Clopidogrel Zentiva (previously Clopidogrel Winthrop)

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clopidogrel

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Clopidogrel Zentiva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Zentiva.

This EPAR was last updated on 29/11/2018

Authorisation details

Product details
Name
Clopidogrel Zentiva (previously Clopidogrel Winthrop)
Agency product number
EMEA/H/C/000975
Active substance
clopidogrel
International non-proprietary name (INN) or common name
clopidogrel
Therapeutic area (MeSH)
  • Stroke
  • Peripheral Vascular Diseases
  • Myocardial Infarction
  • Acute Coronary Syndrome
Anatomical therapeutic chemical (ATC) code
B01AC04
Publication details
Marketing-authorisation holder
Zentiva k.s.
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
15/07/2008
Contact address
U kabelovny 130
102 37 Prague 10
Czech Republic

Product information

25/10/2018 Clopidogrel Zentiva (previously Clopidogrel Winthrop) - EMEA/H/C/000975 - WS/1433

Contents

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Pharmacotherapeutic group

Antithrombotic agents

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 seven days until less than six 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 and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

For further information please refer to section 5.1.

Assessment history

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