Overview
The marketing authorisation for Clopidogrel Teva Generics B.V. has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.
Product information
Latest procedure affecting product information: IB/0010/G
05/11/2013
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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 Teva Generics B.V.
- Active substance
- clopidogrel (as hydrochloride)
- International non-proprietary name (INN) or common name
- clopidogrel
- Therapeutic area (MeSH)
- Peripheral Vascular Diseases
- Acute Coronary Syndrome
- Myocardial Infarction
- Stroke
- Anatomical therapeutic chemical (ATC) code
- B01AC04
Pharmacotherapeutic group
Antithrombotic agentsTherapeutic indication
Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:
- 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.
- 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.
For further information please refer to section 5.1.
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