EU/3/09/672

About

Pomalidomide has been authorised in the EU as Imnovid since 5 August 2013.

On 8 October 2009, orphan designation (EU/3/09/672) was granted by the European Commission to Celgene Europe Limited, United Kingdom, for pomalidomide for the treatment of multiple myeloma.

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

Key facts

Active substance
Pomalidomide
Medicine name
Imnovid
Disease / condition
Treatment of multiple myeloma
Date of first decision
08/10/2009
Outcome
Positive
EU designation number
EU/3/09/672

Review of designation

During its meeting of 11-13 June 2013, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/09/672 for Imnovid, previously Pomalidomide Celgene, (pomalidomide) as an orphan medicinal product for the treatment of multiple myeloma. The COMP assessed whether, at the time of 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 satisfactory methods of treatment. As other methods of treatment for patients with this condition 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 maintained*.


*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.

The Committee for Orphan Medicinal Products reviewed the orphan designation of Imnovid at the time of change to the terms of the marketing authorisation, and confirmed that the orphan designation should be maintained. 

More information is available in the PDF iconorphan medicine assessment report .

Sponsor's contact details

Celgene Europe B.V.
Winthontlaan 6 N
3526 KV Utrecht
Tel. +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:

  • 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;

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