Approval · Notice of Compliance 36662 · 2025
RYBELSUS: Notice of Compliance 36662
Issued December 31, 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
- 36662
- Date
- December 31, 2025
- Company
- Novo Nordisk Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication : To reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or are at high risk for these events.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RYBELSUS | Not yet assigned | — |
Medicinal ingredients
- SEMAGLUTIDE 3 MG per TAB
- SEMAGLUTIDE 7 MG per TAB
- SEMAGLUTIDE 14 MG per TAB
- SEMAGLUTIDE 1.5 MG per TAB
- SEMAGLUTIDE 4 MG per TAB
- SEMAGLUTIDE 9 MG per TAB