Regulatory PathRegulatory requirements compared

Active substance

Hepatitis b virus vaccine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
RECOMBIVAX HBSuspension for injection · Intramuscular use1 VialSAR 46.70Biological · PrescriptionMERCK SHARP AND DOHME LLCValid
ENGERIX B 20MCGµgSuspension for injection · Intramuscular use1 VialSAR 44.70Biological · PrescriptionGLAXOSMITHKLINE (GSK)Withdrawn by MAH · Not Marketed
ENGERIX-B 10MCGµgSuspension for injection · Intramuscular use1 VialSAR 36.00Biological · PrescriptionGLAXOSMITHKLINE (GSK)Withdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

MATERNAL AND CHILD HEALTHCARE- IMMUNIZATION FOR MOTHER AND CHILD; RENAL TRANSPLANT

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.