Is Rozanolixizumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Rozanolixizumab, including Rystiggo (140 mg/ml, Solution for injection, SAR 42158.95).

Is Rozanolixizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Rozanolixizumab, including RYSTIGGO (Prescription).

Is Rozanolixizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Rozanolixizumab: Rystiggo.

Are there safety signals or safety updates for Rozanolixizumab?

US FDA: 1 entry (latest 2025-12-09).

Active substance

Rozanolixizumab

SFDA 2
US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Rystiggo	140 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 42158.95	Biological · Prescription	UCB Pharma S.A.	Valid
Rystiggo	140 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 28105.95	Biological · Prescription	UCB Pharma S.A.	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
RYSTIGGO	280MG/2ML(140MG/ML)	injectable · subcutaneous	UCB INC	Prescription	26 Jun 2023

EMA European Union — centrally authorised medicines

Rystiggo UCB Pharma · Authorised · authorised 5 Jan 2024 · ATC L04AL02

Therapeutic indication (EMA)

Rystiggo is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
RYSTIGGO	02556081	280 MG / 2 ML	SOLUTION · SUBCUTANEOUS	UCB CANADA INC

Safety signals and safety-related labeling changes

US FDA 9 Dec 2025 RYSTIGGO — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for rozanolixizumab →

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.