EU/3/11/924

About

On 27 October 2011, orphan designation (EU/3/11/924) was granted by the European Commission to Celgene Europe Limited, United Kingdom, for lenalidomide for the treatment of mantle cell lymphoma.

Update: lenalidomide for treatment of mantle cell lymphoma has been authorised in the EU as Revlimid since 8 July 2016.

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

Key facts

Active substance
lenalidomide
Medicine name
Revlimid
Disease / condition
Treatment of mantle cell lymphoma
Date of decision
27/10/2011
Outcome
Positive
Orphan decision number
EU/3/11/924

Review of designation

During its meeting of 14-16 June 2016, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/11/924 for Revlimid (lenalidomide) as an orphan medicinal product for the treatment of mantle cell lymphoma. The COMP assessed whether, at the time of addition of a new indication to the marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with mantle cell lymphoma. The COMP recommended that the orphan designation of the medicine be maintained.

Sponsor's contact details

Celgene Europe B.V.
Winthontlaan 6 N
3526 KV Utrecht
Telephone: +31 (0)30 284 4547
E-mail: medinfo.intl@celgene.com

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.

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