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Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Clopidogrel 1A Pharma
Auth. number : EU/1/09/542
Active substance : 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
Marketing Authorisation Holder: Acino Pharma GmbH
Am Windfeld 35, 83714 Miesbach, Deutschland
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
31/07/2009 Centralised - Authorisation EMEA/H/C/1054 (2009)6151 of 28/07/2009
26/08/2009 Centralised - Variation EMEA/H/C/1054/IA/2
Updated with Decision(2010)916 of 09/02/2010
26/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1054/IA/1
09/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1054/II/3
11/02/2010 Centralised - Variation (2010)916 of 09/02/2010
30/03/2010 Referral EMEA/H/C/1054/A-20/4 (2010)2207 of 29/03/2010
06/06/2010 Centralised - Variation EMEA/H/C/1054/IB/5
20/09/2010 Referral EMEA/H/C/1054/A-20/4 (2010)6428 of 16/09/2010
03/02/2011 Centralised - Withdrawal (2011)686 of 01/02/2011