Approval · Notice of Compliance 21769 · 2019
ESBRIET: Notice of Compliance 21769
Issued January 18, 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.
- Notice number
- 21769
- Date
- January 18, 2019
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of an alternate drug product manufacturing and testing site
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ESBRIET | Not yet assigned | — |
Medicinal ingredients
- PIRFENIDONE 267 MG per CAP