ApprovalTrail

Approval · Notice of Compliance 35152 · 2025

IMFINZI: Notice of Compliance 35152

Issued April 10, 2025

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
35152
Date
April 10, 2025
Company
Astrazeneca Canada IncMississauga, Ontario, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication: Metastatic Non-Small Cell Lung Cancer Imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.

Products in this notice

BrandDINStatus today
IMFINZINot yet assigned—

Medicinal ingredients