EU/3/01/066: Orphan designation for the treatment of erythema nodosum leprosum (ENL) or type II lepra reactions


Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in November 2010 on request of the sponsor.

On 20 November 2001, orphan designation (EU/3/01/066) was granted by the European Commission to Pharmion Ltd., United Kingdom, for thalidomide for the treatment of erythema nodosum lepra or type II lepra reactions.

The sponsorship was transferred to Celgene Europe Limited, United Kingdom, in December 2008.

Key facts

Active substance
Intended use
Treatment of erythema nodosum leprosum (ENL) or type II lepra reactions
Orphan designation status
EU designation number
Date of designation
Celgene Europe Limited
Riverside House
Riverside Walk
Windsor SL4 1NA
United Kingdom
Telephone: +44 17 53 24 06 00
Telefax: +44 17 53 24 06 56

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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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