ApprovalTrail

Drug · DIN 02569167

RYBREVANT SC

SINGLE-USE VIAL

Yes: authorized and sold in Canada

Authorized, and the company reports that it sells it in Canada.

Status Marketed since July 24, 2026; first marketed July 24, 2026.
Drug Identification Number (DIN)
02569167
Company (DIN owner)
Janssen Inc.Toronto, Ontario, Canada
Schedule
Schedule d; Prescription
Dosage form
Solution
Route
Subcutaneous
Therapeutic class (ATC)
Amivantamab L01FX18
Class
Human
Record last updated
August 14, 2026

Active ingredients

As listed in the Drug Product Database.

IngredientStrengthPer
AMIVANTAMAB2400 MG15 ML

Notices of Compliance

Health Canada approvals that name this DIN.

  • June 18, 2026: NOC 37731Supplement to a New Drug Submission (SNDS) · New Indications: Rybrevant (amivantamab for injection) is indicated: • in combination with lazertinib 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 epidermal growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations. Rybrevant SC (amivantamab injection) is indicated: • in combination with lazertinib 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 epidermal growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations. • in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with epidermal-growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with osimertinib. • in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic NSCLC with activating EGFR Exon 20 insertion mutations. • as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

Other DINs named RYBREVANT SC