Is Eculizumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Eculizumab, including BEKEMV (10 mg/ml, Concentrate for solution for infusion, SAR 13357.50); Epysqli (300 mg, Concentrate for solution for infusion, SAR 9897.60); Soliris (300 mg, Concentrate for solution for infusion, SAR 15227.15).

Is Eculizumab approved by the US FDA?

Drugs@FDA lists 3 application product lines for Eculizumab, including SOLIRIS (Prescription); BKEMV (Prescription); EPYSQLI (Prescription).

Is Eculizumab authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Eculizumab: Soliris, Bekemv, Epysqli.

Are there safety signals or safety updates for Eculizumab?

US FDA: 3 entries (latest 2025-11-24).

Active substance

Eculizumab

SFDA 3
US FDA 3
EMA 3
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
BEKEMV	10 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 13357.50	Biological · Prescription	Amgen Technology Ireland	Valid
Epysqli	300 mg	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 9897.60	Biological · Prescription	Samsung Bioepis Co Ltd	Valid
Soliris	300 mg	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 15227.15	Biological · Prescription	Alexion Europe SAS	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
SOLIRIS	300MG	injectable · iv (infusion)	ALEXION PHARM	Prescription	16 Mar 2007
BKEMV	300MG/30ML(10MG/ML)	injectable · injection	AMGEN INC	Prescription	28 May 2024
EPYSQLI	300 mg/30 mL (10 mg/mL)	injection · solution	SAMSUNG BIOEPIS CO LTD	Prescription	19 Jul 2024

EMA European Union — centrally authorised medicines

Soliris Alexion Europe SAS · Authorised · authorised 20 Jun 2007 · ATC L04AA25

Therapeutic indication (EMA)

Soliris is indicated in adults and children for the treatment of: Paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1). Atypical haemolytic uremic syndrome (aHUS). Soliris is indicated in adults for the treatment of: Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1). Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease.

Bekemv Amgen Europe B.V. · Authorised · authorised 19 Apr 2023 · ATC L04AJ01

Therapeutic indication (EMA)

Bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1).

Epysqli Samsung Bioepis NL B.V. · Authorised · authorised 26 May 2023 · ATC L04AJ01

Therapeutic indication (EMA)

Epysqli is indicated in adults and children for the treatment of: Paroxysmal nocturnal haemoglobinuria (PNH).Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history. Atypical haemolytic uremic syndrome (aHUS).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SOLIRIS	02322285	10 MG / ML	SOLUTION · INTRAVENOUS	ALEXION PHARMA GMBH

Safety signals and safety-related labeling changes

US FDA 24 Nov 2025 BKEMV — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Feb 2025 SOLIRIS — 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
US FDA 15 Nov 2024 EPYSQLI — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for eculizumab →

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.