Regulatory PathRegulatory requirements compared

Active substance

Omfiloctocog alfa

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
HEMOFIL M 1000 IU VIAL+10ML STERIL WATER1000 IUPowder and solvent for solution for injection · Parenteral use1 VialSAR 1711.75Biological · PrescriptionBAXTERValid
HEMOFIL M 250 IU VIAL+10ML STERIL WATER250 IUPowder and solvent for solution for injection · Parenteral use1 VialSAR 427.95Biological · PrescriptionBAXTERValid
HEMOFIL M 500 IU VIAL500 IUSolution · Parenteral use1 VialSAR 855.85Biological · PrescriptionBAXTERValid
KOATE DVI 1000 IU VIAL1000 IUpowder for solution for injection · Intravenous use1 VialSAR 1225.10Biological · PrescriptionGRIFOLS THERAPEUTICS INCValid
KOATE DVI 250 IU VIAL250 IUpowder for solution for injection · Intravenous use1 VialSAR 306.30Biological · PrescriptionGRIFOLS THERAPEUTICS INCValid
KOATE DVI 500 IU VIAL500 IUpowder for solution for injection · Intravenous use1 VialSAR 612.55Biological · PrescriptionGRIFOLS THERAPEUTICS INCValid
Indications — CHI Daman Drug Formulary

HEMOPHILIA A

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.