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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.
Jorveza : EPAR - Summary for the public (PDF/116.76 KB)
First published: 18/01/2018
Last updated: 04/06/2020
Jorveza : EPAR - Risk-management-plan summary (PDF/13.9 KB)
First published: 04/06/2020
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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.
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.
Dr. Falk Pharma GmbH
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Leinenweber str. 5
10/11/2022 Jorveza - EMEA/H/C/004655 - II/0015
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Antidiarrheals, intestinal antiinflammatory / antiinfective agents
Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020 (updated)27/03/2020