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Zambia. Regulating Medicines for

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World Health Organization
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World Health Organization

This is a publication of thePharmaceutical Regulatory AuthorityAll rights Reserved

FOREWORDThe Vision of the National Drug Policy as inculcated in the Ministry of Health mission on drug legislation and regulation is to provide equity of access for all Zambians to good quality, safe and efficacious medicines which are affordable and rationally used as close to the family as possible.

In order to ensure that medicines conform to the required standards of quality, safety and efficacy throughout the chain of manufacture, importation, exportation, storage, distribution, supply, sale and use, the Pharmaceutical Regulatory Authority is established by an Act of Parliament, i.e. the Pharmaceutical Act (No. 14) of 2004 to not only ascertain that the medicines are safe, effective and of good quality but also that they are manufactured in facilities which are in compliance with current Good Manufacturing Practices (cGMP) standards as recommended by the WHO.

This register has been compiled by the PRA pursuant to Section 28 of the Pharmaceutical Act and contains licensed or registered medicinal products which have been assessed and evaluated based on the information currently available, to conform to the required standards of quality, safety and efficacy. The register has been compiled in such a way as to provide information and guidance to the Ministry of Health, hospitals, clinics, healthcare providers, pharmaceutical industry, consumers (users), general public and interested parties and provides details on the name of the medicinal product, name of product license holder, product license number, presentation or dosage form and method of sale to the public. It should be noted that this is a living document which will be subject to amendments from time to time as medicinal products may be withdrawn for various reasons including their safety, quality and efficacy as data become available from post marketing surveillance activities or additions may be made as we approve them for placement on the Zambian market.

It is also important to note that all medicines approved for placement on the Zambian market are required to comply with labeling requirements as stipulated in the Statutory Instrument No. 47 of 1993. It suffices to say that any deviation from this statutory requirement may be deemed to suggest that the product in question is an imitation or fake and therefore subject to questionable quality, safety and efficacy.

This register had been compiled to serve as a reference/guidance material to the Ministry of Health, hospitals, clinics, healthcare providers, pharmaceutical industry, consumers (users), and general public and interested parties on those medicinal products that are legally available on the Zambian market.

We should also state that this is the first publication and suggestions and comments from all our stakeholders are most welcome. Please ensure that you mention credit to the PRA when quoting information from this register and do not hesitate to contact the PRA Secretariat for further information and clarifications.

E. Mwape (Ms)Director General - PRA

i

EXPLANATORY NOTESIn this register unless the context otherwise requires-

Dosage form- means the pharmaceutical administrable form of a finished medicinal product e.g. tablet, capsule, elixir, injection, suppository;

General sale medicine (GS) – are medicines which may be sold or supplied to the public without a prescription or the supervision of a registered pharmacist e.g. Panado tablets;

Licence number- means an identification number issued to a registered product e.g. in the register the No. 009/167 is the license number for Nystatin tablets and the product license holder is Circle Pharmaceuticals Limited of Ndola, Zambia. The licence numbers are also used to classify the products as medicines for human use, herbal medicines or medicines for veterinary use. Licence numbers for medicines for human use appear as 000/000 without any letters after the number, those for herbal medicines as 000/000HM and those for veterinary use as 000/700V. The first three digits represent the licence holder and the next three digits represent the serial number of the product. HM is for herbal medicine and all veterinary products start from 700 and the letter V is for veterinary

Method of sale- means the category by which the medicine shall be sold or supplied to the public e.g. by General sale (GS), Pharmacy (P) or Prescription Only Medicines (POM);

Pharmacy medicines (P) - are medicines which are not to be sold or supplied to the public except by or under the supervision of the pharmacist or as may be prescribed by an authorised prescriber, e.g. most of the cough mixtures like Benylin Cough Mixture;

Prescription Only Medicines (POM) - are medicines which may be supplied or dispensed only under a prescription issued by an authorised prescriber e.g. all medicines in injectable form;

Product name - means a name by which a medicinal product, pharmaceutical product and herbal medicines is known and as is presented on the Zambian market;

Product Licence holder – means a person or company responsible for placement of the medicinal product on the Zambian Market and to whom a product licence is issued by the Authority.

N.B.: The list is compiled in alphabetical order of the product licence holders.

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LIST OF LICENSED

MEDICINAL PRODUCTS

1 PRA Secretariat / January 2009

128/001 Kaletra capsules Abbott Laboratories S.A (Pty) Ltd, South Africa Capsule oral Prescription Only Medicine128/002 Kaletra solution Abbott Laboratories S.A (Pty) Ltd, South Africa Solution for Oral Use Prescription Only Medicine128/003 Norvir oral solution Abbott Laboratories S.A (Pty) Ltd, South Africa Solution for Oral Use Prescription Only Medicine128/004 Klacid P 125 granules for suspension Abbott Laboratories S.A (Pty) Ltd, South Africa Granules for Suspension Prescription Only Medicine128/005 Klacid P 250 granules for suspension Abbott Laboratories S.A (Pty) Ltd, South Africa Granules for Suspension Prescription Only Medicine128/006 Klacid tablets Abbott Laboratories S.A (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine128/007 Eryderm 2% lotion Abbott Laboratories S.A (Pty) Ltd, South Africa Lotion for Topical Use Prescription Only Medicine128/008 Erythroped Neo granules for oral Abbott Laboratories S.A (Pty) Ltd, South Africa Granules for Oral Use Prescription Only Medicine128/009 Erythroped Neo granules for oral Abbott Laboratories S.A (Pty) Ltd, South Africa Granules for Oral Use Prescription Only Medicine128/010 Erythroped forte granules for oral Abbott Laboratories S.A (Pty) Ltd, South Africa Granules for Oral Use Prescription Only Medicine128/011 Erythrocin 250mg tablets Abbott Laboratories S.A (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine128/012 Erythrocin 500mg tablets Abbott Laboratories S.A (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine128/013 Pediazole granules for suspension Abbott Laboratories S.A (Pty) Ltd, South Africa Granules for Suspension Prescription Only Medicine128/014 Ethrane liquid Abbott Laboratories S.A (Pty) Ltd, South Africa Solution for Inhalation Prescription Only Medicine128/015 Forane tablets Abbott Laboratories S.A (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine128/026 Aluvia tablets Abbott Laboratories S.A (Pty) Ltd, South Africa Tablet Film coated Prescription Only Medicine128/027 Aluvia 100 tablets Abbott Laboratories S.A (Pty) Ltd, South Africa Tablet Film coated Prescription Only Medicine097/001 Sabax Diasol Formula 17 injection Adcock Ingram Pharmaceuticals Ltd, South

AfricaSolution for infusion Prescription Only Medicine

097/002 Sabax Diasol Formula 16 Injection Adcock Ingram Pharmaceuticals Ltd, South Africa

Solution for infusion Prescription Only Medicine

097/003 Sabax Diasol Formula 3 injection Adcock Ingram Pharmaceuticals Ltd, South Africa

Solution for infusion Prescription Only Medicine

097/004 Sabax Osmitrol 20% injection Adcock Ingram Pharmaceuticals Ltd, South Africa

Solution for infusion Prescription Only Medicine

097/005 Sabax Sodium Chloride 0.9% injection Adcock Ingram Pharmaceuticals Ltd, South Africa

Solution for infusion Prescription Only Medicine

097/006 Sabax Glucose 5% + Sodium Chloride 0.9% injection

Adcock Ingram Pharmaceuticals Ltd, South Africa

Solution for infusion Prescription Only Medicine

097/007 Sabax Ringer lactate injection Adcock Ingram Pharmaceuticals Ltd, South Africa

Solution for infusion Prescription Only Medicine

137/001 Lasoprol 30 capsules Aegis Ltd, Cyprus Capsule oral Prescription Only Medicine137/002 Oxacid 200 mg capsules Aegis Ltd, Cyprus Capsule oral Prescription Only Medicine137/003 Cifex suspension Aegis Ltd, Cyprus Suspension for Oral Use Prescription Only Medicine137/004 Cifex 200 tablets Aegis Ltd, Cyprus Tablet Uncoated Prescription Only Medicine137/005 Cefixime 400mg tablets Aegis Ltd, Cyprus Tablet Uncoated Prescription Only Medicine176/001 Agisept antiseptic lozenges Agio Pharmaceutical Ltd, India Lozenges General Sale176/002 Agisept antiseptic lozenges Agio Pharmaceutical Ltd, India Lozenges General Sale176/003 Agisept antiseptic (Classical) lozenges Agio Pharmaceutical Ltd, India Lozenges General Sale176/004 Diclogen tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Pharmacy Medicine176/005 Salbutamol lifeforce tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine176/006 Grisofulvin 500 tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine176/007 Sepralin tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine176/008 Nalidixic Acid Lifeforce tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine176/009 Cloxacillin Lifeforce capsules Agio Pharmaceutical Ltd, India Capsule oral Prescription Only Medicine176/010 Tetracycline Lifeforce capsules Agio Pharmaceutical Ltd, India Capsule oral Prescription Only Medicine176/011 Para force tablets Agio Pharmaceutical Ltd, India Tablet Uncoated General Sale176/012 Ferrous Sulphate tablets Agio Pharmaceutical Ltd, India Tablet Film coated Pharmacy Medicine176/013 Chloramphenicol Lifeforce capsules Agio Pharmaceutical Ltd, India Capsule oral Prescription Only Medicine176/015 Paraforce suspension Agio Pharmaceutical Ltd, India Suspension for Oral Use General Sale176/016 Ferrous Sulphate and Folic Acid tablets Agio Pharmaceutical Ltd, India Tablet Film coated Pharmacy Medicine176/017 Moxforce capsules Agio Pharmaceutical Ltd, India Capsule oral Prescription Only Medicine176/018 Doxycycline Life capsules Agio Pharmaceutical Ltd, India Capsule oral Prescription Only Medicine176/019 Metroforce tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine176/020 Compound Magnesium Trisilicate tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Pharmacy Medicine176/021 Ibufen tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Pharmacy Medicine176/022 Nuamp capsules Agio Pharmaceutical Ltd, India Capsule oral Prescription Only Medicine176/023 Albendazole Lifeforce suspension Agio Pharmaceutical Ltd, India Suspension Pharmacy Medicine

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

PRA Secretariat / January 2009 2

176/024 Gentamicin Lifeforce injection Agio Pharmaceutical Ltd, India Solution for Injection Prescription Only Medicine176/025 Metoclopramide Lifeforce injection Agio Pharmaceutical Ltd, India Solution for Injection Prescription Only Medicine176/026 Mobiram injection Agio Pharmaceutical Ltd, India Solution for Injection Prescription Only Medicine176/027 Dicyclone Lifeforce injection Agio Pharmaceutical Ltd, India Solution for Injection Prescription Only Medicine176/028 Clovirax cream Agio Pharmaceutical Ltd, India Cream Topical Prescription Only Medicine176/029 Micoson 2% cream Agio Pharmaceutical Ltd, India Cream Topical Pharmacy Medicine176/030 Erycin tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine176/031 Methyldopa Lifeforce tablets Agio Pharmaceutical Ltd, India Tablet Film coated Prescription Only Medicine176/032 Salbutamol Lifeforce 4mg tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine176/033 Rulicin 150 mg tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine176/034 B-Complex Agio injection Agio Pharmaceutical Ltd, India Solution for Injection Prescription Only Medicine176/035 Dexamethasone - Agio injection Agio Pharmaceutical Ltd, India Solution for Injection Prescription Only Medicine202/001 Agovir tablets Agog Pharma Ltd, India Tablet Uncoated Prescription Only Medicine202/002 Compound magnesium tablets Agog Pharma Ltd, India Tablet Uncoated Pharmacy Medicine202/003 Indo-25 capsules Agog Pharma Ltd, India Capsule oral Pharmacy Medicine202/004 Cipro 500 tablets Agog Pharma Ltd, India Tablet Uncoated Prescription Only Medicine202/005 Trimago 400 tablets Agog Pharma Ltd, India Tablet Uncoated Prescription Only Medicine202/006 Agofen tablets Agog Pharma Ltd, India Tablet Film coated Pharmacy Medicine202/007 Agoxic tablets Agog Pharma Ltd, India Tablet Uncoated Prescription Only Medicine202/008 Metronidazole tablets Agog Pharma Ltd, India Tablet Film coated Prescription Only Medicine202/009 Diclofenac sodium tablets Agog Pharma Ltd, India Tablet Film coated Pharmacy Medicine202/010 Trimago 200 tablets Agog Pharma Ltd, India Tablet Film coated Prescription Only Medicine202/011 Ibuprofen tablets Agog Pharma Ltd, India Tablet Uncoated Pharmacy Medicine202/012 Heath E.Tonic syrup Agog Pharma Ltd, India Syrup Pharmacy Medicine202/013 Agometro suspension Agog Pharma Ltd, India Suspension for Oral Use Prescription Only Medicine202/014 Ketos tablets Agog Pharma Ltd, India Tablet Uncoated Prescription Only Medicine202/015 B-Cox tablets Agog Pharma Ltd, India Tablet Film coated Pharmacy Medicine202/016 Agomol tablets Agog Pharma Ltd, India Tablet Uncoated General Sale202/017 Fluconazole capsules Agog Pharma Ltd, India Capsule oral Prescription Only Medicine202/018 Ago-C tablets Agog Pharma Ltd, India Tablet Uncoated Pharmacy Medicine202/019 Ago-C tablets Agog Pharma Ltd, India Tablet Chewable Pharmacy Medicine202/020 B-twin tablets Agog Pharma Ltd, India Tablet Film coated Pharmacy Medicine203/001 Metronidazole injection Ahlcon Parenterals (India) Ltd, India Solution for infusion Prescription Only Medicine203/002 Fluconazole injection Ahlcon Parenterals (India) Ltd, India Solution for infusion Prescription Only Medicine203/003 Ciprofloxacin injection Ahlcon Parenterals (India) Ltd, India Solution for Injection Prescription Only Medicine203/004 Darrow’s solution Ahlcon Parenterals (India) Ltd, India Solution for infusion Prescription Only Medicine203/005 Compound sodium lactate solution Ahlcon Parenterals (India) Ltd, India Solution for infusion Prescription Only Medicine115/001 Quinine sulphate tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/001HM Fingurun capsules Ajanta Pharma Ltd, India Capsule oral Pharmacy Medicine115/002 Indoflam capsules Ajanta Pharma Ltd, India Capsule oral Pharmacy Medicine115/002HM Apdyl-H syrup Ajanta Pharma Ltd, India Syrup General Sale115/003 Apkef capsules Ajanta Pharma Ltd, India Capsule oral Prescription Only Medicine115/004 Tyflox capsules Ajanta Pharma Ltd, India Capsule oral Prescription Only Medicine115/004H Thirty Plus capsules Ajanta Pharma Ltd, India Capsule oral Pharmacy Medicine115/005HM Pinkoo gripe water Ajanta Pharma Ltd, India Solution for Topical Use General Sale115/006 Optifenac tablets Ajanta Pharma Ltd, India Tablet Uncoated Pharmacy Medicine115/006HM Rheumanib ointment Ajanta Pharma Ltd, India Ointment topical General Sale115/007 Optifenac tablets Ajanta Pharma Ltd, India Tablet Uncoated Pharmacy Medicine115/008 Apcillin 250 capsules Ajanta Pharma Ltd, India Capsule oral Prescription Only Medicine115/009 Apcillin -500 capsules Ajanta Pharma Ltd, India Capsule oral Prescription Only Medicine115/010 Novaten 50 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/010HM Mobaid tablets Ajanta Pharma Ltd, India Tablet Uncoated Pharmacy Medicine115/011 Novaten 100 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/012 Cloxil 250 capsules Ajanta Pharma Ltd, India Capsule oral Prescription Only Medicine115/013 Anthalben tablets Ajanta Pharma Ltd, India Tablet Uncoated Pharmacy Medicine115/014 Apmox 250 tablets Ajanta Pharma Ltd, India Capsule oral Prescription Only Medicine115/015 Cloxa-Plus capsules Ajanta Pharma Ltd, India Capsule oral Prescription Only Medicine

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

115/017 Supreme S.S. tablet Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/018 Apcalis 10 tablets Ajanta Pharma Ltd, India Tablet Film coated Prescription Only Medicine115/019 Apcalis Plus 20 tablets Ajanta Pharma Ltd, India Tablet Film coated Prescription Only Medicine115/020 Atorfit-10 tablets Ajanta Pharma Ltd, India Tablet Film coated Prescription Only Medicine115/021 Atorfit-20 tablets Ajanta Pharma Ltd, India Tablet Film coated Prescription Only Medicine115/022 Amether suspension Ajanta Pharma Ltd, India Suspension for Oral Use Prescription Only Medicine115/023 Amovax tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/024 Haftrine oral suspension Ajanta Pharma Ltd, India Suspension for Oral Use Prescription Only Medicine115/025 Hafrine tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/026 Mevax tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/027 Primavax 15 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/028 Primavax 2.5 tablets Ajanta Pharma Ltd, India Tablet Film coated Prescription Only Medicine115/029 Primavax 7.5 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/030 Ather injection Ajanta Pharma Ltd, India Solution for Injection Prescription Only Medicine115/031 Kamagra oral gel Ajanta Pharma Ltd, India Gel Oral Prescription Only Medicine115/032 Allnat -50 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/033 Allnat -100 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/035 Anacox Plus LD tablets Ajanta Pharma Ltd, India Tablet Film coated Prescription Only Medicine115/036 Kamagra 100 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/037 Kamagra 50 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/038 Artefan tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/040 Tibinil-P tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/041 Apoxin tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/042 Tibinil-e 200 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/043 Tibnile-400 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/044 Combisunate forte kit tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/045 Combisunate tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine115/046 Artefan tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine158/001 Colirucus gentadexe ear/eye drops Alcon Cusi SA, Spain Ear/Eye Drops Prescription Only Medicine158/002 Oftalmotrin eye drops Alcon Cusi SA, Spain Eye Drops Prescription Only Medicine158/003 Curicrom eye drops Alcon Cusi SA, Spain Eye Drops Prescription Only Medicine158/004 Cusicrom eye drops Alcon Cusi SA, Spain Eye Drops Prescription Only Medicine158/005 Colircusi chloramphenicol eye drops Alcon Cusi SA, Spain Eye Drops Prescription Only Medicine158/006 Cusimolol eye drops Alcon Cusi SA, Spain Eye Drops Prescription Only Medicine227/001 Tobradex ophthalmic suspension Alcon Cusi SA, Spain Eye Suspension Prescription Only Medicine227/002 Tobradex drops Alcon Cusi SA, Spain Eye Drops Prescription Only Medicine227/003 Ciloxan drops Alcon Cusi SA, Spain Eye Drops Prescription Only Medicine009/021 Betoptic solution Alcon Laboratories SA Pty Ltd, South Africa ENT Solution Prescription Only Medicine009/030 Maxidex suspension Alcon Laboratories SA Pty Ltd, South Africa Suspension Prescription Only Medicine009/031 Maxidex ointment Alcon Laboratories SA Pty Ltd, South Africa Ointment topical Prescription Only Medicine009/032 Maxitrol suspension Alcon Laboratories SA Pty Ltd, South Africa Suspension Prescription Only Medicine009/033 Maxitrol ointment Alcon Laboratories SA Pty Ltd, South Africa Ointment topical Prescription Only Medicine009/034 Mydriacyl eye drops Alcon Laboratories SA Pty Ltd, South Africa Eye Drops Prescription Only Medicine009/035 Naphcon eye drops Alcon Laboratories SA Pty Ltd, South Africa Eye Drops Prescription Only Medicine009/036 Tears natural eye drops Alcon Laboratories SA Pty Ltd, South Africa Eye Drops Prescription Only Medicine009/038 Tobrex eye drops Alcon Laboratories SA Pty Ltd, South Africa Eye Drops Prescription Only Medicine009/039 Tobrex ointment Alcon Laboratories SA Pty Ltd, South Africa Ointment topical Prescription Only Medicine215/001 Brozeet solution Alembic Chemical Works Co. Ltd, India Solution for Oral Use Pharmacy Medicine215/002 Benzathine Penicillin injection Alembic Chemical Works Co. Ltd, India Powder for Injection Prescription Only Medicine215/003 Zeet Expectorant syrup Alembic Chemical Works Co. Ltd, India Syrup Pharmacy Medicine215/004 Clarithro-250 tablets Alembic Chemical Works Co. Ltd, India Tablet Uncoated Prescription Only Medicine215/005 Glycodin cough syrup Alembic Chemical Works Co. Ltd, India Syrup Pharmacy Medicine215/006 Lomeg 10 tablets Alembic Chemical Works Co. Ltd, India Tablet Uncoated Prescription Only Medicine215/007 Procain penicillin 3MU injection Alembic Chemical Works Co. Ltd, India Powder for Injection Prescription Only Medicine215/008 Fortified procaine penicillin 4MU injection Alembic Chemical Works Co. Ltd, India Powder for Injection Prescription Only Medicine215/009 Benzyl penicillin 5MU injection Alembic Chemical Works Co. Ltd, India Powder for Injection Prescription Only Medicine215/010 Sparta tablets Alembic Chemical Works Co. Ltd, India Tablet Uncoated Prescription Only Medicine

3 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

215/011 Azithra 200 liquid Alembic Chemical Works Co. Ltd, India Solution for Oral Use Prescription Only Medicine215/012 Althrocin-s-250 oral solution Alembic Chemical Works Co. Ltd, India Solution for Oral Use Prescription Only Medicine215/013 Omezol-20 capsules Alembic Chemical Works Co. Ltd, India Capsule oral Prescription Only Medicine215/014 Ciprown-500 tablets Alembic Chemical Works Co. Ltd, India Tablet Uncoated Prescription Only Medicine215/015 Azithral-250 tablets Alembic Chemical Works Co. Ltd, India Tablet Uncoated Prescription Only Medicine166/001 Erythromycin tablets Alkem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine166/002 Erythromycin suspension Alkem Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine166/003 Broadmex-250 capsules Alkem Laboratories Ltd, India Capsule oral Prescription Only Medicine166/004 Formin-500mg tablets Alkem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine166/005 Cloxacillin capsules Alkem Laboratories Ltd, India Capsule oral Prescription Only Medicine166/006 Taxim injection Alkem Laboratories Ltd, India Powder for Injection Prescription Only Medicine166/007 Decacef suspension Alkem Laboratories Ltd, India Powder for Oral

SuspensionPrescription Only Medicine

166/008 Decacef 500 capsules Alkem Laboratories Ltd, India Capsule oral Prescription Only Medicine166/009 Chloramphenicol oral suspension Alkem Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine166/010 Alcipro 500 tablets Alkem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine166/011 Amoxicillin suspension Alkem Laboratories Ltd, India Powder for Oral

SuspensionPrescription Only Medicine

166/012 Anpicillin oral suspension Alkem Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine166/013 Cloxacillin oral suspension Alkem Laboratories Ltd, India Powder for Oral

SuspensionPrescription Only Medicine

166/014 Omeprazole-20 capsules Alkem Laboratories Ltd, India Capsule oral Prescription Only Medicine166/015 T-prim tablets Alkem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine166/016 Cloxacillin injection Alkem Laboratories Ltd, India Powder for Injection Prescription Only Medicine166/017 Decacef 250 capsules Alkem Laboratories Ltd, India Capsule oral Prescription Only Medicine166/018 Broadclox-500 capsules Alkem Laboratories Ltd, India Capsule oral Prescription Only Medicine252/001 Amitriptylline tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine252/002 Allopurinol tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine252/003 Atenolol 25 tablets Alpharma Ltd, United Kingdom Tablet Film coated Prescription Only Medicine252/004 Atenolol 50 tablets Alpharma Ltd, United Kingdom Tablet Film coated Prescription Only Medicine252/005 Atenolol tablets Alpharma Ltd, United Kingdom Tablet Film coated Prescription Only Medicine252/006 Bendrofluazide tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine252/007 Captopril tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine252/008 Co-amilozide tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine252/009 Glibenclamide tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine252/010 Glyceryl Trinitrate tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine252/011 Isosorbide mononitrate tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine252/012 Metformin tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine252/013 Verapamil tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine252/014 Spironolactone 25 tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine252/015 Spironolactone 50 tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine101/001 Suganril tablets Ambalal Sarabhai Enterprises Ltd, India Tablet Uncoated Prescription Only Medicine101/002 Zodid injection Ambalal Sarabhai Enterprises Ltd, India Solution for Injection Prescription Only Medicine101/003 Zobid SR tablet Ambalal Sarabhai Enterprises Ltd, India Tablet Uncoated Pharmacy Medicine101/004 Nifedipine 10 tablets Ambalal Sarabhai Enterprises Ltd, India Tablet Uncoated Prescription Only Medicine101/005 Pocilin 4 Mega injection Ambalal Sarabhai Enterprises Ltd, India Powder for Injection Prescription Only Medicine101/006 Trimin injection Ambalal Sarabhai Enterprises Ltd, India Solution for Injection Prescription Only Medicine101/007 Amoxicillin oral suspension Ambalal Sarabhai Enterprises Ltd, India Suspension Prescription Only Medicine101/008 Compound magnessium tablets Ambalal Sarabhai Enterprises Ltd, India Tablet Uncoated Pharmacy Medicine101/009 Cofnil-N expectorant syrup Ambalal Sarabhai Enterprises Ltd, India Syrup Pharmacy Medicine101/010 Amphotericin B injection Ambalal Sarabhai Enterprises Ltd, India Solution for Injection Prescription Only Medicine101/011 Streptocin injection Ambalal Sarabhai Enterprises Ltd, India Powder for Injection Prescription Only Medicine101/012 Amoxicillin trihydrate capsules Ambalal Sarabhai Enterprises Ltd, India Capsule oral Prescription Only Medicine101/013 Hemomin capsules Ambalal Sarabhai Enterprises Ltd, India Capsule oral Pharmacy Medicine101/014 Oral Rehydration Salt Ambalal Sarabhai Enterprises Ltd, India Powder for Oral Solution General Sale101/015 Phenoxymethyl Penicillin V tablets Ambalal Sarabhai Enterprises Ltd, India Tablet Uncoated Prescription Only Medicine101/017 Fluphenazine decanoate injection Ambalal Sarabhai Enterprises Ltd, India Solution for Injection Prescription Only Medicine

PRA Secretariat / January 2009 4

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

101/018 Sulphabiotic dusting powder Ambalal Sarabhai Enterprises Ltd, India Powder for Topical use Pharmacy Medicine020/003 Amovit C Calcium tablets Amoun Pharmaceuticals Company, Egypt Tablet Uncoated General Sale020/004 Amovit C tablets Amoun Pharmaceuticals Company, Egypt Tablet Uncoated Pharmacy Medicine020/005 B.B.C spray Amoun Pharmaceuticals Company, Egypt Spray for Topical Use General Sale020/006 Baby cream Amoun Pharmaceuticals Company, Egypt Cream Topical General Sale020/007 Collycrom 4% eye drops Amoun Pharmaceuticals Company, Egypt Eye Drops Prescription Only Medicine020/008 Enemax enema solution Amoun Pharmaceuticals Company, Egypt Solution for Topical Use Prescription Only Medicine020/009 Xenos fruit effervescent granules Amoun Pharmaceuticals Company, Egypt Granules for Oral Use General Sale020/010 For Hair and Nails capsules Amoun Pharmaceuticals Company, Egypt Capsule oral General Sale020/011 Glucose tablets Amoun Pharmaceuticals Company, Egypt Tablet Uncoated General Sale020/012 Michaelon tablets Amoun Pharmaceuticals Company, Egypt Tablet Uncoated Pharmacy Medicine020/013 Minalax tablets Amoun Pharmaceuticals Company, Egypt Tablet Uncoated Pharmacy Medicine020/014 My Sweet Baby syrup Amoun Pharmaceuticals Company, Egypt Syrup General Sale020/015 Vitamount For Women capsules Amoun Pharmaceuticals Company, Egypt Capsule oral General Sale020/016 Vitamount syrup Amoun Pharmaceuticals Company, Egypt Syrup General Sale020/017 Viva-max 3mg tablets Amoun Pharmaceuticals Company, Egypt Tablet Uncoated Prescription Only Medicine279/001 Enerject-12 injection Anglo-French Drugs & Industries Ltd,India Solution for Injection Prescription Only Medicine279/002 Beplex Forte tablets Anglo-French Drugs & Industries Ltd,India Tablet Film coated Pharmacy Medicine279/003 Beplex forte injection Anglo-French Drugs & Industries Ltd,India Solution for Injection Prescription Only Medicine279/004 Maxamin forte tablets Anglo-French Drugs & Industries Ltd,India Tablet Uncoated Pharmacy Medicine248/001 Zincofer capsules Apex Laboratories Ltd, India Capsule oral Pharmacy Medicine248/002 Betzee cream Apex Laboratories Ltd, India Cream Topical Prescription Only Medicine248/003 Betzee G cream Apex Laboratories Ltd, India Cream Topical Prescription Only Medicine248/004 Betzee-M cream Apex Laboratories Ltd, India Cream Topical Prescription Only Medicine248/005 Betzee-GM cream Apex Laboratories Ltd, India Cream Topical Prescription Only Medicine248/006 Betzee-S ointment Apex Laboratories Ltd, India Ointment topical Prescription Only Medicine248/007 Lozee cream Apex Laboratories Ltd, India Cream Topical Prescription Only Medicine248/008 Lozee-gm cream Apex Laboratories Ltd, India Cream Topical Prescription Only Medicine248/009 Zincovit syrup Apex Laboratories Ltd, India Suspension for Oral Use General Sale248/010 Zincovit tablets Apex Laboratories Ltd, India Tablet Uncoated General Sale248/011 Zincovit drops Apex Laboratories Ltd, India Suspension for Oral Use General Sale248/012 Zincofer liquid Apex Laboratories Ltd, India Suspension for Oral Use Pharmacy Medicine248/013 Nalidixic acid tablets Apex Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine256/001 Monocef -O tablets Aristo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine187/001 Ar- Ampi powder Arubhi International, India Suspension for Oral Use Prescription Only Medicine187/002 Ar-Grisco 125mg tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/003 Ar-Griseo 250 tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/004 Ar-Ampicloc capsules Arubhi International, India Capsule oral Prescription Only Medicine187/005 Ar-Ampiclox 125 syrup Arubhi International, India Syrup Prescription Only Medicine187/006 Ar-Clovir tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/007 Ar-Keta 100 tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/008 Ar-Mox Oral suspension Arubhi International, India Suspension for Oral Use Prescription Only Medicine187/009 Ar-Clox capsules Arubhi International, India Capsule oral Prescription Only Medicine187/010 Ar-Cloxa syrup Arubhi International, India Syrup Prescription Only Medicine187/011 Ar-Fol 5 tablets Arubhi International, India Tablet Uncoated Pharmacy Medicine187/012 Arol solution Arubhi International, India Powder for Oral Solution General Sale187/013 Ar-Cetamol tablets Arubhi International, India Tablet Uncoated Pharmacy Medicine187/014 Ar-Sal tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/015 Ar-Ibu tablets Arubhi International, India Tablet Film coated Pharmacy Medicine187/016 Ar-Zole capsules Arubhi International, India Capsule oral Prescription Only Medicine187/017 Ar-Ozine tablets Arubhi International, India Tablet Film coated Pharmacy Medicine187/018 Ar-Cotri tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/019 Ar-Pyra tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/020 Ar Cee tablets Arubhi International, India Tablet Uncoated Pharmacy Medicine187/021 Ar-Gliben - 5 tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/022 Ar-Pred tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/023 Ar-Dar tablets Arubhi International, India Tablet Uncoated Pharmacy Medicine

5 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

187/024 Ar-peridol tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/025 Ar-omycin tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/026 AR-Zole capsules Arubhi International, India Capsule oral Prescription Only Medicine187/027 Ar-Floxacin tablets Arubhi International, India Tablet Film coated Prescription Only Medicine187/028 Ar-tetra capsules Arubhi International, India Capsule oral Prescription Only Medicine187/029 Ar-Diclo tablets Arubhi International, India Tablet Uncoated Pharmacy Medicine187/030 Ar- pramide tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/031 Ar-mazepine tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/032 Ar-Thylodopa tablets Arubhi International, India Tablet Film coated Prescription Only Medicine187/033 Ar-Antacid tablets Arubhi International, India Tablet Chewable General Sale187/034 Ar-hyoscine tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/035 Ar-grisco 500 tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/036 Ar-Metro tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/037 Ar-Vitacee tablets Arubhi International, India Tablet Uncoated General Sale187/038 Arbimazole tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/039 Ardidol tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/040 Arhexol tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/041 Arhexol tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/042 Arnadix tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/043 Arphen tablets Arubhi International, India Tablet Uncoated Pharmacy Medicine187/044 Artopril tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine187/045 Paradol tablets Arubhi International, India Tablet Uncoated General Sale187/046 Ar-Pyron suspension Arubhi International, India Suspension for Oral Use Pharmacy Medicine187/047 AR-INDO 25 capsules Arubhi International, India Capsule oral Pharmacy Medicine187/048 Ar-Ampi 250 caspules Arubhi International, India Capsule oral Prescription Only Medicine187/049 Ar-Amox 250 capsules Arubhi International, India Capsule oral Prescription Only Medicine184/001 Griseofulvin tablets Arvind Remedies Ltd, India Tablet Uncoated Prescription Only Medicine184/002 Cloxacillin capsules Arvind Remedies Ltd, India Capsule oral Prescription Only Medicine184/003 Phenobarbital tablets Arvind Remedies Ltd, India Tablet Uncoated Prescription Only Medicine184/004 Rifampicin + Isoniazid tablets Arvind Remedies Ltd, India Tablet Uncoated Prescription Only Medicine184/005 Propranolol tablets Arvind Remedies Ltd, India Tablet Uncoated Prescription Only Medicine184/006 Promethazine tablets Arvind Remedies Ltd, India Tablet Uncoated Prescription Only Medicine184/007 Methyldopa tablets Arvind Remedies Ltd, India Tablet Uncoated Prescription Only Medicine184/008 Diclofenac BP enteric coated tablets Arvind Remedies Ltd, India Tablet Enteric Coated Pharmacy Medicine184/010 Sulfadoxine USP + Pyrimethamine tablets Arvind Remedies Ltd, India Tablet Uncoated Pharmacy Medicine145/002 Amiloretic H.S tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/003 Arthrexin 25 suppositories Aspen Pharmacare Ltd, South Africa Suppository Prescription Only Medicine145/004 Ketazol cream Aspen Pharmacare Ltd, South Africa Cream Topical Prescription Only Medicine145/005 Panamor 100 SR tablets Aspen Pharmacare Ltd, South Africa Tablet Film coated Pharmacy Medicine145/006 Purbac Adult tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/007 Purata -10 tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/008 Pur-bloka tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/009 Mybulen tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/010 Degramol 200 tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/011 Arthrexin-100 suppositories Aspen Pharmacare Ltd, South Africa Suppository Prescription Only Medicine145/012 Ketazol 200 tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/013 Wormgo tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated General Sale145/014 Cardifen-10 tablets Aspen Pharmacare Ltd, South Africa Capsule oral Prescription Only Medicine145/015 Venteze syrup Aspen Pharmacare Ltd, South Africa Syrup Prescription Only Medicine145/016 Venteze inhaler Aspen Pharmacare Ltd, South Africa Powder for Inhalation Prescription Only Medicine145/017 Purmycin 125 suspension Aspen Pharmacare Ltd, South Africa Suspension for Oral Use Prescription Only Medicine145/018 Hypotone tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/019 Pax-5 tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/020 Trichazole tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/021 Glycomin tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/022 Amiloretic tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/024 Lenisolone tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine

PRA Secretariat / January 2009 6

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

145/025 AP Stavudine15 capsules Aspen Pharmacare Ltd, South Africa Capsule oral Prescription Only Medicine145/026 AP Stavudine 20 capsules Aspen Pharmacare Ltd, South Africa Capsule oral Prescription Only Medicine145/027 AP Stavudine 30 capsules Aspen Pharmacare Ltd, South Africa Capsule oral Prescription Only Medicine145/028 Ap Stavudine 40 capsules Aspen Pharmacare Ltd, South Africa Capsule oral Prescription Only Medicine145/029 Aspen Lamizid tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/030 Aspen Lamivudine tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/031 Aspen Lamivudine syrup Aspen Pharmacare Ltd, South Africa Syrup Prescription Only Medicine145/032 Aspen Zidovudine tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/033 Aspen Zidovudine syrup Aspen Pharmacare Ltd, South Africa Syrup Prescription Only Medicine145/034 Aspen Nevirapine tablets Aspen Pharmacare Ltd, South Africa Tablet Uncoated Prescription Only Medicine145/039 Viread tablets Aspen Pharmacare Ltd, South Africa Tablet Film coated Prescription Only Medicine145/040 Truvada tablets Aspen Pharmacare Ltd, South Africa Tablet Film coated Prescription Only Medicine023/039 Oxis turbuhaler Astra Zeneca UK Ltd, United Kingdom Powder for Inhalation Prescription Only Medicine023/040 Oxis 9mg Turbuhaler Astra Zeneca UK Ltd, United Kingdom Powder for Inhalation Prescription Only Medicine023/041 Pulmcort 100 turbuhaler Astra Zeneca UK Ltd, United Kingdom Powder for Inhalation Prescription Only Medicine023/042 Pulmcort 200 turbuhaler Astra Zeneca UK Ltd, United Kingdom Powder for Inhalation Prescription Only Medicine023/043 Pulmcort 400 turbuhaler Astra Zeneca UK Ltd, United Kingdom Powder for Inhalation Prescription Only Medicine023/044 Losec Mumps 20 tablets Astra Zeneca UK Ltd, United Kingdom Tablet Film coated Prescription Only Medicine023/045 Zestrorectic tablets Astra Zeneca UK Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine023/047 Symbicort turbuhaler Astra Zeneca UK Ltd, United Kingdom Powder for Inhalation Prescription Only Medicine023/052 Nexium 20 tablets Astra Zeneca UK Ltd, United Kingdom Tablet Film coated Prescription Only Medicine023/053 Nexium 40 tablets Astra Zeneca UK Ltd, United Kingdom Tablet Film coated Prescription Only Medicine127/001 Zmox capsules Aurobindo Pharma Ltd, India Capsule oral Prescription Only Medicine127/002 Recipro 500 tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/003 Recipro 250 tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/004 Zcil 250 injection Aurobindo Pharma Ltd, India Powder for Injection Prescription Only Medicine127/005 Renor 400 tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/006 Aurocef capsules Aurobindo Pharma Ltd, India Capsule oral Prescription Only Medicine127/007 Zuclox capsules Aurobindo Pharma Ltd, India Capsule oral Prescription Only Medicine127/008 Cloxil capsules Aurobindo Pharma Ltd, India Capsule oral Prescription Only Medicine127/009 Zolcer capsules Aurobindo Pharma Ltd, India Capsule oral Prescription Only Medicine127/010 Lamivox 150 tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/011 Stavex 40 capsules Aurobindo Pharma Ltd, India Capsule oral Prescription Only Medicine127/012 Nevirex 200 tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/013 Indivex 400 tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/014 Didavex 100 chewable tablets Aurobindo Pharma Ltd, India Tablet Chewable Prescription Only Medicine127/015 Zidovex - L tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/016 Stavex 30L tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/017 Stavex 40 L tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/018 Nelvex 250 tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/019 Aurocef 250 Oral suspension Aurobindo Pharma Ltd, India Suspension for Oral Use Prescription Only Medicine127/020 Aurocef 125 oral suspension Aurobindo Pharma Ltd, India Suspension for Oral Use Prescription Only Medicine127/021 Cetax 1000 injection Aurobindo Pharma Ltd, India Powder for Injection Prescription Only Medicine127/022 Erythromycin suspension Aurobindo Pharma Ltd, India Suspension Prescription Only Medicine127/023 Chloramphenicol injection Aurobindo Pharma Ltd, India Powder for Injection Prescription Only Medicine127/024 Triaxone 1000 injection Aurobindo Pharma Ltd, India Powder for Injection Prescription Only Medicine127/025 Cloxil 500 injection Aurobindo Pharma Ltd, India Powder for Injection Prescription Only Medicine127/026 Lamivudine + Zidovudine tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/027 Nevirapine tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/028 Stavudine 30 capsules Aurobindo Pharma Ltd, India Capsule oral Prescription Only Medicine127/029 Stavudine 40 capsules Aurobindo Pharma Ltd, India Capsule oral Prescription Only Medicine127/030 Efavirenz 600 tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/031 Lamivudine tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/032 Lamivudine tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/033 Zidovudine oral solution Aurobindo Pharma Ltd, India Solution for Oral Use Prescription Only Medicine127/034 Lamivudine oral solution Aurobindo Pharma Ltd, India Solution for Oral Use Prescription Only Medicine127/035 Nevirapine oral solution Aurobindo Pharma Ltd, India Solution for Oral Use Prescription Only Medicine

7 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

127/036 Zidovudine tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/037 Stavudine + Lamivudine tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/038 Stavudine + Lamivudine tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/039 Abacavir tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/040 Stavudine oral solution Aurobindo Pharma Ltd, India Solution for Oral Use Prescription Only Medicine127/041 Abacavir sulphate oral solution Aurobindo Pharma Ltd, India Solution for Topical Use Prescription Only Medicine127/042 Stavudine capsules Aurobindo Pharma Ltd, India Capsule oral Prescription Only Medicine127/043 Stavudine capsules Aurobindo Pharma Ltd, India Capsule oral Prescription Only Medicine127/044 Efavirenz capsules Aurobindo Pharma Ltd, India Capsule oral Prescription Only Medicine127/045 Lamivudine + Zidovudine + Nevirapine

tabletsAurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine

127/046 Lamivudine + Zidovudine tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/047 Efavirenz capsules Aurobindo Pharma Ltd, India Capsule oral Prescription Only Medicine127/049 Kardam 10 tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/050 Kardam 5 tablets Aurobindo Pharma Ltd, India Tablet Uncoated Prescription Only Medicine127/051 Koact oral suspension Aurobindo Pharma Ltd, India Suspension for Oral Use Prescription Only Medicine127/052 Koact oral suspension Aurobindo Pharma Ltd, India Suspension for Oral Use Prescription Only Medicine127/053 Cefurxime 750 injection Aurobindo Pharma Ltd, India Powder for Injection Prescription Only Medicine127/054 Cefurxime 1500 injection Aurobindo Pharma Ltd, India Powder for Injection Prescription Only Medicine127/055 Didanosin chewable tablets Aurobindo Pharma Ltd, India Tablet Film coated Prescription Only Medicine127/056 Didanosin chewable tablets Aurobindo Pharma Ltd, India Tablet Film coated Prescription Only Medicine127/057 Didanosin chewable tablets Aurobindo Pharma Ltd, India Tablet Dispersible Prescription Only Medicine178/001 Tissop capsules Aurochem Laboratories Pvt, Ltd, India Capsule oral Pharmacy Medicine178/002 Feverlet tablets Aurochem Laboratories Pvt, Ltd, India Tablet Uncoated General Sale178/003 Nutrigel suspension Aurochem Laboratories Pvt, Ltd, India Suspension for Oral Use Pharmacy Medicine178/004 Perfopil 50 tablets Aurochem Laboratories Pvt, Ltd, India Tablet Uncoated Prescription Only Medicine178/005 Cerocip 250 tablets Aurochem Laboratories Pvt, Ltd, India Tablet Uncoated Prescription Only Medicine178/006 Cerocip tablets Aurochem Laboratories Pvt, Ltd, India Tablet Uncoated Prescription Only Medicine178/007 Rumifen 200 tablets Aurochem Laboratories Pvt, Ltd, India Tablet Uncoated Pharmacy Medicine178/008 Melamine tablets Aurochem Laboratories Pvt, Ltd, India Tablet Uncoated Pharmacy Medicine178/009 Defnil-SR tablets Aurochem Laboratories Pvt, Ltd, India Tablet Uncoated Pharmacy Medicine178/010 Telmentic suspension Aurochem Laboratories Pvt, Ltd, India Suspension for Oral Use Pharmacy Medicine178/011 Telmentic tablets Aurochem Laboratories Pvt, Ltd, India Tablet Uncoated Pharmacy Medicine178/012 Mucof cough lozenges Aurochem Laboratories Pvt, Ltd, India Lozenges Pharmacy Medicine178/013 Repisprin-300 tablets Aurochem Laboratories Pvt, Ltd, India Tablet Uncoated Pharmacy Medicine178/014 Betaclox solution Aurochem Laboratories Pvt, Ltd, India Solution for Oral Use Prescription Only Medicine178/015 Dr Home cough syrup Aurochem Laboratories Pvt, Ltd, India Syrup Pharmacy Medicine178/016 Lymphocin suspension Aurochem Laboratories Pvt, Ltd, India Suspension for Oral Use Prescription Only Medicine178/017 Alcof syrup Aurochem Laboratories Pvt, Ltd, India Syrup Pharmacy Medicine178/018 Chlorpheniramine 4 tablets Aurochem Laboratories Pvt, Ltd, India Tablet Uncoated Pharmacy Medicine178/019 Chlorpheniramine 2 tablets Aurochem Laboratories Pvt, Ltd, India Tablet Uncoated Pharmacy Medicine178/020 Ketoconazole tablets Aurochem Laboratories Pvt, Ltd, India Tablet Uncoated Prescription Only Medicine178/023 Welvit syrup Aurochem Laboratories Pvt, Ltd, India Syrup General Sale178/024 Zobinace solution Aurochem Laboratories Pvt, Ltd, India Solution for Oral Use Prescription Only Medicine178/025 Neuroflex tablets Aurochem Laboratories Pvt, Ltd, India Tablet Uncoated Pharmacy Medicine015/001 Normal saline solution Autosterile (EA) Ltd, Kenya Solution for infusion Prescription Only Medicine015/002 Autosterile 10% glucose injection Autosterile (EA) Ltd, Kenya Solution for infusion Prescription Only Medicine015/003 Autosterile 5% glucose + 0.9% sodium

chloride injectionAutosterile (EA) Ltd, Kenya Solution for infusion Prescription Only Medicine

015/004 Autosterile half strength Darrows injection Autosterile (EA) Ltd, Kenya Solution for infusion Prescription Only Medicine015/005 Glucose 5% injection Autosterile (EA) Ltd, Kenya Solution for Injection Prescription Only Medicine015/006 Ringers lactate injection Autosterile (EA) Ltd, Kenya Solution for infusion Prescription Only Medicine096/001 Ringers Lactate infusion Autosterile Pvt Ltd, Zimbabwe Solution for infusion Prescription Only Medicine096/002 Glucose infusion Autosterile Pvt Ltd, Zimbabwe Solution for infusion Prescription Only Medicine096/003 Sodium chloride infusion Autosterile Pvt Ltd, Zimbabwe Solution for infusion Prescription Only Medicine288/001 Diabend tablets Bal Pharma Ltd, India Tablet Uncoated Prescription Only Medicine288/004 Dynamox - 250 capsules Bal Pharma Ltd, India Capsule oral Prescription Only Medicine

PRA Secretariat / January 2009 8

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

288/006 Ibuprofen tablets Bal Pharma Ltd, India Tablet Film coated Pharmacy Medicine288/009 Diclofenac Sodium tablets Bal Pharma Ltd, India Tablet Enteric Coated Pharmacy Medicine288/010 Dynamox - 500 capsules Bal Pharma Ltd, India Capsule oral Prescription Only Medicine288/012 Seregra-50 tablets Bal Pharma Ltd, India Tablet Uncoated Prescription Only Medicine288/013 Seregra-100 tablets Bal Pharma Ltd, India Tablet Uncoated Prescription Only Medicine199/001 Praziquantel tablets BDH Industries Ltd, India Tablet Uncoated Prescription Only Medicine199/002 Hydrocortisone ophthalmic suspension BDH Industries Ltd, India Eye Suspension Prescription Only Medicine199/003 Chloramphenicol eye drops BDH Industries Ltd, India Eye Drops Prescription Only Medicine168/001 Betabs prednisolone tablets Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine168/002 Betapen suspension Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Suspension for Oral Use Prescription Only Medicine168/003 Betapen tablets Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine168/004 Candarspor cream Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Cream Topical Prescription Only Medicine168/005 Clear cough syrup Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Syrup Pharmacy Medicine168/006 Codef syrup Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Syrup Prescription Only Medicine168/007 Drilix syrup Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Syrup Pharmacy Medicine168/008 Lo-acid suspension Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Suspension Prescription Only Medicine168/009 B-dol tablets Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine168/010 Betabs chewy tablets Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Tablet Uncoated General Sale168/011 Betafed syrup Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Syrup Pharmacy Medicine168/012 Betalin syrup Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Syrup Pharmacy Medicine168/013 Trifen Expectorant Adult syrup Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Syrup Pharmacy Medicine168/014 Trifen Expectorant Child syrup Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Syrup Pharmacy Medicine168/015 Viteral syrup Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Syrup Pharmacy Medicine168/016 Septadine solution Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Solution for Topical Use General Sale168/017 Septadine ointment Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Ointment topical General Sale168/018 Betaretic tablets Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine168/019 Painagon tablets Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Tablet Uncoated Pharmacy Medicine168/020 Pre-Natal forte tablets Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Capsule oral Pharmacy Medicine168/021 Painagon syrup Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Syrup Pharmacy Medicine168/022 Flustat syrup Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Syrup Pharmacy Medicine168/023 Flustat capsules Be-Tabs Pharmaceuticals (Pty) Ltd, South Africa Capsule oral Pharmacy Medicine241/001 Miconazole cream Beltapharm SPA, Italy Cream Topical Pharmacy Medicine241/002 Anti-Haemorrhoid ointment Beltapharm SPA, Italy Ointment topical Pharmacy Medicine241/003 Clotrimazole powder Beltapharm SPA, Italy Powder for Oral Solution Prescription Only Medicine241/004 Metronidazole powder Beltapharm SPA, Italy Powder for Oral Solution Prescription Only Medicine241/005 Nystatin suspension Beltapharm SPA, Italy Suspension for Oral Use Prescription Only Medicine102/001 Action tablets Beta Healthcare International Ltd, Kenya Tablet Uncoated General Sale102/002 Action junior tablets Beta Healthcare International Ltd, Kenya Tablet Uncoated General Sale102/003 Strepsils regular tablets Beta Healthcare International Ltd, Kenya Tablet Uncoated General Sale102/004 Strepsils honey & lemon tablets Beta Healthcare International Ltd, Kenya Tablet Uncoated General Sale102/005 Paracetamol tablets Beta Healthcare International Ltd, Kenya Tablet Uncoated General Sale102/006 Goodmorning cough tablets Beta Healthcare International Ltd, Kenya Tablet Uncoated General Sale102/007 Goodmorning lung tonic Beta Healthcare International Ltd, Kenya Syrup General Sale102/008 Homoquine tablets Beta Healthcare International Ltd, Kenya Tablet Uncoated Pharmacy Medicine102/009 Asprin tablets Beta Healthcare International Ltd, Kenya Tablet Uncoated General Sale102/010 Aspro tablets Beta Healthcare International Ltd, Kenya Tablet Uncoated General Sale102/011 Betaquine tablets Beta Healthcare International Ltd, Kenya Tablet Uncoated Pharmacy Medicine102/012 Opele lotion Beta Healthcare International Ltd, Kenya Lotion for Topical Use General Sale102/013 Salimia linment ointment Beta Healthcare International Ltd, Kenya Ointment topical General Sale102/014 Beta gripe water Beta Healthcare International Ltd, Kenya Solution for Oral Use General Sale102/015 Prunol syrup Beta Healthcare International Ltd, Kenya Syrup General Sale102/016 Glucolin powder Beta Healthcare International Ltd, Kenya Powder for Oral Solution General Sale102/017 Glucolin dynomite Beta Healthcare International Ltd, Kenya Powder for Oral Solution General Sale233/001 Propovan injection Bharat Biotech Ltd, India Solution for Injection Prescription Only Medicine279/046 Regen-D gel Bharat Biotech Ltd, India Gel Topical Prescription Only Medicine240/001 Ciplast 10mg injection Biochem Pharmaceuticals Industries Ltd, India Powder for Injection Prescription Only Medicine240/002 Cycloxan 1g injection Biochem Pharmaceuticals Industries Ltd, India Solution for Injection Prescription Only Medicine

9 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

240/003 Cycloxan 500mg injection Biochem Pharmaceuticals Industries Ltd, India Powder for Injection Prescription Only Medicine240/004 Flucracil injection Biochem Pharmaceuticals Industries Ltd, India Solution for Injection Prescription Only Medicine240/005 Tamodex citrate tablets Biochem Pharmaceuticals Industries Ltd, India Tablet Uncoated Prescription Only Medicine240/006 Bioposide 100mg injection Biochem Pharmaceuticals Industries Ltd, India Powder for Injection Prescription Only Medicine240/007 Biotrexate 2.5mg tablets Biochem Pharmaceuticals Industries Ltd, India Tablet Uncoated Prescription Only Medicine240/008 Biotrexate injection Biochem Pharmaceuticals Industries Ltd, India Solution for Injection Prescription Only Medicine240/010 Cisplat 50mg injection Biochem Pharmaceuticals Industries Ltd, India Powder for Injection Prescription Only Medicine240/013 Fluracil injection Biochem Pharmaceuticals Industries Ltd, India Solution for Injection Prescription Only Medicine240/015 Petaxel injection Biochem Pharmaceuticals Industries Ltd, India Powder for Injection Prescription Only Medicine240/016 Biocristin injection Biochem Pharmaceuticals Industries Ltd, India Powder for Injection Prescription Only Medicine240/018 Pataxel 260 injection Biochem Pharmaceuticals Industries Ltd, India Powder for Injection Prescription Only Medicine240/019 Biovorin injection Biochem Pharmaceuticals Industries Ltd, India Solution for Injection Prescription Only Medicine240/020 Biocarb 150 injection Biochem Pharmaceuticals Industries Ltd, India Powder for Injection Prescription Only Medicine240/021 Biocarb 450 injection Biochem Pharmaceuticals Industries Ltd, India Powder for Injection Prescription Only Medicine240/022 Cycloxan 50mg tablets Biochem Pharmaceuticals Industries Ltd, India Tablet Uncoated Prescription Only Medicine240/023 Cycloxan 200 injection Biochem Pharmaceuticals Industries Ltd, India Solution for Injection Prescription Only Medicine240/024 Oncolet tablets Biochem Pharmaceuticals Industries Ltd, India Tablet Film coated Prescription Only Medicine290/022 Cycloxan tablets Biochem Pharmaceuticals Industries Ltd, India Tablet Film coated Prescription Only Medicine020/001 Biomol tablets Biodeal Laboratories Pvt Ltd, India Tablet Uncoated General Sale020/002 Biovir cream Biodeal Laboratories Pvt Ltd, India Cream Topical Prescription Only Medicine023/018 Synalar gel Bioglan Laboratories Ltd, United Kingdom Gel Topical Prescription Only Medicine023/019 Synalar C cream Bioglan Laboratories Ltd, United Kingdom Cream Topical Prescription Only Medicine023/032 Synalar cream Bioglan Laboratories Ltd, United Kingdom Cream Topical Prescription Only Medicine023/033 Synalar ointment Bioglan Laboratories Ltd, United Kingdom Ointment topical Prescription Only Medicine023/034 Synalar N cream Bioglan Laboratories Ltd, United Kingdom Cream Topical Prescription Only Medicine023/035 Synalar N ointment Bioglan Laboratories Ltd, United Kingdom Ointment topical Prescription Only Medicine235/001 Cetavlex antiseptic cream Bioglan Laboratories Ltd, United Kingdom Cream Topical General Sale264/001 Recticin 100 suppositories Bliss Chemicals & Pharmaceuticals Ltd, India Suppository Prescription Only Medicine264/002 Anomex suppositories Bliss Chemicals & Pharmaceuticals Ltd, India Suppository Prescription Only Medicine264/003 Vagid pessaries Bliss Chemicals & Pharmaceuticals Ltd, India Tablet Vaginal Prescription Only Medicine245/001 Gvfluc 200 capsules BlissGVS Pharma Ltd, India Capsule oral Prescription Only Medicine245/002 Gvither 0ral suspension BlissGVS Pharma Ltd, India Suspension for Oral Use Prescription Only Medicine245/003 Funbact A cream BlissGVS Pharma Ltd, India Cream Topical Prescription Only Medicine245/004 Comit-50 tablets BlissGVS Pharma Ltd, India Tablet Uncoated Prescription Only Medicine245/005 Lofnac 100 tablets BlissGVS Pharma Ltd, India Gel Topical Pharmacy Medicine245/006 Lofnac gel BlissGVS Pharma Ltd, India Gel Topical Pharmacy Medicine245/007 Alaxin oral suspension BlissGVS Pharma Ltd, India Suspension Prescription Only Medicine245/008 Alaxin tablets BlissGVS Pharma Ltd, India Tablet Uncoated Prescription Only Medicine245/009 Gsunate forte tablets BlissGVS Pharma Ltd, India Tablet Uncoated Prescription Only Medicine245/010 Gvither forte injection BlissGVS Pharma Ltd, India Powder for Injection Prescription Only Medicine245/011 Gsunate kit tablets BlissGVS Pharma Ltd, India Tablet Uncoated Prescription Only Medicine245/012 Alaxin kit tablets BlissGVS Pharma Ltd, India Tablet Uncoated Prescription Only Medicine245/013 Lonart tablets BlissGVS Pharma Ltd, India Tablet Uncoated Prescription Only Medicine245/014 Lonart forte tablets BlissGVS Pharma Ltd, India Tablet Uncoated Prescription Only Medicine245/015 Lonart suspension BlissGVS Pharma Ltd, India Suspension for Oral Use Prescription Only Medicine245/016 Clamoxin 125 suspension BlissGVS Pharma Ltd, India Suspension for Oral Use Prescription Only Medicine245/017 Clamoxin 250 suspension BlissGVS Pharma Ltd, India Suspension for Oral Use Prescription Only Medicine254/001 Adrenaline-Fresenius injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/002 Chlorpromazine Hcl injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/003 Dextrose-Fresenius injection Bodene(PTY) Ltd, South Africa Solution for infusion Prescription Only Medicine254/004 Dobutamine-Fresenius injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/005 Ergometrine maleate -Fresenius injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/006 Fentanyl-Frenesius injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/007 Furosemide-Fresenius injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/008 Heparin sodium injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/009 Heparin sodium injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/010 Intramed Mannitol 20 injection Bodene(PTY) Ltd, South Africa Solution for infusion Prescription Only Medicine

PRA Secretariat / January 2009 10

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

254/011 Intramed Sodium bicarbonate injection Bodene(PTY) Ltd, South Africa Solution for infusion Prescription Only Medicine254/012 Intamed Trichazole injection Bodene(PTY) Ltd, South Africa Solution for infusion Prescription Only Medicine254/013 Ketamine injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/014 Lignocaine 1% injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/015 Lignocaine 2% injection, 20ml Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/016 Lignocaine 2% injection, 5ml Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/017 Morphine sulphate 10 injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/018 Morphine sulphate 15 injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/019 Naloxone 0.042 injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/020 Naloxone 0.42 injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/021 Neostigmine 0.5 injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/022 Neostigmine 2.5 injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/023 Pancuronium bromide injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/024 Pethidine 100 injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/025 Pethidine 50 injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/026 Promethazine injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/027 Quinine injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/028 Suxamethonium chloride injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine254/029 Thiopentone sodium injection Bodene(PTY) Ltd, South Africa Solution for Injection Prescription Only Medicine119/001 Viramune tablets Boehringer Ingelheim Pharmaceuticals (Pty)

Ltd, SATablet Uncoated Prescription Only Medicine

119/002 Viramune suspension Boehringer Ingelheim Pharmaceuticals (Pty) Ltd, SA

Suspension Prescription Only Medicine

136/001 Zerit 1mg/ml syrup Bristol Myers , South Africa Syrup Prescription Only Medicine136/002 Zerit 15mg capsules Bristol Myers , South Africa Capsule oral Prescription Only Medicine136/003 Zerit 20mg capsules Bristol Myers , South Africa Capsule oral Prescription Only Medicine136/004 Zerit 30mg capsules Bristol Myers , South Africa Capsule oral Prescription Only Medicine136/005 Zerit 40mg capsules Bristol Myers , South Africa Capsule oral Prescription Only Medicine136/006 Videx tablets Bristol Myers , South Africa Tablet Uncoated Prescription Only Medicine136/007 Videx tablets Bristol Myers , South Africa Tablet Uncoated Prescription Only Medicine136/008 Videx tablets Bristol Myers , South Africa Tablet Uncoated Prescription Only Medicine136/009 Videx tablets Bristol Myers , South Africa Tablet Uncoated Prescription Only Medicine136/010 Videx peadiatric powder Bristol Myers , South Africa Powder for Oral

SuspensionPrescription Only Medicine

136/011 Videx tablets Bristol Myers , South Africa Tablet Uncoated Prescription Only Medicine136/012 Fungizone 50mg injection Bristol Myers , South Africa Solution for Injection Prescription Only Medicine227/005 Bayer Aspirin Cardio 1 tablets Bristol Myers , South Africa Tablet Enteric Coated Prescription Only Medicine113/001 Perflobid 400 tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/002 Vivorax tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/003 Aciloc tablets Cadilla Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine113/004 Aciloc 150 tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/005 Amdepin 10 tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/007 Ciprodac infusion Cadilla Pharmaceuticals Ltd, India Solution for Injection Prescription Only Medicine113/009 Lovalip tablets Cadilla Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine113/011 Ciprodac 250mg tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/012 Olit 20 capsules Cadilla Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine113/013 Pirofen 20 capsules Cadilla Pharmaceuticals Ltd, India Capsule oral Pharmacy Medicine113/014 Fluzon infusion Cadilla Pharmaceuticals Ltd, India Solution for infusion Prescription Only Medicine113/015 Fluzon 150mg tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/016 Fluzon 100mg tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/017 Wormin A 400mg tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine113/018 Roxibid 150 tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/019 Gempar 300 capsules Cadilla Pharmaceuticals Ltd, India Capsule oral Pharmacy Medicine113/020 Oritaxim 1000mg injection Cadilla Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine113/021 Envas 2.5mg tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/022 Cefamor 250mg capsules Cadilla Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine113/023 Wormin suspension Cadilla Pharmaceuticals Ltd, India Suspension for Oral Use Pharmacy Medicine

11 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

113/024 Cefamor 500mg capsules Cadilla Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine113/025 Dolac 10mg tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/026 Vasograin tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/027 Pirofen 10mg capsules Cadilla Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine113/028 Glamide 5mg tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/029 Fludac 20mg capsules Cadilla Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine113/030 Wormin 100mg tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine113/031 Norfen 400mg tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/032 Cadiprim 480mg tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/033 Cadiprim 240 mg suspension Cadilla Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine113/035 Wormin-A suspension Cadilla Pharmaceuticals Ltd, India Suspension Pharmacy Medicine113/037 Cadiphen 4 mg tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine113/039 Decon Nasal drops Cadilla Pharmaceuticals Ltd, India ENT Solution Prescription Only Medicine113/040 Decon pediatric nasal drops Cadilla Pharmaceuticals Ltd, India Nasal drops Prescription Only Medicine113/041 Ibunate 400 tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine113/042 Nilide 100mg tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/043 Dexasone Eye/Ear drops Cadilla Pharmaceuticals Ltd, India Ear/Eye Drops Prescription Only Medicine113/044 Trigan-D tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/045 EC-350 capsules Cadilla Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine113/046 Mycocox tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/047 Scat 200mg tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/049 Domperon suspension Cadilla Pharmaceuticals Ltd, India Solution for Oral Use Prescription Only Medicine113/050 Herbisept herbal cream Cadilla Pharmaceuticals Ltd, India Cream Topical Pharmacy Medicine113/051 Oritaxim 250mg injection Cadilla Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine113/052 Axone 1000 injection Cadilla Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine113/053 Zycin dry syrup Cadilla Pharmaceuticals Ltd, India Syrup Prescription Only Medicine113/054 Zycin capsules Cadilla Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine113/055 Zycin DT tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/056 Lorcap Eye/Ear drops Cadilla Pharmaceuticals Ltd, India Ear/Eye Drops Prescription Only Medicine113/057 PVA Tears eye drops Cadilla Pharmaceuticals Ltd, India Eye Drops Pharmacy Medicine113/058 Gentamycin Eye drops Cadilla Pharmaceuticals Ltd, India Ear/Eye Drops Prescription Only Medicine113/059 Cadiprim Eye/Ear drops Cadilla Pharmaceuticals Ltd, India Ear/Eye Drops Prescription Only Medicine113/060 Cadilac Eye drops Cadilla Pharmaceuticals Ltd, India Ear/Eye Drops Prescription Only Medicine113/061 Sanvic opthalmic solutions eye drops. Cadilla Pharmaceuticals Ltd, India Eye Drops Prescription Only Medicine113/062 Cefogen 750 injection Cadilla Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine113/063 Sanbeta Eye drops Cadilla Pharmaceuticals Ltd, India Eye Drops Prescription Only Medicine113/065 Mycobutol 800mg tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/066 Decon Eye drops Cadilla Pharmaceuticals Ltd, India Eye Drops Prescription Only Medicine113/067 Tmide Plus Eye drops Cadilla Pharmaceuticals Ltd, India Eye Drops Prescription Only Medicine113/068 Rabeloc injection Cadilla Pharmaceuticals Ltd, India Solution for Injection Prescription Only Medicine113/069 Rabeloc 10 tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/070 Rabeloc-20 tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/071 Scat eye/ear drops Cadilla Pharmaceuticals Ltd, India Ear/Eye Drops Prescription Only Medicine113/072 Locid suspension Cadilla Pharmaceuticals Ltd, India Suspension for Oral Use Pharmacy Medicine113/073 Tambac 50 suspension Cadilla Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine113/074 Nodon 5 tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/075 Piozulin 15 tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine113/076 Piozulin 30 tablets Cadilla Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine271/001 Camedol tablets Cameo Healthcare(L) Pvt Ltd, India Tablet Uncoated General Sale271/002 Cafem- 200 tablets Cameo Healthcare(L) Pvt Ltd, India Tablet Uncoated Pharmacy Medicine271/003 Camelox-250 capsules Cameo Healthcare(L) Pvt Ltd, India Capsule oral Prescription Only Medicine271/004 Camelox-125 oral suspension Cameo Healthcare(L) Pvt Ltd, India Powder for Oral

SuspensionPrescription Only Medicine

271/005 Camecillin-250 capsules Cameo Healthcare(L) Pvt Ltd, India Capsule oral Prescription Only Medicine271/006 Camecillin-125 oral suspension Cameo Healthcare(L) Pvt Ltd, India Powder for Oral

SuspensionPrescription Only Medicine

271/007 Camoxy-250mg capsule Cameo Healthcare(L) Pvt Ltd, India Capsule oral Prescription Only Medicine

PRA Secretariat / January 2009 12

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

271/008 Camoxy-125 oral suspension Cameo Healthcare(L) Pvt Ltd, India Powder for Oral Suspension

Prescription Only Medicine

271/009 Indocame capsules Cameo Healthcare(L) Pvt Ltd, India Capsule oral Pharmacy Medicine271/010 Cotricam 240 oral suspension Cameo Healthcare(L) Pvt Ltd, India Powder for Oral

SuspensionPrescription Only Medicine

271/011 Vitacam B6 tablets Cameo Healthcare(L) Pvt Ltd, India Tablet Uncoated Prescription Only Medicine271/012 Camvit-b tablets Cameo Healthcare(L) Pvt Ltd, India Tablet Uncoated Pharmacy Medicine271/013 Cametrin tablets Cameo Healthcare(L) Pvt Ltd, India Tablet Uncoated Pharmacy Medicine271/014 Cold off Junior syrup Cameo Healthcare(L) Pvt Ltd, India Syrup Pharmacy Medicine271/015 Camflam tablets Cameo Healthcare(L) Pvt Ltd, India Tablet Uncoated Pharmacy Medicine271/016 Fenacam 50 tablets Cameo Healthcare(L) Pvt Ltd, India Tablet Uncoated Pharmacy Medicine271/017 Malsycam tablets Cameo Healthcare(L) Pvt Ltd, India Tablet Uncoated Pharmacy Medicine271/018 Dixicam 500 tablets Cameo Healthcare(L) Pvt Ltd, India Suspension for Oral Use Prescription Only Medicine271/019 Cotricam tablets Cameo Healthcare(L) Pvt Ltd, India Tablet Uncoated Prescription Only Medicine271/020 Metrocam tablets Cameo Healthcare(L) Pvt Ltd, India Tablet Uncoated Prescription Only Medicine271/022 Flucocam 200 capsules Cameo Healthcare(L) Pvt Ltd, India Capsule oral Prescription Only Medicine271/023 Vitacam C tablets Cameo Healthcare(L) Pvt Ltd, India Tablet Uncoated General Sale271/024 Maxivit tablets Cameo Healthcare(L) Pvt Ltd, India Tablet Uncoated Pharmacy Medicine024/001 Amocillin capsules Caps (Private) Ltd, Zimbabwe Capsule oral Prescription Only Medicine024/002 Amocillin capsules Caps (Private) Ltd, Zimbabwe Capsule oral Prescription Only Medicine024/003 Amocillin suspension Caps (Private) Ltd, Zimbabwe Suspension for Oral Use Prescription Only Medicine024/004 Amocillin suspension Caps (Private) Ltd, Zimbabwe Suspension for Oral Use Prescription Only Medicine024/005 Benzylpencillin injection Caps (Private) Ltd, Zimbabwe Powder for Injection Prescription Only Medicine024/006 Benzylpencillin Caps (Private) Ltd, Zimbabwe Powder for Injection Prescription Only Medicine024/007 Capcycline capsules Caps (Private) Ltd, Zimbabwe Capsule oral Prescription Only Medicine024/008 Chlornicol capsules Caps (Private) Ltd, Zimbabwe Capsule oral Prescription Only Medicine024/009 Chlornicol injection Caps (Private) Ltd, Zimbabwe Powder for Injection Prescription Only Medicine024/010 Chlornicol suspension Caps (Private) Ltd, Zimbabwe Suspension for Oral Use Prescription Only Medicine024/014 Co-trimoxazole peadiatric tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/015 Co-trimoxazole suspension Caps (Private) Ltd, Zimbabwe Suspension for Oral Use Prescription Only Medicine024/016 Co-trimoxazole tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/017 Dizam injection Caps (Private) Ltd, Zimbabwe Solution for Injection Prescription Only Medicine024/018 Dizam tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/019 Dizam tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/020 Dolex capsules Caps (Private) Ltd, Zimbabwe Capsule oral Prescription Only Medicine024/021 Dolex capsules Caps (Private) Ltd, Zimbabwe Capsule oral Prescription Only Medicine024/022 Doxyclin capsules Caps (Private) Ltd, Zimbabwe Capsule oral Prescription Only Medicine024/023 Equemote capsules Caps (Private) Ltd, Zimbabwe Capsule oral Prescription Only Medicine024/024 Famicillin capsules Caps (Private) Ltd, Zimbabwe Capsule oral Prescription Only Medicine024/025 Famicillin capsules Caps (Private) Ltd, Zimbabwe Capsule oral Prescription Only Medicine024/026 Famicillin suspension Caps (Private) Ltd, Zimbabwe Suspension for Oral Use Prescription Only Medicine024/027 Famicillin injection Caps (Private) Ltd, Zimbabwe Powder for Injection Prescription Only Medicine024/028 Famicillin suspension Caps (Private) Ltd, Zimbabwe Suspension for Oral Use Prescription Only Medicine024/029 Ferous Sulphate tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Pharmacy Medicine024/030 Hydrochlorothiazide tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/031 Hydrochlorothiazide tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/032 Hypotens tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/033 Kanamycin injection Caps (Private) Ltd, Zimbabwe Solution for Injection Prescription Only Medicine024/034 Malasone tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Pharmacy Medicine024/035 Methocid tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/036 Methocid 50mg caspules Caps (Private) Ltd, Zimbabwe Capsule oral Prescription Only Medicine024/037 Methocid suppositories Caps (Private) Ltd, Zimbabwe Suppository Prescription Only Medicine024/038 Metronidazole suspension Caps (Private) Ltd, Zimbabwe Suspension for Oral Use Prescription Only Medicine024/039 Metronidazole tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/040 Metronidazole tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/041 Mezenol DS tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/042 Paracetamol syrup Caps (Private) Ltd, Zimbabwe Syrup General Sale

13 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

024/043 Paracetamol tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Pharmacy Medicine024/044 Parecon forte injection Caps (Private) Ltd, Zimbabwe Solution for Injection Prescription Only Medicine024/045 Procillin injection Caps (Private) Ltd, Zimbabwe Solution for Injection Prescription Only Medicine024/046 Purinol tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/047 Rexigen tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/048 Rexigen tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/049 Rexigen tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/050 Rexigen tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/051 Streptosol injection Caps (Private) Ltd, Zimbabwe Solution for Injection Prescription Only Medicine024/052 Tetracycline eye ointment Caps (Private) Ltd, Zimbabwe Eye Ointment Prescription Only Medicine024/053 Ultracillin tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/054 Water for injection Caps (Private) Ltd, Zimbabwe Solution for Injection Prescription Only Medicine024/056 Xylone injection Caps (Private) Ltd, Zimbabwe Solution for Injection Prescription Only Medicine024/057 Prednisolone tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/058 Histalix D syrup Caps (Private) Ltd, Zimbabwe Syrup Pharmacy Medicine024/059 Phenobarbitone tablets Caps (Private) Ltd, Zimbabwe Tablet Uncoated Prescription Only Medicine024/060 Allergon cream Caps (Private) Ltd, Zimbabwe Cream Topical Pharmacy Medicine099/001 Zidovir 100 capsules Cipla Ltd, India Capsule oral Prescription Only Medicine099/002 Ciplox tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/003 Ciplox tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/004 Ciplox eye ointment Cipla Ltd, India Eye Ointment Prescription Only Medicine099/005 Ciplox eye/ear drops Cipla Ltd, India Ear/Eye Drops Prescription Only Medicine099/006 Profenac eye drops Cipla Ltd, India Eye Drops Prescription Only Medicine099/007 Fungicip cream Cipla Ltd, India Cream Topical Prescription Only Medicine099/008 Fungicip - 100 tablets Cipla Ltd, India Tablet Vaginal Prescription Only Medicine099/009 Fungicip 200 tablets Cipla Ltd, India Tablet Vaginal Prescription Only Medicine099/010 Triomune 30 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/011 Lamivir-s 30 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/012 Lamivir-s 40 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/013 Efivir -200 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/014 Nelvir tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/015 Lamivir tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/016 Zidovir solution Cipla Ltd, India Solution for Oral Use Prescription Only Medicine099/018 Nevimune oral suspension Cipla Ltd, India Suspension for Oral Use Prescription Only Medicine099/019 Indianan capsules Cipla Ltd, India Capsule oral Prescription Only Medicine099/020 Duovir N tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/021 Stavir 30 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/022 Stavir 40 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/023 Lamivir oral solution Cipla Ltd, India Solution for Oral Use Prescription Only Medicine099/024 Divir 100 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/025 Spectin injection Cipla Ltd, India Powder for Injection Prescription Only Medicine099/026 Tadacip 10 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/027 Lovacard 20 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/028 Cipril 5 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/029 Novatax 1000 injection Cipla Ltd, India Powder for Injection Prescription Only Medicine099/030 Simcard 10 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/032 Acivir 200 dispersible tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/033 Asthalin inhaler Cipla Ltd, India Solution for Inhalation Prescription Only Medicine099/034 Falcither 40 injection Cipla Ltd, India Solution for Injection Prescription Only Medicine099/035 Falcither 80 injection Cipla Ltd, India Solution for Injection Prescription Only Medicine099/036 Forcan capsules Cipla Ltd, India Capsule oral Prescription Only Medicine099/037 Forcan 200 capsules Cipla Ltd, India Capsule oral Prescription Only Medicine099/038 Vasopril -10 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/039 Vasopril 5 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/040 Acivir eye ointment Cipla Ltd, India Eye Ointment Prescription Only Medicine099/041 Alerid tablets Cipla Ltd, India Tablet Uncoated Pharmacy Medicine099/042 Cipcal 250 tablets Cipla Ltd, India Tablet Uncoated Pharmacy Medicine

PRA Secretariat / January 2009 14

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

099/043 Ciplacef injection Cipla Ltd, India Powder for Injection Prescription Only Medicine099/044 Cytocristin injection Cipla Ltd, India Solution for Injection Prescription Only Medicine099/045 Dr Smiths evening primrose capsules Cipla Ltd, India Capsule oral Pharmacy Medicine099/046 Falcinil 100 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/048 Gentacip eye drops Cipla Ltd, India Eye Drops Prescription Only Medicine099/049 Glinil tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/050 Hipres-100 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/051 Hipres-50 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/052 Ocutin 0.25% opthalmic drops Cipla Ltd, India Eye Drops Prescription Only Medicine099/053 Ocutin 0.5% opthalmic drops Cipla Ltd, India Eye Drops Prescription Only Medicine099/054 Osteocip tablets Cipla Ltd, India Tablet Enteric Coated Pharmacy Medicine099/055 Photericin B injection Cipla Ltd, India Solution for Injection Prescription Only Medicine099/056 Profenac 100 SR tablets Cipla Ltd, India Tablet Uncoated Pharmacy Medicine099/057 Quinarsol injection Cipla Ltd, India Solution for Injection Prescription Only Medicine099/058 Roko 2 tablets Cipla Ltd, India Tablet Uncoated Pharmacy Medicine099/059 Synclar 250 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/060 Theoday 400mg tablets Cipla Ltd, India Tablet Uncoated Pharmacy Medicine099/061 Ultac 300 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/062 Zinoral shampoo Cipla Ltd, India Shampoo Prescription Only Medicine099/063 Triomune 30 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/064 Acivir cream Cipla Ltd, India Cream Topical Prescription Only Medicine099/065 Nalucil powder Cipla Ltd, India Powder for Oral Solution Pharmacy Medicine099/067 Ciproric-100 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/068 Ergogin injection Cipla Ltd, India Solution for Injection Prescription Only Medicine099/069 Dexacip injection Cipla Ltd, India Solution for Injection Prescription Only Medicine099/070 Spasmocip capsules Cipla Ltd, India Capsule oral Prescription Only Medicine099/071 Cipladine ointment Cipla Ltd, India Ointment topical Pharmacy Medicine099/072 Digusil MPS tablets Cipla Ltd, India Tablet Uncoated General Sale099/073 Burnheal cream Cipla Ltd, India Cream Topical Pharmacy Medicine099/075 Proflox 400 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/076 Theo asthalin tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/077 Aerocort inhaler Cipla Ltd, India Powder for Inhalation Prescription Only Medicine099/078 Silagra-50 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/079 Aqua tears drops Cipla Ltd, India Eye Drops Pharmacy Medicine099/080 Alerid syrup Cipla Ltd, India Syrup Pharmacy Medicine099/081 Ciplactin tablet Cipla Ltd, India Tablet Uncoated Pharmacy Medicine099/083 Novalac 625 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/084 Pyradox tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/085 Halotrin tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/087 Dr Smith Vitamin capsules Cipla Ltd, India Capsule oral Pharmacy Medicine099/088 Theo asthalin tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/089 Novaclav 375 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/090 Vitacip capsules Cipla Ltd, India Capsule oral General Sale099/092 Asthalin SR tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/093 Cephadex-500 tablets Cipla Ltd, India Capsule oral Prescription Only Medicine099/094 Cephadex 250 capsules Cipla Ltd, India Capsule oral Prescription Only Medicine099/095 C-vit chewable tablets Cipla Ltd, India Tablet Chewable General Sale099/096 Betavit afr capsules Cipla Ltd, India Capsule oral Pharmacy Medicine099/099 Ritomune tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/102 Nevimune 200 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/103 Ciplin tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/104 Lumartem tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/105 Dr Smith’s Garlic Oil capsules Cipla Ltd, India Capsule oral General Sale099/106 Urisoda granules Cipla Ltd, India Powder for Oral Solution General Sale099/107 Dr. Smith’s Vitamin E capsules Cipla Ltd, India Capsule oral Pharmacy Medicine099/108 Trimune baby tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/109 Trimune junior tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine

15 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

099/110 Lamivir S Baby Dispersible tablets Cipla Ltd, India Tablet Dispersible Prescription Only Medicine099/111 Lamivir S Junior Dispersible tablets Cipla Ltd, India Tablet Dispersible Prescription Only Medicine099/112 Stavir dry syrup Cipla Ltd, India Syrup Prescription Only Medicine099/115 Ciplox IV Infusion Cipla Ltd, India Solution for infusion Prescription Only Medicine099/116 Flazole injection Cipla Ltd, India Solution for Injection Prescription Only Medicine099/117 Cipcorlin injection Cipla Ltd, India Powder for Injection Prescription Only Medicine099/118 Cytoplatin injection Cipla Ltd, India Powder for Injection Prescription Only Medicine099/119 Cytotam tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/120 Bleomcip injection Cipla Ltd, India Powder for Injection Prescription Only Medicine099/121 Etosid injection Cipla Ltd, India Powder for Injection Prescription Only Medicine099/122 Cytotam tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/123 Cytocarb 150 injection Cipla Ltd, India Powder for Injection Prescription Only Medicine099/124 Decarb 200 injection Cipla Ltd, India Powder for Injection Prescription Only Medicine099/125 Ciplactin syrup Cipla Ltd, India Syrup Pharmacy Medicine099/126 Naxid tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/127 Tenvir-Em tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/128 Abacavir Sulphate tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/129 Lamivudine Oral solution Cipla Ltd, India Solution for Oral Use Prescription Only Medicine099/130 Efavirenz tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/138 Tinidazole tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/139 Pylokit tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/140 Ibugesic plus tablets Cipla Ltd, India Tablet Uncoated Pharmacy Medicine099/142 Ergogin tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/143 Synclar dry syrup Cipla Ltd, India Syrup Prescription Only Medicine099/144 Nystatin Oral suspension Cipla Ltd, India Suspension for Oral Use Prescription Only Medicine099/146 Profenac injection Cipla Ltd, India Solution for Injection Prescription Only Medicine099/147 Gentacip injection Cipla Ltd, India Solution for Injection Prescription Only Medicine099/148 Ashthalin inhaler Cipla Ltd, India Powder for Inhalation Prescription Only Medicine099/151 Ciplin suspension Cipla Ltd, India Suspension for Oral Use Prescription Only Medicine099/152 Beclate 50 inhaler Cipla Ltd, India Powder for Inhalation Prescription Only Medicine099/153 Beclate 50 inhaler Cipla Ltd, India Powder for Inhalation Prescription Only Medicine099/154 Sulfamon Plus tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/155 Sulphamon plus tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/158 Indivan 400 capsules Cipla Ltd, India Capsule oral Prescription Only Medicine099/159 Stavir 15 capsules Cipla Ltd, India Capsule oral Prescription Only Medicine099/160 Stavir 20 capsules Cipla Ltd, India Capsule oral Prescription Only Medicine099/161 Divir 25 tablets Cipla Ltd, India Tablet Dispersible Prescription Only Medicine099/162 Divir 150 tablets Cipla Ltd, India Tablet Dispersible Prescription Only Medicine099/163 Divir 200 tablets Cipla Ltd, India Tablet Dispersible Prescription Only Medicine099/164 Zidovudine capsules Cipla Ltd, India Capsule oral Prescription Only Medicine099/165 Oncodox 10 injection Cipla Ltd, India Powder for Injection Prescription Only Medicine099/166 Oncodox 50 injection Cipla Ltd, India Powder for Injection Prescription Only Medicine099/167 Amoxicillin oral suspension Cipla Ltd, India Powder for Oral

