Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Clopidogrel DURA   
Auth. number : EU/1/09/560
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: Prevention of atherothrombotic events
Clopidogrel is indicated in:
• Adults 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: Mylan dura GmbH
Wittichstraße 6, D-64295 Darmstadt, 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/1132 (2009)7411 of 21/09/2009
04/01/2010 Centralised - Variation EMEA/H/C/1132/II/1
02/02/2010 Centralised - Variation EMEA/H/C/1132/IB/3
Updated with Decision(2010)1832 of 15/03/2010
17/03/2010 Centralised - Variation (2010)1832 of 15/03/2010
14/06/2010 Centralised - Variation EMEA/H/C/1132/IA/5
14/06/2010 Centralised - Variation EMEA/H/C/1132/IB/4/G
11/08/2010 Centralised - Variation EMEA/H/C/1132/IB/6
Updated with Decision(2011)1645 of 08/03/2011
10/03/2011 Centralised - Variation (2011)1645 of 08/03/2011
27/04/2011 Centralised - Variation EMEA/H/C/1132/IB/7
Updated with Decision(2011)6931 of 22/09/2011
16/08/2011 Centralised - Variation EMEA/H/C/1132/IB/9
Updated with Decision(2011)6931 of 22/09/2011
26/09/2011 Centralised - Variation (2011)6931 of 22/09/2011
18/01/2013 Centralised - Variation EMEA/H/C/1132/IB/10
Updated with Decision(2014)413 of 22/01/2014
21/05/2013 Centralised - Variation EMEA/H/C/1132/IB/13/G
Updated with Decision(2014)413 of 22/01/2014
16/09/2013 Centralised - Variation EMEA/H/C/1132/IB/14/G
Updated with Decision(2014)413 of 22/01/2014
14/11/2013 Centralised - Variation EMEA/H/C/1132/IB/15/G
Updated with Decision(2014)413 of 22/01/2014
19/12/2013 Centralised - Variation EMEA/H/C/1132/IB/16
Updated with Decision(2014)413 of 22/01/2014
24/01/2014 Centralised - Variation (2014)413 of 22/01/2014
23/04/2014 Centralised - Variation EMEA/H/C/1132/IB/19/G
27/05/2014 Centralised - Renewal EMEA/H/C/1132/R/17 (2014)3540 of 22/05/2014