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Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Clopidogrel Acino Pharma GmbH
Auth. number : EU/1/09/548
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: prevention of atherothrombotic event in Patients suffering from myocardial infarction, ischaemic stroke or established peripheral arterial disease
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
23/09/2009 Centralised - Authorisation EMEA/H/C/1175 (2009)7422 of 21/09/2009
16/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1175/IA/1
11/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1175/II/2
11/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1175/II/3
30/03/2010 Referral EMEA/H/C/1175/A-20/4 (2010)2204 of 29/03/2010
10/08/2010 Centralised - Variation EMEA/H/C/1175/IB/5
Updated with Decision(2011)9938 of 19/12/2011
20/09/2010 Referral EMEA/H/C/1175/A-20/4 (2010)6436 of 16/09/2010
12/05/2011 Centralised - Variation EMEA/H/C/1175/IB/6
Updated with Decision(2011)9938 of 19/12/2011
26/07/2011 Centralised - Variation EMEA/H/C/1175/IB/7
Updated with Decision(2011)9938 of 19/12/2011
21/12/2011 Centralised - Variation (2011)9938 of 19/12/2011
15/02/2012 Centralised - Withdrawal (2012)1041 of 13/02/2012