Clopidogrel/Acetylsalicylic acid Teva
Withdrawn
This medicine's authorisation has been withdrawn
clopidogrel / acetylsalicylic acid
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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Clopidogrel/Acetylsalicylic acid Teva is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IA/0002
03/06/2016
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Clopidogrel/Acetylsalicylic acid Teva
- Active substance
- clopidogrel
- acetylsalicylic acid
- International non-proprietary name (INN) or common name
- clopidogrel
- acetylsalicylic acid
- Therapeutic area (MeSH)
- Acute Coronary Syndrome
- Myocardial Infarction
- Anatomical therapeutic chemical (ATC) code
- B01AC30
Pharmacotherapeutic group
combinationsTherapeutic 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
News on Clopidogrel/Acetylsalicylic acid Teva
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