Overview

The marketing authorisation for Clopidogrel Dura has been withdrawn at the request of the marketing authorisation holder.

Clopidogrel DURA : EPAR - Summary for the public

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Product information

Clopidogrel DURA : EPAR - Product Information

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Latest procedure affecting product information: R/0017

05/05/2015

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This medicine’s product information is available in all official EU languages.
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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Clopidogrel DURA : EPAR - All Authorised presentations

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svenska (SV) (483.56 KB - PDF)

Product details

Name of medicine
Clopidogrel DURA
Active substance
clopidogrel (as 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

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.

Authorisation details

EMA product number
EMEA/H/C/001132

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.

Marketing authorisation holder
Mylan dura GmbH

Wittichstraße 6
D-64295 Darmstadt
Germany

Marketing authorisation issued
21/07/2009
Revision
6

Assessment history

Clopidogrel DURA : EPAR - Procedural steps taken and scientific information after authorisation

Clopidogrel DURA : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Clopidogrel DURA

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