Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Grepid   
Auth. number : EU/1/09/535
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, ischaemic stroke or established peripheral arterial disease.
Marketing Authorisation Holder: Pharmathen S.A.
6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

  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/1059 (2009)6153 of 28/07/2009
28/09/2009 Centralised - Variation EMEA/H/C/1059/N/1
Updated with Decision(2010)5604 of 06/08/2010
05/10/2009 Centralised - Variation EMEA/H/C/1059/IA/2
25/11/2009 Centralised - Variation EMEA/H/C/1059/IA/10
25/11/2009 Centralised - Variation EMEA/H/C/1059/IA/9
25/11/2009 Centralised - Variation EMEA/H/C/1059/IA/8
25/11/2009 Centralised - Variation EMEA/H/C/1059/IB/3
25/11/2009 Centralised - Variation EMEA/H/C/1059/IA/12
Updated with Decision(2010)5604 of 06/08/2010
25/11/2009 Centralised - Variation EMEA/H/C/1059/IA/11
Updated with Decision(2010)5604 of 06/08/2010
25/11/2009 Centralised - Variation EMEA/H/C/1059/IA/7
27/11/2009 Centralised - Variation EMEA/H/C/1059/IB/4
Updated with Decision(2010)5604 of 06/08/2010
27/11/2009 Centralised - Variation EMEA/H/C/1059/IB/5
Updated with Decision(2010)5604 of 06/08/2010
22/01/2010 Centralised - Variation EMEA/H/C/1059/N/6
Updated with Decision(2010)5604 of 06/08/2010
30/07/2010 Centralised - Variation EMEA/H/C/1059/IB/13
Updated with Decision(2011)2101 of 24/03/2011
10/08/2010 Centralised - Variation (2010)5604 of 06/08/2010
08/12/2010 Centralised - Variation EMEA/H/C/1059/II/14
29/03/2011 Centralised - Variation (2011)2101 of 24/03/2011
08/04/2011 Centralised - Variation EMEA/H/C/1059/IB/15
Updated with Decision(2011)8690 of 22/11/2011
12/08/2011 Centralised - Variation EMEA/H/C/1059/IB/17/G
Updated with Decision(2011)8690 of 22/11/2011
24/11/2011 Centralised - Variation (2011)8690 of 22/11/2011
10/01/2012 Centralised - Variation EMEA/H/C/1059/IB/19
Updated with Decision(2012)5479 of 26/07/2012
23/03/2012 Centralised - Variation EMEA/H/C/1059/N/20
Updated with Decision(2012)5479 of 26/07/2012
30/07/2012 Centralised - Variation (2012)5479 of 26/07/2012
16/11/2012 Centralised - Variation EMEA/H/C/1059/N/22
Updated with Decision(2014)2644 of 11/04/2014
08/02/2013 Centralised - Variation EMEA/H/C/1059/N/24
Updated with Decision(2014)2644 of 11/04/2014
16/05/2013 Centralised - Variation EMEA/H/C/1059/N/25
Updated with Decision(2014)2644 of 11/04/2014
05/08/2013 Centralised - Variation EMEA/H/C/1059/IB/27/G
Updated with Decision(2014)2644 of 11/04/2014
10/10/2013 Centralised - Variation EMEA/H/C/1059/IB/28/G
Updated with Decision(2014)2644 of 11/04/2014
09/01/2014 Centralised - Variation EMEA/H/C/1059/IB/30
Updated with Decision(2014)2644 of 11/04/2014
15/04/2014 Centralised - Renewal EMEA/H/C/1059/R/29 (2014)2644 of 11/04/2014