Approval · Notice of Compliance 36603 · 2025
BALVERSA: Notice of Compliance 36603
Issued December 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
- 36603
- Date
- December 18, 2025
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph with new safety and efficacy information
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BALVERSA | Not yet assigned | — |
Medicinal ingredients
- ERDAFITINIB 3 MG per TAB
- ERDAFITINIB 4 MG per TAB
- ERDAFITINIB 5 MG per TAB