Approval · Notice of Compliance 28801 · 2022
OPDIVO: Notice of Compliance 28801
Issued August 18, 2022
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
- 28801
- Date
- August 18, 2022
- Company
- Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New Indication Opdivo, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable NSCLC (tumors ¿4 cm or node positive).
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPDIVO | Not yet assigned | — |