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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The marketing authorisation was withdrawn on 28 March 2011.

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products by the European Commission in March 2011 at the time of withdrawal of the marketing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.

Key facts

Active substance
Medicine name
Disease / condition
Treatment of familial adenomatous polyposis (FAP)
Date of first decision
EU designation number

Sponsor's contact details

Pfizer Limited,
Ramsgate Road,
Kent CT13 9NJ,
United Kingdom
Tel. +44 (0)1304 616 161
Fax +44 (0)1304 652 144

Patients' organisations

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.

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