Is Etranacogene dezaparvovec registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Etranacogene dezaparvovec, including Hemgenix (1*10^13 GC, Concentrate for solution for infusion, SAR 13236137.05).

Is Etranacogene dezaparvovec authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Etranacogene dezaparvovec: Hemgenix.

Active substance

Etranacogene dezaparvovec

SFDA 1
EMA 1
Health Canada 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Hemgenix	1*10^13 GC	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 13236137.05	Biological · Prescription	CSL	Valid

EMA European Union — centrally authorised medicines

Hemgenix CSL Behring GmbH · Authorised · authorised 20 Feb 2023 · ATC B02BD

Therapeutic indication (EMA)

Treatment of severe and moderately severe Haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
HEMGENIX	02542560	10000000000000 GENOME COPIES / ML	SUSPENSION · INTRAVENOUS	CSL BEHRING CANADA INC

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.