Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Trudexa
Auth. number : EU/1/03/257
INN : Adalimumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AB - Tumor necrosis factor alpha (TNF-a) inhibitors
Chemical substance: L04AB04 - Adalimumab
(See WHO ATC Index)
Indication: Treatment of moderate to severe, active rheumatoid arthritis in adult patients
Marketing Authorisation Holder: Abbott Laboratories Ltd
Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, 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
03/09/2003 Centralised - Authorisation EMEA/H/C/482 (2003)3199 of 01/09/2003
05/01/2004 Centralised - Variation EMEA/H/C/482/II/3
03/03/2004 Centralised - Variation EMEA/H/C/482/II/7
10/05/2004 Centralised - Variation EMEA/H/C/482/N/9
Updated with Decision(2004)2116 of 10/06/2004
14/06/2004 Centralised - Variation EMEA/H/C/482/II/6 (2004)2116 of 10/06/2004
21/07/2004 Centralised - Variation EMEA/H/C/482/II/10 (2004)2880 of 19/07/2004
04/08/2004 Centralised - Variation EMEA/H/C/482/II/12
04/08/2004 Centralised - Variation EMEA/H/C/482/II/11
22/09/2004 Centralised - Variation EMEA/H/C/482/II/8
07/10/2004 Centralised - Variation EMEA/H/C/482/IA/15
24/11/2004 Centralised - Variation EMEA/H/C/482/II/13
24/11/2004 Centralised - Variation EMEA/H/C/482/II/14
21/12/2004 Centralised - Variation EMEA/H/C/482/II/16
27/01/2005 Centralised - Variation EMEA/H/C/482/II/19 (2005)205 of 25/01/2005
24/02/2005 Centralised - Variation EMEA/H/C/482/II/17
24/02/2005 Centralised - Variation EMEA/H/C/482/II/18
25/04/2005 Centralised - Variation EMEA/H/C/482/II/20
27/04/2005 Centralised - Variation EMEA/H/C/482/II/23 (2005)1348 of 25/04/2005
03/08/2005 Centralised - Variation EMEA/H/C/482/II/21, 22 (2005)3046 of 01/08/2005
30/01/2006 Centralised - Variation EMEA/H/C/482/II/25
01/02/2006 Centralised - Variation EMEA/H/C/482/II/24 (2006)292 of 30/01/2006
22/03/2006 Centralised - Variation EMEA/H/C/482/IA/29
Updated with Decision(2006)2223 of 31/05/2006
02/06/2006 Centralised - Variation EMEA/H/C/482/II/26 (2006)2223 of 31/05/2006
07/06/2006 Centralised - Variation EMEA/H/C/482/II/28
03/08/2006 Centralised - Variation EMEA/H/C/482/II/31
03/08/2006 Centralised - Variation EMEA/H/C/482/II/32
09/11/2006 Centralised - Variation EMEA/H/C/482/II/30, 30 (2006)5423 of 07/11/2006
07/03/2007 Centralised - Variation EMEA/H/C/482/II/34, 35 (2007)822 of 05/03/2007
16/05/2007 Centralised - Variation EMEA/H/C/482/II/36 (2007)2147 of 14/05/2007
06/06/2007 Centralised - Variation EMEA/H/C/482/II/33 (2007)2449 of 04/06/2007
05/07/2007 Centralised - Variation EMEA/H/C/482/II/37 (2007)3290 of 29/06/2007
11/07/2007 Centralised - Withdrawal (2007)3422 of 09/07/2007