ApprovalTrail

Approval · Notice of Compliance 35932 · 2025

EVRYSDI: Notice of Compliance 35932

Issued August 28, 2025

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
35932
Date
August 28, 2025
Company
Hoffmann-La Roche LimitedMississauga, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Product Monograph reformatted to the Master Template. Update to the Product Monograph with new safety information. Addition of new dosage form: Tablet. Addition of new strength: 5 mg

Products in this notice

BrandDINStatus today
EVRYSDINot yet assigned—
EVRYSDI02560747Marketed

Medicinal ingredients