Clopidogrel DURA

Withdrawn

This medicine's authorisation has been withdrawn

clopidogrel

Overview

On 5 May 2015, the European Commission withdrew the marketing authorisation for Clopidogrel DURA (clopidogrel) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Mylan Dura GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Clopidogrel DURA was granted marketing authorisation in the EU on 27 July 2009 for the following indication: 

• Prevention of atherothrombotic events Clopidogrel is indicated in:
  • Adults 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. 

The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2014. Clopidogrel DURA is a generic medicine of Plavix. There are other generic medicinal products of Plavix authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Clopidogrel DURA is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Clopidogrel DURA : EPAR - Summary for the public

Product information

Clopidogrel DURA : EPAR - Product Information

Clopidogrel DURA : EPAR - All Authorised presentations

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
• Withdrawal of marketing authorisation:
  05/05/2015
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Clopidogrel DURA : EPAR - Public assessment report

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

Reference Number: EMEA/CHMP/379512/2009