Approval · Notice of Compliance 30386 · 2023
OPDIVO: Notice of Compliance 30386
Issued March 22, 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
- 30386
- Date
- March 22, 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
- Remove the following indication from the product monograph: OPDIVO is indicated as a monotherapy for the treatment of adult patients with advanced (not amenable to curative therapy or local therapeutic measures) or metastatic hepatocellular carcinoma (HCC) who are intolerant to or have progressed on sorafenib therapy.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPDIVO | Not yet assigned | — |