ApprovalTrail

Approval · Notice of Compliance 23213 · 2020

XIIDRA: Notice of Compliance 23213

Issued February 13, 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
23213
Date
February 13, 2020
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 the product monograph and package insert. the labelling update includes post-market safety information with respect to hypersensitivity and reviisons to the mechanism of action section of the product monograph

Products in this notice

BrandDINStatus today
XIIDRANot yet assigned—

Medicinal ingredients