Is Voretigene neparvovec 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 Voretigene neparvovec, including Luxturna (5*10^12 vg/ml, Concentrate and solvent for solution for injection, SAR 1477790.45).

Is Voretigene neparvovec authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Voretigene neparvovec: Luxturna.

Active substance

Voretigene neparvovec

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
Luxturna	5*10^12 vg/ml	Concentrate and solvent for solution for injection · Subretinal use	3 Vial	SAR 1477790.45	Biological · Prescription	Novartis Europharm Limited	Valid

EMA European Union — centrally authorised medicines

Luxturna Novartis Europharm Limited · Authorised · authorised 22 Nov 2018 · ATC S01XA27

Therapeutic indication (EMA)

Luxturna is indicated for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LUXTURNA	02505851	5000000000000 VG / ML	SOLUTION · SUBRETINAL	NOVARTIS PHARMACEUTICALS 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.