SuspensionPrescription Only Medicine

099/168 Amoxicillin capsules Cipla Ltd, India Capsule oral Prescription Only Medicine099/169 Ginette 35 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/170 Cefix ds oral suspension Cipla Ltd, India Powder for Oral

SuspensionPrescription Only Medicine

099/171 Warf 5 tablets Cipla Ltd, India Tablet Uncoated Prescription Only Medicine099/172 Chloraxin injection Cipla Ltd, India Powder for Injection Prescription Only Medicine099/173 Paracip 500 tablets Cipla Ltd, India Tablet Uncoated General Sale099/174 Frusix injection Cipla Ltd, India Solution for Injection Prescription Only Medicine099/175 Ibugesic- 400 tablets Cipla Ltd, India Tablet Uncoated Pharmacy Medicine009/014 Mycoral oral gel Circle Pharmaceuticals Ltd, Zambia Gel Oral Prescription Only Medicine009/047 Hyoscine butyl bromide tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/068 Chloroquine Phosphate syrup Circle Pharmaceuticals Ltd, Zambia Syrup Prescription Only Medicine009/074 Cephalexin suspension Circle Pharmaceuticals Ltd, Zambia Suspension for Oral Use Prescription Only Medicine

PRA Secretariat / January 2009 16

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

009/075 Cephalexin capsules Circle Pharmaceuticals Ltd, Zambia Capsule oral Prescription Only Medicine009/076 Cephalexin 500mg capsules Circle Pharmaceuticals Ltd, Zambia Capsule oral Prescription Only Medicine009/077 Ampicillin capsules Circle Pharmaceuticals Ltd, Zambia Capsule oral Prescription Only Medicine009/078 Ampicillin capsules Circle Pharmaceuticals Ltd, Zambia Capsule oral Prescription Only Medicine009/079 Rifampicin capsules Circle Pharmaceuticals Ltd, Zambia Capsule oral Prescription Only Medicine009/080 Rifampicin capsules Circle Pharmaceuticals Ltd, Zambia Capsule oral Prescription Only Medicine009/081 Amoxycillin capsules Circle Pharmaceuticals Ltd, Zambia Capsule oral Prescription Only Medicine009/082 Amoxycillin capsules Circle Pharmaceuticals Ltd, Zambia Capsule oral Prescription Only Medicine009/083 Doxycycline capsules Circle Pharmaceuticals Ltd, Zambia Capsule oral Prescription Only Medicine009/084 Piroxicam capsules Circle Pharmaceuticals Ltd, Zambia Capsule oral Prescription Only Medicine009/085 Cloxamp granules Circle Pharmaceuticals Ltd, Zambia Suspension for Oral Use Prescription Only Medicine009/086 Mefenamic acid capsules Circle Pharmaceuticals Ltd, Zambia Capsule oral Prescription Only Medicine009/087 Tetracycline capsules Circle Pharmaceuticals Ltd, Zambia Capsule oral Prescription Only Medicine009/089 Paracetamol tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Pharmacy Medicine009/090 Glibenclamide tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/091 Pyrazinamide tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/092 Gamsidar tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Pharmacy Medicine009/093 Paracetamol tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Pharmacy Medicine009/094 Alluopurinol tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/095 Metronidazole tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/097 Ethambutol tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/098 Gamuretic tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/099 Griseofulvin tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/100 Promethazine injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/101 Streptomycin injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/102 Cloxacillin injection Circle Pharmaceuticals Ltd, Zambia Powder for Injection Prescription Only Medicine009/103 Atropine injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/104 Gentamycin injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/105 Gentamycin injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/107 Kanamycin injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/108 Water for injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Pharmacy Medicine009/109 Allupurinol tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/110 Katamine tablets Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/111 Frusemide injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/112 Metoclopromide injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/113 Chlorpromazine injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/114 Praziquantel tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/115 Metronidazole injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/117 Isoniazid tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/118 Ibuprofen tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Pharmacy Medicine009/119 Pethidine injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/120 Propranolol tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/123 Phenobarbitone tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/124 Phenobarbitone tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/125 Pethidine injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/126 Cloxamp injection Circle Pharmaceuticals Ltd, Zambia Powder for Injection Prescription Only Medicine009/128 Cefotaxime injection Circle Pharmaceuticals Ltd, Zambia Powder for Injection Prescription Only Medicine009/130 Ampicilllin injection Circle Pharmaceuticals Ltd, Zambia Powder for Injection Prescription Only Medicine009/131 Glucose injection Circle Pharmaceuticals Ltd, Zambia Solution for infusion Prescription Only Medicine009/134 Ciprofloxacin tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/135 Diazepam injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/136 Hyoscine butyl bromide injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/137 Norethisterone tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/138 Proguanil tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/139 Propantheline tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/140 Quinine dihydrochloride injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/141 Quinine dihydrochloride tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine

17 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

009/142 Wormcid suspension Circle Pharmaceuticals Ltd, Zambia Suspension for Oral Use Pharmacy Medicine009/143 Metformin tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/145 Ketazole gel Circle Pharmaceuticals Ltd, Zambia Gel Oral Prescription Only Medicine009/146 Gamma cough syrup Circle Pharmaceuticals Ltd, Zambia Syrup Pharmacy Medicine009/148 Phytomenadione injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/149 Ketoconazole tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/150 Benzhexol tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/151 Promethazine injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/152 Dexmethasone injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/153 Phyomenadione injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/154 Enalapril tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/155 Benzhexol tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/156 Nifedipine tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/157 Bendroflumethiazide tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/158 Theophylline compound tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/159 Acyclovir tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/160 Timolol eye drops Circle Pharmaceuticals Ltd, Zambia Eye Drops Prescription Only Medicine009/161 Gentamycin eye drops Circle Pharmaceuticals Ltd, Zambia Eye Drops Prescription Only Medicine009/162 Acetazolamide tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/163 Chloramphenicol suspension Circle Pharmaceuticals Ltd, Zambia Suspension for Oral Use Prescription Only Medicine009/165 Biscodyl tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Pharmacy Medicine009/166 Metoclopramide tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/167 Nystatin tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/168 Nitrofuratoin tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/169 Loperamide tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Pharmacy Medicine009/170 Mebendazole tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Pharmacy Medicine009/171 Fluconazole 2mg injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/172 Cetylpyridinium throat lozenges Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Pharmacy Medicine009/173 Aminophylline tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/174 Ascobic acid tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated General Sale009/175 Atenolol tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/176 Betasone eye drops Circle Pharmaceuticals Ltd, Zambia Eye Drops Prescription Only Medicine009/177 Diclofenac 50mg tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Pharmacy Medicine009/178 Digoxin 0.25mg tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine009/179 Digoxin 0.25mg injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/180 Duosept hospital concentration solution Circle Pharmaceuticals Ltd, Zambia Solution for sterilisation General Sale009/181 Eyecrom eye/ear drops Circle Pharmaceuticals Ltd, Zambia Eye Drops Prescription Only Medicine009/182 Fentanyl 50mcg/2ml injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/183 Fungicid cream Circle Pharmaceuticals Ltd, Zambia Cream Topical Prescription Only Medicine009/184 Gammcort cream Circle Pharmaceuticals Ltd, Zambia Cream Topical Prescription Only Medicine009/185 Nalbuphine injection Circle Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine009/186 Sterdidex solution Circle Pharmaceuticals Ltd, Zambia Solution for sterilisation General Sale009/187 Tac cough syrup Circle Pharmaceuticals Ltd, Zambia Syrup Pharmacy Medicine009/188 Waxpel ear drops Circle Pharmaceuticals Ltd, Zambia Ear Drops Pharmacy Medicine009/189 Atenolol tablets Circle Pharmaceuticals Ltd, Zambia Tablet Uncoated Prescription Only Medicine194/001 Hestar 200 pestastarch infusion Claris Life Sciences Ltd, India Solution for Injection Prescription Only Medicine194/002 Flucanol injection Claris Life Sciences Ltd, India Solution for Injection Prescription Only Medicine194/003 Propofol 1% Intravenous injection Claris Life Sciences Ltd, India Solution for Injection Prescription Only Medicine194/004 Ketajex IV injection Claris Life Sciences Ltd, India Solution for Injection Prescription Only Medicine194/005 Cefo injection Claris Life Sciences Ltd, India Powder for Injection Prescription Only Medicine194/006 Thiopental Sodium injection Claris Life Sciences Ltd, India Powder for Injection Prescription Only Medicine194/007 Bupican injection Claris Life Sciences Ltd, India Solution for Injection Prescription Only Medicine194/008 Dopamine concentrate injection Claris Life Sciences Ltd, India Solution for Injection Prescription Only Medicine194/009 Ciprox injection Claris Life Sciences Ltd, India Solution for Injection Prescription Only Medicine194/010 Curaxone injection Claris Life Sciences Ltd, India Solution for Injection Prescription Only Medicine194/011 Sensinil injection Claris Life Sciences Ltd, India Solution for Injection Prescription Only Medicine194/012 Dflam injection Claris Life Sciences Ltd, India Solution for Injection Prescription Only Medicine

PRA Secretariat / January 2009 18

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

194/013 Metris injection Claris Life Sciences Ltd, India Solution for Injection Prescription Only Medicine194/014 Remetin injection Claris Life Sciences Ltd, India Solution for Injection Prescription Only Medicine201/001 Ferrous Sulphate tablets Colorama Pharmaceuticals Ltd, Uinted Kingdom Tablet Film coated Pharmacy Medicine201/002 Loperamide tablets Colorama Pharmaceuticals Ltd, Uinted Kingdom Tablet Uncoated Pharmacy Medicine201/004 Tetracyline capsules Colorama Pharmaceuticals Ltd, Uinted Kingdom Capsule oral Prescription Only Medicine201/005 Forzid tablets Colorama Pharmaceuticals Ltd, Uinted Kingdom Tablet Uncoated Prescription Only Medicine201/013 Odopa tablets Colorama Pharmaceuticals Ltd, Uinted Kingdom Tablet Uncoated Prescription Only Medicine201/014 Lopine tablets Colorama Pharmaceuticals Ltd, Uinted Kingdom Tablet Uncoated Prescription Only Medicine201/015 Pymint oral suspension Colorama Pharmaceuticals Ltd, Uinted Kingdom Suspension for Oral Use Pharmacy Medicine201/016 Trolox tablets Colorama Pharmaceuticals Ltd, Uinted Kingdom Tablet Uncoated Prescription Only Medicine201/017 Tocure cream Colorama Pharmaceuticals Ltd, Uinted Kingdom Cream Topical Prescription Only Medicine201/018 Trolox suspension Colorama Pharmaceuticals Ltd, Uinted Kingdom Suspension for Oral Use Prescription Only Medicine201/019 Pymint tablets Colorama Pharmaceuticals Ltd, Uinted Kingdom Tablet Uncoated Pharmacy Medicine201/021 Hydrocortisone Acetate cream Colorama Pharmaceuticals Ltd, Uinted Kingdom Cream Topical Prescription Only Medicine263/001 Recartix capsules Comed chemicals Ltd, India Capsule oral Pharmacy Medicine263/002 Caldob capsules Comed chemicals Ltd, India Capsule oral Prescription Only Medicine263/003 Lyser D tablets Comed chemicals Ltd, India Tablet Uncoated Pharmacy Medicine263/004 Simvax 20 tablets Comed chemicals Ltd, India Tablet Film coated Prescription Only Medicine263/005 Simvax 10 tablets Comed chemicals Ltd, India Tablet Film coated Prescription Only Medicine263/006 Ceso-40 tablets Comed chemicals Ltd, India Tablet Uncoated Prescription Only Medicine263/007 Osex capsules Comed chemicals Ltd, India Capsule oral Pharmacy Medicine263/008 Recartix forte tablets Comed chemicals Ltd, India Tablet Uncoated General Sale263/009 Proloc D capsules Comed chemicals Ltd, India Capsule oral Prescription Only Medicine180/001 Softrim tablets Crown Exports, India Tablet Uncoated Prescription Only Medicine180/002 Quintex tablets Crown Exports, India Tablet Uncoated Prescription Only Medicine180/003 Crogyl 200 tablets Crown Exports, India Tablet Uncoated Prescription Only Medicine180/004 Paridol 500 tablets Crown Exports, India Tablet Uncoated Pharmacy Medicine180/005 Amicare 250 capsules Crown Exports, India Capsule oral Prescription Only Medicine180/006 Cromin tablets Crown Exports, India Tablet Uncoated Prescription Only Medicine180/007 Ciprocrown 500 tablets Crown Exports, India Tablet Uncoated Prescription Only Medicine180/008 Ibusoft 200 tablets Crown Exports, India Tablet Uncoated Pharmacy Medicine180/010 Claricid tablets Crown Exports, India Tablet Uncoated Prescription Only Medicine180/011 Vitacrown syrup Crown Exports, India Syrup Pharmacy Medicine180/012 Becofit tablets Crown Exports, India Tablet Uncoated Pharmacy Medicine180/013 Erysoft syrup Crown Exports, India Tablet Uncoated Prescription Only Medicine180/014 Cofdry syrup Crown Exports, India Syrup Pharmacy Medicine151/002 Artesiane suppositories Dafra Pharma Ltd, Belgium Suppository Prescription Only Medicine151/003 Artesiane Oral suspension Dafra Pharma Ltd, Belgium Suspension Prescription Only Medicine151/008 Co-Arinate 100 tablets Dafra Pharma Ltd, Belgium Tablet Uncoated Prescription Only Medicine151/009 Arinate 50 tablets Dafra Pharma Ltd, Belgium Tablet Uncoated Prescription Only Medicine151/010 Arinate 100 tablets Dafra Pharma Ltd, Belgium Tablet Uncoated Prescription Only Medicine151/015 Aneaban capsules Dafra Pharma Ltd, Belgium Capsule oral Prescription Only Medicine151/016 Amonate FDC junior tablets Dafra Pharma Ltd, Belgium Tablet Uncoated Prescription Only Medicine151/018 Fortaline omega-3 syrup Dafra Pharma Ltd, Belgium Syrup Prescription Only Medicine151/019 Pico stick insect repellent Dafra Pharma Ltd, Belgium Solution for Topical Use Pharmacy Medicine055/010 Fidemycin capsules Dawa Phamaceuticals Ltd, Kenya Capsule oral Prescription Only Medicine055/011 Dawacin injection Dawa Phamaceuticals Ltd, Kenya Powder for Injection Prescription Only Medicine055/012 Hycin tablets Dawa Phamaceuticals Ltd, Kenya Tablet Uncoated Prescription Only Medicine055/013 Dawagenta injection Dawa Phamaceuticals Ltd, Kenya Solution for Injection Prescription Only Medicine055/014 Cindomet capsules Dawa Phamaceuticals Ltd, Kenya Capsule oral Pharmacy Medicine055/015 Dawasprin tablets Dawa Phamaceuticals Ltd, Kenya Tablet Uncoated Pharmacy Medicine055/017 Amidiostat powder Dawa Phamaceuticals Ltd, Kenya Powder for Oral Solution General Sale055/018 Aphaquine suspension Dawa Phamaceuticals Ltd, Kenya Suspension for Oral Use Prescription Only Medicine055/019 Fanlar tablets Dawa Phamaceuticals Ltd, Kenya Tablet Uncoated Pharmacy Medicine055/020 Dawanol tablets Dawa Phamaceuticals Ltd, Kenya Tablet Uncoated Pharmacy Medicine055/021 Curamol Plus caplets Dawa Phamaceuticals Ltd, Kenya Caplets oral Uncoated Pharmacy Medicine055/022 DawaCort injection Dawa Phamaceuticals Ltd, Kenya Solution for Injection Prescription Only Medicine

19 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

055/023 Vitamin B tablets Dawa Phamaceuticals Ltd, Kenya Tablet Uncoated Pharmacy Medicine055/024 Dablin tablets Dawa Phamaceuticals Ltd, Kenya Tablet Uncoated Prescription Only Medicine055/025 Dawastin suspension Dawa Phamaceuticals Ltd, Kenya Suspension for Oral Use Prescription Only Medicine055/026 Dawaphenicol injection Dawa Phamaceuticals Ltd, Kenya Powder for Injection Prescription Only Medicine055/027 Dawa-cpm tablets Dawa Phamaceuticals Ltd, Kenya Tablet Film coated Prescription Only Medicine055/028 Dawa Ascorbic acid tablets Dawa Phamaceuticals Ltd, Kenya Tablet Uncoated General Sale130/001 Nifedi-Denk 10 Retard tablets Denk Pharma, Germany Tablet Enteric Coated Prescription Only Medicine130/002 Nifedi-Denk 20 Retard tablets Denk Pharma, Germany Tablet Enteric Coated Prescription Only Medicine130/003 Diclo-Denk 25 tablets Denk Pharma, Germany Tablet Enteric Coated Pharmacy Medicine130/004 Diclo-Denk 50 tablets Denk Pharma, Germany Tablet Film coated Pharmacy Medicine130/005 Diclo-Denk 100 Retard tablets Denk Pharma, Germany Tablet Enteric Coated Pharmacy Medicine130/006 Diclo-Denk 75mg injection Denk Pharma, Germany Solution for Injection Prescription Only Medicine130/007 Diclo-Denk 100 suppositories Denk Pharma, Germany Suppository Pharmacy Medicine130/008 Rani-Denk 150 tablets Denk Pharma, Germany Tablet Film coated Prescription Only Medicine130/009 Rani-Denk 300 tablets Denk Pharma, Germany Tablet Film coated Prescription Only Medicine130/010 Acyclovir-Denk 200 tablets Denk Pharma, Germany Tablet Uncoated Prescription Only Medicine130/011 Acyclovir Denk cream Denk Pharma, Germany Cream Topical Prescription Only Medicine130/012 Clotri-Denk 100 Vaginal tablets Denk Pharma, Germany Tablet Vaginal Prescription Only Medicine130/013 Clotri-Denk 1% cream Denk Pharma, Germany Cream Topical Prescription Only Medicine130/014 Loperamide Denk tablets Denk Pharma, Germany Tablet Enteric Coated Pharmacy Medicine130/015 Metformin-Denk 500 tablets Denk Pharma, Germany Tablet Film coated Prescription Only Medicine130/016 Rheuma-Denk gel Denk Pharma, Germany Gel Topical Pharmacy Medicine130/021 Atenolol Denk tablets Denk Pharma, Germany Tablet Uncoated Prescription Only Medicine130/022 Paradenk 4% syrup Denk Pharma, Germany Syrup Pharmacy Medicine130/023 Para-denk 500 tablets Denk Pharma, Germany Tablet Uncoated Pharmacy Medicine130/024 Captopril/hydrochlorothiazide tablets Denk Pharma, Germany Tablet Uncoated Prescription Only Medicine130/025 Furodenk 40 tablets Denk Pharma, Germany Tablet Uncoated Prescription Only Medicine130/026 Vera-Denk 240 Retard tablets Denk Pharma, Germany Tablet Uncoated Prescription Only Medicine130/027 Famotidine denk tablets Denk Pharma, Germany Tablet Film coated Prescription Only Medicine130/028 Amoxi-denk 500 tablets Denk Pharma, Germany Tablet Uncoated Prescription Only Medicine130/029 Cipro-denk tablets Denk Pharma, Germany Tablet Film coated Prescription Only Medicine130/032 Asunatedenk 100 plus tablets Denk Pharma, Germany Tablet Uncoated Prescription Only Medicine130/033 Asunate Denk 200 tablets Denk Pharma, Germany Tablet Uncoated Prescription Only Medicine130/034 Vit-B-denk tablets Denk Pharma, Germany Tablet Uncoated General Sale130/035 Armether Denk suspension Denk Pharma, Germany Suspension for Oral Use Prescription Only Medicine285/001 Shelcal tablets Elder Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine285/001HM Alonurish Acne gel Elder Pharmaceuticals Ltd, India Gel Topical General Sale285/002HM A.M. P.M. Plus Dental rinse Elder Pharmaceuticals Ltd, India Solution for Oral Use General Sale285/003 Venex 300 tablets Elder Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine285/003HM Alonurish moisturising cream Elder Pharmaceuticals Ltd, India Cream Topical General Sale285/004 Venex tablets Elder Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine285/004HM Alonurish Scalp cleanser Elder Pharmaceuticals Ltd, India Solution for Topical Use General Sale285/005 Conjugate 0.625 tablets Elder Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine285/005HM A.M. P.M. Plus Junior Dental rinse Elder Pharmaceuticals Ltd, India Solution for Oral Use General Sale285/006 Shelcal-500 tablets Elder Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine285/006HM Alonurish Alnite cream Elder Pharmaceuticals Ltd, India Cream Topical Pharmacy Medicine285/007 Deviry 10 tablets Elder Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine285/007HM Alonurish Sunscreen lotion Elder Pharmaceuticals Ltd, India Lotion for Topical Use Pharmacy Medicine285/008 Edge 400 capsules Elder Pharmaceuticals Ltd, India Capsule oral Pharmacy Medicine285/008HM Alonurish Face fleanser Elder Pharmaceuticals Ltd, India Solution for Topical Use General Sale285/009 Zephrol syrup Elder Pharmaceuticals Ltd, India Syrup Prescription Only Medicine285/009HM A.M. P.M. Special Dental rinse Elder Pharmaceuticals Ltd, India Solution for Oral Use General Sale285/010HM Tiger Balm White ointment Elder Pharmaceuticals Ltd, India Ointment topical General Sale285/011 Shelcal syrup Elder Pharmaceuticals Ltd, India Syrup Pharmacy Medicine285/011HM Mucodyne syrup Elder Pharmaceuticals Ltd, India Syrup Pharmacy Medicine285/012 Chymoral Forte tablets Elder Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine285/012HM Solo Cough syrup Elder Pharmaceuticals Ltd, India Syrup Pharmacy Medicine

PRA Secretariat / January 2009 20

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

285/013 Eldervit capsules Elder Pharmaceuticals Ltd, India Capsule oral Pharmacy Medicine174/001 Antizip capsules Eli Lilly (SA) Pty Ltd, South Africa Capsule oral Prescription Only Medicine174/002 Prozac tablets Eli Lilly (SA) Pty Ltd, South Africa Tablet Uncoated Prescription Only Medicine174/003 Lilly-Cefador tablets Eli Lilly (SA) Pty Ltd, South Africa Tablet Uncoated Prescription Only Medicine174/004 Lilly-Cefaclor suspension Eli Lilly (SA) Pty Ltd, South Africa Powder for Oral

SuspensionPrescription Only Medicine

174/005 Lilly Cefaclor granules Eli Lilly (SA) Pty Ltd, South Africa Suspension Prescription Only Medicine188/001 Alugel suspension Elys Chemicals Industries Ltd, Kenya Suspension for Oral Use Pharmacy Medicine188/002 Ampicillin capsules Elys Chemicals Industries Ltd, Kenya Capsule oral Prescription Only Medicine188/003 Bukol tablets Elys Chemicals Industries Ltd, Kenya Tablet Uncoated Prescription Only Medicine188/004 Chestcof syrup Elys Chemicals Industries Ltd, Kenya Syrup General Sale188/005 Elyclox capsules Elys Chemicals Industries Ltd, Kenya Capsule oral Prescription Only Medicine188/006 Elymox capsules Elys Chemicals Industries Ltd, Kenya Capsule oral Prescription Only Medicine188/007 Elyvate ointment Elys Chemicals Industries Ltd, Kenya Ointment topical Prescription Only Medicine188/008 Elyvate cream Elys Chemicals Industries Ltd, Kenya Cream Topical Prescription Only Medicine188/009 Fungistin Vaginal tablets Elys Chemicals Industries Ltd, Kenya Tablet Vaginal Prescription Only Medicine188/010 Junior Aspirin tablets Elys Chemicals Industries Ltd, Kenya Tablet Uncoated General Sale188/011 Nitrofurantoin tablets Elys Chemicals Industries Ltd, Kenya Tablet Uncoated Prescription Only Medicine188/012 Orodar tablets Elys Chemicals Industries Ltd, Kenya Tablet Uncoated Pharmacy Medicine188/013 Promethazine tablets Elys Chemicals Industries Ltd, Kenya Tablet Uncoated Pharmacy Medicine188/014 Quinine tablets Elys Chemicals Industries Ltd, Kenya Tablet Film coated Prescription Only Medicine188/015 Elycort ointment Elys Chemicals Industries Ltd, Kenya Cream Topical Prescription Only Medicine188/016 Elymox powder Elys Chemicals Industries Ltd, Kenya Suspension for Oral Use Prescription Only Medicine188/017 Cloxacillin powder for suspension Elys Chemicals Industries Ltd, Kenya Suspension for Oral Use Prescription Only Medicine188/018 Ampicillin powder Elys Chemicals Industries Ltd, Kenya Suspension for Oral Use Prescription Only Medicine188/019 Elypen tablets Elys Chemicals Industries Ltd, Kenya Tablet Uncoated Prescription Only Medicine188/020 Whitefield ointment Elys Chemicals Industries Ltd, Kenya Ointment topical General Sale188/021 Lyte oral rehydration salt Elys Chemicals Industries Ltd, Kenya Powder for Oral Solution General Sale188/022 Wormol tablets Elys Chemicals Industries Ltd, Kenya Tablet Uncoated Pharmacy Medicine125/040 Rosiz 4 tablets Emcure Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine150/051 Emtri suspension Emcure Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine193/033 Acem-500 tablets Emcure Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine195/001 Augpen 375 tablets Emcure Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine195/002 Augpen 625mg tablets Emcure Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine195/003 Ciprobiotic eye/ear drops Emcure Pharmaceuticals Ltd, India Ear/Eye Drops Prescription Only Medicine195/004 Zeflox eye/ear drops Emcure Pharmaceuticals Ltd, India Ear/Eye Drops Prescription Only Medicine195/005 Diclomove NDS Gel Emcure Pharmaceuticals Ltd, India Gel Topical Pharmacy Medicine195/006 C-Tri injection Emcure Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine195/008 Orofer chewable tablets Emcure Pharmaceuticals Ltd, India Tablet Film coated Pharmacy Medicine195/010 Nusar 50 tablets Emcure Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine195/011 Orofer drops Emcure Pharmaceuticals Ltd, India Solution for Oral Use Pharmacy Medicine195/012 Emtri tablets Emcure Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine195/014 Ciprobiotic FC cream Emcure Pharmaceuticals Ltd, India Cream Topical Prescription Only Medicine195/015 Zosec capsules Emcure Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine195/017 Ciprobiotic Forte tablets Emcure Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine195/021 Orofer capsules Emcure Pharmaceuticals Ltd, India Capsule oral Pharmacy Medicine195/022 Beclasone C 15g Cream Emcure Pharmaceuticals Ltd, India Cream Topical Prescription Only Medicine195/024 Vifex syrup Emcure Pharmaceuticals Ltd, India Syrup Prescription Only Medicine195/026 Caloshel tablets Emcure Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine195/028 C-tax 200mg tablets Emcure Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine195/029 C-tax P dry syrup 50 Emcure Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine195/030 Atorec 10 tablets Emcure Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine195/031 Atorec 20 tablets Emcure Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine195/034 Asomex-2.5 tablets Emcure Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine195/035 Asomex- 5 tablets Emcure Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine195/038 Sylate 500 tablets Emcure Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine195/039 Rosiz 2 tablets Emcure Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine

21 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

195/041 Diclomove SR tablets Emcure Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine195/042 Dinor tablets Emcure Pharmaceuticals Ltd, India Tablet Chewable Prescription Only Medicine195/043 Lamir -150 tablets Emcure Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine195/044 Zidine capsules Emcure Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine195/045 Stadine - 40 capsules Emcure Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine195/046 Efcure tablets Emcure Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine195/047 Emduo-40 tablets Emcure Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine195/048 Zidine tablets Emcure Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine195/049 Zidine oral solution Emcure Pharmaceuticals Ltd, India Solution for Oral Use Prescription Only Medicine195/052 Vintor injection Emcure Pharmaceuticals Ltd, India Solution for Injection Prescription Only Medicine195/053 Emtri Junior tablets Emcure Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine278/001 Rancip tablets Erica Pharma Pvt Ltd, India Tablet Film coated Prescription Only Medicine278/002 Ericef injection Erica Pharma Pvt Ltd, India Powder for Injection Prescription Only Medicine278/003 Ryvakelfin tablets Erica Pharma Pvt Ltd, India Tablet Uncoated Pharmacy Medicine278/004 Erisunat suspension Erica Pharma Pvt Ltd, India Suspension for Oral Use Prescription Only Medicine278/005 Lumether suspension Erica Pharma Pvt Ltd, India Suspension for Oral Use Prescription Only Medicine278/006 Erinin suspension Erica Pharma Pvt Ltd, India Suspension Prescription Only Medicine278/007 Ucon capsules Erica Pharma Pvt Ltd, India Capsule oral Prescription Only Medicine278/008 Optragen eye drops Erica Pharma Pvt Ltd, India Eye Drops Prescription Only Medicine278/009 Eriamp suspension Erica Pharma Pvt Ltd, India Suspension for Oral Use Prescription Only Medicine278/010 Erither oral suspension Erica Pharma Pvt Ltd, India Solution for Oral Use Prescription Only Medicine278/011 Erilife powder Erica Pharma Pvt Ltd, India Powder for Oral Solution Pharmacy Medicine278/012 Erinin tablets Erica Pharma Pvt Ltd, India Tablet Uncoated Prescription Only Medicine278/013 Eridol oral suspension Erica Pharma Pvt Ltd, India Suspension for Oral Use Pharmacy Medicine278/014 Erisunat tablets Erica Pharma Pvt Ltd, India Tablet Uncoated Prescription Only Medicine278/015 Erither injection Erica Pharma Pvt Ltd, India Solution for Injection Prescription Only Medicine278/016 Lumether tablets Erica Pharma Pvt Ltd, India Tablet Film coated Prescription Only Medicine278/017 Rypanta tablets Erica Pharma Pvt Ltd, India Tablet Enteric Coated Prescription Only Medicine278/018 Ryvazole capsules Erica Pharma Pvt Ltd, India Capsule oral Prescription Only Medicine278/019 Amoxer oral suspension Erica Pharma Pvt Ltd, India Suspension for Oral Use Prescription Only Medicine278/020 Tolybion injection Erica Pharma Pvt Ltd, India Solution for Injection Prescription Only Medicine278/021 Ryvakelfin Oral drops Erica Pharma Pvt Ltd, India Solution for Oral Use Pharmacy Medicine278/022 Erither capsules Erica Pharma Pvt Ltd, India Capsule oral Prescription Only Medicine278/023 Erixime injection Erica Pharma Pvt Ltd, India Powder for Injection Prescription Only Medicine278/024 Oral rehydration salt Erica Pharma Pvt Ltd, India Powder for Oral Solution General Sale278/025 Furosemide tablets Erica Pharma Pvt Ltd, India Tablet Uncoated Prescription Only Medicine278/026 Erimet 850 tablets Erica Pharma Pvt Ltd, India Tablet Uncoated Prescription Only Medicine278/027 Erion K syrup Erica Pharma Pvt Ltd, India Syrup Pharmacy Medicine278/028 Clauviax 625mg tablets Erica Pharma Pvt Ltd, India Tablet Uncoated Prescription Only Medicine278/032 Chloramphenicol Sodium Succinate

injectionErica Pharma Pvt Ltd, India Powder for Injection Prescription Only Medicine

278/033 Furosemide injection Erica Pharma Pvt Ltd, India Solution for Injection Prescription Only Medicine278/034 Gentamycin sulphate injection Erica Pharma Pvt Ltd, India Solution for Injection Prescription Only Medicine278/035 Rancip 250 tablets Erica Pharma Pvt Ltd, India Tablet Uncoated Prescription Only Medicine278/036 Cefax -250 tablets Erica Pharma Pvt Ltd, India Tablet Uncoated Prescription Only Medicine278/038 Erimal capsules Erica Pharma Pvt Ltd, India Capsule oral Prescription Only Medicine278/041 Erither 40 injection Erica Pharma Pvt Ltd, India Solution for Injection Prescription Only Medicine278/042 Vagiclin suppositories Erica Pharma Pvt Ltd, India Suppository Prescription Only Medicine278/043 Optracip drops Erica Pharma Pvt Ltd, India Eye Drops Prescription Only Medicine278/044 Vagiclo tablets Erica Pharma Pvt Ltd, India Tablet Vaginal Prescription Only Medicine278/045 Erimet tablets Erica Pharma Pvt Ltd, India Tablet Uncoated Prescription Only Medicine164/001 Water for injections Euro Med Laboratories Ltd, Phillipines Solution for Injection Prescription Only Medicine164/002 Dextrose 5 intravenous injection Euro Med Laboratories Ltd, Phillipines Solution for Injection Prescription Only Medicine164/003 Dextrose 10 intravenous injection Euro Med Laboratories Ltd, Phillipines Solution for Injection Prescription Only Medicine164/004 Sodium chloride intravenous injection Euro Med Laboratories Ltd, Phillipines Solution for Injection Prescription Only Medicine164/005 Lactate Ringers solution Euro Med Laboratories Ltd, Phillipines Solution for Injection Prescription Only Medicine164/006 Eurosol-M solution Euro Med Laboratories Ltd, Phillipines Solution for Injection Prescription Only Medicine

PRA Secretariat / January 2009 22

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

164/007 Dextrose solution Euro Med Laboratories Ltd, Phillipines Solution for Injection Prescription Only Medicine164/008 Dextrose in soduim solution Euro Med Laboratories Ltd, Phillipines Solution for Injection Prescription Only Medicine211/001 Lusia - F tablets Famy Care Ltd, India Tablet Film coated Prescription Only Medicine211/002 Hyan tablets Famy Care Ltd, India Tablet Film coated Prescription Only Medicine211/003 Famyrel tablets Famy Care Ltd, India Tablet Film coated Prescription Only Medicine211/004 Oralcon tablet Famy Care Ltd, India Tablet Film coated Prescription Only Medicine211/005 Pregnon tablets Famy Care Ltd, India Tablet Uncoated Prescription Only Medicine211/006 Oralcon-F tablets Famy Care Ltd, India Tablet Uncoated Prescription Only Medicine197/001 Electral Forte powder FDC Ltd, India Powder for Oral Solution General Sale197/002 Co-trimoxazole tablets FDC Ltd, India Tablet Uncoated Prescription Only Medicine197/003 Moisol Eye drops FDC Ltd, India Eye Drops Prescription Only Medicine197/004 Pilocar eye drops FDC Ltd, India Eye Drops Prescription Only Medicine197/005 Pyricort Eye/Ear drops FDC Ltd, India Ear/Eye Drops Prescription Only Medicine197/006 Pyrimon Eye/Ear drops FDC Ltd, India Ear/Eye Drops Prescription Only Medicine197/007 Zoxan Eye/Ear drops FDC Ltd, India Ear/Eye Drops Prescription Only Medicine197/008 Ibuprofen tablets FDC Ltd, India Tablet Uncoated Pharmacy Medicine197/010 Paracetamol tablets FDC Ltd, India Tablet Uncoated Pharmacy Medicine126/001 Amoxycillin oral suspension Flamingo Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine126/002 Ampicillin injection Flamingo Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine126/003 Ampicillin injection Flamingo Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine126/004 Medampi capsules Flamingo Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine126/005 Benzyl Penicillin injection Flamingo Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine126/006 Tetra 500 capsules Flamingo Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine126/007 Kanamycin injection Flamingo Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine126/008 Fortified Procaine Penicillin injection Flamingo Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine126/009 Ibuprofen tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine126/010 Compound Magnesuim Trisilicate tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine126/011 Co-trimoxazole suspension Flamingo Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine126/012 Cephalexin 500 capsules Flamingo Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine126/013 Amoxin 500 capsules Flamingo Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine126/014 Indo 25 capsules Flamingo Pharmaceuticals Ltd, India Capsule oral Pharmacy Medicine126/015 Erycin 125 suspension Flamingo Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine126/016 Quinine Sulphate tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine126/017 Metronidazole suspension Flamingo Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine126/018 Medfulin tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine126/019 Metroforce 200 tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine126/020 Reducid 300 tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine126/021 Flamodip 10 tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine126/022 Flamodip 5 tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine126/023 Reduced 150 tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine126/024 Ibuprofen tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine126/025 Cardipril 2.5 capsules Flamingo Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine126/026 Mefenamic Acid capsules Flamingo Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine126/027 Neumicin B injection Flamingo Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine126/028 Kamox 250 capsules Flamingo Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine126/029 Aziflam 250 capsules Flamingo Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine126/030 Sodipen-5 injection Flamingo Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine126/031 Corin 50 tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine126/032 Metformin tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine126/033 Glibetics tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine126/034 Medichlor injection Flamingo Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine126/035 Aziflam 500 capsules Flamingo Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine126/036 Chloramphenicol suspension Flamingo Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine126/037 Acenopril 5 tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine126/038 Quinone G-500 tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine126/039 Magacid oral suspension Flamingo Pharmaceuticals Ltd, India Suspension for Oral Use Pharmacy Medicine126/040 Acenopril 10 tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine

23 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

126/041 Corin 100 tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine126/042 Coughex syrup Flamingo Pharmaceuticals Ltd, India Syrup General Sale126/043 Paracetamol BP tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine126/044 Trixone 1 injection Flamingo Pharmaceuticals Ltd, India Solution for Injection Prescription Only Medicine126/045 Trixol 250 injection Flamingo Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine126/047 Lexin 125 Oral suspension Flamingo Pharmaceuticals Ltd, India Suspension Prescription Only Medicine126/048 Lanocid 30 capsules Flamingo Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine126/049 Healz tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine126/051 Profit syrup Flamingo Pharmaceuticals Ltd, India Syrup General Sale126/052 Hyomide 10 tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine126/053 Cloxacillin Sodium Injection Flamingo Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine126/054 Cardilan injection Flamingo Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine126/055 Loperamide tablets Flamingo Pharmaceuticals Ltd, India Capsule oral Pharmacy Medicine126/056 Cefotax Powder for injection Flamingo Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine126/057 Ferrous Sulphate tablets Flamingo Pharmaceuticals Ltd, India Tablet Enteric Coated Pharmacy Medicine126/059 Flamivit syrup Flamingo Pharmaceuticals Ltd, India Syrup General Sale126/063 Erycin tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine139/046 Co-trimoxazole tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine139/050 Roxto-25 tablets Flamingo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine038/712V Poulva pox ae vaccine injection Fort Doge Animal Health (Pty) Ltd, South Africa Powder for Injection Prescription Only Medicine038/713V Poulva NDW vaccine injection Fort Doge Animal Health (Pty) Ltd, South Africa Powder for Injection Prescription Only Medicine038/714V Poulvac bursaa f vaccine injection Fort Doge Animal Health (Pty) Ltd, South Africa Powder for Injection Prescription Only Medicine177/001 Omfil 20 capsules Fourrts (India) Laboratories (Pvt) Ltd, India Capsule oral Prescription Only Medicine177/002 Ampifil 250 capsules Fourrts (India) Laboratories (Pvt) Ltd, India Capsule oral Prescription Only Medicine177/003 Doxefil 100 capsules Fourrts (India) Laboratories (Pvt) Ltd, India Capsule oral Prescription Only Medicine177/004 Indoril 25 capsules Fourrts (India) Laboratories (Pvt) Ltd, India Capsule oral Pharmacy Medicine177/005 Gramofil suspension Fourrts (India) Laboratories (Pvt) Ltd, India Suspension for Oral Use Prescription Only Medicine177/006 Malafil tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine177/007 Griseofil tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine177/008 Micofil cream Fourrts (India) Laboratories (Pvt) Ltd, India Cream Topical Pharmacy Medicine177/009 Megatrim suspension Fourrts (India) Laboratories (Pvt) Ltd, India Suspension for Oral Use Prescription Only Medicine177/010 Prednifil tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine177/011 Combifil 125 tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine177/012 Diclofil 50 tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine177/013 Parafil tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine177/014 Clopen 500 capsules Fourrts (India) Laboratories (Pvt) Ltd, India Capsule oral Prescription Only Medicine177/015 Gelfil tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine177/016 Fungifen cream Fourrts (India) Laboratories (Pvt) Ltd, India Cream Topical Prescription Only Medicine177/017 Mebfil suspension Fourrts (India) Laboratories (Pvt) Ltd, India Suspension for Oral Use Pharmacy Medicine177/018 Felcine capsules Fourrts (India) Laboratories (Pvt) Ltd, India Capsule oral Prescription Only Medicine177/019 Filobex tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine177/020 Gliclan M tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine177/021 Gramofil tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine177/022 Ibufil tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine177/023 Mebfil tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine177/024 Megatrim tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine177/025 Metfil 850 tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine177/026 Salfil 4 tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine177/027 Salfil 2 tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine177/028 Cipfil 500 tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine177/029 Fourts B tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine177/030 Metfil 500 tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine177/031 Salbutamol Oral solution Fourrts (India) Laboratories (Pvt) Ltd, India Solution for Oral Use Prescription Only Medicine177/032 Fogyl suspension Fourrts (India) Laboratories (Pvt) Ltd, India Suspension for Oral Use Prescription Only Medicine177/033 Profil 25 tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine177/035 Cloxafil 250mg capsules Fourrts (India) Laboratories (Pvt) Ltd, India Capsule oral Prescription Only Medicine177/037 Betafil-50 tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine

