Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Jorveza   
Auth. number : EU/1/17/1254
Active substance : budesonide
Orphan market exclusivity for "Treatment of eosinophilic oesophagitis" (based on designation EU/3/13/1181) started on 10/01/2018
   10 years of market exclusivity
   This orphan market exclusivity will expire on 10/01/2028
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A07 - Antidiarrheals, intestinal antiinflammatory/antiinfective agents
Pharmacological subgroup: A07E - Intestinal antiinflammatory agents
Chemical subgroup: A07EA - Corticosteroids for local use
Chemical substance: A07EA06 - budesonide
(See WHO ATC Index)
Indication: Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).
Marketing Authorisation Holder: Dr Falk Pharma GmbH
Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
10/01/2018 Centralised - Authorisation EMEA/H/C/4655 (2018)127 of 8/01/2018