This medicine is authorised for use in the European Union.


An overview of Darzalex and why it is authorised in the EU

Darzalex is a cancer medicine used to treat adults with multiple myeloma (a cancer of the bone marrow). It is used:

  • in combination with the medicines bortezomib, melphalan and prednisone in patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (a transplant of the patient's own blood-producing cells). Bortezomib and melphalan are used for treating multiple myeloma and prednisone suppresses the immune system;
  • on its own when the disease has come back after treatment with cancer medicines (including medicines known as proteasome inhibitors) and immunomodulatory medicines (that act on the immune system), or when the disease has not improved with these medicines;
  • in combination with dexamethasone (a medicine that suppresses the immune system) plus either lenalidomide or bortezomib in patients who have previously received other treatment for the disease. Lenalidomide and bortezomib are medicines used for treating multiple myeloma.

Multiple myeloma is rare and Darzalex was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 17 July 2013.

Darzalex contains the active substance daratumumab.

This EPAR was last updated on 02/10/2018

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Janssen-Cilag International N.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Turnhoutseweg 30
2340 Beerse

Product information

30/08/2018 Darzalex - EMEA/H/C/004077 - II/0011


  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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Pharmacotherapeutic group

  • Antineoplastic agents

  • Monoclonal antibodies

Therapeutic indication

Darzalex is indicated:

  • as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
  • in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone,for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Assessment history

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