Zambia. Regulating Medicines for - World Health Organization

76 Pages·2009·0.73 MB·English

World Health Organization
This is a publication of the
Pharmaceutical Regulatory Authority
All rights Reserved
FOREWORD
The 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to time as medicinal products may be withdrawn for various reasons including their safety,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 NOTES
In 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.
ii
LIST OF LICENSED
MEDICINAL PRODUCTS
LICENCE PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE
NUMBER
128/001 Kaletra capsules Abbott Laboratories S.A (Pty) Ltd, South Africa Capsule oral Prescription Only Medicine
128/002 Kaletra solution Abbott Laboratories S.A (Pty) Ltd, South Africa Solution for Oral Use Prescription Only Medicine
128/003 Norvir oral solution Abbott Laboratories S.A (Pty) Ltd, South Africa Solution for Oral Use Prescription Only Medicine
128/004 Klacid P 125 granules for suspension Abbott Laboratories S.A (Pty) Ltd, South Africa Granules for Suspension Prescription Only Medicine
128/005 Klacid P 250 granules for suspension Abbott Laboratories S.A (Pty) Ltd, South Africa Granules for Suspension Prescription Only Medicine
128/006 Klacid tablets Abbott Laboratories S.A (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine
128/007 Eryderm 2% lotion Abbott Laboratories S.A (Pty) Ltd, South Africa Lotion for Topical Use Prescription Only Medicine
128/008 Erythroped Neo granules for oral Abbott Laboratories S.A (Pty) Ltd, South Africa Granules for Oral Use Prescription Only Medicine
128/009 Erythroped Neo granules for oral Abbott Laboratories S.A (Pty) Ltd, South Africa Granules for Oral Use Prescription Only Medicine
128/010 Erythroped forte granules for oral Abbott Laboratories S.A (Pty) Ltd, South Africa Granules for Oral Use Prescription Only Medicine
128/011 Erythrocin 250mg tablets Abbott Laboratories S.A (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine
128/012 Erythrocin 500mg tablets Abbott Laboratories S.A (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine
128/013 Pediazole granules for suspension Abbott Laboratories S.A (Pty) Ltd, South Africa Granules for Suspension Prescription Only Medicine
128/014 Ethrane liquid Abbott Laboratories S.A (Pty) Ltd, South Africa Solution for Inhalation Prescription Only Medicine
128/015 Forane tablets Abbott Laboratories S.A (Pty) Ltd, South Africa Tablet Uncoated Prescription Only Medicine
128/026 Aluvia tablets Abbott Laboratories S.A (Pty) Ltd, South Africa Tablet Film coated Prescription Only Medicine
128/027 Aluvia 100 tablets Abbott Laboratories S.A (Pty) Ltd, South Africa Tablet Film coated Prescription Only Medicine
097/001 Sabax Diasol Formula 17 injection Adcock Ingram Pharmaceuticals Ltd, South Solution for infusion Prescription Only Medicine
Africa
097/002 Sabax Diasol Formula 16 Injection Adcock Ingram Pharmaceuticals Ltd, South Solution for infusion Prescription Only Medicine
Africa
097/003 Sabax Diasol Formula 3 injection Adcock Ingram Pharmaceuticals Ltd, South Solution for infusion Prescription Only Medicine
Africa
097/004 Sabax Osmitrol 20% injection Adcock Ingram Pharmaceuticals Ltd, South Solution for infusion Prescription Only Medicine
Africa
097/005 Sabax Sodium Chloride 0.9% injection Adcock Ingram Pharmaceuticals Ltd, South Solution for infusion Prescription Only Medicine
Africa
097/006 Sabax Glucose 5% + Sodium Chloride Adcock Ingram Pharmaceuticals Ltd, South Solution for infusion Prescription Only Medicine
0.9% injection Africa
097/007 Sabax Ringer lactate injection Adcock Ingram Pharmaceuticals Ltd, South Solution for infusion Prescription Only Medicine
Africa
137/001 Lasoprol 30 capsules Aegis Ltd, Cyprus Capsule oral Prescription Only Medicine
137/002 Oxacid 200 mg capsules Aegis Ltd, Cyprus Capsule oral Prescription Only Medicine
137/003 Cifex suspension Aegis Ltd, Cyprus Suspension for Oral Use Prescription Only Medicine
