Firazyr: Withdrawal of the application to change the marketing authorisation

icatibant

Overview

On 14 February 2014, Shire Orphan Therapies GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend the use of Firazyr in the treatment of angioedema caused by medicines called angiotensin-converting enzyme inhibitors.

Key facts

Name
Firazyr
Product number
EMEA/H/C/000899
Date of issue of market authorisation valid throughout the European Union (if applicable)
11/07/2008
International non-proprietary name (INN) or common name
  • icatibant
Active substance
  • icatibant
Date of withdrawal
14/02/2014
Company making the application
Shire Orphan Therapies GmbH 
Withdrawal type
Post-authorisation

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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