Approval · Notice of Compliance 19375 · 2017
ESBRIET: Notice of Compliance 19375
Issued June 2, 2017
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
- 19375
- Date
- June 2, 2017
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New dosage form and new manufacturing and testing sites
Products in this notice
Medicinal ingredients
- PIRFENIDONE 267 MG per TAB
- PIRFENIDONE 801 MG per TAB