Regulatory PathRegulatory requirements compared

Active substance

Coagulation factor ix recombinant human

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
BENEFIX 1000 I.U. POWDER FOR SOLUTION FOR INJECTION1000 IUPowder and solvent for solution for injection · Parenteral use1 VialSAR 2520.70Biological · PrescriptionWYETHValid
BENEFIX 2000 I.U. POWDER FOR SOLUTION FOR INJECTION2000 IUPowder and solvent for solution for injection · Parenteral use1 VialSAR 5018.75Biological · PrescriptionWYETHValid
BENEFIX 250 I.U. POWDER FOR SOLUTION FOR INJECTION250 IUPowder and solvent for solution for injection · Parenteral use1 VialSAR 655.60Biological · PrescriptionWYETHValid
BENEFIX 500 I.U. POWDER FOR SOLUTION FOR INJECTION500 IUPowder and solvent for solution for injection · Parenteral use1 VialSAR 1333.85Biological · PrescriptionWYETHValid
FACTOR IX GRIFOLS40-62.5 IU/mlPowder and solvent for solution for injection · Intravenous use1 VialSAR 260.20Biological · PrescriptionInstituto Grifols, S.AValid
FACTOR IX GRIFOLS40-62.5 IU/mlPowder and solvent for solution for injection · Intravenous use1 VialSAR 520.40Biological · PrescriptionInstituto Grifols, S.AValid
FACTOR IX GRIFOLS40-62.5 IU/mlPowder and solvent for solution for injection · Intravenous use1 VialSAR 1040.80Biological · PrescriptionInstituto Grifols, S.AValid
FACTOR IX GRIFOLS40-62.5 IU/mlPowder and solvent for solution for injection · Intravenous use1 VialSAR 1561.20Biological · PrescriptionInstituto Grifols, S.AValid
IMMUNINE 1200I.U. LOY. POW. FOR I.V. INJ1200 IUPowder and solvent for solution for injection · Parenteral use1 VialSAR 1478.90Biological · PrescriptionBAXTER AG - AUSTRIAWithdrawn by MAH · Not Marketed
IMMUNINE 200I.U. LOY. POW. FOR I.V. INJ200 IUPowder for solution for infusion · Parenteral use1 VialSAR 308.60Biological · PrescriptionBAXTER AG - AUSTRIAWithdrawn by MAH · Not Marketed
IMMUNINE 600I.U. LOY. POW. FOR I.V. INJ600 IUPowder and solvent for solution for injection · Parenteral use1 VialSAR 739.45Biological · PrescriptionBAXTER AG - AUSTRIAWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

HEMOPHILIA B

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.