Approval · Notice of Compliance 31965 · 2023
ULTOMIRIS: Notice of Compliance 31965
Issued October 30, 2023
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
- 31965
- Date
- October 30, 2023
- Company
- Alexion Pharma GmbhBaar, --, Switzerland
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indication: Neuromyelitis Optica Spectrum Disorder (NMOSD): ULTOMIRIS (ravulizumab for injection) is indicated for the treatment of adult patients with antiaquaporin 4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD).
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ULTOMIRIS | Not yet assigned | — |
Medicinal ingredients
- RAVULIZUMAB 10 MG per ML
- RAVULIZUMAB 300 MG per 3ML
- RAVULIZUMAB 1,100 MG per 11ML