Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Clopidogrel Sandoz
Auth. number : EU/1/09/547
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: 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
23/09/2009 Centralised - Authorisation EMEA/H/C/1174 (2009)7409 of 21/09/2009
14/10/2009 Centralised - Variation EMEA/H/C/1174/IA/3
Updated with Decision(2010)2012 of 23/03/2010
16/10/2009 Centralised - Variation EMEA/H/C/1174/IA/1
16/10/2009 Centralised - Variation EMEA/H/C/1174/IA/2
09/02/2010 Centralised - Variation EMEA/H/C/1174/IA/6
12/02/2010 Centralised - Variation EMEA/H/C/1174/II/4
12/02/2010 Centralised - Variation EMEA/H/C/1174/II/5
25/03/2010 Centralised - Variation (2010)2012 of 23/03/2010
30/03/2010 Referral EMEA/H/C/1174/A-20/7 (2010)2206 of 29/03/2010
14/05/2010 Centralised - Variation EMEA/H/C/1174/IA/8
08/06/2010 Centralised - Variation EMEA/H/C/1174/N/9
Updated with Decision(2011)1881 of 17/03/2011
28/06/2010 Corrigendum (2010)2206 corr of 24/06/2010
06/08/2010 Centralised - Variation EMEA/H/C/1174/IB/10
Updated with Decision(2011)1881 of 17/03/2011
20/09/2010 Referral EMEA/H/C/1174/A-20 (2010)6433 of 16/09/2010
17/11/2010 Centralised - Variation EMEA/H/C/1174/WS/53
08/12/2010 Centralised - Variation EMEA/H/C/1174/WS/52
22/03/2011 Centralised - Variation (2011)1881 of 17/03/2011
04/04/2011 Centralised - Withdrawal (2011)2423 of 31/03/2011