ApprovalTrail

Approval · Notice of Compliance 36769 · 2026

IMFINZI: Notice of Compliance 36769

Issued January 22, 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
36769
Date
January 22, 2026
Company
Astrazeneca Canada IncMississauga, Ontario, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Priority
Reason
New indication: Resectable Gastric or Gastroesophageal Junction Adenocarcinoma IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) (Stage II to IVA).

Products in this notice

BrandDINStatus today
IMFINZINot yet assigned—

Medicinal ingredients