Clopidogrel Teva Generics B.V.

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clopidogrel

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Clopidogrel Teva Generics B.V. has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.

This EPAR was last updated on 12/05/2014

Authorisation details

Product details
Name
Clopidogrel Teva Generics B.V.
Agency product number
EMEA/H/C/002254
Active substance
clopidogrel hydrochloride
International non-proprietary name (INN) or common name
clopidogrel
Therapeutic area (MeSH)
  • Peripheral Vascular Diseases
  • Acute Coronary Syndrome
  • Myocardial Infarction
  • Stroke
Anatomical therapeutic chemical (ATC) code
B01AC04
GenericGeneric

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
3
Date of issue of marketing authorisation valid throughout the European Union
28/10/2010
Contact address
Computerweg 10
NL-3542 DR Utrecht
The Netherlands

Product information

05/11/2013 Clopidogrel Teva Generics B.V. - EMEA/H/C/002254 - IB/0010/G

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

Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:

  • 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.
  • 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.

For further information please refer to section 5.1.

Assessment history

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