Bhd
26 February 2013 till
25 February 2018 POM
962 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
Baxter Pharmaceuticals
Solutions LLC, USA. & Pfizer
Ireland Pharmaceuticals,
Dublin, Ireland
Zuellig Pharma Sdn
Bhd
26 February 2013 till
25 February 2018 POM
963 BRU13021009PHemabate Sterile Solution
250mcg/ml
Carboprost (as tromethamine)
250mcg/ml
Pharmacia & Upjohn
Company, USA
Zuellig Pharma Sdn
Bhd
26 February 2013 till
25 February 2018 POM
964 BRU13021010PHumulin® 30/70 Injection
100iu/ml (catridge)
Human Insulin 100IU/ml (recombinant) -
30% Soluble insulin & 70% Isophane
Insulin
Eli Lilly and Company,
Indiana, USA
Zuellig Pharma Sdn
Bhd
26 February 2013 till
25 February 2018 GSL
965 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,
SingaporeMedipharm Sdn Bhd
26 February 2013 till
25 February 2018 POM
966 BRU13021012P Afinitor Tablet 10mg Everolimus 10mgNovartis Pharma Stein AG,
Stein, Switzerland
Zuellig Pharma Sdn
Bhd
26 February 2013 till
25 February 2018 POM
BDMCA/RMP/1215 Page 70 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
967 BRU13021013P Ketovid Cream 2% Ketoconazole 2.0% w/w Hovid Bhd, Perak, MalaysiaG & H Trading
Company
26 February 2013 till
25 February 2018 POM
968 BRU13021014P Progynova® Tablet 2mg Estradiol Valerate 2mgDelpharm Lille SAS, Lys Les
Lannoy, Franc
Zuellig Pharma Sdn
Bhd
26 February 2013 till
25 February 2018 POM
969 BRU13021015P Azopt Eye Drops, Suspension Brinzolamide 10mg/ml (1.0%w/w)S.A. Alcon-Couvreur N.V.,
Belgium
Hongkiat Trading &
Co
26 February 2013 till
25 February 2018 POM
970 BRU13021016P Rhewlin SR Tablet Diclofenac Sodium 100mgBeacons Pharmaceutical Pte
Ltd, Singapore
Hongkiat Trading &
Co
26 February 2013 till
25 February 2018 POM
971 BRU13021017PHydrogen Peroxide Solution
6%
Hydrogen Peroxide 6% w/v (equivalent
to 20 volumes of oxygen)
Xepa-Soul Pattinson
(Malaysia) Sdn Bhd,
Malaysia
Hongkiat Trading &
Co
26 February 2013 till
25 February 2018 P
972 BRU13021018P Inpanol Tablets 40mg Propranolol BP 40mgDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
26 February 2013 till
25 February 2018 POM
973 BRU13021019PStilamin 3000 for Injection
3mg/ampouleSomatostatin (as acetate) 3mg
Merck Serono SA, Aubonne,
Switzerland
G&H Trading
Company
26 February 2013 till
25 February 2018 POM
974 BRU13021020P Loradine Syrup 1mg/ml Loratadine 1mg/ml
Y.S.P Industries (M) Sdn
Bhd, Selangor Darul Ehsan,
Malaysia
Asterix United (B)
Sdn Bhd
26 February 2013 till
25 February 2018
P
975 BRU13021021P Decozol Oral Gel 2% w/w Miconazole 2% w/wHOE Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
26 February 2013 till
25 February 2018 GSL
976 BRU13021022P Rasitol Injection 20mg/2ml Furosemide 20mg/2mlYung Shin Pharmaceutical
Ind. Co. Ltd., Taiwan, ROC
Asterix United (B)
Sdn Bhd
26 February 2013 till
25 February 2018 POM
977 BRU13021023P Fusate-250 Tablet Sodium fusidate 250mg
Noripharma Sdn Bhd,
Selangor Darul Ehsan,
Malaysia
K-Seri Pharma Sdn
Bhd
26 February 2013 till
25 February 2018 POM
978 BRU13021024P Premarin Vaginal Cream Conjugated Oestrogen (CE) 0.625mg/g Pfizer Canada Inc., CanadaZuellig Pharma Sdn
Bhd
26 February 2013 till
25 February 2018 POM
979 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, Singapore
G & H Trading
Company
26 February 2013 till
25 February 2018 GSL
BDMCA/RMP/1215 Page 71 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
980 BRU13021026PKaletra Film-coated Tablet
200mg/50mgLopinavir 200mg; Ritonavir 50mg
AbbVie Deutschland GmbH
& Co. KG, Germany
Zuellig Pharma Sdn
Bhd
26 February 2013 till
25 February 2018 POM
981 BRU13021027P Sustanon 250
Per 1ml - Testosterone decanoate
100mg; Testosterone phenylpropionate
60mg; Testosterone isocaproate 60mg;
Testosterone propionate 30mg
[Equivalent to Testosterone 176mg/ml]
Merck Sharp & Dohme, the
Netherlands
Zuellig Pharma Sdn
Bhd
26 February 2013 till
25 February 2018 POM
982 BRU13021028P Holoxan for Injection Ifosfamide 1gBaxter Oncology GmbH,
Germany
Zuellig Pharma Sdn
Bhd
26 February 2013 till
25 February 2018 POM
983 BRU13031029NP Panadol Extend Tablet Paracetamol 665mgGlaxoSmithKline Australia
Pty Ltd, Australia
Kingston Beverage &
Creamery Sdn Bhd
28 March 2013 till 27
March 2018 GSL
984 BRU13031030P Canesten Cream 1% w/w Clotrimazole 1% w/wEncube Ethicals Private Ltd,
India
Zuellig Pharma Sdn
Bhd
28 March 2013 till 27
March 2018 GSL
985 BRU13031032PPantaprazole Winthrop 20mg
Tablet
Pantoprazole (as sodium sesquihydrate)
20mg
Sanofi-Aventis S.P.Z.O.O.,
PolandMedipharm Sdn Bhd
28 March 2013 till 27
March 2018 POM
986 BRU13031033P Metoclopramide Tablet 10mgMetoclopramide HCl BP (equivalent to
Metoclopramide HCl anhydrous 10mg)
Drug House of Australia Pte
Ltd, Singapore
G & H Trading
Company
28 March 2013 till 27
March 2018 POM
987 BRU13031034P Loperamil Tablet 2mg Loperamide 2mgDrug House of Australia Pte
Ltd, Singapore
G & H Trading
Company
28 March 2013 till 27
March 2018 POM
988 BRU13031035P Hydralazine Tablet 50mg Hydralazine HCl 50mgBeacons Pharmaceuticals
Pte Ltd, Singapore
Hongkiat Trading &
Co
28 March 2013 till 27
March 2018 POM
989 BRU13031036P Dhacort Cream 1%w/wHydrocortisone acetate BP (micronised)
1% w/w
Drug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
28 March 2013 till 27
March 2018 POM
990 BRU13031037P Tracidol Capsule 50mg Tramadol HCl 50mgY.S.P Industries (M) Sdn Bhd
Malaysia
Asterix United (B)
Sdn Bhd
28 March 2013 till 27
March 2018 POM
991 BRU13031038PSolcoseryl Dental Adhesive
Paste
Per g - Solcoseryl CMC 2.125mg;
Polidocanol 10mg
Legacy Pharmaceuticals
Switzreland GmbH,
Switzerland
Zuellig Pharma Sdn
Bhd
28 March 2013 till 27
March 2018 POM
992 BRU13031039NP Infusol® S3 Sodium Chloride 3% w/vAin Medicare Sdn Bhd,
Malaysia
Syarikat Pakatan
Indah
28 March 2013 till 27
March 2018 POM
993 BRU13031040P Indapamide SR Tablet 1.5mg Indapamide 1.5mgTorrent Pharmaceuticals
Ltd., India
K-Seri Pharma Sdn
Bhd
28 March 2013 till 27
March 2018 POM
BDMCA/RMP/1215 Page 72 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
994 BRU13031041P Dhatifen Syrup 1mg/5mlKetotifen (as hydrogen fumarate)
1mg/5ml
Drug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
28 March 2013 till 27
March 2018 POM
995 BRU13031042P Inox Capsule 100mg Itraconazole 100mg Hovid Bhd, MalaysiaG & H Trading
Company
28 March 2013 till 27
March 2018 POM
996 BRU13031043P Doxycap capsule 100mg Anhydrous Doxycycline 100mg Hovid Bhd, MalaysiaG & H Trading
Company
28 March 2013 till 27
March 2018 POM
997 BRU13031044P Zenmolin tablet 2mg Salbutamol (as sulphate) 2mgDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
28 March 2013 till 27
March 2018 POM
998 BRU13031045PRecormon Pre-filled Syringe
2000IU/0.3mlErythropoetin Beta 2,000iu/0.3ml
Roche Diagnostics GmbH,
Germany
Zuellig Pharma Sdn
Bhd
28 March 2013 till 27
March 2018 POM
999 BRU13031046P Leukeran Tablet 2mg Chlorambucil 2mg Excella GmbH, GermanyZuellig Pharma Sdn
Bhd
28 March 2013 till 27
March 2018 POM
1000 BRU13031047PRecormon Pre-filled Syringe
4000IU/0.3mlErythropoetin Beta 4,000iu/0.3ml
Roche Diagnostics GmbH,
Germany
Zuellig Pharma Sdn
Bhd
28 March 2013 till 27
March 2018 POM
1001 BRU13031048PD.T.Vax Suspension for
Injection in Multidose
Purified Diphteria Toxoid ≥ 30 i.u;
Purified Tetanus Toxoid ≥ 40 i.uSanofi Pasteur S.A., France
Zuellig Pharma Sdn
Bhd
28 March 2013 till 27
March 2018 POM
1002 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
1003 BRU13031050P Isentress 400mg TabletRaltegravir 400mg (as potassium
434.4mg)
MSD Technology Singapore
Pte Ltd., Singapore
Zuellig Pharma Sdn
Bhd
28 March 2013 till 27
March 2018 POM
1004 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
1005 BRU13041052PFosamax Plus Tablet
70mg/5600IU
Alendronic Acid 70mg (as Sodium
91.37mg); Colecalciferol 140mcg
(5,600IU)
MSD Frosst Iberica, S.A.,
Madrid, Spain
Zuellig Pharma Sdn
Bhd
30 April 2013 till 29
April 2018 POM
1006 BRU13041053PGlucovance Tablet
500mg/2.5mg
Metformin HCl 500mg, Glibenclamide
2.5mg
Merck Sante SAS, Semoy,
France
Zuellig Pharma Sdn
Bhd
30 April 2013 till 29
April 2018 POM
1007BRU13041054PS1 &
BRU13041054PS2
Rebif ® Pre-filled Syringe
22mcg/0.5mlInterferon beta-1a 22mcg (6MIU) / 0.5ml
Merck Serono S.p.A.,
Modugno, Italy (S1); Merck
Serono S.A., Aubonne,
Switzerland
G & H Trading
Company
30 April 2013 till 29
April 2018 POM
1008 BRU13041055P Alpranax Tablet 0.5mg Alprazolam 0.5mgY.S.P Industries (M) Sdn Bhd
Malaysia
K-Seri Pharma Sdn
Bhd
30 April 2013 till 29
April 2018 POM
BDMCA/RMP/1215 Page 73 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1009 BRU13041056NP Liquid Paraffin Liquid Paraffin 100%w/wBeacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
30 April 2013 till 29
April 2018 GSL
1010 BRU13041057P Fucithalmic® Eye Drops 1% Fusidic acid 10mg/g (1.0%w/w)LEO Laboratories Ltd,
Dublin, Ireland
Zuellig Pharma Sdn
Bhd
30 April 2013 till 29
April 2018 POM
1011 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 &
Co
30 April 2013 till 29
April 2018 POM
1012 BRU13041059P Borymycin Capsule 50mg Minocycline HCl 50mgY.S.P Industries (M) Sdn Bhd
Malaysia
Asterix United (B)
Sdn Bhd
30 April 2013 till 29
April 2018 POM
1013 BRU13041060P Kytril Tablet 1mg Granisetron 1mg (as HCl) Roche S.p.A., ItalyHongkiat Trading &
Co
30 April 2013 till 29
April 2018 POM
1014 BRU13041061PVenofer® Solution for Injection
100mg/5ml
Iron (III) [as Iron (III)-hydroxide sucrose
complex] 100mg/5ml
IDT Biologika GmbH,
Germany; BIPSO GmbH,
Germany
Hongkiat Trading &
Co
30 April 2013 till 29
April 2018 POM
1015 BRU13041062NP Calamine cream Calamine 4%w/w; Zinc Oxide 3% w/wBeacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
30 April 2013 till 29
April 2018 GSL
1016 BRU13041063P Apuzin tablet 25mg Captopril 25mgBeacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
30 April 2013 till 29
April 2018 POM
1017 BRU13041064PLezpain film-coated tablet
135mgMebeverine HCl 135mg
Y.S.P. Industries (M) Sdn
Bhd Malaysia
Asterix United (B)
Sdn Bhd
30 April 2013 till 29
April 2018 POM
1018 BRU13041065P Copegus Tablet 200mg Ribavarin 200mg
Hoffman-La Roche Inc., USA;
Patheon Inc., Ontario,
Canada
Hongkiat Trading &
Co
30 April 2013 till 29
April 2018 POM
1019 BRU13041066P Celexin 250 Film-coated Tablet Cephalexin 250mg (as monohydrate) Hovid Bhd, MalaysiaK-Seri Pharma Sdn
Bhd
30 April 2013 till 29
April 2018 POM
1020 BRU13041067NP White Soft Paraffin White Soft Paraffin Sasaol Wax GmbH, GermanyHongkiat Trading &
Co
30 April 2013 till 29
April 2018 GSL
1021 BRU13041068NP Calamine Lotion 15% w/v Calamine 15%w/vBeacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
30 April 2013 till 29
April 2018 GSL
BDMCA/RMP/1215 Page 74 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1022 BRU13061069PVotrient™ Film-coated tablets
200mgPazopanib (as hydrochloride) 200mg
Glaxo Operations UK Ltd,
Hertfordshire, UK
Zuellig Pharma Sdn
Bhd
04 June 2013 till 03
June 2018 POM
1023 BRU13061070P
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
Medipharm Sdn Bhd04 June 2013 till 03
June 2018 POM
1024 BRU13061071P Duphaston Tablet 10mg Dydrogesterone 10mgAbbott Biologicals B.V., The
Netherlands
Zuellig Pharma Sdn
Bhd
04 June 2013 till 03
June 2018 POM
1025 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, MalaysiaG & H Trading
Company
04 June 2013 till 03
June 2018 GSL
1026 BRU13061073P Prednisolone Tablet 20mg Prednisolone 20mgBeacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
04 June 2013 till 03
June 2018 POM
1027 BRU13061074P Kytril For Infusion 3mg/3ml Granisetron 3mg (as HCl 3.36mg) Cenexi SAS, FranceHongkiat Trading &
Co
04 June 2013 till 03
June 2018 POM
1028 BRU13061075P Minison Tablet 1mg Prazosin 1mg (as HCl 1.095mg)Y.S.P. Industries (M) Sdn
Bhd Malaysia
Asterix United (B)
Sdn Bhd
04 June 2013 till 03
June 2018 POM
1029 BRU13061076P Xeloda™ Tablets 500mg Capecatibine 500mgProductos Roche S.A. de C.V,
Mexico
Zuellig Pharma Sdn
Bhd
04 June 2013 till 03
June 2018 POM
1030 BRU13061077P Chloramphenicol Eye Ointment Chloramphenicol 10mg/g KRKA d.d., SloveniaK-Seri Pharma Sdn
Bhd
04 June 2013 till 03
June 2018 POM
1031 BRU13061078NP Zentel Tablet 200mg Albendazole 200mgTianjin SKF Labs Ltd, Tianjin,
China
Kingston Beverage &
Creamery Sdn Bhd
04 June 2013 till 03
June 2018 GSL
1032 BRU13061079NP Maltofer® Syrup Iron (III) [as Iron (III)-hydroxide-
polymaltose complex] 10mg/ml
Vifor S.A., Switzerland &
Vifor (International) Inc.,
Switzerland
Medipharm Sdn Bhd04 June 2013 till 03
June 2018 GSL
1033 BRU13061080P Noriday® Tablet Norethisterone 0.35mgPiramal Healthcare UK
Limited, United Kingdom
Zuellig Pharma Sdn
Bhd
04 June 2013 till 03
June 2018 POM
1034 BRU13061081PKeppra 250mg Film-coated
TabletLevetiracetam 250mg UCB Pharma S.A., Belgium
Zuellig Pharma Sdn
Bhd
04 June 2013 till 03
June 2018 POM
1035 BRU13061082PKeppra 500mg Film-coated
TabletLevetiracetam 500mg UCB Pharma S.A., Belgium
Zuellig Pharma Sdn
Bhd
04 June 2013 till 03
June 2018 POM
BDMCA/RMP/1215 Page 75 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1036
BRU13061083PS1,
BRU13061083PS2 &
BRU13061083PS3
Avastin Concentrate For
Solution For Infusion
400mg/16ml
Bevacizumab 400mg/16ml
Genetech Inc., USA; F
Hoffmann-LA Roche Ltd,
Switzerland; Roche
Diagnostics GmbH,
Germany; F. Hoffmann-La
Roche Ltd, Wurmisweg,
Switzerland
Medicare04 June 2013 till 03
June 2018 POM
1037 BRU13061084P Xeloda Tablet 150mg Capecatibine 150mgProductos Roche S.A. de C.V,
Mexico
Zuellig Pharma Sdn
Bhd
04 June 2013 till 03
June 2018 POM
1038 BRU13061085PUripax Film-coated Tablet
200mgFlavoxate HCl 200mg
Y.S.P. Industries (M) Sdn
Bhd Malaysia
Asterix United (B)
Sdn Bhd
04 June 2013 till 03
June 2018 POM
1039 BRU13061086P Storvas Tablet 10mg Atorvastatin (as calcium) 10mgRanbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company
04 June 2013 till 03
June 2018 POM
1040 BRU13061087PElonva Solution for Injection
150mcg/0.5mlCorifollitrophin alfa 150mcg/0.5ml
Vetter Pharma-Fertigung
GmbH & Co. KG, Germany
Zuellig Pharma Sdn
Bhd
27 June 2013 till 26
June 2018 POM
1041 BRU13061088P Maxitrol Eye Ointment
Per g: Neomycin Sulfate 3,500 IU;
Polymyxin B Sulfate 6,000IU;
Dexamethasone 0.1%
S.A. Alcon-Couvreur N.V.,
Belgium
Hongkiat Trading &
Co
27 June 2013 till 26
June 2018 POM
1042 BRU13061089P Maxidex® Eye Ointment Dexamethasone 0.1% w/wS.A. Alcon-Couvreur N.V.,
Belgium
Hongkiat Trading &
Co
27 June 2013 till 26
June 2018 POM
1043 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
1044 BRU13061091NPInfusol® W Intravenous
Infusion BPWater for Injection BP
Ain Medicare Sdn Bhd
Malaysia
Syarikat Pakatan
Indah
27 June 2013 till 26
June 2018 GSL
1045 BRU13061092P Isoket Ampoule 10mg/10ml Isosorbide Dinitrate 10mg/10ml (0.1%)EVER Pharma Jena GmbH,
Germany
Zuellig Pharma Sdn
Bhd
27 June 2013 till 26
June 2018 POM
1046 BRU13061093P Invoril tablets 10mg Enalapril maleate 10mgRanbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company
27 June 2013 till 26
June 2018 POM
1047 BRU13061094PPharmaniaga Simvastatin
tablet 10mgSimvastatin 10mg
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
27 June 2013 till 26
June 2018 POM
1048 BRU13061095P Vitamin B1 Tablet Thiamine HCl 10mgBeacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
27 June 2013 till 26
June 2018 POM
1049 BRU13061096P Invoril tablets 20mg Enalapril maleate 20mgRanbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company
27 June 2013 till 26
June 2018 POM
BDMCA/RMP/1215 Page 76 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1050 BRU13061097P Seldron Cleaning Lotion Selenium Sulphide USP 2.5% w/vICM Pharma Pte Ltd,
Singapore
Mc Quipp Technisell
Marketing Sdn Bhd
27 June 2013 till 26
June 2018 GSL
1051 BRU13071098P Cortal for Children Tablet Acetaminophen (Paracetamol) 80mgSterling Drug (Malaya) Sdn
Bhd, Malaysia
Kingston Beverage &
Creamery Sdn Bhd
30 July 2013 till 29 July
2018 GSL
1052 BRU13071099PChampix 1mg film-coated
tabletVarenicline Tartrate 1mg
Pfizer Manufacturing
Deutschland GmbH,
Germany
Zuellig Pharma Sdn
Bhd
30 July 2013 till 29 July
2018 POM
1053 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
1054 BRU13071101PGlucophage XR 500mg
Extended Release TabletMetformin HCl 500mg Merck Sante SAS, France
Zuellig Pharma Sdn
Bhd
30 July 2013 till 29 July
2018 POM
1055 BRU13071102P Victrelis Capsule 200mg Boceprevir 200mgSchering-Plough (Singapore)
Pte Ltd, Singapore
Zuellig Pharma Sdn
Bhd
30 July 2013 till 29 July
2018 POM
1056 BRU13071103P Axcel Cefaclor-250 Capsule Cefaclor (as monohydrate) 250mgKotra Pharma (M) Sdn Bhd,
Malaysia Medicorp Sdn Bhd
30 July 2013 till 29 July
2018 POM
1057 BRU13071104P
Gonal-F Powder and Solvent
for Solution for Injection 75IU
(5.5mcg)/ vial
Follitrophin Alfa 75 IU ( 5.5mcg)
Merck Serono S.p.A., Bari
(MSB), Italy; Merck Serono
S.A. (MSA), Swizerland
G & H Trading
Company
30 July 2013 till 29 July
2018 POM
1058 BRU13071105P Lignocaine Injection 2% x 5ml Lignocaine Hydrochloride 20mg/mlPfizer (Perth) Pty Ltd,
Australia
Zuellig Pharma Sdn
Bhd
30 July 2013 till 29 July
2018 POM
1059 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
1060 BRU13071107P Tamiflu Capsules 75mg Oseltamivir 75mg
Cenexi SAS, France; Catalent
Germany Schorndorf GmbH,
Germany; Roche S.p.A., Italy
Zuellig Pharma Sdn
Bhd
30 July 2013 till 29 July
2018 POM
1061 BRU13071108P Revlimid® Capsules 25mg Lenalidomide 25mg
Penn Pharmaceutical
Services Limited, UK &
Celgene International Sarl,
Switzerland
Zuellig Pharma Sdn
Bhd
30 July 2013 till 29 July
2018 POM
BDMCA/RMP/1215 Page 77 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1062 BRU13071109P Revlimid® Capsules 15mg Lenalidomide 15mg
Penn Pharmaceutical
Services Limited, UK &
Celgene International Sarl,
Switzerland
Zuellig Pharma Sdn
Bhd
30 July 2013 till 29 July
2018 POM
1063 BRU13071110P Solcoseryl Eye Gel Solcoseryl 120 Concentrate 8.3mg/g
Legacy Pharmaceuticals
Switzreland GmbH,
Switzerland
Zuellig Pharma Sdn
Bhd
30 July 2013 till 29 July
2018 POM
1064 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
1065 BRU13071112PPharmaniaga Labetalol Tablet
100mgLabetalol Hydrochloride 100mg
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
30 July 2013 till 29 July
2018 POM
1066 BRU13071113P Hydralazine Tablet 10mg Hydralazine Hydrochloride 10mgDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
30 July 2013 till 29 July
2018 POM
1067 BRU13071114PSandimmun Neoral Capsule
25mgCiclosporin A 25mg
R.P. Scherer GmbH & Co.
