Approval · Notice of Compliance 22821 · 2019
BALVERSA: Notice of Compliance 22821
Issued October 25, 2019
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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 22821
- Date
- October 25, 2019
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- With conditions
- Yes (NOC/c)
Products in this notice
Medicinal ingredients
- ERDAFITINIB 3 MG per TAB
- ERDAFITINIB 4 MG per TAB
- ERDAFITINIB 5 MG per TAB