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 02/05/2018

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
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Shire Orphan Therapies GmbH 
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
11/07/2008
Contact address
Shire Orphan Therapies GmbH
Friedrichstrasse 149
D-10117 Berlin
Germany

Product information

26/04/2018 Firazyr - EMEA/H/C/000899 - PSUSA/00001714/201707

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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