Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Bextra
Auth. number : EU/1/02/239
INN : Valdecoxib
ATC: Anatomical main group: M - Musculo-skeletal system
Therapeutic subgroup: M01 - Antiinflammatory and antirheumatic products
Pharmacological subgroup: M01A - Antiinflammatory and antirheumatic products, non-steroids
Chemical subgroup: M01AH - Coxibs
Chemical substance: M01AH03 - Valdecoxib
(See WHO ATC Index)
Indication: Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.
Treatment of primary dysmenorrhoea
Marketing Authorisation Holder: Pharmacia Europe EEIG
Ramsgate Road, Sandwich, Kent CT13 9NJ, 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
31/03/2003 Centralised - Authorisation EMEA/H/C/431 (2003)1134 of 27/03/2003
09/02/2004 Centralised - Variation EMEA/H/C/431/N/2 (2004)234 of 27/01/2004
05/04/2004 Centralised - Variation EMEA/H/C/431/IA/7
05/04/2004 Centralised - Variation EMEA/H/C/431/IA/6
20/04/2004 Centralised - Variation EMEA/H/C/431/IA/9
Updated with Decision(2004)4625 of 25/11/2004
22/04/2004 Centralised - Variation EMEA/H/C/431/IB/4
22/04/2004 Centralised - Variation EMEA/H/C/431/IB/5
04/05/2004 Centralised - Variation EMEA/H/C/431/II/3 (2004)1684 of 22/04/2004
04/08/2004 Centralised - Variation EMEA/H/C/431/IB/10
Updated with Decision(2004)4625 of 25/11/2004
29/11/2004 Centralised - Variation (2004)4625 of 25/11/2004
01/02/2005 Centralised - Variation EMEA/H/C/431/II/11, 12 (2005)232 of 26/01/2005
14/06/2005 Centralised - Variation EMEA/H/C/431/II/14 (2005)1806 of 10/06/2005
19/10/2005 Referral EMEA/H/C/431/A-18/633 (2005)4088 of 13/10/2005
31/03/2008 Centralised - Withdrawal