Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Clopidogrel ratiopharm
Auth. number : EU/1/09/554
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 (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: Archie Samuel s.r.o.
Slunná 16, CZ-61700 Brno, Česká republika
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/1173 (2009)7468 of 23/09/2009
14/10/2009 Centralised - Variation EMEA/H/C/1173/IA/3
Updated with Decision(2010)2010 of 23/03/2010
16/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1173/IA/1
16/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1173/IA/5
16/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1173/IA/2
04/11/2009 Centralised - Variation EMEA/H/C/1173/IB/4
Updated with Decision(2010)2010 of 23/03/2010
27/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1173/II/6
27/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1173/II/7
25/03/2010 Centralised - Variation (2010)2010 of 23/03/2010
30/03/2010 Referral EMEA/H/C/1172/A-20/4 (2010)2205 of 29/03/2010
28/06/2010 Corrigendum (2010)2205 corr of 24/06/2010
06/08/2010 Centralised - Variation EMEA/H/C/1173/IB/9
Updated with Decision(2011)2094 of 24/03/2011
20/09/2010 Referral EMEA/H/C/1173/A-20 (2010)6432 of 16/09/2010
17/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1173/WS/53
08/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1173/WS/52
28/03/2011 Centralised - Variation (2011)2094 of 24/03/2011
16/05/2011 Centralised - Variation EMEA/H/C/1173/IB/10
Updated with Decision(2011)9742 of 14/12/2011
27/07/2011 Centralised - Variation EMEA/H/C/1173/IB/11
Updated with Decision(2011)9742 of 14/12/2011
19/12/2011 Centralised - Variation (2011)9742 of 14/12/2011
13/09/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1173/T/15 (2012)6424 of 11/09/2012
03/12/2012 Centralised - Notification EMEA/H/C/1173/N/16
30/07/2013 Centralised - Variation EMEA/H/C/1173/IB/18/G
28/10/2013 Centralised - Withdrawal (2013)7276 of 25/10/2013