Is Onasemnogene abeparvovec 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 Onasemnogene abeparvovec, including Zolgensma (2000000000000 vg/ml, Suspension for injection, SAR 7984675.90).

Is Onasemnogene abeparvovec authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Onasemnogene abeparvovec: Zolgensma, Itvisma.

Active substance

Onasemnogene abeparvovec

SFDA 1
EMA 2
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
Zolgensma	2000000000000 vg/ml	Suspension for injection · Intravenous use	9 Vial	SAR 7984675.90	Biological · Prescription	Novartis Europharm Limited	Valid

Indications — CHI Daman Drug Formulary

SPINAL MUSCULAR ATROPHY

EMA European Union — centrally authorised medicines

Zolgensma Novartis Europharm Limited · Authorised · authorised 18 May 2020 · ATC M09AX09

Therapeutic indication (EMA)

Zolgensma is indicated for the treatment of: patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1, or patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene.

Itvisma Novartis Europharm Limited · Authorised · authorised 30 Jun 2026 · ATC M09AX09

Therapeutic indication (EMA)

Itvisma is indicated for the treatment of 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene in patients 2 years of age and older.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ZOLGENSMA	02509695	20000000000000 VG / ML	SOLUTION · INTRAVENOUS	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.