EU/3/13/1153

About

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
Daratumumab
Medicine name
Darzalex
Date of first decision
17/07/2013
Outcome
Positive
EU designation number
EU/3/13/1153

Review of designation

Sponsor's contact details

Janssen-Cilag International N.V.
Turnhoutseweg, 30
2340 Beerse
Belgium
Tel. +32 146 031 89
Fax +32 146 055 33
E-mail: http://www.janssen-emea.com/contactus

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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