Approval · Notice of Compliance 24623 · 2020
OPDIVO: Notice of Compliance 24623
Issued November 17, 2020
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
- 24623
- Date
- November 17, 2020
- 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, is indicated for the treatment of adult patients with metastatic nsclc, expressing pd-L1>1% as determined by a validated test, with no egfr or alk genomic tumour aberrations, and no prior systemic therapy for metastatic nsclc (see clinical trials for the treatment benefit by pd-L1 tumour expression
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPDIVO | Not yet assigned | — |