Approval · Notice of Compliance 38031 · 2026
TECVAYLI: Notice of Compliance 38031
Issued July 31, 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
- 38031
- Date
- July 31, 2026
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: Tecvayli (teclistamab injection) is indicated: •in combination with daratumumab for the treatment ofadults with relapsed or refractory multiple myeloma whohave received one to three prior lines of therapy,including a proteasome inhibitor and animmunomodulatory agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TECVAYLI | Not yet assigned | — |
Medicinal ingredients
- TECLISTAMAB 30 MG per 3ML
- TECLISTAMAB 153 MG per 1.7ML