EU/3/13/1205: Orphan designation for the treatment of eosinophilic oesophagitis

Human monoclonal antibody against human interleukin 13


On 13 November 2013, orphan designation (EU/3/13/1205) was granted by the European Commission to Novartis Europharm Limited, United Kingdom, for human monoclonal antibody against human interleukin 13 for the treatment of eosinophilic oesophagitis.

The sponsorship was transferred to Novartis Europharm Limited, Ireland, in May 2018.

Key facts

Active substance
Human monoclonal antibody against human interleukin 13
Intended use
Treatment of eosinophilic oesophagitis
Orphan designation status
EU designation number
Date of designation
Novartis Europharm Limited
Vista Building
Elm Park
Merrion Road
Dublin 4
Tel. +41 61 324 11 11 (Switzerland)

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Update history

Date Update
August 2022 Please note that this product was withdrawn from the Union Register of orphan medicinal products in August 2022 on request of the Sponsor.

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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