Approval · Notice of Compliance 28663 · 2022
OPDIVO: Notice of Compliance 28663
Issued July 25, 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
- 28663
- Date
- July 25, 2022
- 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 (nivolumab) is indicated for: Unresectable or Metastatic Esophageal Squamous Cell Carcinoma (ESCC): OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable or metastatic ESCC, with tumour cell PD-L1 expression ¿ 1% as determined by a validated test, and no prior systemic therapy for metastatic ESCC. OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with unresectable or metastatic ESCC, with tumour cell PD-L1 ¿ 1% as determined by a validated test, and no prior systemic therapy for metastatic ESCC.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPDIVO | Not yet assigned | — |