137/004 Cifex 200 tablets Aegis Ltd, Cyprus Tablet Uncoated Prescription Only Medicine
137/005 Cefixime 400mg tablets Aegis Ltd, Cyprus Tablet Uncoated Prescription Only Medicine
176/001 Agisept antiseptic lozenges Agio Pharmaceutical Ltd, India Lozenges General Sale
176/002 Agisept antiseptic lozenges Agio Pharmaceutical Ltd, India Lozenges General Sale
176/003 Agisept antiseptic (Classical) lozenges Agio Pharmaceutical Ltd, India Lozenges General Sale
176/004 Diclogen tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Pharmacy Medicine
176/005 Salbutamol lifeforce tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine
176/006 Grisofulvin 500 tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine
176/007 Sepralin tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine
176/008 Nalidixic Acid Lifeforce tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine
176/009 Cloxacillin Lifeforce capsules Agio Pharmaceutical Ltd, India Capsule oral Prescription Only Medicine
176/010 Tetracycline Lifeforce capsules Agio Pharmaceutical Ltd, India Capsule oral Prescription Only Medicine
176/011 Para force tablets Agio Pharmaceutical Ltd, India Tablet Uncoated General Sale
176/012 Ferrous Sulphate tablets Agio Pharmaceutical Ltd, India Tablet Film coated Pharmacy Medicine
176/013 Chloramphenicol Lifeforce capsules Agio Pharmaceutical Ltd, India Capsule oral Prescription Only Medicine
176/015 Paraforce suspension Agio Pharmaceutical Ltd, India Suspension for Oral Use General Sale
176/016 Ferrous Sulphate and Folic Acid tablets Agio Pharmaceutical Ltd, India Tablet Film coated Pharmacy Medicine
176/017 Moxforce capsules Agio Pharmaceutical Ltd, India Capsule oral Prescription Only Medicine
176/018 Doxycycline Life capsules Agio Pharmaceutical Ltd, India Capsule oral Prescription Only Medicine
176/019 Metroforce tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine
176/020 Compound Magnesium Trisilicate tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Pharmacy Medicine
176/021 Ibufen tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Pharmacy Medicine
176/022 Nuamp capsules Agio Pharmaceutical Ltd, India Capsule oral Prescription Only Medicine
176/023 Albendazole Lifeforce suspension Agio Pharmaceutical Ltd, India Suspension Pharmacy Medicine
1 PRA Secretariat / January 2009
LICENCE PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE
NUMBER
176/024 Gentamicin Lifeforce injection Agio Pharmaceutical Ltd, India Solution for Injection Prescription Only Medicine
176/025 Metoclopramide Lifeforce injection Agio Pharmaceutical Ltd, India Solution for Injection Prescription Only Medicine
176/026 Mobiram injection Agio Pharmaceutical Ltd, India Solution for Injection Prescription Only Medicine
176/027 Dicyclone Lifeforce injection Agio Pharmaceutical Ltd, India Solution for Injection Prescription Only Medicine
176/028 Clovirax cream Agio Pharmaceutical Ltd, India Cream Topical Prescription Only Medicine
176/029 Micoson 2% cream Agio Pharmaceutical Ltd, India Cream Topical Pharmacy Medicine
176/030 Erycin tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine
176/031 Methyldopa Lifeforce tablets Agio Pharmaceutical Ltd, India Tablet Film coated Prescription Only Medicine
176/032 Salbutamol Lifeforce 4mg tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine
176/033 Rulicin 150 mg tablets Agio Pharmaceutical Ltd, India Tablet Uncoated Prescription Only Medicine
176/034 B-Complex Agio injection Agio Pharmaceutical Ltd, India Solution for Injection Prescription Only Medicine
176/035 Dexamethasone - Agio injection Agio Pharmaceutical Ltd, India Solution for Injection Prescription Only Medicine
202/001 Agovir tablets Agog Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
202/002 Compound magnesium tablets Agog Pharma Ltd, India Tablet Uncoated Pharmacy Medicine
202/003 Indo-25 capsules Agog Pharma Ltd, India Capsule oral Pharmacy Medicine
202/004 Cipro 500 tablets Agog Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
202/005 Trimago 400 tablets Agog Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
