Regulatory PathRegulatory requirements compared

Active substance

Factor ix

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
OCTANINE F 1000 I.U\10ML VIAL1000 IUPowder and solvent for solution for injection · Parenteral use1 VialSAR 1213.85Biological · PrescriptionOCTAPHARMAValid
OCTANINE F 500 IU500 IUPowder and solvent for solution for injection · Parenteral use1 VialSAR 610.25Biological · PrescriptionOCTAPHARMAValid
OCTANINE F 250IU VIAL200 IUSolution · Parenteral use1 VialSAR 321.20Biological · PrescriptionOCTAPHARMAWithdrawn by MAH · Not Marketed
REPLENINE-VF 500IU+10ML STERILISED WATER50 IUPowder for injection · Parenteral use1 VialSAR 684.70Biological · PrescriptionBIO-PRODUCT LABWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

HEMOPHILIA B, ACQUIRED HEMOPHILIA

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.