Regulatory PathRegulatory requirements compared

Active substance

Albutrepenonacog alfa

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Idelvion250 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 2323.55Biological · PrescriptionCSLValid
Idelvion500 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 4647.10Biological · PrescriptionCSLValid
Idelvion1000 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 9294.30Biological · PrescriptionCSLValid
Idelvion2000 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 18588.60Biological · PrescriptionCSLValid
Idelvion3500 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 35978.05Biological · PrescriptionCSLValid
Indications — CHI Daman Drug Formulary

HEMOPHILIA B

EMA European Union — centrally authorised medicines

Idelvion CSL Behring GmbH · Authorised · authorised 11 May 2016 · ATC B02BD04

Therapeutic indication (EMA)

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

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.