ApprovalTrail

Approval · Notice of Compliance 31088 · 2023

WEGOVY: Notice of Compliance 31088

Issued June 29, 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
31088
Date
June 29, 2023
Company
Novo Nordisk Canada IncMississauga, Ontario, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Indication expansion Wegovy (semaglutide injection) is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in: - Pediatric patients aged 12 to less than 18 years: - with an initial BMI at the 95th percentile or greater for age and sex (obesity; see Error! Reference source not found.), and - a body weight above 60 kg (132 lbs), and - an inadequate response to reduced calorie diet and physical activity alone.

Products in this notice

BrandDINStatus today
WEGOVYNot yet assigned—

Medicinal ingredients