Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Ablavar
Auth. number : EU/1/05/313
INN : Gadofosveset Trisodium
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V08 - Contrast media
Pharmacological subgroup: V08C - Magnetic resonance imaging contrast media
Chemical subgroup: V08CA - Paramagnetic contrast media
Chemical substance: V08CA11 - Gadofosveset
(See WHO ATC Index)
Indication: Contrast enhancement in magnetic resonance angiography (CE-MRA)
Marketing Authorisation Holder: TMC Pharma Services Ltd.
Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, 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
05/10/2005 Centralised - Authorisation EMEA/H/C/601 (2005)3748 of 03/10/2005
27/02/2006 Centralised - Variation EMEA/H/C/601/II/2
13/03/2006 Centralised - Variation EMEA/H/C/601/IA/3
24/10/2006 Centralised - Variation EMEA/H/C/601/II/5
24/10/2006 Centralised - Variation EMEA/H/C/601/II/4
16/03/2007 Centralised - Variation EMEA/H/C/601/II/6 (2007)1276 of 14/03/2007
30/03/2007 Centralised - Variation EMEA/H/C/601/IA/10
Updated with Decision(2007)2445 of 04/06/2007
03/05/2007 Centralised - Variation EMEA/H/C/601/II/7
03/05/2007 Centralised - Variation EMEA/H/C/601/II/9
06/06/2007 Centralised - Variation EMEA/H/C/601/II/8 (2007)2445 of 04/06/2007
25/10/2007 Centralised - Variation EMEA/H/C/601/II/11 (2007)5274 of 23/10/2007
28/02/2008 Centralised - Variation EMEA/H/C/601/II/13
28/02/2008 Centralised - Variation EMEA/H/C/601/II/12
09/07/2008 Centralised - Variation EMEA/H/C/601/II/14 (2008)3558 of 07/07/2008
22/06/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/601/T/16 (2009)5048 of 18/06/2009
22/03/2010 Centralised - Variation EMEA/H/C/601/IA/17
Updated with Decision(2010)7543 of 25/10/2010
14/06/2010 Referral EMEA/H/C/601/A-20/15 (2010)3877 of 10/06/2010
27/10/2010 Centralised - Renewal EMEA/H/C/601/R/18 (2010)7543 of 25/10/2010
21/01/2011 Centralised - Variation EMEA/H/C/601/IA/19
20/05/2011 Centralised - Variation EMEA/H/C/601/IB/20
19/10/2011 Centralised - Withdrawal (2011)7595 of 17/10/2011