PRA Secretariat / January 2009 24

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

177/038 Gliclan 80mg tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine177/039 Fomycetin 250mg capsules Fourrts (India) Laboratories (Pvt) Ltd, India Capsule oral Prescription Only Medicine177/040 Fogyl-S tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine3129/05 Cipfil 500 tablets Fourrts (India) Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine274/001 Glyciphage tablets Franco-Indian Remedies Pvt Ltd, India Tablet Uncoated Prescription Only Medicine274/002 Beneuron forte tablets Franco-Indian Remedies Pvt Ltd, India Tablet Film coated Pharmacy Medicine274/003 Beetrion tablets Franco-Indian Remedies Pvt Ltd, India Tablet Film coated Pharmacy Medicine253/001 Propofol 1% infusion Frenesius Kabi S.A (Pty) Ltd, South Africa Solution for infusion Prescription Only Medicine253/002 Voluven emulsion Frenesius Kabi S.A (Pty) Ltd, South Africa Emulsion Prescription Only Medicine218/001 Fungigen cream Galentic Pharma Ltd, India Cream Topical Prescription Only Medicine218/002 Derm Keta cream Galentic Pharma Ltd, India Cream Topical Prescription Only Medicine218/003 Netracort ointment Galentic Pharma Ltd, India Ointment topical Prescription Only Medicine218/004 Sylvadex cream Galentic Pharma Ltd, India Cream Topical Pharmacy Medicine218/005 Kloraxin Eye ointment Galentic Pharma Ltd, India Eye Ointment Prescription Only Medicine218/006 Diclofenac gel Galentic Pharma Ltd, India Gel Topical Pharmacy Medicine200/001 Helmanil oral suspension Galpha Laboratories Ltd,India Suspension for Oral Use Pharmacy Medicine200/002 Odicef injection Galpha Laboratories Ltd,India Powder for Injection Prescription Only Medicine200/003 Aben oral suspension Galpha Laboratories Ltd,India Suspension for Oral Use Pharmacy Medicine200/004 Galmox capsules Galpha Laboratories Ltd,India Capsule oral Prescription Only Medicine200/005 Clanoxy 375 tablets Galpha Laboratories Ltd,India Tablet Film coated Prescription Only Medicine200/006 Galexin 250 capsules Galpha Laboratories Ltd,India Capsule oral Prescription Only Medicine200/008 Galmox 125 oral suspension Galpha Laboratories Ltd,India Powder for Oral

SuspensionPrescription Only Medicine

200/009 Malartem injection Galpha Laboratories Ltd,India Solution for Injection Prescription Only Medicine200/010 Gallin oral suspension Galpha Laboratories Ltd,India Powder for Oral

SuspensionPrescription Only Medicine

200/011 Potamp 500 capsules Galpha Laboratories Ltd,India Capsule oral Prescription Only Medicine200/012 Galin capsules Galpha Laboratories Ltd,India Capsule oral Prescription Only Medicine200/014 Metrogal oral suspension Galpha Laboratories Ltd,India Suspension for Oral Use Prescription Only Medicine200/015 Clanoxy Dry syrup Galpha Laboratories Ltd,India Powder for Oral

SuspensionPrescription Only Medicine

200/016 Galdic SR 100 tablets Galpha Laboratories Ltd,India Tablet Film coated Pharmacy Medicine200/017 Hydrocortisone Sodium injection Galpha Laboratories Ltd,India Powder for Injection Prescription Only Medicine200/018 Restum 500 tablets Galpha Laboratories Ltd,India Tablet Uncoated Prescription Only Medicine200/019 Restum 250 tablets Galpha Laboratories Ltd,India Tablet Uncoated Prescription Only Medicine200/020 Altax Powder for injection Galpha Laboratories Ltd,India Powder for Injection Prescription Only Medicine200/022 Galprim-p suspension Galpha Laboratories Ltd,India Suspension Prescription Only Medicine200/023 Ecocin suspension Galpha Laboratories Ltd,India Suspension for Oral Use General Sale200/024 Clanoxy 625 tablets Galpha Laboratories Ltd,India Tablet Uncoated Prescription Only Medicine200/025 Galclox oral suspension Galpha Laboratories Ltd,India Suspension for Oral Use Prescription Only Medicine200/026 Galthrox 125 oral suspension Galpha Laboratories Ltd,India Suspension for Oral Use Prescription Only Medicine200/027 Dr-x 50 tablets Galpha Laboratories Ltd,India Tablet Uncoated Prescription Only Medicine200/028 Galexin 125 suspension Galpha Laboratories Ltd,India Suspension for Oral Use Prescription Only Medicine273/001 Desol ear drops Geno Pharmaceuticals Ltd, India Ear Drops Prescription Only Medicine273/002 Cypon syrup Geno Pharmaceuticals Ltd, India Syrup Pharmacy Medicine159/001 Deriphyllin Retard tablets Germany Remedies, India Tablet Film coated Prescription Only Medicine159/002 Deriphyllin 150 retard tablets Germany Remedies, India Tablet Film coated Prescription Only Medicine159/003 Deriphylline tablets Germany Remedies, India Tablet Uncoated Prescription Only Medicine159/004 Deriphylline injection Germany Remedies, India Solution for Injection Prescription Only Medicine159/005 Deriphylline syrup Germany Remedies, India Syrup Prescription Only Medicine159/006 Kalzana tablets Germany Remedies, India Tablet Uncoated General Sale179/001 Clavulin suspension GlaxoSmithKline SA (Pty) Ltd, South Africa Suspension for Oral Use Prescription Only Medicine179/002 Clavulin tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine179/003 Bactroban cream GlaxoSmithKline SA (Pty) Ltd, South Africa Cream Topical Prescription Only Medicine179/004 Ziagen tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine179/005 Combivir tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine179/006 Epivir oral solution GlaxoSmithKline SA (Pty) Ltd, South Africa Solution for Oral Use Prescription Only Medicine

25 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

179/007 Epivir tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Film coated Prescription Only Medicine179/008 Alben 400 tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Uncoated Pharmacy Medicine179/009 Augmentin Oral suspension GlaxoSmithKline SA (Pty) Ltd, South Africa Suspension for Oral Use Prescription Only Medicine179/010 Telzir suspension GlaxoSmithKline SA (Pty) Ltd, South Africa Suspension for Oral Use Prescription Only Medicine179/011 Kivexa tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Film coated Prescription Only Medicine179/013 Zinnat suspension GlaxoSmithKline SA (Pty) Ltd, South Africa Suspension for Oral Use Prescription Only Medicine179/015 Zinnat 500 tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine179/016 Zinacef injection GlaxoSmithKline SA (Pty) Ltd, South Africa Solution for Injection Prescription Only Medicine179/017 Zinnat 250 tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine179/018 Engerix B Paediatric tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine179/019 Engerix B adult tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine179/020 Halfan suspension GlaxoSmithKline SA (Pty) Ltd, South Africa Suspension for Oral Use Prescription Only Medicine179/021 Halfan tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine179/022 Zentel tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Uncoated Pharmacy Medicine179/024 Tracruim injection GlaxoSmithKline SA (Pty) Ltd, South Africa Solution for Injection Prescription Only Medicine179/025 Retrovir capsules GlaxoSmithKline SA (Pty) Ltd, South Africa Capsule oral Prescription Only Medicine179/026 Retrovir capsules GlaxoSmithKline SA (Pty) Ltd, South Africa Capsule oral Prescription Only Medicine179/028 Otosporin ear drops GlaxoSmithKline SA (Pty) Ltd, South Africa Ear Drops Prescription Only Medicine179/029 Lanoxin tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine179/030 Augmentin sf suspension GlaxoSmithKline SA (Pty) Ltd, South Africa Suspension for Oral Use Prescription Only Medicine179/032 Augmentin bd suspension GlaxoSmithKline SA (Pty) Ltd, South Africa Suspension for Oral Use Prescription Only Medicine179/033 Zentel suspension GlaxoSmithKline SA (Pty) Ltd, South Africa Suspension for Oral Use Pharmacy Medicine179/034 Flixotide inhaler GlaxoSmithKline SA (Pty) Ltd, South Africa Solution for Inhalation Prescription Only Medicine179/035 Flixotide 125 inhaler GlaxoSmithKline SA (Pty) Ltd, South Africa Solution for Inhalation Prescription Only Medicine179/036 Floxotide inhaler GlaxoSmithKline SA (Pty) Ltd, South Africa Solution for Inhalation Prescription Only Medicine179/037 Augmentin tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine179/038 Ventolin cfc inhaler GlaxoSmithKline SA (Pty) Ltd, South Africa Solution for Inhalation Prescription Only Medicine179/039 Seretide inhaler GlaxoSmithKline SA (Pty) Ltd, South Africa Solution for Inhalation Prescription Only Medicine179/040 Seretide inhaler GlaxoSmithKline SA (Pty) Ltd, South Africa Solution for Inhalation Prescription Only Medicine179/041 Seretide inhaler GlaxoSmithKline SA (Pty) Ltd, South Africa Solution for Inhalation Prescription Only Medicine179/042 Seretide inhaler GlaxoSmithKline SA (Pty) Ltd, South Africa Solution for Inhalation Prescription Only Medicine179/043 Seretide inhaler GlaxoSmithKline SA (Pty) Ltd, South Africa Solution for Inhalation Prescription Only Medicine179/044 Seretide inhaler GlaxoSmithKline SA (Pty) Ltd, South Africa Solution for Inhalation Prescription Only Medicine179/045 Augmentin suspension GlaxoSmithKline SA (Pty) Ltd, South Africa Suspension for Oral Use Prescription Only Medicine179/046 Augmentin BD SF suspension GlaxoSmithKline SA (Pty) Ltd, South Africa Suspension for Oral Use Prescription Only Medicine179/049 Bactroban ointment GlaxoSmithKline SA (Pty) Ltd, South Africa Ointment topical Prescription Only Medicine179/051 Eltroxin tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine179/052 Eltroxin tablets GlaxoSmithKline SA (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine093/001 Candid B cream Glenmark Pharmaceuticals Ltd, India Cream Topical Prescription Only Medicine093/002 Candid B lotion Glenmark Pharmaceuticals Ltd, India Lotion for Topical Use Prescription Only Medicine093/003 Candid cream Glenmark Pharmaceuticals Ltd, India Cream Topical Prescription Only Medicine093/004 Candiderm cream Glenmark Pharmaceuticals Ltd, India Cream Topical Prescription Only Medicine093/005 Candid Dusting Powder Glenmark Pharmaceuticals Ltd, India Powder for Topical use Prescription Only Medicine093/006 Candid Ear drops Glenmark Pharmaceuticals Ltd, India Solution for Topical Use Prescription Only Medicine093/007 Candid lotion Glenmark Pharmaceuticals Ltd, India Lotion for Topical Use Prescription Only Medicine093/008 Candid Mouth Paint Glenmark Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine093/009 Candid TV suspension Glenmark Pharmaceuticals Ltd, India Lotion for Topical Use Prescription Only Medicine093/010 Candid V gel Glenmark Pharmaceuticals Ltd, India Gel Vaginal Prescription Only Medicine093/011 CandidV-1 Vaginal tablets Glenmark Pharmaceuticals Ltd, India Tablet Vaginal Prescription Only Medicine093/012 CandidV-3 Vaginal tablets Glenmark Pharmaceuticals Ltd, India Tablet Vaginal Prescription Only Medicine093/013 Candid V-6 Vaginal tablets Glenmark Pharmaceuticals Ltd, India Tablet Vaginal Prescription Only Medicine093/014 Diziron tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/015 Scaboma cream Glenmark Pharmaceuticals Ltd, India Cream Topical Pharmacy Medicine093/016 Scaboma lotion Glenmark Pharmaceuticals Ltd, India Lotion for Topical Use Pharmacy Medicine093/017 Supricort cream Glenmark Pharmaceuticals Ltd, India Cream Topical Prescription Only Medicine093/018 Supricort N cream Glenmark Pharmaceuticals Ltd, India Cream Topical Prescription Only Medicine093/019 Supricort Skin lotion Glenmark Pharmaceuticals Ltd, India Lotion for Topical Use Prescription Only Medicine

PRA Secretariat / January 2009 26

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

093/020 Syntran DS tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/021 Syntran Paediatric syrup Glenmark Pharmaceuticals Ltd, India Syrup Prescription Only Medicine093/022 Vorth 10 tablets Glenmark Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine093/023 Vorth 20 tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/024 Deriva aqueous gel Glenmark Pharmaceuticals Ltd, India Gel Topical Pharmacy Medicine093/025 Rosicon-2mg tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/026 Rosicon-4 tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/027 Mumfer syrup Glenmark Pharmaceuticals Ltd, India Syrup Pharmacy Medicine093/028 Mumfer drops Glenmark Pharmaceuticals Ltd, India Solution for Oral Use Pharmacy Medicine093/029 Esoz tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/031 Glevo-250 tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/032 Glevo-500 tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/033 Glevo 500 infusion Glenmark Pharmaceuticals Ltd, India Solution for infusion Prescription Only Medicine093/034 Powercort cream Glenmark Pharmaceuticals Ltd, India Cream Topical Prescription Only Medicine093/035 Mumfer chewable tab Glenmark Pharmaceuticals Ltd, India Tablet Chewable Pharmacy Medicine093/036 Alovera cream Glenmark Pharmaceuticals Ltd, India Cream Topical Pharmacy Medicine093/038 Relcer Gel suspension Glenmark Pharmaceuticals Ltd, India Suspension for Oral Use Pharmacy Medicine093/039 Glenseng capsules Glenmark Pharmaceuticals Ltd, India Capsule oral General Sale093/040 Ascoril Expectorant Glenmark Pharmaceuticals Ltd, India Solution for Oral Use Prescription Only Medicine093/041 Altacef suspension Glenmark Pharmaceuticals Ltd, India Powder for Oral

SuspensionPrescription Only Medicine

093/042 Altacef tablets Glenmark Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine093/043 Altacef tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/044 Ciproglen tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/045 Glimulin tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/046 Enamate 10 tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/047 Altacef 750 injection Glenmark Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine093/049 Glucar tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/050 Erythromycin tablets Glenmark Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine093/051 Perigard 2 tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/052 Perigard 4 tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/053 Telma 20 tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/054 Telma 40 tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/055 Telma-H tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/056 Valus AP tablets Glenmark Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine093/057 Doxetaxel injection Glenmark Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine093/058 Doxetaxel injection Glenmark Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine093/061 Oxaliplatino Servycal injection Glenmark Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine093/063 Doxorubicina Servycal injection Glenmark Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine093/064 Doxorubicina Servycal injection Glenmark Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine093/065 Carboplastino Servycal injection Glenmark Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine093/066 Carboplastino Servycal injection Glenmark Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine093/067 Paclitaxel Servycal injection Glenmark Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine093/068 Paclitaxel Servycal injection Glenmark Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine093059 Irinotecan Servycal injection Glenmark Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine093060 Irinotecan Servycal injection Glenmark Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine093062 Oxaliplatino Servycal injection Glenmark Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine221/001 Ferrous sulphate tablets Glow Export Trading Pvt Ltd, India Tablet Uncoated Pharmacy Medicine221/002 Cetrol powder Glow Export Trading Pvt Ltd, India Powder for Oral Solution Pharmacy Medicine221/003 Artesunate tablets Glow Export Trading Pvt Ltd, India Tablet Uncoated Prescription Only Medicine221/004 G-Prop tablets Glow Export Trading Pvt Ltd, India Tablet Uncoated Prescription Only Medicine169/001 Pharmadar tablets Glumex Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine169/002 Eryomycin syrup Glumex Pharmaceuticals (Pvt) Ltd, India Syrup Prescription Only Medicine169/003 C.P.Mex syrup Glumex Pharmaceuticals (Pvt) Ltd, India Syrup Pharmacy Medicine169/004 Glucain tablets Glumex Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated General Sale169/005 Pharmadar suspension Glumex Pharmaceuticals (Pvt) Ltd, India Suspension for Oral Use Pharmacy Medicine169/006 Biovit-Z-syrup Glumex Pharmaceuticals (Pvt) Ltd, India Syrup Pharmacy Medicine

27 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

169/007 Cold care tablets Glumex Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine169/008 Gluvit syrup Glumex Pharmaceuticals (Pvt) Ltd, India Syrup Pharmacy Medicine169/009 Ketomex tablets Glumex Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine169/010 Lopamet capsules Glumex Pharmaceuticals (Pvt) Ltd, India Capsule oral Pharmacy Medicine169/011 Apectin tablets Glumex Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine169/012 Clopin syrup Glumex Pharmaceuticals (Pvt) Ltd, India Powder for Oral Solution Prescription Only Medicine169/013 Cephamex syrup Glumex Pharmaceuticals (Pvt) Ltd, India Powder for Oral Solution Prescription Only Medicine169/014 Flucomex capsules Glumex Pharmaceuticals (Pvt) Ltd, India Capsule oral Prescription Only Medicine169/015 Eromycin tablets Glumex Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine169/016 Ketomex suspension Glumex Pharmaceuticals (Pvt) Ltd, India Suspension for Oral Use Prescription Only Medicine169/017 Amiloride and hydrochlorothiazide tablets Glumex Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine169/018 Methyldopa tablets Glumex Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine169/019 Zovex tablets Glumex Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine169/021 Paracetamol tablets Glumex Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine169/022 Pyridoxine tablets Glumex Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine169/023 Nalidiixic acid oral suspension Glumex Pharmaceuticals (Pvt) Ltd, India Suspension for Injection Prescription Only Medicine169/024 Aminophylline tablets Glumex Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine169/025 Glibenclamide tablets Glumex Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine169/026 Viengray tablets Glumex Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine169/027 Apectine syrup Glumex Pharmaceuticals (Pvt) Ltd, India Syrup Pharmacy Medicine169/028 Ebut capsules Glumex Pharmaceuticals (Pvt) Ltd, India Capsule oral Pharmacy Medicine165/001 Ibuprofen tablets Gracure Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine165/002 Asbaquine tablets Gracure Pharmaceuticals Ltd, India Tablet Film coated Pharmacy Medicine165/003 Ugiflox tablets Gracure Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine165/004 Folic Acid tablets Gracure Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine165/005 Citox 1000 injection Gracure Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine165/006 Multivitamin tablets Gracure Pharmaceuticals Ltd, India Tablet Uncoated General Sale165/007 New Ketax tablets Gracure Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine165/008 Clofen-25 tablets Gracure Pharmaceuticals Ltd, India Tablet Film coated Pharmacy Medicine165/009 Curiben tablets Gracure Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine165/010 Ciprofloxacin tablets Gracure Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine165/011 Paracetamol tablets Gracure Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine165/012 Ampicillin BP injection Gracure Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine165/013 Ampicillin capsules Gracure Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine165/014 Co-trimoxazole tablets Gracure Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine165/016 Rantid -150mg tablets Gracure Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine165/017 Metronidazole tablets Gracure Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine165/018 Kamestin Vaginal tablets Gracure Pharmaceuticals Ltd, India Tablet Vaginal Prescription Only Medicine261/001 Polyinosinic-polycytidylic acid injection Guangdong Bang Min Pharmaceutical Co.

Ltd,ChinaSolution for Injection Prescription Only Medicine

043/001 Artescore for children tablets Guilin Pharmaceuticals Co Ltd,China Tablet Uncoated Prescription Only Medicine043/002 Artescore tablets Guilin Pharmaceuticals Co Ltd,China Tablet Uncoated Prescription Only Medicine190/001 Chlorpheniramine tablets Healthy Life Pharma (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine190/002 Hecmetro 200 tablets Healthy Life Pharma (Pvt) Ltd, India Tablet Film coated Prescription Only Medicine190/003 Jantrax tablets Healthy Life Pharma (Pvt) Ltd, India Tablet Film coated General Sale190/004 Cold plus syrup Healthy Life Pharma (Pvt) Ltd, India Syrup General Sale190/005 Trimoxazole Oral suspension Healthy Life Pharma (Pvt) Ltd, India Suspension for Oral Use Prescription Only Medicine190/006 Citrovit syrup Healthy Life Pharma (Pvt) Ltd, India Syrup General Sale190/007 Cirogan syrup Healthy Life Pharma (Pvt) Ltd, India Syrup Prescription Only Medicine190/008 Anmol syrup Healthy Life Pharma (Pvt) Ltd, India Syrup General Sale190/009 Mebendazole oral suspension Healthy Life Pharma (Pvt) Ltd, India Suspension for Oral Use Pharmacy Medicine190/011 Kofex syrup Healthy Life Pharma (Pvt) Ltd, India Syrup Pharmacy Medicine190/012 Dextrose 50%w/v injection Healthy Life Pharma (Pvt) Ltd, India Solution for Injection Prescription Only Medicine190/013 Chloramphenicol sodium injection Healthy Life Pharma (Pvt) Ltd, India Powder for Injection Prescription Only Medicine190/014 Ibuprofen tablets Healthy Life Pharma (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine190/015 Kofmint syrup Healthy Life Pharma (Pvt) Ltd, India Syrup Pharmacy Medicine190/016 Kofex cough tablets Healthy Life Pharma (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine

PRA Secretariat / January 2009 28

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

190/017 Dexamethasone ear/eye drops Healthy Life Pharma (Pvt) Ltd, India Ear/Eye Drops Prescription Only Medicine190/018 Betnew Ear/Eye drops Healthy Life Pharma (Pvt) Ltd, India Ear/Eye Drops Prescription Only Medicine190/019 Indometacin capsules Healthy Life Pharma (Pvt) Ltd, India Capsule oral Pharmacy Medicine190/020 Amoxicillin Oral suspension Healthy Life Pharma (Pvt) Ltd, India Suspension for Oral Use Prescription Only Medicine190/021 Erythromycin Estolate suspension Healthy Life Pharma (Pvt) Ltd, India Suspension for Oral Use Prescription Only Medicine190/022 Vita+ iron tablets Healthy Life Pharma (Pvt) Ltd, India Tablet Uncoated General Sale150/001 Zido-H 300 tablets Hetero Drugs Ltd, India Tablet Uncoated Prescription Only Medicine150/002 Heptavir 150 tablets Hetero Drugs Ltd, India Tablet Uncoated Prescription Only Medicine150/003 Indivir -400 capsules Hetero Drugs Ltd, India Capsule oral Prescription Only Medicine150/004 Stag-30 capsules Hetero Drugs Ltd, India Capsule oral Prescription Only Medicine150/005 Stag 40 capsules Hetero Drugs Ltd, India Capsule oral Prescription Only Medicine150/006 Nevivir 200 tablets Hetero Drugs Ltd, India Tablet Uncoated Prescription Only Medicine150/007 Zidolam tablets Hetero Drugs Ltd, India Tablet Uncoated Prescription Only Medicine150/008 Nevilast 30 tablets Hetero Drugs Ltd, India Tablet Uncoated Prescription Only Medicine150/009 Nevilast - 40 tablets Hetero Drugs Ltd, India Tablet Uncoated Prescription Only Medicine150/010 Zidolam-N tablets Hetero Drugs Ltd, India Tablet Uncoated Prescription Only Medicine150/011 Estiva-600 tablets Hetero Drugs Ltd, India Tablet Uncoated Prescription Only Medicine157/001 Cycloz Ophthalmic ointment Highnoon Laboratories Ltd, Pakistan Eye Ointment Prescription Only Medicine157/002 Cycloz cream Highnoon Laboratories Ltd, Pakistan Cream Topical Prescription Only Medicine157/003 Cycloz tablets Highnoon Laboratories Ltd, Pakistan Tablet Uncoated Prescription Only Medicine157/004 Loprin tablets Highnoon Laboratories Ltd, Pakistan Tablet Uncoated Prescription Only Medicine157/005 Loprin tablets Highnoon Laboratories Ltd, Pakistan Tablet Uncoated General Sale157/006 Loprin tablets Highnoon Laboratories Ltd, Pakistan Tablet Uncoated General Sale157/007 Evacef suspension Highnoon Laboratories Ltd, Pakistan Suspension for Oral Use Prescription Only Medicine157/008 Evacef suspension Highnoon Laboratories Ltd, Pakistan Suspension for Oral Use Prescription Only Medicine157/009 Tramadol injection Highnoon Laboratories Ltd, Pakistan Solution for Injection Prescription Only Medicine157/010 Griseofulvin tablets Highnoon Laboratories Ltd, Pakistan Tablet Uncoated Prescription Only Medicine157/011 Ciprofloxacin tablets Highnoon Laboratories Ltd, Pakistan Tablet Uncoated Prescription Only Medicine157/012 Cyprocin tablets Highnoon Laboratories Ltd, Pakistan Tablet Uncoated Prescription Only Medicine157/013 Tamadol capsules Highnoon Laboratories Ltd, Pakistan Capsule oral Prescription Only Medicine157/014 Tramadol injection Highnoon Laboratories Ltd, Pakistan Solution for Injection Prescription Only Medicine146/001 Beprosone cream Hoe Pharmaceuticals Sdn BHD, Malaysia Cream Topical Prescription Only Medicine146/002 Beprosone ointment Hoe Pharmaceuticals Sdn Bhd, Malaysia Ointment topical Prescription Only Medicine146/003 Beprogel topical solution Hoe Pharmaceuticals Sdn Bhd, Malaysia Solution for Topical Use Prescription Only Medicine146/004 Beprosalic ointment Hoe Pharmaceuticals Sdn Bhd, Malaysia Ointment topical Prescription Only Medicine146/005 Cloderm cream Hoe Pharmaceuticals Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine146/006 Cloderm ointment Hoe Pharmaceuticals Sdn Bhd, Malaysia Ointment topical Prescription Only Medicine146/007 Cloderm scalp application solution Hoe Pharmaceuticals Sdn Bhd, Malaysia Solution for Topical Use Prescription Only Medicine146/008 Candazole cream Hoe Pharmaceuticals Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine146/009 Candazole lotion Hoe Pharmaceuticals Sdn Bhd, Malaysia Solution for Topical Use Prescription Only Medicine146/010 Candacort cream Hoe Pharmaceuticals Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine146/011 Ecocort cream Hoe Pharmaceuticals Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine146/012 Dezor cream Hoe Pharmaceuticals Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine146/013 Dezor shampoo Hoe Pharmaceuticals Sdn Bhd, Malaysia Shampoo Prescription Only Medicine146/014 Decozol cream Hoe Pharmaceuticals Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine146/015 Decocort cream Hoe Pharmaceuticals Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine146/017 Tolnaderm lotion Hoe Pharmaceuticals Sdn Bhd, Malaysia Lotion for Topical Use Prescription Only Medicine146/018 foban cream Hoe Pharmaceuticals Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine146/019 Foban ointment Hoe Pharmaceuticals Sdn Bhd, Malaysia Ointment topical Prescription Only Medicine146/020 Fobancort ointment Hoe Pharmaceuticals Sdn Bhd, Malaysia Ointment topical Prescription Only Medicine146/021 Declovir cream Hoe Pharmaceuticals Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine146/022 A-Lices shampoo Hoe Pharmaceuticals Sdn Bhd, Malaysia Solution for Topical Use Pharmacy Medicine146/023 Gentamicin cream Hoe Pharmaceuticals Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine146/024 Beprosalic lotion Hoe Pharmaceuticals Sdn Bhd, Malaysia Lotion for Topical Use Prescription Only Medicine146/027 Poviderm ointment Hoe Pharmaceuticals Sdn Bhd, Malaysia Ointment topical General Sale146/028 U-closone ointment Hoe Pharmaceuticals Sdn Bhd, Malaysia Ointment topical Prescription Only Medicine146/029 Menzze cream Hoe Pharmaceuticals Sdn Bhd, Malaysia Cream Topical Pharmacy Medicine

29 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

146/030 Zellox-DS suspension Hoe Pharmaceuticals Sdn Bhd, Malaysia Suspension for Oral Use Prescription Only Medicine146/031 Rhuma gel Hoe Pharmaceuticals Sdn Bhd, Malaysia Gel Topical Pharmacy Medicine146/032 C-mycin gel Hoe Pharmaceuticals Sdn Bhd, Malaysia Gel Topical Prescription Only Medicine146/033 C-mycin lotion Hoe Pharmaceuticals Sdn Bhd, Malaysia Lotion for Topical Use Prescription Only Medicine146/034 H-cort ointment Hoe Pharmaceuticals Sdn Bhd, Malaysia Ointment topical Prescription Only Medicine146/035 Beprogent cream Hoe Pharmaceuticals Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine146/036 oxy-nase nasal spray Hoe Pharmaceuticals Sdn Bhd, Malaysia Spray For Nasal Use Prescription Only Medicine146/037 Oxy-nase drops Hoe Pharmaceuticals Sdn Bhd, Malaysia Nasal drops Prescription Only Medicine146/038 Oxy-Nase nasal spray Hoe Pharmaceuticals Sdn Bhd, Malaysia Spray For Nasal Use Prescription Only Medicine146/039 U-closone cream Hoe Pharmaceuticals Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine146/040 Orrepaste oral paste Hoe Pharmaceuticals Sdn Bhd, Malaysia Oral paste Prescription Only Medicine225/001 Cloveg tablets Household Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine225/002 Cloveg 1%cream Household Pharmaceuticals Ltd, India Cream Topical Prescription Only Medicine225/003 Trioderm cream Household Pharmaceuticals Ltd, India Cream Topical Prescription Only Medicine173/001 Ampigran granules for suspension Hovid Sdn Bhd, Malaysia Granules for Suspension Prescription Only Medicine173/002 Griseofulvin 500 tablets Hovid Sdn Bhd, Malaysia Tablet Uncoated Prescription Only Medicine173/003 Nutrivit syrup Hovid Sdn Bhd, Malaysia Syrup General Sale173/004 Hostan 250 capsules Hovid Sdn Bhd, Malaysia Capsule oral Prescription Only Medicine173/006 Prozotab tablets Hovid Sdn Bhd, Malaysia Tablet Uncoated Prescription Only Medicine173/007 Amoxiclav 625 tablets Hovid Sdn Bhd, Malaysia Tablet Film coated Prescription Only Medicine173/008 Nizole tablets Hovid Sdn Bhd, Malaysia Tablet Uncoated Prescription Only Medicine173/009 Feloxicam 20 capsules Hovid Sdn Bhd, Malaysia Capsule oral Prescription Only Medicine173/010 Clofenac SR tablets Hovid Sdn Bhd, Malaysia Tablet Film coated Pharmacy Medicine173/011 Clofenac 50 SR tablets Hovid Sdn Bhd, Malaysia Tablet sustained release Pharmacy Medicine173/012 Amoxicap 250mg capsules Hovid Sdn Bhd, Malaysia Capsule oral Prescription Only Medicine173/013 Suprim 480 tablets Hovid Sdn Bhd, Malaysia Tablet Uncoated Prescription Only Medicine173/014 Thelmin tablets Hovid Sdn Bhd, Malaysia Tablet Film coated Pharmacy Medicine173/015 Ternolol tablets Hovid Sdn Bhd, Malaysia Tablet Uncoated Prescription Only Medicine173/016 Chloramphenicol eye drops Hovid Sdn Bhd, Malaysia Eye Drops Prescription Only Medicine173/017 Ternolol 50 tablets Hovid Sdn Bhd, Malaysia Tablet Film coated Prescription Only Medicine173/018 Dapatab M 250 tablets Hovid Sdn Bhd, Malaysia Tablet Film coated Prescription Only Medicine173/019 Omezole 20 capsules Hovid Sdn Bhd, Malaysia Capsule oral Prescription Only Medicine173/020 Horamine syrup Hovid Sdn Bhd, Malaysia Syrup Pharmacy Medicine173/021 Hopranolol tablets Hovid Sdn Bhd, Malaysia Tablet Film coated Prescription Only Medicine173/023 Norelut tablets Hovid Sdn Bhd, Malaysia Tablet Uncoated Prescription Only Medicine173/024 Hovid Cod Liver Oil capsule Hovid Sdn Bhd, Malaysia Capsule oral General Sale173/025 Hovid Vitamin E Calcium capsules Hovid Sdn Bhd, Malaysia Capsule oral Prescription Only Medicine173/026 Ampicap 250 capsules Hovid Sdn Bhd, Malaysia Capsule oral Prescription Only Medicine173/027 Virest 200mg tablet Hovid Sdn Bhd, Malaysia Tablet Film coated Prescription Only Medicine173/028 Tinazole 2% cream Hovid Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine173/029 Celexin capsules Hovid Sdn Bhd, Malaysia Capsule oral Prescription Only Medicine173/030 Doxicap capsules Hovid Sdn Bhd, Malaysia Capsule oral Prescription Only Medicine173/031 Tetracap 250mg capsules Hovid Sdn Bhd, Malaysia Capsule oral Prescription Only Medicine173/032 Cortisone cream Hovid Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine173/033 Virest cream Hovid Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine173/034 Betasone cream Hovid Sdn Bhd, Malaysia Cream Topical Prescription Only Medicine173/035 Ventamol 2mg tablets Hovid Sdn Bhd, Malaysia Tablet Uncoated Prescription Only Medicine173/036 Ventamol 4mg tablets Hovid Sdn Bhd, Malaysia Tablet Uncoated Prescription Only Medicine173/037 Prednisolone tablets Hovid Sdn Bhd, Malaysia Tablet Uncoated Prescription Only Medicine173/038 Hostan Paediatric suspension Hovid Sdn Bhd, Malaysia Suspension for Oral Use Prescription Only Medicine173/039 Neurovit tablets Hovid Sdn Bhd, Malaysia Tablet Uncoated Pharmacy Medicine173/040 Colodium capsules Hovid Sdn Bhd, Malaysia Capsule oral Pharmacy Medicine173/041 Hovid Betaton capsules Hovid Sdn Bhd, Malaysia Capsule oral Pharmacy Medicine173/042 Erotab Erythromycin tablets Hovid Sdn Bhd, Malaysia Tablet Film coated Prescription Only Medicine173/043 Cloxamp 250mg capsules Hovid Sdn Bhd, Malaysia Capsule oral Prescription Only Medicine173/044 Ventamol syrup Hovid Sdn Bhd, Malaysia Syrup Prescription Only Medicine173/045 Diabetmin tablets Hovid Sdn Bhd, Malaysia Tablet Film coated Prescription Only Medicine

PRA Secretariat / January 2009 30

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

173/046 Amoxigram granules Hovid Sdn Bhd, Malaysia Granules for Oral Use Prescription Only Medicine173/047 Ketoconazole tablets Hovid Sdn Bhd, Malaysia Tablet Uncoated Prescription Only Medicine173/048 Colospan tablets Hovid Sdn Bhd, Malaysia Tablet Film coated Prescription Only Medicine173/049 Clamide-5 tablets Hovid Sdn Bhd, Malaysia Tablet Uncoated Prescription Only Medicine222/001 Praziquantel tablets IDA Foundation, The Netherlands Tablet Uncoated Prescription Only Medicine260/001 Clarie-250 tablets Ind-Swift Ltd, India Tablet Uncoated Prescription Only Medicine260/002 Netazox 500 tablets Ind-Swift Ltd, India Tablet Uncoated Prescription Only Medicine260/003 Netazox oral suspension Ind-Swift Ltd, India Suspension for Oral Use Prescription Only Medicine260/004 Candez 4 tablets Ind-Swift Ltd, India Tablet Uncoated Prescription Only Medicine152/001 Metaplex syrup Indoco Remedies Ltd, India Syrup General Sale152/002 Flamar cream Indoco Remedies Ltd, India Cream Topical Pharmacy Medicine152/003 Indo 250 tablets Indoco Remedies Ltd, India Tablet Film coated Prescription Only Medicine152/004 Concise 50 tablets Indoco Remedies Ltd, India Tablet Uncoated Prescription Only Medicine152/005 Ciprind 250 tablets Indoco Remedies Ltd, India Tablet Uncoated Prescription Only Medicine152/006 Nimind tablets Indoco Remedies Ltd, India Tablet Uncoated Prescription Only Medicine152/007 Dexoren Eye/Ear drops Indoco Remedies Ltd, India Ear/Eye Drops Prescription Only Medicine152/008 Tamigen Eye/Ear drops Indoco Remedies Ltd, India Ear/Eye Drops Prescription Only Medicine152/009 Atropen-P eye drops Indoco Remedies Ltd, India Eye Drops Prescription Only Medicine085/002 Dicloflame tablets Intas International Pharmaceuticals Co. Ltd,

IndiaTablet Enteric Coated Pharmacy Medicine

085/003 Presilone tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/004 Methyldopa tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/005 Amoxycillin tablets Intas International Pharmaceuticals Co. Ltd, India

Capsule oral Prescription Only Medicine

085/006 Intacillin tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/007 Binimycin tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/008 Asthamol tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/009 Intrim 480 tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/010 Piroflame tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/011 Intafen tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Pharmacy Medicine

085/012 Intalol 100mg tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/015 Intalol tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/017 Spasmine injection Intas International Pharmaceuticals Co. Ltd, India

Solution for Injection Prescription Only Medicine

085/018 Ranloc tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Film coated Prescription Only Medicine

085/019 Carditas retard tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Film coated Prescription Only Medicine

085/020 Monit-10 tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/021 Monit-20 tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/023 Astem-10 tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Pharmacy Medicine

085/024 Enapril - 10mg tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/025 Enapril 5mg tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/026 FCN tablets Intas International Pharmaceuticals Co. Ltd, India

Capsule oral Prescription Only Medicine

31 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

085/027 Kwinil-300 tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Film coated Prescription Only Medicine

085/028 Intagenta injection Intas International Pharmaceuticals Co. Ltd, India

Solution for Injection Prescription Only Medicine

085/029 Dicloflame injection Intas International Pharmaceuticals Co. Ltd, India

Solution for Injection Prescription Only Medicine

085/030 Ciflox tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/031 Malostat tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/032 Zen-200 tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/033 Cimecid tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/035 Doxytas capsules Intas International Pharmaceuticals Co. Ltd, India

Capsule oral Prescription Only Medicine

085/038 Meflostats tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/039 Praziquantel tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/040 Rifampicin+Isoniazid tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Prescription Only Medicine

085/041 Spasmintas-10 tablets Intas International Pharmaceuticals Co. Ltd, India

Tablet Enteric Coated Prescription Only Medicine

085/043 Intavita capsules Intas International Pharmaceuticals Co. Ltd, India

Tablet Uncoated Pharmacy Medicine

057/701V Colexin pump solution Interchemie werkende Adelaar, BV, Holland Solution for Oral Use Prescription Only Medicine057/702V Glucort-20 injection Interchemie werkende Adelaar, BV, Holland Solution for Injection Prescription Only Medicine057/703V Introvit WS powder Interchemie werkende Adelaar, BV, Holland Powder for Oral Solution Pharmacy Medicine057/704V Intrafer-100 injection Interchemie werkende Adelaar, BV, Holland Solution for Injection Prescription Only Medicine057/705V Sulfadimidin WS powder Interchemie werkende Adelaar, BV, Holland Powder for Oral Solution Prescription Only Medicine057/706V Limoxin-200LA injection Interchemie werkende Adelaar, BV, Holland Solution for Injection Prescription Only Medicine057/707V LIMOXIN-100 injection Interchemie werkende Adelaar, BV, Holland Solution for Injection Prescription Only Medicine057/708V Intermectin injection Interchemie werkende Adelaar, BV, Holland Solution for Injection Prescription Only Medicine155/001 Mims Co-trimoxazole tablets International Drug Company Ltd, Zambia Tablet Uncoated Prescription Only Medicine155/002 Mims Pain Rub ointment International Drug Company Ltd, Zambia Ointment topical General Sale155/003 Mims Antacid suspension International Drug Company Ltd, Zambia Suspension for Oral Use Pharmacy Medicine155/004 Mims Children Cough syrup International Drug Company Ltd, Zambia Syrup General Sale155/005 Mims metronidazole tablets International Drug Company Ltd, Zambia Tablet Uncoated Prescription Only Medicine155/006 Mims vitamin B complex tablets International Drug Company Ltd, Zambia Tablet Uncoated Pharmacy Medicine155/007 Mims Co-trimoxazole suspension International Drug Company Ltd, Zambia Suspension for Oral Use Prescription Only Medicine155/008 Mims No-Coff syrup International Drug Company Ltd, Zambia Syrup General Sale155/009 Mims Fastamol syrup International Drug Company Ltd, Zambia Syrup General Sale155/010 Mims Gripe Water solution International Drug Company Ltd, Zambia Solution for Oral Use General Sale155/011 Mims Pheniramine tablets International Drug Company Ltd, Zambia Tablet Uncoated Pharmacy Medicine155/012 Mims Salbutamol syrup International Drug Company Ltd, Zambia Syrup Prescription Only Medicine155/013 Mims GV Paint suspension International Drug Company Ltd, Zambia Suspension Pharmacy Medicine155/014 Mims Whitefield ointment International Drug Company Ltd, Zambia Ointment topical Pharmacy Medicine155/016 Mims Metronidazole suspension International Drug Company Ltd, Zambia Suspension for Oral Use Prescription Only Medicine155/017 Dextrose 5% intravenous fluid International Drug Company Ltd, Zambia Solution for infusion Prescription Only Medicine155/018 Sodium Chloride intravenous fluid International Drug Company Ltd, Zambia Solution for infusion Prescription Only Medicine155/019 Darrows solution for injection International Drug Company Ltd, Zambia Solution for infusion Prescription Only Medicine155/020 Ringer’s Lactate intravenous fluid International Drug Company Ltd, Zambia Solution for infusion Prescription Only Medicine155/021 Dextrose Intravenous fluid International Drug Company Ltd, Zambia Solution for Injection Prescription Only Medicine155/022 Dextrose2.5%+half strength darrows i.v

infusionInternational Drug Company Ltd, Zambia Solution for Injection Prescription Only Medicine

