Approval · Notice of Compliance 38136 · 2026
OPDIVO SC: Notice of Compliance 38136
Issued August 19, 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
- 38136
- Date
- August 19, 2026
- 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: Microsatellite Instability-High (MSI-H) / Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer: • Opdivo SC, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer following first-line combination treatment with intravenous nivolumab and ipilimumab. Unresectable or Advanced Hepatocellular Carcinoma (HCC): • Opdivo SC as monotherapy is indicated for the treatment of adult patients with unresectable or advanced HCC following first-line combination treatment with intravenous nivolumab and ipilimumab.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPDIVO SC | Not yet assigned | — |
Medicinal ingredients
- NIVOLUMAB 120 MG per ML