EU/3/04/192

About

On 8 March 2004, orphan designation (EU/3/04/192) was granted by the European Commission to Gregory Fryer Associates Limited, United Kingdom, for 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione for the treatment of myelodysplastic syndromes.

The sponsorship was transferred to Celgene Europe Limited in July 2005.

3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione in treatment of myelodysplastic syndromes has been authorised in the EU as Revlimid since 13 June 2013.

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

Key facts

Active substance
3-(4'Aminoisoindoline-1'-one)-1-piperidine-2,6-dione
Medicine name
Revlimid
Disease / condition
Treatment of myelodysplastic syndromes
Date of decision
07/03/2004
Outcome
Positive
Orphan decision number
EU/3/04/192

Review of designation

During its meeting of 14-15 May 2013, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EMA/OD/083/03 for Revlimid (lenalidomide, previously known as 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione) as an orphan medicinal product for the treatment of myelodysplastic syndromes. 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 conditions, and the existence of other satisfactory methods of treatment. As other methods of treatment for patients with myelodysplastic syndromes are authorised in the European Union (EU), the COMP also looked at the significant benefit of the product over existing treatments. The COMP recommended that the orphan designation of the medicine be maintained1.


1 The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication cannot be placed on the market.

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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