EU/3/13/1181: Orphan designation for the treatment of eosinophilic oesophagitis

budesonide

Overview

On 5 August 2013, orphan designation (EU/3/13/1181) was granted by the European Commission to Dr Falk Pharma GmbH, Germany, for budesonide for the treatment of eosinophilic oesophagitis.

Budesonide has been authorised in the EU as Jorveza since 8 January 2018.

Key facts

Active substance
budesonide
Intended use
Treatment of eosinophilic oesophagitis
Orphan designation status
Positive
EU designation number
EU/3/13/1181
Date of designation
05/08/2013
Sponsor

Dr. Falk Pharma GmbH
Leinenweberstrasse 5
D-79108 Freiburg i.Br.
Germany
Tel. +49 7611514 0
Fax +49 7611514 391
E-mail: zentrale@drfalkpharma.de

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Jorveza at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF icon orphan medicine assessment report .

Documents related to this orphan designation evaluation

Patients' organisations

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

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

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

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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