Iscover

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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 Iscover. 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 Iscover.

This EPAR was last updated on 05/12/2018

Authorisation details

Product details
Name
Iscover
Agency product number
EMEA/H/C/000175
Active substance
clopidogrel
International non-proprietary name (INN) or common name
clopidogrel
Therapeutic area (MeSH)
  • Stroke
  • Peripheral Vascular Diseases
  • Atrial Fibrillation
  • Myocardial Infarction
  • Acute Coronary Syndrome
Anatomical therapeutic chemical (ATC) code
B01AC04
Publication details
Marketing-authorisation holder
Sanofi-Aventis Groupe
Revision
39
Date of issue of marketing authorisation valid throughout the European Union
14/07/1998
Contact address
54 rue La Boétie
F-75008 Paris
France

Product information

25/10/2018 Iscover - EMEA/H/C/000175 - 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 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.

Assessment history

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