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PLAVIX 75mg Film-coated tablet (2011)

Active ingredients: Clopidogrel

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.

Chemical substance
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
Authorization dates

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

Date of first authorisation: 15 July 1998
Date of latest renewal: 15 July 2008

Marketing authorization number:

EU/1/98/069/005a – Cartons of 30 film-coated tablets in PVC/PVDC/Alu blisters