ApprovalTrail

Approval · Notice of Compliance 28129 · 2022

FLAGYL: Notice of Compliance 28129

Issued May 10, 2022

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
28129
Date
May 10, 2022
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 interference of metronidazole with certain laboratory tests and the risk of QT prolongation, particularly when metronidazole is administered with other QT prolonging drugs

Products in this notice

BrandDINStatus today
FLAGYLNot yet assigned—

Medicinal ingredients