SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| Rybrevant | 160 mg/ml | Solution for injection · Subcutaneous use | 1 Vial | SAR 20043.65 | Biological · Prescription | Janssen Cilag | Valid |
| Rybrevant 350 mg per 7 ml | 50 mg/ml | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 5962.70 | Biological · Prescription | Janssen-Cilag International NV | Valid |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| RYBREVANT | 350MG/7ML(50MG/ML) | injectable · injection | JANSSEN BIOTECH | Prescription | 21 May 2021 |
EMA European Union — centrally authorised medicines
Rybrevant · Authorised · authorised 9 Dec 2021 · ATC L01FX18
Therapeutic indication (EMA)
Rybrevant is indicated: in combination with lazertinib for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations. in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI). in combination with carboplatin and pemetrexed for the first line treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations. as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum based therapy.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| RYBREVANT | 02526182 | 350 MG / 7 ML | SOLUTION · INTRAVENOUS | JANSSEN INC |
| RYBREVANT SC | 02569140 | 1600 MG / 10 ML | SOLUTION · SUBCUTANEOUS | JANSSEN INC |
| RYBREVANT SC | 02569159 | 2240 MG / 14 ML | SOLUTION · SUBCUTANEOUS | JANSSEN INC |
| RYBREVANT SC | 02569167 | 2400 MG / 15 ML | SOLUTION · SUBCUTANEOUS | JANSSEN INC |
| RYBREVANT SC | 02569175 | 3520 MG / 22 ML | SOLUTION · SUBCUTANEOUS | JANSSEN INC |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.