Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Clopidogrel BMS
Auth. number : EU/1/08/464
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 and patients suffering from acute coronary syndrome
Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

  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
18/07/2008 Centralised - Authorisation EMEA/H/C/974 (2008)3870 of 16/07/2008
11/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/974/IB/2
11/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/974/IB/1
03/11/2008 Centralised - Variation EMEA/H/C/974/IB/6
Updated with Decision(2009)1101 of 13/02/2009
03/11/2008 Centralised - Variation EMEA/H/C/974/IB/5
Updated with Decision(2009)1101 of 13/02/2009
05/11/2008 Centralised - Variation EMEA/H/C/974/IB/4
Updated with Decision(2009)1101 of 13/02/2009
22/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/974/IB/7
17/02/2009 Centralised - Variation EMEA/H/C/974/II/3 (2009)1101 of 13/02/2009
11/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/974/IB/10
11/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/974/IB/9
11/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/974/IB/11
17/08/2009 Centralised - Variation EMEA/H/C/974/II/8 (2009)6474 of 13/08/2009
21/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/974/IA/13
26/10/2009 Centralised - Notification EMEA/H/C/974/N/12
10/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/974/IB/15
16/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/974/IB/16
17/11/2009 Centralised - Withdrawal (2009)9057 of 12/11/2009