Approval · Notice of Compliance 35310 · 2025
TECVAYLI: Notice of Compliance 35310
Issued May 1, 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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 35310
- Date
- May 1, 2025
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Fulfilment of commitment 2 (b) of the Qualifying Notice dated July 10, 2023 issued under SNDS Control #269369.
- With conditions
- Yes (NOC/c)
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