Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 02 August 2018

Indication(s)

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.

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/004077
Orphan designation Yes
Date First Approved 20-05-2016
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Janssen-Cilag International N.V.