ApprovalTrail

Approval · Notice of Compliance 25933 · 2021

COSENTYX: Notice of Compliance 25933

Issued May 26, 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
25933
Date
May 26, 2021
Company
Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New Indication: COSENTYX is indicated for the treatment of active nonradiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).

Products in this notice

BrandDINStatus today
COSENTYXNot yet assigned—

Medicinal ingredients