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European public assessment report for Clopidogrel Qualimed is updated to reflect that the marketing authorisation is no longer valid.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