Approval · Notice of Compliance 35232 · 2025
SARCLISA: Notice of Compliance 35232
Issued April 17, 2025
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
- 35232
- Date
- April 17, 2025
- Company
- Sanofi-Aventis Canada Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: Sarclisa (isatuximab for injection) is indicated in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SARCLISA | Not yet assigned | — |
Medicinal ingredients
- ISATUXIMAB 100 MG per 5ML
- ISATUXIMAB 500 MG per 25ML