EU/3/03/177: Orphan designation for the treatment of multiple myeloma

3-(4'Aminoisoindoline-1'-one)-1-piperidine-2,6-dione (lenalidomide)

Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in June 2017 at the end of the period of market exclusivity.

On 12 December 2003, orphan designation (EU/3/03/177) was granted by the European Commission to Gregory Fryer Associates Ltd, United Kingdom, for 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione for the treatment of multiple myeloma. The sponsorship was transferred to Celgene Europe Limited in July 2005.

3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione in treatment of multiple myeloma has been authorised in the EU as Revlimid since 14 June 2007.

This medicine is now known as lenalidomide.

Key facts

Active substance
3-(4'Aminoisoindoline-1'-one)-1-piperidine-2,6-dione (lenalidomide)
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
Telephone: +44 208 831 83 00
Telefax: +44 208 831 83 01

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:

How useful was this page?

Add your rating
2 ratings