Regulatory PathRegulatory requirements compared

Active substance

Nonacog beta pegol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Refixia500 IUPowder and solvent for solution for injection · Intravenous use1 Pre-filled syringeSAR 3052.55Biological · PrescriptionNOVO NORDISKValid
Refixia1000 IUPowder and solvent for solution for injection · Intravenous use1 Pre-filled syringeSAR 6105.70Biological · PrescriptionNOVO NORDISKValid
Refixia2000 IUPowder and solvent for solution for injection · Intravenous use1 Pre-filled syringeSAR 12211.95Biological · PrescriptionNOVO NORDISKValid

EMA European Union — centrally authorised medicines

Refixia Novo Nordisk A/S · Authorised · authorised 2 Jun 2017 · ATC B02BD04

Therapeutic indication (EMA)

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