Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: DuoPlavin   
Auth. number : EU/1/10/619
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: DuoPlavin is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoPlavin 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 Clir SNC
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/1143 (2010)1817 of 15/03/2010
28/04/2010 Centralised - Variation EMEA/H/C/1143/IA/2
Updated with Decision(2010)5616 of 06/08/2010
27/05/2010 Centralised - Variation EMEA/H/C/1143/IG/4/G
Updated with Decision(2010)5616 of 06/08/2010
01/06/2010 Centralised - Variation EMEA/H/C/1143/IB/3/G
11/08/2010 Centralised - Variation EMEA/H/C/1143/II/1 (2010)5616 of 06/08/2010
16/09/2010 Centralised - Variation EMEA/H/C/1143/IB/6
16/09/2010 Centralised - Variation EMEA/H/C/1143/IB/5
23/12/2010 Centralised - Variation EMEA/H/C/1143/II/4 (2010)9637 of 20/12/2010
18/04/2012 Centralised - Variation EMEA/H/C/1143/IG/171
Updated with Decision(2012)3616 of 25/05/2012
01/06/2012 Centralised - Variation EMEA/H/C/1143/II/10 (2012)3616 of 25/05/2012
03/06/2013 Centralised - Variation EMEA/H/C/1143/WS/365, 366, 367, 368, 369 (2013)3389 of 30/05/2013
23/07/2013 Centralised - Variation EMEA/H/C/1143/WS/378, 397 (2013)4809 of 19/07/2013
19/09/2013 Centralised - Variation EMEA/H/C/1143/WS/409
07/10/2013 Centralised - Variation EMEA/H/C/1143/IAin/135/G
23/01/2014 Centralised - Variation EMEA/H/C/1143/WS/477
23/01/2014 Centralised - Variation EMEA/H/C/1143/II/WS/476