Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Clopidogrel Mylan   
Auth. number : EU/1/09/559
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: Mylan S.A.S
117 allée des Parcs, F-69800 Saint Priest, 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
23/09/2009 Centralised - Authorisation EMEA/H/C/1134 (2009)7420 of 21/09/2009
09/11/2009 Centralised - Variation EMEA/H/C/1134/IA/3
Updated with Decision(2010)2241 of 30/03/2010
09/11/2009 Centralised - Variation EMEA/H/C/1134/IA/4
Updated with Decision(2010)2241 of 30/03/2010
09/11/2009 Centralised - Variation EMEA/H/C/1134/IA/5
Updated with Decision(2010)2241 of 30/03/2010
09/11/2009 Centralised - Variation EMEA/H/C/1134/IA/6
Updated with Decision(2010)2241 of 30/03/2010
09/11/2009 Centralised - Variation EMEA/H/C/1134/IA/7
Updated with Decision(2010)2241 of 30/03/2010
09/11/2009 Centralised - Variation EMEA/H/C/1134/IA/2
Updated with Decision(2010)2241 of 30/03/2010
09/11/2009 Centralised - Variation EMEA/H/C/1134/IA/8
Updated with Decision(2010)2241 of 30/03/2010
23/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1134/IA/9
04/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1134/II/1
04/02/2010 Centralised - Variation EMEA/H/C/1134/IB/11
Updated with Decision(2010)2241 of 30/03/2010
01/04/2010 Centralised - Variation (2010)2241 of 30/03/2010
14/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1134/IA/13
14/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1134/IB/12/G
11/08/2010 Centralised - Variation EMEA/H/C/1134/IB/14
Updated with Decision(2011)1644 of 08/03/2011
03/01/2011 Centralised - Notification EMEA/H/C/1134/N/15
Updated with Decision(2011)1644 of 08/03/2011
10/03/2011 Centralised - Variation (2011)1644 of 08/03/2011
27/04/2011 Centralised - Variation EMEA/H/C/1134/IB/16
Updated with Decision(2011)8258 of 10/11/2011
16/08/2011 Centralised - Variation EMEA/H/C/1134/IB/18
Updated with Decision(2011)8258 of 10/11/2011
15/11/2011 Centralised - Variation (2011)8258 of 10/11/2011
09/04/2013 Centralised - Variation EMEA/H/C/1134/IB/21
Updated with Decision(2014)2591 of 10/04/2014
21/05/2013 Centralised - Variation EMEA/H/C/1134/IB/22/G
Updated with Decision(2014)2591 of 10/04/2014
21/08/2013 Centralised - Variation EMEA/H/C/1134/IB/23/G
Updated with Decision(2014)2591 of 10/04/2014
14/11/2013 Centralised - Variation EMEA/H/C/1134/IB/25/G
Updated with Decision(2014)2591 of 10/04/2014
11/03/2014 Centralised - Variation EMEA/H/C/1134/IB/29/G
Updated with Decision(2014)2591 of 10/04/2014
14/04/2014 Centralised - Yearly update (2014)2591 of 10/04/2014
23/04/2014 Centralised - Variation EMEA/H/C/1134/IB/30/G
27/05/2014 Centralised - Renewal EMEA/H/C/1134/R/27 (2014)3541 of 22/05/2014