KG., Germany
Zuellig Pharma Sdn
Bhd
30 July 2013 till 29 July
2018 POM
1068 BRU13081115P Champix 0.5mg & 1mg TabletVarenicline Tartrate 0.5mg & Varenicline
Tartrate 1mg
Pfizer Manufacturing
Deutschland GmbH,
Germany
Zuellig Pharma Sdn
Bhd
27 August 2013 till 26
August 2018 POM
1069 BRU13081116P Daktarin Oral Gel 2% Miconzaole 2%Janssen Pharmaceutical NV,
Belgium
Zuellig Pharma Sdn
Bhd
27 August 2013 till 26
August 2018 P
1070 BRU13081117P Dhasedyl DM Syrup
Per 5ml - Dextromethorphan HBr 10mg;
Promethazine HCl 3.6mg/ Ephedrine HCl
6mg
Drug House of Australia
(Asia) Pte Ltd, Singapore
G & H Trading
Company
27 August 2013 till 26
August 2018 POM
1071 BRU13081118P Daivonex® Cream Calcipotriol 50mcg/g (0.0005% w/w)LEO Laboratories Ltd (LEO
Pharma), Ireland
Zuellig Pharma Sdn
Bhd
27 August 2013 till 26
August 2018 POM
1072 BRU13081119P Zoral Cream Acyclovir USP 5% w/wDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
27 August 2013 till 26
August 2018 POM
1073 BRU13081120PEnbrel® 25mg solution for
injection in pre-filled syringeEtanercept 25mg/0.5ml
Pfizer Ireland
Pharmaceuticals, Ireland
Zuellig Pharma Sdn
Bhd
27 August 2013 till 26
August 2018 POM
1074 BRU13081121P Xenical Capsule 120mg Orlistat 120mg Roche SpA, ItalyZuellig Pharma Sdn
Bhd
27 August 2013 till 26
August 2018 POM
1075 BRU13081122P Requip® Tablet 1mg Ropinirole (as Hydrochloride) 1mg Glaxo Wellcome S.A., SpainZuellig Pharma Sdn
Bhd
27 August 2013 till 26
August 2018 POM
1076 BRU13081123P Minazol Powder 2% Miconzaole Nitrate 2% w/wBiosis Pharmaceuticals Sdn
Bhd., Malaysia
Zuellig Pharma Sdn
Bhd
27 August 2013 till 26
August 2018 P
BDMCA/RMP/1215 Page 78 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1077 BRU13081124P Heparinol 5000IU/ml Heparin Sodium (bovine) 5,000IU/mlAin Medicare Sdn Bhd
Malaysia
Syarikat Pakatan
Indah
27 August 2013 till 26
August 2018 POM
1078 BRU13081125PPharmaniaga Pyrazinamide
Tablet 500mgPyrazinamide 500mg
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
27 August 2013 till 26
August 2018 POM
1079 BRU13081126P Sathrocin ES Tablet 400mg Erythromycin (as ethylsuccinate) 400mgPharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
27 August 2013 till 26
August 2018 POM
1080 BRU13081127P Ketovid Shampoo 2% w/v Ketoconazole (micronised) 2% w/w Hovid Bhd, MalaysiaG & H Trading
Company
27 August 2013 till 26
August 2018 POM
1081 BRU13081128P Maxitrol Eye Drops
Per 1ml - Dexamethasone 0.1%;
Neomycin Sulphate 3,500IU; Polymyxin B
Sulphate 6,000 IU
S.A. Alcon-Couvreur N.V.,
Belgium
Hongkiat Trading &
Co
27 August 2013 till 26
August 2018 POM
1082 BRU13091129P VentolinTM Syrup 2mg/5ml (T)Salbutamol Sulphate (as sulphate)
5mg/5ml
SmithKlineBeecham, Rizal,
Philippines
Zuellig Pharma Sdn
Bhd
28 September 2013 till
27 September 2018 POM
1083 BRU13091130PErbitux® 5mg/ml Solution for
InfusionCetuximab 5mg/ml
Boehringer Ingelheim,
Germany & Merck KGaA,
Germany (1 Artwork)
Zuellig Pharma Sdn
Bhd
28 September 2013 till
27 September 2018 POM
1084 BRU13091132NP Beafort Syrup
Each 5ml contains: Thiamine HCl 5mg;
Riboflavin 2.5mg; Pyridoxine HCl 2mg;
Cyanocobalamin 5mcg; Nicotinamide
20mg; Calcium Panthothenate 1.5mg
Beacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
28 September 2013 till
27 September 2018 GSL
1085 BRU13091133PClexane 4000/0.4ml Anti XA
Pre-filled Syringe
Enoxaprin sodium 4,000 anti-Xa IU/0.4ml
equivalent to 40mg/0.4ml
Sanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
28 September 2013 till
27 September 2018 POM
1086 BRU13091134PPantaprazole Winthrop 40mg
Tablet
Pantoprazole (as sodium Sesquihydate)
40mg
Sanofi-Aventis S.P.Z.O.O.,
PolandMedipharm Sdn Bhd
28 September 2013 till
27 September 2018 POM
1087 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
1088 BRU13091136P Anlodin Tablet 10mg Amlodipine (as besylate) 10mgY.S.P Industries (M) Sdn Bhd
Malaysia
Asterix United (B)
Sdn Bhd
28 September 2013 till
27 September 2018 POM
1089 BRU13091137P Effient Tablet 5mg Prasugrel HCl 5mg Eli Lilly & Co., USAZuellig Pharma Sdn
Bhd
28 September 2013 till
27 September 2018 POM
BDMCA/RMP/1215 Page 79 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1090 BRU13091138PClexane 6000/0.6ml Anti-Xa IU
Pre-filled Syringe
Enoxaprin sodium 6,000 anti-Xa IU/0.6ml
equivalent to 60mg/0.6ml
Sanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
28 September 2013 till
27 September 2018 POM
1091 BRU13091139PSimvastatin Winthrop 40mg
TabletSimvastatin 40mg
Sanofi Aventis S.p.z.o.o,
PolandMedipharm Sdn Bhd
28 September 2013 till
27 September 2018 POM
1092 BRU13091140P Camazol Tablet 5mg Carbimazole 5mgXepa-Soul Pattinson (M) Sdn
Bhd Malaysia
Hongkiat Trading &
Co
28 September 2013 till
27 September 2018 POM
1093 BRU13091141P Pulin Injection 10mg/2ml Metoclopramide HCl 10mg/2mlYung Shin Pharmaceutical
Ind. Co. Ltd., Taiwan
Asterix United (B)
Sdn Bhd
28 September 2013 till
27 September 2018 POM
1094 BRU13091142NP Sulbutiamine 200 capsule Sulbutiamine 200mgPahang Pharmacy Sdn Bhd,
Malaysia
K-Seri Pharma Sdn
Bhd
28 September 2013 till
27 September 2018 GSL
1095 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 Sdn
Bhd
28 September 2013 till
27 September 2018 POM
1096 BRU13091144P Bezamidin Tablet 200mg Bezafibrate 200mgNoripharma Sdn. Bhd.,
Malaysia
K-Seri Pharma Sdn
Bhd
28 September 2013 till
27 September 2018 POM
1097 BRU13091145NP A-Bite Cream Crotamiton 10%w/wHOE Pharmaceuticals Sdn
Bhd Malaysia
G & H Trading
Company
28 September 2013 till
27 September 2018 GSL
1098 BRU13091146P Tipidin Tablet 250mg Ticolopidine HCl BP 250mgDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
28 September 2013 till
27 September 2018 POM
1099 BRU13091147P Gynera Tablets Ethinylestradiol 0.03mg; Gestodene
0.075mg
Schering do Brasil Quimica e
Farmaceutica Ltda., Sao
Paulo, Brazil
Zuellig Pharma Sdn
Bhd
28 September 2013 till
27 September 2018 POM
1100 BRU13101148P Eumovate™ Cream Clobetasone 17-butyrate 0.05% w/wGlaxo Wellcome Opration,
UK
Zuellig Pharma Sdn
Bhd
31 October 2013 till 31
October 2018 POM
1101 BRU13101149PErycin Film Coated Tablet
250mgErythromycin (as stearate) 250mg
Y.S.P. Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
31 October 2013 till 31
October 2018 POM
BDMCA/RMP/1215 Page 80 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1102 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
1103 BRU13101152P Hycamtin™ Injection 1MG Topotecan (as HCl) 1mg
GlaxoSmithKline
Manufacturing S.p.A.,
Parma, Italy
Zuellig Pharma Sdn
Bhd
31 October 2013 till 31
October 2018 POM
1104 BRU13101153PClexane 2000 anti-Xa IU/0.2ml
(Pre-filled Syringe for Injection)
Enoxaparin Sodium 2,000 anti-Xa
IU/0.2ml
Sanofi Winthrop Industrie,
FranceMedipharm Sdn Bhd
31 October 2013 till 31
October 2018 POM
1105 BRU13101154PAxcel Mefenamic Acid
SuspensionMefenamic Acid 125mg/5ml
Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
31 October 2013 till 31
October 2018 POM
1106 BRU13101155P
Ovidrel Solution for Injection
250mcg/0.5ml in Pre-filled
Syringe
Choriogonadotropin alfa 250mcg/0.5ml
Merck Serono S.p.A., Italy &
Merck Serono S.A.,
Switzerland
G & H Trading
Company
31 October 2013 till 31
October 2018 POM
1107 BRU13101156PSandimmun Neoral Capsule
100mgCiclosporin 100mg
R.P Scherer GmbH & Co,
Baden, Germany
Zuellig Pharma Sdn
Bhd
31 October 2013 till 31
October 2018 POM
1108 BRU13101157P Tobrex Eye Ointment Tobramycin 0.3% (3mg/g)S.A. Alcon-Couvreur N.V.,
Belgium
Hongkiat Trading &
Co
31 October 2013 till 31
October 2018 POM
1109 BRU13101158P Endoxan Tablet 50mgCyclophosphamide anhydrous (as
monohydrate) 50mg
Prasfarma Oncologicos S.L.,
Barcelona, Spain; Haupt
Pharma Amareg GmBH,
Germany
Zuellig Pharma Sdn
Bhd
31 October 2013 till 31
October 2018 POM
1110 BRU13101159P CEF-4® Injection 500mg Ceftazidime (as pentahydrate) 500mgSiam Bheasach Co. Ltd.,
Bangkok, Thailand
K-Seri Pharma Sdn
Bhd
31 October 2013 till 31
October 2018 POM
1111 BRU13101160P Premarin Tablet 0.625mg Conjugated Estrogens 0.625mg
Pfizer Ireland
Pharmaceuticals, Kildare,
Ireland
Zuellig Pharma Sdn
Bhd
31 October 2013 till 31
October 2018 POM
1112BRU13101161PS1;
BRU13101161PS2Revlimid capsules 10mg Lenalidomide 10mg
Penn Pharmaceutical
Services, Gwent, UK (S1) &
Celgene International Sarl,
Boudry, Switzerlnd (S2)
Zuellig Pharma Sdn
Bhd
31 October 2013 till 31
October 2018 POM
1113 BRU13101162PPharmaniaga Cephalexin
Suspension 125mg Cephalexin (as anhydrous) 125mg/5ml
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
31 October 2013 till 31
October 2018 POM
BDMCA/RMP/1215 Page 81 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1114 BRU13101163P Tolbutamide Tablets 500mg Tolbutamide 500mgDrug Houses Australia Pte
Ltd., Singapore
G & H Trading
Company
31 October 2013 till 31
October 2018 POM
1115 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
1116 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
1117 BRU13121166P SCMC Syrup 125mg/5ml S-Carboxymethyl-cysteine 125mg/5mlUpha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
Hongkiat Trading &
Co
02 December 2013 till
01 December 2018 P
1118 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
1119 BRU13121168P Ucort CreamPer g – Urea 100mg; Hydrocortisone
acetate 10mg
Y.S.P Industries (M) Sdn Bhd
Malaysia
Asterix United (B)
Sdn Bhd
02 December 2013 till
01 December 2018 P
1120 BRU13121169PPradaxa® Hard Capsules
150mg
Dabigatran etexilate 150mg (as mesilate
172.95g)
Boehringer Ingelheim
Pharma GmbH &Co,
Ingelheim am Rhein,
Germany
Hongkiat Trading &
Co
02 December 2013 till
01 December 2018 POM
1121 BRU13121170PPradaxa® Hard Capsules
110mg
Dabigatran etexilate 110mg (as mesilate
126.83g)
Boehringer Ingelheim
Pharma GmbH & Co., KG,
Germany
Hongkiat Trading &
Co
02 December 2013 till
01 December 2018 POM
1122 BRU13121171P Amoxicillin Capsule 250mg Amoxicillin Trihydrate 250mgYung Shin Pharmaceutical
Ind. Co. Ltd., Taiwan
Asterix United (B)
Sdn Bhd
02 December 2013 till
01 December 2018 POM
1123 BRU13121172NP
Dianeal Low Calcium
(2.5mEq/L) Peritoneal Dialysis
Solution with 1.5% Dextrose (T)
Each 100ml contains: Calcium Choloride
18.3mg; Dextrose hydrous 1.5g;
Magnesium Chloride 5.08mg; Sodium
Chloride 538mg; Sodium Lactate 448mg
Baxter Healthcare SA,
SingaporeMedipharm Sdn Bhd
02 December 2013 till
01 December 2018 POM
1124 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
1125 BRU13121174P Temodal Capsules 100mg Temozolomide 100mg Orion Corporation, FinlandZuellig Pharma Sdn
Bhd
02 December 2013 till
01 December 2018 POM
BDMCA/RMP/1215 Page 82 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1126 BRU13121175PBetagan® Liquifilm Ophthalmic
Solution 0.5%Levobunolol Hydrochloride 0.5% w/v
Allergan Pharmaceuticals
Ireland, IrelandMedipharm Sdn Bhd
02 December 2013 till
01 December 2018 POM
1127 BRU13121176P Dhasolone Tablet 5mg Prednisolone BP (micronized) 5mgDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
02 December 2013 till
01 December 2018 POM
1128 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
1129 BRU13121178P Betawin Tablet 50mg (T) Metoprolol Tartrate 50mgDuopharma (M) Sdn Bhd
Malaysia
Hongkiat Trading &
Co
02 December 2013 till
01 December 2018 POM
1130 BRU13121179P Imigran FD Tablets 50mg Sumatriptan 50mg ( as succinate) Glaxo Operations UK Ltd, UKZuellig Pharma Sdn
Bhd
30 December 2013 till
29 December 2018 POM
1131 BRU13121180P Glucovance Tablet 500mg/5mgMetformin HCl 500mg; Glibenclamide
5mgMerck Sante SAS, France
Zuellig Pharma Sdn
Bhd
30 December 2013 till
29 December 2018 POM
1132 BRU13121181P
Priorix-Tetra Powder and
Diluent for Solution for
Injection
Composition of Priorix™ per dose
(0.5ml): Live attenuated measles virus
(Schwarz strain) ≥103.0 CCID50, Live
attenuated mumps virus (RIT4385 strain)
≥103.7 CCID50, Live attenuated rubella
virus (Wistar RA 27/3 strain) ≥103.0
CCID50, Live attenuated Varicella Virus
(OKA strain) ≥103.3 PFU
Glaxosmithkline Biologicals
S.A., Belgium
Zuellig Pharma Sdn
Bhd
30 December 2013 till
29 December 2018 POM
1133 BRU13121182P Hycamtin Injection 4mg Topotecan (as Hydrochloride) 4mgGlaxoSmithKline
Manufacturing S.p.A., Italy
Zuellig Pharma Sdn
Bhd
30 December 2013 till
29 December 2018 POM
1134 BRU13121183P Anarex TabletsParacetamol 450mg; Orphenadrine
citrate 35mg
Beacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
30 December 2013 till
29 December 2018 POM
1135 BRU13121184PAtarax Film-Coated Tablet
25mgHydroxyzine Hydrochloride 25mg UCB Pharma S.A., Belgium
Zuellig Pharma Sdn
Bhd
30 December 2013 till
29 December 2018 POM
BDMCA/RMP/1215 Page 83 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1136 BRU13121185P Propylthiouracil Tablets 50mg Propylthouracil 50mgDrug Houses of Australia Pte
Ltd., Singapore
G & H Trading
Company
30 December 2013 till
29 December 2018 POM
1137 BRU13121186P Xyzal Oral Drops 5mg/mlPer mL - Levocetitrizine Hydrochloride
5mg
Aesica Pharmaceuticals S.r.L
Pianezza, Italy
Zuellig Pharma Sdn
Bhd
30 December 2013 till
29 December 2018 POM
1138 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
1139 BRU13121188PDaivonex Scalp Solution
50mcg/mlCalcipotriol 50mcg/ml
Leo Pharmaceutical
Products Ltd., A/S (Leo
Pharma), Denmark
Zuellig Pharma Sdn
Bhd
30 December 2013 till
29 December 2018 POM
1140 BRU13121189PHeparinised Saline Injection
10iu/ml (5ml)
Heparin Sodium (Bovine Mucosa)
10i.u./ml
B Braun Industries Sdn Bhd,
Malaysia
Hongkiat Trading &
Co
30 December 2013 till
29 December 2018 POM
1141 BRU13121190P Rescuvolin Tablet 15mgCalcium Folinate (equiv. to Folinic Acid)
15mg
Teva Pharmaceutical Works
Pte Ltd Co., Debrecen Site,
Hungary
K-Seri Pharma Sdn
Bhd
30 December 2013 till
29 December 2018 POM
1142 BRU13121191PQuinax Sterile Ophthalmic
Solution
Sodium Dihydroazapentacene
Polysulfonate 0.15mg/ml
S.A. Alcon-Couvreur N.V.,
Belgium
Hongkiat Trading &
Co
30 December 2013 till
29 December 2018 POM
1143 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 &
Co
30 December 2013 till
29 December 2018 POM
1144BRU14011193PS1 &
BRU14011193PS2Alimta 500mg Powder for
Solution for Infusion
Pemetrexed (as Pemetrexed disodium)
500mg/vial
Eli Lilly and Company, USA
(S1); Lilly France, France (S2)
Zuellig Pharma Sdn
Bhd
28 January 2014 till 27
January 2019 POM
1145BRU14011194P
Gemzar 1G Powder for
Solution for InfusionGemcitabine 1000mg (as gemcitabine
hydrochloride)
Eli Lilly and Company, USA Zuellig Pharma Sdn
Bhd
28 January 2014 till 27
January 2019POM
1146 BRU14011195P Imigran FD Tablets 100mgSumatriptan 100mg (as the succinate) GlaxoSmithKline
Pharmaceuticals SA, Poland
Zuellig Pharma Sdn
Bhd
28 January 2014 till 27
January 2019 POM
1147 BRU14011196P Largo Tablets 100mgChlorpromazine HCl 100mg Beacons Pharmaceuticals
Pte Ltd, Singapore
Hongkiat Trading &
Company
28 January 2014 till 27
January 2019POM
1148 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
BDMCA/RMP/1215 Page 84 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1149 BRU14011198NP Bepanthen® First Aid CreamDexpanthenol 5%w/w; Chlorhexidine
hydrochloride 0.5% w/w
GP Grenzach Produktions
GmbH, Germany
Zuellig Pharma Sdn
Bhd
28 January 2014 till 27
January 2019GSL
1150 BRU14011199NPDextrose 5% and Sodium
Chloride 0.9% Injection USPDextrose 5%; Sodium Chloride 0.9% Baxter Healthcare
Corporation, USA
Zuellig Pharma Sdn
Bhd
28 January 2014 till 27
January 2019POM
1151 BRU14011200NP Macgel® TabletMagnesium 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
1152 BRU14011201PPrefrin Liquifilm Eye Drops
0.12%Phenylephrine Hydrochloride 0.12% Allergan Sales, LLC., USA MediPharm Sdn Bhd 28 January 2014 till 27
January 2019P
1153 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
1154 BRU14011203P Betaserc 24mg TabletBetahistine dihydrochloride 24mg Abbott Healthcare SAS,
France
Zuellig Pharma Sdn
Bhd
28 January 2014 till 27
January 2019POM
1155 BRU14011204PHumalog 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 SAS, France Zuellig Pharma Sdn
Bhd
28 January 2014 till 27
January 2019POM
1156 BRU14011205NP Panamol Tablet 500mgParacetamol 500mg Beacons Pharmaceuticals
Pte Ltd, Singapore
Hongkiat Trading &
Company
28 January 2014 till 27
January 2019GSL
1157 BRU14011206PSeretide™ Evohaler™
25/50mcgFluticasone propionate 50mcg;
Salmeterol (as xinafoate) 25mcg
Glaxo Wellcome S.A., Spain Zuellig Pharma Sdn
Bhd
28 January 2014 till 27
January 2019POM
1158 BRU14011207P Tobrex® Eye Drops SolutionTobramycin 0.3% (3mg/ml) S.A. Alcon-Couvreur N.V.,
Belgium
Hongkiat Trading &
Company
28 January 2014 till 27
January 2019POM
1159 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 Sdn
Bhd
28 January 2014 till 27
