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Clopidogrel 1A Pharma (clopidogrel)

Generic
Region
🇪🇺 EU
Active substance
clopidogrel
Company
Acino Pharma GmbH
Status
Withdrawn
Therapeutic area
Peripheral Vascular Diseases
EU approval
Tue 28 Jul 2009
Designations
Generic
Application
EMEA/H/C/001054
ATC
B01AC04
Official record
www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.