Approval · Notice of Compliance 37443 · 2026
FABHALTA: Notice of Compliance 37443
Issued April 30, 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
- 37443
- Date
- April 30, 2026
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of new indication: Fabhalta is indicated for the treatment of adult patients with C3 glomerulopathy (C3G) to reduce proteinuria
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FABHALTA | Not yet assigned | — |
Medicinal ingredients
- IPTACOPAN HYDROCHLORIDE 200 MG per CAP