January 2019
POM
1160 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
1161 BRU14011210P Axcel Famotidine-20 CapsuleFamotidine 20mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd,
Malaysia
28 January 2014 till 27
January 2019POM
1162 BRU14011211NPTears Naturale II Eye Drops
SolutionDextran 70 0.1% (1mg/ml); Hypromellose
0.3% (3mg/ml)
S.A. Alcon-Couvreur N.V.,
Belgium
Hongkiat Trading &
Company
28 January 2014 till 27
January 2019GSL
BDMCA/RMP/1215 Page 85 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1163 BRU14011212PAxcel Chlorpheniramine-4
SyrupChlorpheniramine Maleate 4mg/5ml Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd,
Malaysia
28 January 2014 till 27
January 2019P
1164 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.,
Thailand
Zuellig Pharma Sdn
Bhd
28 January 2014 till 27
January 2019POM
1165BRU14021214P Panaflex Extra Gel Diclofenac Sodium 10mg/1gm United Biomedical Inc., Asia,
Taiwan
Zuellig Pharma Sdn
Bhd
27 February 2014 till
26 February 2019
P
1166BRU14021215P Havrix 1440 Vaccine Inactivated Hepatitis A virus antigen
(HAV), HM175 strain 1440 ELISA Units
(EL.U.)/ml
GlaxoSmithKline Biologicals
SA, Belgium
Zuellig Pharma Sdn
Bhd
27 February 2014 till
26 February 2019
POM
1167BRU14021216P 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
1168BRU14021217P VotrientTM Film-coated tablets
400mg
Pazopanib (as hydrochloride) 400mg Glaxo Operations UK
Limited, UK
Zuellig Pharma Sdn
Bhd
27 February 2014 till
26 February 2019
POM
1169BRU14021218P Motilium tablets 10mg Domperidone 10mg Janssen Pharmaceutica NV,
Belgium
Zuellig Pharma Sdn
Bhd
27 February 2014 till
26 February 2019
POM
1170BRU14021219P Novorapid® Flexpen® 100IU/ml 1ml of solution contains 100U insulin
aspart (r-DNA) (equivalent to 3.5mg)
Novo Nordisk Producao
Farmaceutica do Brasil Ltda.,
Brazil
Medipharm Sdn Bhd 27 February 2014 till
26 February 2019
POM
1171BRU14021220P 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
1172BRU14021221NP 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
1173
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 Sdn
Bhd
27 February 2014 till
26 February 2019
POM
1174
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 Sdn
Bhd
27 February 2014 till
26 February 2019
POM
BDMCA/RMP/1215 Page 86 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1175
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 Sdn
Bhd
27 February 2014 till
26 February 2019
POM
1176
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 Sdn
Bhd
27 February 2014 till
26 February 2019
POM
1177BRU14021226P 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
1178BRU14021227P 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
1179BRU14021228NP 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
1180
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
1181BRU14021230NP 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
1182BRU14021231P Axcel Loratadine syrup Loratadine 5mg/5ml Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 27 February 2014 till
26 February 2019
P
BDMCA/RMP/1215 Page 87 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1183BRU14021232P Cymbalta Capsule 30mg Duloxetine (as hydrochloride) 30mg Eli Lilly and Company,
Indiana, USA; Lilly del
Caribe, Inc., Puerto Rico
Zuellig Pharma Sdn
Bhd
27 February 2014 till
26 February 2019
POM
1184BRU14021233P TykerbTM tablets 250mg Lapatinib 250mg (as ditosylate
monohydrate)
Glaxo Wellcome Operations,
UK
Zuellig Pharma Sdn
Bhd
27 February 2014 till
26 February 2019
POM
1185BRU14021234P Axcel Mefenamic Acid Capsules Mefenamic acid 250mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 27 February 2014 till
26 February 2019
POM
1186BRU14021235P Dostinex tablet 0.5mg Cabergoline 0.5mg Pfizer Italia S.r.I, Italy Zuellig Pharma Sdn
Bhd
27 February 2014 till
26 February 2019
POM
1187BRU14021236NP Lactated Ringer’s Injection
USP4
Sodium Chloride 6g/L; Sodium Lactate
3.1g/L; Potassium Chloride 0.3g/L;
Calcium Chloride 0.2g/L
Baxter Healthcare
Corporation, USA
Zuellig Pharma Sdn
Bhd
27 February 2014 till
26 February 2019
GSL
1188BRU14021237P Imuran 50mg tablet Azathioprine 50mg Excella GmbH, Germany Zuellig Pharma Sdn
Bhd
27 February 2014 till
26 February 2019
POM
1189BRU14021238NP 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
1190BRU14021239P Humulin R Injection 100IU/ml Regular Human Insulin (recombinant
DNA origin) Biosynthetic
Eli Lilly an Company, USA Zuellig Pharma Sdn
Bhd
27 February 2014 till
26 February 2019
POM
1191BRU14021240NP 5% Dextrose and 0.45%
Sodium Chloride Injection, USP
Dextrose 5%; Sodium Chloride 0.45% Baxter Healthcare
Corporation, USA
Zuellig Pharma Sdn
Bhd
27 February 2014 till
26 February 2019
GSL
1192BRU14021241P Giona Easyhaler 200mcg/dose
Inhalation Powder
Budesonide 200mcg Orion Corporation, Finland Hongkiat Trading &
Co
27 February 2014 till
26 February 2019
POM
1193BRU14021242P 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
1194BRU14021243NP Neurobion tablet thiamine disulfide 100mg; Pyridoxine
hydroxide 200mg & Cyanocobalamin
200mcg
Merck KGaA & Co, Austria Zuellig Pharma Sdn
Bhd
27 February 2014 till
26 February 2019
P
1195BRU14021244P 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
BDMCA/RMP/1215 Page 88 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1196BRU14021245P Keppra Concentrate for
solution for (infusion) /
intravenous
Levetiracetam 500mg/5ml Patheon Italia S.p.A., Italy Zuellig Pharma Sdn
Bhd
27 February 2014 till
26 February 2019
POM
1197
BRU14021246P Imojev Japanese Encephalitis
Vaccine (live, attenuated)
Live, attenuated, recombinant Japanese
Encephalitis virus 4.0 - 5.8 log PFU*/
dose (0.5ml) * Plaque Forming Unit
Government Pharmaceutical
organization-Meriux
Biological Products Co., Ltd.,
Thailand
Zuellig Pharma Sdn
Bhd
27 February 2014 till
26 February 2019
POM
1198BRU14021247P Pradaxa® Hard Capsules 75mg
Dabigatran etexilate 75mg (as mesilate
86.48mg)
Boehringer Ingelheim
Pharma GmbH & Co., KG,
Germany
Hongkiat Trading &
Co
27 February 2014 till
26 February 2019
POM
1199BRU14021248P 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
1200BRU14031249P Tygacil 50mg Lyophilised
Powder for Intravenous
Infusion
Tigecycline 50mg Wyeth Lederle S.r.L, Italy Zuellig Pharma Sdn
Bhd
27 March 2014 till 26
March 2019
POM
1201
BRU14031250PS1;B
RU14031250PS2
Levemir Flexpen 100IU/ml Insulin Detemir 100U/ml (equivalent to
14.2mg
Novo Nordisk A/S, Denmark
(S1); Novo Nordisk Producao
Farmaceutica do Brasil Ltda.,
Brazil (S2)
MediPharm Sdn Bhd 27 March 2014 till 26
March 2019
POM
1202BRU14031251P Stalevo 75/18.75/200mg Film-
coated Tablet
Levodopa 75mg; Carbidopa 18.75mg;
Entacapone 200mg
Orion Corporation, Finland Zuellig Pharma Sdn
Bhd
27 March 2014 till 26
March 2019
POM
1203BRU14031252P Stalevo 200/50/200mg Film-
coated Tablet
Levodopa 200mg; Carbidopa 50mg;
Entacapone 200mg
Orion Corporation, Finland Zuellig Pharma Sdn
Bhd
27 March 2014 till 26
March 2019
POM
1204BRU14031253P Humulin N Injection 100iu/vial Insulin (Human) Isophane 100iu/ml Eli Lilly and Company, USA Zuellig Pharma Sdn
Bhd
27 March 2014 till 26
March 2019
POM
BDMCA/RMP/1215 Page 89 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1205
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
1206BRU14031255P Effient™ Tablet 10mg Prasugrel (as hydrochloride) 10mg Eli Lilly and Company, USA Zuellig Pharma Sdn
Bhd
27 March 2014 till 26
March 2019
POM
1207BRU14031256P 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
1208
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
1209BRU14031258P Volibris 5mg Film-coated
TabletAmbrisentan 5mg Patheon Inc., Ontario, USA
Zuellig Pharma Sdn
Bhd27 March 2014 till 26
March 2019
POM
1210BRU14031259P Volibris 10mg Film-coated
TabletAmbrisentan 10mg Patheon Inc., Ontario, USA
Zuellig Pharma Sdn
Bhd27 March 2014 till 26
March 2019
POM
1211BRU14031260P Atarax™ Syrup 2mg/ml
Hydroxyzine hydrochloride 2mg/ml NextPharma SAS, FranceZuellig Pharma Sdn
Bhd27 March 2014 till 26
March 2019
POM
1212BRU14031261P Prograf Capsule 1mg
Tacrolimus 1mg Astellas Ireland Ltd, IrelandZuellig Pharma Sdn
Bhd27 March 2014 till 26
March 2019
POM
1213BRU14031262P Loperamil Syrup 1mg/5ml
Loperamide HCl 1mg/5mlDrug Houses of Australia Pte
Ltd, Singapore
G&H Trading
Company 27 March 2014 till 26
March 2019
POM
1214BRU14031263P Patanol® Eye Drops, Solution
0.1%Olopatadine (as HCl) 0.1%
S.A. Alcon-Couvreur N.V.,
Belgium
Hongkiat Trading &
Company27 March 2014 till 26
March 2019
POM
1215BRU14031264P Travatan® Eye Drops 40mcg/ml
Travoprost 40mcg/mlS.A. Alcon-Couvreur N.V.,
Belgium
Hongkiat Trading &
Company27 March 2014 till 26
March 2019
POM
BDMCA/RMP/1215 Page 90 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1216BRU14031265P Chlorpheniramine tablet 4mg
Chlorpheniramine Maleate 4mgDrug Houses of Australia Pte
Ltd, Singapore
G&H Trading
Company 27 March 2014 till 26
March 2019
POM
1217BRU14031266P Allertyn Tablet 10mg
Loratadine (micronized) 10mgDrug Houses of Australia Pte
Ltd, Singapore
G&H Trading
Company 27 March 2014 till 26
March 2019
P
1218BRU14031267P Motilium Suspension 1mg/ml
Domperidone 1mg/mlJanssen Pharmaceutica NV,
Belgium
Zuellig Pharma Sdn
Bhd27 March 2014 till 26
March 2019
POM
1219BRU14031268P Elonva Solution for Injection
100mcg/0.5mlCorifollitropin alfa 100mcg/0.5ml
Vetter Pharma-Fertigung
GmbH & Co. KG, Germany
Zuellig Pharma Sdn
Bhd27 March 2014 till 26
March 2019
POM
1220
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 Sdn
Bhd
27 March 2014 till 26
March 2019
POM
1221BRU14031270P Enbrel® 50mg solution for
Injection in a pre-filled syringe Etanercept 50.0mg/1.0mlPfizer Ireland
Pharmaceuticals, Ireland
Zuellig Pharma Sdn
Bhd
27 March 2014 till 26
March 2019
POM
1222BRU14031271P Betnovate-N Cream Betamethasone (as betamethasone 17-
valerate BP) 0.1% w/w and Neomycin
sulphate BP 0.5% w/w
Glaxo Wellcome Operations,
UK
Zuellig Pharma Sdn
Bhd
27 March 2014 till 26
March 2019
POM
BDMCA/RMP/1215 Page 91 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1223BRU14031272P Seretide Evohaler dose-
counter 25/250mcg
Salmeterol 25mcg (as the xinafoate) and
Fluticasone Propionate 250mcgGlaxo Wellcome S.A., Spain
Zuellig Pharma Sdn
Bhd27 March 2014 till 26
March 2019
POM
1224
BRU14031273PS1;
BRU14031273PS2
Galvus Met 50/500mg Film-
coated Tablet Vildagliptin 50mg; Metformin HCl
500mg(corresponding to 390mg
Metformin)
Novartis Pharma Stein AG,
Switzerland (S1); Novartis
Pharma Produktions GmbH,
Germany (S2)
Zuellig Pharma Sdn
Bhd
27 March 2014 till 26
March 2019
POM
1225
BRU14031274PS1;
BRU14031274PS2
Galvus Met 50/1000mg Film-
coated Tablet Vildagliptin 50mg; Metformin HCl
1000mg(corresponding to 780mg
Metformin)
Novartis Pharma Stein AG,
Switzerland (S1); Novartis
Pharma Produktions GmbH,
Germany (S2)
Zuellig Pharma Sdn
Bhd
27 March 2014 till 26
March 2019
POM
1226
BRU14031275PS1;
BRU14031275PS2
Galvus Met 50/850mg Film-
coated Tablet Vildagliptin 50mg; Metformin HCl
850mg(corresponding to 660mg
Metformin)
Novartis Pharma Stein AG,
Switzerland (S1); Novartis
Pharma Produktions GmbH,
Germany (S2)
Zuellig Pharma Sdn
Bhd
27 March 2014 till 26
March 2019
POM
1227BRU14031276P Galvus 50mg Tablet
Vildagliptin 50mgNovartis Farmaceutica SA,
Spain
Zuellig Pharma Sdn
Bhd27 March 2014 till 26
March 2019
POM
1228
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 Sdn
Bhd
27 March 2014 till 26
March 2019
POM
1229
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
1230BRU14031279NP 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
1231BRU14031280P Lamictal Dispersible/Chewable
Tablet 25mg
Lamotrigine 25mg GlaxoSmithKline
Pharmaceutical SA, Poland
Zuellig Pharma Sdn
Bhd
27 March 2014 till 26
March 2019
POM
1232BRU14031281P Panaco Tablets Paracetamol 500mg; Codeine Phosphate
9mg
Beacons Pharmaceuticals
Pte Ltd, Singapore
Hongkiat Trading &
Company
27 March 2014 till 26
March 2019
POM
1233BRU14031282P 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
1234BRU14031283P 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
BDMCA/RMP/1215 Page 92 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1235BRU14031284P Xalatan Eyedrops Latanoprost 0.005% w/v Pfizer Manufacturing
Belgium NV, Belgium
Zuellig Pharma Sdn
Bhd
27 March 2014 till 26
March 2019
POM
1236
BRU14041285P Giona Easyhaler® 100mcg/dose
Inhalation Powder
Budesonide 100mcg/dose Orion Corporation, Finland Hongkiat Trading &
Company
26 April 2014 till 25
April 2019
POM
1237BRU14041286P 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
POM
1238BRU14041287P XareltoTM Film-coated tablet
15mg
Rivaroxaban 15mg Bayer Pharma AG, Germany Zuellig Pharma Sdn
Bhd
26 April 2014 till 25
April 2019
POM
1239BRU14041288P XareltoTM Film-coated tablet
20mg
Rivaroxaban 20mg Bayer Pharma AG, Germany Zuellig Pharma Sdn
Bhd
26 April 2014 till 25
April 2019
POM
1240BRU14041289P 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
1241BRU14041290NP 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
1242BRU14041291NP Sodium Chloride Injection USP
0.9% in Mini-Bag Plus
Container
Sodium Chloride 0.9% Baxter Healthcare
Corporation, USA
Zuellig Pharma Sdn
Bhd
26 April 2014 till 25
April 2019
GSL
1243
BRU14041292PS1&
BRU14041292PS2
Rasilez® Film-coated Tablet
300mg
Aliskiren (as hemifumarate) 300mg Novartis Pharma Stein AG,
Switzerland (S1); Novartis
Farma S.p.A., Italy (S2)
Zuellig Pharma Sdn
Bhd
26 April 2014 till 25
April 2019
POM
1244BRU14041293P Endoxan® Injection 200mg/vial Cyclophosphamide monohydrate
213.8mg (eq. to anhydrous
Cyclophosphamide 200mg)
Baxter Oncology GmbH,
Germany
Zuellig Pharma Sdn
Bhd
26 April 2014 till 25
April 2019
POM
1245BRU14041294P Certican Tablet 0.25mg Everolimus 0.25mg Novartis Pharma Stein, AG,
Switzerland
Zuellig Pharma Sdn
Bhd
26 April 2014 till 25
April 2019
POM
1246BRU14041295P Certican Tablet 0.75mg Everolimus 0.75mg Novartis Pharma Stein, AG,
Switzerland
Zuellig Pharma Sdn
Bhd
26 April 2014 till 25
April 2019
POM
1247BRU14041296P 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
1248BRU14041297P DuoTrav Eye Drops, Solution Travoprost 40mcg/ml; Timolol 5mg/ml
(as timolol maleate)
S.A. Alcon-Couvreur N.V.,
Belgium
Hongkiat Trading &
Company
26 April 2014 till 25
April 2019
POM
1249BRU14041298P 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
1250BRU14041299P 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
BDMCA/RMP/1215 Page 93 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1251BRU14041300P Hypernol Tablets 50mg Atenolol 50mg Drug Houses of Australia Pte
Ltd, Singapore
G&H Trading
Company
26 April 2014 till 25
April 2019
POM
1252BRU14041301P DermovateTM Ointment Clobetasol Propionate 0.05% w/w Glaxo Wellcome Operations,
UK
Zuellig Pharma Sdn
Bhd
26 April 2014 till 25
April 2019
POM
1253BRU14041302P Tasigna Capsule 150mg Nilotinib (as hydrochloride,
monohydrate) 150mg
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
26 April 2014 till 25
April 2019
POM
1254BRU14041303P Tasigna Capsule 200mg Nilotinib (as hydrochloride,
monohydrate) 200mg
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
26 April 2014 till 25
April 2019
POM
1255BRU14041304NP 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
1256BRU14041305NP 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
1257BRU14041306P 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
1258BRU14041307P Alimta 100mg Powder for
Solution for Infusion
Pemetrexed (as Pemetrexed disodium)
100mg/vial
Eli Lilly and Company, USA Zuellig Pharma Sdn
Bhd
26 April 2014 till 25
April 2019
POM
1259BRU14041308P 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
1260BRU14041309NP 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
1261BRU14041310P Famotin Tablet 40mg Famotidine 40mg Drug Houses of Australia Pte
Ltd, Singapore
G&H Trading
Company
26 April 2014 till 25
April 2019
POM
1262BRU14041311P 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
POM
1263BRU14041312P One-Alpha® 0.25mcg Capsule Alfacalcidol 0.25mcg Leo Pharmaceutical
Products Ltd., A/S (Leo
Pharma), Denmark
Zuellig Pharma Sdn
Bhd
26 April 2014 till 25
April 2019
POM
1264BRU14041313P 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
1265BRU14041314NP Sodium Chloride Injection
0.9%, USP
Sodium Chloride 0.9% Baxter Healthcare
Corporation, USA
Zuellig Pharma Sdn
Bhd
26 April 2014 till 25
April 2019
GSL
1266BRU14041315P 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
1267BRU14041316P 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
1268BRU14041317P Rozidal Tablet 1mg Risperidone 1mg Ranbaxy (Malaysia) Sdn.
