Approval · Notice of Compliance 35694 · 2025
FASENRA: Notice of Compliance 35694
Issued July 18, 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
- 35694
- Date
- July 18, 2025
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Indication expansion: Fasenra is indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FASENRA | Not yet assigned | — |
| FASENRA PEN | Not yet assigned | — |
Medicinal ingredients
- BENRALIZUMAB 30 MG per ML