Clopidogrel Teva Generics B.V. (clopidogrel)
- Region
- 🇪🇺 EU
- Active substance
- clopidogrel
- Company
- Teva Pharma B.V.
- Status
- Lapsed
- Therapeutic area
- Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
- EU approval
- Thu 28 Oct 2010
- Designations
- Generic
- Application
- EMEA/H/C/002254
- ATC
- B01AC04
- Official record
- www.ema.europa.eu
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. For further information please refer to section 5.1.
Regulatory milestones
No milestones recorded in the last year.
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