Data from EMA (European Medicines Agency) - Curated by Marshall Pearce - Last updated 13 September 2017

Indication(s)

Zydelig is indicated in combination with an anti-CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
- who have received at least one prior therapy, or
- as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.

Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.

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Category Value
Agency product number EMEA/H/C/003843
Orphan designation No
Date First Approved 18-09-2014
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Gilead Sciences International Ltd
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