Is Lanadelumab 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 Lanadelumab, including Takhzyro (300 mg, Solution for injection, SAR 52774.45).

Is Lanadelumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Lanadelumab, including TAKHZYRO (Prescription).

Is Lanadelumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Lanadelumab: Takhzyro.

Active substance

Lanadelumab

SFDA 2
US FDA 1
EMA 1
Health Canada 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Takhzyro	300 mg	Solution for injection · Subcutaneous use	1 Vial	SAR 52774.45	Biological · Prescription	Takeda Pharmaceuticals International AG	Valid
Takhzyro	300 mg	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 52771.15	Biological · Prescription	Takeda Pharmaceuticals International AG	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
TAKHZYRO	300MG/2ML (150MG/ML)	solution · subcutaneous	DYAX CORP.	Prescription	23 Aug 2018

EMA European Union — centrally authorised medicines

Takhzyro Takeda Pharmaceuticals International AG Ireland Branch · Authorised · authorised 22 Nov 2018 · ATC B06AC05

Therapeutic indication (EMA)

Takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 years and older.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TAKHZYRO	02480948	300 MG / 2 ML	SOLUTION · SUBCUTANEOUS	TAKEDA CANADA INC
TAKHZYRO	02505614	300 MG / 2 ML	SOLUTION · SUBCUTANEOUS	TAKEDA CANADA INC
TAKHZYRO	02564483	300 MG / 2 ML	SOLUTION · SUBCUTANEOUS	TAKEDA CANADA INC

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.