Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2011 Publisher: Sanofi Pharma Bristol-Myers Squibb SNC, 174 Avenue de France, F-75013, Paris, France
Plavix 75 mg film-coated tablets.
| Pharmaceutical Form |
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Film-coated tablet. Pink, round, biconvex, engraved with «75» on one side and «1171» on the other side. |
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
Excipients: each film-coated tablet contains 3 mg of lactose and 3.3 mg of hydrogenated castor oil.
For a full list of excipients, see section 6.1.
| Active Ingredient |
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Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation. Clopidogrel must be metabolised by CYP450 enzymes to produce the active metabolite that inhibits platelet aggregation. |
| List of Excipients |
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Core: Mannitol (E421) Coating: Hypromellose (E464) Polishing agent: Carnauba wax |
PVC/PVDC/Aluminium blisters in cardboard cartons containing 30 film-coated tablets.
Sanofi Pharma Bristol-Myers Squibb SNC, 174 Avenue de France, F-75013, Paris, France
EU/1/98/069/005a – Cartons of 30 film-coated tablets in PVC/PVDC/Alu blisters
Date of first authorisation: 15 July 1998
Date of latest renewal: 15 July 2008
| Drug | Countries | |
|---|---|---|
| PLAVIX | Austria, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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