This is a summary of the European public assessment report (EPAR) for Clopidogrel ratiopharm. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Clopidogrel ratiopharm.
For practical information about using Clopidogrel ratiopharm, patients should read the package leaflet or contact their doctor or pharmacist.
Clopidogrel ratiopharm : EPAR - Summary for the public (PDF/98.38 KB)
First published: 11/03/2015
Last updated: 11/03/2015
Clopidogrel-ratiopharm : EPAR - Risk-management-plan summary (PDF/42.62 KB)
First published: 11/03/2015
Last updated: 19/11/2019
|Agency product number||
clopidogrel hydrogen sulphate
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
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.
|Date of issue of marketing authorisation valid throughout the European Union||
21/02/2020 Clopidogrel ratiopharm - EMEA/H/C/004006 - IB/0016/G
- 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
Please note that the size of the above document can exceed 50 pages.
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Secondary prevention of atherothrombotic events
Clopidogrel is indicated in:
- Adult 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.
- Adult 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.
Prevention of atherothrombotic and thromboembolic events in atrial fibrillation
In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.