Is Garadacimab 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 Garadacimab, including Andembry (200 mg, Solution for injection, SAR 87550.10).

Is Garadacimab approved by the US FDA?

Drugs@FDA lists 1 application product line for Garadacimab, including ANDEMBRY (Prescription).

Is Garadacimab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Garadacimab: Andembry.

Active substance

Garadacimab

SFDA 1
US FDA 1
EMA 1
Health Canada 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Andembry	200 mg	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 87550.10	Biological · Prescription	CSL	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
ANDEMBRY	200MG/1.2ML	injectable · subcutaneous	CSL BEHRING LLC	Prescription	16 Jun 2025

EMA European Union — centrally authorised medicines

Andembry CSL Behring GmbH · Authorised · authorised 10 Feb 2025 · ATC B06AC07

Therapeutic indication (EMA)

Andembry is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ANDEMBRY	02559773	200 MG / 1.2 ML	SOLUTION · SUBCUTANEOUS	CSL BEHRING 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.