The marketing authorisation for Clopidogrel Hexal has been withdrawn at the request of the marketing-authorisation holder.
Clopidogrel Hexal : EPAR - Summary for the public (PDF/261.73 KB)
First published: 08/09/2009
Last updated: 26/07/2012
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This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
Acino Pharma GmbH
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09/02/2012 Clopidogrel Hexal - EMEA/H/C/001139 - A20/0006
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.