155/023 Dextrose + sodium chloride infusion International Drug Company Ltd, Zambia Solution for infusion Prescription Only Medicine155/024 Mims Idphen syrup International Drug Company Ltd, Zambia Solution for Oral Use Pharmacy Medicine155/025 Mims mutivitamins syrup International Drug Company Ltd, Zambia Syrup General Sale

PRA Secretariat / January 2009 32

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

155/026 Mims Benzyl Benzoate Application 25% w/w

International Drug Company Ltd, Zambia Solution for Topical Use Pharmacy Medicine

155/027 Mims Phenamine syrup International Drug Company Ltd, Zambia Syrup Pharmacy Medicine155/028 Fenelyn expectorant International Drug Company Ltd, Zambia Solution for Oral Use Pharmacy Medicine155/029 Mims Promine elixir International Drug Company Ltd, Zambia Elixir Pharmacy Medicine155/030 Mims Calamine lotion International Drug Company Ltd, Zambia Solution for Topical Use Pharmacy Medicine155/031 Mims Peppermint Coughs and Cold syrup International Drug Company Ltd, Zambia Syrup Pharmacy Medicine155/032 Mims Zinc &Castor Oil ointment International Drug Company Ltd, Zambia Ointment topical Pharmacy Medicine155/033 Mims vapour rub ointment International Drug Company Ltd, Zambia Ointment topical General Sale114/001 Butafen-400 tablets Ipca Laboratories Ltd, India Tablet Enteric Coated Pharmacy Medicine114/002 Butafen-200 tablets Ipca Laboratories Ltd, India Tablet Uncoated Pharmacy Medicine114/003 Cimet -200 tablets Ipca Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine114/004 Cimet -400 tablets Ipca Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine114/005 Chloramphenicol capsules Ipca Laboratories Ltd, India Capsule oral Prescription Only Medicine114/006 Tetracycline 250mg capsules. Ipca Laboratories Ltd, India Capsule oral Prescription Only Medicine114/007 Giardyl suspension Ipca Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine114/008 Nebagin injection Ipca Laboratories Ltd, India Solution for Injection Prescription Only Medicine114/009 Prednisolone tablets Ipca Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine114/010 Metoclopromide solution Ipca Laboratories Ltd, India Solution for Oral Use Prescription Only Medicine114/011 Perinan injection Ipca Laboratories Ltd, India Solution for Injection Prescription Only Medicine114/012 Nemocid tablets Ipca Laboratories Ltd, India Tablet Uncoated Pharmacy Medicine114/013 pyrantel pamoate suspension Ipca Laboratories Ltd, India Suspension for Oral Use Pharmacy Medicine114/014 Erythromycin suspension Ipca Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine114/015 Pacimol tablets Ipca Laboratories Ltd, India Tablet Uncoated Pharmacy Medicine114/016 Pacimol syrup Ipca Laboratories Ltd, India Syrup General Sale114/017 Hydroxy chloroquine tablets Ipca Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine114/018 Clarbact tablets Ipca Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine114/019 Clarbact 500 tablets Ipca Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine114/020 Normax tablets Ipca Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine114/021 Stericef injection Ipca Laboratories Ltd, India Powder for Injection Prescription Only Medicine114/022 Larither 40 injection Ipca Laboratories Ltd, India Solution for Injection Prescription Only Medicine114/023 Cincoma injection Ipca Laboratories Ltd, India Solution for Injection Prescription Only Medicine114/024 Imox trihydrate capsules Ipca Laboratories Ltd, India Capsule oral Prescription Only Medicine114/025 Imox dry syrup Ipca Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine114/026 Ipcacillin capsules Ipca Laboratories Ltd, India Capsule oral Prescription Only Medicine114/027 Ipcavite-m Ipca Laboratories Ltd, India Syrup General Sale114/028 Laridox tablets Ipca Laboratories Ltd, India Tablet Uncoated Pharmacy Medicine114/029 Larither-80 injection Ipca Laboratories Ltd, India Solution for Injection Prescription Only Medicine114/030 Procip-250 capsules Ipca Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine114/031 Tenolol tablets Ipca Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine114/032 Tenolol-50 tablets Ipca Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine114/033 Zerodol tablets Ipca Laboratories Ltd, India Tablet Uncoated Pharmacy Medicine114/034 Lumerax 20/120 tablets Ipca Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine114/035 Pari -cr 12.5 tablets Ipca Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine114/036 Pari-cr 25 tablets Ipca Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine114/037 Lisoril-5 tablets Ipca Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine004/001 Beclasone CFC free metered doses

InhalerIvax Pharma Ireland, Ireland Powder for Inhalation Prescription Only Medicine

004/002 Salmol CFC free metered dose inhaler Ivax Pharma Ireland, Ireland Powder for Inhalation Prescription Only Medicine004/003 Haycrom aquous eye drops Ivax Pharma Ireland, Ireland Eye Drops Prescription Only Medicine004/004 Warfarin tablets Ivax Pharma Ireland, Ireland Tablet Uncoated Prescription Only Medicine189/001 Ivytimol Eye drops Ivee Aqua EPZ Ltd, Kenya Eye Drops Prescription Only Medicine189/002 Ivygentacin eye/ear drops Ivee Aqua EPZ Ltd, Kenya Ear/Eye Drops Prescription Only Medicine189/003 Ivyphenicol eye drops Ivee Aqua EPZ Ltd, Kenya Eye Drops Prescription Only Medicine189/004 Ivyzoxam Eye/Ear drops Ivee Aqua EPZ Ltd, Kenya Ear/Eye Drops Prescription Only Medicine189/005 Ivynoraxine Eye/Ear drops Ivee Aqua EPZ Ltd, Kenya Ear/Eye Drops Prescription Only Medicine189/006 Ivydexone Eye drops Ivee Aqua EPZ Ltd, Kenya Eye Drops Prescription Only Medicine

33 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

189/007 Ivysone Ophthalmic solution Ivee Aqua EPZ Ltd, Kenya Eye Drops Prescription Only Medicine189/008 Ivysolone opthlamic suspension Ivee Aqua EPZ Ltd, Kenya Eye Suspension Prescription Only Medicine189/009 Ivydexnicol eye drops Ivee Aqua EPZ Ltd, Kenya Eye Drops Prescription Only Medicine189/010 Ivydexgent Eye/Ear drops Ivee Aqua EPZ Ltd, Kenya Ear/Eye Drops Prescription Only Medicine189/011 Ivydexneocin Eye/Ear drops Ivee Aqua EPZ Ltd, Kenya Ear/Eye Drops Prescription Only Medicine189/012 Ivytimol eye drops Ivee Aqua EPZ Ltd, Kenya Eye Drops Prescription Only Medicine189/013 Ivysine Eye drops Ivee Aqua EPZ Ltd, Kenya Eye Drops Prescription Only Medicine189/014 Ivyzinc Eye drops Ivee Aqua EPZ Ltd, Kenya Eye Drops Prescription Only Medicine189/015 Ivuflur Eye drops Ivee Aqua EPZ Ltd, Kenya Eye Drops Prescription Only Medicine189/016 Ivymoicell Eye drops Ivee Aqua EPZ Ltd, Kenya Eye Drops Prescription Only Medicine189/017 Ivufrin for Nasal drops Ivee Aqua EPZ Ltd, Kenya Nasal drops Prescription Only Medicine189/018 Ivyfrin nasal drops Ivee Aqua EPZ Ltd, Kenya Nasal drops Prescription Only Medicine189/019 Ivynozvin adult drops Ivee Aqua EPZ Ltd, Kenya Nasal drops Prescription Only Medicine189/020 Ivyfrin peadiatric drops Ivee Aqua EPZ Ltd, Kenya Nasal drops Prescription Only Medicine189/021 Ivyfchlornicol ear drops drops Ivee Aqua EPZ Ltd, Kenya Ear Drops Prescription Only Medicine189/022 Ivybetasone Eye drops Ivee Aqua EPZ Ltd, Kenya Eye Drops Prescription Only Medicine189/023 Ivybetaneocin Eye/Ear drops Ivee Aqua EPZ Ltd, Kenya Ear/Eye Drops Prescription Only Medicine189/024 Ivyxolol eye drops Ivee Aqua EPZ Ltd, Kenya Eye Drops Prescription Only Medicine189/025 Water For injection Ivee Aqua EPZ Ltd, Kenya Solution for Injection Prescription Only Medicine189/026 Ivycarp Eye drops Ivee Aqua EPZ Ltd, Kenya Eye Drops Prescription Only Medicine189/027 Ivycrom Eye drops Ivee Aqua EPZ Ltd, Kenya Ear Drops Prescription Only Medicine022/001 Spymal tablets JMB Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine022/002 Besix tablets JMB Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine022/003 Nystem tablets JMB Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine022/004 Multi mix tablets JMB Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine022/005 METROZ - 200 tablet JMB Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine022/006 Loperid capsules JMB Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine022/007 Kotrim tablets JMB Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine022/008 Frude tablets JMB Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine022/009 Flucoz-200 tablets JMB Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine022/010 Fego tablets JMB Pharmaceuticals Ltd, India Tablet Uncoated General Sale022/011 DS - 100 tablets JMB Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine022/012 Beco tablets JMB Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine022/013 Pentra-50 tablets JMB Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine022/014 Vitacy tablet JMB Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine048/001 Combatrin tablets Johnson $ Johnson (Pty) Ltd, South Africa Tablet Uncoated Pharmacy Medicine050/001 Visine original eye drops Johnson $ Johnson (Pty) Ltd, South Africa Eye Drops Pharmacy Medicine082/006 Oraldine mouth wash Johnson $ Johnson (Pty) Ltd, South Africa Solution for Oral Use General Sale082/007 Chaberlain’s cough remedy regular syrup Johnson $ Johnson (Pty) Ltd, South Africa Syrup Pharmacy Medicine082/008 Chaberlain’s cough remedy peppermint

syrupJohnson $ Johnson (Pty) Ltd, South Africa Syrup Pharmacy Medicine

082/026 Anusol suppositories Johnson $ Johnson (Pty) Ltd, South Africa Suppository Pharmacy Medicine082/031 Cool mint listerine mouth wash Johnson $ Johnson (Pty) Ltd, South Africa Solution for Oral Use General Sale082/032 Anusol ointment Johnson $ Johnson (Pty) Ltd, South Africa Ointment topical Pharmacy Medicine082/034 Listerine antiseptic mouthwash Johnson $ Johnson (Pty) Ltd, South Africa Solution for Oral Use General Sale082/039 Benylin wet cough methol syrup Johnson $ Johnson (Pty) Ltd, South Africa Syrup Pharmacy Medicine082/046 Benylin DMD Decongestant syrup Johnson $ Johnson (Pty) Ltd, South Africa Syrup Pharmacy Medicine082/047 Benylin Dry Cough syrup Johnson $ Johnson (Pty) Ltd, South Africa Syrup Pharmacy Medicine082/048 Benylin four flu liqiud Johnson $ Johnson (Pty) Ltd, South Africa Syrup Pharmacy Medicine082/049 Benylin with Codeine syrup Johnson $ Johnson (Pty) Ltd, South Africa Syrup Pharmacy Medicine082/050 Benylin Original Cough syrup Johnson $ Johnson (Pty) Ltd, South Africa Syrup Pharmacy Medicine082/051 Benylin Chest Cough syrup Johnson $ Johnson (Pty) Ltd, South Africa Syrup Pharmacy Medicine082/053 Tarter control listerine antiseptic

mouthwashJohnson $ Johnson (Pty) Ltd, South Africa Solution for Oral Use General Sale

082/054 Fresburst listerine mouthwash Johnson $ Johnson (Pty) Ltd, South Africa Solution for Oral Use General Sale098/001 Karbazole tablets Kamal International Ltd, India (Formerly

Simrone Pharmaceuticals Ltd)Tablet Uncoated Prescription Only Medicine

PRA Secretariat / January 2009 34

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

098/002 Kamlodipine tablets Kamal International Ltd, India (Formerly Simrone Pharmaceuticals Ltd)

Tablet Uncoated Prescription Only Medicine

098/003 Keto-200 tablets Kamal International Ltd, India (Formerly Simrone Pharmaceuticals Ltd)

Tablet Uncoated Prescription Only Medicine

098/004 For-flu tablets Kamal International Ltd, India (Formerly Simrone Pharmaceuticals Ltd)

Tablet Uncoated Pharmacy Medicine

098/005 Kamcold tablets Kamal International Ltd, India (Formerly Simrone Pharmaceuticals Ltd)

Tablet Uncoated Pharmacy Medicine

098/006 Power-apetite tablets Kamal International Ltd, India (Formerly Simrone Pharmaceuticals Ltd)

Tablet Uncoated Pharmacy Medicine

098/007 Kaonil tablets Kamal International Ltd, India (Formerly Simrone Pharmaceuticals Ltd)

Tablet Uncoated Prescription Only Medicine

098/008 Mixiderm cream Kamal International Ltd, India (Formerly Simrone Pharmaceuticals Ltd)

Cream Topical Prescription Only Medicine

098/009 Spironolactone tablets Kamal International Ltd, India (Formerly Simrone Pharmaceuticals Ltd)

Tablet Uncoated Prescription Only Medicine

098/010 Kafen 100 tablets Kamal International Ltd, India (Formerly Simrone Pharmaceuticals Ltd)

Tablet Uncoated Pharmacy Medicine

098/011 Griseofulvin tablets Kamal International Ltd, India (Formerly Simrone Pharmaceuticals Ltd)

Tablet Uncoated Prescription Only Medicine

098/012 Kamtrax tablets Kamal International Ltd, India (Formerly Simrone Pharmaceuticals Ltd)

Tablet Uncoated Pharmacy Medicine

098/013 Sure cream Kamal International Ltd, India (Formerly Simrone Pharmaceuticals Ltd)

Cream Topical Prescription Only Medicine

219/001 Boro Pearl cream Kamdhenu Agro-Chem Industries, India Cream Topical Pharmacy Medicine219/002HM Foot heal cream Kamdhenu Agro-Chem Industries, India Cream Topical General Sale219/003 Pain off cream Kamdhenu Agro-Chem Industries, India Cream Topical Pharmacy Medicine219/004HM Granny’s formula gel Kamdhenu Agro-Chem Industries, India Gel Topical Pharmacy Medicine255/001 Benzyl Penicillin injection Karnataka Antibiotics & Pharmaceuticals Ltd,

IndiaPowder for Injection Prescription Only Medicine

255/002 Benzyl Penicillin injection Karnataka Antibiotics & Pharmaceuticals Ltd, India

Powder for Injection Prescription Only Medicine

255/003 Ampicillin & Cloxacillin injection Karnataka Antibiotics & Pharmaceuticals Ltd, India

Powder for Injection Prescription Only Medicine

255/004 Cloxacillin injection Karnataka Antibiotics & Pharmaceuticals Ltd, India

Powder for Injection Prescription Only Medicine

255/005 Ampicillin 500 injection Karnataka Antibiotics & Pharmaceuticals Ltd, India

Powder for Injection Prescription Only Medicine

255/006 Cefotaxime 1g injection Karnataka Antibiotics & Pharmaceuticals Ltd, India

Powder for Injection Prescription Only Medicine

255/007 Cefotaxime 500mg injection Karnataka Antibiotics & Pharmaceuticals Ltd, India

Powder for Injection Prescription Only Medicine

255/008 Cefotaxime 250mg injection Karnataka Antibiotics & Pharmaceuticals Ltd, India

Powder for Injection Prescription Only Medicine

255/009 Procaine Penicillin injection Karnataka Antibiotics & Pharmaceuticals Ltd, India

Powder for Injection Prescription Only Medicine

255/010 Benzathine Penicillin injection Karnataka Antibiotics & Pharmaceuticals Ltd, India

Powder for Injection Prescription Only Medicine

255/011 Gentamycin sulphate injection Karnataka Antibiotics & Pharmaceuticals Ltd, India

Solution for Injection Prescription Only Medicine

255/012 Ampicillin 1000 injection Karnataka Antibiotics & Pharmaceuticals Ltd, India

Powder for Injection Prescription Only Medicine

007/001 Propranolol tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine007/002 Chlorapheniramine tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Pharmacy Medicine007/003 Cimetidine tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine007/004 Folic acid tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Pharmacy Medicine007/005 Tetracycline capsules Kausikh Therapeutics (P) Ltd, India Capsule oral Prescription Only Medicine007/006 Furosemide tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine007/007 Methydopa tablets Kausikh Therapeutics (P) Ltd, India Tablet Film coated Prescription Only Medicine007/008 Nifedipine tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine007/010 Aminophylline tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine

35 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

007/011 Ketoconazole tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine007/012 Penicillin V tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine007/013 Cloxacillin capsules Kausikh Therapeutics (P) Ltd, India Capsule oral Prescription Only Medicine007/014 Ampicillin capsules Kausikh Therapeutics (P) Ltd, India Capsule oral Prescription Only Medicine007/016 Omeprazole capsules Kausikh Therapeutics (P) Ltd, India Capsule oral Prescription Only Medicine007/017 Ampicillin and Cloxacillin capsules Kausikh Therapeutics (P) Ltd, India Capsule oral Prescription Only Medicine007/018 Hypocare-5 tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine007/019 Ayocare tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine007/020 Luxopril-20 tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine007/021 Luxcee 500 tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated General Sale007/022 Albendazole tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Pharmacy Medicine007/023 Capril tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine007/024 Domidome tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine007/025 Erythromycin tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine007/026 Paracetamol tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated General Sale007/027 Acyclvir tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine007/028 Acyclovir tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine007/029 Carbamazepine tablets Kausikh Therapeutics (P) Ltd, India Tablet Uncoated Prescription Only Medicine267/001 Emthex 50 injection Khandelwal Laboratories Pvt.Ltd, India Powder for Injection Prescription Only Medicine267/002 Oncomide 500 injection Khandelwal Laboratories Pvt.Ltd, India Powder for Injection Prescription Only Medicine267/003 Platinex 50 injection Khandelwal Laboratories Pvt.Ltd, India Powder for Injection Prescription Only Medicine267/004 Womastin injection Khandelwal Laboratories Pvt.Ltd, India Solution for Injection Prescription Only Medicine267/005 Urafil 50 injection Khandelwal Laboratories Pvt.Ltd, India Solution for Injection Prescription Only Medicine267/006 Mamofen 10 tablets Khandelwal Laboratories Pvt.Ltd, India Tablet Uncoated Prescription Only Medicine267/007 Mamofen 20 tablets Khandelwal Laboratories Pvt.Ltd, India Tablet Uncoated Prescription Only Medicine267/008 Zophost tablets Khandelwal Laboratories Pvt.Ltd, India Tablet Uncoated Prescription Only Medicine267/009 Anafortan tablets Khandelwal Laboratories Pvt.Ltd, India Tablet Film coated Prescription Only Medicine267/010 Converten 5 tablets Khandelwal Laboratories Pvt.Ltd, India Tablet Uncoated Prescription Only Medicine267/011 Allerfast 120 tablets Khandelwal Laboratories Pvt.Ltd, India Tablet Film coated Prescription Only Medicine267/012 Prenoxid 100 tablets Khandelwal Laboratories Pvt.Ltd, India Tablet Film coated Prescription Only Medicine104/001 Salbutamol syrup Kings Pharmaceuticals Ltd, Lusaka Syrup Prescription Only Medicine104/005 Kotrim suspension Kings Pharmaceuticals Ltd, Lusaka Suspension for Oral Use Prescription Only Medicine104/006 Magnesium Trisicilcate mixture Kings Pharmaceuticals Ltd, Lusaka Suspension for Oral Use Pharmacy Medicine104/012 Whitefields ointment Kings Pharmaceuticals Ltd, Lusaka Ointment topical Pharmacy Medicine104/018 Antacid tablets Kings Pharmaceuticals Ltd, Lusaka Tablet Uncoated Pharmacy Medicine104/020 Kotrim tablets Kings Pharmaceuticals Ltd, Lusaka Tablet Uncoated Prescription Only Medicine104/030 Aspirin tablets Kings Pharmaceuticals Ltd, Lusaka Tablet Uncoated Pharmacy Medicine104/031 Metronidazole tablets Kings Pharmaceuticals Ltd, Lusaka Tablet Uncoated Prescription Only Medicine104/032 Mebendazole tablets Kings Pharmaceuticals Ltd, Lusaka Tablet Uncoated Pharmacy Medicine104/034 Triphen 4 Flu syrup Kings Pharmaceuticals Ltd, Lusaka Syrup Pharmacy Medicine104/035 Pharmadol tablets Kings Pharmaceuticals Ltd, Lusaka Tablet Uncoated Pharmacy Medicine250/001 Difisal SR tablets Kopran Ltd, India Tablet Film coated Pharmacy Medicine250/002 Ciproquin tablets Kopran Ltd, India Tablet Uncoated Prescription Only Medicine250/003 Amyn capsules Kopran Ltd, India Capsule oral Prescription Only Medicine250/004 Ampicloxa Dry suspension Kopran Ltd, India Suspension for Oral Use Prescription Only Medicine250/005 Paralget tablets Kopran Ltd, India Tablet Uncoated General Sale250/006 Eryko Oral suspension Kopran Ltd, India Suspension Prescription Only Medicine250/007 Az-1 capsules Kopran Ltd, India Capsule oral Prescription Only Medicine250/008 Lokit capsules Kopran Ltd, India Capsule oral Prescription Only Medicine250/009 Difisal tablets Kopran Ltd, India Tablet Uncoated Pharmacy Medicine250/010 Ciproquin 250 tablets Kopran Ltd, India Tablet Uncoated Prescription Only Medicine250/011 Bren-200 tablets Kopran Ltd, India Tablet Film coated Pharmacy Medicine250/012 Kometro 200 tablets Kopran Ltd, India Tablet Uncoated Prescription Only Medicine250/013 Rintid 150 tablets Kopran Ltd, India Tablet Uncoated Prescription Only Medicine250/014 Quinolox 400 tablets Kopran Ltd, India Tablet Uncoated Prescription Only Medicine250/015 Trim 480 tablets Kopran Ltd, India Tablet Uncoated Prescription Only Medicine250/017 Ampik capsules Kopran Ltd, India Capsule oral Prescription Only Medicine

PRA Secretariat / January 2009 36

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

250/018 Bren-400 tablets Kopran Ltd, India Tablet Uncoated Pharmacy Medicine250/019 Trim suspension Kopran Ltd, India Suspension for Oral Use Prescription Only Medicine250/020 Eryko 250 tablets Kopran Ltd, India Tablet Film coated Prescription Only Medicine250/021 Amyn syrup Kopran Ltd, India Granules for Solution Prescription Only Medicine250/023 Nubend 400 tablets Kopran Ltd, India Tablet Uncoated Pharmacy Medicine250/024 Klodip-5 tablets Kopran Ltd, India Tablet Uncoated Prescription Only Medicine250/025 Zimat tablets Kopran Ltd, India Tablet Uncoated Prescription Only Medicine250/026 Felexin 500 capsules Kopran Ltd, India Capsule oral Prescription Only Medicine135/002 Artemether 40mg tablets Kunming Pharmaceutical Corp. (KPC), China Tablet Uncoated Prescription Only Medicine135/003 Artemether 50mg tablets Kunming Pharmaceutical Corp. (KPC), China Tablet Uncoated Prescription Only Medicine135/004 Gentamedine injection Kunming Pharmaceutical Corp. (KPC), China Solution for Injection Prescription Only Medicine135/005 Vitamedine injection Kunming Pharmaceutical Corp. (KPC), China Solution for Injection Prescription Only Medicine207/001 Rapid Relief Hot gel L`amar Natural Products Pvt Ltd,India Gel Topical Pharmacy Medicine207/002 Rapid relief cold gel L`amar Natural Products Pvt Ltd,India Gel Topical Pharmacy Medicine149/001 Moxileb dry syrup Leben Laboratories (Pvt) Ltd, India Suspension for Oral Use Prescription Only Medicine149/002 Cipium tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine149/003 Regurg 10mg tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine149/004 Moxileb 250mg capsules Leben Laboratories (Pvt) Ltd, India Capsule oral Prescription Only Medicine149/005 Nalidixic Acid tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine149/006 Trifluoperazine tablets Leben Laboratories (Pvt) Ltd, India Tablet Film coated Prescription Only Medicine149/007 Amphen capsules Leben Laboratories (Pvt) Ltd, India Capsule oral Prescription Only Medicine149/008 Alclox capsules Leben Laboratories (Pvt) Ltd, India Capsule oral Prescription Only Medicine149/010 Griseben 125mg tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine149/011 Propanolol 40mg tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine149/012 Ateleb 100mg tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine149/013 Ateleb 50mg tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine149/014 Silveleb 1% cream Leben Laboratories (Pvt) Ltd, India Cream Topical Pharmacy Medicine149/015 Scabcur lotion Leben Laboratories (Pvt) Ltd, India Lotion for Topical Use Pharmacy Medicine149/016 Benzyl Benzoate application Leben Laboratories (Pvt) Ltd, India Solution for Topical Use Pharmacy Medicine149/017 Tetret-250mg capsules Leben Laboratories (Pvt) Ltd, India Capsule oral Prescription Only Medicine149/018 Indul 25mg capsules Leben Laboratories (Pvt) Ltd, India Capsule oral Pharmacy Medicine149/019 Ciproleb 500 tablets Leben Laboratories (Pvt) Ltd, India Tablet Film coated Prescription Only Medicine149/020 Ibut 200mg tablets Leben Laboratories (Pvt) Ltd, India Tablet Film coated Pharmacy Medicine149/021 Promethazine 25mg tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine149/022 Zylo-P solution Leben Laboratories (Pvt) Ltd, India Solution for Topical Use Pharmacy Medicine149/023 Folic acid 5mg tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine149/024 QSM suspension Leben Laboratories (Pvt) Ltd, India Suspension for Oral Use Prescription Only Medicine149/025 Kelvin tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine149/028 Lebasma syrup Leben Laboratories (Pvt) Ltd, India Syrup Prescription Only Medicine149/029 Lebasma-4 tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine149/030 Promethazine syrup Leben Laboratories (Pvt) Ltd, India Syrup Pharmacy Medicine149/031 Beclomin ointment Leben Laboratories (Pvt) Ltd, India Ointment topical Prescription Only Medicine149/033 Chlorpromazine tablets Leben Laboratories (Pvt) Ltd, India Tablet Film coated Prescription Only Medicine149/035 Lampy-250 capsules Leben Laboratories (Pvt) Ltd, India Capsule oral Prescription Only Medicine149/037 Cipium syrup Leben Laboratories (Pvt) Ltd, India Syrup Pharmacy Medicine149/038 Cebay-Trx-1000 injection Leben Laboratories (Pvt) Ltd, India Powder for Injection Prescription Only Medicine149/039 Cefaxil-1000 injection Leben Laboratories (Pvt) Ltd, India Powder for Injection Prescription Only Medicine149/040 Prohibin capsules Leben Laboratories (Pvt) Ltd, India Capsule oral Prescription Only Medicine149/041 Kelvin syrup Leben Laboratories (Pvt) Ltd, India Syrup General Sale149/042 Antagit-DS gel Leben Laboratories (Pvt) Ltd, India Suspension for Oral Use General Sale149/043 Alclox suspension Leben Laboratories (Pvt) Ltd, India Powder for Oral

SuspensionPrescription Only Medicine

149/044 Adiflan injection Leben Laboratories (Pvt) Ltd, India Solution for Injection Prescription Only Medicine149/045 Cortileb cream Leben Laboratories (Pvt) Ltd, India Cream Topical Prescription Only Medicine149/046 Elcuf syrup Leben Laboratories (Pvt) Ltd, India Syrup Pharmacy Medicine149/047 Enderm G.M cream Leben Laboratories (Pvt) Ltd, India Cream Topical Prescription Only Medicine149/048 Nystaleb suspension Leben Laboratories (Pvt) Ltd, India Suspension for Oral Use Prescription Only Medicine

37 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

149/050 Pyraleb suspension Leben Laboratories (Pvt) Ltd, India Suspension for Oral Use Pharmacy Medicine149/051 Zylo-P ointment Leben Laboratories (Pvt) Ltd, India Ointment topical Pharmacy Medicine149/052 Pyraleb tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine149/054 Cexil syrup Leben Laboratories (Pvt) Ltd, India Syrup Prescription Only Medicine149/055 Hykophos syrup Leben Laboratories (Pvt) Ltd, India Syrup Prescription Only Medicine149/056 Cexil 500mg tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine149/057 Chlorpromazine 25mg tablets Leben Laboratories (Pvt) Ltd, India Tablet Film coated Prescription Only Medicine149/058 Haloperidol tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine149/059 Chelferron liquid Leben Laboratories (Pvt) Ltd, India Solution for Oral Use General Sale149/061 Q.S.M tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine149/062 Cebay - Trx 250 injection Leben Laboratories (Pvt) Ltd, India Powder for Injection Prescription Only Medicine149/063 Lebasma 2 tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine149/064 Cebay 100 dry Powder Leben Laboratories (Pvt) Ltd, India Powder for Oral

SuspensionPrescription Only Medicine

149/065 Praziquantel tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine149/066 Amitriptyline tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine149/067 Betaleb ointment Leben Laboratories (Pvt) Ltd, India Ointment topical Prescription Only Medicine149/068 Kelvin-P syrup Leben Laboratories (Pvt) Ltd, India Syrup Pharmacy Medicine149/069 Adiflam Compound tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine149/070 Adiflam Plus tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine149/071 Ciproleb 250 tablets Leben Laboratories (Pvt) Ltd, India Tablet Film coated Prescription Only Medicine149/073 Lamizol O suspension Leben Laboratories (Pvt) Ltd, India Suspension for Oral Use Prescription Only Medicine149/074 Lamizol O tablets Leben Laboratories (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine149/075 Ferrous Sulphate tablets Leben Laboratories (Pvt) Ltd, India Tablet Enteric Coated Pharmacy Medicine149/076 Multivitamins tablets Leben Laboratories (Pvt) Ltd, India Tablet Film coated General Sale284/001 Lib-Mox 250 capsules Liberal Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine284/002 Lib-Mox suspension Liberal Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine284/003 Lib-Dox-100 capsules Liberal Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine284/004 Lib-Tetra capsules Liberal Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine284/005 Lib-Indo-25 capsules Liberal Pharmaceuticals Ltd, India Capsule oral Pharmacy Medicine228/001 Chloramphenicol injection Lincoln Pharmaceuticals Ltd, India Solution for Injection Prescription Only Medicine228/002 Lincosone cream Lincoln Pharmaceuticals Ltd, India Cream Topical Prescription Only Medicine228/003 TE-DE-V tablets Lincoln Pharmaceuticals Ltd, India Tablet Vaginal Prescription Only Medicine228/004 Vivian gel Lincoln Pharmaceuticals Ltd, India Gel Topical Pharmacy Medicine228/005 Neovag ointment Lincoln Pharmaceuticals Ltd, India Ointment topical Prescription Only Medicine228/006 Deexa Eye drops Lincoln Pharmaceuticals Ltd, India Eye Drops Prescription Only Medicine228/007 Deexa-N Eye drops Lincoln Pharmaceuticals Ltd, India Eye Drops Prescription Only Medicine228/008 Omlink-20 capsules Lincoln Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine228/009 Daolin tablets Lincoln Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine228/010 Malarid-200 tablets Lincoln Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine228/011 Rifalin tablets Lincoln Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine228/012 Konazol cream Lincoln Pharmaceuticals Ltd, India Cream Topical Prescription Only Medicine228/013 Cotrimoxazole Oral suspension Lincoln Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine228/014 Compound Magnesium trislicate tablets Lincoln Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine228/015 Carbamezapine tablets Lincoln Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine228/016 Frusemide tablets Lincoln Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine228/017 Metronidazole suspension Lincoln Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine228/018 Ampicillin sodium injection Lincoln Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine228/019 Salbutamol tablets Lincoln Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine228/020 Benzyl penicillin injection Lincoln Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine228/021 Ethambutol tablets Lincoln Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine228/022 Metochlopromide injection Lincoln Pharmaceuticals Ltd, India Solution for Injection Prescription Only Medicine228/023 Rantidine tablets Lincoln Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine228/024 Vitamin B complex injection Lincoln Pharmaceuticals Ltd, India Solution for Injection Prescription Only Medicine228/025 Tetracycline capsules Lincoln Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine228/026 Folic acid tablets Lincoln Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine228/027 Penizin tablets Lincoln Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine

PRA Secretariat / January 2009 38

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

228/028 Bet.N cream Lincoln Pharmaceuticals Ltd, India Cream Topical Prescription Only Medicine228/029 Clotrilin Mouthwash Lincoln Pharmaceuticals Ltd, India Solution for Oral Use Prescription Only Medicine228/031 Dermofulvin tablets Lincoln Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine228/032 Hydrocortisone sodium injection Lincoln Pharmaceuticals Ltd, India Solution for Injection Prescription Only Medicine228/033 Nystatin oral suspension Lincoln Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine228/034 Neovag vaginal tablets Lincoln Pharmaceuticals Ltd, India Tablet Vaginal Prescription Only Medicine228/035 Perfloxacin tablets Lincoln Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine228/036 Povidone iodine ointment Lincoln Pharmaceuticals Ltd, India Ointment topical Pharmacy Medicine228/037 Pyrazanamide tablets Lincoln Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine228/039 Diclofenac sodium injection Lincoln Pharmaceuticals Ltd, India Solution for Injection Prescription Only Medicine228/040 Micolin cream Lincoln Pharmaceuticals Ltd, India Cream Topical Pharmacy Medicine228/041 L-genta drops Lincoln Pharmaceuticals Ltd, India Ear/Eye Drops Prescription Only Medicine228/042 Allphenicol eye drops Lincoln Pharmaceuticals Ltd, India Ear/Eye Drops Prescription Only Medicine228/044 Doxycycline capsules Lincoln Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine228/045 Clotrimazole cream Lincoln Pharmaceuticals Ltd, India Cream Topical Prescription Only Medicine228/046 Fortified procaine pencillin injection Lincoln Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine228/047 Paracetamol tablets Lincoln Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine228/048 Lignocaine injection Lincoln Pharmaceuticals Ltd, India Solution for Injection Prescription Only Medicine281/001 Tonac -10mg tablets Lupin laboratories Ltd, India Tablet Film coated Prescription Only Medicine281/002 Ceff pead tablets Lupin laboratories Ltd, India Tablet Uncoated Prescription Only Medicine281/003 Tonac-20mg tablets Lupin laboratories Ltd, India Tablet Uncoated Prescription Only Medicine281/004 Ceff dry syrup Lupin laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine281/006 Esiflo inhaler Lupin laboratories Ltd, India Powder for Inhalation Prescription Only Medicine281/012 Salbair solution Lupin laboratories Ltd, India Solution for Inhalation Prescription Only Medicine281/013 Salbair-1 solution Lupin laboratories Ltd, India Solution for Inhalation Prescription Only Medicine281/014 Salbair-B Lupin laboratories Ltd, India Solution for Inhalation Prescription Only Medicine281/015 Hepp Forte syrup Lupin laboratories Ltd, India Syrup Prescription Only Medicine281/016 Cetil -250 tablets Lupin laboratories Ltd, India Tablet Uncoated Prescription Only Medicine281/017 Cetil -500 tablets Lupin laboratories Ltd, India Tablet Uncoated Prescription Only Medicine281/018 Odicef injection Lupin laboratories Ltd, India Solution for Injection Prescription Only Medicine281/019 Ceff-250 capsules Lupin laboratories Ltd, India Capsule oral Prescription Only Medicine281/020 Novapime injection Lupin laboratories Ltd, India Solution for Injection Prescription Only Medicine281/021 Ceff 500 capsules Lupin laboratories Ltd, India Capsule oral Prescription Only Medicine281/022 Esiflo 125 inhaler Lupin laboratories Ltd, India Powder for Inhalation Prescription Only Medicine281/023 Esflo 125 inhaler Lupin laboratories Ltd, India Powder for Inhalation Prescription Only Medicine281/024 Odoxil tablets Lupin laboratories Ltd, India Tablet Uncoated Prescription Only Medicine281/025 Odoxil oral suspension Lupin laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine163/001 Lyforan injection Lyka Labs Ltd, India Powder for Injection Prescription Only Medicine163/002 Fas-3 Kit tablets Lyka Labs Ltd, India Tablet Uncoated Prescription Only Medicine163/003 Lyproquin tablets Lyka Labs Ltd, India Tablet Uncoated Prescription Only Medicine163/004 Lyramycin injection Lyka Labs Ltd, India Solution for Injection Prescription Only Medicine163/005 Imidil Vaginal tablets Lyka Labs Ltd, India Tablet Uncoated Prescription Only Medicine163/006 Lamoxy capsules Lyka Labs Ltd, India Capsule oral Prescription Only Medicine163/007 Lycortin-s-injection Lyka Labs Ltd, India Powder for Injection Prescription Only Medicine163/008 Basin 500 capsules Lyka Labs Ltd, India Capsule oral Prescription Only Medicine163/009 Anquin 400 tablets Lyka Labs Ltd, India Tablet Film coated Prescription Only Medicine163/010 Ampicillin injection Lyka Labs Ltd, India Powder for Injection Prescription Only Medicine163/011 Sepexin-250 capsules Lyka Labs Ltd, India Capsule oral Prescription Only Medicine163/012 Lamoxyl syrup Lyka Labs Ltd, India Suspension for Oral Use Prescription Only Medicine163/013 Lamoxy syrup Lyka Labs Ltd, India Powder for Oral Solution Prescription Only Medicine163/014 Lyfaxone injection Lyka Labs Ltd, India Powder for Injection Prescription Only Medicine163/015 Lyseptol tablets Lyka Labs Ltd, India Tablet Uncoated Prescription Only Medicine163/016 Lanol 500 tablets Lyka Labs Ltd, India Tablet Uncoated General Sale163/017 Imidil Vaginal tablets Lyka Labs Ltd, India Tablet Vaginal Prescription Only Medicine163/018 Sulfadar tablet Lyka Labs Ltd, India Tablet Uncoated Pharmacy Medicine163/019 Klox 250 capsules Lyka Labs Ltd, India Capsule oral Prescription Only Medicine163/020 Lyproquin tablets Lyka Labs Ltd, India Tablet Uncoated Prescription Only Medicine

39 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

163/021 Lydic tablets Lyka Labs Ltd, India Tablet Uncoated Pharmacy Medicine206/001 Ampicillin 250 capsules Maan Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine206/002 Amoxicillin 250 capsules Maan Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine192/001 Primacort 100 injection Macleods Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine192/002 kanamac 1000 injection Macleods Pharmaceuticals Ltd, India Solution for Injection Prescription Only Medicine192/003 Maxcox Plus 100 tablets Macleods Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine192/004 Anti-thyrox tablets Macleods Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine192/005 Amilodipine tablets Macleods Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine192/006 Ecox 400 tablets Macleods Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine192/007 Macrozide 500 tablets Macleods Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine192/008 Azicure 250 tablets Macleods Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine192/009 Azicure 500 tablets Macleods Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine192/010 Azicure 200/5ml oral suspension Macleods Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine192/011 Chloramphenicol sodium injection Macleods Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine192/012 Econex 400 tablets Macleods Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine192/013 Forecox-Trac tablets Macleods Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine192/014 Levomac 500 I.V infusion Macleods Pharmaceuticals Ltd, India Solution for infusion Prescription Only Medicine192/015 Levovac 250 tablets Macleods Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine192/016 Levovac 500 tablets Macleods Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine192/017 Kapocin injection Macleods Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine192/018 Coxerin tablets Macleods Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine167/001 Vepan tablets Macs Pharmaceuticals Ltd, Kenya Tablet Uncoated Prescription Only Medicine167/002 Maxabeta cream Macs Pharmaceuticals Ltd, Kenya Cream Topical Prescription Only Medicine167/003 Allynox 500 capsules Macs Pharmaceuticals Ltd, Kenya Capsule oral Prescription Only Medicine167/004 Gynostatin pessaries Macs Pharmaceuticals Ltd, Kenya Tablet Vaginal Prescription Only Medicine167/005 Doxymax capsules Macs Pharmaceuticals Ltd, Kenya Capsule oral Prescription Only Medicine167/006 Maxicort cream Macs Pharmaceuticals Ltd, Kenya Cream Topical Prescription Only Medicine167/007 Erythomax capsules Macs Pharmaceuticals Ltd, Kenya Capsule oral Prescription Only Medicine167/008 Maxotrim tablets Macs Pharmaceuticals Ltd, Kenya Tablet Uncoated Prescription Only Medicine167/009 Dioral tablets Macs Pharmaceuticals Ltd, Kenya Tablet Uncoated Pharmacy Medicine167/010 Lemoxipen capsules Macs Pharmaceuticals Ltd, Kenya Capsule oral Prescription Only Medicine167/011 Tumbocid tablets Macs Pharmaceuticals Ltd, Kenya Tablet Chewable Pharmacy Medicine167/012 Maxadol tablets Macs Pharmaceuticals Ltd, Kenya Tablet Uncoated General Sale167/013 Cofrid tablets Macs Pharmaceuticals Ltd, Kenya Tablet Uncoated Pharmacy Medicine167/014 Flamax cream Macs Pharmaceuticals Ltd, Kenya Cream Topical Pharmacy Medicine167/015 Ampimax capsules Macs Pharmaceuticals Ltd, Kenya Capsule oral Prescription Only Medicine167/016 Cloxipen capsules Macs Pharmaceuticals Ltd, Kenya Capsule oral Prescription Only Medicine167/017 Pyromax capsules Macs Pharmaceuticals Ltd, Kenya Capsule oral Prescription Only Medicine167/018 Fansimax Tablets Macs Pharmaceuticals Ltd, Kenya Tablet Uncoated Pharmacy Medicine186/002 Candican liquid infusion Marck Biosciences Ltd, India Solution for infusion Prescription Only Medicine186/004 Mannitol intravenous solution Marck Biosciences Ltd, India Solution for infusion Prescription Only Medicine186/005 Sterilised water Marck Biosciences Ltd, India Solution for Injection Prescription Only Medicine186/009 Paracetin eye drop Marck Biosciences Ltd, India Eye Drops Prescription Only Medicine148/001 Septimar tablets Mars Life Sciences Ltd, India Tablet Uncoated Prescription Only Medicine148/002 Marquinite tablets Mars Life Sciences Ltd, India Tablet Film coated Prescription Only Medicine148/003 O-mar capsules Mars Life Sciences Ltd, India Capsule oral Prescription Only Medicine148/004 Moxmar capsules Mars Life Sciences Ltd, India Capsule oral Prescription Only Medicine148/005 Marthrocin tablets Mars Life Sciences Ltd, India Tablet Uncoated Prescription Only Medicine148/006 Candimar cream Mars Life Sciences Ltd, India Cream Topical Prescription Only Medicine148/007 Flumar 200 capsules Mars Life Sciences Ltd, India Capsule oral Prescription Only Medicine148/008 Marzid injection Mars Life Sciences Ltd, India Powder for Injection Prescription Only Medicine148/010 Installeen gel Mars Life Sciences Ltd, India Gel Topical Pharmacy Medicine148/011 Mardip GC cream Mars Life Sciences Ltd, India Cream Topical Prescription Only Medicine148/012 Marixime-100 tablets Mars Life Sciences Ltd, India Tablet Uncoated Prescription Only Medicine148/013 Haemar-z capsules Mars Life Sciences Ltd, India Capsule oral Pharmacy Medicine148/014 Marixime-200 tablets Mars Life Sciences Ltd, India Tablet Film coated Prescription Only Medicine148/015 Marvoran-50 tablets Mars Life Sciences Ltd, India Tablet Enteric Coated Pharmacy Medicine

