agenda 4.1 - registered medicinal products in ... documents/traditional medicines...lampiran a –...

Lampiran A – 31st BDMCA of 14

AGENDA 4.1 - REGISTERED MEDICINAL PRODUCTS IN THE 135th, 136th, 137th and 138th DRC MEETING

The following have been evaluated and were found to be satisfactory, and recommended by the Drug Registration Committee for endorsement by the BDMCA for registration

135th DRC Meeting (19 applications)

No Product Licence

Number

Product Application Ref.

No. Product Name Active Ingredients Manufaturer Licence Holder

Product Classification

Pack Size

1

BRU19032530P 15/S0104 Imexa powder for oral suspension 200mg/5ml

Azithromycin 200mg/5ml

Xepa-Soul Pattinson (Malaysia) Sdn Bhd

Hongkiat Trading & Company

POM

20ml suspension (upon reconstitution per bottle), 1 bottle

per box

2 BRU19032531P 16/S0019

Dysolvon Syrup (Raspberry)

Bromhexine hydrochloride 4mg/5ml

Dynapharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd

P 60ml per bottle

3

BRU19032532NP 16/S0022 Paracil Tablet 500mg

Paracetamol 500mg SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company

GSL a) 100 x 10’s b) 2 x

10’s

4

BRU19032533NP 16/S0049 Cap Kaki Tiga Ai Kan Shan Fever Powder

Paracetamol 500mg / sachet Syarikat Wen Ken Drug Sdn Bhd, Malaysia

Syarikat Rajamas Bersama

GSL 10 sachets x 1.0g

5 BRU19032534NP 16/S0060

Dyna Calamine Lotion

Calamine Powder 150mg/ml (15% w/v)

Dynapharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd

GSL Bottles of 100ml

6

BRU19032535P 16/S0076

Gazyva Concentrate for Solution for Infusion

Obinutuzumab 1000mg/40mL Roche Diagnostics GmbH, Germany

MediPharm Sdn Bhd

POM 50ml vial, pack size of

1 vial

7 BRU19032536P 16/S0112

Pyrimine Tablet 60mg

Pyridostigmine Bromide 60mg

Sriprasit Pharma Co., Ltd., Thailand

Medicorp Sdn Bhd

POM Pack of 15 blister

strips x 10’s

8

BRU19032537P 16/S0119 Ceftriaxone-AFT Powder for Injection 1g

Ceftriaxone sodium 1.079g (equivalent to ceftriaxone 1g)

Qilu Pharmaceutical Co., Ltd., China

MediPharm Sdn Bhd

POM Vials per box: 1, 5 or

10

9

BRU19032538NP 16/S0139 U-Lite Effervescent Granules

Each 4.1gm contains: Sodium Bicarbonate 1.76g Citric Acid 0.72g Sodium Citrate 0.63g Tartaric Acid 0.89g

Winwa Medical Sdn Bhd, Pulau Pinang, Malaysia

Medicorp Sdn Bhd

GSL 4.1gm x 12’s x 12’s

10 BRU19032539P 16/S0140

Coldmax Suspension

Each 5ml contains: Paracetamol 250mg Pseudoephedrine HCl 15mg

Winwa Medical Sdn Bhd, Pulau Pinang, Malaysia

Medicorp Sdn Bhd

P 60ml & 100ml



No Product Licence

Number




Pack Size

Chlorpheniramine Maleate 1mg

11

BRU19032540NP 16/S0142 Kidz PCM 250 Suspension (Orange)

Paracetamol 250mg/5ml Winwa Medical Sdn Bhd, Pulau Pinang, Malaysia

Medicorp Sdn Bhd

GSL

60ml per bottle, 12 bottles packed in a

white outer box 100ml per bottle, 12 bottles packed in a

white outer box 120ml per bottle, each

bottle packed in a labelled printed outer box; 6 boxes shrink-

wrap together

12

BRU19032541NP 17/S0021 UNI-MA ENEMA SOLUTION

Each 118ml (delivered dose) contains:: Sodium bisphosphonate 19g; Sodium phosphate 7g

Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd

P 133ml

13

BRU19032542P 17/S0113 Ciprocep Tablet 250mg

Ciprofloxacin Hydrochloride 291.5mg equivalent to Ciprofloxacin 250mg

T.O. Pharma Co. Ltd., Thailand

Medicorp Sdn Bhd

POM 50 x10’s

14 BRU19032543P 17/S0121

Ferriprox 1000mg Film Coated Tablet

Deferiprone 1000mg Apotex Inc., Canada

Medicorp Sdn Bhd

POM 50’s

15

BRU19032544P 17/S0152 Octocaine 100

Each ml contains: i) Lidocaine Hydrochloride 20mg ii) Epinephrine bitartrate 0.018mg

Novocol Pharmaceutical of Canada Inc., Canada

Medicorp Sdn Bhd

POM 5 blister trays of 10 x

1.8ml cartridges (50’s)



No Product Licence

Number




Pack Size

16

BRU19032545NP 17/S0169 ANIOSGEL 85 NPC Ethanol 70% (700mg/g i.e 755ml/L

Laboratoires Anios, France


GSL

30ml bottle -100’s 75ml bottle -20’s

300 ml bottle with screwed pump -6’s 500ml bottle with

screwed pump -12’s 1L bottle with

screwed pump- 12’s 500ml bottle for dispenser- 12’s

1L bottle for dispenser- 12’s

1 L Airless bottle- 12’s 5L can- 12’s

17

BRU19032546NP 17/S0174 ANTHPHLAMINE S LOTION

Methylsalicylate 20% w/w L-Menthol 6% w/w

Yuhan Corporation, South Korea

Kingsley Medical Supplies Sdn Bhd

GSL 100ml

18

BRU19032547NP 18/S0061

Woods Peppermint Cough Syrup for Children

Guaiphenesin 50mg/5ml IDS Manufacturing Sdn Bhd, Malaysia

M.S. Makmur Trading Company

GSL Pack of 50ml & 100ml

19

BRU19032548NP 18/S0074 Xubil Oral Solution

Each 5ml contains:Monobasic sodium phosphate 2.4 g;Dibasic sodium phosphate 0.9 g

Unison Laboratories Co., Ltd., Thailand


POM (Note to BDMCA: POM

considering that the dose is found

to exceed the maximum

recommended dose given for

self-medication of occasional

constipation for 10 – 11 years of

age and 5 – 9 years of age.

45ml x 1’s



No Product Licence

Number

Product Application

Ref. No. Product Name Active Ingredients Manufaturer Licence Holder


Pack Size

1

BRU19042549P 14/S0311 Oxytocin-Richter Solution for Injection 10 IU/1ml

Oxytocin 10 I.U./1ml Gedeon Richter Plc., Hungary


POM 100’s x 1ml

2

BRU19042550P 15/S0215 Vivic Tablet 100mg Sildenafil 100mg

Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia


POM 4’s per box

3

BRU19042551P 15/S0222 Requip PD 24 hour Prolonged Release Tablet 4mg

Ropinirole hydrochloride (eq to 4mg ropinirole free base)

Glaxo Wellcome S.A, Spain

Zuellig Pharma (B) Sdn Bhd

POM 28’s

4 BRU19042552NP 15/S0225 Axcel Folic Acid 5mg Folic Acid 5mg

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd

GSL 100's (10 x 10’s)

5

BRU19042553P 16/S0026 Maxigesic Tablet 500mg/150mg

Paracetamol 500mg Ibuprofen 150mg

Sigma Laboratories Ltd, India

Medipharm Sdn Bhd

P

10’s (1x 10’s), 16’s (2 x 8’s), 32’s (4 x 8’s), 50’s

(5 x 10’s) and 100’s (10 x 10’s)

6

BRU19042554P 16/S0045 Arnetin 50mg/2ml Solution for Injection/Infusion

Ranitidine (as ranitidine hydrochloride) 50mg/2ml

Medochemie Ltd., Cyprus

Medicorp Sdn Bhd

POM 5 x 2ml ampoules

7

BRU19042555P 16/S0106 Clavomax 625mg Tablet

Each tablet contains: 573.96mg Amoxicillin Trihydrate (eq. to Amoxicillin 500mg) and 148.91mg Potassium Clavulanate (eq. to Clavulanic acid 125mg)