202/006 Agofen tablets Agog Pharma Ltd, India Tablet Film coated Pharmacy Medicine
202/007 Agoxic tablets Agog Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
202/008 Metronidazole tablets Agog Pharma Ltd, India Tablet Film coated Prescription Only Medicine
202/009 Diclofenac sodium tablets Agog Pharma Ltd, India Tablet Film coated Pharmacy Medicine
202/010 Trimago 200 tablets Agog Pharma Ltd, India Tablet Film coated Prescription Only Medicine
202/011 Ibuprofen tablets Agog Pharma Ltd, India Tablet Uncoated Pharmacy Medicine
202/012 Heath E.Tonic syrup Agog Pharma Ltd, India Syrup Pharmacy Medicine
202/013 Agometro suspension Agog Pharma Ltd, India Suspension for Oral Use Prescription Only Medicine
202/014 Ketos tablets Agog Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
202/015 B-Cox tablets Agog Pharma Ltd, India Tablet Film coated Pharmacy Medicine
202/016 Agomol tablets Agog Pharma Ltd, India Tablet Uncoated General Sale
202/017 Fluconazole capsules Agog Pharma Ltd, India Capsule oral Prescription Only Medicine
202/018 Ago-C tablets Agog Pharma Ltd, India Tablet Uncoated Pharmacy Medicine
202/019 Ago-C tablets Agog Pharma Ltd, India Tablet Chewable Pharmacy Medicine
202/020 B-twin tablets Agog Pharma Ltd, India Tablet Film coated Pharmacy Medicine
203/001 Metronidazole injection Ahlcon Parenterals (India) Ltd, India Solution for infusion Prescription Only Medicine
203/002 Fluconazole injection Ahlcon Parenterals (India) Ltd, India Solution for infusion Prescription Only Medicine
203/003 Ciprofloxacin injection Ahlcon Parenterals (India) Ltd, India Solution for Injection Prescription Only Medicine
203/004 Darrow’s solution Ahlcon Parenterals (India) Ltd, India Solution for infusion Prescription Only Medicine
203/005 Compound sodium lactate solution Ahlcon Parenterals (India) Ltd, India Solution for infusion Prescription Only Medicine
115/001 Quinine sulphate tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/001HM Fingurun capsules Ajanta Pharma Ltd, India Capsule oral Pharmacy Medicine
115/002 Indoflam capsules Ajanta Pharma Ltd, India Capsule oral Pharmacy Medicine
115/002HM Apdyl-H syrup Ajanta Pharma Ltd, India Syrup General Sale
115/003 Apkef capsules Ajanta Pharma Ltd, India Capsule oral Prescription Only Medicine
115/004 Tyflox capsules Ajanta Pharma Ltd, India Capsule oral Prescription Only Medicine
115/004H Thirty Plus capsules Ajanta Pharma Ltd, India Capsule oral Pharmacy Medicine
115/005HM Pinkoo gripe water Ajanta Pharma Ltd, India Solution for Topical Use General Sale
115/006 Optifenac tablets Ajanta Pharma Ltd, India Tablet Uncoated Pharmacy Medicine
115/006HM Rheumanib ointment Ajanta Pharma Ltd, India Ointment topical General Sale
115/007 Optifenac tablets Ajanta Pharma Ltd, India Tablet Uncoated Pharmacy Medicine
115/008 Apcillin 250 capsules Ajanta Pharma Ltd, India Capsule oral Prescription Only Medicine
115/009 Apcillin -500 capsules Ajanta Pharma Ltd, India Capsule oral Prescription Only Medicine
115/010 Novaten 50 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/010HM Mobaid tablets Ajanta Pharma Ltd, India Tablet Uncoated Pharmacy Medicine
115/011 Novaten 100 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/012 Cloxil 250 capsules Ajanta Pharma Ltd, India Capsule oral Prescription Only Medicine
115/013 Anthalben tablets Ajanta Pharma Ltd, India Tablet Uncoated Pharmacy Medicine
115/014 Apmox 250 tablets Ajanta Pharma Ltd, India Capsule oral Prescription Only Medicine
115/015 Cloxa-Plus capsules Ajanta Pharma Ltd, India Capsule oral Prescription Only Medicine
PRA Secretariat / January 2009 2
LICENCE PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE
NUMBER
115/017 Supreme S.S. tablet Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/018 Apcalis 10 tablets Ajanta Pharma Ltd, India Tablet Film coated Prescription Only Medicine
115/019 Apcalis Plus 20 tablets Ajanta Pharma Ltd, India Tablet Film coated Prescription Only Medicine
