Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Clopidogrel TAD   
Auth. number : EU/1/09/555
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: TAD Pharma GmbH
Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland

  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/1136 (2009)7471 of 23/09/2009
08/01/2010 Centralised - Variation EMEA/H/C/1136/II/1
14/01/2010 Centralised - Variation EMEA/H/C/1136/IB/2
Updated with Decision(2010)2011 of 23/03/2010
29/01/2010 Centralised - Variation EMEA/H/C/1136/N/3
Updated with Decision(2010)2011 of 23/03/2010
25/03/2010 Centralised - Variation (2010)2011 of 23/03/2010
08/06/2010 Centralised - Variation EMEA/H/C/1136/IA/6
15/06/2010 Centralised - Variation EMEA/H/C/1136/IB/5/G
14/07/2010 Centralised - Variation EMEA/H/C/1136/IA/7
06/08/2010 Centralised - Variation EMEA/H/C/1136/IB/8
Updated with Decision(2011)1498 of 28/02/2011
04/03/2011 Centralised - Variation (2011)1498 of 28/02/2011
05/05/2011 Centralised - Variation EMEA/H/C/1136/IB/9
Updated with Decision(2011)8065 of 03/11/2011
12/08/2011 Centralised - Variation EMEA/H/C/1136/IB/12
Updated with Decision(2011)8065 of 03/11/2011
12/08/2011 Centralised - Variation EMEA/H/C/1136/IB/11
Updated with Decision(2011)8065 of 03/11/2011
07/11/2011 Centralised - Variation (2011)8065 of 03/11/2011
07/03/2012 Centralised - Variation EMEA/H/C/1136/IB/14
Updated with Decision(2012)6454 of 12/09/2012
14/09/2012 Centralised - Variation (2012)6454 of 12/09/2012
20/11/2012 Centralised - Variation EMEA/H/C/1136/N/17
Updated with Decision(2014)3556 of 22/05/2014
20/08/2013 Centralised - Variation EMEA/H/C/1136/IB/18/G
Updated with Decision(2014)3556 of 22/05/2014
14/11/2013 Centralised - Variation EMEA/H/C/1136/IB/21/G
Updated with Decision(2014)3556 of 22/05/2014
20/01/2014 Centralised - Variation EMEA/H/C/1136/IB/23
Updated with Decision(2014)3556 of 22/05/2014
03/06/2014 Centralised - Renewal (2014)3556 of 22/05/2014