Clopidogrel Apotex (previously Clopidogrel Mylan Pharma)

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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 Apotex. 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 Apotex.

This EPAR was last updated on 12/10/2018

Authorisation details

Product details
Name
Clopidogrel Apotex (previously Clopidogrel Mylan Pharma)
Agency product number
EMEA/H/C/001189
Active substance
clopidogrel besilate
International non-proprietary name (INN) or common name
clopidogrel
Therapeutic area (MeSH)
  • Peripheral Vascular Diseases
  • Stroke
  • Myocardial Infarction
Anatomical therapeutic chemical (ATC) code
B01AC04
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic medicines.

Publication details
Marketing-authorisation holder
Apotex Europe B.V.
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
16/10/2009
Contact address

Archimedesweg 2
2333 CN Leiden
The Netherlands

Product information

18/09/2018 Clopidogrel Apotex (previously Clopidogrel Mylan Pharma) - EMEA/H/C/001189 - N/0031

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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 and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of therothrombotic and thromboembolic events, including stroke.

Assessment history

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