115/020 Atorfit-10 tablets Ajanta Pharma Ltd, India Tablet Film coated Prescription Only Medicine
115/021 Atorfit-20 tablets Ajanta Pharma Ltd, India Tablet Film coated Prescription Only Medicine
115/022 Amether suspension Ajanta Pharma Ltd, India Suspension for Oral Use Prescription Only Medicine
115/023 Amovax tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/024 Haftrine oral suspension Ajanta Pharma Ltd, India Suspension for Oral Use Prescription Only Medicine
115/025 Hafrine tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/026 Mevax tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/027 Primavax 15 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/028 Primavax 2.5 tablets Ajanta Pharma Ltd, India Tablet Film coated Prescription Only Medicine
115/029 Primavax 7.5 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/030 Ather injection Ajanta Pharma Ltd, India Solution for Injection Prescription Only Medicine
115/031 Kamagra oral gel Ajanta Pharma Ltd, India Gel Oral Prescription Only Medicine
115/032 Allnat -50 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/033 Allnat -100 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/035 Anacox Plus LD tablets Ajanta Pharma Ltd, India Tablet Film coated Prescription Only Medicine
115/036 Kamagra 100 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/037 Kamagra 50 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/038 Artefan tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/040 Tibinil-P tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/041 Apoxin tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/042 Tibinil-e 200 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/043 Tibnile-400 tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/044 Combisunate forte kit tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/045 Combisunate tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
115/046 Artefan tablets Ajanta Pharma Ltd, India Tablet Uncoated Prescription Only Medicine
158/001 Colirucus gentadexe ear/eye drops Alcon Cusi SA, Spain Ear/Eye Drops Prescription Only Medicine
158/002 Oftalmotrin eye drops Alcon Cusi SA, Spain Eye Drops Prescription Only Medicine
158/003 Curicrom eye drops Alcon Cusi SA, Spain Eye Drops Prescription Only Medicine
158/004 Cusicrom eye drops Alcon Cusi SA, Spain Eye Drops Prescription Only Medicine
158/005 Colircusi chloramphenicol eye drops Alcon Cusi SA, Spain Eye Drops Prescription Only Medicine
158/006 Cusimolol eye drops Alcon Cusi SA, Spain Eye Drops Prescription Only Medicine
227/001 Tobradex ophthalmic suspension Alcon Cusi SA, Spain Eye Suspension Prescription Only Medicine
227/002 Tobradex drops Alcon Cusi SA, Spain Eye Drops Prescription Only Medicine
227/003 Ciloxan drops Alcon Cusi SA, Spain Eye Drops Prescription Only Medicine
009/021 Betoptic solution Alcon Laboratories SA Pty Ltd, South Africa ENT Solution Prescription Only Medicine
009/030 Maxidex suspension Alcon Laboratories SA Pty Ltd, South Africa Suspension Prescription Only Medicine
009/031 Maxidex ointment Alcon Laboratories SA Pty Ltd, South Africa Ointment topical Prescription Only Medicine
009/032 Maxitrol suspension Alcon Laboratories SA Pty Ltd, South Africa Suspension Prescription Only Medicine
009/033 Maxitrol ointment Alcon Laboratories SA Pty Ltd, South Africa Ointment topical Prescription Only Medicine
009/034 Mydriacyl eye drops Alcon Laboratories SA Pty Ltd, South Africa Eye Drops Prescription Only Medicine
009/035 Naphcon eye drops Alcon Laboratories SA Pty Ltd, South Africa Eye Drops Prescription Only Medicine
009/036 Tears natural eye drops Alcon Laboratories SA Pty Ltd, South Africa Eye Drops Prescription Only Medicine
009/038 Tobrex eye drops Alcon Laboratories SA Pty Ltd, South Africa Eye Drops Prescription Only Medicine
009/039 Tobrex ointment Alcon Laboratories SA Pty Ltd, South Africa Ointment topical Prescription Only Medicine
215/001 Brozeet solution Alembic Chemical Works Co. Ltd, India Solution for Oral Use Pharmacy Medicine
