Approval · Notice of Compliance 24006 · 2020
OPDIVO: Notice of Compliance 24006
Issued August 6, 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
- 24006
- Date
- August 6, 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 and 2 cycles of platinum-doublet chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no EGFR or ALK genomic tumor aberrations, and no prior systemic therapy for metastatic NSCLC.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPDIVO | Not yet assigned | — |
Medicinal ingredients
- NIVOLUMAB 10 MG per ML