Approval · Notice of Compliance 25583 · 2021
BALVERSA: Notice of Compliance 25583
Issued March 26, 2021
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
- 25583
- Date
- March 26, 2021
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Safety update of the labelling
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BALVERSA | Not yet assigned | — |
| BALVERSA | 02493241 | Approved |
Medicinal ingredients
- ERDAFITINIB 3 MG per TAB
- ERDAFITINIB 4 MG per TAB
- ERDAFITINIB 5 MG per TAB