ApprovalTrail

Approval · Notice of Compliance 31071 · 2023

MAYZENT: Notice of Compliance 31071

Issued June 28, 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
31071
Date
June 28, 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
Safety update relying on clinical trial data from study A2130 related to non-live attenuated vaccination and CYP2C9 less frequent alleles.

Products in this notice

BrandDINStatus today
MAYZENTNot yet assigned—

Medicinal ingredients