Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan) (clopidogrel;acetylsalicylic acid)

Generic

Region: 🇪🇺 EU
Active substance: clopidogrel;acetylsalicylic acid
Company: Mylan Pharmaceuticals Limited
Status: Authorised
Therapeutic area: Acute Coronary Syndrome; Myocardial Infarction
CHMP opinion: Thu 14 Nov 2019
EU approval: Thu 09 Jan 2020
Designations: Generic
Application: EMEA/H/C/004996
ATC: B01AC30
Official record: www.ema.europa.eu

Indication

Clopidogrel/Acetylsalicylic acid Viatris is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Clopidogrel/Acetylsalicylic acid Viatris 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 ST segment elevation acute myocardial infarction 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/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🇪🇺 Clopidogrel/Acetylsalicylic acid Teva Withdrawn · Teva Pharma B.V.
🇪🇺 DuoCover Application withdrawn · Bristol Myers Squibb Pharma EEIG
🇪🇺 DuoPlavin Application withdrawn · Sanofi Pharma Bristol-Myers Squibb

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