Approval · Notice of Compliance 37769 · 2026
AKEEGA: Notice of Compliance 37769
Issued June 23, 2026
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 37769
- Date
- June 23, 2026
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph with new safety and efficacy information / Addition of new indication: AKEEGA® (niraparib and abiraterone acetate) is indicated with prednisone or prednisolone for: The treatment of adult patients with deleterious or suspected deleterious BRCA mutated (germline and/or somatic) metastatic castration-sensitive prostate cancer (mCSPC). Patients must have confirmation of BRCA mutation before AKEEGA treatment is initiated / Product Monograph reformatted to the Master Template
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AKEEGA | Not yet assigned | — |
Medicinal ingredients
- ABIRATERONE ACETATE 500 MG per TAB
- NIRAPARIB TOSYLATE 50 MG per TAB
- NIRAPARIB TOSYLATE 100 MG per TAB