China Chemical & Pharmaceutical Co. Ltd, Taiwan

Medicorp Sdn Bhd

POM 20 x 6’s and 10 x 10’s

8

BRU19042556P 16/S0113 Chlorop Eye Ointment 1%

Chloramphenicol 10mg/g (1%)

SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company

POM 5g

9 BRU19042557P 16/S0136

Akoset Injection 20mg/2ml

Frusemide 20mg/2ml Duopharma (M) Sdn Bhd, Malaysia


POM 10’s and 100’s

10

BRU19042558P 16/S0187 Lipiodol Ultra Fluid 480mg l/ml, Solution for Injection

Ethyl esters of iodized fatty acids of poppy seed oil corresponds to iodine 480mg/ml

Delpharm Tours, France

Manning Jaya Trading (B) Sdn Bhd

POM 1 x 10mL



No Product Licence

Number

Product Application



Pack Size

11

BRU19042559NP 16/S0201 Povil Antacid Mixture (Peppermint)

Each 10ml contains: Aluminium Hydroxide 400 mg Magnesium Hydroxide 400 mg

Winwa Medical Sdn Bhd, Malaysia

Yuh Hua Trading Company

GSL 100ml and 120ml

12

BRU19042560P 16/S0177 Betacort Cream 0.1% w/w

Each gram cream contains: Betamethasone Valerate equivalent to 1mg Betamethasone (0.1%w/w).

SM Biomed Sdn Bhd, Malaysia

G&H Trading Company

POM 15g

13

BRU19042561P 17/S0020 Cravit Ophthalmic Solution 0.5%

Levofloxacin hydrate 5mg/mL

Santen Pharmaceutical Asia Pte. Ltd., Singapore

Medipharm Sdn Bhd

POM 1 x 5mL

14 BRU19042562P 17/S0038 Esmya Tablet 5mg Ulipristal Acetate 5mg Cenexi, France


POM 2 x 14’s

15

BRU19042563P 17/S0039 Apo-Amilzide Tablet Each tablet contains: Hydrochlorothiazide 50mg, Amiloride Hydrochloride 5mg

Apotex Inc., Canada

Medipharm Sdn Bhd

POM 50 x 10’s and 100 x

10’s

16

BRU19042564P 17/S0057 Tenof-EM Tablet Emtricitabine 200mg, Tenofovir Disproxil Fumarate 300mg

Hetero Labs Limited, India


POM 30's

17 BRU19042565P 17/S0098 Freederm Lotion Terbinafine HCl 1% w/v



GSL 30ml

18 BRU19042566NP 17/S0100 Yellow Lotion 0.4%

Acriflavine Hydrochloride 0.4% w/v



GSL 15ml, 30ml, 60ml and

1L

19

BRU19042567P 17/S0102 Kovaltry Powder and Solvent for Solution for Injection 250IU/vial

Powder - Antihemophilic Factor (Recombinant Factor VIII) 250IU Diluent - Water for Injection

Bayer Healthcare LLC, USA


POM

1 vial of powder for injection (10ml), 1 prefilled syringe of diluent (2.5ml), 1

sterile vial adapter and 1 administration

set

20

BRU19042568P 17/S0103 Kovaltry Powder and Solvent for Solution for Injection 500IU/vial

Powder - Antihemophilic Factor (Recombinant Factor VIII) 500IU Diluent - Water for Injection

Bayer Healthcare LLC, USA


POM

1 vial of powder for injection (10ml), 1 prefilled syringe of diluent (2.5ml), 1

sterile vial adapter



No Product Licence

Number

Product Application



Pack Size

and 1 administration set /

21

BRU19042569P 17/S0111 Lamitor 50mg Tablet Lamotrigine 50mg Torrent Pharmaceuticals Limited, India


POM 1 x 10’s, 3 x 10’s, 5 x

10’s, 10 x 10’s

22 BRU19042570P 17/S0126 Onsia Tablet 8mg

Ondansetron hydrochloride dihydrate (9.977mg) eq to ondansetron 8mg

Siam Bheasach Co. Ltd., Thailand


POM 10 x 10’s

23 BRU19042571P 18/S0014

Tivicay™ 50mg Film-Coated Tablets

Dolutegravir 50mg (as dolutegravir sodium)

