EU/3/13/1153: Orphan designation for the treatment of plasma-cell myeloma



On 17 July 2013, orphan designation (EU/3/13/1153) was granted by the European Commission to Janssen-Cilag International N.V., Belgium, for daratumumab for the treatment of plasma-cell myeloma.

Update: daratumumab has been authorised in the EU as Darzalex since 20 May 2016.

More information on Darzalex can be found in the European public assessment report (EPAR) on the Agency's website.

Key facts

Active substance
Medicine name
Intended use
Treatment of plasma-cell myeloma
Orphan designation status
EU designation number
Date of designation

Janssen-Cilag International N.V.
Turnhoutseweg, 30
2340 Beerse
Tel. +32 146 031 89
Fax +32 146 055 33

Review of designation

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

More information is available in the PDF icon orphan medicine assessment report

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Darzalex (daratumumab) for the treatment of plasma cell myeloma (PDF/79.76 KB)


    First published: 08/06/2016
    Last updated: 08/06/2016

  • 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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