Approval · Notice of Compliance 32868 · 2024
BIMZELX: Notice of Compliance 32868
Issued March 11, 2024
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
- 32868
- Date
- March 11, 2024
- Company
- Ucb Canada IncOakville, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indications: Ankylosing Spondylitis (AS, radiographic spondyloarthritis) The treatment of adult patients with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy. Non-radiographic axial spondyloarthritis (nr-axSpA) The treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BIMZELX | Not yet assigned | — |
Medicinal ingredients
- BIMEKIZUMAB 160 MG per ML