Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Clopidogrel Apotex   
Auth. number : EU/1/09/568
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: Apotex Europe B.V.
Darwinweg 20, NL- 2333 CR Leiden, Nederland

  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
20/10/2009 Centralised - Authorisation EMEA/H/C/1189 (2009)8138 of 16/10/2009
30/11/2009 Centralised - Variation EMEA/H/C/1189/IA/9
16/12/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1189/T/1 (2009)10331 of 11/12/2009
21/01/2010 Centralised - Variation EMEA/H/C/1189/IB/2
Updated with Decision(2010)6905 of 30/09/2010
14/06/2010 Centralised - Variation EMEA/H/C/1189/IB/3/G
Updated with Decision(2010)6905 of 30/09/2010
09/08/2010 Centralised - Variation EMEA/H/C/1189/IB/4
Updated with Decision(2010)6905 of 30/09/2010
05/10/2010 Centralised - Variation (2010)6905 of 30/09/2010
10/11/2010 Centralised - Variation EMEA/H/C/1189/IB/6
Updated with Decision(2012)7398 of 15/10/2012
29/11/2010 Centralised - Variation EMEA/H/C/1189/II/5
05/08/2011 Centralised - Variation EMEA/H/C/1189/IB/8/G
Updated with Decision(2012)7398 of 15/10/2012
04/04/2012 Centralised - Variation EMEA/H/C/1189/IB/9/G
Updated with Decision(2012)7398 of 15/10/2012
17/05/2012 Centralised - Variation EMEA/H/C/1189/IB/7/G
Updated with Decision(2012)7398 of 15/10/2012
17/10/2012 Centralised - Variation (2012)7398 of 15/10/2012
01/03/2013 Centralised - Variation EMEA/H/C/1189/N/10
11/10/2013 Centralised - Variation EMEA/H/C/1189/IB/13/G
14/10/2013 Centralised - Variation EMEA/H/C/1189/IAin/14/G
31/10/2013 Centralised - Variation EMEA/H/C/1189/IB/15/G
03/01/2014 Centralised - Variation EMEA/H/C/1189/IB/16
29/04/2014 Centralised - Variation EMEA/H/C/1189/IB/19/G