Bhd., Malaysia
G&H Trading
Company
26 April 2014 till 25
April 2019
POM
BDMCA/RMP/1215 Page 94 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1269BRU14071318PS1 &
BRU14071318PS2
Rebif ® 44 Pre-filled Syringe
44mcg/0.5mlInterferon-beta-1a (12MIU) 44mcg/0.5ml Merck Serono S.p.A., Italy
G & H Trading
Company
02 July 2014 till 01 July
2019POM
1270BRU14071319PS1 &
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
1271 BRU14071320P Protopic® Ointment 0.3% Tacrolimus 0.3mg/g (0.3%)Astellas Pharma Tech Co.,
Ltd., Japan
Zuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
1272 BRU14071321P Beathorphan Elixir 15mg/5ml Dextromethorphan HBr 15mg/5mlBeacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
02 July 2014 till 01 July
2019POM
1273 BRU14071322P Nootropil 1200mg Tablet Piracetam 1200mg UCB Pharma S.A., BelgiumZuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
1274 BRU14071323P Nootropil 800mg Tablet Piracetam 80mg UCB Pharma S.A., BelgiumZuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
1275 BRU14071324PLuvox® Film-coated Tablets
50mgFluvoxamine maleate 50mg
Abbott Healthcare SAS,
France
Zuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
1276 BRU14071325PLuvox® Film-coated Tablets
100mgFluvoxamine maleate 100mg
Abbott Healthcare SAS,
France
Zuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
1277 BRU14071326P TobraDex® Eye Ointment Tobramycin 0.3%, Dexamethasone 0.1%S.A. Alcon-Couvreur N.V.,
Belgium
Hongkiat Trading &
Co
02 July 2014 till 01 July
2019POM
1278 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., Italy
Zuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
1279 BRU14071328P Lanvis® Tablet 40mg Thioguanin 40mg Excella GmbH, GermanyZuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
BDMCA/RMP/1215 Page 95 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1280 BRU14071329NP Axcel Papain Tablet
Papain Pure equiv. to proteolytic
enzymes from carica papaya 10,000 USP
Units
Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
02 July 2014 till 01 July
2019GSL
1281 BRU14071330P Humalog Kwikpen 100units/ml Insulin Lispro 100units/ml
Lilly France S.A.S., France
(repacker - Eli Lilly And
Company, USA)
Zuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
1282 BRU14071331PShincort IM Injection "Yung
Shin" 40mg/ml ampoulesTriamcinolone acetonide 40mg
Yung Shin Pharmaceutical
Ind. Co. Ltd., Taiwan
Asterix United (B)
Sdn Bhd
02 July 2014 till 01 July
2019POM
1283 BRU14071332PEmend IV Powder For Solution
for Infusion 150mg
Fosaprepitant 150mg (as fosaprepitant
dimeglumine)
DSM Pharmaceuticals Inc.,
USA
Zuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
1284 BRU14071333P Zytiga Tablets 250mg Abiraterone acetate 250mg Patheon Inc. CanadaZuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
1285 BRU14071334P Axcel Cefaclor-500 Capsule Cefaclor 500mg (as monohydrate)Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
02 July 2014 till 01 July
2019POM
1286 BRU14071335P Anlodin Tablet 5mg Amlodipine 5mg (as Besylate 6.93mg)Y.S.P Industries (M) Sdn Bhd
Malaysia
Asterix United (B)
Sdn Bhd
02 July 2014 till 01 July
2019POM
1287 BRU14071336P Aldara Cream 5%w/w Imiquimod 5% w/w3M Health Care Limited,
England
Zuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
1288 BRU14071337P Premarin Tablet 0.3mg Conjugated estrogens 0.3mgPfizer Ireland
Pharmaceuticals, Ireland
Zuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
1289 BRU14071338P Regro Lotion 5% Minoxidil USP 5% w/vDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
02 July 2014 till 01 July
2019P
1290 BRU14071339P Regro Lotion 3% Minoxidil USP 3% w/vDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
02 July 2014 till 01 July
2019P
1291 BRU14071340NP Dequalinium Lozenges Dequalinium Chloride 0.25mgDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
02 July 2014 till 01 July
2019GSL
1292 BRU14071341P DHA-Ketozole Tablet 200mg Ketoconazole 200mgDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
02 July 2014 till 01 July
2019POM
1293 BRU14071342PAxcel Ibuprofen Paediatric
SyrupIbuprofen 100mg/5ml
Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
02 July 2014 till 01 July
2019P
1294 BRU14071343P Pharynx LozengesCetylpyridinium Chloride 1.50mg,
Benzocaine 3.33mg
Drug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
02 July 2014 till 01 July
2019GSL
BDMCA/RMP/1215 Page 96 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1295 BRU14071344P Bislan Tablet 8mg Bromhexine Hydrochloride 8mgY.S.P. Industries (M) Sdn
Bhd Malaysia
Asterix United (B)
Sdn Bhd
02 July 2014 till 01 July
2019POM
1296 BRU14071345P Tren Capsules 250mg Tranexamic Acid 250mgY.S.P. Industries (M) Sdn
Bhd Malaysia
Asterix United (B)
Sdn Bhd
02 July 2014 till 01 July
2019POM
1297 BRU14071346P Hydrocort Cream Hydrocortisone acetate 10mg/g (1%
w/w)
Y.S.P. Industries (M) Sdn
Bhd Malaysia
Asterix United (B)
Sdn Bhd
02 July 2014 till 01 July
2019POM
1298 BRU14071347P Invoril Tablet 5mg Enalapril Maleate 5mgRanbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company
02 July 2014 till 01 July
2019POM
1299 BRU14071348PAtropine Sulphate 1mg/1ml
InjectionAtropine Sulphate 1mg/ml
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
02 July 2014 till 01 July
2019POM
1300 BRU14071349P Dhacodine Syrup 15mg/5ml Pholocodine 15mg/5mlDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
02 July 2014 till 01 July
2019POM
1301 BRU14071350P Roaccutane Capsules 20mg Isotretinion 20mgR P Scherer GmbH & Co KG.,
Germany
Hongkiat Trading &
Co
02 July 2014 till 01 July
2019POM
1302 BRU14071351P Roaccutane Capsule 10mg Isotretinion 10mgR.P. Scherer GmbH & Co.
KG., Germany
Hongkiat Trading &
Co
02 July 2014 till 01 July
2019POM
1303 BRU14071352P Ipolipid 600mg Tablets Gemfibrozil 600mg Medochemie Ltd., CyprusHongkiat Trading &
Co
02 July 2014 till 01 July
2019POM
1304 BRU14071353P Salbutamol Injection 0.5mg/mlSalbutamol Sulphate 0.5mg/ml
(equivalent to salbutamol base)
Yung Shin Pharmaceutical
Ind., Co. Ltd., Taichong,
Taiwan
Asterix United (B)
Sdn Bhd
02 July 2014 till 01 July
2019POM
1305 BRU14071354P Glipizide Tablet 5mg Glipizide 5mgDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
02 July 2014 till 01 July
2019POM
1306 BRU14071355PAxcel Dexchlorpheniramine
TabletDexchlorpheniramine 2mg
Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
02 July 2014 till 01 July
2019POM
1307 BRU14071356P Phenexpect CD Syrup
Per 5 ml - Diphenhydramine HCl BP
12.5mg; Ammonium Chloride BP 135mg;
Codeine Phosphate BP 5.7mg
Drug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
02 July 2014 till 01 July
2019POM
1308 BRU14071357PQuinine Sulphate Tablet
300mgQuinine Sulphate BP 300mg
Beacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
02 July 2014 till 01 July
2019POM
1309 BRU14071358NP20% Glucose Intravenous
Infusion BPGlucose (as monohydrate) 20%
B. Braun Medical Industries
Sdn Bhd Malaysia
Hongkiat Trading &
Co
02 July 2014 till 01 July
2019POM
BDMCA/RMP/1215 Page 97 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1310 BRU14071359PPharmaniaga Spironolactone
Tablet 25mgSpironolactone 25mg
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
02 July 2014 till 01 July
2019POM
1311 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
1312 BRU14071361P Heparinol 1000IU/ml Heparin sodium (bovine) BP 1000IU/mlAin Medicare Sdn Bhd
Malaysia
Syarikat Pakatan
Indah
02 July 2014 till 01 July
2019POM
1313 BRU14071362PAlphagan Ophthalmic Solution
0.2%
Brimonidine tartrate (anhydrous basis)
2mg/ml
Allergan Pharmaceuticals
Ireland, IrelandMedipharm Sdn Bhd
02 July 2014 till 01 July
2019POM
1314 BRU14071363P Dormicum Injection 15mg/3ml Midazolam 15mg/3ml Cenexi SAS, FranceZuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
1315 BRU14071364P Dormicum Injection 5mg/5ml Midazolam 5mg/5ml Cenexi SAS, FranceZuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
1316 BRU14071365NP
0.18% sodium Chloride and
4.3% Glucose Intravenous
Infusion
0.18% Sodium Chloride 0.18%; Glucose
4.3%
B.Braun Medical Industries
Sdn Bhd., Malaysia
Hongkiat Trading &
Co
02 July 2014 till 01 July
2019POM
1317BRU14071366PS1 &
BRU14071366PS2
Rasilez Film-coated Tablet
150mgAliskiren 150mg (as Hemifumarate)
Novartis Pharma Stein AG,
Switzerland & Novartis
Farma S.p.A., Italy
Zuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
1318 BRU14071367P
Invega Sustenna Prolonged
Release Suspension for IM
Injection 150mg/2.25ml
Paliperidone 150mg/2.25ml (as
palmitate 234mg)
Janssen Pharmaceutical NV,
Belgium
Zuellig Pharma Sdn
Bhd
02 July 2014 till 01 July
2019POM
1319 BRU14071368PYondelis® Powder for Injection
1mg/vial Trabectedin 0.05mg/ml
Baxter Oncology GmbH,
Germany
Zuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1320 BRU14071369PTrajenta film-coated tablet
5mgLinagliptin 5mg
Boehringer Ingelhein Roxane
Inc., USA
Hongkiat Trading &
Company
24 July 2014 till 23 July
2019POM
1321 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
1322 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
1323BRU14071372PS1 &
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 Sdn
Bhd
24 July 2014 till 23 July
2019POM
BDMCA/RMP/1215 Page 98 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1324BRU14071373PS1 &
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 Sdn
Bhd
24 July 2014 till 23 July
2019POM
1325BRU14071374PS1 &
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 Sdn
Bhd
24 July 2014 till 23 July
2019POM
1326 BRU14071375PLucentis 10mg/ml Solution for
InjectionRanibizumab 10mg/ml
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1327 BRU14071376P
Onbrez Breezhaler 150mcg
Inhalation Powder, Hard
Capsule
Indacterol 150mcg (as maleate 194mcg) Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1328 BRU14071377P
Onebrez Breezhaler 300mcg
Inhalation Powder Hard
Capsule
Indacterol 300mcg (as maleate 389mcg) Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1329 BRU14071378PRequip PD 24hr Prolong
Release Tablet 2mgRopinirole 2mg (as Hydrochloride) Glaxo Wellcome SA Spain
Zuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1330 BRU14071379PDifflam Anti-Inflammatory
Lozenges (with Anti-bacterial)
Benzydamine Hydrochloride 3mg;
Cetylpyridinium Chloride 1.33mg
Unique Pharmaceutical
Laboratories, India
Zuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019GSL
1331 BRU14071380PVfend Powder For Oral
Suspension 40mg/mlVoriconazole 40mg/ml Pfizer PGM, France
Zuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1332 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
1333 BRU14071382PAlphagan P Ophthalmic
Solution 0.15%Brimonidine tartrate 0.15% Allergan Sales LLC, USA Medipharm Sdn Bhd
24 July 2014 till 23 July
2019POM
1334 BRU14071383P Mapenem® IV Injection 500mg Meropenem 500mg (as trihydrate)Siam Bheasach Co. Ltd.,
Thailand
K-Seri Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1335 BRU14071384PCuram Powder for oral
Suspension 312.5mg/5ml
Amoxycillin 250mg (as trihydrate);
Clavulanic Acid 62.5mg (as potassium
salt)
Sandoz GmbH, AustriaZuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1336 BRU14071385P Topamax® 25 Tablet 25mg Topiramate 25mg CILAG AG, Switzerland Zuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1337 BRU14071386P Tussils 5 Lozenge 5mg Dextromethorphan Hydrobromide 5mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand)
Limited, Thailand
Zuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
BDMCA/RMP/1215 Page 99 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1338 BRU14071387P Kivexa Tablets 600mg/300mgAbacavir 600mg (as sulfate); Lamivudine
300mgGlaxo Operations UK Ltd, UK
Zuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1339 BRU14071388P Lucrin® depot 3.75mg Injection Leuproprelin acetate 3.75mgTakeda Pharmaceutical
Company Limited, Japan
Zuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1340 BRU14071389PLucrin® depot 11.25mg
InjectionLeuproprelin acetate 11.25mg
Takeda Pharmaceutical
Company Limited, Japan
Zuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1341 BRU14071390P Axcel Diclofenac-50 Tablet Diclofenac Sodium 50mgKotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
24 July 2014 till 23 July
2019POM
1342 BRU14071391P Lamictal Tablet 50mg Lamotrigine 50mgGlaxosmithkline
Pharmaceuticals SA, Poland
Zuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1343 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
1344 BRU14071393NP Kaolin & Pectin Mixture Per 5ml - Kaolin Light BP 1g; Pectin 50mgDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
24 July 2014 till 23 July
2019P
1345 BRU14071394PDuodart 0.5mg/0.4mg
CapsulesDutasteride 0.5mg; Tamsulosin 0.4mg
Catalent Germany
Schorndorf GmbH, Germany
Zuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1346 BRU14071395PAxcel Metronidazole-400
TabletMetronidazole 400mg
Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
24 July 2014 till 23 July
2019POM
1347 BRU14071396P Cefazolin Sandoz 1g Vial Cefazolin 1g Sandoz GmbH, AustriaZuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1348
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 Sdn
Bhd
24 July 2014 till 23 July
2019POM
1349 BRU14071398P Lamitor 100mg Tablet Lamotrigine 100mgTorrent Pharmaceuticals
Ltd., India
K-Seri Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1350 BRU14071399PVigamox® Ophthalmic Solution
0.5% Moxifloxacin 0.5% (as hydrochloride) Alcon Laboratories, Inc., USA
Hongkiat Trading &
Co
24 July 2014 till 23 July
2019POM
1351 BRU14071400P Cementin Tablet 200mg Cimetidene 200mgDrug Houses of Australia Pte
Ltd, Singapore
G & H Trading
Company
24 July 2014 till 23 July
2019POM
BDMCA/RMP/1215 Page 100 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1352BRU14071401PS1 &
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 Sdn
Bhd
24 July 2014 till 23 July
2019GSL
1353 BRU14071402PImexa Film-Coated Tablet
250mgAzithromycin 250mg (as dihydrate)
Xepa-Soul Pattinson (M) Sdn
Bhd Malaysia
Hongkiat Trading &
Co
24 July 2014 till 23 July
2019POM
1354 BRU14071403P Cymbalta Capsule 60mg Duloxetine 60mg (as hydrochloride)Eli Lilly and Co., USA & Lilly
del Caibe Inc, Puerto Rico
Zuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1355 BRU14071404P Beanamine Expectorant Per 5ml - Diphenhydramine BP 10mg;
Ammonium Chloride BP 120mg)
Beacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
24 July 2014 till 23 July
2019POM
1356 BRU14071405P Setrof Tablet 50mg Sertraline 50mg Hovid Bhd, MalaysiaG & H Trading
Company
24 July 2014 till 23 July
2019POM
1357 BRU14071406P Dimenate Tablet 50mg Dimenhydrinate BP 50mgDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
24 July 2014 till 23 July
2019POM
1358 BRU14071407P Dhatifen Tablet 1mgKetotifen 1mg (as hydrogen fumarate
1.38mg)
Drug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
24 July 2014 till 23 July
2019POM
1359 BRU14071408P Melashine Cream 4% Hydroquinone 40mg/gY.S.P. Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
24 July 2014 till 23 July
2019POM
1360 BRU14071409P Asumalife Syrup 1.38mg/5mlPer 5ml - Ketotifen 1mg (as hydrogen
fumarate 1.38mg)
Y.S.P. Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
24 July 2014 till 23 July
2019POM
1361 BRU14071410P Lovastin Tablet 20mg Lovastatin 20mgY.S.P. Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
24 July 2014 till 23 July
2019POM
1362 BRU14071411P Requip tablet 0.25mg Ropinirole 0.25mg (as Hydrochloride) Glaxo Wellcome S.A., SpainZuellig Pharma Sdn
Bhd
24 July 2014 till 23 July
2019POM
1363 BRU14071412NP Zoben Tablet 200mg Albendazole 200mgPharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
24 July 2014 till 23 July
2019P
1364 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
1365 BRU14071414P Garbose Tablet 50mg Acarbose 50mgY.S.P. Industries (M) Sdn
Bhd, Malaysia
Asterix United (B)
Sdn Bhd
24 July 2014 till 23 July
2019POM
BDMCA/RMP/1215 Page 101 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1366 BRU14071415P Dexamethasone 4mg Tablet Dexamethasone 4mgBeacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
24 July 2014 till 23 July
2019POM
1367 BRU14081416P Sevorane Inhalation Liquid Sevoflurane 100%v/vAesica Queensborough Ltd,
UK
Zuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1368 BRU14081417P Emend Tri-Pack CapsuleEach capsule either contains Aprepitant
80mg or 125mg
Merck Sharp & Dohme Corp.
