ApprovalTrail

Approval · Notice of Compliance 21782 · 2019

OPDIVO: Notice of Compliance 21782

Issued January 23, 2019

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
21782
Date
January 23, 2019
Company
Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Fulfilment of commitment g(i)a of the Letter of Undertaking dated November 8, 2017, issued under SNDS Control #203286

Products in this notice

BrandDINStatus today
OPDIVONot yet assigned—

Medicinal ingredients