ApprovalTrail

Approval · Notice of Compliance 19290 · 2017

OPDIVO: Notice of Compliance 19290

Issued May 12, 2017

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
19290
Date
May 12, 2017
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: opdivo is indicated for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (scchn) in adults progressing on or after platinum-based therapy.

Products in this notice

BrandDINStatus today
OPDIVONot yet assigned—

Medicinal ingredients