EU/3/01/067: Orphan designation for the treatment of multiple myeloma


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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in April 2018 at the end of the 10-year period of market exclusivity.

On 20 November 2001, orphan designation (EU/3/01/067) was granted by the European Commission to Pharmion Ltd, United Kingdom, for thalidomide for the treatment of multiple myeloma.

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

Thalidomide has been authorised in the EU as Thalidomide Celgene since 16 April 2008.

Key facts

Active substance
Medicine name
Thalidomide Celgene
Intended use
Treatment of multiple myeloma
Orphan designation status
EU designation number
Date of designation
Celgene Europe Limited
1 Longwalk Road
Stockley Park
Middlesex UB11 1DB
United Kingdom
Tel. +44 (0)20 8831 8300
Fax +44 (0)20 8831 8301

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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