Jorveza

RSS

budesonide

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

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.

This EPAR was last updated on 04/06/2020

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
Accelerated assessmentAccelerated 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.

OrphanOrphan

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
2
Date of issue of marketing authorisation valid throughout the European Union
08/01/2018
Contact address
Leinenweber str. 5
79108 Freiburg
Germany

Product information

20/05/2020 Jorveza - EMEA/H/C/004655 - X/0007/G

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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).

Assessment history

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