Clopidogrel Krka d.d. (previously Zopya) (clopidogrel)
- Region
- 🇪🇺 EU
- Active substance
- clopidogrel
- Company
- Norpharm Regulatory Services Ltd
- Status
- Authorised
- Therapeutic area
- Peripheral Vascular Diseases; Stroke; Myocardial Infarction
- EU approval
- Sun 20 Sep 2009
- Designations
- Generic
- Application
- EMEA/H/C/001137
- ATC
- B01AC03
- Official record
- www.ema.europa.eu
Indication
Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35days), ischaemic stroke (from 7days until less than 6months) 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.
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 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.
- 🇪🇺 Clopidogrel Taw Pharma (previously Clopidogrel Mylan) Authorised · Taw Pharma (Ireland) Limited
Follow Clopidogrel Krka d.d. (previously Zopya)
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.