Table of contents
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.
Firazyr : EPAR - Summary for the public (PDF/77.45 KB)
First published: 14/07/2008
Last updated: 06/12/2017
Firazyr : EPAR - Risk management plan summary (PDF/41.67 KB)
First published: 11/01/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Takeda Pharmaceuticals International AG
|Date of issue of marketing authorisation valid throughout the European Union||
50-58 Baggot Street Lower
20/04/2023 Firazyr - EMEA/H/C/000899 - IB/0057
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency).