Is Icatibant 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 Icatibant, including Firazyr 30 mg per 3 ml (10 mg/ml, Solution for injection, SAR 4781.10).

Is Icatibant approved by the US FDA?

Drugs@FDA lists 11 application product lines for Icatibant, including FIRAZYR (Prescription); ICATIBANT ACETATE (Prescription); ICATIBANT ACETATE (Prescription); ICATIBANT ACETATE (Prescription); ICATIBANT ACETATE (Prescription).

Is Icatibant authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Icatibant: Firazyr, Icatibant Accord.

Are there safety signals or safety updates for Icatibant?

US FDA: 1 entry (latest 2024-01-19).

Active substance

Icatibant

SFDA 1
US FDA 11
EMA 2
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
Firazyr 30 mg per 3 ml	10 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 4781.10	NCE · Prescription	Takeda Pharmaceuticals International AG	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	injectable · subcutaneous	TAKEDA PHARMS USA	Prescription	25 Aug 2011
ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	injectable · subcutaneous	TEVA PHARMS USA	Prescription	15 Jul 2019
ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	injectable · subcutaneous	JIANGSU HANSOH PHARM	Prescription	9 Mar 2020
ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	injectable · subcutaneous	FRESENIUS KABI USA	Prescription	18 Jun 2020
ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	injectable · subcutaneous	CIPLA	Prescription	13 Jul 2020
ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	injectable · subcutaneous	WILSHIRE PHARMS INC	Prescription	2 Sep 2020
ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	injectable · subcutaneous	NANG KUANG PHARM CO	Prescription	16 Dec 2020
ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	injectable · subcutaneous	EUGIA PHARMA	Prescription	14 Aug 2023
ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	injectable · subcutaneous	ALEMBIC	Prescription	14 Jun 2024
ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	injectable · subcutaneous	CAPLIN	Discontinued	5 Oct 2020
ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	injectable · subcutaneous	GLENMARK PHARMS LTD	Discontinued	21 May 2021

EMA European Union — centrally authorised medicines

Firazyr Takeda Pharmaceuticals International AG · Authorised · authorised 11 Jul 2008 · ATC B06AC02

Therapeutic indication (EMA)

Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency).

Icatibant Accord Accord Healthcare S.L.U. · Authorised · authorised 16 Jul 2021 · ATC B06AC02

Therapeutic indication (EMA)

Icatibant Accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1 esterase inhibitor deficiency.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
FIRAZYR	02425696	10 MG / ML	SOLUTION · SUBCUTANEOUS	TAKEDA CANADA INC
ICATIBANT INJECTION	02547562	10 MG / ML	SOLUTION · SUBCUTANEOUS	JAMP PHARMA CORPORATION

Safety signals and safety-related labeling changes

US FDA 19 Jan 2024 FIRAZYR — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for icatibant →

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.