Approval · Notice of Compliance 18019 · 2016
OPDIVO: Notice of Compliance 18019
Issued April 25, 2016
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
- 18019
- Date
- April 25, 2016
- 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 (nivolumab) is indicated for the treatment of adult patients with advanced or metastatic renal cell carcinoma (rcc) who have received prior anti-angiogenic therapy