Approval · Notice of Compliance 35691 · 2025
OPDIVO: Notice of Compliance 35691
Issued July 16, 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
- 35691
- Date
- July 16, 2025
- Company
- Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indication: Opdivo in combination with ipilimumab, the first-line treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPDIVO | Not yet assigned | — |
Medicinal ingredients
- NIVOLUMAB 10 MG per ML