ApprovalTrail

Approval · Notice of Compliance 23158 · 2020

VOSEVI: Notice of Compliance 23158

Issued January 28, 2020

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
23158
Date
January 28, 2020
Company
Gilead Sciences Canada IncMississauga, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
To update the vosevi product monograph with respect to hcv-infected adult patients with severe renal impairment and end-stage renal disease (esrd) requiring dialysis

Products in this notice

BrandDINStatus today
VOSEVINot yet assigned—

Medicinal ingredients