Glaxo Operations UK Ltd, United Kingdom


POM 30’s

24

BRU19042572P 18/S0027 Minirin® Nasal Spray 0.1mg/ml

Desmopressin acetate 0.1mg/ml eq. to 89mcg desmopressin (10mcg/dose)

Ferring GmBH, Germany


POM 1 bottle of 2.5ml (25

doses of 10mcg)

25

BRU19042573P 18/S0042 URSA 250MG CAPSULE Ursodeoxycholic acid 250mg

Daewoong Pharmaceutical Co. Ltd., Republic of Korea


POM 10 x 10’s

26

BRU19042574P 18/S0056 Spiriva Respimat 2.5mcg Solution for Inhalation

Per puff: 2.5mcg Tiotropium eq. to 3.124mcg tiotropium bromide monohydrate

Boehringer Ingelheim Pharma GmBH & Co. KG, Germany


POM 1 cartridge containing inhalation solution + 1

Respimat inhaler

27

BRU19042575P 18/S0086 Lavudin Standard F.C. Tablet 100mg

Lamivudine 100mg Standard Chem. & Pharm. Co. Ltd, Taiwan


POM 2 x 14’s

28

BRU19042576P 18/S0091 Faslodex Solution for Injection 250mg/5ml

Fulvestrant 250mg/5ml

Vetter Pharma-Fertigung GmbH & Co. KG, Germany


POM 5ml x 2's



No Product Licence

Number

Product Application



Pack Size

29

BRU19042577NP 18/S0080

Multibic potassium-Free Solution for Haemofiltration (Solution, sterile)

1000 ml of the ready-to-use solution contain: Sodium chloride 6.136 g; Sodium hydrogen carbonate 2.940 g Calcium chloride dihydrate 0.2205 g Magnesium chloride hexahydrate 0.1017 g Glucose monohydrate 1.100 g (anhydrous glucose 1.000 g)

Fresenius Medical Care Deutschland GmbH, Germany

Medix Supplier GSL 5000ml x 2’s



No Product Licence

Number

Product Application



Pack Size

1

BRU19052578P 15/S0010 Pregeb Capsules 75mg Pregabalin 75mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma (B) Sdn Bhd

POM 10's (1x10's) and 30's

(3x 10's)

2

BRU19052579NP 15/S0219 Omnipaque 300mg l/mL, Solution for Injection/Infusion

Iohexol (INN) 300 mg I/ml (647 mg equivalent to 300mg I)

GE Healthcare (Shanghai) Co., China

Medipharm Sdn Bhd

POM 10 x 50mL, 10 x 75mL & 10 x 100mL

3

BRU19052580NP 15/S0220 Omnipaque 350mg l/mL, Solution for Injection/Infusion

Iohexol (INN) 350 mg I/ml (755 mg equivalent to 350mg I)

GE Healthcare (Shanghai) Co., China

Medipharm Sdn Bhd

POM 10 x 50mL, 10 x 75mL & 10 x 100mL

4

BRU19052581P 16/S0068 Streptin Injection 1g Streptomycin Sulphate equivalent to Streptomycin 1g

SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company

POM 25 x 5ml

5

BRU19052582P 16/S0071 Aricept Evess 5mg Orodispersible Tablet

Donepezil hydrochloride 5mg

Bushu Pharmaceuticals Ltd. 950, Japan

Medipharm Sdn Bhd

POM 2 x 14’s

6

BRU19052583P 16/S0072 Aricept Evess 10mg Orodispersible Tablet

Donepezil hydrochloride 10mg

Bushu Pharmaceuticals Ltd. 950, Japan

Medipharm Sdn Bhd

POM 2 x 14’s

7 BRU19052584P 16/S0189

Yucomy Shampoo 2% w/w

Ketoconazole 20mg/g (2% w/w)

