PLAVIX 75mg Film-coated tablet

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.

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
Austria, Brazil, Canada, Cyprus, Germany, Spain, Finland, France, Hong Kong, Ireland, Italy, Lithuania, Netherlands, Poland, Singapore, Tunisia, United Kingdom, United States