Jorveza
budesonide
Table of contents
Overview
Jorveza is a medicine used to treat adults with eosinophilic oesophagitis. Eosinophilic oesophagitis is inflammation of the oesophagus (the passage that leads from the mouth to the stomach), which causes symptoms such as dysphagia (difficulty swallowing) and blockage of the oesophagus. It is caused by a large build-up of white blood cells called eosinophils in the lining of the oesophagus.
Eosinophilic oesophagitis is rare, and Jorveza was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 5 August 2013. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3131181.
Jorveza contains the active substance budesonide.
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List item
Jorveza : EPAR - Summary for the public (PDF/116.76 KB)
First published: 18/01/2018
Last updated: 04/06/2020
EMA/170647/2020 -
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List item
Jorveza : EPAR - Risk-management-plan summary (PDF/13.9 KB)
First published: 04/06/2020
Authorisation details
Product details | |
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Name |
Jorveza
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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
|
Accelerated assessment |
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment. |
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 | |
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Marketing-authorisation holder |
Dr. Falk Pharma GmbH
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Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
08/01/2018
|
Contact address |
Product information
20/05/2020 Jorveza - EMEA/H/C/004655 - X/0007/G
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
Antidiarrheals, intestinal antiinflammatory / antiinfective agents
Therapeutic indication
Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).