ApprovalTrail

Approval · Notice of Compliance 26344 · 2021

BENLYSTA: Notice of Compliance 26344

Issued July 29, 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
26344
Date
July 29, 2021
Company
Glaxosmithkline IncMississauga, Ontario, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication: Benlysta (belimumab) is indicated in addition to standard therapy for: treatment of active lupus nephritis in adult patients.

Products in this notice

BrandDINStatus today
BENLYSTANot yet assigned—

Medicinal ingredients