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

Asterix United (B) Sdn Bhd

GSL 120ml

8 BRU19052585P 16/S0213

Mapin 0.4mg/ml Injection

Naloxone Hydrochloride 0.4mg/ml

Duopharma (M) Sdn Bhd., Malaysia


POM 10 x 1ml

9 BRU19052586P 17/S0051

Apo-Warfarin 1mg Tablet

Warfarin Sodium 1mg Apotex Inc., Canada

Medipharm Sdn Bhd

POM 100’s

10

BRU190525871PS1 &

BRU190525871PS2 17/S0085 Medovir 400mg Tablet Aciclovir 400mg

Medochemie Ltd. Cyprus (S1) Medochemie (Far East) Ltd. – Oral Factory, Vietnam (S2)


POM 100’s (10 x 10’s) and 1000’s (100 x 10’s)

11

BRU19052588P 17/S0156 Bisloc 2.5 Bisoprolol Fumarate 2.5mg Unison Laboratories Co., Thailand


POM 10 x 10’s



No Product Licence

Number

Product Application



Pack Size

12

BRU19052589P 17/S0179 Derzid Cream

Each 100g contains betamethasone valerate equivalent to betamethasone 0.1g (0.1% w/w)

Unison Laboratories Co. Ltd., Thailand


POM 450g

13

BRU19052590P 18/S0006 Pentasa® Prolonged Release Tablet 500mg

Mesalazine 500mg

Ferring International Center SA, Switzerland

Zuellig Pharma Sdn Bhd

POM 10X10’s

14

BRU19052591P 18/S0018 Apo-montelukast Chewable Tablets 4mg USP

Montelukast (as sodium) 5mg Apotex Research Private Ltd, India

Medicorp Sdn Bhd

POM 3X10’s

15

BRU19052592P 18/S0019 Apo-montelukast Chewable Tablets 5mg USP

Montelukast (as sodium) 5mg Apotex Research Private Ltd, India

Medicorp Sdn Bhd

POM 3X10’s

16 BRU19052593P 18/S0036

Apo-montelukast Tablets 10mg

Montelukast (as sodium) 10mg

Apotex Research Private Ltd, India

Medicorp Sdn Bhd

POM 3X10’s

17

BRU19052594P 18/S0020 SW Bromhexine Elixir Bromhexine Hydrochloride 4mg/5ml

Sunward Pharmaceutical Sdn Bhd, Malaysia

G&H Trading Company

POM 60ml & 120ml

18

BRU19052595P 18/S0033 Allersin Syrup 4mg/5ml Chlorpheniramine maleate 4mg/5ml

Sunward Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company

P 60ml, 120ml and 3.8L

19

BRU19052596P 18/S0037 Quetiapine Sandoz 100mg Tablets

Quetiapine (as fumarate) 100mg

Sandoz Ilac Sanayi ve Ticaret A.S, Turkey


POM 3 X 10’s, 10 X 10’s, 4 X

15’s

20 BRU19052597P 18/S0055

Cifloxin Infusion (2mg/ml)

Ciprofloxacin 2mg/ml Siam Bheasach Co. Ltd., Thailand


POM 50ml, 100ml and

200ml

21

BRU19052598NP 18/S0066 Tiger Balm Soft

) Cajuput Oil 13.0% w/w ii) Menthol 12.0% w/w iii) Camphor 10.0% w/w iv) Clove Oil 1.5% w/w

