Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Valdyn (ex Kudeq)
Auth. number : EU/1/02/244
Active substance : 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: Pfizer Limited
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/437 (2003)1135 of 27/03/2003
06/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/437/IA/6
06/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/437/IA/7
22/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/437/IB/5
22/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/437/IB/4
27/04/2004 Centralised - Variation EMEA/H/C/437/II/3 (2004)1683 of 22/04/2004
26/07/2004 Centralised - Variation EMEA/H/C/437/IB/9
Updated with Decision(2005)239 of 26/01/2005
31/01/2005 Centralised - Variation EMEA/H/C/437/II/10, 11 (2005)239 of 26/01/2005
07/06/2005 Centralised - Variation EMEA/H/C/437/II/12 (2005)1746 of 03/06/2005
28/06/2005 Centralised - Withdrawal (2005)1980 of 24/06/2005