Clopidogrel ratiopharm GmbH (clopidogrel)
- Region
- 🇪🇺 EU
- Active substance
- clopidogrel
- Company
- Archie Samiel s.r.o.
- Status
- Withdrawn
- Therapeutic area
- Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
- EU approval
- Tue 28 Jul 2009
- Designations
- Generic
- Application
- EMEA/H/C/001165
- 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.
Regulatory milestones
No milestones recorded in the last year.
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