Tiger Balm (M) Sdn Bhd., Malaysia

Hamitan Marketing

GSL 25g & 50g

22

BRU19052599P 18/S0083 Vizomet Cream 0.1% w/w

Mometasone Furoate 0.1% w/w


Syarikat Bumimedic

POM 15g



No Product Licence

Number

Product Application



Pack Size

23

BRU19052600P 18/S0088 Vizomet Ointment 0.1% w/w

Mometasone Furoate 0.1% w/w


Syarikat Bumimedic

POM 15g

24

BRU19052601P 18/S0096 Eperon Film Coated Tablets 2mg

Risperidone 2mg Medochemie Ltd (Central Factory), Cyprus


POM 10 x 10’s and 100 x

10’s

25

BRU19052602P 18/S0123 Quetiapine Sandoz 25mg Tablets

Quetiapine (as fumarate) 25mg

Sandoz Ilac Sanayi ve Ticaret A.S, Turkey


POM 3 X 10’s, 10 X 10’s and

4 X 15’s



No Product Licence

Number




Pack Size

1 BRU19072603P 17/S0158

Vectibix Concentrate for Solution for Infusion 100mg/vial

Each vial contains 100mg of panitumumab in 5ml

Amgen Manufacturing Limited, United States

Medipharm Sdn Bhd

POM 1 X 5ml

2 BRU19072604P 16/S0015

Simponi I.V. Concentrate for Solution for Infusion 12.5mg/1ml

Golimumab 12.5mg/ml Cilag AG, Switzerland


POM 1 x 4ml

3 BRU19072605P 16/S0081

Sovenor 10mcg/hr Transdermal Patch

Buprenorphine 10mg/patch (10 mcg/hr)

LTS Lohmann Therapie-Systeme AG, Germany


POM 2's

4 BRU19072606P 16/S0082 Sovenor 5mcg/hr Transdermal Patch

Buprenorphine 5mg/patch (5mcg/hr)

LTS Lohmann Therapie-Systeme AG, Germany


POM 2's

5 BRU19072607NP 16/S0101 Thelban Suspension

Albendazole 100mg/5ml Biolab Company Ltd., Thailand


GSL 20ml

6 BRU19072608NP 16/S0153 Xenetix 300 Solution for Injection

Iobitridol 65.81g/100ml (corresponding to 30g iodine/100ml

Guerbet, France Manning Jaya Trading (B) Sdn Bhd

POM 25 x50ml and 10 x

100ml

7 BRU19072609NP 16/S0154 Xenetix 350 Solution for Injection

Iobitridol 76.78g/100ml (corresponding to 35g iodine/100ml)

Guerbet, France Manning Jaya Trading (B) Sdn Bhd

POM 25 x50ml and 10 x

100ml

8 BRU19072610P 16/S0160 Fycompa 2mg Film-Coated Tablets

Perampanel 2mg

Eisai Manufacturing Limited. United Kingdom

Medipharm Sdn Bhd

POM 1 x 7’s and 2 x 14’s


Perampanel 4mg


Medipharm Sdn Bhd

POM 2 x 14’s



No Product Licence

Number




Pack Size


Perampanel 8mg


Medipharm Sdn Bhd

POM 2 x 14’s

11 BRU19072613NP 16/S0165 Renal-Sol B1

Each litre of concentrate contains: Sodium Chloride (BP) 30.58g; Sodium Bicarbonate (BP) 66.00g; Highly Purified Water (B) 1000.0ml

Renal Laboratories Sdn Bhd, Malaysia


GSL 10L

12 BRU19072614P 16/S0174 Tacarline Injection 1mg/ml

Each ampoule contains: Adrenaline Acid Tartate 1.8mg/ml

Duopharma (M) Sdn. Bhd., Malaysia


POM 10 x 1ml

13 BRU19072615P 17/S0030 Ranexa Prolonged-release Tablet 375mg

Ranolazine 375mg Menarini, Germany


POM 30’s, 60’s and 100’s


Ranolazine 500 mg Menarini, Germany


POM 30’s, 60’s and 100’s


Ranolazine 750 mg Menarini, Germany


POM 30’s, 60’s and 100’s

16 BRU19072618P 17/S0035 SotaHexal 80mg Tablet

Sotalol Hydrochloride 80mg Salutas Pharma GmbH, Germany


POM 2 x 10'S or 4 x 25'S

17 BRU19072619P 17/S0073 Zafibral 200mg Tablets Film Coated

Bezafibrate 200mg Medochemie Ltd, Cyprus

G & H Trading Company

POM 10 x 10’s

18 BRU19072620P 17/S0074 Apo-Azathioprine 50mg tablets

Azathioprine 50mg RPG Lifesciences Limited, India

Medicorp Sdn. Bhd

POM 100’s

19 BRU19072621P 17/S0136

Pergoveris Powder and Solvent for Solution for Injection

One vial contains 150IU (equivalent to 11 micrograms) of follitropin alfa (r-hFSH) and 75IU (equivalent to 3 micrograms) of lutropin alfa (r-hLH).

