Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 31 August 2018

Indication(s)

IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

IMBRUVICA as a single agent is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.

IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

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More information

Category Value
Agency product number EMEA/H/C/003791
Orphan designation Yes
Date First Approved 21-10-2014
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Janssen-Cilag International NV
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions