Firazyr: Withdrawal of the application to change the marketing authorisation



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

Product number
Date of issue of market authorisation valid throughout the European Union (if applicable)
International non-proprietary name (INN) or common name
  • icatibant
Active substance
  • icatibant
Date of withdrawal
Company making the application
Takeda Pharmaceuticals International AG
Withdrawal type

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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