Is Inebilizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Inebilizumab, including UPLIZNA (Prescription).

Is Inebilizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Inebilizumab: Uplizna.

Are there safety signals or safety updates for Inebilizumab?

US FDA: 1 entry (latest 2025-12-11).

Active substance

Inebilizumab

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
UPLIZNA	100MG/10ML	injectable · injection	VIELA BIO	Prescription	11 Jun 2020

EMA European Union — centrally authorised medicines

Uplizna Amgen Europe B.V. · Authorised · authorised 25 Apr 2022 · ATC L04AA

Therapeutic indication (EMA)

Uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin 4 immunoglobulin G (AQP4-IgG) seropositive (see section 5.1).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
UPLIZNA	02543931	10 MG / ML	SOLUTION · INTRAVENOUS	AMGEN CANADA INC

Safety signals and safety-related labeling changes

US FDA 11 Dec 2025 UPLIZNA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for inebilizumab →

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.