EU/3/03/133: Orphan designation for the treatment of angioedema

icatibant acetate

Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in July 2020 at the end of the 12-year period of market exclusivity.

On 17 February 2003, orphan designation (EU/3/03/133) was granted by the European Commission to Jerini AG, Germany, for icatibant acetate for the treatment of angioedema.

In September 2013, Jerini AG changed name to Shire Orphan Therapies GmbH.

Icatibant acetate has been authorised in the EU as Firazyr since 11 July 2008.

The sponsorship was transferred to Shire Pharmaceuticals Ireland Limited, Ireland in September 2018.

Key facts

Active substance
icatibant acetate
Intended use
Treatment of angioedema
Orphan designation status
EU designation number
Date of designation

Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza
50 - 58 Baggot Street Lower
Dublin 2
Tel. +353 1 6422161

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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