215/002 Benzathine Penicillin injection Alembic Chemical Works Co. Ltd, India Powder for Injection Prescription Only Medicine
215/003 Zeet Expectorant syrup Alembic Chemical Works Co. Ltd, India Syrup Pharmacy Medicine
215/004 Clarithro-250 tablets Alembic Chemical Works Co. Ltd, India Tablet Uncoated Prescription Only Medicine
215/005 Glycodin cough syrup Alembic Chemical Works Co. Ltd, India Syrup Pharmacy Medicine
215/006 Lomeg 10 tablets Alembic Chemical Works Co. Ltd, India Tablet Uncoated Prescription Only Medicine
215/007 Procain penicillin 3MU injection Alembic Chemical Works Co. Ltd, India Powder for Injection Prescription Only Medicine
215/008 Fortified procaine penicillin 4MU injection Alembic Chemical Works Co. Ltd, India Powder for Injection Prescription Only Medicine
215/009 Benzyl penicillin 5MU injection Alembic Chemical Works Co. Ltd, India Powder for Injection Prescription Only Medicine
215/010 Sparta tablets Alembic Chemical Works Co. Ltd, India Tablet Uncoated Prescription Only Medicine
3 PRA Secretariat / January 2009
LICENCE PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE
NUMBER
215/011 Azithra 200 liquid Alembic Chemical Works Co. Ltd, India Solution for Oral Use Prescription Only Medicine
215/012 Althrocin-s-250 oral solution Alembic Chemical Works Co. Ltd, India Solution for Oral Use Prescription Only Medicine
215/013 Omezol-20 capsules Alembic Chemical Works Co. Ltd, India Capsule oral Prescription Only Medicine
215/014 Ciprown-500 tablets Alembic Chemical Works Co. Ltd, India Tablet Uncoated Prescription Only Medicine
215/015 Azithral-250 tablets Alembic Chemical Works Co. Ltd, India Tablet Uncoated Prescription Only Medicine
166/001 Erythromycin tablets Alkem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine
166/002 Erythromycin suspension Alkem Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine
166/003 Broadmex-250 capsules Alkem Laboratories Ltd, India Capsule oral Prescription Only Medicine
166/004 Formin-500mg tablets Alkem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine
166/005 Cloxacillin capsules Alkem Laboratories Ltd, India Capsule oral Prescription Only Medicine
166/006 Taxim injection Alkem Laboratories Ltd, India Powder for Injection Prescription Only Medicine
166/007 Decacef suspension Alkem Laboratories Ltd, India Powder for Oral Prescription Only Medicine
Suspension
166/008 Decacef 500 capsules Alkem Laboratories Ltd, India Capsule oral Prescription Only Medicine
166/009 Chloramphenicol oral suspension Alkem Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine
166/010 Alcipro 500 tablets Alkem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine
166/011 Amoxicillin suspension Alkem Laboratories Ltd, India Powder for Oral Prescription Only Medicine
Suspension
166/012 Anpicillin oral suspension Alkem Laboratories Ltd, India Suspension for Oral Use Prescription Only Medicine
166/013 Cloxacillin oral suspension Alkem Laboratories Ltd, India Powder for Oral Prescription Only Medicine
Suspension
166/014 Omeprazole-20 capsules Alkem Laboratories Ltd, India Capsule oral Prescription Only Medicine
166/015 T-prim tablets Alkem Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine
166/016 Cloxacillin injection Alkem Laboratories Ltd, India Powder for Injection Prescription Only Medicine
166/017 Decacef 250 capsules Alkem Laboratories Ltd, India Capsule oral Prescription Only Medicine
166/018 Broadclox-500 capsules Alkem Laboratories Ltd, India Capsule oral Prescription Only Medicine
252/001 Amitriptylline tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine
252/002 Allopurinol tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine
252/003 Atenolol 25 tablets Alpharma Ltd, United Kingdom Tablet Film coated Prescription Only Medicine
252/004 Atenolol 50 tablets Alpharma Ltd, United Kingdom Tablet Film coated Prescription Only Medicine
252/005 Atenolol tablets Alpharma Ltd, United Kingdom Tablet Film coated Prescription Only Medicine
252/006 Bendrofluazide tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine
