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(Actor Pharmaceuticals Pty Ltd)

Sponsor
Actor Pharmaceuticals Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
151 (255 working days)
Active ingredients
abiraterone acetate, prednisolone
Registration type
New combination
Indication

ANDRIGA-5 is indicated for the treatment of:

  • newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).

ANDRIGA-10 is indicated 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
  • patients with mCRPC who have received prior chemotherapy containing a taxane