Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Clopidogrel Krka d.d.   
Auth. number : EU/1/09/562
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: Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija

  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/1137 (2009)7418 of 21/09/2009
14/01/2010 Centralised - Variation EMEA/H/C/1137/IB/1
Updated with Decision(2010)1654 of 11/03/2010
15/03/2010 Centralised - Variation (2010)1654 of 11/03/2010
09/08/2010 Centralised - Variation EMEA/H/C/1137/IB/2
Updated with Decision(2011)2105 of 24/03/2011
28/10/2010 Centralised - Variation EMEA/H/C/1137/IB/8/G
Updated with Decision(2012)2030 of 21/03/2012
29/03/2011 Centralised - Variation (2011)2105 of 24/03/2011
19/04/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1137/T/3 (2011)2800 of 14/04/2011
05/05/2011 Centralised - Variation (refusal) EMEA/H/C/1137/IA/6
20/05/2011 Centralised - Variation EMEA/H/C/1137/IA/7
Updated with Decision(2012)2030 of 21/03/2012
20/05/2011 Centralised - Variation EMEA/H/C/1137/IB/4/G
Updated with Decision(2012)2030 of 21/03/2012
07/12/2011 Centralised - Variation EMEA/H/C/1137/IB/9
Updated with Decision(2012)2030 of 21/03/2012
06/03/2012 Centralised - Variation EMEA/H/C/1137/IB/10
Updated with Decision(2012)6455 of 12/09/2012
26/03/2012 Centralised - Variation (2012)2030 of 21/03/2012
14/09/2012 Centralised - Variation (2012)6455 of 12/09/2012
23/09/2013 Centralised - Variation EMEA/H/C/1137/IB/15/G
Updated with Decision(2014)3819 of 03/06/2014
28/10/2013 Centralised - Variation EMEA/H/C/1137/IB/17/G
Updated with Decision(2014)3819 of 03/06/2014
20/01/2014 Centralised - Variation EMEA/H/C/137/IB/19
Updated with Decision(2014)3819 of 03/06/2014
24/04/2014 Centralised - Variation EMEA/H/C/1137/IB/21
05/06/2014 Centralised - Renewal EMEA/H/C/1137/R/18 (2014)3819 of 03/06/2014