Basic Information
Clopidogrel ratiopharm
Regulatory Information
EMEA/H/C/004006
February 18, 2015
December 18, 2014
15
March 26, 2024
Company Information
the netherlands
Swensweg 5 2031GA Haarlem
Teva Pharma B.V.
Drug Classification
Active Substances Detail
clopidogrel (as hydrogen sulfate)
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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.
Overview Summary
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.