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Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Clopidogrel ratiopharm GmbH   
Auth. number : EU/1/09/541
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: Archie Samuel s.r.o.
Slunná 16, CZ-61700 Brno, Česká republika

  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
31/07/2009 Centralised - Authorisation EMEA/H/C/1165 (2009)6150 of 28/07/2009
26/08/2009 Centralised - Variation EMEA/H/C/1165/IA/2
Updated with Decision(2010)1950 of 19/03/2010
01/09/2009 Centralised - Variation EMEA/H/C/1165/IB/3
Updated with Decision(2010)1950 of 19/03/2010
11/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1165/IA/4
18/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1165/IA/5
16/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1165/IA/6
09/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1165/II/8
09/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1165/II/7
23/03/2010 Centralised - Variation (2010)1950 of 19/03/2010
30/03/2010 Referral EMEA/H/C/1165/A-20/9 (2010)2218 of 29/03/2010
06/08/2010 Centralised - Variation EMEA/H/C/1165/IB/10
Updated with Decision(2012)406 of 20/01/2012
20/09/2010 Referral EMEA/H/C/1165/A-20/9 (2010)6430 of 16/09/2010
26/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1165/WS/53
19/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1165/WS/52
03/02/2011 Centralised - Notification EMEA/H/C/1165/N/11
Updated with Decision(2012)406 of 20/01/2012
12/05/2011 Centralised - Variation EMEA/H/C/1165/IB/12
Updated with Decision(2012)406 of 20/01/2012
26/07/2011 Centralised - Variation EMEA/H/C/1165/IB/14
Updated with Decision(2012)406 of 20/01/2012
24/01/2012 Centralised - Variation (2012)406 of 20/01/2012
19/09/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1165/T/18 (2012)6526 of 17/09/2012
03/12/2012 Centralised - Notification EMEA/H/C/1165/N/19
Updated with Decision(2014)3555 of 22/05/2014
30/07/2013 Centralised - Variation EMEA/H/C/1165/IB/21/G
Updated with Decision(2014)3555 of 22/05/2014
14/11/2013 Centralised - Variation EMEA/H/C/1165/IB/22/G
Updated with Decision(2014)3555 of 22/05/2014
09/01/2014 Centralised - Variation EMEA/H/C/1165/IB/28
Updated with Decision(2014)3555 of 22/05/2014
23/01/2014 Centralised - Variation EMEA/H/C/1165/II/23/G
Updated with Decision(2014)3555 of 22/05/2014
27/05/2014 Centralised - Renewal EMEA/H/C/1165/R/27 (2014)3555 of 22/05/2014
29/05/2014 Centralised - Variation EMEA/H/C/1165/IB/30