Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information


EU orphan designation number: EU/3/01/070
Active ingredient: Celecoxib
Indication: Treatment of Familial Adenomatous Polyposis
Sponsor: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Onsenal on 17/10/2003 with the number EU/1/03/259

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
21/11/2001 Orphan designation EMEA/OD/011/01 (2001)3572 of 20/11/2001
28/06/2004 Change of name and/or address of sponsor
2/01/2008 Transfer of orphan designation EMEA/OD/011/01/T/01 (2007)6874 of 21/12/2007
29/03/2011 Removal of orphan designation from Community Register