Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 12 April 2018

Indication(s)

Xtandi is indicated for:
• the treatment of adult men with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated,
• the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.

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More information

Category Value
Agency product number EMEA/H/C/002639
Orphan designation No
Date First Approved 21-06-2013
Type Medicinal product subject to medical prescription
Marketing authorisation holder Astellas Pharma Europe B.V.
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