Is Satralizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Satralizumab, including ENSPRYNG (Prescription).

Is Satralizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Satralizumab: Enspryng.

Are there safety signals or safety updates for Satralizumab?

US FDA: 1 entry (latest 2022-09-14).

Active substance

Satralizumab

US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
ENSPRYNG	120MG/ML	injectable · injection	GENENTECH	Prescription	14 Aug 2020

EMA European Union — centrally authorised medicines

Enspryng Roche Registration GmbH · Authorised · authorised 24 Jun 2021 · ATC L04AC

Therapeutic indication (EMA)

Satralizumab (Enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ENSPRYNG	02499681	120 MG / ML	SOLUTION · SUBCUTANEOUS	HOFFMANN-LA ROCHE LIMITED

Safety signals and safety-related labeling changes

US FDA 14 Sep 2022 ENSPRYNG — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for satralizumab →

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.