Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: DuoCover   
Auth. number : EU/1/10/623
INN : clopidogrel / acetylsalicylic acid
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: B01AC30 - Combinations
(See WHO ATC Index)
Indication: DuoCover is indicated for the prevention of atherothrombotic events in adult patients already taking
both clopidogrel and acetylsalicylic acid (ASA). DuoCover is a fixed-dose combination medicinal
product for continuation of therapy in:
Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave
myocardial infarction) including patients undergoing a stent placement following percutaneous
coronary intervention
ST segment elevation acute myocardial infarction in medically treated patients eligible for
thrombolytic therapy
Marketing Authorisation Holder: Sanofi-Aventis groupe
54 rue La Boétie, F-75008 Paris, France

  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
17/03/2010 Centralised - Authorisation EMEA/H/C/1144 (2010)1816 of 15/03/2010
18/05/2010 Centralised - Variation EMEA/H/C/1144/IA/1
Updated with Decision(2010)5395 of 28/07/2010
24/05/2010 Centralised - Variation EMEA/H/C/1144/IA/4/G
Updated with Decision(2010)5395 of 28/07/2010
01/06/2010 Centralised - Variation EMEA/H/C/1144/IB/3/G
30/07/2010 Centralised - Variation EMEA/H/C/1144/II/2 (2010)5395 of 28/07/2010
14/10/2010 Centralised - Variation EMEA/H/C/1144/IB/5
14/10/2010 Centralised - Variation EMEA/H/C/1144/IB/4
23/12/2010 Centralised - Variation EMEA/H/C/1144/II/6 (2010)9623 of 20/12/2010
08/09/2011 Centralised - Variation EMEA/H/C/1144/N/8
Updated with Decision(2012)3566 of 25/05/2012
30/05/2012 Centralised - Variation EMEA/H/C/1144/II/11 (2012)3566 of 25/05/2012
04/03/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1144/T/15 (2013)1254 of 28/02/2013
26/03/2013 Corrigendum (2013)1845 of 22/03/2013
29/05/2013 Centralised - Variation EMEA/H/C/1144/WS/365, 366, 367, 368, 369 (2013)3228 of 27/05/2013
31/07/2013 Centralised - Variation EMEA/H/C/1144/WS/378, 397 (2013)5012 of 26/07/2013
19/09/2013 Centralised - Variation EMEA/H/C/1144/WS/409
15/11/2013 Corrigendum (2013)8069 of 13/11/2013
23/01/2014 Centralised - Variation EMEA/H/C/1144/WS/476
23/01/2014 Centralised - Variation EMEA/H/C/1144/WS/477