EU/3/12/1097: Orphan designation for the treatment of follicular lymphoma



On 24 January 2013, orphan designation (EU/3/12/1097) was granted by the European Commission to Celgene Europe Limited, United Kingdom, for lenalidomide for the treatment of follicular lymphoma.

The sponsorship was transferred to Celgene Europe B.V., The Netherlands, in July 2018.

Please note that this product (marketed as Revlimid) was withdrawn from the Community Register of designated orphan medicinal products in December 2019 upon request of the marketing authorisation holder at the time of the granting of a change to the terms of the marketing authorisation.

Key facts

Active substance
Intended use
Treatment of follicular lymphoma
Orphan designation status
EU designation number
Date of designation
Celgene Europe B.V.
Winthontlaan 6 N
3526 KV Utrecht
Tel. +31 (0)30 284 4547

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Revlimid at the time of a change to the terms of the marketing authorisation

The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the PDF icon withdrawal assessment report – orphan maintenance  

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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