ApprovalTrail

Approval · Notice of Compliance 26678 · 2021

FLAGYL: Notice of Compliance 26678

Issued September 17, 2021

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
26678
Date
September 17, 2021
Company
Sanofi-Aventis Canada Inc.Toronto, Ontario, 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 safety information regarding suicidal ideation and vertigo based on the latest Company Core Data Sheets (CCDS), and to convert the PM into the 2020 PM format

Products in this notice

BrandDINStatus today
FLAGYLNot yet assigned—

Medicinal ingredients