Regulatory PathRegulatory requirements compared

Active substance

Efanesoctocog alfa

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Altuvoct250 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 1225.10Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
Altuvoct500 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 2450.25Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
Altuvoct1000 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 4900.50Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
Altuvoct2000 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 9801.00Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
Altuvoct3000 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 14701.50Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
Altuvoct4000 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 19602.00Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid

EMA European Union — centrally authorised medicines

Altuvoct Swedish Orphan Biovitrum AB (publ) · Authorised · authorised 17 Jun 2024 · ATC B02BD02

Therapeutic indication (EMA)

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

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.