ApprovalTrail

Approval · Notice of Compliance 18029 · 2016

TASIGNA: Notice of Compliance 18029

Issued April 20, 2016

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
18029
Date
April 20, 2016
Company
Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
To update carton labels due to new carton size/format for the 200 mg capsules pack size; update text on the 150 mg capsules labels to maintain consistency; and to implement editorial changes to the text on the 150 mg and 200 mg capsule foil labels

Products in this notice

BrandDINStatus today
TASIGNANot yet assigned—

Medicinal ingredients