On 20 November 2001, orphan designation (EU/3/01/070) was granted by the European Commission to Pharmacia-Pfizer EEIG, United Kingdom, for celecoxib for the treatment of familial adenomatous polyposis (FAP).
The sponsorship was transferred to Pfizer Limited, United Kingdom, in December 2007.
Celecoxib was authorised in the EU as Onsenal on 17 October 2003.
The marketing authorisation was withdrawn on 28 March 2011.
Please note that this product was withdrawn from the Community Register of designated orphan medicinal products by the European Commission in March 2011 at the time of withdrawal of the marketing authorisation.
|Disease / condition||
Treatment of familial adenomatous polyposis (FAP)
|Date of decision||
|Orphan decision number||
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;