Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Clopidogrel Krka   
Auth. number : EU/1/09/556
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.
Marketing Authorisation Holder: Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija

  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
25/09/2009 Centralised - Authorisation EMEA/H/C/1056 (2009)7469 of 23/09/2009
21/10/2009 Centralised - Variation EMEA/H/C/1056/IA/2
13/11/2009 Centralised - Variation EMEA/H/C/1056/IA/3
Updated with Decision(2010)2009 of 23/03/2010
16/11/2009 Centralised - Variation EMEA/H/C/1056/IB/4
Updated with Decision(2010)2009 of 23/03/2010
08/01/2010 Centralised - Variation EMEA/H/C/1056/II/1
14/01/2010 Centralised - Variation EMEA/H/C/1056/IB/5
Updated with Decision(2010)2009 of 23/03/2010
25/03/2010 Centralised - Variation (2010)2009 of 23/03/2010
26/03/2010 Centralised - Variation EMEA/H/C/1056/N/6
Updated with Decision(2011)982 of 11/02/2011
06/05/2010 Centralised - Variation EMEA/H/C/1056/IAin/8
28/05/2010 Centralised - Variation EMEA/H/C/1056/IB/7/G
26/07/2010 Centralised - Variation EMEA/H/C/1056/IB/9
Updated with Decision(2011)982 of 11/02/2011
15/02/2011 Centralised - Variation (2011)982 of 11/02/2011
19/04/2011 Centralised - Variation EMEA/H/C/1056/IB/10
Updated with Decision(2011)8064 of 03/11/2011
13/05/2011 Centralised - Variation EMEA/H/C/1056/IB/11
Updated with Decision(2011)8064 of 03/11/2011
07/11/2011 Centralised - Variation (2011)8064 of 03/11/2011
07/03/2012 Centralised - Variation EMEA/H/C/1056/IB/14
Updated with Decision(2012)6453 of 12/09/2012
14/09/2012 Centralised - Variation (2012)6453 of 12/09/2012
09/10/2013 Centralised - Variation EMEA/H/C/1056/IB/19/G
Updated with Decision(2014)3363 of 14/05/2014
28/10/2013 Centralised - Variation EMEA/H/C/1056/IB/21/G
Updated with Decision(2014)3363 of 14/05/2014
20/01/2014 Centralised - Variation EMEA/H/C/1056/IB/23
Updated with Decision(2014)3363 of 14/05/2014
16/04/2014 Centralised - Variation EMEA/H/C/1056/IB/25
16/05/2014 Centralised - Renewal EMEA/H/C/1056/R/22 (2014)3363 of 14/05/2014