Is Lecanemab 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 Lecanemab, including Leqembi (100 mg/ml, Concentrate for solution for infusion, SAR 1156.20).

Is Lecanemab approved by the US FDA?

Drugs@FDA lists 2 application product lines for Lecanemab, including LEQEMBI (Prescription); LEQEMBI IQLIK (Prescription).

Is Lecanemab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Lecanemab: Leqembi.

Are there safety signals or safety updates for Lecanemab?

US FDA: 2 entries (latest 2026-07-13).

Active substance

Lecanemab

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

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Leqembi	100 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 1156.20	Biological · Prescription	EISAI	Valid
Leqembi	100 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 2890.50	Biological · Prescription	EISAI	Valid

Indications — CHI Daman Drug Formulary

ALZHEIMER / DEMENTIA

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

Product	Strength	Form · route	Applicant	Status	First approved
LEQEMBI	500MG/5ML; 200MG/2ML	injectable · injection	EISAI INC	Prescription	6 Jan 2023
LEQEMBI IQLIK	360MG/1.8ML(200MG/ML)	injectable · subcutaneous	EISAI INC	Prescription	29 Aug 2025

EMA European Union — centrally authorised medicines

Leqembi Eisai GmbH · Authorised · authorised 15 Apr 2025 · ATC N06DX04

Therapeutic indication (EMA)

Leqembi is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E 4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology (see section 4.4).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LEQEMBI	02562383	100 MG / ML	SOLUTION · INTRAVENOUS	EISAI LIMITED

Safety signals and safety-related labeling changes

US FDA 13 Jul 2026 LEQEMBI IQLIK — safety-related labeling change
Labeling sections changed: Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 Dec 2025 LEQEMBI — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for lecanemab →

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.