Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Clopidogrel HCS   
Auth. number : EU/1/10/651
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: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:
  • 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.
  • 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: HCS bvba
H. Kennisstraat 53, B-2650 Edegem, België

  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
02/11/2010 Centralised - Authorisation EMEA/H/C/2255 (2010)7620 of 28/10/2010
08/04/2011 Centralised - Variation (no change in Commission Decision)
02/05/2011 Centralised - Variation EMEA/H/C/2255/IB/2
Updated with Decision(2011)8846 of 24/11/2011
27/07/2011 Centralised - Variation EMEA/H/C/2255/IB/4
Updated with Decision(2011)8846 of 24/11/2011
20/09/2011 Centralised - Variation EMEA/H/C/2255/IB/6
Updated with Decision(2011)8846 of 24/11/2011
29/11/2011 Centralised - Variation (2011)8846 of 24/11/2011
20/04/2012 Centralised - Variation EMEA/H/C/2255/IB/9
Updated with Decision(2012)7649 of 24/10/2012
26/10/2012 Centralised - Variation (2012)7649 of 24/10/2012
21/08/2013 Centralised - Variation EMEA/H/C/2255/IB/11/G
Updated with Decision(2014)6094 of 22/08/2014
21/10/2013 Centralised - Variation EMEA/H/C/2255/IB/12
Updated with Decision(2014)6094 of 22/08/2014
13/01/2014 Centralised - Variation EMEA/H/C/2255/IB/13
Updated with Decision(2014)6094 of 22/08/2014
24/04/2014 Centralised - Variation EMEA/H/C/2255/IB/17
Updated with Decision(2014)6094 of 22/08/2014
27/08/2014 Centralised - Yearly update (2014)6094 of 22/08/2014