ApprovalTrail

Approval · Notice of Compliance 23983 · 2020

OZEMPIC: Notice of Compliance 23983

Issued July 31, 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
23983
Date
July 31, 2020
Company
Novo Nordisk Canada IncMississauga, Ontario, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Expansion of indication: Ozempic to be used in combination with: metformin or a sulfonylurea and a sodium-glucose cotransporter 2 inhibitor (SGLT2i) when diet and exercise plus metformin or a sulfonylurea, in addition to an SGLT2i, do not achieve adequate glycemic control.

Products in this notice

BrandDINStatus today
OZEMPICNot yet assigned—

Medicinal ingredients