Approval · Notice of Compliance 33535 · 2024
RYBREVANT: Notice of Compliance 33535
Issued June 28, 2024
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
- 33535
- Date
- June 28, 2024
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: RYBREVANT (amivantamab for injection) is indicated: in combination with carboplatin and pemetrexed for the first line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RYBREVANT | Not yet assigned | — |
Medicinal ingredients
- AMIVANTAMAB 350 MG per 7ML