Clopidogrel BMS (clopidogrel)
- Region
- 🇪🇺 EU
- Active substance
- clopidogrel
- Company
- Bristol-Myers Squibb Pharma EEIG
- Status
- Withdrawn
- Therapeutic area
- Stroke; Peripheral Vascular Diseases; Myocardial Infarction; Acute Coronary Syndrome
- EU approval
- Wed 16 Jul 2008
- Application
- EMEA/H/C/000974
- 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.
Same substance in other markets
- 🇪🇺 DuoPlavin Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Clopidogrel Zentiva (previously Clopidogrel Winthrop) Authorised · Zentiva k.s.
- 🇪🇺 Clopidogrel Viatris (previously Clopidogrel Taw Pharma) Authorised · Viatris Limited
- 🇪🇺 Iscover Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Plavix Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Grepid Authorised · Pharmathen S.A.
- 🇪🇺 Clopidogrel Krka Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Clopidogrel Krka d.d. (previously Zopya) Authorised · Norpharm Regulatory Services Ltd
- 🇪🇺 Clopidogrel TAD Authorised · Tad Pharma GmbH
- 🇪🇺 Zyllt Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan) Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Clopidogrel ratiopharm Authorised · Teva B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.