Approval · Notice of Compliance 31168 · 2023
RYBREVANT: Notice of Compliance 31168
Issued July 11, 2023
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
- 31168
- Date
- July 11, 2023
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Fulfilment of commitment 2b of the Letter of Undertaking dated February 22, 2022, issued under NDS Control #254440
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RYBREVANT | Not yet assigned | — |
Medicinal ingredients
- AMIVANTAMAB 350 MG per 7ML