Australia
Zuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1369 BRU14081418P Protopic Ointment 0.1% Tacrolimus 0.1% (as monohydrate)Astellas Pharma Tech Co.,
Ltd., Japan
Zuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1370BRU14081419PS1 &
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 Sdn
Bhd
30 August 2014 till 29
August 2019POM
1371BRU14081420PS1 &
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 Sdn
Bhd
30 August 2014 till 29
August 2019POM
1372BRU14081421PS1 &
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 Sdn
Bhd
30 August 2014 till 29
August 2019POM
1373BRU14081422PS1 &
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 Sdn
Bhd
30 August 2014 till 29
August 2019POM
1374BRU14081423PS1 &
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 Sdn
Bhd
30 August 2014 till 29
August 2019POM
1375 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
1376 BRU14081425PLipanthyl Penta 145 Film-
Coated tabletFenofibrate 145mg Recipharm Fontaine, France
Zuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1377 BRU14081426P Dexamethasone Tablet 0.5mg Dexamethasone 0.5mgBeacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
30 August 2014 till 29
August 2019POM
1378 BRU14081427P FlixotideTM Evohaler 50mcg Fluticasone Propionate 50mg\cg GlaxoWellcome S.A., SpainZuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
BDMCA/RMP/1215 Page 102 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1379BRU14081428PS1
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 Sdn
Bhd
30 August 2014 till 29
August 2019POM
1380BRU14081429PS1
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 Sdn
Bhd
30 August 2014 till 29
August 2019POM
1381BRU14081430PS1
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 Sdn
Bhd
30 August 2014 till 29
August 2019POM
1382 BRU14081431P Napan Capsules 250mg Mefenamic Acid 250mgDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
30 August 2014 till 29
August 2019POM
1383
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 Sdn
Bhd
30 August 2014 till 29
August 2019POM
1384 BRU14081433P EraxisTM 100mg for Injection Anidulafungin 100mg/vialPharmacia & Upjohn
Company, USA
Zuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1385 BRU14081434P Moxiclav 1G Tablet
Amoxycillin 875mg (as sodium);
Clavulanic Acid 125mg (as Clavulanate
potassium)
Medochemie Ltd., CyprusHongkiat Trading &
Co
30 August 2014 till 29
August 2019POM
1386 BRU14081435P Lisdene 10mg tablet Lisinopril 10mg (as dihydrate)Lek Pharmaceuticals D.D.,
Slovenia
Zuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1387 BRU14081436P Dilatrend Tablet 25mg Carvedilol 25mg Roche S.p.A., ItalyZuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1388 BRU14081437P Dilatrend Tablet 12.5mg Carvedilol 12.5mg Roche S.p.A., ItalyZuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1389 BRU14081438P Dilatrend Tablet 6.25mg Carvedilol 6.25mg Roche S.p.A., ItalyZuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1390 BRU14081439P Carzepin 200mg Tablet Carbamazepine 200mg Hovid Bhd, MalaysiaG & H Trading
Company
30 August 2014 till 29
August 2019POM
1391 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
BDMCA/RMP/1215 Page 103 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1392 BRU14081441P Lamictal 100mg Tablet Lamotrigine 100mgGlaxosmithkline
Pharmaceuticals SA, Poland
Zuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1393 BRU14081442P Axcel Loratadine Tablet Loratadine 10mgKotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
30 August 2014 till 29
August 2019P
1394 BRU14081443NP Neuroxel Tablet
Thiamine Mononitrate 100mg;
Pyridoxine HCl 200mg; Cynocobalamin
200mcg
Drug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
30 August 2014 till 29
August 2019P
1395 BRU14081444P Rhiniramine SR Tablet 6mg Dexhlorpheniramine Maleate 6mgDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
30 August 2014 till 29
August 2019POM
1396 BRU14081445P
Buventhol Easyhaler
100mcg/dose inhalation
powder
Salbutamol sulphate 100mcg/actuation
(delivered dose 90mcg/actuation)Orion Corporation, Finland
Hongkiat Trading &
Co
30 August 2014 till 29
August 2019POM
1397 BRU14081446P
Buventhol Easyhaler
200mcg/dose inhalation
powder
Salbutamol sulphate 300mcg/actuation
(delivered dose 180mcg/actuation)Orion Corporation, Finland
Hongkiat Trading &
Co
30 August 2014 till 29
August 2019POM
1398 BRU14081447P Axcel Cefaclor-125 Suspension Cefaclor 125mg (as monohydrate)Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
30 August 2014 till 29
August 2019POM
1399 BRU14081448P Dextramine Tablet 2mg Dexchlorpheniramine 2mgBiosis Pharmaceuticals Sdn
Bhd., Malaysia
K-Seri Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1400 BRU14081449PMircera Pre-filled Syringe
75mcg/0.3ml
Methoxy polyethylene glycol-epoetin
Beta 75mcg/0.3ml
Roche Diagnostics GmbH,
Germany
Zuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1401 BRU14081450P Creobic (New Formula) Cream Clotrimazole 1%w/wKotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
30 August 2014 till 29
August 2019GSL
1402 BRU14081451P Axcel Cetirizine Syrup Cetirizine Dihydrochloride 5mg/5mlKotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
30 August 2014 till 29
August 2019P
1403 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
1404 BRU14081453P Sunex Cough Syrup
Per 5ml - Diphenhydramine HCl 14mg;
Ammonium chloride 135mg; Sodium/
Trisodium citrate 57.5mg
Sunward Pharmaceutical
Sdn Bhd Malaysia
G & H Trading
Company
30 August 2014 till 29
August 2019POM
1405 BRU14081454P Loxof Tablets 500mg Levofloxacin 500mgRanbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company
30 August 2014 till 29
August 2019POM
1406 BRU14081455PProluton Depot 250mg
InjectionHydroxyprogesterone Caproate 250mg
Bayer Pharma AG,
Leverkeusen, Germany
Zuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
BDMCA/RMP/1215 Page 104 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1407 BRU14081456P Nurofen for Children Ibuprofen 100mg/5ml
Reckitt Benckiser Healthcare
Manufacturing (Thailand)
Limited, Thailand
Zuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019P
1408 BRU14081457P Axcel Sabutamol Syrup Salbutamol 2mg/5mlKotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
30 August 2014 till 29
August 2019POM
1409 BRU14081458P Doxymycin Capsule 100mg Doxycycline Hydrochloride 100mgY.S.P. Industries (M) Sdn
Bhd Malaysia
Asterix United (B)
Sdn Bhd
30 August 2014 till 29
August 2019POM
1410 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
1411 BRU14081460PClarimycin Film Coated Tablet
500mgClarithromycin 500mg
Y.S.P. Industries (M) Sdn
Bhd Malaysia
Asterix United (B)
Sdn Bhd
30 August 2014 till 29
August 2019POM
1412 BRU14081461NP Mentar ShampooCoal Tar solution 9% v/v; Menthol 1%
w/w
HOE Pharmaceuticals Sdn
Bhd Malaysia
G & H Trading
Company
30 August 2014 till 29
August 2019GSL
1413 BRU14081462NP Menzza CreamMethyl Salicylate 25%w/w; Menthol
5%w/w
Hoe Pharmaceuticals Sdn
Bhd Malaysia
G & H Trading
Company
30 August 2014 till 29
August 2019GSL
1414 BRU14081463P Difnal OD Tablet 100mg Diclofenac Sodium 100mgRanbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company
30 August 2014 till 29
August 2019POM
1415 BRU14081464PHumulin N Injection 100IU/ml
(Catridges)
Human Insulin 100IU/ml (recombinant
DNA oigin)Lilly France SAS, France
Zuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1416 BRU14081465NP Bayer Aspirin Tablet 500mg Aspirin 500mg (Acetylsalicylic acid)PT Bayer Indonesia, East
Jakarta
Zuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019GSL
1417 BRU14081466P Doridone Tablet 10mg Domperidone 10mgDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
30 August 2014 till 29
August 2019POM
1418 BRU14081467PTobradex® Eye Drops
SuspensionTobramycin 0.3%; Dexamethasone 0.1%
S.A. Alcon-Couvreur N.V.,
Belgium
Hongkiat Trading &
Co
30 August 2014 till 29
August 2019POM
1419 BRU14081468NPFerrous Fumarate Tablet
200mg
Ferrous fumarate 200mg (equivalent to
65mg of elemental iron)
Drug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
30 August 2014 till 29
August 2019GSL
1420 BRU14081469P Tamoxifen 20mg Tablet Tamoxifen 20mg (as citrate 30.4mg)Teva Pharmaceutical
Industries Ltd, Israel
K-Seri Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1421 BRU14081470PRotaqor 10mg film-coated
tabletAtorvastatin 10mg (as calcium)
Lek Pharmaceuticals D.D.,
Slovenia
Zuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1422 BRU14081471P Zoral 200 tablet 200mg Acyclovir USP 200mgDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
30 August 2014 till 29
August 2019POM
BDMCA/RMP/1215 Page 105 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1423 BRU14081472P Vamlo Tablets 5mg Amlodipine 5mg (as besilate)Ranbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company
30 August 2014 till 29
August 2019POM
1424 BRU14081473P Clofenac SR Tablet Diclofenac Sodium 100mg Hovid Bhd, MalaysiaG & H Trading
Company
30 August 2014 till 29
August 2019POM
1425 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 Sdn
Bhd
30 August 2014 till 29
August 2019GSL
1426 BRU14081475P Cera-Scalp OintmentCoal Tar solution 12% w/w; Salicylic acid
2%; Sulphur 4% w/w
HOE Pharmaceuticals Sdn
Bhd Malaysia
G & H Trading
Company
30 August 2014 till 29
August 2019GSL
1427 BRU14081476P Lisdene 20mg Tablet Lisinopril 20mg (as dihydrate)Lek Pharmaceuticals DD.,
Slovenia
Zuellig Pharma Sdn
Bhd
30 August 2014 till 29
August 2019POM
1428BRU14091477P Suprane Inhalation Liquid
100%
Desflurane 100% Baxter Healthcare
Corporation, USA
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1429BRU14091478P Buclizine Tablet 25mg Buclizine 25mg Beacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
30 September 2014 till
29 September 2019
P
1430
BRU14091479PS1;
BRU14091479PS2
Cetrotide Injection 0.25mg Cetrotrelix 0.25mg (as Acetate) Baxter Oncology GmbH,
Germany (S1); Pierre Fabre
Medicament Production,
France (S2)
G & H Trading
Company
30 September 2014 till
29 September 2019
POM
1431BRU14091480P Mivacron Injection 10mg/5ml Mivacurium Chloride 10mg/5ml GlaxoSmithKline
Manufacturing S.p.A., Italy
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1432BRU14091481P Xolair Powder and Solvent for
Solution for Injection
Omalizumab 150mg Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1433BRU14091482P Frusemide Tablet 40mg Furosemide 40mg Drug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
30 September 2014 till
29 September 2019
POM
1434BRU14091483P Penegesic 50 Capsule Tramadol HCl 50mg Hovid Bhd, Malaysia G & H Trading
Company
30 September 2014 till
29 September 2019
POM
1435BRU14091486P Crinone Progestrone Vaginal
Gel 8%
Progestrone 8% Fleet Laboratories Ltd,
United Kingdom
G & H Trading
Company
30 September 2014 till
29 September 2019
POM
BDMCA/RMP/1215 Page 106 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1436BRU14091487NP Pinetarsol Gel Tar 1.6% EGO Pharmaceuticals Pty
Ltd., Australia
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
GSL
1437BRU14091488P 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
1438BRU14091489P Magrilan 20mg capsules Fluoxetine 20mg (as Hydrochloride) Medochemie Ltd., Cyprus Hongkiat Trading &
Co
30 September 2014 till
29 September 2019
POM
1439BRU14091490P Trileptal 600mg Film-coated
Tablets
Oxcarbazepine 600mg Novartis Farma S.p.A., Italy Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1440BRU14091491P Binozyt 500mg film-coated
tablet
Azithromycin 500mg (as monohydrate) Novartis (Bangladesh) Ltd.,
Bangladesh
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1441
BRU14091492P Nurofen 400 Caplet Ibuprofen 400mg Reckitt Benckiser Healthcare
Manufacturing (Thailand)
Limited, Thailand
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
P
1442BRU14091493P Recormon Pre-filled Syringe
30,000Iu/0.6ml
Epoetin beta 30,000 IU/0.6ml Roche Diagnostics GmbH,
Germany
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1443BRU14091494P Eprex® 10000 Prefilled Syringes
10,000iu/1ml
Epoetin alfa 10,000 IU/ml Cilag AG, Switzerland Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1444BRU14091495P 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
1445BRU14091496P Hydrochlorothiazide Tablet
50mg
Hydrochlorothiazide BP 50mg Drug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
30 September 2014 till
29 September 2019
POM
1446BRU14091497P Famotin Tablet 20mg Famotidine USP 20mg Drug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
30 September 2014 till
29 September 2019
POM
1447BRU14091498P 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
BDMCA/RMP/1215 Page 107 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1448BRU14091501P 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
1449BRU14091502P 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
1450BRU14091503P Rasitol Tablet 40mg Furosemide 40mg YSP Industries (M) Sdn Bhd
Malaysia
Asterix United (B)
Sdn Bhd
30 September 2014 till
29 September 2019
POM
1451BRU14091504P 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
1452
BRU14091505P Nurofen Caplet 200mg Ibuprofen 200mg Reckitt Benckiser Healthcare
Manufacturing (Thailand)
Limited, Thailand
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
p
1453BRU14091506P 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
1454BRU14091507P Afinitor 2.5mg Tablet Everolimus 2.5mg Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1455BRU14091508P 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
1456BRU14091509P Chloramine Syrup 4mg/5ml Chlorpheniramine maleate 4mg/5ml Beacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
30 September 2014 till
29 September 2019
p
1457BRU14091510P Difnal-K Tablet 50mg Diclofenac Potassium 50mg Ranbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company
30 September 2014 till
29 September 2019
POM
1458BRU14091511NP 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
1459
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
BDMCA/RMP/1215 Page 108 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1460BRU14091513P HBVaxPro® 5mcg/0.5ml
Injection
Hepatitis B surface Antigen 5mcg/0.5ml Merck Sharp & Dohme
Corp., West Point,
Pensylvania, USA
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1461BRU14091514P HBVaxPro® 10mcg/1.0ml
Injection
Hepatitis B surface Antigen 10mcg/1.0ml Merck Sharp & Dohme
Corp., West Point,
Pensylvania, USA
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1462BRU14091515P HBvaxPro® 40mcg/1.0ml
Injection
Hepatitis B surface Antigen 40mcg/1.0ml Merck Sharp & Dohme
Corp., USA
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1463BRU14091516P 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
1464BRU14091517P Stalevo 125/31.25/200mg film-
coated tablet
Levodopa 125mg, Carbidopa 31.25mg,
Entacapone 200mg
Baxter Bioscience
Manufacturing Sarl,
Switzerland
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1465BRU14091518P 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
1466BRU14091519P Afinitor 5mg Tablet Everolimus 5mg Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1467
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
1468BRU14091521P Ospexin 500mg Film-coated
Tablets
Cefalexin 500mg (as monohydrate) Sandoz GmbH, Austria Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1469BRU14091522PS1 &
BRU14091522PS2
Androcur Tablet 50mg Cyproterone acetate 50mg Delpharm Lille SAS, France Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1470BRU14091523P Poviderm Ointment Povidone Iodine 10% w/w Hoe Pharmaceuticals Sdn
Bhd Malaysia
G & H Trading
Company
30 September 2014 till
29 September 2019
GSL
1471BRU14091524P 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
BDMCA/RMP/1215 Page 109 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1472BRU14091525P Calumid 50mg Film-coated Bicalutamide 50mg Gedeon Richter Plc.,
Hungary
K-Seri Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1473BRU14091526P 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
1474BRU14091527P 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
1475BRU14091528P Campto 300mg/15ml Injection Irinotecan Hydrochloride Trihydrate
300mg/15ml
Pfizer (Perth) Pty Ltd,
Australia
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1476
BRU14091529NP Strepsils Cool Lozenges Each lozenge contains: Amymetacresol
0.6mg, 2,4-Dichlorobezyl alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand)
Limited, Thailand
Syarikat Rajamas
Bersama
30 September 2014 till
29 September 2019
GSL
1477
BRU14091530NP Strepsils Sugar Free Lemon
Lozenges
Each lozenge contains: Amymetacresol
0.6mg, 2,4-Dichlorobezyl alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand)
Limited, Thailand
Syarikat Rajamas
Bersama
30 September 2014 till
29 September 2019
GSL
1478BRU14091531P Nordette 21 Tablet Levonogestrel 150mcg, Ethinyl estradiol
30mcg
Haupt Pharma Munster
GmbH., Germany
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1479
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
1480BRU14091533P 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
1481BRU14091534P Deplatt Tablet 75mg Clopidogrel 75mg Torrent Pharmaceuticals
Ltd., India
K-Seri Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
BDMCA/RMP/1215 Page 110 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1482
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
1483BRU14091536NP 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
1484BRU14091537P Synagis 100mg Powder and
Solvent for Solution for
Injection
Palivizumab 100mg Boehringer Ingelheim
Pharma KG, Germany
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1485BRU14091538P 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
1486
BRU14091539P ZmaxTM Extended-Release
Granules for Oral Suspension
2g
Azithromycin 2g (as dihydrate) Pfizer Pharmaceuticals LLC
Vega Baja, Puerto Rico
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1487BRU14091540P Eturion 10mg Film Coated
Tablet
Atorvastatin 10mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceuticals LLC,
Puerto Rico
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1488BRU14091541P Eturion 20mg Film Coated
Tablet
Atorvastatin 20mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceuticals LLC,
Puerto Rico, USA
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1489BRU14091542P Eturion 40mg Film Coated
Tablet
Atorvastatin 40mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceutical LLC,
Puerto Rico, USA
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1490BRU14091543P Eturion 80mg Film Coated
Tablet
Atorvastatin 80mg (as crystalline
atorvastatin calcium)
Pfizer Pharmaceuticals LLC,
Puerto Rico, USA
Zuellig Pharma Sdn
Bhd
30 September 2014 till
29 September 2019
POM
1491BRU14111544P
(vial)
EYLEA Solution for Injection
(vial)
Aflibercept 40mg/ml Regeneron Pharmaceuticals
Inc., New York, USA
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
BDMCA/RMP/1215 Page 111 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1492BRU14111545P EYLEA Solution for Injection
(pre-filled syringe)
Aflibercept 40mg/ml Regeneron Pharmaceuticals
Inc., New York, USA
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1493BRU14111546P Binocrit Solution for Injection
2000 IU/ml in Pre-filled Syringe
Epoetin Alfa 2,000 IU/ml IDT Biologika GmbH,
Germany
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1494BRU14111547P Binocrit Solution for Injection
4000 IU/0.4ml in Pre-filled
Syringe
Epoetin Alfa 4,000IU/0.4ml IDT Biologika GmbH,
Germany
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1495BRU14111548P Nootropil Infusion 12g/60ml Piracetam 12g/60ml Aesica Pharmaceuticals SRL.,
Italy
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1496BRU14111549P Nootropil Injection 1g/5ml Piracetam 1g/5ml UCB Pharma S.P.A., Italy Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1497BRU14111550P Advagraf Prolonged Release
Hard Capsule 0.5mg
Tacrolimus 0.5mg (as monohydrate) Astellas Ireland Co Ltd.,
Ireland
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1498BRU14111551P Advagraf Prolonged Release
Hard Capsule 1mg
Tacrolimus 1mg (as monohydrate) Astellas Ireland Co Ltd.,
Ireland
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1499BRU14111552P Advagraf Prolonged Release
Hard Capsule 5mg
Tacrolimus 5mg (as monohydrate) Astellas Ireland Co Ltd.,
Ireland
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1500BRU14111553P Dynastat Powder and Solvent
for Solution for Injection 40mg
Parecoxib (as Sodium) 40mg Pharmacia & Upjohn
Company, USA
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1501BRU14111554P Invanz Powder for Injection
1g/vial
Ertapenem 1g (as Sodium 1.046g) Laboratories Merck Sharp &
Dohme-Chibret, France
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1502
BRU14111555P 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 SAS, France Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1503BRU14111556P Brozil Capsule 300mg Gemfibrozil 300mg YSP Industries (M) Sdn Bhd
Malaysia
Asterix United (B)
Sdn Bhd
01 November 2014 till
31 October 2019
POM
1504BRU14111557NP Menzza Ice Gel Menthol 4% w/w Hoe Pharmaceuticals Sdn
Bhd Malaysia
G & H Trading
Company
01 November 2014 till
31 October 2019
GSL
1505BRU14111558P Trileptal Film-coated Tablets
300mg
Oxcarbazepine 300mg Novartis Pharma S.p.A., Italy Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1506BRU14111559NP Alka Seltzer Lemon Acetylsalicylic Acid 324mg; Sodium
Bicarbonate 1.737g; Citric Acid
(anhydrous) 1.223g.
Bayer de Mexico SA De CV,
Mexico
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
GSL
1507BRU14111560P 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
BDMCA/RMP/1215 Page 112 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1508
BRU14111561NP Strepsils Original Lozenges Amylmetacresol 0.6mg; 2,4-
Dichlorobenzyl Alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand)
Limited, Thailand
Syarikat Rajamas
Bersama
01 November 2014 till
31 October 2019
GSL
1509
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 Rajamas
Bersama
01 November 2014 till
31 October 2019
GSL
1510BRU14111563P Loette 21 Tablet Levonorgetsrel 100mcg; ethinylestradiol
20mcg
Haupt Pharma Munster
GmbH., Germany
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1511BRU14111564P 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
1512BRU14111565P NIMBEXTM Injection 2mg/ml
(5ml)
Cisatracurium Besylate 10mg/5ml GLaxoSmithKline
Manufacturing S.p.A., Italy
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1513
BRU14111566P Aggrastat Concentrate for
Infusion 0.25mg/ml
Tirofibon 0.25mg/ml (as hydrochloride
monohydrate 0.281mg/ml)
DSM Pharmaceuticals Inc.,
USA & Orion Corporation,
Espoo, Finland
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1514BRU14111567P 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
1515BRU14111568P 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
1516BRU14111569P 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
1517BRU14111570P Olmetec Plus 20/12.5mg Film-
coated Tablet
Olmesartan Medoxomil 20mg;
Hydrochlorothiazide 12.5mg
Daiichi Sankyo Europe
GmbH, Germany
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1518BRU14111571P Norfox 400 Tablet Norfloxacin 400mg The United Drug (1966) Co.
