PLAVIX 75mg Film-coated tablet Ref.[2675] Active ingredients: Clopidogrel

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

Product name and form

Plavix 75 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Pink, round, biconvex, engraved with «75» on one side and «1171» on the other side.

Qualitative and quantitative composition

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 Description
Clopidogrel

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

Core:

Mannitol (E421)
Macrogol 6000
Microcrystalline cellulose
Hydrogenated castor oil
Low substituted hydroxypropylcellulose

Coating:

Hypromellose (E464)
Lactose monohydrate
Triacetin (E1518)
Titanium dioxide (E171)
Red iron oxide (E172)

Polishing agent:

Carnauba wax

Pack sizes and marketing

PVC/PVDC/Aluminium blisters in cardboard cartons containing 30 film-coated tablets.

Marketing authorization holder

Sanofi Pharma Bristol-Myers Squibb SNC, 174 Avenue de France, F-75013, Paris, France

Marketing authorization dates and numbers

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

Drugs

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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