ApprovalTrail

Approval · Notice of Compliance 19188 · 2017

ERIVEDGE: Notice of Compliance 19188

Issued April 21, 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
19188
Date
April 21, 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
Safety update to the product monograph based on findings from a post-approval phase II study (steevie)

Products in this notice

BrandDINStatus today
ERIVEDGENot yet assigned—

Medicinal ingredients