Is Lebrikizumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Lebrikizumab, including Ebglyss (250 mg, Solution for injection, SAR 4413.45).

Is Lebrikizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Lebrikizumab, including EBGLYSS (Prescription).

Is Lebrikizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Lebrikizumab: Ebglyss.

Are there safety signals or safety updates for Lebrikizumab?

US FDA: 1 entry (latest 2025-10-28).

Active substance

Lebrikizumab

SFDA 1
US FDA 1
EMA 1
Health Canada 2
US price lines 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
Ebglyss	250 mg	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 4413.45	Biological · Prescription	Eli Lilly and Company	Valid

Indications — CHI Daman Drug Formulary

ECZEMA

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

Product	Strength	Form · route	Applicant	Status	First approved
EBGLYSS	250MG/2ML	injectable · injection	ELI LILLY AND CO	Prescription	13 Sep 2024

EMA European Union — centrally authorised medicines

Ebglyss Almirall, S.A. · Authorised · authorised 16 Nov 2023 · ATC D11AH10

Therapeutic indication (EMA)

Ebglyss is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
EBGLYSS	02549123	250 MG / 2 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
EBGLYSS	02549131	250 MG / 2 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	EBGLYSS 250 MG/2 ML PEN	$1783.52375	per ML	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 28 Oct 2025 EBGLYSS — safety-related labeling change
Labeling sections changed: Use in Specific Populations

All safety entries for lebrikizumab →

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.