Approval · Notice of Compliance 35707 · 2025
BYLVAY: Notice of Compliance 35707
Issued July 22, 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
- 35707
- Date
- July 22, 2025
- Company
- Medison Pharma Canada Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of new indication: the treatment of cholestatic pruritus in patients aged 12 months or older with Alagille syndrome (ALGS). Addition of new pediatric indication: Based on the data submitted and reviewed by Health Canada, the safety and efficacy of BYLVAY in pediatric patients aged 12 months or older for the treatment of pruritus in ALGS have been established. Therefore, Health Canada has authorized an indication for pediatric use. The safety and efficacy of BYLVAY in pediatric patients < 12 months of age for the treatment of pruritus in ALGS have not been established.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BYLVAY | Not yet assigned | — |
Medicinal ingredients
- ODEVIXIBAT 200 MCG per CAP
- ODEVIXIBAT 400 MCG per CAP
- ODEVIXIBAT 600 MCG per CAP
- ODEVIXIBAT 1,200 MCG per CAP