ApprovalTrail

Approval · Notice of Compliance 21932 · 2019

FUZEON: Notice of Compliance 21932

Issued March 6, 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
21932
Date
March 6, 2019
Company
Hoffmann-La Roche LimitedMississauga, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Labelling Only
Reason
Updates to inner and outer labels abd package insert to be in compliance with plain language labelling requirements

Products in this notice

BrandDINStatus today
FUZEONNot yet assigned—

Medicinal ingredients