Ltd., Thailand
K-Seri Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1519
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 Sdn
Bhd
01 November 2014 till
31 October 2019
POM
BDMCA/RMP/1215 Page 113 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1520BRU14111573P Eliquis Film-coated Tablets
2.5mg
Apixaban 2.5mg Bristol-Myers Squibb
Manufacturing Company,
Puerto Rico, USA
Zuellig Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1521BRU14111574P 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
1522BRU14111575P 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
1523BRU14111576NP 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
1524BRU14111577NP 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
1525BRU14111578P Tolanz Tablet 5mg Olanzapine 5mg Torrent Pharmaceuticals
Ltd., India
K-Seri Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1526BRU14111579P Tolanz Tablet 10mg Olanzapine 10mg Torrent Pharmaceuticals
Ltd., India
K-Seri Pharma Sdn
Bhd
01 November 2014 till
31 October 2019
POM
1527BRU14111580P 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
1528
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 Sdn
Bhd
01 November 2014 till
31 October 2019
P
1529BRU14111582P Covinace Tablet 4mg Perindopril Ter-butylamine 4mg Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
01 November 2014 till
31 October 2019
POM
1530
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
BDMCA/RMP/1215 Page 114 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1531BRU14111584NP Panamol Forte Suspension
250mg/5ml
Paracetamol 250mg/5ml Beacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
01 November 2014 till
31 October 2019
GSL
1532
BRU14111585PS1,
BRU14111585PS2,
BRU14111585PS3,
BRU14111585PS4
Avastin 100mg/4ml Bevacizumab 25mg/ml (Humanised anti-
VEGF monoclonal antibody)
Genentech Inc., USA (S1); F-
Hoffman-La Roche Ltd,
Basel, Switzerland (S2);
Roche Diagnostics GmbH,
Manheim, Germany (S3); F
Hoffmann-La Roche Ltd,
Kaiseraugst, Switzerland (S4)
Medicare 01 November 2014 till
31 October 2019
POM
1533BRU14111586P Zyvox 20mg/ml Granules For
Oral Suspension
Linezolid 100mg/5ml Pfizer Pharmaceuticals LLC,
USA
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1534BRU14111587P Axcel Cimetidine-400 Tablet Cimetidine 400mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 19 May 2015 till 18
May 2020
POM
1535BRU14111588P Humulin R Injection 100IU/ml
(Catridges)
Human Insulin (Recombinant DNA origin)
100IU/ml
Lilly France SAS, France Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1536BRU14111589P Resolor film-coated tablet 1mg Prucalopride 1mg (as succinate 1.321mg) Janssen-Cilag SpA., Italy Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1537
BRU14111590NP Maltofer Fol Chewable Tablet Iron (III) 100mg (as hydroxide-
polymaltose Complex); Folic acid 0.35mg
Vifor S.A., Switzerland &
Iberfar-Industria
Farmacetutica S.A.,
Barcelona, Portugal
Medipharm Sdn Bhd 19 May 2015 till 18
May 2020
GSL
1538BRU14111591P Pristiq 50mg Extended-Release
Tablets
Desvenlafaxine 50mg (as succinate
75.87mg)
Pfizer Ireland
Pharmaceuticals, Ireland
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1539BRU14111592P ElIquis 5mg Film-coated Tablet Apixaban 5mg Bristol-Myers Squibb
Manufacturing Company,
Puerto Rico, USA
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1540BRU14111593P 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
1541BRU14111594P Rocephin for Injection 1g IV Ceftriaxone 1g F.Hoffmann-La Roche Ltd.,
Basel, Switzerland
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1542BRU14111595P Advate 250 IU Powder and
Solvent for Solution for
Injection
Octocog alfa (recombinant human
coagulation factor VIII) 250 IU
Baxter Bioscience
Manufacturing Sarl,
Switzerland
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1543BRU14111596P Glibenclamide Tablet 5mg Glibenclamide 5mg Drug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
19 May 2015 till 18
May 2020
POM
BDMCA/RMP/1215 Page 115 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1544BRU14111597NP 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
1545
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
1546BRU14111599P 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
1547BRU14111600P 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
1548BRU14111601NP T3 Pimple Gel Rescorcinol 2% w/w HOE Pharmaceuticals Sdn
Bhd Malaysia
G & H Trading
Company
19 May 2015 till 18
May 2020
GSL
1549
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
1550BRU14111603P 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
1551BRU14111604NP 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
1552BRU14111605P Zimmex Tablet 10mg Simvastatin 10mg Silom Medical Co. Ltd.,
Thailand
Medicorp Sdn Bhd 19 May 2015 till 18
May 2020
POM
1553
BRU14111606NP Strepsils Warm Lozenges Amymetacresol 0.6mg; 2,4-
Dichlorobenzyl Alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand)
Limited, Thailand
Syarikat Rajamas
Bersama
19 May 2015 till 18
May 2020
GSL
1554BRU14111607NP 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
1555BRU14111608P Binozyt 200mg/5ml Powder for
Oral Suspension
Azithromycin 200mg Sandoz S.R.L., Romania Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
BDMCA/RMP/1215 Page 116 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1556
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
1557BRU14111610NP 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
1558BRU14111611P Kogrel 75mg Film Coated
Tablet
Clopidogrel 75mg (as bisulfate
97.875mg)
Sandoz Private Limited,
Mumbai, India
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1559BRU14111612P Chloramine Tablet 4mg Chlorpheniramine maleate 4mg Beacons Pharmaceuticals,
Pte ltd, Singapore
Hongkiat Trading &
Co
19 May 2015 till 18
May 2020
P
1560BRU14111613P Tolnaderm Cream 1% Tolnaftate 1% w/w HOE Pharmaceuticals Sdn
Bhd Malaysia
G & H Trading
Company
19 May 2015 till 18
May 2020
GSL
1561BRU14111614P Medoflucon Capsule 50mg Fluconazole 50mg Medochemie Ltd., Cyprus Hongkiat Trading &
Co
19 May 2015 till 18
May 2020
POM
1562BRU14111615P Curam 156.25mg/5ml Powder
for Oral Suspension
Per 5ml - Amoxycillin 125mg (as
trihydrate); Clavulanic acid 31.25mg
Sandoz GmbH, Austria Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1563BRU14111616P Exjade Dispersible Tablet
250mg
Deferasirox 250mg Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1564BRU14111617P 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
1565
BRU14111618NP Strepsils Extra Strong Lozenge Amymetacresol 0.6mg; 2,4-
Dichlorobenzyl Alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand)
Limited, Thailand
Syarikat Rajamas
Bersama
19 May 2015 till 18
May 2020
GSL
1566BRU14111619P Crixan Tablet 250mg Clarithromycin 250mg Ranbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company
19 May 2015 till 18
May 2020
POM
1567BRU14111620P Storvas Tablet 20mg Atorvastatin 20mg (as calcium) Ranbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company
19 May 2015 till 18
May 2020
POM
1568BRU14111621P 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
1569BRU14111622NP 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
1570BRU14111623P Botox (Botulinium Toxin, Type
A) Injection 100units/vial
Clostridium Botulinum Toxin Type A
Purified Neurotoxin Complex
100Units/vial
Allergan Pharmaceuticals
Ireland, Ireland
Medipharm Sdn Bhd 19 May 2015 till 18
May 2020
POM
BDMCA/RMP/1215 Page 117 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1571BRU14111624P 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
1572BRU14111625P 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
1573BRU14111626P Lovir Tablets 200mg Acyclovir 200mg Ranbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company
19 May 2015 till 18
May 2020
POM
1574BRU14111627P Cellcept Tablet 500mg Mycophenolate mofetil 500mg Roche S.p.A., Italy Medicare 19 May 2015 till 18
May 2020
POM
1575BRU14111628NP 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
1576BRU14111629P Xorimax 500mg Coated Tablet Cefuroxime 500mg (as axetil) PenCef Pharma GmbH,
Germany
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1577BRU14111630P Xorimax 250mg Coated Tablet Cefuroxime 250mg (as axetil) PenCef Pharma GmbH,
Germany
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1578
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 Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1579BRU14111632P Axcel Orlistat 120 Tablet Orlistat 120mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 19 May 2015 till 18
May 2020
POM
1580BRU14111633P 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
1581BRU14111634P Epimate 50mg Tablet Topiramate 50mg Torrent Pharmaceuticals
Ltd., India
K-Seri Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1582BRU14111635NP 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
1583BRU14111636P 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
1584BRU14111637NP 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
1585BRU14111638P Primovists 0.25mmol/ml
solution for injection
Gadoxetic acid, Sodium 0.25mmol/ml Bayer Pharma AG,
Leverkeusen, Germany
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
BDMCA/RMP/1215 Page 118 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1586BRU14111639P Servidipine 30mg Film-coated
Tablets
Nifedipine 30mg Lek Pharmaceuticals D.D.,
Slovenia
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1587BRU14111640P Servidipine 60mg Film-coated
Tablets
Nifedipine 60mg Lek Pharmaceuticals D.D.,
Slovenia
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1588BRU14111641NP Hoemal Oral Suspension Paracetamol 250mg/5ml (5%) Hoe Pharmaceuticals Sdn
Bhd Malaysia
G & H Trading
Company
19 May 2015 till 18
May 2020
GSL
1589BRU14111642P 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
1590BRU14111643NP Woodward's Gripe Water
(Alcohol Free)
Per 5ml - Terpeneless Dill Seed Oil
2.3mg; Sodium Bicarbonate 52.5mg
IDS Manufacturing Sdn Bhd,
Malaysia
Syarikat Rajamas
Bersama
19 May 2015 till 18
May 2020
GSL
1591BRU14111644P 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
1592BRU14111645P 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
1593
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
1594BRU14111647P 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
1595BRU14111648P Pharmaniaga Cetirizine 10mg
tablet
Cetirizine 10mg (as hydrochloride) Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
19 May 2015 till 18
May 2020
P
1596BRU14111649P Hovid Lipiduce-20 Tablet Atorvastatin 20mg (as calcium) Hovid Bhd, Malaysia G & H Trading
Company
19 May 2015 till 18
May 2020
POM
1597BRU14111650P Invokana Film-coated Tablet
100mg
Canagliflozin 100mg (as hemihydrate) Janssen-Cilag SpA Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1598BRU14111651P Axcel Chlorpheniramine-2
Syrup
Chlorpheniramine maleate 2mg/5ml Kotra Pharma (M) Sdn Bhd,
Malaysia
G & H Trading
Company
19 May 2015 till 18
May 2020
P
1599BRU14111652P Binozyt Film-Coated Tablet
250mg
Azithromycin 250mg (as monohydrate) Novartis (Bangladesh) Ltd.,
Bangladesh
K-Seri Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1600BRU14111653P Asmol 2 tablet Salbutamol 2mg (as sulphate) Sunward Pharmaceutical
Pte. Ltd., Singapore
G & H Trading
Company
19 May 2015 till 18
May 2020
POM
1601BRU14111654NP Paracetamol Kabi Solution for
infusion 10mg/ml
Paracetamol 10mg/ml i) Fresenius Kabi Germany
AB ii) Fresenius Kabi Austria
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1602BRU14111655P Risperdal Solution 1mg/ml Risperidone 1mg/ml Janssen Pharmaceutical NV,
Belgium
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
BDMCA/RMP/1215 Page 119 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1603BRU14111656P Visudyne Injection Verteprofin 15mg JHP Pharmaceuticals LLC,
United States
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1604 BRU14121657PRasilez® HCT 150/12.5mg Film-
Coated Tablet
Aliskiren (as hemifumarate) 150mg and
hydrochlorothiazide 12.5mg
Novartis Farma S.p.A. Via
Provinciale Schito 131 80058
Torre Annunziata Italy
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1605 BRU14121658PRasilez® HCT 300/12.5mg Film-
Coated Tablet
Aliskiren (as hemifumarate) 300mg and
hydrochlorothiazide 12.5mg
Novartis Farma S.p.A. Via
Provinciale Schito 131 80058
Torre Annunziata Italy
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1606 BRU14121659PRasilez® HCT 150/25mg Film-
Coated Tablet
Aliskiren (as hemifumarate) 150mg and
hydrochlorothiazide 25mg
Novartis Farma S.p.A. Via
Provinciale Schito 131 80058
Torre Annunziata Italy
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1607 BRU14121660PRasilez HCT 300/25mg Film-
coated Tablet
Aliskiren (as hemifumarate) 300mg and
hydrochlorothiazide 25mg
Novartis Farma S.p.A. Via
Provinciale Schito 131 80058
Torre Annunziata Italy
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1608 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
1609 BRU14121662P Ipolipid Capsules 300mgGemfibrozil 300mg Medochemic Ltd., Cyprus Hongkiat Trading &
Co
19 May 2015 till 18
May 2020
POM
1610 BRU14121663PCuram 625mg Film-coated
TabletAmoxicillin 500mg; Clavulanic acid as
potassium salt 125mg
Sandoz GmbH, Austria Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1611 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
1612 BRU14121665PDoribax Powder for Injection
500mgDoripenem monohydrate 500mg Shionogi Kanegasaki Plant,
Japan
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1613 BRU14121666P Amoxicap 500 CapsuleAmoxicillin (as trihydrate 574mg) 500mg Hovid Bhd, Malaysia G & H Trading
Company
19 May 2015 till 18
May 2020
POM
1614 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
1615 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
BDMCA/RMP/1215 Page 120 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1616 BRU14121669P Visanne 2mg Tablet
Dienogest 2mg Bayer Weimar GmbH und.
Co. KG., Dobereinesrtr. 20, D-
99427, Weimar, Germany
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1617 BRU14121670P Medoflucon Capsule 150mgFluconazole 150mg Medochemie Ltd., Cyprus Hongkiat Trading &
Co
19 May 2015 till 18
May 2020
POM
1618 BRU14121671P Topamax 100 Tablets 100mgTopiramate 100mg Cilag AG, Switzerland Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1619 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
1620 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 Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1621 BRU14121674P Milosec Capsule 20mgOmeprazole 20mg The United Drug (1966) Co.
Ltd., Thailand
Medicorp Sdn Bhd 19 May 2015 till 18
May 2020
POM
1622 BRU14121675P Ziagen Oral SolutionAbacavir (as Abacavir Sulfate) 20mg/ml GlaxoSmithKline Inc.,
Canada
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1623 BRU14121676P Minulet 21 TabletGestodene 75mcg; ethinylestradiol
30mcg
Haupt Pharma Munster
GmbH., Germany
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1624 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
1625 BRU14121678P Provironum Tablet 25mgMesterolone 25mg Schering Do Brasil Quimica e
Farmaceutica Ltda., San
Paulo-SP, Brazil
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1626 BRU14121681NPStrepsils Strawberry Sugar Free
Children
Amylmetacresol 0.6mg; 2.4-
Dichlorobenzyl Alcohol 1.2mg
Reckitt Benckiser Healthcare
International Limited, UK
Syarikat Rajamas
Bersama
19 May 2015 till 18
May 2020
GSL
1627 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
1628 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
1629 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
1630 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
1631 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/1215 Page 121 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1632 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
1633 BRU14121688P Cuvarlix Capsule 120mgOrlistat 120mg Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
19 May 2015 till 18
May 2020
POM
1634 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
P
1635 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
1636 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
1637 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
1638 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
1639 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
1640 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
1641 BRU14121696P Methacid 25mg tabletIndomethacin 25mg Sunward Pharmaceutical
Sdn Bhd, Malaysia
G & H Trading
Company
19 May 2015 till 18
May 2020
POM
1642 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
1643 BRU14121698PEdurant Film-Coated 25mg
tabletRilpivirine (as hydrochloride) 25mg Janssen-Cilag S.p.A., Italy Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1644 BRU14121699P Invokana 300mg FCTCanagliflozin 300mg (as hemihydrate) Janssen Ortho, LLC, Puerto
Rico
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1645 BRU14121700P Amlodipine Tablet 10mgAmlodipine Tablet 10mg Jubilant Life Sciences Ltd.,
India
Asterix United (B)
Sdn Bhd
19 May 2015 till 18
May 2020
POM
1646 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
1647 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
1648 BRU14121703P Atoris Film-coated Tablet 20mgAtorvastatin (as calcium) 20mg KRKA, d.d., Slovenia K-Seri Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
BDMCA/RMP/1215 Page 122 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1649 BRU14121704NPNutrilite Glucosamine HCl
Capsule 375mg
Glucosamine HCl 375mg Pharmaniaga Manufacturing
Berhad, Malaysia
Amway Sdn Bhd 19 May 2015 till 18
May 2020
GSL
1650 BRU14121705PUltibro Breehaler 40/50mcg
Inhalation Powder CapsuleIndacaterol (as maleate) 110mcg;
Glycopyrronium (as bromide) 50mcg
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1651 BRU15011706PZyprexa Zydis
OrodispersibleTablet 5mgOlanzapine micronized 5mg
Catalent UK Swindon Zydis
Ltd, UK
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1652 BRU15011707PZyprexa Zydis
OrodispersibleTablet 10mgOlanzapine micronized 10mg
Catalent UK Swindon Zydis
Ltd, UK
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1653 BRU15011708PRequip PD 24hr 8mg Prolong
Release TabletRopinirole 8mg (as hydrochloride) Glaxo Wellcome SA Spain
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1654 BRU15011709P Klacid MR 500mg Tablet Clarithromycin 500mgAesica Queensborough Ltd,
UK
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1655 BRU15011710P Klerimed 250mg FC Tablets Clarithromycin 250mg (as anhydrous) Medochemie Ltd., CyprusHongkiat Trading &
Co19 May 2015 till 18
May 2020POM
1656 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
1657 BRU15011712NP Dhalumag Suspension
Per 5ml - Magnesium trisilicate BP
500mg, Dried Aluminium Hydroxide BP
250mg
Drug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
19 May 2015 till 18
May 2020 GSL
1658 BRU15011713PBinoclar® 500mg Film-coated
TabletsClarithromycin 500mg
Novartis Bangladesh Ltd,
Bangladesh
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1659 BRU15011714POspamox 250mcg/5ml
granules for suspensionAmoxicillin 250mg (as trihydrate 287mg) Sandoz GmbH, Austria
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1660 BRU15011715P Ospamox 250mg Capsule Amoxicillin 250mg (as trihydrate 287mg) Sandoz GmbH, AustriaZuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1661 BRU15011716POspamox 500mg Film-coated
TabletAmoxicillin 500mg (as trihydrate 574mg) Sandoz GmbH, Austria
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1662 BRU15011717P
Salofalk® 500mg Gastro-
Resistant Prolonged-Release
Granules
Mesalazine 500mgLosan Pharma GmbH,
Germany
LF Asia (Borneo) Sdn
Bhd
19 May 2015 till 18
May 2020 POM
1663 BRU15011718P
Salofalk® 1000mg Gastro-
Resistant Prolonged-Release
Granules
Mesalazine 1000mgLosan Pharma GmbH,
Germany
LF Asia (Borneo) Sdn
Bhd
19 May 2015 till 18
May 2020 POM
1664 BRU15011719P Vaqta® Vaccine 50U/mlHepatitis A Virus, Purified, Inactivated
50U/ml
Merck Sharp & Dohme
Corp., USA
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1665 BRU15011720P Vaqta® Vaccine 25U/mlHepatitis A Virus, Purified, Inactivated
25U/ml
Merck Sharp & Dohme
Corp., USA
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
BDMCA/RMP/1215 Page 123 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1666 BRU15011721P
Salofalk® 3000mg Gastro-
Resistant Prolonged-Release
Granules
Mesalazine 3gLosan Pharma GmbH,
Germany
LF Asia (Borneo) Sdn
Bhd
19 May 2015 till 18
May 2020 POM
1667 BRU15011722P T3 Ada Gel 0.1% Adapalene 0.1%Hoe Pharmaceuticals Sdn
Bhd Malaysia
G & H Trading
Company19 May 2015 till 18
May 2020POM
1668 BRU15011723PClarimycin Film Coated Tablet
250mgClarithromycin 250mg
Y.S.P. Industries (M) Sdn
Bhd Malaysia
Asterix United (B)
Sdn Bhd19 May 2015 till 18
May 2020POM
1669 BRU15011724P Forteo Injection 20mcg/80mcl
Each ml contains 250mcg of Teriparatide
(recombinant of human parathyroid
hormone (1-34) [rhPTH (1-34)])
Lilly France SAS, FranceZuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020 POM
1670 BRU15011725PTorisel Concentrate for
Injection 25mg/mlTemsirolimus 25mg/ml
Pierre Fabre Medicament
Production (PFMP), France
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020 POM
1671 BRU15011726PUrsofalk 500mg Film-coated
TabletsUrsodeoxycholic acid 500mg
Losan Pharma GmbH,
Germany
LF Asia (Borneo) Sdn
Bhd19 May 2015 till 18
May 2020POM
1672 BRU15011727P Bactigen Eye Drops 0.3%Gentamicin 0.3% (as Gentamicin
Sulphate)FDC Limited, India
K-Seri Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1673 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 Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1674 BRU15011729P Nootropil Solution 20% Piracetam 20g/100ml NextPharma SAS., FranceZuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1675 BRU15011730PBridion Solution for Injection
100mg/mlSugammadex 100mg/ml
N.V. Organon, The
Netherlands; Organon
(Ireland) Ltd., Ireland
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020 POM
BDMCA/RMP/1215 Page 124 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1676 BRU15011731P Serlift Tablets 100mg Setraline hydrochloride 100mgRanbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company19 May 2015 till 18
May 2020POM
1677 BRU15011732NPStrepsils Soothing Honey &
Lemon
Amylmetacresol 0.6ml; 2,4-
Dichlorobenzyl alcohol 1.2mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand)
Limited, Thailand
Syarikat Rajamas
Bersama
19 May 2015 till 18
May 2020 GSL
1678 BRU15011733NPStrepsils Max Blackcurrant
LozengeHexylresorcinol 2.4mg
Reckitt Benckiser Healthcare
Manufacturing (Thailand)
Limited, Thailand
Syarikat Rajamas
Bersama
19 May 2015 till 18
May 2020 GSL
1679 BRU15011734P Implanon NXT Implant 68mg EtonogestrelN.V. Organon, The
Netherlands
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1680BRU15011735PS1 &
BRU15011735PS2Stocrin Tablet 200mg Efavirenz 200mg
Merck Sharp & Dohme
(Australia) Pte Ltd Australia;
Zhejian Huahai
Pharmaceutical Co. Ltd.,
China
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020POM
1681BRU15011736PS1 &
BRU15011736PS2Stocrin Tablet 600mg Efavirenz 600mg
Merck Sharp & Dohme
(Australia) Pte Ltd Australia;
Zhejian Huahai
Pharmaceutical Co. Ltd.,
China
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020POM
1682 BRU15011737P Magnevist Injection 469mg/ml
Each ml contains 0.5mmol
gadopentetate dimeglumine (eqv. to
469.01mg gadopentetate dimeglumine)
Bayer Pharma AG,
Leverkeusen, Germany
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020 POM
1683 BRU15011738NP Bactidol Mouthwash Hexetidine 0.1% w/vInterphill Laboratories Inc.,
Philippines
LF Asia (Borneo) Sdn
Bhd19 May 2015 till 18
May 2020GSL
1684 BRU15011739P Nicotinell TTS 10 Nicotine 17.5mg (delivers 7mg/24hours)LTS Lohmann Therapie-
System AG, Germany
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020GSL
1685 BRU15011740P Nicotinell TTS 20 Nicotine 35mg (delivers 14mg/24 hours)LTS Lohmann Therapie-
System AG, Germany
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020GSL
1686 BRU15011741P Nicotinell TTS 30 Nicotine 52.5mg (delivers 21mg/24
hours)
LTS Lohmann Therapie-
System AG, Germany
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020GSL
1687 BRU15011742NP Natzema Eczema Relief Cream
Benzoin tincture 10mg/g; Lavender
Angustifolia Oil 5mg/g; Citrus Sinensis
Peel Oil 5mg/g
Cosmetics Manufacturer
(Aust) Pty Ltd, Australia
Bossom Buddies
Enterprise
19 May 2015 till 18
May 2020 GSL
BDMCA/RMP/1215 Page 125 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1688 BRU15011743PPharmaniaga Germacid Cream
2%Fusidic acid 2.0% w/w
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
19 May 2015 till 18
May 2020 POM
1689 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 Branch
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1690 BRU15011745P Seladin 250mg tablet Naproxen 250mgY.S.P Industries (M) Sdn
Bhd., Malaysia
Asterix United (B)
Sdn Bhd19 May 2015 till 18
May 2020POM
1691 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, SwedenZuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1692 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, SwedenZuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1693 BRU15011748P Caslot 6.25mg tablet Carvedilol 6.25mgRanbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company19 May 2015 till 18
May 2020POM
1694 BRU15011749P Caslot 12.5mg tablet Carvedilol 12.5mgRanbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company19 May 2015 till 18
May 2020POM
1695 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
1696 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 Sdn
Bhd
19 May 2015 till 18
May 2020 POM
1697 BRU15021752PKogenate FS for Injection
500IU/vial
Antihemophilic factor (recombinant)
sucrose formulated 500IU
Bayer Healthcare LLC,
United States
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
BDMCA/RMP/1215 Page 126 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1698 BRU15021753P Dimenate Syrup 15mg/5ml Dimenhydrinate 15mg/5mlDrug Houses of Australia
Private Limited, Singapore
G & H Trading
Company
19 May 2015 till 18
May 2020 POM
1699 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, BelgiumZuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1700 BRU15021755P Baneocin OintmentBacitracin Zinc 250IU/1g; Neomycin
Sulphate 5000 IU (5mg)/1g
Merck
Kommanditgesellschaft Auf
Aktein & Co., Werk, Austria
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020 POM
1701 BRU15021756POspexin 125mg/5ml granules
for oral suspensionCephalexin 125mg/5ml Sandoz GmbH, Austria
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020 POM
1702 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 Sdn
Bhd
19 May 2015 till 18
May 2020 POM
1703 BRU15021758P Histac Tablets 150mg Ranitidine Hydrochloride 150mgRanbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company19 May 2015 till 18
May 2020POM
1704 BRU15021759PBeclazone 100micrograms CFC-
Free Inhaler
Beclomethasone Dipropionate
100micrograms/metered inhalation
Norton Waterford T/A Ivax
Pharmaceuticals Ireland
G & H Trading
Company
19 May 2015 till 18
May 2020 POM
1705BRU15021760PS1 &
BRU15021760PS2
Insulatard 100IU/ml Suspnsion
for Injection (vial)
1ml of suspension contain 100IU (3.5g)
of insulinNovo Nordisk A/S, Denmark Medipharm Sdn Bhd
19 May 2015 till 18
May 2020 POM
1706 BRU15021761P Covapril Tablet 4mg Perindopril ErbumineUpha Pharmaceutical Mfg
(M) Sdn Bhd, Malaysia
K-Seri Pharma Sdn
Bhd
19 May 2015 till 18
May 2020 POM
BDMCA/RMP/1215 Page 127 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1707 BRU15021762P Axcel Amlodipine 5mg TabletAmlodipine Besylate equivalent to
Amlodipine 5mg
Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
19 May 2015 till 18
May 2020POM
1708 BRU15021763P Neurontin Capsule 400mg Gabapentin 400mgPfizer Pharmaceuticals LLC.,
Puerto Rico
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1709 BRU15021764P Miostat Intraocular Solution Carbachol 0.1mg/ml Alcon Laboratories Inc., USAHongkiat Trading &
Co19 May 2015 till 18
May 2020POM
1710 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
1711 BRU15021766PNeulastim Pre-filled Syringe
6mg/0.6mlPegfilgrastim 6mg/0.6ml
F-Hoffman-La Roche Ltd.,
SwitzerlandMedipharm Sdn Bhd
19 May 2015 till 18
May 2020POM
1712 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
1713 BRU15021768P Exelon Patch 15Rivastigmine base 27mg / 15cm2 (In vivo
release rate 13.3mg/24h)
LTS Lohmann Therapie-
Systeme AG, Germany
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020POM
1714 BRU15021769PZellox-II, Double Strength
Liquid Antacid
Per 10ml - Aluminium Hydroxide 800mg;
Magnesium Hydroxide 800mg;
Simethicone 60mg
Hoe Pharmaceuticals Sdn
Bhd Malaysia
G & H Trading
Company
19 May 2015 till 18
May 2020 GSL
1715 BRU15021770P Bonjela Gel 15g tubeCholine Salicylate 8.714% & Cetalkonium
chloride 0.01%
Reckitt Benckiser Healthcare
(UK) Ltd., UK
Syarikat Rajamas
Bersama19 May 2015 till 18
May 2020GSL
1716 BRU15021771P Gilenya 0.5mg hard capsuleFingolimod 0.5mg (corresponding to
0.56mg Fingolimod Hydrochloride)
Novartis Pharma Stein AG,
Switzerland
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1717 BRU15021772P Presolin 150 tablet Irbesartan 150mgUnison Laboratories Co.
