EU/3/13/1181: Orphan designation for the treatment of eosinophilic oesophagitis
Table of contents
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.
Treatment of eosinophilic oesophagitis
|Orphan designation status||
|EU designation number||
|Date of designation||
Dr. Falk Pharma GmbH
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 orphan medicine assessment report .
Documents related to this orphan designation evaluation
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: