Approval · Notice of Compliance 32436 · 2023
OPDIVO: Notice of Compliance 32436
Issued December 29, 2023
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
- 32436
- Date
- December 29, 2023
- 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: Adjuvant Treatment of Melanoma: Opdivo, as monotherapy, is indicated for the adjuvant treatment of adult patients with Stage IIB or IIC melanoma following complete resection
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPDIVO | Not yet assigned | — |
Medicinal ingredients
- NIVOLUMAB 10 MG per ML