Approval · Notice of Compliance 36428 · 2025
NUBEQA: Notice of Compliance 36428
Issued November 25, 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
- 36428
- Date
- November 25, 2025
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a manufacturing site and/or manufacturer involving production of the intermediate.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| NUBEQA | Not yet assigned | — |
Medicinal ingredients
- DAROLUTAMIDE 300 MG per TAB