Approval · Notice of Compliance 34232 · 2024
BALVERSA: Notice of Compliance 34232
Issued September 25, 2024
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
- 34232
- Date
- September 25, 2024
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Fulfillment of the post-approval commitments for the Notice of Compliance with conditions. Change to existing indication: BALVERSA® (erdafitinib) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor (FGFR)3 genetic alterations, who have disease progression during or following at least one line of prior therapy including within 12 months of neoadjuvant or adjuvant therapy. BALVERSA® should not be used for the treatment of patients who are eligible for and have not received prior programmed death receptor-1 (PD-1) or programmed death-ligand 1(PD-L1) inhibitor therapy.. Treatment with BALVERSA® should be initiated following confirmation of a susceptible FGFR genetic alteration using a validated test.
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