Merck Serono S.A. (MS-Aubonne), Switzerland

G & H Trading Company

POM 1’s, 3’s or 10’s



No Product Licence

Number




Pack Size

20 BRU19072622P 17/S0143 Trustiva Tablet

i) Efavirenz 600mg ii) Emtricitabine 200mg iii) Tenofovir Disoproxil Fumarate 300mg eq. to Tenofovir Disoproxil 245mg

Hetero Labs Limited, India


POM 30’s

21 BRU19072623P 17/S0170 Miloz Injection 15mg/3ml

Midazolam 5mg/ml

PT Novell Pharmaceutical Laboratories, Indonesia

G&H Trading Company

POM 5’s x 3ml

22 BRU19072624P 17/S0172 Pemirex Injection 100mg

Pemetrexed 100mg Korea United Pharm Inc., Republic of Korea


POM 1's

23 BRU19072625P 17/S0173 Pemirex Injection 500mg

Pemetrexed 500mg Korea United Pharm Inc., Republic of Korea


POM 1's

24 BRU19072626P 18/S0005 Tapcom-S Ophthalmic Solution

Tafluprost 15μg/ml, Timolol 5mg/ml

Laboratoire Unither, France

Medipharm Sdn Bhd

POM 10 containers per

pouch, 30 (3 pouches) x 0.3ml per box

25 BRU19072627P 18/S0063

Cyramza 100mg/10ml Concentrate For Solution For Infusion

Ramucirumab 10mg/ml Eli Lilly and Company, USA


POM 1 x 10ml

26 BRU19072628P 18/S0064

Cyramza 500mg/50ml Concentrate For Solution For Infusion

Ramucirumab 10mg/ml Eli Lilly and Company, USA


POM 1 x 50ml

27 BRU19072629P 18/S0089 Hydrocortisone cream 1% W/W

Hydrocortisone 1% w/w


Syarikat BumiMedic

POM 15G

28 BRU19072630NP 18/S0099

Microshield 4 Chlorhexidine Surgical Handwash

Chlorhexidine Gluconate 4% w/v

Alliance Formulations, India

Medicorp Sdn Bhd GSL 500ml & 5L



No Product Licence

Number




Pack Size

29 BRU19072631P 18/S0105 Glumil 850mg Tablet

Metformin Hydrochloride 850mg

The United Drug (1996) Co., Ltd., Thailand

Medicorp Sdn Bhd POM 10 x 10’s (100’s)

30 BRU19072632NP 18/S0110 Betadine Sore Throat Spray 0.45% w/v

Povidone-Iodine 0.45% w/v Mundipharma Pharmaceuticals Ltd., Cyprus

Zuellig Pharma (B) Sdn. Bhd

GSL 50ml

31 BRU19072633P 18/S0113

Fludarabine Sandoz 50mg/2Ml concentrate FOR Solution for Injection or Infusion

Fludarabine phosphate 50mg/2ml

Ebewe Pharma Ges.m.b.H.Nfg.KG, Austria


POM 1 vial x 2ml and 5 vials

x 2ml

32 BRU19072634P 18/S0115

Platol (Cisplatin Concentrate for Solution for Infusion 50mg/50ml)

Cisplatin 50mg/50ml Venus Remedies Limited, India


POM 1 x 50ml

33 BRU19072635P 18/S0119

Doxorubicin 2mg/ml concentrate for solution for infusion

Doxorubicin hydrochloride 2mg/ml

Sichuan Huiyu Pharmaceutical Co., Ltd., China


POM 1 x 5ml; 1 x 10ml, 1 x 25ml, 1 x 50ml & 1

x100ml

34 BRU19072636P 18/S0121

Montelukast Sandoz 10mg Film-coated Tablet

10mg montelukast Sandoz Ilac Sanayi ve Ticaret A.S., Turkey


POM 7’s x 4 (28’s), 10’s x 3

(30’s) & 10’s x 10 (100’s

agenda 4.1 - registered medicinal products in ... documents/traditional medicines...lampiran a –...

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