Approval · Notice of Compliance 29356 · 2022
ULTOMIRIS: Notice of Compliance 29356
Issued November 1, 2022
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
- 29356
- Date
- November 1, 2022
- Company
- Alexion Pharma GmbhBaar, --, Switzerland
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: - the treatment of pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH); - the treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complementmediated thrombotic microangiopathy (TMA).
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ULTOMIRIS | Not yet assigned | — |
Medicinal ingredients
- RAVULIZUMAB 10 MG per ML