Regulatory PathRegulatory requirements compared

Active substance

Efmoroctocog alfa

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ELOCTA 1000 IU POWDER FOR SOLUTION FOR INJECTION1000 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 2959.05Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
ELOCTA 1500 IU POWDER FOR SOLUTION FOR INJECTION1500 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 4438.85Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
ELOCTA 2000 IU POWDER FOR SOLUTION FOR INJECTION2000 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 5918.70Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
ELOCTA 250 IU POWDER FOR SOLUTION FOR INJECTION250 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 739.30Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
ELOCTA 3000 IU POWDER FOR SOLUTION FOR INJECTION3000 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 8878.35Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
ELOCTA 500 IU POWDER FOR SOLUTION FOR INJECTION500 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 1479.25Biological · PrescriptionSWEDISH ORPHAN BIOVITRUM INTERNATIONAL ABValid
Indications — CHI Daman Drug Formulary

HEMOPHILIA A

EMA European Union — centrally authorised medicines

Elocta Swedish Orphan Biovitrum AB (publ) · Authorised · authorised 18 Nov 2015 · ATC B02BD02

Therapeutic indication (EMA)

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

Safety signals and safety-related labeling changes

All safety entries for efmoroctocog 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.