EU/3/01/070: Orphan designation for the treatment of familial adenomatous polyposis (FAP)


Table of contents


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The marketing authorisation was withdrawn on 28 March 2011.

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products by the European Commission in March 2011 at the time of withdrawal of the marketing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
Intended use
Treatment of familial adenomatous polyposis (FAP)
Orphan designation status
EU designation number
Date of designation
Pfizer Limited,
Ramsgate Road,
Kent CT13 9NJ,
United Kingdom
Tel. +44 (0)1304 616 161
Fax +44 (0)1304 652 144

Documents related to this orphan designation evaluation

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.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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