Is Ravulizumab 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 Ravulizumab, including Ultomiris (100 mg/ml, Concentrate for solution for infusion, SAR 20440.70).

Is Ravulizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Ravulizumab, including ULTOMIRIS (Prescription).

Is Ravulizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ravulizumab: Ultomiris.

Are there safety signals or safety updates for Ravulizumab?

US FDA: 1 entry (latest 2024-09-19).

Active substance

Ravulizumab

SFDA 3
US FDA 1
EMA 1
Health Canada 2
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
Ultomiris	100 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 20440.70	Biological · Prescription	Alexion Pharmaceuticals Inc	Valid
Ultomiris	100 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 74949.15	Biological · Prescription	Alexion Pharmaceuticals Inc	Valid
Ultomiris 300 mg/30 mL	10 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 20440.70	Biological · Prescription	Alexion Pharmaceuticals Inc	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
ULTOMIRIS	300MG/30ML(10MG/ML)	injectable · injection	ALEXION PHARM	Prescription	21 Dec 2018

EMA European Union — centrally authorised medicines

Ultomiris Alexion Europe SAS · Authorised · authorised 2 Jul 2019 · ATC L04AA43

Therapeutic indication (EMA)

Paroxysmal nocturnal haemoglobinuria (PNH)Ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with PNH:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity.- in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5.1). Atypical haemolytic uremic syndrome (aHUS)Ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with aHUS who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5.1). Generalized myasthenia gravis (gMG)Ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody-positive. Neuromyelitis Optica Spectrum Disorder (NMOSD)Ultomiris is indicated in the treatment of adult patients with NMOSD who are anti-aquaporin 4 (AQP4) antibody-positive (see section 5.1). Ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity.- in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. Ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ULTOMIRIS	02533448	300 MG / 3 ML	SOLUTION · INTRAVENOUS	ALEXION PHARMA GMBH
ULTOMIRIS	02533456	1100 MG / 11 ML	SOLUTION · INTRAVENOUS	ALEXION PHARMA GMBH

Safety signals and safety-related labeling changes

US FDA 19 Sep 2024 ULTOMIRIS — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ravulizumab →

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.