ApprovalTrail

Approval · Notice of Compliance 24643 · 2020

AZARGA: Notice of Compliance 24643

Issued November 18, 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
24643
Date
November 18, 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 add a new adverse reaction of hallucination to the product monograph, in the post-marketing adverse drug reactions section based on post marketing spontaneous case reports and literature cases

Products in this notice

BrandDINStatus today
AZARGA02331624Marketed

Medicinal ingredients