Ltd., Thailand
K-Seri Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1718 BRU15021773P Presolin 300 tablet Irbesartan 300mgUnison Laboratories Co.
Ltd., Thailand
K-Seri Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1719 BRU15021774P Tracidol Injection 50mg/ml Tramadol Hydrochloride 50mg/mlY.S.P. Industries (M) Sdn
Bhd Malaysia
Asterix United (B)
Sdn Bhd19 May 2015 till 18
May 2020POM
1720 BRU15021775P Hurix Skin Ointment 5%w/wBenzoic 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
1721 BRU15021776P Apo-Risperidone 2mg tablet Risperidone 2mg Apotex Inc, Canada Medicorp Sdn Bhd19 May 2015 till 18
May 2020POM
BDMCA/RMP/1215 Page 128 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1722 BRU15021777P Apo-Megestrol 160mg tablet Megestrol acetate 160mg Apotex Inc, Canada Medicorp Sdn Bhd19 May 2015 till 18
May 2020POM
1723 BRU15021778P Olapine 5mg FCT Olanzapine 5mgSalutas Pharma GmbH,
Germany
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1724 BRU15021779PTrajenta Duo 2.5mg/500mg
FCT tablet
Linagliptin 2.5mg; Metformin
hydrochloride 500mg
Boehringer Ingelheim GmbH
and Co. KG., Germany
Hongkiat Trading &
Co
19 May 2015 till 18
May 2020 POM
1725 BRU15021780PTrajenta Duo 2.5mg/850mg
FCT
Linagliptin 2.5mg; Metformin
hydrochloride 850mg
Boehringer Ingelheim GmbH
and Co. KG., Germany
Hongkiat Trading &
Co
19 May 2015 till 18
May 2020 POM
1726 BRU15021781PTrajenta Duo 2.5mg/1000mg
film-coated tablets
Linagliptin 2.5mg; Metformin
hydrochloride 1000mg
Boehringer Ingelheim GmbH
and Co. KG., Germany
Hongkiat Trading &
Co
19 May 2015 till 18
May 2020 POM
1727 BRU15021782P Humalog 100u/ml (Catridge) Insulin Lispro 100 units/ml Lillly France, FranceZuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1728 BRU15021783P Acustop Cataplasma Flurbiprofen 40mgGreen Cross Corporation,
Korea
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1729 BRU15021784PToviaz 4mg prolonged-release
tablet
Fesoterodine fumarate equivalent to
3.1mg fesoterodine
Aesica Pharmaceuticals
GmbH, Germany
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1730 BRU15021785PToviaz 8mg prolonged-release
tablet
Fesoterodine fumarate equivalent to
6.2mg fesoterodine
Aesica Pharmaceuticals
GmbH, Germany
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1731 BRU15021786PGiotrif 20mg film-coated
tablets (Afatinib 20mg)Afatinib (as dimaleate) 20mg
Boehringer Ingelheim GmbH
and Co. KG., Germany
Hongkiat Trading &
Co
19 May 2015 till 18
May 2020 POM
1732 BRU15021787PGiotrif 30mg film-coated
tablets (Afatinib 20mg)Afatinib (as dimaleate) 30mg
Boehringer Ingelheim GmbH
and Co. KG., Germany
Hongkiat Trading &
Co
19 May 2015 till 18
May 2020 POM
1733 BRU15021788PGiotrif 40mg film-coated
tablets (Afatinib 20mg)Afatinib (as dimaleate) 40mg
Boehringer Ingelheim GmbH
and Co. KG., Germany
Hongkiat Trading &
Co
19 May 2015 till 18
May 2020 POM
1734 BRU15021789PGiotrif 50mg film-coated
tablets (Afatinib 20mg)Afatinib (as dimaleate) 50mg
Boehringer Ingelheim GmbH
and Co. KG., Germany
Hongkiat Trading &
Co
19 May 2015 till 18
May 2020 POM
1735 BRU15021790PMikostat oral suspension 30ml
(Nystatin 100,000 IU/ml)Nystatin 100,000 IU/ml
Gulf Pharmaceutical
Industries (Julphar), United
Arab Emirates
K-Seri Pharma Sdn
Bhd
19 May 2015 till 18
May 2020 POM
1736 BRU15021791P Losartan Winthrop 50mg tablet Losartan Potassium 50mgZentiva, a.as., Slovak
RepublicMedipharm Sdn Bhd
19 May 2015 till 18
May 2020POM
BDMCA/RMP/1215 Page 129 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1737 BRU15021792PLosartan Winthrop 100mg
tabletLosartan Potassium 100mg
Zentiva, a.as., Slovak
RepublicMedipharm Sdn Bhd
19 May 2015 till 18
May 2020POM
1738 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 Sdn
Bhd
19 May 2015 till 18
May 2020POM
1739 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 Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1740 BRU15021795P Ceflour CFT 250mg Cefuroxime (as Cefuroxime Axetil) 250mg
Yung Shin Pharmaceutical
Ind. Co. Ltd., Republic of
China
Asterix United (B)
Sdn Bhd
19 May 2015 till 18
May 2020 POM
1741 BRU15021796PMontelair 10mg film-coated
tablet
Montelukast (as Montelukast Sodium)
10mgHovid Bhd., Malaysia
G & H Trading
Company19 May 2015 till 18
May 2020POM
1742 BRU15021797P Amlibon 10mg tablet Amlodipine (as Amlodipine Besilate)
10mg
Lek Pharmaceuticals D.D.,
Solvenia
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1743 BRU15021798NP
Dianeal Low Calcium
(2.5MEq/L) Peritoneal Dialysis
Solution with 4.25% Dextrose
(2L Ultrabag)
Each 100ml contains: Dextrose Hydrous
4.25g; Sodium Chloride 538mg; Sodium
Lactate 448mg; Calcium Chloride
dihydrate 18.3mg; and Magnesium
Chloride Hexhydrate 5.08mg
Baxter Healthcare SA.,
Singapore Branch
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1744 BRU15021799NP
Dianeal Low Calcium
(2.5MEq/L) Peritoneal Dialysis
Solution 2.5% Dextrose (2L
Ultrabag and 2.5L Ultrabag)
Each 100ml contains: Dextrose Hydrous
2.5g; Sodium Chloride 538mg; Sodium
Lactate 448mg; Calcium Chloride
dihydrate 18.3mg; and Magnesium
Chloride Hexhydrate 5.08mg
Baxter Healthcare SA.,
Singapore Branch
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
BDMCA/RMP/1215 Page 130 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1745 BRU15021800NP
Dianeal Low Calcium
(2.5MEq/L) Peritoneal Dialysis
Solution 1.5% Dextrose (2L
Ultrabag and 2.5L Ultrabag)
Each 100ml contains: Dextrose Hydrous
1.5g; Sodium Chloride 538mg; Sodium
Lactate 448mg; Calcium Chloride
dihydrate 18.3mg; and Magnesium
Chloride Hexhydrate 5.08mg
Baxter Healthcare SA.,
Singapore Branch
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1746 BRU15021801NP Calactate 300mg tab Calcium Lactate pentahydrate 300mg Hovid Bhd, MalaysiaG & H Trading
Company19 May 2015 till 18
May 2020GSL
1747 BRU15021802P Xylid 250mg tab Cefuroxime Axetil 250mgPharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
19 May 2015 till 18
May 2020 POM
1748 BRU15021803PColospan 10mg sugar coated
tabletHyoscine Butylbromide 10mg Hovid Bhd, Malaysia
G & H Trading
Company19 May 2015 till 18
May 2020POM
1749 BRU15021804P Caslot 25mg tablet Carvedilol 25mgRanbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company19 May 2015 till 18
May 2020POM
1750 BRU15021805P Serenata 50mg TabletSertraline hydrochloride 56mg
equivalent to Sertraline 50mg
Torrent Pharmaceuticals
Ltd., India
K-Seri Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1751 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
1752 BRU15021807P Gammaplex 5% w/v 5g Human Immunoglobulin G 5g/100ml Bio Product Lab, UK Medipharm Sdn Bhd19 May 2015 till 18
May 2020POM
1753 BRU15021808P Gammaplex 5% w/v 10g Human Immunoglobulin G 10g/200ml Bio Product Lab, UK Medipharm Sdn Bhd19 May 2015 till 18
May 2020POM
1754 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
1755 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 2020 POM
1756 BRU15031811P Zemplar Injection Paricalcitol 5mcg/ml Hospira S.p.A., ItalyZuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1757 BRU15031812P Lamotrix 100mg Tablets Lamotrigine 100mg Medochemie Ltd., CyprusHongkiat Trading &
Company19 May 2015 till 18
May 2020POM
1758 BRU15031813P Lamotrix 50mg Tablets Lamotrigine 50mg Medochemie Ltd., CyprusHongkiat Trading &
Company19 May 2015 till 18
May 2020POM
BDMCA/RMP/1215 Page 131 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1759 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., Belgium
Zuellig Pharma Sdn.
Bhd.
19 May 2015 till 18
May 2020
POM
1760 BRU15031815P Cialis 2.5mg Tablet Tadalafil 2.5mgLily del Caribe Inc., Puerto
Rico
Zuellig Pharma Sdn.
Bhd.19 May 2015 till 18
May 2020POM
1761 BRU15031816P Cialis 5mg Tablet Tadalafil 5mgLily del Caribe Inc., Puerto
Rico
Zuellig Pharma Sdn.
Bhd.19 May 2015 till 18
May 2020POM
1762 BRU15031817P Cialis 20mg Tablet Tadalafil 20mgLily del Caribe Inc., Puerto
Rico
Zuellig Pharma Sdn.
Bhd.19 May 2015 till 18
May 2020POM
1763 BRU15031818NP Tempol Tablet 500mg Paracetamol Tablet 500mgDuopharma (M) Sdn. Bhd.,
Malaysia
Hongkiat Trading &
Company19 May 2015 till 18
May 2020P (50 x 10’s)
1764 BRU15031819PPlacta Film-coated Tablets
75mgClopidogrel (as bisulphate) 75mg Actavis Ltd., Malta
G&H Trading
Company19 May 2015 till 18
May 2020POM
1765 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, SwedenZuellig Pharma Sdn.
Bhd
19 May 2015 till 18
May 2020 POM
1766 BRU15031821P Ometec capsule 20mg Omeprazole 20mgNoripharma Sdn. Bhd.,
Malaysia
K-Seri Pharma Sdn.
Bhd.19 May 2015 till 18
May 2020POM
1767 BRU15031822PElantan® long sustained-
release capsuleIsosorbide-5-mononitrate 50mg
GlaxoSmithKline
Pharmaceuticals Sdn. Bhd.,
Malaysia
Zuellig Pharma Sdn.
Bhd
19 May 2015 till 18
May 2020 POM
1768 BRU15031823P
ADVATE 500IU Powder and
Solvent for Solution for
Injection
Octocog alfa (recombinant human
coagulation factor VIII)
Baxter BioScience
Manufacturing Sàrl,
Switzerland
Zuellig Pharma Sdn.
Bhd
19 May 2015 till 18
May 2020 POM
1769 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., MalaysiaG&H Trading
Company
19 May 2015 till 18
May 2020
GSL
BDMCA/RMP/1215 Page 132 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1770 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
1771 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
1772 BRU15031827P Torpezil Tablets 10mg Donepezil hydrochloride 10mgTorrent Pharmaceuticals
Ltd., India
K-Seri Pharma Sdn.
Bhd.19 May 2015 till 18
May 2020POM
1773 BRU15031828P Torpezil Tablets 5mg Donepezil hydrochloride 5mgTorrent Pharmaceuticals
Ltd., India
K-Seri Pharma Sdn.
Bhd.19 May 2015 till 18
May 2020POM
1774 BRU15031829NP BrevoxylTM 4% creamHydrous Benzoyl Peroxide (eq. to
benzoyl peroxide 4%)
Glaxo Operations UK
Limited, UK
Zuellig Pharma Sdn.
Bhd19 May 2015 till 18
May 2020GSL
1775 BRU15031830NP Gaviscon Liquid Sachet
Each 10ml contains: Sodium alginate
500mg, Sodium bicarbonate 267mg and
Calcium carbonate 160mg
Reckitt Benckiser Healthcare
(UK) Ltd., UK
Zuellig Pharma Sdn.
Bhd
19 May 2015 till 18
May 2020 GSL
1776 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
1777 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
1778 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 2020 GSL
1779 BRU15041834PRotaqor 20mg film-coated
tabletAtorvastatin Calcium 20mg
Lek Pharmaceuticals D.D.,
Slovenia
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1780 BRU15041835P Jakavi 20mg tabletRuxolitinib (as phosphate 26.40mg)
20mg
Novartis Pharma Stein, AG,
Switzerland
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1781 BRU15041836P Jakavi 15mg tablet Ruxolitinib (as phosphate 19.8mg) 15mgNovartis Pharma Stein, AG,
Switzerland
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1782 BRU15041837P Jakavi 5mg tablet Ruxolitinib (as phosphate 6.6mg) 5mgNovartis Pharma Stein, AG,
Switzerland
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1783 BRU15041838PRocephin for Injection 250mg
IM
Ceftriaxone sodium (eq. to ceftriaxone
250mg/vial)
F.Hoffman-La Roche Ltd.,
France
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020POM
1784 BRU15041839PArchifar 500mg powder for
injection/infusionMeropenem (as trihydrate) 500mg Medochemie Ltd, Cyprus
Hong Kiat Trading &
Co.19 May 2015 till 18
May 2020POM
1785 BRU15041840PCiproflo 2mg/ml solution for IV
infusionCiprofloxacin 2mg/ml (as hydrochloride)
Sin Guan Chem. Ind. Co.
Ltd., Republic of China
K-Seri Pharma Sdn.
Bhd.19 May 2015 till 18
May 2020POM
BDMCA/RMP/1215 Page 133 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1786 BRU15041841P Omezole 20mg capsule Omeprazole 20mg Hovid Bhd., MalaysiaG & H Trading
Company19 May 2015 till 18
May 2020POM
1787 BRU15041842P B-Mycin cream
Betamethasone dipropionate 0.643mg
(eq. to 0.5mg betamethasone);
Gentamicin Sulfate 1mg (potency)
Y.S.P. Industries (M) Sdn.
Bhd., Malaysia
Asterix United (B)
Sdn Bhd
19 May 2015 till 18
May 2020 POM
1788 BRU15041843P Mucodin syrup 250mg/5ml Carbocysteine 250mg/5mlSunward Pharmaceutical
Sdn. Bhd., Malaysia
G & H Trading
Company19 May 2015 till 18
May 2020P
1789 BRU15041844PPharmaniaga Loratadine tablet
10mgLoratadine 10mg
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading
Company
19 May 2015 till 18
May 2020
P
1790 BRU15041845P Curam 1000mg tablet
Amoxycillin 875 (as trihydrate);
clavulanic acid 125mg (as potassium
clavulanate)
Sandoz GmbH, AustriaZuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020 POM
1791 BRU15041846P Vancotex Injection 500mg Vancomycin (as hydrochloride) 500mg Fisiopharma S.r.L., ItalyK-Seri Pharma Sdn.