PRA Secretariat / January 2009 40

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

149/009 Resflo granules Mars Life Sciences Ltd, India Powder for Oral Suspension

Prescription Only Medicine

014/001 Lopinavir and Ritonivir tablets Matrix Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine014/002 Tenofivir Disoproxil Fumurate /

Lamivudine tabletsMatrix Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine

014/003 Tenofivir Disoproxil Fumurate tablets Matrix Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine014/004 Abacavir Sulphate tablets Matrix Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine014/005 Tenofivir Disoproxil Fumurate +

Emtricitabine tabletsMatrix Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine

014/006 Lamivudine tablets Matrix Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine014/007 Efavirenz tablets Matrix Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine014/008 Lamivudine + Stavudine tablets Matrix Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine277/001 Miconaz cream Medical Union Pharmaceuticals Ltd, Egypt Cream Topical Pharmacy Medicine277/003 Miconaz Vaginal ovules Medical Union Pharmaceuticals Ltd, Egypt Tablet Vaginal Prescription Only Medicine277/004 Miconaz oral gel Medical Union Pharmaceuticals Ltd, Egypt Gel Oral Prescription Only Medicine277/005 Miconaz-H emugel Medical Union Pharmaceuticals Ltd, Egypt Gel Topical Prescription Only Medicine277/006 Vagyl powder Medical Union Pharmaceuticals Ltd, Egypt Powder for Topical use Pharmacy Medicine277/007 Sediproct cream Medical Union Pharmaceuticals Ltd, Egypt Cream Topical Prescription Only Medicine277/008 Biovit 12 Depot injection Medical Union Pharmaceuticals Ltd, Egypt Solution for Injection Prescription Only Medicine277/009 Phytovit MM injection Medical Union Pharmaceuticals Ltd, Egypt Solution for Injection Prescription Only Medicine058/001 Fantem tablets Medinomics Healthcare Pvt Ltd, India Tablet Uncoated Pharmacy Medicine142/001 Nevirapine tablets Meditab Specialities (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine142/002 Indinavir 40O capsules Meditab Specialities (Pvt) Ltd, India Capsule oral Prescription Only Medicine142/003 Stavudine30 capsules Meditab Specialities (Pvt) Ltd, India Capsule oral Prescription Only Medicine142/004 Stavudine 40 capsules Meditab Specialities (Pvt) Ltd, India Capsule oral Prescription Only Medicine142/005 Medivir- L tablets Meditab Specialities (Pvt) Ltd, India Tablet Film coated Prescription Only Medicine142/006 Zidovudine capsules Meditab Specialities (Pvt) Ltd, India Capsule oral Prescription Only Medicine142/007 Efavirenz capsules Meditab Specialities (Pvt) Ltd, India Capsule oral Prescription Only Medicine142/008 LSN-30 tablets Meditab Specialities (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine142/009 Medilam S 30 tablets Meditab Specialities (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine142/010 Medivir LN tablets Meditab Specialities (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine142/011 Medilan S-40 tablets Meditab Specialities (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine142/012 LSN- 40 tablets Meditab Specialities (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine142/013 Zidovudine tablets Meditab Specialities (Pvt) Ltd, India Tablet Film coated Prescription Only Medicine106/001 Lomexel tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/002 Helmintol tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine106/003 Axane gel Medley Pharmaceuticals Ltd, India Gel Topical General Sale106/005 Prosup syrup Medley Pharmaceuticals Ltd, India Syrup Prescription Only Medicine106/006 Encardil 2.5 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/007 Encardil 5 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/008 Encardil 10 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/009 Encardil 20 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/010 Astem tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine106/012 Xymex syrup Medley Pharmaceuticals Ltd, India Syrup Pharmacy Medicine106/015 Geramed injection Medley Pharmaceuticals Ltd, India Solution for Injection Prescription Only Medicine106/016 Deximed injection Medley Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine106/018 Moxmed-250 capsules Medley Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine106/019 Ultigra-180 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/020 Oncet 10 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/021 Helmintol suspension Medley Pharmaceuticals Ltd, India Suspension Pharmacy Medicine106/022 Zoxil 500 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/023 Zoxil dt tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/024 Spocelin 250 capsules Medley Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine106/025 Ofoxin 200 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/026 Primodil 5 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/027 Lansoprazole capsule Medley Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine106/028 Rofexib 25 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine

41 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

106/029 Cefo L-200 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/030 Cefo L-100 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/031 Pantaz tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/032 Ceftriaxone injection Medley Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine106/033 Primodil 10 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/034 Ofloxin 400 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/035 Ultigra 120 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/036 Ecoflox -500 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/037 Ecoflox-250 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/038 Decifen SR tablets Medley Pharmaceuticals Ltd, India Tablet Film coated Pharmacy Medicine106/039 Floxilet 300 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/040 Spocelin 500 capsules Medley Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine106/041 Rofexib 12.5 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/042 Vasortan-50 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/043 Glucozid tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/044 Zoxil 125 Rediuse suspension Medley Pharmaceuticals Ltd, India Suspension Prescription Only Medicine106/045 Gtn spray Medley Pharmaceuticals Ltd, India Solution for Inhalation Prescription Only Medicine106/046 Spasmonorm tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/047 Gromin drops Medley Pharmaceuticals Ltd, India Solution for Oral Use Pharmacy Medicine106/048 Motinorm syrup Medley Pharmaceuticals Ltd, India Syrup Prescription Only Medicine106/049 Motinorm tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/050 Motinorm drops Medley Pharmaceuticals Ltd, India Solution for Oral Use Prescription Only Medicine106/051 Trisoliv syrup Medley Pharmaceuticals Ltd, India Syrup Pharmacy Medicine106/052 Poraz-20 capsules Medley Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine106/053 Atorin 10 tablets Medley Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine106/054 BP Norm 50 tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/055 New Tuxiril syrup Medley Pharmaceuticals Ltd, India Syrup Pharmacy Medicine106/056 R.B.Tone syrup Medley Pharmaceuticals Ltd, India Syrup Pharmacy Medicine106/057 Coldrid day and night tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine106/058 Atroin tablets Medley Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine106/095 Supiclox injection Medley Pharmaceuticals Ltd, India Powder for Injection Prescription Only Medicine272/008 Amitriptyline tablets Medopharm,India Tablet Uncoated Prescription Only Medicine272/009 Amoxicillin BP capsules Medopharm,India Capsule oral Prescription Only Medicine272/010 Cimetidine tablets Medopharm,India Tablet Uncoated Prescription Only Medicine272/011 Co-trimoxazole tablets Medopharm,India Tablet Uncoated Prescription Only Medicine272/012 Cyproheptadine tablets Medopharm,India Tablet Uncoated Pharmacy Medicine272/013 Diclofenac tablets Medopharm,India Tablet Uncoated Pharmacy Medicine272/014 Griseofulvin tablets Medopharm,India Tablet Uncoated Prescription Only Medicine272/015 Metronidazole tablets Medopharm,India Tablet Uncoated Prescription Only Medicine272/016 Norfloxacin tablets Medopharm,India Tablet Uncoated Prescription Only Medicine272/017 Nitrofurantoin tablets Medopharm,India Tablet Uncoated Prescription Only Medicine272/018 Ranitidine tablets Medopharm,India Tablet Uncoated Prescription Only Medicine272/019 Amoxicillin suspension Medopharm,India Suspension for Oral Use Prescription Only Medicine272/020 Ethionamide tablets Medopharm,India Tablet Uncoated Prescription Only Medicine272/021 Ofloxacin tablets Medopharm,India Tablet Uncoated Prescription Only Medicine181/001 Betanil GM cream Merck Ltd, India Cream Topical Prescription Only Medicine181/002 Betanil cream Merck Ltd, India Cream Topical Prescription Only Medicine181/003 Betanil N cream Merck Ltd, India Cream Topical Prescription Only Medicine181/004 Diclofenac Diethylamine cream Merck Ltd, India Gel Topical Pharmacy Medicine181/005 Nasivion Adult Nasal drops Merck Ltd, India Nasal drops Pharmacy Medicine181/006 Navison Paediatric Nasal drops Merck Ltd, India Nasal drops Pharmacy Medicine181/007 Evion 200 capsules Merck Ltd, India Capsule oral Pharmacy Medicine181/008 Evion 400 capsules Merck Ltd, India Capsule oral Pharmacy Medicine181/009 Evion cream Merck Ltd, India Cream Topical General Sale181/010 Neurobion Forte tablets Merck Ltd, India Tablet Uncoated Pharmacy Medicine181/011 Neurobion Forte injection Merck Ltd, India Solution for Injection Prescription Only Medicine181/012 Polybion syrup Merck Ltd, India Syrup Pharmacy Medicine

PRA Secretariat / January 2009 42

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

181/013 Polybion tablets Merck Ltd, India Tablet Uncoated Pharmacy Medicine105/007 Atripla tablets Merck Sharpe & Dohme (Pty) Ltd,France Tablet Uncoated Prescription Only Medicine019/002 Fiberex powder Meyer Organics Pvt Ltd, India Powder for Oral

SuspensionGeneral Sale

019/003 Gericare capsules Meyer Organics Pvt Ltd, India Capsule oral General Sale019/004 Kidcare Plus syrup Meyer Organics Pvt Ltd, India Syrup General Sale019/005 Lactulin solution Meyer Organics Pvt Ltd, India Solution for Oral Use Pharmacy Medicine019/006 Mim capsules Meyer Organics Pvt Ltd, India Capsule oral General Sale019/007 Mim organic tonic Meyer Organics Pvt Ltd, India Solution for Oral Use General Sale019/008 Motionil capsules Meyer Organics Pvt Ltd, India Capsule oral Prescription Only Medicine019/009 Wingora tablets Meyer Organics Pvt Ltd, India Tablet Uncoated Prescription Only Medicine019/010 Lomez capsules Meyer Organics Pvt Ltd, India Capsule oral Prescription Only Medicine019/011 Aloesilk cream Meyer Organics Pvt Ltd, India Cream Topical General Sale019/012 Babygesic drops Meyer Organics Pvt Ltd, India Solution for Oral Use Pharmacy Medicine019/013 Candifem vaginal tablets Meyer Organics Pvt Ltd, India Tablet Vaginal Prescription Only Medicine019/014 Congestyl syrup Meyer Organics Pvt Ltd, India Syrup Pharmacy Medicine019/015 Ugesic tablets Meyer Organics Pvt Ltd, India Capsule oral Pharmacy Medicine019/016 Colicaid drops Meyer Organics Pvt Ltd, India Solution for Oral Use Pharmacy Medicine019/017 Fevril suspension Meyer Organics Pvt Ltd, India Suspension for Oral Use Pharmacy Medicine019/018 Fairyl cream Meyer Organics Pvt Ltd, India Cream Topical General Sale019/019 Zedcal tablets Meyer Organics Pvt Ltd, India Tablet Uncoated Pharmacy Medicine019/020 Coldcare tablets Meyer Organics Pvt Ltd, India Tablet Uncoated General Sale019/021 Gastracid liquid Meyer Organics Pvt Ltd, India Suspension for Oral Use Pharmacy Medicine019/HM001

Cofaid liquid solution Meyer Organics Pvt Ltd, India Solution for Oral Use Pharmacy Medicine

170/001 Antim tablets Mihika Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine170/002 Effecip-500 tablets Mihika Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine170/003 Acyclex 200mg tablets Mihika Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine170/004 Dermiral 200 tablets Mihika Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine170/005 Zolmed 150 tablets Mihika Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine170/006 Actiflam 200 tablets Mihika Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine170/007 Endorm-100 tablets Mihika Pharmaceuticals Ltd, India Tablet Uncoated Pharmacy Medicine170/008 Mihizole 200 tablets Mihika Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine170/009 Cloxasafe 250 capsules Mihika Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine170/010 Novoxi Oral suspension Mihika Pharmaceuticals Ltd, India Suspension for Oral Use Prescription Only Medicine170/012 Ompalen 20mg capsules Mihika Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine170/013 Spasmorid-10mg tablets Mihika Pharmaceuticals Ltd, India Tablet Film coated Prescription Only Medicine170/014 Voltika 50 tablets Mihika Pharmaceuticals Ltd, India Tablet Enteric Coated Pharmacy Medicine170/016 Histergan 25 tablets Mihika Pharmaceuticals Ltd, India Tablet Film coated Pharmacy Medicine280/004 Betrim tablets Milan Laboratories Pvt Ltd, India Tablet Uncoated Prescription Only Medicine280/005 Milzor tablets Milan Laboratories Pvt Ltd, India Tablet Uncoated General Sale280/006 Mil-Cotri suspension Milan Laboratories Pvt Ltd, India Suspension for Oral Use Prescription Only Medicine280/007 Mil-Metro suspension Milan Laboratories Pvt Ltd, India Suspension for Oral Use Prescription Only Medicine280/008 Strepto tablet Milan Laboratories Pvt Ltd, India Tablet Uncoated General Sale280/009 Milmaleate tablets Milan Laboratories Pvt Ltd, India Tablet Uncoated Prescription Only Medicine280/010 furosimide tablets Milan Laboratories Pvt Ltd, India Tablet Uncoated Prescription Only Medicine210/001 Ciprodex tablets Nabros Pharma Ltd, India Tablet Film coated Prescription Only Medicine210/002 Nifedipine capsules Nabros Pharma Ltd, India Capsule oral Prescription Only Medicine210/003 Flucoldex tablets Nabros Pharma Ltd, India Tablet Uncoated Pharmacy Medicine182/001 Mycol injection Neon Antibiotics Pvt Ltd, India Solution for Injection Prescription Only Medicine226/001 Fluconazole capsules Nibin Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine103/001 Sterile polygeline solution Nicholas Piramal (India) Ltd, India Solution for infusion Prescription Only Medicine103/002 Halothane calibrated solution Nicholas Piramal (India) Ltd, India Solution for Inhalation Prescription Only Medicine103/003 Metronidazole injection Nicholas Piramal (India) Ltd, India Solution for Injection Prescription Only Medicine103/004 Ciprofloxacin injection Nicholas Piramal (India) Ltd, India Solution for Injection033/001 Benzylpenicillin injection North China Pharmaceutical Group International

Corporation, ChinaSolution for Injection Prescription Only Medicine

43 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

033/002 Benzylpenicillin injection North China Pharmaceutical Group International Corporation, China

Solution for Injection Prescription Only Medicine

033/003 Amoxicillin capsules North China Pharmaceutical Group International Corporation, China

Capsule oral Prescription Only Medicine

025/001 Actifed compound lictus Norvatis Consumer Health International, Switzerland

Syrup Pharmacy Medicine

025/002 Actifed expectorant syrup Norvatis Consumer Health International, Switzerland

Syrup Pharmacy Medicine

025/003 Actifed syrup Norvatis Consumer Health International, Switzerland

Syrup Pharmacy Medicine

025/005 Antigesic tablets Norvatis Consumer Health International, Switzerland

Tablet Uncoated Pharmacy Medicine

025/014 Linctifed expectorant forte syrup Norvatis Consumer Health International, Switzerland

Syrup Pharmacy Medicine

025/015 Linctifed expectorant forte syrup Norvatis Consumer Health International, Switzerland

Syrup Pharmacy Medicine

025/018 Calpol suspension Norvatis Consumer Health International, Switzerland

Suspension for Oral Use General Sale

025/031 Sudafed syrup Norvatis Consumer Health International, Switzerland

Syrup Pharmacy Medicine

025/033 Sudagesic tablets Norvatis Consumer Health International, Switzerland

Tablet Uncoated Pharmacy Medicine

242/001 Otrivin gel Norvatis Consumer Health International, Switzerland

Gel Topical Pharmacy Medicine

242/002 Fenistil drops Norvatis Consumer Health International, Switzerland

Syrup Pharmacy Medicine

242/003 Vibrocil Nasal drops Norvatis Consumer Health International, Switzerland

Nasal drops Prescription Only Medicine

242/004 Proctoglyvenol cream Norvatis Consumer Health International, Switzerland

Cream Topical Prescription Only Medicine

242/005 Slow Iron & Folic acid tablets Norvatis Consumer Health International, Switzerland

Tablet Film coated Pharmacy Medicine

242/006 Otrivin spray Norvatis Consumer Health International, Switzerland

Spray For Nasal Use Prescription Only Medicine

242/007 Pulmex Baby ointment Norvatis Consumer Health International, Switzerland

Ointment topical Pharmacy Medicine

242/008 Lamil cream Norvatis Consumer Health International, Switzerland

Cream Topical Prescription Only Medicine

242/009 Travegyl ampoules Norvatis Consumer Health International, Switzerland

Solution for Injection Prescription Only Medicine

242/010 Travegyl syrup Norvatis Consumer Health International, Switzerland

Syrup Prescription Only Medicine

242/011 Travegyl 1mg syrup Norvatis Consumer Health International, Switzerland

Syrup Prescription Only Medicine

242/012 Eurax cream Norvatis Consumer Health International, Switzerland

Cream Topical Prescription Only Medicine

242/013 Otrivin Nasal drops Norvatis Consumer Health International, Switzerland

Nasal drops Pharmacy Medicine

242/014 Otrivin Nasal drops-Adults Norvatis Consumer Health International, Switzerland

Nasal drops Pharmacy Medicine

242/015 Voltarex emulgel Norvatis Consumer Health International, Switzerland

Gel Topical Prescription Only Medicine

242/016 Calcium Sandoz tablets Norvatis Consumer Health International, Switzerland

Tablet Uncoated Pharmacy Medicine

242/017 Calcium Sandoz + Vitamin C tablets Norvatis Consumer Health International, Switzerland

Tablet Uncoated Pharmacy Medicine

0359/05 Voltaren tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Prescription Only Medicine121/001 Coartem tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Prescription Only Medicine121/002 Voltaren D tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Pharmacy Medicine121/003 Cataflam drops Novartis Pharma Services Inc, Kenya Solution for Topical Use Pharmacy Medicine121/004 Elidel cream Novartis Pharma Services Inc, Kenya Cream Topical Prescription Only Medicine121/005 Voltaren SR tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Pharmacy Medicine

PRA Secretariat / January 2009 44

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

121/006 Lescol XL tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Prescription Only Medicine121/007 Co-Diovan tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Prescription Only Medicine121/008 Cataflam tablets Novartis Pharma Services Inc, Kenya Pharmacy Medicine121/009 Lamisil tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Prescription Only Medicine121/010 Tegretol syrup Novartis Pharma Services Inc, Kenya Syrup Prescription Only Medicine121/011 Tofranil tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Prescription Only Medicine121/012 Voltaren 50 suppositories Novartis Pharma Services Inc, Kenya Suppository Pharmacy Medicine121/013 Voltaren 100 suppositories Novartis Pharma Services Inc, Kenya Suppository Pharmacy Medicine121/014 Voltaren injection Novartis Pharma Services Inc, Kenya Solution for Injection Prescription Only Medicine121/015 Anafranil tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Prescription Only Medicine121/016 Diovan tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Prescription Only Medicine121/017 Diovan tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Prescription Only Medicine121/018 Co-Diovan tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Prescription Only Medicine121/019 Voltfast tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Pharmacy Medicine121/020 Voltaren 12.5 suppositories Novartis Pharma Services Inc, Kenya Suppository Pharmacy Medicine121/021 Tegretol CR tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Prescription Only Medicine121/022 Tegretol tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Prescription Only Medicine121/023 Slow K tablets Novartis Pharma Services Inc, Kenya Tablet Uncoated Prescription Only Medicine040/009 Insulin Actrapid HM injection Novo Nordisk (Pty) Ltd, South Africa Solution for Injection Prescription Only Medicine040/010 Insulin Actrapid Penfil injection Novo Nordisk (Pty) Ltd, South Africa Solution for Injection Prescription Only Medicine040/011 Insulin Protaphane injection Novo Nordisk (Pty) Ltd, South Africa Solution for Injection Prescription Only Medicine040/012 Insulin Protaphane HM Penfil injection Novo Nordisk (Pty) Ltd, South Africa Solution for Injection Prescription Only Medicine040/014 Insulin Actraphane hm penfil Novo Nordisk (Pty) Ltd, South Africa Solution for Injection Prescription Only Medicine040/015 Insulin Monotard HM injection Novo Nordisk (Pty) Ltd, South Africa Solution for Injection Prescription Only Medicine287/001 Acfree gel Ochoa Laboratories Ltd, India Gel Topical Pharmacy Medicine287/002 Ultican 50 tablets Ochoa Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine287/003 Ultican 150 tablets Ochoa Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine287/004 Ultican 200 tablets Ochoa Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine287/005 Terbofin cream Ochoa Laboratories Ltd, India Cream Topical Prescription Only Medicine287/006 Terbofin tablets Ochoa Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine287/007 Exevate G cream Ochoa Laboratories Ltd, India Cream Topical Prescription Only Medicine287/008 Xtraderm cream Ochoa Laboratories Ltd, India Cream Topical Prescription Only Medicine287/009 Topibact ointment Ochoa Laboratories Ltd, India Ointment topical Prescription Only Medicine287/011 Doloact injection Ochoa Laboratories Ltd, India Solution for Injection Prescription Only Medicine141/001 Bivir tablets Okasa Pharma Ltd, India Tablet Film coated Prescription Only Medicine141/002 Maxivir 30 tablets Okasa Pharma Ltd, India Tablet Uncoated Prescription Only Medicine141/003 Maxivir 40 tablets Okasa Pharma Ltd, India Tablet Uncoated Prescription Only Medicine141/005 Okavir Oral solution Okasa Pharma Ltd, India Solution for Oral Use Prescription Only Medicine141/006 Okamune tablets Okasa Pharma Ltd, India Tablet Uncoated Prescription Only Medicine141/007 Oka -Ceftriaxone injection Okasa Pharma Ltd, India Powder for Injection Prescription Only Medicine141/008 Efiva 200 capsules Okasa Pharma Ltd, India Capsule oral Prescription Only Medicine141/009 Oka-Vincristine injection Okasa Pharma Ltd, India Powder for Injection Prescription Only Medicine141/010 Efiva 600 capsules Okasa Pharma Ltd, India Tablet Uncoated Prescription Only Medicine141/012 Cefurox 500 tablets Okasa Pharma Ltd, India Tablet Enteric Coated Prescription Only Medicine141/013 Oka-Azithromycin tablets Okasa Pharma Ltd, India Tablet Uncoated Prescription Only Medicine141/014 Okavir S 30 tablets Okasa Pharma Ltd, India Tablet Uncoated Prescription Only Medicine141/016 Artheleria Oral suspension Okasa Pharma Ltd, India Suspension for Oral Use Prescription Only Medicine2709/04 Duozid tablets Okasa Pharma Ltd, India Tablet Uncoated Prescription Only Medicine258/001 Viscodril Expectorant syrup Oman Pharmaceutical Products Co. LLC,

OmanSyrup Pharmacy Medicine

258/002 Opizole cream Oman Pharmaceutical Products Co. LLC, Oman

Cream Topical Prescription Only Medicine

258/003 Clofast gel Oman Pharmaceutical Products Co. LLC, Oman

Gel Topical Pharmacy Medicine

258/004 Dimet 650 tablets Oman Pharmaceutical Products Co. LLC, Oman

Tablet Uncoated Prescription Only Medicine

258/005 Dimet 500 tablets Oman Pharmaceutical Products Co. LLC, Oman

Tablet Uncoated Prescription Only Medicine

45 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

258/006 Medicoril-E syrup Oman Pharmaceutical Products Co. LLC, Oman

Syrup Pharmacy Medicine

258/007 Atormin 50 tablets Oman Pharmaceutical Products Co. LLC, Oman

Tablet Uncoated Prescription Only Medicine

258/008 Atormin 100 tablets Oman Pharmaceutical Products Co. LLC, Oman

Tablet Uncoated Prescription Only Medicine

258/009 Pmol syrup Oman Pharmaceutical Products Co. LLC, Oman

Syrup General Sale

258/010 Pmol caplets Oman Pharmaceutical Products Co. LLC, Oman

Capsule oral General Sale

185/001 Cefacure capsules Orchid Healthcare Ltd, India Capsule oral Prescription Only Medicine185/002 Cefacure capsules Orchid Healthcare Ltd, India Capsule oral Prescription Only Medicine185/003 Cefogram injection Orchid Healthcare Ltd, India Powder for Injection Prescription Only Medicine185/004 Cefogram injection Orchid Healthcare Ltd, India Powder for Injection Prescription Only Medicine185/005 Orzid injection Orchid Healthcare Ltd, India Powder for Injection Prescription Only Medicine185/006 Orzid injection Orchid Healthcare Ltd, India Powder for Injection Prescription Only Medicine185/007 Tax-o-BID injection Orchid Healthcare Ltd, India Powder for Injection Prescription Only Medicine185/008 Tax-o-BID injection Orchid Healthcare Ltd, India Powder for Injection Prescription Only Medicine185/009 Tax-o-BID injection Orchid Healthcare Ltd, India Powder for Injection Prescription Only Medicine185/010 Spizef tablets Orchid Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine185/011 Spizef 500 tablets Orchid Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine185/012 Ulti - mate 50 tablets Orchid Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine185/013 Ulti-mate 100 Sildenafil tablets Orchid Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine185/014 Orpime injection Orchid Healthcare Ltd, India Solution for Injection Prescription Only Medicine185/015 Orfix capsules Orchid Healthcare Ltd, India Capsule oral Prescription Only Medicine185/016 Manorest tablets Orchid Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine185/017 Cepotil 200 tablets Orchid Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine185/018 Cepotil 100 tablets Orchid Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine185/019 E-pril -10 tablets Orchid Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine185/020 Epril 5 tablets Orchid Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine185/021 Monorest tablets Orchid Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine213/001 Gentamycin Sulphate injection Ouyi Pharma Co.Ltd, China Solution for Injection Prescription Only Medicine120/001 Diflucan tablets Pfizer Global Pharmaceuticals Ltd, Nigeria Tablet Uncoated Prescription Only Medicine120/002 Zithromax tablets Pfizer Global Pharmaceuticals Ltd, Nigeria Tablet Uncoated Prescription Only Medicine120/003 Viagra tablets Pfizer Global Pharmaceuticals Ltd, Nigeria Tablet Uncoated Prescription Only Medicine120/005 Liptor tablets Pfizer Global Pharmaceuticals Ltd, Nigeria Tablet Uncoated Prescription Only Medicine120/006 Liptor tablets Pfizer Global Pharmaceuticals Ltd, Nigeria Tablet Uncoated Prescription Only Medicine120/007 Diflucan tablets Pfizer Global Pharmaceuticals Ltd, Nigeria Tablet Uncoated Prescription Only Medicine120/008 Feldene tablets Pfizer Global Pharmaceuticals Ltd, Nigeria Tablet Uncoated Prescription Only Medicine120/009 Diflucan tablets Pfizer Global Pharmaceuticals Ltd, Nigeria Tablet Uncoated Prescription Only Medicine120/010 Fansigyln tablets Pfizer Global Pharmaceuticals Ltd, Nigeria Tablet Uncoated Prescription Only Medicine120/011 Xalatan eye drops Pfizer Global Pharmaceuticals Ltd, Nigeria Eye Drops Prescription Only Medicine120/013 Norvasc tablets Pfizer Global Pharmaceuticals Ltd, Nigeria Tablet Uncoated Prescription Only Medicine120/014 Terracotril eye/ear drops Pfizer Global Pharmaceuticals Ltd, Nigeria Ear/Eye Drops Prescription Only Medicine120/015 Feldene injection Pfizer Global Pharmaceuticals Ltd, Nigeria Solution for Injection Prescription Only Medicine120/017 Prostine E 2 vaginal tablets Pfizer Global Pharmaceuticals Ltd, Nigeria Tablet Uncoated Prescription Only Medicine120/018 Feldene capsules Pfizer Global Pharmaceuticals Ltd, Nigeria Capsule oral Prescription Only Medicine120/021 Trobicin injection Pfizer Global Pharmaceuticals Ltd, Nigeria Solution for Injection Prescription Only Medicine120/022 Depo medrol injection Pfizer Global Pharmaceuticals Ltd, Nigeria Solution for Injection Prescription Only Medicine120/024 Accupril tablets Pfizer Global Pharmaceuticals Ltd, Nigeria Tablet Uncoated Prescription Only Medicine120/025 Accupril tablets Pfizer Global Pharmaceuticals Ltd, Nigeria Tablet Uncoated Prescription Only Medicine120/026 Accupretic tablets Pfizer Global Pharmaceuticals Ltd, Nigeria Tablet Uncoated Prescription Only Medicine120/027 Ponstan capsules Pfizer Global Pharmaceuticals Ltd, Nigeria Capsule oral Prescription Only Medicine120/028 Ponstan suspension Pfizer Global Pharmaceuticals Ltd, Nigeria Suspension for Oral Use Prescription Only Medicine120/029 Feldene topical gel Pfizer Global Pharmaceuticals Ltd, Nigeria Gel Topical Prescription Only Medicine120/030 Zithromax suspension Pfizer Laboratories Ltd, Kenya Suspension for Oral Use Prescription Only Medicine131/008 Tetracycline capsules Pharco Ltd,Zambia Capsule oral Prescription Only Medicine132/002 Normavir tablets Pharco Ltd,Zambia Tablet Uncoated Prescription Only Medicine

PRA Secretariat / January 2009 46

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

132/003 Cimetidine tablets Pharco Ltd,Zambia Tablet Uncoated Prescription Only Medicine132/004 Chlorpheniramine tablets Pharco Ltd,Zambia Tablet Uncoated Pharmacy Medicine132/005 Co-trimoxazole tablets Pharco Ltd,Zambia Tablet Uncoated Prescription Only Medicine132/006 Metronidazole tablets Pharco Ltd,Zambia Tablet Uncoated Prescription Only Medicine132/007 Folic Acid tablets Pharco Ltd,Zambia Tablet Uncoated Pharmacy Medicine132/009 Pyrazinamide tablets Pharco Ltd,Zambia Tablet Uncoated Prescription Only Medicine132/010 Paracetamol tablets Pharco Ltd,Zambia Tablet Uncoated General Sale132/011 Paracetamol tablets Pharco Ltd,Zambia Tablet Uncoated Pharmacy Medicine132/012 Sulphadoxine / pyrimethamine tablets Pharco Ltd,Zambia Tablet Uncoated Pharmacy Medicine132/013 Carbamazepine tablets Pharco Ltd,Zambia Tablet Uncoated Prescription Only Medicine132/014 Metoclopramide tablets Pharco Ltd,Zambia Tablet Uncoated Prescription Only Medicine132/015 Quinine Sulphate tablets Pharco Ltd,Zambia Tablet Uncoated Prescription Only Medicine247/001 Depogest injection Pharmacarechem International Ltd, England Solution for Injection Prescription Only Medicine247/002 Cloxacillin Dry Syrup Pharmacarechem International Ltd, England Syrup Prescription Only Medicine247/003 Amoxicillin dry syrup Pharmacarechem International Ltd, England Suspension for Oral Use Prescription Only Medicine247/004 Erythromycin oral suspension Pharmacarechem International Ltd, England Suspension for Oral Use Prescription Only Medicine247/005 Ampicillin dry syrup Pharmacarechem International Ltd, England Syrup Prescription Only Medicine247/006 Phenoxymethyl Penicillin suspension Pharmacarechem International Ltd, England Suspension for Oral Use Prescription Only Medicine198/001 Solu Medrol injection Pharmacia & Upjohn Worldwide, Kalamazoo,

U.S.ASolution for Injection Prescription Only Medicine

198/002 Medrol tablets Pharmacia & Upjohn Worldwide, Kalamazoo, U.S.A

Tablet Uncoated Prescription Only Medicine

198/003 Halcion tablets Pharmacia & Upjohn Worldwide, Kalamazoo, U.S.A

Tablet Uncoated Prescription Only Medicine

198/005 Xalatan solution Pharmacia & Upjohn Worldwide, Kalamazoo, U.S.A

Eye Drops Prescription Only Medicine

198/006 Provera tablets Pharmacia & Upjohn Worldwide, Kalamazoo, U.S.A

Tablet Uncoated Prescription Only Medicine

198/007 Dalacin C injection Pharmacia & Upjohn Worldwide, Kalamazoo, U.S.A

Solution for Injection Prescription Only Medicine

198/008 Dalacin C capsules Pharmacia & Upjohn Worldwide, Kalamazoo, U.S.A

Capsule oral Prescription Only Medicine

198/009 Dalacin C syrup Pharmacia & Upjohn Worldwide, Kalamazoo, U.S.A

Solution for Oral Use Prescription Only Medicine

198/010 Caverject Powder For injection. Pharmacia & Upjohn Worldwide, Kalamazoo, U.S.A

Powder for Injection Prescription Only Medicine

198/011 Neo Medrol Acne lotion Pharmacia & Upjohn Worldwide, Kalamazoo, U.S.A

Lotion for Topical Use Prescription Only Medicine

198/012 Solu Cortef injection Pharmacia & Upjohn Worldwide, Kalamazoo, U.S.A

Solution for Injection Prescription Only Medicine

198/013 Unicarp M capsules Pharmacia & Upjohn Worldwide, Kalamazoo, U.S.A

Capsule oral Pharmacy Medicine

198/015 Togamycin injection Pharmacia & Upjohn Worldwide, Kalamazoo, U.S.A

Powder for Injection Prescription Only Medicine

198/016 Depo Provera injection Pharmacia & Upjohn Worldwide, Kalamazoo, U.S.A

Suspension for Injection Prescription Only Medicine

144/001 Chloroquine Phosphate tablets Pharmadanica A/S, Denmark Tablet Uncoated Prescription Only Medicine144/002 Co-trimoxazole Oral suspension Pharmadanica A/S, Denmark Suspension for Oral Use Prescription Only Medicine144/003 Co-trimoxazole tablets Pharmadanica A/S, Denmark Tablet Uncoated Prescription Only Medicine144/004 Ampicillin Oral suspension Pharmadanica A/S, Denmark Powder for Oral

SuspensionPrescription Only Medicine

144/005 Amoxicillin Oral suspension Pharmadanica A/S, Denmark Powder for Oral Suspension

Prescription Only Medicine

144/006 Metronidazole tablets Pharmadanica A/S, Denmark Tablet Uncoated Prescription Only Medicine144/007 Paracetamol tablets Pharmadanica A/S, Denmark Tablet Uncoated Pharmacy Medicine144/008 Ibuprofen tablets Pharmadanica A/S, Denmark Tablet Uncoated Pharmacy Medicine144/009 Diclofenac tablets Pharmadanica A/S, Denmark Tablet Uncoated Pharmacy Medicine144/010 Sulfadoxine + Pyrimethamine tablets Pharmadanica A/S, Denmark Tablet Uncoated Pharmacy Medicine144/011 Nystatin Oral suspension Pharmadanica A/S, Denmark Suspension for Oral Use Prescription Only Medicine144/012 Aspirin tablets Pharmadanica A/S, Denmark Tablet Uncoated Pharmacy Medicine

47 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

144/013 Amoxicillin capsules Pharmadanica A/S, Denmark Tablet Uncoated Prescription Only Medicine144/014 Benzathine benzylpenicillin injection

2.4muPharmadanica A/S, Denmark Solution for Injection Prescription Only Medicine

144/015 Benzylpenicillin injection 1m.u. Pharmadanica A/S, Denmark Solution for Injection Prescription Only Medicine144/016 Benzylpenicillin injection 5m.u. Pharmadanica A/S, Denmark Solution for Injection Prescription Only Medicine144/017 Diazepam injection 5mg/ml Pharmadanica A/S, Denmark Solution for Injection Prescription Only Medicine144/018 Lidocaine hydrochloride injection Pharmadanica A/S, Denmark Solution for Injection Prescription Only Medicine144/019 Mebendazole 100mg tablets Pharmadanica A/S, Denmark Tablet Uncoated Pharmacy Medicine144/020 Methyllergonovine injection 0.2mg/ml Pharmadanica A/S, Denmark Solution for Injection Prescription Only Medicine144/021 Nitrofurantoin 50mg tablets Pharmadanica A/S, Denmark Tablet Uncoated Prescription Only Medicine144/022 Paracetamol 500mg tablets Pharmadanica A/S, Denmark Tablet Uncoated Pharmacy Medicine144/023 Chlorpheniramine 4mg tablets Pharmadanica A/S, Denmark Tablet Uncoated Pharmacy Medicine144/024 Clotrimazole 1% cream Pharmadanica A/S, Denmark Tablet Uncoated Prescription Only Medicine144/025 Erythromycin stearate 250mg tablets Pharmadanica A/S, Denmark Tablet Uncoated Prescription Only Medicine144/026 Ferrous sulphate 50mg tablets Pharmadanica A/S, Denmark Tablet Uncoated Pharmacy Medicine144/027 Folic acid 5mg tablets Pharmadanica A/S, Denmark Tablet Uncoated Pharmacy Medicine144/028 Hydrocortisone acetate ointment 1% Pharmadanica A/S, Denmark Ointment topical Prescription Only Medicine144/029 Compound Magnesium trisilicate tablets Pharmadanica A/S, Denmark Tablet Uncoated Pharmacy Medicine144/030 Salbutamol 2mg tablets Pharmadanica A/S, Denmark Tablet Uncoated Prescription Only Medicine144/031 Procain Penicillin injection Pharmadanica A/S, Denmark Solution for Injection Prescription Only Medicine144/032 Salbutamol tablets Pharmadanica A/S, Denmark Tablet Uncoated Prescription Only Medicine144/033 Phenoxymethylpenicillin tablets Pharmadanica A/S, Denmark Tablet Uncoated Prescription Only Medicine144/034 Nystatin Oral suspension Pharmadanica A/S, Denmark Suspension for Oral Use Prescription Only Medicine144/035 Doxycycline tablets Pharmadanica A/S, Denmark Tablet Uncoated Prescription Only Medicine144/036 Multivitamin tablets Pharmadanica A/S, Denmark Tablet Uncoated Pharmacy Medicine144/037 Water for injections Pharmadanica A/S, Denmark Solution for Injection Prescription Only Medicine144/038 Metronidazole tablets Pharmadanica A/S, Denmark Tablet Uncoated Prescription Only Medicine017/001 Closcript Vaginal cream Pharmanova (Pty) Ltd, Zimbabwe Cream Topical Prescription Only Medicine017/002 Closcript Topical cream Pharmanova (Pty) Ltd, Zimbabwe Cream Topical Prescription Only Medicine017/003 Goldgesic syrup Pharmanova (Pty) Ltd, Zimbabwe Syrup Pharmacy Medicine017/004 Grays Eye drops Pharmanova (Pty) Ltd, Zimbabwe Eye Drops Prescription Only Medicine017/005 Goldgesic tablets Pharmanova (Pty) Ltd, Zimbabwe Tablet Uncoated Pharmacy Medicine007/009 Novidar tablets Pharmanova (Z) Ltd, Zambia Tablet Uncoated Pharmacy Medicine077/001 Adult Cafemol tablets Pharmanova (Z) Ltd, Zambia Tablet Uncoated General Sale077/002 Child Cafemol tablets Pharmanova (Z) Ltd, Zambia Tablet Uncoated General Sale077/003 Panado tablets Pharmanova (Z) Ltd, Zambia Tablet Uncoated General Sale077/006 Novaderm dusting powder Pharmanova (Z) Ltd, Zambia Powder for Topical use General Sale077/007 Phipps Gripe Water Pharmanova (Z) Ltd, Zambia Solution for Oral Use General Sale077/008 Novatrim tablets Pharmanova (Z) Ltd, Zambia Tablet Uncoated Prescription Only Medicine077/011 Drews Liver Salt Pharmanova (Z) Ltd, Zambia Powder for Oral Solution General Sale077/014 Co-trimoxazole tablets Pharmanova (Z) Ltd, Zambia Tablet Uncoated Prescription Only Medicine077/018 Aspirin Tablets Pharmanova (Z) Ltd, Zambia Tablet Uncoated Pharmacy Medicine077/019 Novalyte ORS Pharmanova (Z) Ltd, Zambia Powder for Oral Solution General Sale077/020 Novidar Plus tablets Pharmanova (Z) Ltd, Zambia Tablet Uncoated257/001 Aspirin Pharmanova (Malawi) Ltd, Malawi Tablet Uncoated Pharmacy Medicine257/002 Phipps Milk of Magnesia Pharmanova (Malawi) Ltd, Malawi Suspension for Oral Use General Sale257/003 Panadol tablets for children Pharmanova (Malawi) Ltd, Malawi Tablet Uncoated General Sale257/019 Stearns pine tar Pharmanova (Malawi) Ltd, Malawi Syrup General Sale183/001 Q-Med Adrenaline Injection Preterius Patents CC, South Africa Solution for Injection Prescription Only Medicine265/001 Alphacillin 250 capsules Prime Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine265/002 Acyzon tablets Prime Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine265/003 Primox 250 capsules Prime Pharmaceuticals Ltd, India Capsule oral Prescription Only Medicine265/004 Ketoniz tablets Prime Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine246/001 Clotflush injection Prisma Pharmaceuticals Ltd, United Kingdom Solution for Injection Prescription Only Medicine246/002 Priskacin 250 injection Prisma Pharmaceuticals Ltd, United Kingdom Powder for Injection Prescription Only Medicine246/003 Purectal tablets Prisma Pharmaceuticals Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine246/004 Priskacin 500 injection Prisma Pharmaceuticals Ltd, United Kingdom Powder for Injection Prescription Only Medicine246/005 Synolube injection Prisma Pharmaceuticals Ltd, United Kingdom Solution for Injection Prescription Only Medicine

