Clopidogrel Teva (hydrogen sulphate)

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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). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

This EPAR was last updated on 05/12/2018

Authorisation details

Product details
Name
Clopidogrel Teva (hydrogen sulphate)
Agency product number
EMEA/H/C/001053
Active substance
clopidogrel hydrogen sulphate
International non-proprietary name (INN) or common name
clopidogrel
Therapeutic area (MeSH)
  • Acute Coronary Syndrome
  • Peripheral Vascular Diseases
  • Myocardial Infarction
  • Stroke
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 and hybrid medicines.

Publication details
Marketing-authorisation holder
Teva Pharma B.V.
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
27/07/2009
Contact address
TEVA Pharma B.V.
Computerweg 10
NL-3542 DR Utrecht
The Netherlands

Product information

13/04/2018 Clopidogrel Teva (hydrogen sulphate) - EMEA/H/C/001053 - IB/0045

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

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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