ApprovalTrail

Approval · Notice of Compliance 28351 · 2022

OPDIVO: Notice of Compliance 28351

Issued June 2, 2022

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
28351
Date
June 2, 2022
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 2g(i)b of the Letter of Undertaking dated November 8, 2017, issued under SNDS Control #203286
With conditions
Yes (NOC/c)

Products in this notice

BrandDINStatus today
OPDIVONot yet assigned—

Medicinal ingredients