Pharmaceuticals - Union Register

  

Register of orphan medicinal products


GRANTED  

Product information

Budesonide

EU orphan designation number: EU/3/13/1181   
Active ingredient: Budesonide
Indication: Treatment of eosinophilic oesophagitis
Sponsor: Dr Falk Pharma GmbH
Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Jorveza on 8/01/2018 with the number EU/1/17/1254

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
8/08/2013 Orphan designation EMA/OD/078/13 (2013)5280 of 5/08/2013
1/10/2013 Corrigendum (2013)6438 of 27/09/2013
7/12/2017 Other procedure