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Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Clopidogrel Teva Pharma B.V.   
Auth. number : EU/1/10/649
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.
Marketing Authorisation Holder: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, 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
21/06/2011 Centralised - Authorisation EMEA/H/C/1226 (2011)4394 of 16/06/2011
15/11/2011 Centralised - Variation EMEA/H/C/1226/IB/1/G
Updated with Decision(2012)3577 of 25/05/2012
30/05/2012 Centralised - Variation (2012)3577 of 25/05/2012
22/06/2012 Centralised - Variation EMEA/H/C/1226/IB/3
Updated with Decision(2012)7988 of 31/10/2012
06/11/2012 Centralised - Variation (2012)7988 of 31/10/2012
21/05/2013 Centralised - Variation EMEA/H/C/1226/IA/4
Updated with Decision(2014)3415 of 16/05/2014
15/08/2013 Centralised - Variation EMEA/H/C/1226/IB/5
Updated with Decision(2014)3415 of 16/05/2014
10/10/2013 Centralised - Variation EMEA/H/C/1226/IB/6
Updated with Decision(2014)3415 of 16/05/2014
10/02/2014 Centralised - Variation EMEA/H/C/1226/IB/7
Updated with Decision(2014)3415 of 16/05/2014
15/05/2014 Centralised - Variation EMEA/H/C/1226/IB/9/G
20/05/2014 Centralised - Variation (2014)3415 of 16/05/2014