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CIP ABIRATERONE (Cipla Australia Pty Ltd)
Product name
CIP ABIRATERONE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
112 (255 working days)
Active ingredients
abiraterone acetate
Registration type
New generic medicine
Indication
[Trade name] is indicated in combination with prednisone or prednisolone for the treatment of:
- newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mHSPC) incombination with androgen deprivation therapy (ADT), or
- patients with metastatic advanced prostate cancer (castration resistant prostatecancer, mCRPC) who are asymptomatic or mildly symptomatic after failure ofandrogen deprivation therapy (ADT) or
- patients with mCRPC who have received prior chemotherapy containing a taxane.