PRA Secretariat / January 2009 48

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

246/009 Odicef 1000 injection Prisma Pharmaceuticals Ltd, United Kingdom Powder for Injection Prescription Only Medicine246/010 Odicef 50 injection Prisma Pharmaceuticals Ltd, United Kingdom Powder for Injection Prescription Only Medicine246/011 Odicef 250 injection Prisma Pharmaceuticals Ltd, United Kingdom Powder for Injection Prescription Only Medicine246/014 Clavex injection Prisma Pharmaceuticals Ltd, United Kingdom Solution for Injection Prescription Only Medicine246/016 LMW Enox injection Prisma Pharmaceuticals Ltd, United Kingdom Solution for Injection Prescription Only Medicine246/017 LMW Enox injection Prisma Pharmaceuticals Ltd, United Kingdom Solution for Injection Prescription Only Medicine246/018 LMW Enox injection Prisma Pharmaceuticals Ltd, United Kingdom Solution for Injection Prescription Only Medicine162/001 Co-trimoxazole tablets Pure Pharma Ltd, India Tablet Uncoated Prescription Only Medicine162/002 Feefen tablet Pure Pharma Ltd, India Tablet Uncoated Pharmacy Medicine162/004 Sulphadoxine + Pyrimethamine tablets Pure Pharma Ltd, India Tablet Uncoated Pharmacy Medicine162/006 Praziquantel tablets Pure Pharma Ltd, India Tablet Uncoated Prescription Only Medicine162/008 Peevaran tablets Pure Pharma Ltd, India Tablet Uncoated Pharmacy Medicine162/009 Peemox capsules Pure Pharma Ltd, India Capsule oral Prescription Only Medicine162/010 Indomethacin capsules Pure Pharma Ltd, India Capsule oral Pharmacy Medicine162/011 Cloxacillin capsules Pure Pharma Ltd, India Capsule oral Prescription Only Medicine112/001 Sporidex 500 capsules Ranbaxy Laboratories Ltd, India Capsule oral Prescription Only Medicine112/002 Sporidex capsules Ranbaxy Laboratories Ltd, India Capsule oral Prescription Only Medicine112/003 Simvor 10 tablets Ranbaxy Laboratories Ltd, India Tablet Film coated Prescription Only Medicine112/004 Simvor 20 tablets Ranbaxy Laboratories Ltd, India Tablet Film coated Prescription Only Medicine112/005 Effical tablets Ranbaxy Laboratories Ltd, India Tablet Film coated Pharmacy Medicine112/006 Zanocin 200 tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/007 Enhancin injection Ranbaxy Laboratories Ltd, India Solution for Injection Prescription Only Medicine112/008 Canova-25 tablets Ranbaxy Laboratories Ltd, India Tablet Film coated Prescription Only Medicine112/009 Canova-50 tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/010 Canova-100 tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/011 Zamocin OD 400 tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/012 Fluroric 50 capsules Ranbaxy Laboratories Ltd, India Capsule oral Prescription Only Medicine112/013 Fluroric 150 capsules Ranbaxy Laboratories Ltd, India Capsule oral Prescription Only Medicine112/014 Gynostatum cream Ranbaxy Laboratories Ltd, India Cream Topical Prescription Only Medicine112/015 Gynostatum pessaries Ranbaxy Laboratories Ltd, India Tablet Vaginal Prescription Only Medicine112/016 Silverex cream Ranbaxy Laboratories Ltd, India Cream Topical Pharmacy Medicine112/017 Diprovate cream Ranbaxy Laboratories Ltd, India Cream Topical Prescription Only Medicine112/018 Volini gel Ranbaxy Laboratories Ltd, India Gel Topical Pharmacy Medicine112/019 Statum cream Ranbaxy Laboratories Ltd, India Cream Topical Prescription Only Medicine112/020 Calcibra capsules Ranbaxy Laboratories Ltd, India Capsule oral Prescription Only Medicine112/021 Calcibra capsules Ranbaxy Laboratories Ltd, India Capsule oral Prescription Only Medicine112/022 Ceroxim 250 tablets Ranbaxy Laboratories Ltd, India Tablet Film coated Prescription Only Medicine112/023 Storvas20mg tablets Ranbaxy Laboratories Ltd, India Tablet Film coated Prescription Only Medicine112/024 Storvas 10mg tablets Ranbaxy Laboratories Ltd, India Tablet Film coated Prescription Only Medicine112/025 Ranophage tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/026 Enhancin 1000 tablets Ranbaxy Laboratories Ltd, India Tablet Film coated Prescription Only Medicine112/027 Amlovas tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/028 Ceroxim suspension Ranbaxy Laboratories Ltd, India Suspension Prescription Only Medicine112/029 Ceroxim suspension Ranbaxy Laboratories Ltd, India Suspension Prescription Only Medicine112/030 Flucoric 100mg capsules Ranbaxy Laboratories Ltd, India Capsule oral Prescription Only Medicine112/031 Klabax tablets Ranbaxy Laboratories Ltd, India Tablet Film coated Prescription Only Medicine112/032 Klabax 500 tablets Ranbaxy Laboratories Ltd, India Tablet Film coated Prescription Only Medicine112/033 Flucoric capsules Ranbaxy Laboratories Ltd, India Capsule oral Prescription Only Medicine112/034 Rannmoxy suspension Ranbaxy Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine112/035 Ranmoxy suspension Ranbaxy Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine112/036 Cifran OD tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/037 Cifran OD tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/038 Ranxoyl suspension Ranbaxy Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine112/039 Lovir tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/040 Oframax 250 injection Ranbaxy Laboratories Ltd, India Powder for Injection Prescription Only Medicine112/041 Oframax injection Ranbaxy Laboratories Ltd, India Powder for Injection Prescription Only Medicine112/042 Ranferon - 12 capsules Ranbaxy Laboratories Ltd, India Capsule oral Pharmacy Medicine

49 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

112/043 Roscillin 250 capsules Ranbaxy Laboratories Ltd, India Capsule oral Prescription Only Medicine112/044 Cifran 250 tablets Ranbaxy Laboratories Ltd, India Tablet Film coated Prescription Only Medicine112/045 Ceroxim 500 tablets Ranbaxy Laboratories Ltd, India Tablet Film coated Prescription Only Medicine112/046 Loxof infusion Ranbaxy Laboratories Ltd, India Solution for infusion Prescription Only Medicine112/047 Avostav 30 capsules Ranbaxy Laboratories Ltd, India Capsule oral Prescription Only Medicine112/048 Avostav 40 capsules Ranbaxy Laboratories Ltd, India Capsule oral Prescription Only Medicine112/049 Loxf-250 tablets Ranbaxy Laboratories Ltd, India Tablet Film coated Prescription Only Medicine112/050 Loxof 500 tablets Ranbaxy Laboratories Ltd, India Tablet Film coated Prescription Only Medicine112/051 Rancotrim suspension Ranbaxy Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine112/052 Celica tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/053 Celica tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/054 Copril capsules Ranbaxy Laboratories Ltd, India Capsule oral Prescription Only Medicine112/055 Amlovas tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/056 Bucavine 500 injection Ranbaxy Laboratories Ltd, India Solution for Injection Prescription Only Medicine112/057 Contiflo capsules Ranbaxy Laboratories Ltd, India Capsule oral Prescription Only Medicine112/058 Avolam tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/059 Avocomb tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/060 Avocomb-N tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/061 Abac 300 tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/062 Aviro-z tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/063 Nevipan tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/064 Histac 150 tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/065 Histac tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/066 Kefloxin suspension Ranbaxy Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine112/067 Kefloxoxin capsules Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/068 Histac tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/069 Enhancin 375 tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/070 Enhancin 675 tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/071 Sporidex suspension Ranbaxy Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine112/072 Cifran 500mg tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/073 Triviro 30 --LNS tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/074 Triviro 40 -LNS tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/075 Coviro-LS 30 compliance pack tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/076 Coviro-LS 40 compliance pack tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/077 Abac-lz tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/078 Avirodin caps Ranbaxy Laboratories Ltd, India Capsule oral Prescription Only Medicine112/079 Aviranz tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/080 Aviranz tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/081 Chericoff syrup Ranbaxy Laboratories Ltd, India Tablet Chewable Pharmacy Medicine112/082 Cifran c.t tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/083 Riconia liquid Ranbaxy Laboratories Ltd, India Syrup Pharmacy Medicine112/084 Sebifin tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/085 Riconia tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/086 Monsin Ointment Ranbaxy Laboratories Ltd, India Ointment topical Prescription Only Medicine112/087 Cepodem suspension Ranbaxy Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine112/088 Cepodem tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/089 Ranophage tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/090 Cepodem tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/091 Brustan tablets Ranbaxy Laboratories Ltd, India Tablet Film coated Pharmacy Medicine112/092 Brustan suspension Ranbaxy Laboratories Ltd, India Suspension for Oral Use Pharmacy Medicine112/093 Corpril tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/094 Corpril tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/095 Avocomb-E Compliance pack tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/096 Coviro-E 30 Compliance pack tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/097 Coviro-E 40 compliance pack tablets Ranbaxy Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine112/098 Triviro LNS Kid Dispersible tablets Ranbaxy Laboratories Ltd, India Tablet Dispersible Prescription Only Medicine112/099 Triviro LNS Kid Dispersible tablets Ranbaxy Laboratories Ltd, India Tablet Dispersible Prescription Only Medicine

PRA Secretariat / January 2009 50

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

112/100 Ranferon-12 syrup Ranbaxy Laboratories Ltd, India Syrup Pharmacy Medicine112/101 Enhancin suspension Ranbaxy Laboratories Ltd, India Granules for Suspension Prescription Only Medicine112/102 Lovir cream Ranbaxy Laboratories Ltd, India Cream Topical Prescription Only Medicine112/103 Klabax suspension -12 Ranbaxy Laboratories Ltd, India Suspension Prescription Only Medicine133/007 Bonjela clear gel Reckitt Benckiser Pharmaceutical (Pty) Ltd, SA Gel Topical General Sale205/001 Delased Chesty syrup Regal Pharmaceuticals Ltd,Kenya Syrup Pharmacy Medicine205/002 Delased Dry syrup Regal Pharmaceuticals Ltd,Kenya Syrup Pharmacy Medicine205/003 Coldcap syrup Regal Pharmaceuticals Ltd,Kenya Syrup Pharmacy Medicine205/004 Delased syrup Regal Pharmaceuticals Ltd,Kenya Syrup Pharmacy Medicine205/005 Coldcap capsules Regal Pharmaceuticals Ltd,Kenya Capsule oral Pharmacy Medicine205/006 Whitfield ointment Regal Pharmaceuticals Ltd,Kenya Ointment topical Pharmacy Medicine205/007 Rinavit syrup Regal Pharmaceuticals Ltd,Kenya Syrup Pharmacy Medicine205/008 Ibumex suspension Regal Pharmaceuticals Ltd,Kenya Suspension for Oral Use Pharmacy Medicine205/009 Rinalin syrup Regal Pharmaceuticals Ltd,Kenya Syrup Pharmacy Medicine205/010 Megayl - 200 tablets Regal Pharmaceuticals Ltd,Kenya Tablet Uncoated Prescription Only Medicine205/011 Cetamol syrup Regal Pharmaceuticals Ltd,Kenya Syrup General Sale205/012 Salbutamol syrup Regal Pharmaceuticals Ltd,Kenya Syrup Prescription Only Medicine205/013 Compound Magnesium tablets Regal Pharmaceuticals Ltd,Kenya Tablet Uncoated Pharmacy Medicine205/014 Ruben cream Regal Pharmaceuticals Ltd,Kenya Cream Topical Pharmacy Medicine205/015 Cetanol tablets Regal Pharmaceuticals Ltd,Kenya Tablet Uncoated General Sale209/001 Cilox tablets Remedica Ltd, Cyprus Tablet Film coated Prescription Only Medicine209/002 Alfoxan 250 capsules Remedica Ltd, Cyprus Capsule oral Prescription Only Medicine209/003 Cyclovax 200 tablets Remedica Ltd, Cyprus Tablet Film coated Prescription Only Medicine209/004 Ibuprofen tablets Remedica Ltd, Cyprus Tablet Film coated Pharmacy Medicine209/005 Korandil 10 tablets Remedica Ltd, Cyprus Tablet Uncoated Prescription Only Medicine209/006 Nifelat SR tablets Remedica Ltd, Cyprus Tablet Film coated Prescription Only Medicine209/007 Nifelat 10 tablets Remedica Ltd, Cyprus Tablet Film coated Prescription Only Medicine209/008 Ova-Mit 50 tablets Remedica Ltd, Cyprus Tablet Film coated Prescription Only Medicine209/009 Remethan 25 tablets Remedica Ltd, Cyprus Tablet Film coated Pharmacy Medicine209/010 Roxitan 10 capsules Remedica Ltd, Cyprus Capsule oral Prescription Only Medicine209/011 Zindolin 250 tablets Remedica Ltd, Cyprus Tablet Film coated Prescription Only Medicine032/001 Moxypen capsules SADM Pharmaceuticals Ltd, Malawi Capsule oral Prescription Only Medicine032/002 Puromylon tablets SADM Pharmaceuticals Ltd, Malawi Tablet Uncoated Prescription Only Medicine032/003 Trichozole tablets SADM Pharmaceuticals Ltd, Malawi Tablet Uncoated Prescription Only Medicine032/004 Len VK tablets SADM Pharmaceuticals Ltd, Malawi Tablet Uncoated Prescription Only Medicine032/005 Doxycline capsules SADM Pharmaceuticals Ltd, Malawi Capsule oral Prescription Only Medicine032/006 Quinine tablets SADM Pharmaceuticals Ltd, Malawi Tablet Enteric Coated Prescription Only Medicine032/007 Pertecillin capsules SADM Pharmaceuticals Ltd, Malawi Tablet Uncoated Prescription Only Medicine249/001 Trimaprim tablets Saga Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine249/002 Flamcid capsules Saga Laboratories Ltd, India Capsule oral Pharmacy Medicine249/003 Safexin 500mg capsules Saga Laboratories Ltd, India Capsule oral Prescription Only Medicine249/004 Q-Bact tablets Saga Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine249/005 Rufen 200 tablets Saga Laboratories Ltd, India Tablet Uncoated Pharmacy Medicine249/006 Rythrocine tablets Saga Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine249/007 Omecid capsules Saga Laboratories Ltd, India Capsule oral Prescription Only Medicine249/008 Finapril tablets Saga Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine249/009 Finapril tablets Saga Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine249/010 Finapril tablets Saga Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine249/011 Hexantel tablets Saga Laboratories Ltd, India Tablet Uncoated Pharmacy Medicine249/012 Eze DT tablets Saga Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine249/013 Antipress 100 tablets Saga Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine249/014 Antipress 50 tablets Saga Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine249/015 Nifetab 10 tablets Saga Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine249/016 Nifetab 20 tablets Saga Laboratories Ltd, India Tablet extended release Prescription Only Medicine249/017 Vitarich tablets Saga Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine249/018 Allerban tablets Saga Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine249/019 Pyranim tablets Saga Laboratories Ltd, India Tablet Uncoated Pharmacy Medicine

51 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

249/020 Piroximicam tablets Saga Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine249/021 Diarid suspension Saga Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine249/022 ACE Selenium tablets Saga Laboratories Ltd, India Tablet Uncoated Pharmacy Medicine249/023 Diarest suspension Saga Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine249/024 Airmax -Plus syrup Saga Laboratories Ltd, India Syrup Pharmacy Medicine249/025 Abvit drops Saga Laboratories Ltd, India Solution for Oral Use General Sale249/026 Lamoryl suspension Saga Laboratories Ltd, India Suspension for Oral Use Pharmacy Medicine249/027 Iburex capsules Saga Laboratories Ltd, India Capsule oral Pharmacy Medicine249/028 Hexantel suspension Saga Laboratories Ltd, India Suspension for Oral Use Pharmacy Medicine175/002 Phenergan 25 tablets Sanofi Aventis Pharma Ltd, Kenya Tablet Film coated Prescription Only Medicine175/003 Phenergan elixir Sanofi Aventis Pharma Ltd, Kenya Elixir Pharmacy Medicine175/004 Tritace 5 tablets Sanofi Aventis Pharma Ltd, Kenya Tablet Uncoated Prescription Only Medicine175/005 Tritace 2.5 tablets Sanofi Aventis Pharma Ltd, Kenya Tablet Uncoated Prescription Only Medicine175/006 Largactil tablets Sanofi Aventis Pharma Ltd, Kenya Tablet Uncoated Prescription Only Medicine175/007 Largactil injection Sanofi Aventis Pharma Ltd, Kenya Solution for Injection Prescription Only Medicine175/008 Largactil 25 tablets Sanofi Aventis Pharma Ltd, Kenya Tablet Film coated Prescription Only Medicine175/009 Stemetil injection Sanofi Aventis Pharma Ltd, Kenya Solution for Injection Prescription Only Medicine175/010 Stemitil 5 tablets Sanofi Aventis Pharma Ltd, Kenya Tablet Uncoated Prescription Only Medicine175/011 Flagyl suppository Sanofi Aventis Pharma Ltd, Kenya Suppository Prescription Only Medicine175/012 Flagyl 400 tablets Sanofi Aventis Pharma Ltd, Kenya Tablet Uncoated Prescription Only Medicine175/013 Flagyl 200 tablets Sanofi Aventis Pharma Ltd, Kenya Tablet Uncoated Prescription Only Medicine175/014 Amaryl 4 tablets Sanofi Aventis Pharma Ltd, Kenya Tablet Uncoated Prescription Only Medicine175/015 Amaryl 2 tablets Sanofi Aventis Pharma Ltd, Kenya Tablet Uncoated Prescription Only Medicine175/016 Amaryl 1 tablets Sanofi Aventis Pharma Ltd, Kenya Tablet Uncoated Prescription Only Medicine175/017 Flagyl injection Sanofi Aventis Pharma Ltd, Kenya Solution for Injection Prescription Only Medicine175/018 Clexane 20 injection Sanofi Aventis Pharma Ltd, Kenya Solution for Injection Prescription Only Medicine175/019 Clexane 60 injection Sanofi Aventis Pharma Ltd, Kenya Solution for Injection Prescription Only Medicine175/020 Clexane 40 injection Sanofi Aventis Pharma Ltd, Kenya Solution for Injection Prescription Only Medicine175/021 Clexane 80 Injection Sanofi Aventis Pharma Ltd, Kenya Solution for Injection Prescription Only Medicine035/003 Nystanova pessaries Scanpharm A/S, Denmark Tablet Vaginal Prescription Only Medicine035/013 Viminova drops Scanpharm A/S, Denmark Solution for Oral Use Pharmacy Medicine035/021 Spasmonova injection Scanpharm A/S, Denmark Solution for Injection Prescription Only Medicine035/028 Ergonova injection Scanpharm A/S, Denmark Solution for Injection Prescription Only Medicine035/029 Oxy Ergonova injection Scanpharm A/S, Denmark Solution for Injection Prescription Only Medicine035/033 Mezonova suspension Scanpharm A/S, Denmark Suspension for Oral Use Prescription Only Medicine035/034 Neo-polynova ear/eye drops Scanpharm A/S, Denmark Ear/Eye Drops Prescription Only Medicine035/042 Gyno-nova pesseries Scanpharm A/S, Denmark Tablet Vaginal Prescription Only Medicine035/044 Dexanova injection Scanpharm A/S, Denmark Solution for Injection Prescription Only Medicine035/045 Oxytocin injection Scanpharm A/S, Denmark Solution for Injection Prescription Only Medicine035/047 Cloronova ear drops Scanpharm A/S, Denmark Ear Drops Prescription Only Medicine035/048 Cloronova eye drops Scanpharm A/S, Denmark Eye Drops Prescription Only Medicine035/049 Viminova tablets Scanpharm A/S, Denmark Tablet Uncoated Pharmacy Medicine042/001 Claritine syrup Schering-Plough Labo N.V, Belgium Syrup Prescription Only Medicine042/002 Claritine tablets Schering-Plough Labo N.V, Belgium Tablet Uncoated Prescription Only Medicine042/003 Elocom cream Schering-Plough Labo N.V, Belgium Cream Topical Prescription Only Medicine042/004 Elocom lotion Schering-Plough Labo N.V, Belgium Emulsion Prescription Only Medicine042/005 Elocom ointment Schering-Plough Labo N.V, Belgium Ointment topical Prescription Only Medicine075/001 Alcozyme XP Syrup Shalina Laboratories Ltd, India Syrup Pharmacy Medicine075/002 Shaltoux syrup Shalina Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine075/003 Ketazol Shampoo Shalina Laboratories Ltd, India Shampoo Prescription Only Medicine075/004 Polygel Shalina Laboratories Ltd, India Suspension for Oral Use Pharmacy Medicine075/005 Polygel mango suspension Shalina Laboratories Ltd, India Syrup Pharmacy Medicine075/006 Polygel Shalina Laboratories Ltd, India Suspension for Oral Use Pharmacy Medicine075/007 Floxan Shalina Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine075/008 Floxan Shalina Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine075/009 Sulatrim susp Shalina Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine075/010 Leopard baume Shalina Laboratories Ltd, India Ointment topical Prescription Only Medicine

PRA Secretariat / January 2009 52

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

075/011 Gogynax Shalina Laboratories Ltd, India Cream Topical Prescription Only Medicine269/001 Kanamycin injection Shanghai Pharmateq Company Ltd, China Solution for Injection Prescription Only Medicine269/002 Calcium gluconate injection Shanghai Pharmateq Company Ltd, China Solution for Injection Prescription Only Medicine269/003 Promethazine injection Shanghai Pharmateq Company Ltd, China Solution for Injection Prescription Only Medicine269/004 Diclofenac sodium injection Shanghai Pharmateq Company Ltd, China Solution for Injection Prescription Only Medicine269/005 Atropine injection Shanghai Pharmateq Company Ltd, China Solution for Injection Prescription Only Medicine269/006 Frusemide injection Shanghai Pharmateq Company Ltd, China Solution for Injection Prescription Only Medicine269/007 Dexamethasone sodium injection Shanghai Pharmateq Company Ltd, China Solution for Injection Prescription Only Medicine269/008 Adrenaline injection Shanghai Pharmateq Company Ltd, China Solution for Injection Prescription Only Medicine269/009 Analgin injection Shanghai Pharmateq Company Ltd, China Solution for Injection Prescription Only Medicine269/010 Oxytocin injection Shanghai Pharmateq Company Ltd, China Solution for infusion Prescription Only Medicine269/011 Menadione injection Shanghai Pharmateq Company Ltd, China Solution for Injection Prescription Only Medicine269/012 Quinine Dihydrochloride injection Shanghai Pharmateq Company Ltd, China Solution for Injection Prescription Only Medicine269/013 Hydrocortisone injection Shanghai Pharmateq Company Ltd, China Powder for Injection Prescription Only Medicine134/001 Koflyn syrup Shelys Pharmaceuticals Ltd, Tanzania Syrup Pharmacy Medicine134/003 Diclofenac sodium tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Pharmacy Medicine134/004 Chloramphenicol suspension Shelys Pharmaceuticals Ltd, Tanzania Suspension for Oral Use Prescription Only Medicine134/005 Shelys Gripe water Shelys Pharmaceuticals Ltd, Tanzania Solution for Oral Use Pharmacy Medicine134/006 Ibuprofen 200 tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Pharmacy Medicine134/007 Amolin suspension Shelys Pharmaceuticals Ltd, Tanzania Powder for Oral

SuspensionPrescription Only Medicine

134/008 Sheladol suspension Shelys Pharmaceuticals Ltd, Tanzania Suspension for Oral Use General Sale134/009 Ampishel capsules Shelys Pharmaceuticals Ltd, Tanzania Capsule oral Prescription Only Medicine134/010 Hemovit capsules Shelys Pharmaceuticals Ltd, Tanzania Capsule oral General Sale134/011 Hemovit syrup Shelys Pharmaceuticals Ltd, Tanzania Syrup General Sale134/012 Aspirin tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Pharmacy Medicine134/013 Histin tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Pharmacy Medicine134/015 Shetrin tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Prescription Only Medicine134/016 Mebendazole tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Pharmacy Medicine134/017 Alben suspension Shelys Pharmaceuticals Ltd, Tanzania Suspension Pharmacy Medicine134/018 Shelgyl 200 tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Prescription Only Medicine134/020 Chloramphenicol capsules Shelys Pharmaceuticals Ltd, Tanzania Capsule oral Prescription Only Medicine134/021 Ascorbic Acid tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Pharmacy Medicine134/022 Bactol solution Shelys Pharmaceuticals Ltd, Tanzania Solution for Topical Use Pharmacy Medicine134/023 Folic Acid tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Pharmacy Medicine134/024 Sulphadar tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Pharmacy Medicine134/025 Erythromycin tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Prescription Only Medicine134/030 Cloxashel capsules Shelys Pharmaceuticals Ltd, Tanzania Capsule oral Prescription Only Medicine134/031 Vitamin B Complex tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Pharmacy Medicine134/032 Amolin capsules Shelys Pharmaceuticals Ltd, Tanzania Capsule oral Prescription Only Medicine134/034 Cloxam Dry syrup Shelys Pharmaceuticals Ltd, Tanzania Suspension for Oral Use Prescription Only Medicine134/035 Megavit syrup Shelys Pharmaceuticals Ltd, Tanzania Syrup General Sale134/036 Hyosine butyl bromide tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Prescription Only Medicine134/037 Mucolyn paediatric syrup Shelys Pharmaceuticals Ltd, Tanzania Syrup Pharmacy Medicine134/038 Feritone syrup Shelys Pharmaceuticals Ltd, Tanzania Syrup Pharmacy Medicine134/039 Praziquantel 600mg tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Film coated Prescription Only Medicine134/040 Bromoxil capsules Shelys Pharmaceuticals Ltd, Tanzania Capsule oral Prescription Only Medicine134/044 Sheladol tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Pharmacy Medicine134/045 Shelgyl Oral suspension Shelys Pharmaceuticals Ltd, Tanzania Suspension for Oral Use Prescription Only Medicine134/046 Mucolyn syrup Shelys Pharmaceuticals Ltd, Tanzania Syrup Pharmacy Medicine134/048 Ampishel syrup Shelys Pharmaceuticals Ltd, Tanzania Suspension Prescription Only Medicine134/049 Erthromycin dry syrup Shelys Pharmaceuticals Ltd, Tanzania Powder for Oral

SuspensionPrescription Only Medicine

134/050 Diclopar 550mg tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Pharmacy Medicine134/051 Amodar suspension Shelys Pharmaceuticals Ltd, Tanzania Suspension Pharmacy Medicine134/052 Cipron tablets Shelys Pharmaceuticals Ltd, Tanzania Capsule oral Prescription Only Medicine134/053 Coldril syrup Shelys Pharmaceuticals Ltd, Tanzania Syrup Pharmacy Medicine

53 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

134/054 Malafin tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Pharmacy Medicine134/055 Malather tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Prescription Only Medicine134/057 Amodar tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Pharmacy Medicine134/058 Gastocid suspension Shelys Pharmaceuticals Ltd, Tanzania Suspension for Oral Use General Sale134/059 Gastrocid Chewable tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Chewable General Sale134/060 Flucozal 150 tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Prescription Only Medicine134/062 Flucozal 200 tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Prescription Only Medicine134/063 Maladar adult kit tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Prescription Only Medicine134/064 Maladar Pead kit tablets Shelys Pharmaceuticals Ltd, Tanzania Tablet Uncoated Prescription Only Medicine134/065 Save oral rehydration salt Shelys Pharmaceuticals Ltd, Tanzania Powder for Oral Solution General Sale212/001 Benzathine Penicillin injection Shijiazhvang Pharma Group, Zhonghuo

Pharmaceutical Co., Ltd, ChinaPowder for Injection Prescription Only Medicine

212/002 Ampicillin sodium injection Shijiazhvang Pharma Group, Zhonghuo Pharmaceutical Co., Ltd, China

Powder for Injection Prescription Only Medicine

212/003 Ceftriaxone sodium injection Shijiazhvang Pharma Group, Zhonghuo Pharmaceutical Co., Ltd, China

Powder for Injection Prescription Only Medicine

143/003 Cichlor Eye drops Shreechem Pharmaceuticals (Pvt) Ltd, India Eye Drops Prescription Only Medicine143/004 Vitamin B Complex injection Shreechem Pharmaceuticals (Pvt) Ltd, India Solution for Injection Prescription Only Medicine143/005 Sangel tablets Shreechem Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine143/006 Multivitamins tablets Shreechem Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated General Sale143/007 Maxinfen tablets Shreechem Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine143/008 Ciphenicol 250 capsules Shreechem Pharmaceuticals (Pvt) Ltd, India Capsule oral Prescription Only Medicine143/009 Apetito tablets Shreechem Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine143/010 Bumol capsules Shreechem Pharmaceuticals (Pvt) Ltd, India Capsule oral Pharmacy Medicine143/011 Deworm tablets Shreechem Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine143/012 Lignocaine injection Shreechem Pharmaceuticals (Pvt) Ltd, India Solution for Injection Prescription Only Medicine143/013 Cimol tablets Shreechem Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated General Sale143/014 Chaptone extra tablets Shreechem Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine143/015 Ceagra tablets Shreechem Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine143/016 Chapsulf ointment Shreechem Pharmaceuticals (Pvt) Ltd, India Ointment topical Prescription Only Medicine143/017 Cindo-25 capsules Shreechem Pharmaceuticals (Pvt) Ltd, India Capsule oral Pharmacy Medicine143/018 Cibufen-200 tablets Shreechem Pharmaceuticals (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine107/001 Misotac tablets Sigma Pharmaceuticals Ltd, Egypt Tablet Uncoated Prescription Only Medicine151/051 Frusemide tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/001 Chloroquine Phosphate injection SK Age Exports, India Solution for Injection Prescription Only Medicine161/002 Chloroquine Phosphate injection SK Age Exports, India Solution for Injection Prescription Only Medicine161/003 Melquin 250 tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/004 Malacure tablets SK Age Exports, India Tablet Uncoated Pharmacy Medicine161/005 Amoxykant capsules SK Age Exports, India Capsule oral Prescription Only Medicine161/006 Promethazine Hydrochloride injection SK Age Exports, India Solution for Injection Prescription Only Medicine161/007 Gentamycin injection SK Age Exports, India Solution for Injection Prescription Only Medicine161/009 Metronikant suspension SK Age Exports, India Suspension for Oral Use Prescription Only Medicine161/010 Cotrikant Oral suspension SK Age Exports, India Suspension for Oral Use Prescription Only Medicine161/011 Paracetamol tablets SK Age Exports, India Tablet Uncoated Pharmacy Medicine161/012 Dalaquin tablets SK Age Exports, India Tablet Enteric Coated Prescription Only Medicine161/013 Salbukant 4 tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/014 Cotrikant tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/015 Ampikant capsules SK Age Exports, India Capsule oral Prescription Only Medicine161/016 Ibukant tablets SK Age Exports, India Tablet Uncoated Pharmacy Medicine161/017 Erythrokant suspension SK Age Exports, India Suspension Prescription Only Medicine161/018 Doxykant capsules SK Age Exports, India Capsule oral Prescription Only Medicine161/019 Phenoxymethyl Penicillin tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/020 Cloxikant capsules SK Age Exports, India Capsule oral Prescription Only Medicine161/022 Apicloxkant capsules SK Age Exports, India Capsule oral Prescription Only Medicine161/023 Aspikant tablets SK Age Exports, India Tablet Uncoated Pharmacy Medicine161/024 Metrokant tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/025 Magtrikant tablets SK Age Exports, India Tablet Uncoated Pharmacy Medicine

PRA Secretariat / January 2009 54

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

161/026 Cpkant tablets SK Age Exports, India Tablet Uncoated Pharmacy Medicine161/027 Salbukant syrup SK Age Exports, India Syrup Prescription Only Medicine161/028 Parakant syrup SK Age Exports, India Syrup General Sale161/029 Amoxykant syrup SK Age Exports, India Syrup Prescription Only Medicine161/030 Procaine Penicillin injection SK Age Exports, India Powder for Injection Prescription Only Medicine161/031 Diclokant tablets SK Age Exports, India Tablet Uncoated Pharmacy Medicine161/032 Cimetidine 200 tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/033 Cimetidine 400 tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/034 Oral Rehydration Salts SK Age Exports, India Powder for Oral Solution General Sale161/036 Apiclockant capsules SK Age Exports, India Capsule oral Prescription Only Medicine161/037 Ferrous+ Folic Acid tablets SK Age Exports, India Tablet Uncoated Pharmacy Medicine161/038 Nalikant tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/039 Aminophyline tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/040 Prazikant tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/041 Mebekant tablets SK Age Exports, India Tablet Uncoated Pharmacy Medicine161/042 Ampicillin injection SK Age Exports, India Powder for Injection Prescription Only Medicine161/043 ciprokant 250 tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/044 Meldol tablets SK Age Exports, India Tablet Uncoated Pharmacy Medicine161/045 Painrid capsules SK Age Exports, India Capsule oral General Sale161/046 Coldnil tablets SK Age Exports, India Tablet Uncoated Pharmacy Medicine161/047 Melcid tablets SK Age Exports, India Tablet Uncoated Pharmacy Medicine161/048 Melkoff tablets SK Age Exports, India Tablet Uncoated Pharmacy Medicine161/049 Metronidazole tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/050 Melkoff tablets SK Age Exports, India Tablet Uncoated Pharmacy Medicine161/052 Good Night syrup SK Age Exports, India Syrup Pharmacy Medicine161/053 Propranolol tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/054 Methyldopa tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/055 Pyrazinamide tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/056 Erythrokant tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine161/057 Folicant 5 tablets SK Age Exports, India Tablet Uncoated Pharmacy Medicine161/058 Tetrakant 250 capsules SK Age Exports, India Capsule oral Prescription Only Medicine162/005 Amoxykant 250 capsules SK Age Exports, India Capsule oral Prescription Only Medicine162/007 Metronol tablets SK Age Exports, India Tablet Uncoated Prescription Only Medicine231/001 Cloxispa capsules Sparsh Biotech Pvt Ltd, India Capsule oral Prescription Only Medicine231/002 Spamcil capsules Sparsh Biotech Pvt Ltd, India Capsule oral Prescription Only Medicine231/003 Spmox capsules Sparsh Biotech Pvt Ltd, India Capsule oral Prescription Only Medicine231/004 Speniv tablets Sparsh Biotech Pvt Ltd, India Tablet Uncoated Prescription Only Medicine231/005 Speniv Oral solution Sparsh Biotech Pvt Ltd, India Powder for Oral

SuspensionPrescription Only Medicine

231/006 Spamox capsules Sparsh Biotech Pvt Ltd, India Capsule oral Prescription Only Medicine231/007 Spamox dispersible tablets Sparsh Biotech Pvt Ltd, India Tablet Dispersible Prescription Only Medicine039/030 Esoz 40 tablets Stada Vietnam Joint Venture Co. Ltd, Vietnam Capsule oral Prescription Only Medicine016/001 Stalclox capsules Stallion Laboratories Ltd, India Capsule oral Prescription Only Medicine016/002 Cedril-250 tablets Stallion Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine016/003 Endulax powder Stallion Laboratories Ltd, India Powder for Oral

SuspensionPharmacy Medicine

016/004 Ole-400 tablets Stallion Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine016/005 Ciptid-500 tablets Stallion Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine016/006 Stalfin tablets Stallion Laboratories Ltd, India Tablet Uncoated Pharmacy Medicine016/007 P-Cam 20 caspules Stallion Laboratories Ltd, India Capsule Sustained

ReleasePharmacy Medicine

016/008 Endulx Garlic tablets Stallion Laboratories Ltd, India Tablet Uncoated Pharmacy Medicine016/009 Quinlin-300 tablets Stallion Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine016/010 Endulax Karela capsules Stallion Laboratories Ltd, India Capsule oral Pharmacy Medicine122/701V Alvenax 2500 bolus Star Laboratories Pvt Ltd, Pakistan Tablet Uncoated Pharmacy Medicine122/702V Rasomycin L.A injection Star Laboratories Pvt Ltd, Pakistan Solution for Injection Prescription Only Medicine122/703V Biquin injection Star Laboratories Pvt Ltd, Pakistan Solution for Injection Prescription Only Medicine

55 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

122/704V Ivotek injection Star Laboratories Pvt Ltd, Pakistan Solution for Injection Prescription Only Medicine090/001 Lamivudine + Zidovudine tablets Strides Arcolab Ltd, India Tablet Uncoated Prescription Only Medicine090/002 Stavudine capsules Strides Arcolab Ltd, India Capsule oral Prescription Only Medicine090/003 Efavirenz tablets Strides Arcolab Ltd, India Tablet Uncoated Prescription Only Medicine090/004 Stavudine + Lamivudine + Nevirapine

tabletsStrides Arcolab Ltd, India Tablet Uncoated Prescription Only Medicine

090/005 Stavudine + Lamivudine tablets Strides Arcolab Ltd, India Tablet Uncoated Prescription Only Medicine262/001 Sterile water for injection Sunny Impex Private Ltd, India Solution for Injection Prescription Only Medicine262/002 Oral Rehydrate Salts Sunny Impex Private Ltd, India Powder for Oral Solution General Sale056/001 Water for injection Svizera Europe BV, The Netherlands Solution for Injection Prescription Only Medicine131/002 Synerpen injection T3A Pharma Group, Egypt Solution for Injection Prescription Only Medicine131/003 Synerpen T3A injection T3A Pharma Group, Egypt Solution for Injection Prescription Only Medicine131/004 Synerpen T3A injection T3A Pharma Group, Egypt Solution for Injection Prescription Only Medicine131/005 Cefotax T3A injection T3A Pharma Group, Egypt Solution for Injection Prescription Only Medicine238/001 Bacticid injection Tablets (India) Ltd, India Powder for Injection Prescription Only Medicine238/002 Ambrolite syrup Tablets (India) Ltd, India Syrup Prescription Only Medicine238/003 Omnicort injection Tablets (India) Ltd, India Solution for Injection Prescription Only Medicine238/004 Ferup syrup Tablets (India) Ltd, India Syrup Pharmacy Medicine238/005 Tilprome injection Tablets (India) Ltd, India Solution for Injection Prescription Only Medicine238/006 Ednisol tablets Tablets (India) Ltd, India Tablet Uncoated Prescription Only Medicine238/007 Tocosules 400 capsules Tablets (India) Ltd, India Tablet Uncoated Prescription Only Medicine238/009 Tilzole tablets Tablets (India) Ltd, India Tablet Uncoated Pharmacy Medicine238/010 Neutrosec syrup Tablets (India) Ltd, India Syrup Pharmacy Medicine238/011 Cifrotil injection Tablets (India) Ltd, India Solution for Injection Prescription Only Medicine238/012 Statasmin-4 tablets Tablets (India) Ltd, India Tablet Uncoated Prescription Only Medicine238/013 Fevastin tablets Tablets (India) Ltd, India Tablet Uncoated General Sale238/015 Tilstigmin injection Tablets (India) Ltd, India Suspension for Oral Use Pharmacy Medicine238/017 Astymin Forte capsules Tablets (India) Ltd, India Capsule oral Prescription Only Medicine238/018 Tilprome tablets Tablets (India) Ltd, India Tablet Uncoated Prescription Only Medicine238/019 Tilvit syrup Tablets (India) Ltd, India Syrup Pharmacy Medicine238/020 Astyfer liquid Tablets (India) Ltd, India Solution for Oral Use Pharmacy Medicine238/021 Antoxyl Forte capsules Tablets (India) Ltd, India Capsule oral Prescription Only Medicine238/022 Movactive capsules Tablets (India) Ltd, India Capsule oral Pharmacy Medicine008/002HM Tasly Sea Oil capsules Tasly(S.A) Pty Ltd, South Africa Capsule oral General Sale008/006HM Tasly Danshen Tea Tasly(S.A) Pty Ltd, South Africa Granules for Oral Use General Sale008/007HM Tasly Miss Bee Royal Jelly capsules Tasly(S.A) Pty Ltd, South Africa Capsule oral General Sale008/008HM Tasly Miss Bee Propolis Soft gel Tasly(S.A) Pty Ltd, South Africa Capsule oral General Sale008/009HM Tasly Miss Bee Camellia Bee Tasly(S.A) Pty Ltd, South Africa Capsule oral General Sale008/010HM Tasly AL capsules Tasly(S.A) Pty Ltd, South Africa Capsule oral General Sale008/011HM Tasly Propolis syrup Tasly(S.A) Pty Ltd, South Africa Syrup General Sale008/012HM Tasly Miss Bee Propolis + Water pollen

capsuleTasly(S.A) Pty Ltd, South Africa Capsule oral General Sale

008/013HM Tasly Kings capsules Tasly(S.A) Pty Ltd, South Africa Capsule oral General Sale008/014HM Tasly Bitter Melon Powder capsules Tasly(S.A) Pty Ltd, South Africa Capsule oral General Sale147/001 Adrenalline injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/002 Atropine injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/003 Amonophylline injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/004 Chlorpromazine injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/005 Diazepam injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/006 Furosemide injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/007 Gentamycin injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/008 Pethidine injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/009 Quinine injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/010 Chloramphenicol drops Tejay Pharmaceuticals Ltd, Zambia Eye Drops Prescription Only Medicine147/011 Betamethasone drops Tejay Pharmaceuticals Ltd, Zambia Eye Drops Prescription Only Medicine147/012 Betamethasone plus drops Tejay Pharmaceuticals Ltd, Zambia Eye Drops Prescription Only Medicine147/013 Ciprofloxacin eye /ear drops Tejay Pharmaceuticals Ltd, Zambia Eye Drops Prescription Only Medicine

