EU/3/06/365: Orphan designation for the treatment of renal-cell carcinoma


Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in November 2017, at the end of the 10-year period of market exclusivity.

On 6 April 2006, orphan designation (EU/3/06/365) was granted by the European Commission to Wyeth Europa Limited, United Kingdom, for temsirolimus for the treatment of renal cell carcinoma.

The sponsorship was transferred to Pfizer Limited, United Kingdom, in September 2011.

Temsirolimus in treatment of renal cell carcinoma has been authorised in the EU as Torisel 19 November 2007.


Key facts

Active substance
Medicine name
Intended use
Treatment of renal-cell carcinoma
Orphan designation status
EU designation number
Date of designation
Pfizer Limited
Ramsgate Road
Kent CT13 9NJ
United Kingdom
Te. +44 (0)1304 616161
Fax: +44 (0)1304 652144

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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