Approval · Notice of Compliance 22682 · 2019
SOLIRIS: Notice of Compliance 22682
Issued September 24, 2019
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
- 22682
- Date
- September 24, 2019
- Company
- Alexion Pharma GmbhBaar, --, Switzerland
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: neuromyelitis optica spectrum disorder (nmosd). soliris (eculizumab for injection) is indicated for the treatment of nmsod in adult patients who are anti-aquaporin-4 (aqp4) antibody positive. soliris in not intended for acute treatment of nmosd relapse
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SOLIRIS | Not yet assigned | — |
Medicinal ingredients
- ECULIZUMAB 10 MG per ML