Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 24 July 2018

Indication(s)

ZYTIGA is indicated with prednisone or prednisolone for:
- the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT)
- the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
- the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

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Category Value
Agency product number EMEA/H/C/002321
Orphan designation No
Date First Approved 05-09-2011
Type Medicinal product subject to medical prescription
Marketing authorisation holder Janssen-Cilag International N.V.
Warnings This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.