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RYBREVANT SC DIN 02569140

Status: Marketed
Holder: JANSSEN INC
Molecule: AMIVANTAMAB

Health Canada record

Active ingredient(s)AMIVANTAMAB 1600 MG
Dosage formSolution
RouteSubcutaneous
SchedulePRESCRIPTION; SCHEDULE D
ClassHuman
ATCL01FX18 AMIVANTAMAB
Original market date24-Jul-2026
Current status date24-Jul-2026
SourceHealth Canada DPD

Establishment licence of the holder

Janssen Inc — licence 100239, currently licensed, last inspection rating C (2026-03-09).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing AMIVANTAMAB

DINProductCompanyFormStrengthStatus
02526182RYBREVANTJANSSEN INCSolutionAMIVANTAMAB 350 MGMarketed
02569159RYBREVANT SCJANSSEN INCSolutionAMIVANTAMAB 2240 MGMarketed
02569167RYBREVANT SCJANSSEN INCSolutionAMIVANTAMAB 2400 MGMarketed
02569175RYBREVANT SCJANSSEN INCSolutionAMIVANTAMAB 3520 MGMarketed

Notices of Compliance

NOCDateSubmissionReason
377312026-06-18Supplement 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.
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