Zyllt (clopidogrel)
- Region
- 🇪🇺 EU
- Active substance
- clopidogrel
- Company
- KRKA tovarna zdravil d.d. Novo mesto
- Status
- Authorised
- Therapeutic area
- Peripheral Vascular Diseases; Stroke; Acute Coronary Syndrome; Myocardial Infarction
- EU approval
- Mon 28 Sep 2009
- Designations
- Generic
- Application
- EMEA/H/C/001058
- ATC
- B01AC04
- Official record
- www.ema.europa.eu
Indication
Prevention Secondary 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.
Same substance in other markets
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- 🇪🇺 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
- 🇪🇺 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
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