Clopidogrel Teva Pharma B.V. (clopidogrel)
- Region
- 🇪🇺 EU
- Active substance
- clopidogrel
- Company
- Teva Pharma B.V.
- Status
- Withdrawn
- Therapeutic area
- Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
- EU approval
- Thu 16 Jun 2011
- Designations
- Generic
- Application
- EMEA/H/C/001226
- ATC
- B01AC04
- Official record
- www.ema.europa.eu
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 7 days until less than 6 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 (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Regulatory milestones
No milestones recorded in the last year.
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