ApprovalTrail

Approval · Notice of Compliance 36884 · 2026

OPDIVO: Notice of Compliance 36884

Issued February 9, 2026

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
36884
Date
February 9, 2026
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: in combination with platinum-doublet chemotherapy, the neoadjuvant treatment of adult patients with resectable Stage II (>4 cm), IIIA, IIIB (T3-4N2) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by OPDIVO as a single agent in the adjuvant setting after surgical resection.

Products in this notice

BrandDINStatus today
OPDIVONot yet assigned—

Medicinal ingredients