Approval · Notice of Compliance 26388 · 2021
ESBRIET: Notice of Compliance 26388
Issued August 6, 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
- 26388
- Date
- August 6, 2021
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Safety updates to the product monograph and update the product monograph to the 2020 format.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ESBRIET | Not yet assigned | — |
Medicinal ingredients
- PIRFENIDONE 801 MG per TAB
- PIRFENIDONE 267 MG per TAB
- PIRFENIDONE 267 MG per CAP