Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Clopidogrel Zentiva   
Auth. number : EU/1/08/465
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:
  • Adult 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.

  • Adult patients suffering from acute coronary syndrome:
    • 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, in combination with acetylsalicylic acid (ASA).

    • ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.

Prevention of atherothrombotic and thromboembolic events in atrial fibrillation
In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
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
18/07/2008 Centralised - Authorisation EMEA/H/C/975 (2008)3869 of 16/07/2008
11/08/2008 Centralised - Variation EMEA/H/C/975/IB/1
11/08/2008 Centralised - Variation EMEA/H/C/975/IB/2
04/11/2008 Centralised - Variation EMEA/H/C/975/IB/6
Updated with Decision(2009)1103 of 13/02/2009
04/11/2008 Centralised - Variation EMEA/H/C/975/IB/5
Updated with Decision(2009)1103 of 13/02/2009
05/11/2008 Centralised - Variation EMEA/H/C/975/IB/4
Updated with Decision(2009)1103 of 13/02/2009
14/01/2009 Centralised - Variation EMEA/H/C/975/IB/16
22/01/2009 Centralised - Variation EMEA/H/C/975/IB/7
17/02/2009 Centralised - Variation EMEA/H/C/975/II/3 (2009)1103 of 13/02/2009
11/08/2009 Centralised - Variation EMEA/H/C/975/IB/9
11/08/2009 Centralised - Variation EMEA/H/C/975/IB/10
11/08/2009 Centralised - Variation EMEA/H/C/975/IB/11
17/08/2009 Centralised - Variation EMEA/H/C/975/II/8 (2009)6475 of 13/08/2009
21/10/2009 Centralised - Variation EMEA/H/C/975/IA/12
10/11/2009 Centralised - Variation EMEA/H/C/975/IB/14
16/11/2009 Centralised - Variation EMEA/H/C/975/IB/15
14/12/2009 Centralised - Variation EMEA/H/C/975/IA/19
Updated with Decision(2010)711 of 29/01/2010
21/12/2009 Centralised - Variation EMEA/H/C/975/IB/13
02/02/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/975/T/18 (2010)711 of 29/01/2010
03/05/2010 Centralised - Variation EMEA/H/C/975/II/20 (2010)2945 of 29/04/2010
25/05/2010 Centralised - Variation EMEA/H/C/975/IA/21
27/05/2010 Centralised - Variation EMEA/H/C/975/IA/4/G
Updated with Decision(2010)6248 of 06/09/2010
09/09/2010 Centralised - Variation (2010)6248 of 06/09/2010
16/09/2010 Centralised - Variation EMEA/H/C/975/IB/24
16/09/2010 Centralised - Variation EMEA/H/C/975/IB/23
17/01/2011 Centralised - Variation EMEA/H/C/975/II/17, 22 (2011)191 of 13/01/2011
09/06/2011 Centralised - Variation EMEA/H/C/975/II/25 (2011)4166 of 07/06/2011
24/08/2011 Centralised - Variation EMEA/H/C/975/IA/26
Updated with Decision(2011)8243 of 10/11/2011
15/11/2011 Centralised - Variation (2011)8243 of 10/11/2011
02/03/2012 Centralised - Variation EMEA/H/C/975/IA/31/G
Updated with Decision(2012)3615 of 25/05/2012
04/06/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/975/T/33 (2012)3615 of 25/05/2012
19/12/2012 Centralised - Renewal EMEA/H/C/975/R/34 (2012)9815 of 17/12/2012
03/06/2013 Centralised - Variation EMEA/H/C/975/WS/365, 366 (2013)3869 of 30/05/2013
23/07/2013 Centralised - Variation EMEA/H/C/975/WS/378, 397 (2013)4808 of 19/07/2013
19/09/2013 Centralised - Variation EMEA/H/C/975/WS/409
23/01/2014 Centralised - Variation EMEA/H/C/975/WS/476
23/01/2014 Centralised - Variation EMEA/H/C/975/WS/477