Jorveza - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

budesonide

Opinion

On 26 February 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Jorveza. The marketing authorisation holder for this medicinal product is Dr. Falk Pharma GmbH.

The CHMP adopted a new pharmaceutical form, oral suspension, with a new strength, 0.2 mg/ml, associated with a new indication as follows:

Jorveza 0.2 mg/mL oral suspension is indicated for the treatment of eosinophilic esophagitis (EoE) in paediatric patients 2 to 17 years of age.

The indication for Jorveza orodispersible tablets remains unchanged, as follows:

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

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

CHMP post-authorisation summary of positive opinion for Jorveza (X/0000257468)

Adopted Reference Number: EMADOC-1700519818-2896158

Key facts

• Name of medicine:
  Jorveza
• EMA product number:
  EMEA/H/C/004655
• Active substance:
  Budesonide
• International non-proprietary name (INN) or common name:
  budesonide
• Therapeutic area (MeSH):
  Esophageal Diseases
• Anatomical therapeutical 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.

• Marketing authorisation holder:
  Dr. Falk Pharma GmbH
• Date of opinion:
  26/02/2026
• Status:
  Positive