Is Nusinersen 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 Nusinersen, including SPINRAZA 2.4 mg/ml Vial (12 mg, Solution for injection, SAR 355286.25).

Is Nusinersen approved by the US FDA?

Drugs@FDA lists 1 application product line for Nusinersen, including SPINRAZA (Prescription).

Is Nusinersen authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Nusinersen: Spinraza.

Are there safety signals or safety updates for Nusinersen?

EMA PRAC: 1 entry; US FDA: 1 entry; MHRA: 1 entry (latest 2026-03-27).

Active substance

Nusinersen

SFDA 1
US FDA 1
EMA 1
Health Canada 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
SPINRAZA 2.4 mg/ml Vial	12 mg	Solution for injection · Intrathecal use	1 Vial	SAR 355286.25	NCE · Prescription	Biogen Idec B.V-Natherland	Valid

Indications — CHI Daman Drug Formulary

SPINAL MUSCULAR ATROPHY

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

Product	Strength	Form · route	Applicant	Status	First approved
SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML); EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML); EQ 50MG BASE/5ML (EQ 10MG BASE/ML)	solution · intrathecal	BIOGEN	Prescription	23 Dec 2016

EMA European Union — centrally authorised medicines

Spinraza Biogen Netherlands B.V. · Authorised · authorised 30 May 2017 · ATC M09

Therapeutic indication (EMA)

Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SPINRAZA	02465663	2.4 MG / ML	SOLUTION · INTRATHECAL	BIOGEN CANADA INC

Safety signals and safety-related labeling changes

US FDA 27 Mar 2026 SPINRAZA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations
EMA PRAC 16 Mar 2023 PRAC signal: Arachnoiditis
Action for MAH: update of the product information: No
MHRA 25 Sep 2018 Nusinersen (Spinraza▼): reports of communicating hydrocephalus; discuss symptoms with patients and carers and investigate urgently
Advise patients and their caregivers to seek urgent medical attention if any signs or symptoms of communicating hydrocephalus develop during nusinersen therapy for spinal muscular atrophy. Patients with communicating hydrocephalus may require treatment with a cerebrospinal fluid (CSF) shunt.

All safety entries for nusinersen →

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.