Firazyr

RSS

icatibant

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Firazyr. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Firazyr.

For practical information about using Firazyr, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 28/04/2023

Authorisation details

Product details
Name
Firazyr
Agency product number
EMEA/H/C/000899
Active substance
icatibant
International non-proprietary name (INN) or common name
icatibant
Therapeutic area (MeSH)
Angioedemas, Hereditary
Anatomical therapeutic chemical (ATC) code
B06AC02
Publication details
Marketing-authorisation holder
Takeda Pharmaceuticals International AG
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
11/07/2008
Contact address

50-58 Baggot Street Lower
Block 2 Miesian Plaza
Dublin 2
Co Dublin
D02 HW68
IRELAND

Product information

20/04/2023 Firazyr - EMEA/H/C/000899 - IB/0057

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Cardiac therapy

Therapeutic indication

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

Assessment history

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