ZYTIGA (Janssen-Cilag Pty Ltd)
Product name
ZYTIGA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
155 working days (255)
Active ingredients
abiraterone acetate
Registration type
EOI
Indication
ZYTIGA (tablets) is now also indicated for the treatment of newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).