Approval · Notice of Compliance 34686 · 2025
RYBREVANT: Notice of Compliance 34686
Issued January 13, 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.
- Notice number
- 34686
- Date
- January 13, 2025
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: RYBREVANT (amivantamab for injection) is indicated: In combination with carboplatin and pemetrexed for the treatment of patients with locally advanced (not amenable to curative therapy) or metastatic NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with Osimertinib
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RYBREVANT | Not yet assigned | — |
Medicinal ingredients
- AMIVANTAMAB 350 MG per 7ML