Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 15 May 2018

Indication(s)

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.

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Category Value
Agency product number EMEA/H/C/001136
Orphan designation No
Date First Approved 23-09-2009
Type Medicinal product subject to medical prescription
Marketing authorisation holder Tad Pharma GmbH