On 3 June 2016, the European Commission withdrew the marketing authorisation for Clopidogrel/Acetylsalicylic acid Teva (clopidogrel / acetylsalicylic acid) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva Pharma B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons. Clopidogrel/Acetylsalicylic acid Teva was granted marketing authorisation in the EU on 1 September 2014 for the prevention of atherothrombotic events. Clopidogrel/Acetylsalicylic acid Teva is a medicine that contains two active substances, clopidogrel and acetylsalicylic. There are other medicinal products marketed in the EU that contain this combination of substances as well as products containing clopidogrel or acetylsalicylic alone. The European Public Assessment Report (EPAR) for Clopidogrel/Acetylsalicylic acid Teva is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Therapeutic Indication
### Therapeutic indication Clopidogrel/Acetylsalicylic acid Teva is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Clopidogrel/Acetylsalicylic acid Teva 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
Therapeutic Area (MeSH)
ATC Code
B01AC30
ATC Item
combinations
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
EMA Name
Clopidogrel/Acetylsalicylic acid Teva
Medicine Name
Clopidogrel/Acetylsalicylic acid Teva
Aliases
N/A
