ABIRATERONE-TEVA (Teva Pharma Australia Pty Ltd)
Product name
ABIRATERONE-TEVA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
138 (255 working days
Active ingredients
Abiraterone acetate
Registration type
New generic medicine
Indication
ABIRATERONE-TEVA 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
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine