ApprovalTrail

Approval · Notice of Compliance 29219 · 2022

EVUSHELD: Notice of Compliance 29219

Issued October 18, 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
29219
Date
October 18, 2022
Company
Astrazeneca Canada IncMississauga, Ontario, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication : EVUSHELD (tixagevimab and cilgavimab) is indicated for the treatment of mild to moderate COVID-19 in adults and adolescents (>12 years of age weighing at least 40 kg)

Products in this notice

BrandDINStatus today
EVUSHELDNot yet assigned—

Medicinal ingredients