Approval · Notice of Compliance 29861 · 2023
ULTOMIRIS: Notice of Compliance 29861
Issued January 6, 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
- 29861
- Date
- January 6, 2023
- Company
- Alexion Pharma GmbhBaar, --, Switzerland
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: Generalized Myasthenia Gravis (gMG) ULTOMIRIS (ravulizumab for injection) is indicated for the treatment of adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized Myasthenia Gravis (gMG). ULTOMIRIS was studied in adult gMG patients with a Myasthenia Gravis Foundation of America (MGFA) clinical classification Class II to IV and a Myasthenia Gravis Activities of Daily Living (MG-ADL) total score ¿ 6
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ULTOMIRIS | Not yet assigned | — |
Medicinal ingredients
- RAVULIZUMAB 10 MG per ML