DuoPlavin (clopidogrel;acetylsalicylic acid)
- Region
- 🇪🇺 EU
- Active substance
- clopidogrel;acetylsalicylic acid
- Company
- Sanofi Winthrop Industrie
- Status
- Authorised
- Therapeutic area
- Acute Coronary Syndrome; Myocardial Infarction
- CHMP opinion
- Thu 17 Dec 2009
- EU approval
- Sun 14 Mar 2010
- Application
- EMEA/H/C/001143
- ATC
- B01AC30
- Official record
- www.ema.europa.eu
Indication
DuoPlavin is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoPlavin is a fixed-dose combination medicinal product for continuation of therapy in: 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 (PCI); ST segment elevation acute myocardial infarction (STEMI) in patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. For further information please refer to section 5.1.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan) Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover) Authorised · Sanofi-Aventis Groupe
- 🇪🇺 Clopidogrel/Acetylsalicylic acid Teva Withdrawn · Teva Pharma B.V.
- 🇪🇺 DuoCover Application withdrawn · Bristol Myers Squibb Pharma EEIG
- 🇪🇺 DuoPlavin Application withdrawn · Sanofi Pharma Bristol-Myers Squibb
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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.