Clopidogrel Qualimed

RSS

clopidogrel

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Clopidogrel Qualimed has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 08/09/2014

Authorisation details

Product details
Name
Clopidogrel Qualimed
Agency product number
EMEA/H/C/001135
Active substance
clopidogrel hydrochloride
International non-proprietary name (INN) or common name
clopidogrel
Therapeutic area (MeSH)
  • Peripheral Vascular Diseases
  • Stroke
  • Myocardial Infarction
Anatomical therapeutic chemical (ATC) code
B01AC06
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
Qualimed
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
23/09/2009
Contact address
117 allée des Parcs
F-69 800 Saint Priest
France

Product information

01/09/2014 Clopidogrel Qualimed - EMEA/H/C/001135 - IB/0008

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.

For further information please refer to section 5.1.

Assessment history

How useful was this page?

Add your rating