Regulatory PathRegulatory requirements compared

Active substance

Eftrenonacog alfa

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ALPROLIX 1000 I.U Powder And Solvent For Solution For Injection1000 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 6196.20Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
ALPROLIX 2000 I.U Powder And Solvent For Solution For Injection2000 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 12392.40Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
ALPROLIX 250 I.U Powder And Solvent For Solution For Injection250 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 1549.05Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
ALPROLIX 3000 I.U Powder And Solvent For Solution For Injection3000 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 18588.65Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
ALPROLIX 500 I.U Powder And Solvent For Solution For Injection500 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 3098.10Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
Indications — CHI Daman Drug Formulary

HEMOPHILIA B

EMA European Union — centrally authorised medicines

Alprolix Swedish Orphan Biovitrum AB (publ) · Authorised · authorised 12 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.