252/007 Captopril tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine
252/008 Co-amilozide tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine
252/009 Glibenclamide tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine
252/010 Glyceryl Trinitrate tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine
252/011 Isosorbide mononitrate tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine
252/012 Metformin tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine
252/013 Verapamil tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine
252/014 Spironolactone 25 tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine
252/015 Spironolactone 50 tablets Alpharma Ltd, United Kingdom Tablet Uncoated Prescription Only Medicine
101/001 Suganril tablets Ambalal Sarabhai Enterprises Ltd, India Tablet Uncoated Prescription Only Medicine
101/002 Zodid injection Ambalal Sarabhai Enterprises Ltd, India Solution for Injection Prescription Only Medicine
101/003 Zobid SR tablet Ambalal Sarabhai Enterprises Ltd, India Tablet Uncoated Pharmacy Medicine
101/004 Nifedipine 10 tablets Ambalal Sarabhai Enterprises Ltd, India Tablet Uncoated Prescription Only Medicine
101/005 Pocilin 4 Mega injection Ambalal Sarabhai Enterprises Ltd, India Powder for Injection Prescription Only Medicine
101/006 Trimin injection Ambalal Sarabhai Enterprises Ltd, India Solution for Injection Prescription Only Medicine
101/007 Amoxicillin oral suspension Ambalal Sarabhai Enterprises Ltd, India Suspension Prescription Only Medicine
101/008 Compound magnessium tablets Ambalal Sarabhai Enterprises Ltd, India Tablet Uncoated Pharmacy Medicine
101/009 Cofnil-N expectorant syrup Ambalal Sarabhai Enterprises Ltd, India Syrup Pharmacy Medicine
101/010 Amphotericin B injection Ambalal Sarabhai Enterprises Ltd, India Solution for Injection Prescription Only Medicine
101/011 Streptocin injection Ambalal Sarabhai Enterprises Ltd, India Powder for Injection Prescription Only Medicine
101/012 Amoxicillin trihydrate capsules Ambalal Sarabhai Enterprises Ltd, India Capsule oral Prescription Only Medicine
101/013 Hemomin capsules Ambalal Sarabhai Enterprises Ltd, India Capsule oral Pharmacy Medicine
101/014 Oral Rehydration Salt Ambalal Sarabhai Enterprises Ltd, India Powder for Oral Solution General Sale
101/015 Phenoxymethyl Penicillin V tablets Ambalal Sarabhai Enterprises Ltd, India Tablet Uncoated Prescription Only Medicine
101/017 Fluphenazine decanoate injection Ambalal Sarabhai Enterprises Ltd, India Solution for Injection Prescription Only Medicine
PRA Secretariat / January 2009 4
LICENCE PRODUCT NAME PRODUCT LICENCE HOLDER DOSAGE FORM METHOD OF SALE
NUMBER
101/018 Sulphabiotic dusting powder Ambalal Sarabhai Enterprises Ltd, India Powder for Topical use Pharmacy Medicine
020/003 Amovit C Calcium tablets Amoun Pharmaceuticals Company, Egypt Tablet Uncoated General Sale
020/004 Amovit C tablets Amoun Pharmaceuticals Company, Egypt Tablet Uncoated Pharmacy Medicine
020/005 B.B.C spray Amoun Pharmaceuticals Company, Egypt Spray for Topical Use General Sale
020/006 Baby cream Amoun Pharmaceuticals Company, Egypt Cream Topical General Sale
020/007 Collycrom 4% eye drops Amoun Pharmaceuticals Company, Egypt Eye Drops Prescription Only Medicine
020/008 Enemax enema solution Amoun Pharmaceuticals Company, Egypt Solution for Topical Use Prescription Only Medicine
020/009 Xenos fruit effervescent granules Amoun Pharmaceuticals Company, Egypt Granules for Oral Use General Sale
020/010 For Hair and Nails capsules Amoun Pharmaceuticals Company, Egypt Capsule oral General Sale
020/011 Glucose tablets Amoun Pharmaceuticals Company, Egypt Tablet Uncoated General Sale
020/012 Michaelon tablets Amoun Pharmaceuticals Company, Egypt Tablet Uncoated Pharmacy Medicine
020/013 Minalax tablets Amoun Pharmaceuticals Company, Egypt Tablet Uncoated Pharmacy Medicine
020/014 My Sweet Baby syrup Amoun Pharmaceuticals Company, Egypt Syrup General Sale
020/015 Vitamount For Women capsules Amoun Pharmaceuticals Company, Egypt Capsule oral General Sale
