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NOVAZET (Nova Pharmaceuticals Australasia Pty Ltd)
Product name
NOVAZET
Date registered
Evaluation commenced
Decision date
Approval time
145 (255 working days)
Active ingredients
abiraterone acetate
Registration type
New generic medicine
Indication
[TRADE NAME] is indicated in combination with prednisolone for the treatment of:
- newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT), or
- patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) or
- patients with mCRPC who have received prior chemotherapy containing a taxane.