Basic Information
Grepid
Regulatory Information
EMEA/H/C/001059
July 27, 2009
May 29, 2009
28
January 15, 2024
Company Information
Greece
6, Dervenakion str. Pallini Attiki
PHARMATHEN S.A.
Drug Classification
Active Substances Detail
clopidogrel (as besilate)
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication **Prevention of atherothrombotic events** Clopidogrel is indicated in: - adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease; - adult 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. **Prevention of atherothrombotic and thromboembolic events in atrial fibrillation** In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Overview Summary
This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine. If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).