Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Clopidogrel Hexal
Auth. number : EU/1/09/534
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 in:Patients suffering from myocardial infarction or established peripheral arterial disease and patients suffering from acute coronary syndrome.
Marketing Authorisation Holder: Acino Pharma GmbH
Am Windfeld 35, D-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/1139 (2009)6152 of 28/07/2009
26/08/2009 Centralised - Variation EMEA/H/C/1139/IA/2
Updated with Decision(2010)1758 of 15/03/2010
26/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1139/IA/1
11/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1139/IA/3
03/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1139/II/4
03/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1139/II/5
17/03/2010 Centralised - Variation (2010)1758 of 15/03/2010
30/03/2010 Referral EMEA/H/C/1139/A-20/6 (2010)2210 of 29/03/2010
06/08/2010 Centralised - Variation EMEA/H/C/1139/IB/7
Updated with Decision(2011)1795 of 14/03/2011
20/09/2010 Referral EMEA/H/C/1139/A-20/6 (2010)6435 of 16/09/2010
21/03/2011 Centralised - Variation (2011)1795 of 14/03/2011
07/12/2011 Centralised - Variation EMEA/H/C/1139/IB/9
Updated with Decision(2011)9171 of 05/12/2011
07/12/2011 Centralised - Variation EMEA/H/C/1139/IB/8
Updated with Decision(2011)9171 of 05/12/2011
07/12/2011 Centralised - Variation (2011)9171 of 05/12/2011
13/02/2012 Centralised - Withdrawal (2012)896 of 09/02/2012