Approval · Notice of Compliance 21059 · 2018
OPDIVO: Notice of Compliance 21059
Issued July 6, 2018
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
- 21059
- Date
- July 6, 2018
- 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: metastatic renal cell carcinoma. opdivo, in combination with ipilmumab is indicated for the treatment of adult patiaents with intermediate / poor-risk advancecd or metastatic rcc
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPDIVO | Not yet assigned | — |
Medicinal ingredients
- NIVOLUMAB 10 MG per ML