ApprovalTrail

Approval · Notice of Compliance 35547 · 2025

OPDIVO: Notice of Compliance 35547

Issued June 19, 2025

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
35547
Date
June 19, 2025
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: in combination with ipilimumab, the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC).

Products in this notice

BrandDINStatus today
OPDIVONot yet assigned—

Medicinal ingredients