Jorveza

RSS

budesonide

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Jorveza. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Jorveza.

For practical information about using Jorveza, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 18/01/2018

Authorisation details

Product details
Name
Jorveza
Agency product number
EMEA/H/C/004655
Active substance
budesonide
International non-proprietary name (INN) or common name
budesonide
Therapeutic area (MeSH)
Esophageal Diseases
Anatomical therapeutic chemical (ATC) code
A07EA06
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Dr. Falk Pharma GmbH
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
08/01/2018
Contact address
Leinenweber str. 5
79108 Freiburg
Germany

Product information

08/01/2018 Jorveza - EMEA/H/C/004655 - -

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

  • Intestinal anti inflammatory agents
  • Corticosteroids acting locally

Therapeutic indication

Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).

Assessment history

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