Bhd.19 May 2015 till 18
May 2020POM
1792 BRU15041847P Sunadine tablet 10mg Loratadine 10mgSunward Pharmaceutical
Sdn. Bhd., Malaysia
G & H Trading
Company19 May 2015 till 18
May 2020
P
1793 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., China
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020
POM
1794 BRU15041849NP Folic acid 5mg tablet Folic acid 5mgSunward Pharmaceutical
Sdn. Bhd., Malaysia
G & H Trading
Company19 May 2015 till 18
May 2020P
1795 BRU15041850P Estelle-35 tabletCyproterone acetate 2mg;
Ethinylestradiol 0.03mg
Douglas Manufacturing
Limited, New Zealand
G & H Trading
Company19 May 2015 till 18
May 2020POM
1796 BRU15041851NPCetomacragol emulsifying
ointment
Cetomacragol emulsifying wax 30% w/w;
liquid paraffin 20%; white soft paraffin
50%
Hovid Bhd., MalaysiaG & H Trading
Company
19 May 2015 till 18
May 2020 GSL
BDMCA/RMP/1215 Page 134 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1797BRU15041852PS1/
BRU15041852PS2
Glucophage® XR 1000mg
Extended-release tablet
Metformin (as hydrochloride 1000mg)
780mg
1. Merck Sante SAS, France;
2. Merck KGaA, Germany
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020 POM
1798 BRU15041853P Duofilm LiquidSalicylic acid 16.7% w/w; lactic acid
16.7%
Stiefel Labs (Ireland) Ltd.,
Ireland
Zuellig Pharma Sdn
Bhd19 May 2015 till 18
May 2020P
1799 BRU15041854NPVoluven Solution for Infusion
6%
Per 1000ml: Poly (O-2-hydroxyethyl)
starch 60.0g; sodium chloride 9.00g
Frensius Kabi Deutschland
GmbH, Germany
Zuellig Pharma Sdn
Bhd
19 May 2015 till 18
May 2020 POM
1800 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
1801 BRU15041856POnzapin film-coated tablet
5mgOlanzapine 5mg Actavis Ltd., Malta
G & H Trading
Company19 May 2015 till 18
May 2020POM
1802 BRU15041857POnzapin film-coated tablet
10mgOlanzapine 10mg Actavis Ltd., Malta
G & H Trading
Company19 May 2015 till 18
May 2020POM
1803 BRU15041858NPFisherman’s friend aniseed
lozengesMenthol 5.75mg
Lofthouse of Fleetwood
Limited, UK
Kingston Beverage &
Creamery Sdn Bhd
19 May 2015 till 18
May 2020 GSL
1804 BRU15041859NPFisherman’s Friend Sugar Free
Mint LozengesMenthol 3.45mg
Lofthouse of Fleetwood
Limited, UK
Kingston Beverage &
Creamery Sdn Bhd
19 May 2015 till 18
May 2020 GSL
1805 BRU15041860NP
Fisherman’s Friend Sugar Free
Cherry Lozenges With
Menthol 6.9mg
Menthol 6.9mg Lofthouse of Fleetwood
Limited, UK
Kingston Beverage &
Creamery Sdn Bhd
19 May 2015 till 18
May 2020 GSL
1806 BRU15041861NPChlorHex 5% Concentrate
Solution
Chlorhexidine gluconate 5% w/v;
isopropylaocohol 3.15% w/v
Pahang Pharmacy Sdn Bhd,
Malaysia
G & H Trading
Company19 May 2015 till 18
May 2020GSL
1807 BRU15041862P Salmax CR tablet 4mg Salbutamol sulphate 4mgUpha Pharmaceuticals Sdn
Bhd, Malaysia
Hongkiat Trading &
Co19 May 2015 till 18
May 2020POM
1808BRU15051863NP SP Pharma Paracetamol
Tablets 500mg
Paracetamol 500mgSimpor Pharma Sendirian
Berhad, Brunei Darussalam
Simpor Pharma
Sendirian Berhad
19 May 2015 till 18
May 2020P (200’s)
1809
BRU15051864NP Addamel™ N Concentrate for
Infusion1 mL contains: Chromic chloride 6 H2O
5.33 µg; Copper chloride 2 H2O 340 µg;
Ferric chloride 6 H2O 540 µg; Manganese
chloride 4 H2O 99 µg; Potassium iodide
16.6 µg; Sodium fluoride 210 µg; Sodium
molybdate 2 H2O 4.85 µg; Sodium
selenite anhydrous 6.90 µg; Zinc chloride
1.36 mg
Fresenius Kabi Norge AS,
Norway
Zuellig Pharma Sdn
Bhd
28 July 2015 till 27 July
2020
POM
BDMCA/RMP/1215 Page 135 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1810BRU15051865NP
Dettol Moisturing Formula
Antiseptic Cream
Triclosan 0.3%; Chloroxylenol 0.3%;
Edetic acid 0.2%
Reckitt Benckiser Healthcare
(UK) Ltd., UK
Syarikat Aliaa Sdn
Bhd
28 July 2015 till 27 July
2020 GSL
1811BRU15051866P
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
1812
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 Sdn
Bhd
28 July 2015 till 27 July
2020
POM
1813BRU15051868NP
Kabiven Emulsion for InfusionFresenius Kabi AB, Uppsala,
Sweden
Zuellig Pharma Sdn
Bhd
28 July 2015 till 27 July
2020POM
1814BRU15051869P
Dopatab M250 Tablet Methyldopa 250mg Hovid Bhd., MalaysiaG & H Trading
Company
28 July 2015 till 27 July
2020POM
1815BRU15051870P
Fenagesic Tablet 250mg Mefenamic acid 250mgSunward Pharmaceutical Pte
Ltd., Singapore
G & H Trading
Company
28 July 2015 till 27 July
2020POM
1816BRU15051871P
Metta SR Tablets 500mg Metformin Hydrochloride USP 500mgTorrent Pharmaceuticals
Ltd., Indrad, India
K-Seri Pharma Sdn
Bhd
28 July 2015 till 27 July
2020POM
1817BRU15051872P
Diamitex Tablet 80mg Gliclazide 80mgDuopharma (M) Sdn Bhd,
Malaysia
K-Seri Pharma Sdn
Bhd
28 July 2015 till 27 July
2020POM
1818BRU15051873NP
Calamine Lotion Calamine BP 15% w/v
Royce Pharma
Manufacturing Sdn Bhd,
Malaysia
SWL Biomed Sales &
Services
28 July 2015 till 27 July
2020GSL
1819BRU15051874NP
Fisherman’s Friend Original
LozengesMenthol 10.35mg; Eucalyptus oil 1.73mg
Lofthouse of Fleetwood
Limited, UK
Kingston beverage &
Creamary Sdn Bhd
28 July 2015 till 27 July
2020GSL
1820BRU15051875NP
Fisherman’s Friend Mint
Lozenges
Menthol 4.6mg; Peppermint oil
11.270mg
Lofthouse of Fleetwood
Limited, UK
Kingston beverage &
Creamary Sdn Bhd
28 July 2015 till 27 July
2020GSL
BDMCA/RMP/1215 Page 136 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1821BRU15051876NP
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
2020GSL
1822
BRU15051877P
Progyluton Tablet
Estradiol Valerate (in brown tablet) 2mg;
Estradiol Valerate (in white tablet) 2mg;
Norgestrel (in brown tablet) 0.5mg
Bayer Weimar GmbH und
Co. KG., Germany
Zuellig Pharma Sdn
Bhd
28 July 2015 till 27 July
2020POM
1823BRU15051878P
Loratyn-10 Loratadine 10mg Hovid Bhd., MalaysiaG & H Trading
Company
28 July 2015 till 27 July
2020POM (100's);
P (20's)
1824BRU15051879P
Candazole V Single Dose Cream
10% w/wClotrimazole 10% w/w
HOE Pharmaceuticals Sdn
Bhd, Malaysia
G & H Trading
Company
28 July 2015 till 27 July
2020 POM
1825BRU15061880P Keppra® Oral Solution
100mg/ml
Levetiracetam 10mg/ml NextPharma SAS., France Zuellig Pharma Sdn
Bhd
28 July 2015 till 27 July
2020
POM
1826
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
1827BRU15061882P Aceprin 10mg tablet Aspirin 100mg Hovid Bhd, Malaysia G & H Trading
Company
28 July 2015 till 27 July
2020
POM
1828BRU15061883P 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
1829BRU15061884P 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
1830BRU15061885P Zorax Suspension 200mg/5ml Aciclovir 200mg/5ml Sunward Pharmaceutical
Pte. Ltd., Singapore
G & H Trading
Company
28 July 2015 till 27 July
2020
POM
1831BRU15061886P Ganaton 50mg tablet Itopride hydrochloride 50mg Abbott Japan Co. Ltd., Japan Zuellig Pharma Sdn
Bhd
28 July 2015 till 27 July
2020
POM
1832BRU15061887P 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
1833
BRU15061888P Herceptin Powder for Injection
440mg/vial
Trastuzumab 440mg Genentech Inc., California,
USA; Genentech Inc.,
Oregon, USA
Medicare 28 July 2015 till 27 July
2020
POM
1834BRU15061889P Azoren 20mg/5mg Film-Coated
Tablet
Olmesartan medoxomil 20mg and
Amlodipine (as amlodipine
besylate) 5mg
Daiichi Sankyo Europe
GmbH, Germany
Zuellig Pharma Sdn
Bhd
28 July 2015 till 27 July
2020
POM
BDMCA/RMP/1215 Page 137 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1835BRU15061890P Azoren 40mg/10mg Film-
Coated Tablet
Olmesartan medoxomil 40mg and
Amlodipine (as amlodipine
besylate) 10mg
Daiichi Sankyo Europe
GmbH, Germany
Zuellig Pharma Sdn
Bhd
28 July 2015 till 27 July
2020
POM
1836BRU15061891P Azoren 40mg/5mg Film-Coated
Tablet
Olmesartan medoxomil 40mg and
Amlodipine (as amlodipine
besylate) 5mg
Daiichi Sankyo Europe
GmbH, Germany
Zuellig Pharma Sdn
Bhd
28 July 2015 till 27 July
2020
POM
1837BRU15061892P Perindosyl 4mg Tablet Perindopril tert-butylamine 4mg (eqv. to
3.338mg perindopril)
Lek Pharmaceuticals DD.,
Slovenia
Zuellig Pharma Sdn
Bhd
28 July 2015 till 27 July
2020
POM
1838BRU15061893NP 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
1839BRU15061894NP Oxy Cover Cream Benzoyl peroxide 10% w/w Rohto-Mentholatum
(Vietnam) Co. Ltd., Vietnam
Hamitan Marketing 28 July 2015 till 27 July
2020
GSL
1840BRU15061895NP Oxy Acne Wash Triclosan 0.30% Rohto-Mentholatum
(Vietnam) Co. Ltd., Vietnam
Hamitan Marketing 28 July 2015 till 27 July
2020
GSL
1841BRU15061896NP Hocodin Lozenge 250mcg Dequalinium chloride 250mcg Winwa Medical Sdn. Bhd.,
Malaysia
Medicorp Sdn. Bhd. 28 July 2015 till 27 July
2020
GSL
1842BRU15061897NP Gaviscon Advance Peppermint Sodium alginate 500mg/5ml
Potassium bicarbonate 100mg/5ml
Reckitt Benckiser Healthcare
(UK) Ltd., UK
Zuellig Pharma Sdn
Bhd
28 July 2015 till 27 July
2020
GSL
1843BRU15071898P Celluvisc Lubricating Eye Drops
1%
Carboxymethylcellulose sodium 1% Allergan Sales, LLC, USA Medipharm Sdn Bhd 09 Dec 2015 till 08 Dec
2020
GSL
1844BRU15071899P 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
1845BRU15071900NP Gaviscon Liquid Per 10ml - Sodium alginate 500mg;
Sodium bicarbonate 267mg; Calcium
carbonate 160mg
Reckitt Benckiser Healthcare
(UK) Ltd, UK
Zuellig Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020
GSL
1846BRU15071901P Zapine 100mg Tablet Clozapine100mg Taiwan Biotech Co. Ltd,
Taiwan
G & H Trading
Company
09 Dec 2015 till 08 Dec
2020
POM
1847BRU15071902P Alendronate Sandoz 70mg FCT Alendronic acid 70mg Lek Pharmaceuticals D.D.,
Ljubljana
Zuellig Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020
POM
1848BRU15071903NP Chlorhex 4% antiseptic solution Chlorhexidine gluconate 4% Pahang Pharmacy Sdn Bhd.,
Malaysia
G & H Trading
Company
09 Dec 2015 till 08 Dec
2020
GSL
1849BRU15071904P Resolor Film-coated Tablet
2mg
Prucalopride succinate 2.642mg eqv
Prucalopride 2mg
Janssen-Cilag S.p.A., Italy Zuellig Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020
POM
1850BRU15071905P Proglutrol 500 Extended
Release Tablets
Metformin Hydrochloride 500mg Inventia Healthcare Pvt. Ltd.,
India
Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec
2020
POM
BDMCA/RMP/1215 Page 138 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1851BRU15071906NP Gaviscon Double Action Liquid Per 10ml - Sodium Alginate 500mg;
Sodium Bicarbonate 213mg; Calcium
Carbonate 325mg
Reckitt Benckiser Healthcare
(UK) Ltd, UK
Zuellig Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020
GSL
1852BRU15071907NP Gaviscon Double Action Tablet Sodium Alginate 250mg; Sodium
Bicarbonate 106.5mg; Calcium
Carbonate 187.5mg
Reckitt Benckiser Healthcare
(UK) Ltd, UK
Zuellig Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020
GSL
1853BRU15071908P Daivobet Gel Calcipotriol (as monohydrate) 50mcg/g &
betamethasone (as dipropionate)
0.5mg/g
LEO Laboratories Ltd.,
Ireland
Zuellig Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020
POM
1854BRU15071909NP Oxy 10 Lotion Benzoyl peroxide 10% w/w Rohto-Mentholatum
(Vietnam) Co. Ltd., Vietnam
Hamitan Marketing 09 Dec 2015 till 08 Dec
2020
GSL
1855BRU15071910NP Oxy 5 Lotion Benzoyl peroxide 5% w/w Rohto-Mentholatum
(Vietnam) Co. Ltd., Vietnam
Zuellig Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020
GSL
1856BRU15071911P 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
1857BRU15071912P Keppra Film-coated Tablet
1000mg
Levetiracetam 1000mg UCB Pharma SA, Belgium Zuellig Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020
POM
1858BRU15081913NP Zentel Suspension
400mg/10ml
Albendazole 400mg/10ml Smithkline Beecham,
Philippines
Kingston Beverage &
Creamery Sdn Bhd
09 Dec 2015 till 08 Dec
2020
GSL
1859BRU15081914P Xalacom Eye Drops 1ml contains latanoprost 50 micrograms
and timolol maleate 6.8mg (eq to 5mg
timolol)
Pfizer Manufacturing
Belgium NV, Belgium
Zuellig Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020
POM
1860BRU15081915P 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 Sdn
Bhd
09 Dec 2015 till 08 Dec
2020
POM
1861BRU15081916P 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
1862BRU15081917P Olmetec 40 Tablet Olmesartan Medoxomil 40mg Daiichi Sankyo Europe
GmbH, Germany
Zuellig Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020
POM
1863BRU15081918P Olanzapine Orodispersible
Tablets 5mg
Olanzapine 5mg Jubilant Life Sciences Ltd.,
India
Asterix United (B)
Sdn Bhd
09 Dec 2015 till 08 Dec
2020
POM
1864BRU15081919P Olanzapine Orodispersible
Tablets 10mg
Olanzapine 10mg Jubilant Life Sciences Ltd.,
India
Asterix United (B)
Sdn Bhd
09 Dec 2015 till 08 Dec
2020
POM
1865BRU15081920P Metrogyl Injection 5mg/ml Metronidazole 500mg/100mL Unique Pharmaceutical
Laboratories, India
K-Seri Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020
POM
BDMCA/RMP/1215 Page 139 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1866BRU15081921P 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
1867BRU15081922P Olmetec Plus 40/12.5mg Film-
Coated Tablet
Olmesartan Medoxomil 40mg;
Hydrochlorothiazide 12.5mg
Daiichi Sankyo Europe
GmbH, Germany
Zuellig Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020
POM
1868BRU15081923P Risperdal Tablet 1mg Risperidone 1mg Janssen Cilag SPA, Italy Zuellig Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020
POM
1869BRU15081924P Risperdal Tablet 2mg Risperidone 2mg Janssen Cilag SPA, Italy Zuellig Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020
POM
1870BRU15081925P Apo-Clopidogrel Tablet 75mg Clopidogrel (as bisulfate) 75mg Apotex Inc. Canada, Canada Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec
2020
POM
1871
BRU15081926NP Win-Aqueous CreamEmulsifying 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
POM
1872 BRU15091927P Axcel Piroxicam-10 Capsule Piroxicam 10mgKotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
09 Dec 2015 till 08 Dec
2020POM
1873 BRU15091928PAcular Ophthalmic Solution
0.5%Ketorolac Trometamol 0.50% w/v
Allergan Pharmaceuticals
Ireland, IrelandMediPharm Sdn Bhd
09 Dec 2015 till 08 Dec
2020POM
1874 BRU15091929P Dilantin capsule 30mg Phenytoin Sodium 30mgPfizer Australia Pty Ltd,
Australia
Zuellig Pharma Sdn
Bhd09 Dec 2015 till 08 Dec
2020POM
1875 BRU15091930PZymar® (gatifloxacin opthalmic
solution) 0.3%Gatifloxacin 0.3% Allergan Sales, United States MediPharm Sdn Bhd
09 Dec 2015 till 08 Dec
2020POM
1876 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
1877 BRU15091932PGadovist Injection 1.0mmol/ml
Prefilled syringe 5.0ml
Gadobutrol pure 604.72mg & Calcium
sodium butrol 0.513mgBayer Pharma AG, Germany
Zuellig Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020 POM
1878 BRU15091933P Gadovist Injection 1.0mmol/mlGadobutrol pure 604.72mg & Calcium
sodium butrol 0.513mgBayer Pharma AG, Germany
Zuellig Pharma Sdn
Bhd09 Dec 2015 till 08 Dec
2020POM
1879 BRU15091934P
Neostigmine Methysulphate –
Fresenius 2.5mg/1ml
(Ampoules)
Neostigmine methylsulphate 2.5mg/ml
Fresenius Kabi
Manufacturing SA (Pty) Ltd.,
Republic of South Africa.
K-Seri Pharma Sdn.
Bhd.
09 Dec 2015 till 08 Dec
2020 POM
BDMCA/RMP/1215 Page 140 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1880 BRU15091935P Cardiprin 100 Tablet Aspirin 100mgReckitt Benckiser Healthcare
(UK),United Kingdom
Zuellig Pharma Sdn
Bhd
09 Dec 2015 till 08 Dec
2020 POM
1881 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
1882 BRU15091937P Guafensin Syrup 20mg/ml Guaifenesin 20mg/mlY.S.P. Industries (M) Sdn.
Bhd., Malaysia
Asterix United (B)
Sdn Bhd09 Dec 2015 till 08 Dec
2020POM
1883 BRU15091938P Storvas C Tablets 10mgAtorvastatin 10mg as Atorvastatin
Calcium Trihydrate
Ranbaxy (Malaysia) Sdn.
Bhd., Malaysia
G & H Trading
Company09 Dec 2015 till 08 Dec
2020POM
1884 BRU15091939NP Zinc Cream Zinc Oxide 32% w/wHOE Pharmaceuticals Sdn.
Bhd., Malaysia
G & H Trading
Company09 Dec 2015 till 08 Dec
2020GSL
1885 BRU15091940PPirimat Injection 10mg/ml (1ml
ampoule)Chlorpheniramine Maleate 10mg/m
Duopharma (M) Sdn Bhd,
Malaysia
Hongkiat Trading &
Company09 Dec 2015 till 08 Dec
2020POM
1886 BRU15091941P Irprestan Tablet 150mg Irbesartan 150mg Actavis ehf, IcelandG & H Trading
Company09 Dec 2015 till 08 Dec
2020POM
1887 BRU15091942P Irprestan Tablet 300mg Irbesartan 300mg Actavis ehf, IcelandG & H Trading
Company09 Dec 2015 till 08 Dec
2020POM
1888 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
1889 BRU15091944P Fucid Ointment 2% w/wSodium Fusidate (Micronised) 20mg/g
(2% w/w)
Noripharma Sdn Bhd,
Malaysia
Asterix United (B)
Sdn Bhd09 Dec 2015 till 08 Dec
2020POM
1890 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
1891 BRU15091946PAxcel Bromhexine (Children)
ElixirBromhexine Hydrochloride 4mg
Kotra Pharma (M) Sdn Bhd.,
MalaysiaMedicorp Sdn Bhd.
09 Dec 2015 till 08 Dec
2020POM
1892 BRU15101947PCetyrol 10mg Film-coated
TabletCetirizine dihydrochloride 10mg
Salutas Pharma GmbH,
Germany
Zuellig Pharma Sdn
Bhd09 Dec 2015 till 08 Dec
2020POM
1893 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
1894 BRU15101949P Antismine Syrup 2mg/5ml Chlorpheniramine maleate 2mg/5mlWinwa Medical Sdn Bhd.,
MalaysiaMedicorp Sdn Bhd
09 Dec 2015 till 08 Dec
2020P
BDMCA/RMP/1215 Page 141 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1895 BRU15101950P Respidon 2mg Tablets Risperidone 2mgTorrent Pharmaceuticals
Ltd., India
K-Seri Pharma Sdn
Bhd09 Dec 2015 till 08 Dec
2020POM
1896 BRU15101951P Respidon 1mg Tablets Risperidone 1mgTorrent Pharmaceuticals
Ltd., India
K-Seri Pharma Sdn
Bhd09 Dec 2015 till 08 Dec
2020POM
1897 BRU15101952NP Flexjoint 1500mg Powder
Crystalline glucosamine sulphate 1884mg
(equivalent to glucosamine sulphate
1500mg)
Winwa Medical Sdn Bhd.,
MalaysiaMedicorp Sdn Bhd
09 Dec 2015 till 08 Dec
2020 GSL
1898 BRU15101953NP Colin Cough Syrup 100mg Guaiphenesin 100mg/5mlWinwa Medical Sdn Bhd.,
Malaysia
Yuh Hua Trading
Company09 Dec 2015 till 08 Dec
2020GSL
1899 BRU15101954P Tystatin Oral Suspension Nystatin BP 100,000 unitsT.O. Chemicals (1979) Co.
Ltd., ThailandMedicorp Sdn Bhd
09 Dec 2015 till 08 Dec
2020POM
1900 BRU15101955P Ezede Tablet 10mg Loratadine 10mgXepa-Soul Pattinson (M) Sdn
Bhd., Malaysia
Hongkiat Trading &
Co09 Dec 2015 till 08 Dec
2020P
1901 BRU15101956PPred Forte Sterile Ophthalmic
Suspension 1%Prednisolone acetate 1% w/v
Allergan Pharmaceuticals
Ireland, Mayo, Ireland
Zuellig Pharma Sdn
Bhd09 Dec 2015 till 08 Dec
2020POM
1902 BRU15111957P Stivarga Tablet 40mg
Regorafenib
(40mg Regorafenib equivalent to
41.49mg Regorafenib monohydrate)
Bayer Pharma AG, Germany.Zuellig Pharma Sdn
Bhd,
09 Dec 2015 till 08 Dec
2020 POM
1903 BRU15111958P A Scabs Lotion Permethrin 5.0% w/vHOE Pharmaceuticals Sdn.
Bhd., Malaysia
G & H Trading
Company09 Dec 2015 till 08 Dec
2020GSL
1904 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
1905 BRU15111960P Tetradox Capsules 100mgDoxycycline Hydrochloride/Hcylate eq to
Doxycycline 100mg
Ranbaxy (Malaysia) Sdn Bhd,
Malaysia
G & H Trading
Company09 Dec 2015 till 08 Dec
2020POM
1906 BRU15111961NP Infusol® NS (Ampoule) Sodium chloride 0.9%w/vAIN Medicare Sdn. Bhd.,
Malaysia
Syarikat Pakatan
Indah09 Dec 2015 till 08 Dec
2020GSL
1907 BRU15111962NPInfusol W (Sterilised Water for
Injection BP)Water for injection BP
AIN Medicare Sdn. Bhd.,
Malaysia
Syarikat Pakatan
Indah09 Dec 2015 till 08 Dec
2020GSL
1908 BRU15111963P Elan Forte CreamTolnaftate 10mg/g; Chlorhexidine HCl
2mg/g
Y.S.P. Industries (M) Sdn.
Bhd.,Malaysia
Asterix United (B)
Sdn Bhd.09 Dec 2015 till 08 Dec
2020GSL
1909 BRU15111964P Valparin XR 500mg Tablet
i) Sodium Valproate 333mg
ii) Valproic Acid 145mg
(Both together correspond to sodium
valproate 500mg)
Torrent Pharmaceuticals
Limited, India
K-Seri Pharma Sdn
Bhd.,
09 Dec 2015 till 08 Dec
2020 POM
1910 BRU15111965P Axcel Betamethasone Cream Betamethasone 17-Valerate (micronized)
equivalent to Betamethasone 0.1% w/w
Kotra Pharma (M) Sdn Bhd,
MalaysiaMedicorp Sdn Bhd
09 Dec 2015 till 08 Dec
2020 POM
BDMCA/RMP/1215 Page 142 of 143

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)
1911 BRU15111966P Freederm Gel Terbinafine HCl 1%w/w Winwa Medical Sdn Bhd.,
Malaysia
Yuh Hua Trading
Company 09 Dec 2015 till 08 Dec
2020GSL
1912 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
1913 BRU15111968PT Atehexal Comp Mite Tablet Atenolol 50mg; Chlorthalidone 12.5mgSalutas Pharma GmbH,
Federal Republic of
Germany
Medicorp09 Dec 2015 till 28
April 2019POM
1914 BRU15111969PTHurricane Topical Anaesthetic
Gel – Original Wild CherryBenzocaine 20%
Dental Technologies Inc. ,
United States L S Kai Care09 Dec 2015 till 16 Feb
2018POM
1915 BRU15111970PT Duocaine Cream 5% w/w Lidocaine 2.5% w/w; Prilocaine 2.5% w/wHoe Pharmaceuticals Sdn
Bhd, MalaysiaG & H Trading Co
09 Dec 2015 till 14 Jan
2019POM
1916 BRU15111971PTSOLIRIS Concentrate for
Solution for Infusion 300mgEculizumab 300mg
DSM Pharmaceuticals Inc,
USAMedipharm Sdn Bhd
09 Dec 2015 till
23/11/2018POM
BDMCA/RMP/1215 Page 143 of 143