Approval · Notice of Compliance 35012 · 2025
AKEEGA: Notice of Compliance 35012
Issued March 12, 2025
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
- 35012
- Date
- March 12, 2025
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Fulfillment of commitment of the LOU dated May 29, 2023, issued under NDS control # 265223.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AKEEGA | Not yet assigned | — |
Medicinal ingredients
- ABIRATERONE ACETATE 500 MG per TAB
- NIRAPARIB TOSYLATE 100 MG per TAB
- NIRAPARIB TOSYLATE 50 MG per TAB