ApprovalTrail

Approval · Notice of Compliance 26842 · 2021

OPDIVO: Notice of Compliance 26842

Issued October 13, 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.

Notice number
26842
Date
October 13, 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
OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced (not amenable to curative surgery or radiation therapy) or metastatic Renal Cell Carcinoma (RCC)

Products in this notice

BrandDINStatus today
OPDIVONot yet assigned—

Medicinal ingredients