Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Clopidogrel BGR   
Auth. number : EU/1/09/558
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
23/09/2009 Centralised - Authorisation EMEA/H/C/1138 (2009)7419 of 21/09/2009
24/11/2009 Centralised - Variation EMEA/H/C/1138/IB/1
Updated with Decision(2010)1830 of 15/03/2010
17/03/2010 Centralised - Variation (2010)1830 of 15/03/2010
30/07/2010 Centralised - Variation EMEA/H/C/1138/IB/2
Updated with Decision(2011)1217 of 21/02/2011
07/01/2011 Centralised - Variation EMEA/H/C/1138/IA/3
28/02/2011 Centralised - Variation (2011)1217 of 21/02/2011
17/06/2011 Centralised - Variation EMEA/H/C/1138/IB/4
Updated with Decision(2011)8260 of 10/11/2011
06/09/2011 Centralised - Variation EMEA/H/C/1138/IB/5/G
Updated with Decision(2011)8260 of 10/11/2011
16/11/2011 Centralised - Variation (2011)8260 of 10/11/2011
05/08/2013 Centralised - Variation EMEA/H/C/1138/IB/8/G
Updated with Decision(2014)3176 of 08/05/2014
21/10/2013 Centralised - Variation EMEA/H/C/1138/IB/9/G
Updated with Decision(2014)3176 of 08/05/2014
13/12/2013 Centralised - Variation EMEA/H/C/1138/IAIN/11
Updated with Decision(2014)3176 of 08/05/2014
19/02/2014 Centralised - Variation EMEA/H/C/1138/IB/14
Updated with Decision(2014)3176 of 08/05/2014
23/04/2014 Centralised - Variation EMEA/H/C/1138/IB/16/G
Updated with Decision(2014)6217 of 27/08/2014
13/05/2014 Centralised - Renewal EMEA/H/C/1138/R/13 (2014)3176 of 08/05/2014
14/07/2014 Centralised - Variation EMEA/H/C/1138/IAIN/19
Updated with Decision(2014)6217 of 27/08/2014