Approval · Notice of Compliance 25207 · 2021
OPDIVO: Notice of Compliance 25207
Issued February 11, 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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 25207
- Date
- February 11, 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 in combination with ipilimumab is indicated for the treatment of adult patients with microsatellite instabiloity-high (msi-H) or mismatch repair deficient (dmmr) meastatic colorectal cancer after prior fuoropyrimidine-based therapy in combination with oxaplatin or irinotecan
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPDIVO | Not yet assigned | — |
Medicinal ingredients
- NIVOLUMAB 10 MG per ML