Approval · Notice of Compliance 18599 · 2016
OPDIVO: Notice of Compliance 18599
Issued October 26, 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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 18599
- Date
- October 26, 2016
- 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 indications: opdivo is indicated for the treatment of unresectable or metastatic braf V600 mutation-positive melanoma in previously untreated adults. an improvement in survival has not yet been established. opdivo in combination with ipilimumab is indicated for the treatment of unresectable or metastatic melanoma in previously untreated adults. relative to opdivo monotherapy, an increase in P[rogression-free survival (pfs) for the combination of opdivo with ipilimumab is established only in patients with loiw tumour pd-L1 expression (based on the predefined expression level of <5%). an improvement of survival has not yet been established
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPDIVO | Not yet assigned | — |