EU/3/06/420: Orphan designation for the treatment of mantle cell lymphoma


Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in August 2019 at the end of the 10-year period of market exclusivity.

On 6 November 2006, orphan designation (EU/3/06/420) was granted by the European Commission to Wyeth Europa Limited, United Kingdom, for temsirolimus for the treatment of mantle cell lymphoma.

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

Temsirolimus in treatment of mantle cell lymphoma has been authorised in the EU as Torisel 21 August 2009.

The sponsorship was transferred to Pfizer Europe MA EEIG, Belgium, in July 2018.

Key facts

Active substance
Medicine name
Intended use
Treatment of mantle cell lymphoma
Orphan designation status
EU designation number
Date of designation

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Brussels-Capital Region

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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