Approval · Notice of Compliance 26237 · 2021
OPDIVO: Notice of Compliance 26237
Issued July 2, 2021
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
- 26237
- Date
- July 2, 2021
- 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 is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer in patients who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPDIVO | Not yet assigned | — |