Approval · Notice of Compliance 38408 · 2026
DARZALEX SC: Notice of Compliance 38408
Issued October 2, 2026
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
- 38408
- Date
- October 2, 2026
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: For the treatment of adult patients with high-risk smouldering multiple myeloma (SMM).
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DARZALEX SC | Not yet assigned | — |
Medicinal ingredients
- DARATUMUMAB 1,800 MG per 15ML