Regulatory PathRegulatory requirements compared

Active substance

Turoctocog alfa pegol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Esperoct500 IUPowder and solvent for solution for injection · Intravenous use1 Pre-filled syringeSAR 1504.75Biological · PrescriptionNOVO NORDISKValid
Esperoct1000 IUPowder and solvent for solution for injection · Intravenous use1 Pre-filled syringeSAR 3009.55Biological · PrescriptionNOVO NORDISKValid
Esperoct1500 IUPowder and solvent for solution for injection · Intravenous use1 Pre-filled syringeSAR 4514.30Biological · PrescriptionNOVO NORDISKWithdrawn by MAH · Not Marketed
Esperoct2000 IUPowder and solvent for solution for injection · Intravenous use1 Pre-filled syringeSAR 6019.10Biological · PrescriptionNOVO NORDISKWithdrawn by MAH · Not Marketed
Esperoct3000 IUPowder and solvent for solution for injection · Intravenous use1 Pre-filled syringeSAR 9028.65NCE · PrescriptionNOVO NORDISKWithdrawn by MAH · Not Marketed

EMA European Union — centrally authorised medicines

Esperoct Novo Nordisk A/S · Authorised · authorised 20 Jun 2019 · ATC B02BD02

Therapeutic indication (EMA)

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Esperoct 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.