EPARs human use - Plavix//Clopidogrel hydrogen sulphate

FICHA FARMACOLÓGICA de Clopidogrel hydrogen sulphate. Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Cerasale. JUNIO 02, 2009.-

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EPARs for authorised medicinal products for human use - Plavix

Marketing Authorisation Holder
Sanofi Pharma Bristol-Myers Squibb SNC
174 Avenue de France
75013 Paris - France

Active Substance
Clopidogrel hydrogen sulphate
International Nonproprietary Name or Common Name
Clopidogrel
Pharmaco-therapeutic Group
Platelet aggregation inhibitors excl. Heparin
ATC Code
BO1 A C04

Therapeutic Indication:
Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:

• Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease

• Patients suffering from acute coronary syndrome:
- Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
- ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy

Date of issue of Marketing Authorisation valid throughout the European Union
15 July 1998