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ABIRATERONE DR.REDDY'S (Dr Reddys Laboratories Australia Pty Ltd)
Product name
ABIRATERONE DR.REDDY'S
Date registered
Evaluation commenced
Decision date
Approval time
251 (255 working days)
Active ingredients
abiraterone acetate
Registration type
New generic medicine
Indication
ABIRATERONE DR.REDDY'S is indicated with prednisone or prednisolone for the treatment of 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
- who have received prior chemotherapy containing a taxane.