Is Tralokinumab 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 Tralokinumab, including Adtralza (150 mg, Solution for injection, SAR 4413.45).

Is Tralokinumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Tralokinumab, including ADBRY (Prescription).

Is Tralokinumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tralokinumab: Adtralza.

Are there safety signals or safety updates for Tralokinumab?

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

Active substance

Tralokinumab

SFDA 1
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
Adtralza	150 mg	Solution for injection · Subcutaneous use	4 Pre-filled syringe	SAR 4413.45	Biological · Prescription	Pharmaceutical Products	Valid

Indications — CHI Daman Drug Formulary

ECZEMA

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

Product	Strength	Form · route	Applicant	Status	First approved
ADBRY	150MG/ML	injectable · injection	LEO PHARMA AS	Prescription	27 Dec 2021

EMA European Union — centrally authorised medicines

Adtralza LEO Pharma A/S · Authorised · authorised 17 Jun 2021 · ATC D11

Therapeutic indication (EMA)

Adtralza is indicated for the treatment of moderate to severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ADTRALZA	02521288	150 MG / ML	SOLUTION · SUBCUTANEOUS	LEO PHARMA INC
ADTRALZA	02540193	300 MG / 2 ML	SOLUTION · SUBCUTANEOUS	LEO PHARMA INC

Safety signals and safety-related labeling changes

US FDA 12 Dec 2025 ADBRY — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations

All safety entries for tralokinumab →

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.