Is Tofersen 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 Tofersen, including Qalsody (6.7 mg/ml, Solution for injection, SAR 98211.15).

Is Tofersen approved by the US FDA?

Drugs@FDA lists 1 application product line for Tofersen, including QALSODY (Prescription).

Is Tofersen authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tofersen: Qalsody.

Active substance

Tofersen

SFDA 1
US FDA 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
Qalsody	6.7 mg/ml	Solution for injection · Intrathecal use	1 Vial	SAR 98211.15	NCE · Prescription	Biogen Idec B.V-Natherland	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
QALSODY	100MG/15ML (6.7MG/ML)	solution · intrathecal	BIOGEN MA	Prescription	25 Apr 2023

EMA European Union — centrally authorised medicines

Qalsody Biogen Netherlands B.V. · Authorised · authorised 29 May 2024 · ATC N07XX22

Therapeutic indication (EMA)

Qalsody is indicated for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
QALSODY	02555735	100 MG / 15 ML	SOLUTION · INTRATHECAL	BIOGEN 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.