ApprovalTrail

Approval · Notice of Compliance 30157 · 2023

AZOPT: Notice of Compliance 30157

Issued February 10, 2023

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
30157
Date
February 10, 2023
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 (PM) with new safety information about Steven Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

Products in this notice

BrandDINStatus today
AZOPTNot yet assigned—

Medicinal ingredients