Clopidogrel Qualimed

Withdrawn

This medicine's authorisation has been withdrawn

clopidogrel

Overview

On 23 September 2009, the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Clopidogrel Qualimed, generic of Plavix, which had been approved for 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 holder (MAH) responsible for Clopidogrel Qualimed was Qualimed. On 01 September 2014, the European Commission issued a decision to withdraw the marketing authorisation for Clopidogrel Qualimed, following its receipt of a letter dated 10 August 2014 notifying the Commission of the MAH’s decision to voluntarily withdraw the marketing authorisation for this product for marketing reason. Clopidogrel Qualimed was not marketed in any European country. 

Pursuant to this decision, the European public assessment report for Clopidogrel Qualimed is updated to reflect that the marketing authorisation is no longer valid.

Clopidogrel Qualimed : EPAR - Summary for the public

Product information

Clopidogrel Qualimed : EPAR - Product Information

Product details

• Name of medicine:
  Clopidogrel Qualimed
• 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:
  B01AC06

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.

Authorisation details

• EMA product number:
  EMEA/H/C/001135
• 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:
  Qualimed

  117 allée des Parcs; F-69 800 Saint Priest; France

• Marketing authorisation issued:
  23/09/2009
• Withdrawal of marketing authorisation:
  01/09/2014
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Clopidogrel Qualimed : EPAR - Public assessment report