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Clopidogrel Teva Pharma B.V.

Active Substance: clopidogrel hydrobromide
Common Name: clopidogrel
ATC Code: B01AC04
Marketing Authorisation Holder: Teva Pharma B.V.  
Active Substance: clopidogrel hydrobromide
Status: Withdrawn
Authorisation Date: 2011-06-16
Therapeutic Area: Peripheral Vascular Diseases Stroke Acute Coronary Syndrome Myocardial Infarction
Pharmacotherapeutic Group: Antithrombotic agents

Therapeutic Indication

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.

The marketing authorisation for Clopidogrel Teva Pharma B.V. has been withdrawn at the request of the marketing authorisation holder.

Source: European Medicines Agency

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