PRA Secretariat / January 2009 56

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

147/014 Analgin injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/015 Dexamethasone+ Neoomycin Eye /Ear

dropsTejay Pharmaceuticals Ltd, Zambia Ear/Eye Drops Prescription Only Medicine

147/016 Promethazine injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/018 Gentamycin Eye/Ear drops Tejay Pharmaceuticals Ltd, Zambia Ear/Eye Drops Prescription Only Medicine147/020 Lignocaine 2% injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/021 Hydralazine injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/022 Dexamethasone injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/023 Diclofenac sodium injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/024 Metoclopromide injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/025 Hyoscine butylbromide injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/026 Potassium chloride injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/027 Calcium gluconate injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/028 Pilocarpine nitrate eye drops Tejay Pharmaceuticals Ltd, Zambia Eye Drops Prescription Only Medicine147/029 Sodium cromoglycate eye drops Tejay Pharmaceuticals Ltd, Zambia Eye Drops Prescription Only Medicine147/030 Xylomethazoline nasal drops Tejay Pharmaceuticals Ltd, Zambia Nasal drops Prescription Only Medicine147/031 Timolol eye drops Tejay Pharmaceuticals Ltd, Zambia Eye Drops Prescription Only Medicine147/032 Sodium bicarbonate injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/033 Magnesium Sulphate injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/034 Atropin sulphate eye drops Tejay Pharmaceuticals Ltd, Zambia Eye Drops Prescription Only Medicine147/035 Morphine sulphate injection Tejay Pharmaceuticals Ltd, Zambia Solution for Injection Prescription Only Medicine147/036 Asmarid syrup Tejay Pharmaceuticals Ltd, Zambia Syrup Prescription Only Medicine147/037 Histinil syrup Tejay Pharmaceuticals Ltd, Zambia Syrup Pharmacy Medicine147/038 Panridol syrup Tejay Pharmaceuticals Ltd, Zambia Syrup Pharmacy Medicine147/039 Promethazine syrup Tejay Pharmaceuticals Ltd, Zambia Syrup Pharmacy Medicine147/040 Guaiphen cough syrup Tejay Pharmaceuticals Ltd, Zambia Syrup Pharmacy Medicine147/041 Co-trimoxazole suspension Tejay Pharmaceuticals Ltd, Zambia Suspension for Oral Use Prescription Only Medicine003/004 Menthozathum deep rub The Mentholatum company Ltd, UK Cream Topical Pharmacy Medicine003/006 Mentholatum balm The Mentholatum company Ltd, UK Ointment topical General Sale171/001 Sepgard gel Themis Medicare Ltd, India Gel Topical Pharmacy Medicine171/002 Simvastol tablets Themis Medicare Ltd, India Tablet Uncoated Prescription Only Medicine171/003 Simvastol Themis Medicare Ltd, India Tablet Uncoated Prescription Only Medicine171/004 Hemolok solution Themis Medicare Ltd, India Solution for Topical Use Pharmacy Medicine171/005 E mal injection Themis Medicare Ltd, India Solution for Injection Prescription Only Medicine082/022 Listril-10 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/003 Rantin-150 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/007 Quintor-500 tablets Torrent Exports Ltd, India Tablet Film coated Prescription Only Medicine089/008 Herpex-200 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/009 Herpex cream Torrent Exports Ltd, India Cream Topical Prescription Only Medicine089/010 Calcigard Retard tablets Torrent Exports Ltd, India Tablet extended release Prescription Only Medicine089/011 Tozaar - 50 tablets Torrent Exports Ltd, India Tablet Film coated Prescription Only Medicine089/012 Domstal tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/013 Domstal suspension Torrent Exports Ltd, India Suspension for Oral Use Prescription Only Medicine089/014 Ranitin injection Torrent Exports Ltd, India Solution for Injection Prescription Only Medicine089/015 Fungicide tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/016 Toroxx -MT-50 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/017 Deplatt tablets Torrent Exports Ltd, India Tablet Film coated Prescription Only Medicine089/018 Uroflox -400 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/019 Betacard-100 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/020 Syscan-100 caspules Torrent Exports Ltd, India Capsule oral Prescription Only Medicine089/021 Omizac capsules Torrent Exports Ltd, India Capsule oral Prescription Only Medicine089/023 Syscan capsules Torrent Exports Ltd, India Capsule oral Prescription Only Medicine089/024 Tocofer-200soft gelatin capsules Torrent Exports Ltd, India Capsule oral Prescription Only Medicine089/025 Tocofer-400 capsules Torrent Exports Ltd, India Capsule oral Prescription Only Medicine089/026 Batacard-50 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/027 Syscan-150 capsules Torrent Exports Ltd, India Capsule oral Prescription Only Medicine089/028 Calcigard-10 capsules Torrent Exports Ltd, India Capsule oral Prescription Only Medicine

57 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

089/029 Lopamide tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/030 Ive Metro injection Torrent Exports Ltd, India Solution for Injection Prescription Only Medicine089/031 Tormoxine 250 capsules Torrent Exports Ltd, India Capsule oral Prescription Only Medicine089/032 Listril-5 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/033 Fegen 100 tablets Torrent Exports Ltd, India Tablet Uncoated Pharmacy Medicine089/035 Herpex 800 DT tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/036 Modlip 10 tablets Torrent Exports Ltd, India Tablet Film coated Prescription Only Medicine089/037 Domstal O capsules Torrent Exports Ltd, India Capsule oral Prescription Only Medicine089/038 Modlip 20 tablets Torrent Exports Ltd, India Tablet Film coated Prescription Only Medicine089/039 Lamitor 100 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/040 Nebicard -5 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/041 Velos-20 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/042 Velos-tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/043 Valparin 200 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/044 Tide-10 Tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/045 Lefra 20 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/046 Karvil-6.25 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/047 Esam-2.5 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/048 Azulix 2 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/049 Topril capsules Torrent Exports Ltd, India Capsule oral Prescription Only Medicine089/050 Serenata-50 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/051 Valzaar 80 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/052 Valzaar 160 tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/053 Tozarr-H 62.5mg tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine089/054 Tozaar-100mg tablets Torrent Exports Ltd, India Tablet Uncoated Prescription Only Medicine

Chloramphenicol 250mg capsules Troge Medical GMBH, Germany Capsule oral Prescription Only Medicine110/002 Acetyl Salicylic Acid tablets 300mg Troge Medical GMBH, Germany Tablet Uncoated Pharmacy Medicine110/003 Amoxicillin 250 capsules Troge Medical GMBH, Germany Capsule oral Prescription Only Medicine110/003 Trio-vital tablets Troge Medical GMBH, Germany Tablet Uncoated Pharmacy Medicine110/004 Amoxicillin suspension Troge Medical GMBH, Germany Powder for Oral

SuspensionPrescription Only Medicine

110/005 Tetracycline 250mg capsules Troge Medical GMBH, Germany Capsule oral Prescription Only Medicine110/006 Tetracycline Opthalmic Ointment Troge Medical GMBH, Germany Eye Ointment Prescription Only Medicine110/008 Ampicillin injection Troge Medical GMBH, Germany Powder for Injection Prescription Only Medicine110/009 Ampicillin 0ral suspension Troge Medical GMBH, Germany Suspension for Oral Use Prescription Only Medicine110/010 Streptomycin injection Troge Medical GMBH, Germany Powder for Injection Prescription Only Medicine110/011 Vitamin B Complex injection Troge Medical GMBH, Germany Solution for Injection Prescription Only Medicine110/012 Crystalline Benzylpenicillin injection Troge Medical GMBH, Germany Solution for Injection Prescription Only Medicine110/015 Indomethacin 25mg capsules Troge Medical GMBH, Germany Capsule oral Pharmacy Medicine110/016 Metronidazole 200mg tablets Troge Medical GMBH, Germany Tablet Uncoated Prescription Only Medicine110/018 Phenoxymethylpenicillin 250 tablets Troge Medical GMBH, Germany Tablet Uncoated Prescription Only Medicine110/019 Crystalline Benzyl Penicillin injection Troge Medical GMBH, Germany Solution for Injection Prescription Only Medicine110/021 Chloramphenicol Eye ointment Troge Medical GMBH, Germany Eye Ointment Prescription Only Medicine110/022 Fortified Procaine Penicillin injection Troge Medical GMBH, Germany Powder for Injection Prescription Only Medicine110/023 Gentamycin injection Troge Medical GMBH, Germany Solution for Injection Prescription Only Medicine110/024 Griseofulvin tablets Troge Medical GMBH, Germany Tablet Uncoated Prescription Only Medicine110/025 Chloramphenicol injection Troge Medical GMBH, Germany Powder for Injection Prescription Only Medicine110/026 Co-trimoxazole tablets Troge Medical GMBH, Germany Tablet Uncoated Prescription Only Medicine110/027 Ampicillin/Cloxacillin capsules Troge Medical GMBH, Germany Capsule oral Prescription Only Medicine110/029 Erythromycin tablets Troge Medical GMBH, Germany Tablet Uncoated Prescription Only Medicine268/001 Unimezol tablets Unichem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine268/002 Zyncet tablets Unichem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine268/003 Zyncet syrup Unichem Laboratories Ltd, India Syrup Prescription Only Medicine268/004 Evaflox tablets Unichem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine268/005 Evaflox 400 tablets Unichem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine268/006 M-Cam 15 tablets Unichem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine268/007 M-Cam 7.5 tablets Unichem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine

PRA Secretariat / January 2009 58

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

268/008 Corvadil-A tablets Unichem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine268/009 Tagera forte tablets Unichem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine268/010 Sulbacin injection Unichem Laboratories Ltd, India Powder for Injection Prescription Only Medicine268/011 Sulbacin 375 tablets Unichem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine268/012 Domadol capsules Unichem Laboratories Ltd, India Capsule oral Prescription Only Medicine268/013 Domadol injection Unichem Laboratories Ltd, India Solution for Injection Prescription Only Medicine268/014 Tg tor tablets Unichem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine268/015 Corvadil 5 tablets Unichem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine268/016 Losar-50 tablets Unichem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine223/001 Lenor 72 tablets Unicure Remedies (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine223/002 Mepen 250 tablets Unicure Remedies (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine223/003 NC Norm-P tablets Unicure Remedies (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine223/004 Eros 10 tablets Unicure Remedies (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine223/005 Lactone 25 tablets Unicure Remedies (Pvt) Ltd, India Tablet Uncoated Prescription Only Medicine223/006 Flagon 50 tablets Unicure Remedies (Pvt) Ltd, India Tablet Uncoated Pharmacy Medicine072/011 Pedvite forte capsules Unique Pharmaceyticals Laboratories, India Capsule oral General Sale283/002 Univir cream Universal Corporation Ltd, Kenya Cream Topical Prescription Only Medicine283/003 Univir tablets Universal Corporation Ltd, Kenya Tablet Uncoated Prescription Only Medicine283/004 Strox tablets Universal Corporation Ltd, Kenya Tablet Uncoated Prescription Only Medicine283/005 Unilyte oral powder Universal Corporation Ltd, Kenya Powder for Oral Solution General Sale283/007 Nelzole suspension Universal Corporation Ltd, Kenya Suspension for Oral Use Prescription Only Medicine283/008 Universal Gripe Water Universal Corporation Ltd, Kenya Solution for Oral Use General Sale283/009 Sulfran Paediatric suspension Universal Corporation Ltd, Kenya Suspension for Oral Use Prescription Only Medicine283/010 Unified ointment Universal Corporation Ltd, Kenya Ointment topical Pharmacy Medicine283/011 Dinac tablets Universal Corporation Ltd, Kenya Tablet Uncoated Pharmacy Medicine283/012 Sulfran tablets Universal Corporation Ltd, Kenya Tablet Uncoated Prescription Only Medicine283/013 Ulzol capsules Universal Corporation Ltd, Kenya Capsule oral Prescription Only Medicine283/014 Acnesol cream Universal Corporation Ltd, Kenya Cream Topical Prescription Only Medicine283/015 Dinac gel Universal Corporation Ltd, Kenya Gel Topical Pharmacy Medicine283/016 Clobit cream Universal Corporation Ltd, Kenya Cream Topical Prescription Only Medicine283/017 Clotrine pessaries Universal Corporation Ltd, Kenya Tablet Vaginal Prescription Only Medicine283/018 Clotrine cream Universal Corporation Ltd, Kenya Cream Topical Prescription Only Medicine283/019 Flutrox capsules Universal Corporation Ltd, Kenya Capsule oral Prescription Only Medicine283/020 Lockit tablets Universal Corporation Ltd, Kenya Tablet Uncoated Prescription Only Medicine283/021 Nelstat oral drops Universal Corporation Ltd, Kenya Solution for Oral Use Prescription Only Medicine283/022 Unibazole suspension Universal Corporation Ltd, Kenya Suspension for Oral Use Pharmacy Medicine283/023 Unibazole tablets Universal Corporation Ltd, Kenya Tablet Uncoated Pharmacy Medicine283/024 Unibet cream Universal Corporation Ltd, Kenya Cream Topical Prescription Only Medicine283/025 Univir 200 tablets Universal Corporation Ltd, Kenya Tablet Uncoated Prescription Only Medicine283/026 Neladol Extra caplets Universal Corporation Ltd, Kenya Caplets oral Uncoated General Sale283/027 Co-max tablets Universal Corporation Ltd, Kenya Tablet Uncoated Prescription Only Medicine282/001 Glynase XL-5 tablets USV Ltd, India Tablet Uncoated Prescription Only Medicine282/002 Grovit drops USV Ltd, India Syrup General Sale282/003 Pioz-15 tablets USV Ltd, India Tablet Uncoated Prescription Only Medicine282/004 Ecorin-75 tablets USV Ltd, India Tablet Uncoated Prescription Only Medicine282/005 Lipicard capsules USV Ltd, India Capsule oral Prescription Only Medicine160/001 Tetra 250 capsules Vardman Exports, India Capsule oral Prescription Only Medicine160/002 Vardhmans silver cream Vardman Exports, India Cream Topical Prescription Only Medicine160/003 Vardex cream Vardman Exports, India Cream Topical Prescription Only Medicine160/004 Betavard cream Vardman Exports, India Cream Topical Prescription Only Medicine160/005 Tetraskin ointment Vardman Exports, India Ointment topical Prescription Only Medicine160/006 Vardman strong cream Vardman Exports, India Cream Topical Pharmacy Medicine160/007 Pen-v oral solution suspension Vardman Exports, India Suspension for Oral Use Prescription Only Medicine160/008 Blimketas tablets Vardman Exports, India Tablet Uncoated Pharmacy Medicine160/009 Conjex tablets Vardman Exports, India Tablet Uncoated General Sale160/010 Cotrim 480 tablets Vardman Exports, India Tablet Uncoated Prescription Only Medicine160/011 Doloprim tablets Vardman Exports, India Tablet Uncoated Prescription Only Medicine

59 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

160/012 Go-cough tablets Vardman Exports, India Tablet Uncoated General Sale160/013 Indo-25 caspules Vardman Exports, India Capsule oral Pharmacy Medicine160/014 Jeri Stop Cold tablets Vardman Exports, India Tablet Uncoated Pharmacy Medicine160/015 Mebenda-100 tablets Vardman Exports, India Tablet Uncoated Pharmacy Medicine160/016 Mekalfin tablets Vardman Exports, India Tablet Uncoated Pharmacy Medicine160/017 Metro-200 tablets Vardman Exports, India Tablet Uncoated Prescription Only Medicine160/018 MCT tablets Vardman Exports, India Tablet Uncoated Pharmacy Medicine160/019 Parapain capsules Vardman Exports, India Capsule oral Pharmacy Medicine160/020 Salbuta 2 tablets Vardman Exports, India Tablet Uncoated Prescription Only Medicine160/021 Symaclox 500 capsules Vardman Exports, India Capsule oral Prescription Only Medicine160/022 Analgin tablets Vardman Exports, India Tablet Uncoated Prescription Only Medicine160/023 Pyramoate suspension Vardman Exports, India Suspension for Oral Use Pharmacy Medicine160/024 Jonacan cream Vardman Exports, India Cream Topical Prescription Only Medicine160/026 Dawaquin tablets Vardman Exports, India Tablet Film coated Pharmacy Medicine160/027 Ibu-200 tablets Vardman Exports, India Tablet Uncoated Pharmacy Medicine160/028 Lopamide capsules Vardman Exports, India Capsule oral Prescription Only Medicine160/029 Nystatin vaginal tablets Vardman Exports, India Tablet Vaginal Prescription Only Medicine160/030 Stamache tablets Vardman Exports, India Tablet Uncoated General Sale160/031 Kezoral cream Vardman Exports, India Cream Topical Prescription Only Medicine160/032 Vardacort cream Vardman Exports, India Cream Topical Prescription Only Medicine160/033 Vardacort ointment Vardman Exports, India Ointment topical Prescription Only Medicine160/034 Vardamin tablets Vardman Exports, India Tablet Uncoated Prescription Only Medicine160/035 Vardaplex super tablets Vardman Exports, India Tablet Uncoated General Sale160/036 Vardaplex forte tablets Vardman Exports, India Tablet Uncoated General Sale160/037 Diclofenac gel Vardman Exports, India Gel Topical Pharmacy Medicine160/038 Isoniazid tablets Vardman Exports, India Tablet Uncoated Prescription Only Medicine160/039 Vard blood tonic Vardman Exports, India Suspension for Oral Use Pharmacy Medicine160/040 Kofsil lozenges Vardman Exports, India Lozenges General Sale160/041 Safiphen syrup Vardman Exports, India Syrup Pharmacy Medicine160/042 Vardavit syrup Vardman Exports, India Syrup General Sale160/043 Benzathine penicillin injection Vardman Exports, India Powder for Injection Prescription Only Medicine160/044 Dexamycin Eye/Ear drops Vardman Exports, India Ear/Eye Drops Prescription Only Medicine160/045 Mr. Power 500 tablets Vardman Exports, India Tablet Uncoated General Sale160/046 Benzyl peniciliin Vardman Exports, India Powder for Injection Prescription Only Medicine160/048 Anti-diar suspension Vardman Exports, India Suspension for Oral Use General Sale160/049 Ciprofin 250 tablets Vardman Exports, India Tablet Uncoated Prescription Only Medicine160/050 Ciprofin 500 tablets Vardman Exports, India Tablet Uncoated Prescription Only Medicine160/051 Syamoxil 500 capsules Vardman Exports, India Capsule oral Prescription Only Medicine160/052 Cimedine 200 tablets Vardman Exports, India Tablet Uncoated Prescription Only Medicine160/053 Rifa 300 capsules Vardman Exports, India Capsule oral Prescription Only Medicine160/054 Paladol tablets Vardman Exports, India Tablet Uncoated Pharmacy Medicine160/056 Chlorphen Eye/Ear drops Vardman Exports, India Ear/Eye Drops Prescription Only Medicine160/057 Chlorpheniramine suspension Vardman Exports, India Suspension Prescription Only Medicine160/058 Tetracycline Eye drops Vardman Exports, India Eye Drops Prescription Only Medicine160/059 Betnovate cream Vardman Exports, India Cream Topical Prescription Only Medicine160/060 Diarstop tablets Vardman Exports, India Tablet Uncoated Pharmacy Medicine160/061 Cimedine 400 tablets Vardman Exports, India Tablet Uncoated Prescription Only Medicine160/062 Wintogram 500 tablets Vardman Exports, India Tablet Uncoated General Sale160/063 Ferenol 500 tablets Vardman Exports, India Tablet Uncoated General Sale160/064 Dawanol 500 tablets Vardman Exports, India Tablet Uncoated General Sale160/065 Nystatin Oral suspension Vardman Exports, India Suspension for Oral Use Prescription Only Medicine160/066 Salbuta 4 tablets Vardman Exports, India Tablet Uncoated Prescription Only Medicine160/067 Go Coff Cough syrup Vardman Exports, India Syrup Pharmacy Medicine160/068 Vardhaman ORS powder Vardman Exports, India Powder for Oral Solution Pharmacy Medicine214/001 Erythromycin tablets Venkant Pharma Ltd, India Tablet Uncoated Prescription Only Medicine214/002 Cephalexin capsules Venkant Pharma Ltd, India Capsule oral Prescription Only Medicine214/003 Ibuprofen tablets Venkant Pharma Ltd, India Tablet Film coated Pharmacy Medicine

PRA Secretariat / January 2009 60

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

214/004 Diclofenac tablets Venkant Pharma Ltd, India Tablet Uncoated Pharmacy Medicine214/005 Amoxycillin capsules Venkant Pharma Ltd, India Capsule oral Prescription Only Medicine214/006 Omeprazole capsules Venkant Pharma Ltd, India Capsule oral Prescription Only Medicine214/007 Indomethacin capsules Venkant Pharma Ltd, India Capsule oral Pharmacy Medicine214/008 Ampicillin capsules Venkant Pharma Ltd, India Capsule oral Prescription Only Medicine236/001 Osteocare tablets Vitabiotics Ltd, England Tablet Uncoated Pharmacy Medicine236/002 Immunace capsules Vitabiotics Ltd, England Capsule oral Pharmacy Medicine236/003 Perfectil capsules Vitabiotics Ltd, England Capsule oral Pharmacy Medicine236/004 Ferroglobin B12 syrup Vitabiotics Ltd, England Syrup Pharmacy Medicine236/005 Omega H3 capsules Vitabiotics Ltd, England Capsule oral Pharmacy Medicine236/006 Wellwoman capsules Vitabiotics Ltd, England Capsule oral Pharmacy Medicine236/007 Wellman capsules Vitabiotics Ltd, England Capsule oral Pharmacy Medicine236/008 Visionace capsules Vitabiotics Ltd, England Capsule oral Pharmacy Medicine236/009 Cardioace capsules Vitabiotics Ltd, England Capsule oral Pharmacy Medicine236/010 Jointace capsules Vitabiotics Ltd, England Capsule oral Pharmacy Medicine236/011 Diabetone capsules Vitabiotics Ltd, England Capsule oral Pharmacy Medicine236/012 Feroglobin B12 capsules Vitabiotics Ltd, England Capsule oral Pharmacy Medicine236/013 Neurozan capsules Vitabiotics Ltd, England Capsule oral Pharmacy Medicine191/001 Vital Multime capsules Vital Health Foods (Pvt) Ltd, South Africa Capsule oral General Sale191/002 Vital Dolomite 200’s tablets Vital Health Foods (Pvt) Ltd, South Africa Tablet Film coated Pharmacy Medicine191/003 Multitime Potency capsules Vital Health Foods (Pvt) Ltd, South Africa Capsule oral Pharmacy Medicine243/001 Vivamox suspension VVS Pharmaceuticals and Chemicals (P)

Ltd,IndiaPowder for Oral Suspension

Prescription Only Medicine

243/002 Vivamox capsules VVS Pharmaceuticals and Chemicals (P) Ltd,India

Capsule oral Prescription Only Medicine

243/003 Vigrex D5 tablets VVS Pharmaceuticals and Chemicals (P) Ltd,India

Tablet Film coated Prescription Only Medicine

243/004 Vecostatin injection VVS Pharmaceuticals and Chemicals (P) Ltd,India

Solution for Injection Prescription Only Medicine

243/005 Inal gel VVS Pharmaceuticals and Chemicals (P) Ltd,India

Gel Topical Pharmacy Medicine

220/001 Grilinctus syrup Wardex Pharmaceuticals Pvt Ltd, India Syrup Pharmacy Medicine220/002 Grilintus BM syrup Wardex Pharmaceuticals Pvt Ltd, India Syrup Pharmacy Medicine220/003 Grilinctus BM pediatric syrup Wardex Pharmaceuticals Pvt Ltd, India Syrup Pharmacy Medicine220/004 Dexorange syrup Wardex Pharmaceuticals Pvt Ltd, India Syrup General Sale082/052 Benylin Paediatric Warner Lambert SA (Pty) Ltd, South Africa Syrup Pharmacy Medicine011/001 Welden-10 tablet West-Coast Pharmaceutical Works, India,

LusakaTablet Uncoated Prescription Only Medicine

011/002 Welden-20 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Prescription Only Medicine

011/003 Profen 200 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

011/004 Profen 400 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

011/005 Samaol-2 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Prescription Only Medicine

011/006 Samaol-4 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Prescription Only Medicine

011/007 Ulcidin-200 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

011/008 Metamide tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

011/009 Tenil tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

011/010 Tenil 100 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

011/011 Clofen 25 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

011/012 Clofen 50 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

61 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

011/013 Hexin tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

011/014 Wescolax tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

011/015 Prodin tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

011/016 Nefed-5 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

011/017 Nefed-10 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

011/018 Clomzol tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

011/019 Zepine tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

011/020 Tizole 150 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Prescription Only Medicine

011/021 Tizole 300 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Prescription Only Medicine

011/022 Tizole 500 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Prescription Only Medicine

011/023 Glemide 2.5 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Prescription Only Medicine

011/024 Glemide 5 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Prescription Only Medicine

011/025 Dawacid suspension West-Coast Pharmaceutical Works, India, Lusaka

Suspension for Oral Use Pharmacy Medicine

011/026 Wescogyl oral suspension West-Coast Pharmaceutical Works, India, Lusaka

Suspension for Oral Use Prescription Only Medicine

011/027 Nytin pessaries West-Coast Pharmaceutical Works, India, Lusaka

Tablet Vaginal Prescription Only Medicine

011/028 Allucid tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Pharmacy Medicine

011/029 Wamargan syrup West-Coast Pharmaceutical Works, India, Lusaka

Syrup Pharmacy Medicine

011/030 Loptil capsules West-Coast Pharmaceutical Works, India, Lusaka

Capsule oral Prescription Only Medicine

011/031 Oralyt powder West-Coast Pharmaceutical Works, India, Lusaka

Powder for Oral Solution Pharmacy Medicine

011/032 B-covit tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated General Sale

011/033 Samol syrup West-Coast Pharmaceutical Works, India, Lusaka

Syrup Prescription Only Medicine

011/034 Bacrizole 480 tablets West-Coast Pharmaceutical Works, India, Lusaka

Tablet Uncoated Prescription Only Medicine

124/001 Glucose intravenous infusion Wockhardt Ltd, India Solution for infusion Prescription Only Medicine124/002 Glucose intravenous infusion Wockhardt Ltd, India Solution for infusion Prescription Only Medicine124/003 Compound sodium lactate injection Wockhardt Ltd, India Solution for infusion Prescription Only Medicine124/004 Pelox-400 tablets Wockhardt Ltd, India Tablet Uncoated Prescription Only Medicine124/005 Metronidazole injection Wockhardt Ltd, India Solution for infusion Prescription Only Medicine124/006 Wokadine Germicide gargles Wockhardt Ltd, India Solution for Oral Use Prescription Only Medicine124/007 Wokadine vaginal pesseries Wockhardt Ltd, India Tablet Uncoated Prescription Only Medicine124/008 Zedex cough syrup Wockhardt Ltd, India Syrup General Sale124/009 Soduim chloride injection Wockhardt Ltd, India Solution for Injection Prescription Only Medicine124/010 Aziwork usp capsules Wockhardt Ltd, India Capsule oral Prescription Only Medicine124/011 Bro-zedex cough syrup Wockhardt Ltd, India Syrup General Sale124/012 Aziwork suspension Wockhardt Ltd, India Syrup Prescription Only Medicine124/013 Proxyvon capsules Wockhardt Ltd, India Capsule oral Prescription Only Medicine124/014 Pelox-400 tablets Wockhardt Ltd, India Tablet Uncoated Prescription Only Medicine124/015 Wokadine 10%w/w ointment Wockhardt Ltd, India Ointment topical Prescription Only Medicine124/016 Powercef 125mg injection Wockhardt Ltd, India Powder for Injection Prescription Only Medicine124/017 Powercef 250 injection Wockhardt Ltd, India Powder for Injection Prescription Only Medicine

PRA Secretariat / January 2009 62

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

124/018 Powercef 500mg injection Wockhardt Ltd, India Powder for Injection Prescription Only Medicine124/019 Powercef 1000mg injection Wockhardt Ltd, India Powder for Injection Prescription Only Medicine124/020 Sparx-200 tablets Wockhardt Ltd, India Tablet Uncoated Prescription Only Medicine124/021 Wepox 2000 injection Wockhardt Ltd, India Solution for Injection Prescription Only Medicine116/001 Advil CS tablets Wyeth Laboratories (Pty) Ltd, South Africa Tablet Uncoated Pharmacy Medicine116/002 Preparation H ointment Wyeth Laboratories (Pty) Ltd, South Africa Ointment topical Pharmacy Medicine116/003 Anadin tablets Wyeth Laboratories (Pty) Ltd, South Africa Tablet Uncoated Pharmacy Medicine116/004 Preparation H suppositories Wyeth Laboratories (Pty) Ltd, South Africa Suppository Pharmacy Medicine116/005 Premarin tablets Wyeth Laboratories (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine091/001 Deltaprim tablets Zimbabwe Pharmaceuticals (Pvt) Ltd,

ZimbabweTablet Uncoated Pharmacy Medicine

091/002 Betaco syrup Zimbabwe Pharmaceuticals (Pvt) Ltd, Zimbabwe

Syrup Pharmacy Medicine

091/003 Betafed Syrup Zimbabwe Pharmaceuticals (Pvt) Ltd, Zimbabwe

Syrup Pharmacy Medicine

091/004 Betamint Cough syrup Zimbabwe Pharmaceuticals (Pvt) Ltd, Zimbabwe

Syrup Pharmacy Medicine

091/005 Betamol syrup Zimbabwe Pharmaceuticals (Pvt) Ltd, Zimbabwe

Syrup Pharmacy Medicine

091/006 Betapro syrup Zimbabwe Pharmaceuticals (Pvt) Ltd, Zimbabwe

Syrup Pharmacy Medicine

113/006 Amidepin 5 tablets Zydus Cadila Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine139/001 R-Loc 150 tablets Zydus Cadila Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine139/002 Tiniba 500 tablets Zydus Cadila Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine139/003 Betanese 5 tablets Zydus Cadila Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine139/004 Amlodac-5 tablets Zydus Cadila Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine139/005 Amilodac 10 tablets Zydus Cadila Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine139/006 Piricam 10 capsules Zydus Cadila Healthcare Ltd, India Capsule oral Prescription Only Medicine139/007 Piricam 20 capsules Zydus Cadila Healthcare Ltd, India Capsule oral Prescription Only Medicine139/008 Odace 5 tablets Zydus Cadila Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine139/009 Nilfast suspension Zydus Cadila Healthcare Ltd, India Suspension for Oral Use Prescription Only Medicine139/010 Cefotim 1000 injection Zydus Cadila Healthcare Ltd, India Powder for Injection Prescription Only Medicine139/011 Hipen capsules Zydus Cadila Healthcare Ltd, India Capsule oral Prescription Only Medicine139/012 Loridin Rapitas tablets Zydus Cadila Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine139/013 Loridin suspension Zydus Cadila Healthcare Ltd, India Suspension for Oral Use Prescription Only Medicine139/014 Norswell tablets Zydus Cadila Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine139/015 Tramazac injection Zydus Cadila Healthcare Ltd, India Solution for Injection Prescription Only Medicine139/016 Tramazac capsules Zydus Cadila Healthcare Ltd, India Capsule oral Prescription Only Medicine139/017 Odace-10 tablets Zydus Cadila Healthcare Ltd, India Tablet Uncoated Prescription Only Medicine216/001 Valizgy eczema cream Zyg Pharma Ltd, India Cream Topical Prescription Only Medicine216/002 Herpizyg cream Zyg Pharma Ltd, India Cream Topical Prescription Only Medicine216/003 Butate antifungal cream Zyg Pharma Ltd, India Cream Topical Prescription Only Medicine216/004 Dipvite cream Zyg Pharma Ltd, India Cream Topical Prescription Only Medicine216/005 Naftol topical solution Zyg Pharma Ltd, India Solution for Topical Use Prescription Only Medicine216/006 Clodip cream Zyg Pharma Ltd, India Cream Topical Prescription Only Medicine216/007 Fosure cream Zyg Pharma Ltd, India Cream Topical Prescription Only Medicine216/008 Dermix skin cream Zyg Pharma Ltd, India Cream Topical Prescription Only Medicine216/009 Epiklin ointment Zyg Pharma Ltd, India Ointment topical Prescription Only Medicine216/010 Naftatin cream Zyg Pharma Ltd, India Cream Topical Prescription Only Medicine

63 PRA Secretariat / January 2009

LICENCE NUMBER

PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE

ANNEX I

LABELING OF MEDICINES BASED ON STATUTORY INSTRUMENT No.47 OF 1993

LABELLING OF MEDICINES(1) Every package or container of medicine shall be labelled to show -

(a) The name of the medicine;(b) The pharmacological properties;(c) The names and quantities of active ingredients;(d) The quality of the medicine;(e) The directions for use;(f) The contra-indications, warnings and precautions;(g) The storage instructions, when necessary;(h) The expiry date;(i) The batch number;(j) The date of manufacture;(k) The licence number;(l) The name and address of the manufacturer;(m) The method of sale, that is to say, if it is to be by-

i. Prescription only;ii. Pharmacy sale only; oriii. General sale.

(2) When the space on the container of medicine is not adequate to accommodate the information specified in sub-paragraph (1), the container shall be labelled to indicate the particulars (a), (c), (d), (h) and (m) of sub-paragraph (l):

Provided that the particulars specified under paragraph (b), (e), (f), (g), (i), (j), (k) and (l) of sub-paragraph (1) shall be set out on the package.

(3) Where the container of medicine is in the form of a blister or strip packet, the container shall be labelled to indicate the particulars specified in paragraphs (a) and (m) of sub-paragraph (1) and the other particulars specified in that sub-paragraph shall be set out on the package.

(4) The provisions of this paragraph shall not apply to dispensed medicine:

(5) Every package or container of dispensed medicine shall be labelled to indicate-(a) The name of the person to whom the medicine is to be administered;(b) The dosage or where the medicine is to be used;(c) The date on which the medicine is dispensed; and(d) Any other information necessary to ensure the correct use of the medicine.

(6) A package or container of dispensed medicine may indicate the name and address of suppliers of the medicine.

(7) Where a package or container of dispensed medicine is to be administered to an animal, the package or container shall be labelled to indicate –

(a) The name and addressed of the person in control of the animal;(b) Name and address of the suppliers of medicine;(c) The date on which the medicine is dispensed; and(d) Any other information necessary to ensure the correct use of the medicine

65 PRA Secretariat / January 2009

ANNEX II

SCHEDULE OF FEES BASED ON STATUTORY INSTRUMENT No.7 OF 2008

FEE SCHEDULEA. RETAIL / HOSPITAL PHARMACY

N0. DESCRIPTIONFEE UNITS (1 fee Unit = K180)

APPLICATION FEES (ZMK)

1 Application for registration certificate to operate a retail pharmacy 5,000 900,000.00

2 Application for registration certificate to operate a hospital pharmacy 2,834 510,000.00

3 Inspection fee to operate a retail / hospital pharmacy 4,223 760,000.004 Application for change of premises 2,500 450,000.005 Re-inspection fee for retail / hospital pharmacy 2,500 450,000.00

6 (A) Application for renewal of a retail pharmacy registration certificate 6,667 1,200,000.00

(B) Application for renewal of hospital pharmacy registration certificate 4,445 800,000.00

Hospital pharmacy - any institution established as a hospital and includes a clinic, nursing home, health centre, surgery, consulting room, hospice and any facility authorised to dispense medicines and drugs

B. IMPORT / WHOLESALE DEALER’S LICENCES

N0. DESCRIPTIONFEE UNITS ( 1 fee Unit = K180)

APPLICATION FEES (ZMK)

1 (i) Application for import licence 5,556 1,000,000.00 (ii) Application for Wholesale dealer’s licence 5,000.00 900,000.00

2 Inspection fees (i) wholesale dealing 4,223.00 760,000.00

3 Renewal for import licence 5,000.00 900,000.00 Renewal for wholesale dealer’s licence 7,778.00 1,400,000.00

4 Application for change of premises for wholesale dealing 4,445.00 800,000.00

5 Re-inspection fee 2,778.00 500,000.00

C. MANUFACTURER’S LICENCE

N0. DESCRIPTIONFEE UNITS (1 fee Unit = K180)

APPLICATION FEES (ZMK)

1 Application for licence to manufacture 10,000 1,800,000.00 Inspection fee (local manufacture) 20,000 3,600,000.00

2 Renewal for manufacture licence 10,000 1,800,000.003 Application for change of premises 5,000 900,000.00 4 (i) Issue of licence to manufacture (5 years) 50,000 9,000,000.00 5 Application for manufacturer’s licence :

(i) To repackage medicines 10,000 1,800,000.00 (ii) Inspection fee 11,112 2,000,000.00

(iii) Annual renewal 7,778 1,400,000.00 (iv) Re-inspection fee 5,000 900,000.00 (v) Change of premises 4,445 800,000.00

67 PRA Secretariat / January 2009

OTHER SERVICES

N0. DESCRIPTION FEE UNITS (1 fee Unit = K180)

FEES (ZMK)

1 Screening fees for import authorisation 2% of invoice value

2 Screening for export authorisation 278 50,000.00

3 Application for clinical trial certificate 2,778 500,000.00

4 Application for product licence of an investigational product 16,889 3,040,000.00

5 Application for issue of GMP certificate 2,223 400,000.00

6 Application for import of narcotic drugs and psychotropic substances 278 50,000.00

7 Minor Amendments to dossier / labeling 1,389 250,000.00

8 Major amendments to dossier 2,778 500,000.00

9 Issue of Certificate of a Pharmaceutical Product (CPP) 278 50,000.00

10 Amendment to product licence (imported) 1,389 250,000.00

11 Amendments to Licences and certificates (locally manufacturered & locally packaged)

1,389 250,000.00

12 Amendments to import / export authorisation - 1% of invoice value

13 Application for approval of advertisement, promotion, launch, etc 5,556 1,000,000.00

14 Application for fast-track registration 18,334 3,300,000.00

15 Good Clinical Practice inspection 29,445 5,300,000.00

16 inspection and supervision for disposal of expired products 500 90,000.00 per day

17 Application for importation / exportation of a medicine by a person for personal use for that person

278 50,000.00

18 Application for change of category of distribution 5,556 1,000,000.00

19 Inspection of premises for issue of a GMP certificate 2,000 3,600,000.00

20 Application for the importation of small quantities of drugs by an authorised institution for specific patient(s)

2,500 450,000.00

21 Application for registration for import of a medicine for supply through government public tenders. (Should the medicine be required to be maintained on the market, fresh application fee to be paid as the case may be).

4,223 760,000.00

22 Replacement of lost documents (Licences and certificates) 1,389 250,000.00

23 Application for restoration of a product licence 16,667 3,000,000.00

PRA Secretariat / January 2009 68

PRODUCT REGISTRATION

NO. DESCRIPTION FEE UNITS (1 fee Unit = K180)

REGISTRATION FEES (ZMK)

FEE UNITS (1 fee Unit = K180)

RETENTION FEE(ZMK)

1.

2.

3.

Human medicinesApplication for registration

(i) Imported as finished product

(ii) Packaged in Zambia(iii) Locally manufactured (iv) New Chemical Entities(v) Biological products

including vaccines

Veterinary medicinesApplication for registration:(i) Imported as a finished

product(ii) Packaged in Zambia(iii) Locally manufactured

Herbal medicinal product Application for registration:(i) Imported as a finished

product(ii) Herbal medicinal

product packaged in Zambia

(iii) Herbal medicine locally Manufactured

21,11218,334 4,22323,33423,334

12,778

8,4452,834

21,112

12,778

4,223

3,800,000.003,300,000.00 760,000.004,200,000.004,200,000.00

2,300,000.00

1,520,000.00 510,000.00

3,800,000.00

2,300,000.00

760,000.00

14,05614,056 2,77811,27811,278

10,556

10,556 2,223

14,056

10,556

2,778

2,530,000.002,530,000.00 500,000.002,030,000.002,030,000.00

1,900,000.00

1,900,000.00 400,000.00

2,530,000.00

1,900,000.00

500,000.00

4. Allied substances (ii) Registration of an allied

substance 4,223 760,000.00 2,778 500,000.00

69 PRA Secretariat / January 2009

Plot No. 6903,

Report Adverse Drug Reactions to:The Pharmacovigiliance Unit, Tel: +260 211 220088 / 220098 / 220109, Lusaka


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