Regulatory PathRegulatory requirements compared

Active substances

Human coagulation factor viii + Human von willebrand factor

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Haemate P250,600 IU,IUPowder and solvent for solution for injection/infusion · Intravenous use1 VialSAR 918.85Biological · PrescriptionCSLValid
Haemate P500,1200 IU,IUPowder and solvent for solution for injection/infusion · Intravenous use1 VialSAR 1837.70Biological · PrescriptionCSLValid
IMMUNATE S-D 1000 I.U. POWDER FOR INJ1000,750 IU,IUPowder and solvent for solution for injection · Parenteral use1 VialSAR 1138.90Biological · PrescriptionTakeda Manufacturing AGValid
IMMUNATE S-D 250 I.U. POWDER FOR INJ250,190 IU,IUPowder and solvent for solution for injection · Parenteral use1 VialSAR 331.90Biological · PrescriptionTakeda Manufacturing AGValid
IMMUNATE S-D 500 I.U. POWDER FOR INJ500,375 IU,IUPowder and solvent for solution for injection · Parenteral use1 VialSAR 663.80Biological · PrescriptionTakeda Manufacturing AGValid
WILATE 1000 IU Powder and Solvent for Solution for Injection1000,1000 IU,IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 2738.10Biological · PrescriptionOCTAPHARMA AGValid
WILATE 500 IU Powder and Solvent for Solution for Injection500,500 IU,IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 1369.05Biological · PrescriptionOCTAPHARMA AGValid
Indications — CHI Daman Drug Formulary

VON WILLEBRAND DISEASE, HEMOPHILIA A

EMA European Union — centrally authorised medicines

Voncento CSL Behring GmbH · Authorised · authorised 12 Aug 2013 · ATC B02BD06

Therapeutic indication (EMA)

Von Willebrand disease (VWD) Prophylaxis and treatment of haemorrhage or surgical bleeding in patients with VWD, when desmopressin (DDAVP) treatment alone is ineffective or contraindicated. Haemophilia A (congenital factor-VIII deficiency) Prophylaxis and treatment of bleeding in patients with haemophilia A.

Components

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.