ApprovalTrail

Approval · Notice of Compliance 22627 · 2019

TRACLEER: Notice of Compliance 22627

Issued September 10, 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
22627
Date
September 10, 2019
Company
Janssen Inc.Toronto, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Labelling Only
Reason
Updates to the carton and blister labels, the product monograph and the package insert

Products in this notice

BrandDINStatus today
TRACLEERNot yet assigned—

Medicinal ingredients