Clopidogrel DURA

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clopidogrel

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Clopidogrel Dura has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 10/07/2015

Authorisation details

Product details
Name
Clopidogrel DURA
Agency product number
EMEA/H/C/001132
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
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
Mylan dura GmbH
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
21/07/2009
Contact address
Wittichstraße 6
D-64295 Darmstadt
Germany

Product information

05/05/2015 Clopidogrel DURA - EMEA/H/C/001132 - R/0017

Contents

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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.

Assessment history

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