Regulatory PathRegulatory requirements compared

Active substance

Lonoctocog alfa

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Afstyla250 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 628.75Biological · PrescriptionCSLValid
Afstyla500 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 1257.55Biological · PrescriptionCSLValid
Afstyla1000 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 2515.00Biological · PrescriptionCSLValid
Afstyla2000 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 5030.10Biological · PrescriptionCSLValid
Afstyla3000 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 7545.00Biological · PrescriptionCSLValid

EMA European Union — centrally authorised medicines

Afstyla CSL Behring GmbH · Authorised · authorised 4 Jan 2017 · ATC B02BD02

Therapeutic indication (EMA)

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Afstyla can be used for all age groups.

Safety signals and safety-related labeling changes

All safety entries for lonoctocog alfa →

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.