Approval · Notice of Compliance 32113 · 2023
ESBRIET: Notice of Compliance 32113
Issued November 16, 2023
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
- 32113
- Date
- November 16, 2023
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Updates to the Product Monograph. Updates to the package insert
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ESBRIET | Not yet assigned | — |
Medicinal ingredients
- PIRFENIDONE 267 MG per CAP
- PIRFENIDONE 267 MG per TAB
- PIRFENIDONE 801 MG per TAB