Clopidogrel Qualimed

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Withdrawn

This medicine's authorisation has been withdrawn

clopidogrel
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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European public assessment report for Clopidogrel Qualimed is updated to reflect that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: IB/0008
01/09/2014
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

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).

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

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