Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Clopidogrel Qualimed   
Auth. number : EU/1/09/557
INN : Clopidogrel
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AC - Platelet aggregation inhibitors excluding Heparin
Chemical substance: B01AC04 - Clopidogrel
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Qualimed
117 allée des Parcs, F-69800 Saint Priest, France

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
25/09/2009 Centralised - Authorisation EMEA/H/C/1135 (2009)7470 of 23/09/2009
08/12/2009 Centralised - Variation EMEA/H/C/1135/IA/2
Updated with Decision(2010)2176 of 26/03/2010
07/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1135/II/1
29/01/2010 Centralised - Variation EMEA/H/C/1135/IB/4
Updated with Decision(2010)2176 of 26/03/2010
30/03/2010 Centralised - Variation (2010)2176 of 26/03/2010
08/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1135/IA/6
24/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1135/IB/5/G
16/08/2010 Centralised - Variation EMEA/H/C/1135/IB/7
Updated with Decision(2011)1499 of 28/02/2011
04/03/2011 Centralised - Variation (2011)1499 of 28/02/2011
12/08/2011 Centralised - Variation EMEA/H/C/1135/IB/8
Updated with Decision(2012)1339 of 23/02/2012
27/02/2012 Centralised - Variation (2012)1339 of 23/02/2012
03/09/2014 Centralised - Withdrawal (2014)6264 of 01/09/2014