Approval · Notice of Compliance 35692 · 2025
IMFINZI: Notice of Compliance 35692
Issued July 17, 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
- 35692
- Date
- July 17, 2025
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: Imfinzi is indicated for the treatment of patients with resectable muscle invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by adjuvant IMFINZI monotherapy treatment after radical cystectomy
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| IMFINZI | Not yet assigned | — |
Medicinal ingredients
- DURVALUMAB 50 MG per ML