EU/3/12/1037

About

Please note that this product (marketed as Empliciti) was withdrawn from the Community Register of designated Orphan Medicinal Products by the European Commission in April 2016, at the time of the granting of a marketing authorisation.

On 9 August 2012, orphan designation (EU/3/12/1037) was granted by the European Commission to Bristol-Myers Squibb Pharma EEIG, United Kingdom, for elotuzumab for the treatment of multiple myeloma.

Key facts

Active substance
Elotuzumab
Disease / condition
Treatment of multiple myeloma
Date of first decision
09/08/2012
Outcome
Withdrawn
EU designation number
EU/3/12/1037

Review of designation

On 8 April 2016, the Committee for Orphan Medicinal Products (COMP) completed its review of the designation EU/3/12/1037 of Empliciti (elotuzumab) 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 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 multiple myeloma. The COMP concluded that one of the criteria for orphan designation was no longer met and therefore recommended that the orphan designation of the product should not be maintained1.


1The removal of the orphan designation at time of marketing authorisation means that the product cannot benefit from 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with the same therapeutic indication can be placed on the market.

Sponsor's contact details

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom
Telephone: +44 18 95 52 37 40
Telefax: +44 18 95 52 36 77
E-mail: medical.information@bms.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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