ApprovalTrail

Approval · Notice of Compliance 25952 · 2021

OPDIVO: Notice of Compliance 25952

Issued May 28, 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
25952
Date
May 28, 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
New Indication: OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy for MPM.

Products in this notice

BrandDINStatus today
OPDIVONot yet assigned—

Medicinal ingredients