020/016 Vitamount syrup Amoun Pharmaceuticals Company, Egypt Syrup General Sale
020/017 Viva-max 3mg tablets Amoun Pharmaceuticals Company, Egypt Tablet Uncoated Prescription Only Medicine
279/001 Enerject-12 injection Anglo-French Drugs & Industries Ltd,India Solution for Injection Prescription Only Medicine
279/002 Beplex Forte tablets Anglo-French Drugs & Industries Ltd,India Tablet Film coated Pharmacy Medicine
279/003 Beplex forte injection Anglo-French Drugs & Industries Ltd,India Solution for Injection Prescription Only Medicine
279/004 Maxamin forte tablets Anglo-French Drugs & Industries Ltd,India Tablet Uncoated Pharmacy Medicine
248/001 Zincofer capsules Apex Laboratories Ltd, India Capsule oral Pharmacy Medicine
248/002 Betzee cream Apex Laboratories Ltd, India Cream Topical Prescription Only Medicine
248/003 Betzee G cream Apex Laboratories Ltd, India Cream Topical Prescription Only Medicine
248/004 Betzee-M cream Apex Laboratories Ltd, India Cream Topical Prescription Only Medicine
248/005 Betzee-GM cream Apex Laboratories Ltd, India Cream Topical Prescription Only Medicine
248/006 Betzee-S ointment Apex Laboratories Ltd, India Ointment topical Prescription Only Medicine
248/007 Lozee cream Apex Laboratories Ltd, India Cream Topical Prescription Only Medicine
248/008 Lozee-gm cream Apex Laboratories Ltd, India Cream Topical Prescription Only Medicine
248/009 Zincovit syrup Apex Laboratories Ltd, India Suspension for Oral Use General Sale
248/010 Zincovit tablets Apex Laboratories Ltd, India Tablet Uncoated General Sale
248/011 Zincovit drops Apex Laboratories Ltd, India Suspension for Oral Use General Sale
248/012 Zincofer liquid Apex Laboratories Ltd, India Suspension for Oral Use Pharmacy Medicine
248/013 Nalidixic acid tablets Apex Laboratories Ltd, India Tablet Uncoated Prescription Only Medicine
256/001 Monocef -O tablets Aristo Pharmaceuticals Ltd, India Tablet Uncoated Prescription Only Medicine
187/001 Ar- Ampi powder Arubhi International, India Suspension for Oral Use Prescription Only Medicine
187/002 Ar-Grisco 125mg tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine
187/003 Ar-Griseo 250 tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine
187/004 Ar-Ampicloc capsules Arubhi International, India Capsule oral Prescription Only Medicine
187/005 Ar-Ampiclox 125 syrup Arubhi International, India Syrup Prescription Only Medicine
187/006 Ar-Clovir tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine
187/007 Ar-Keta 100 tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine
187/008 Ar-Mox Oral suspension Arubhi International, India Suspension for Oral Use Prescription Only Medicine
187/009 Ar-Clox capsules Arubhi International, India Capsule oral Prescription Only Medicine
187/010 Ar-Cloxa syrup Arubhi International, India Syrup Prescription Only Medicine
187/011 Ar-Fol 5 tablets Arubhi International, India Tablet Uncoated Pharmacy Medicine
187/012 Arol solution Arubhi International, India Powder for Oral Solution General Sale
187/013 Ar-Cetamol tablets Arubhi International, India Tablet Uncoated Pharmacy Medicine
187/014 Ar-Sal tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine
187/015 Ar-Ibu tablets Arubhi International, India Tablet Film coated Pharmacy Medicine
187/016 Ar-Zole capsules Arubhi International, India Capsule oral Prescription Only Medicine
187/017 Ar-Ozine tablets Arubhi International, India Tablet Film coated Pharmacy Medicine
187/018 Ar-Cotri tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine
187/019 Ar-Pyra tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine
187/020 Ar Cee tablets Arubhi International, India Tablet Uncoated Pharmacy Medicine
187/021 Ar-Gliben - 5 tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine
187/022 Ar-Pred tablets Arubhi International, India Tablet Uncoated Prescription Only Medicine
187/023 Ar-Dar tablets Arubhi International, India Tablet Uncoated Pharmacy Medicine
5 PRA Secretariat / January 2009