Xerava - opinion on variation to marketing authorisation

Opinion

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

eravacycline

Opinion

On 13 November 2025, 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 Xerava. The marketing authorisation holder for this medicinal product is Paion Pharma GmbH.

The CHMP adopted an extension to the existing indication, as follows:

Xerava is indicated in adolescents from the age of 12 years weighing at least 50 kg, and in adults, for the treatment of complicated intra-abdominal infections (cIAI) in adults (see sections 4.4 and 5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

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.

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CHMP post-authorisation summary of positive opinion for Xerava (EMAVR0000265697)

Adopted Reference Number: EMADOC-1700519818-2615480

Key facts

• Name of medicine:
  Xerava
• EMA product number:
  EMEA/H/C/004237
• Active substance:
  eravacycline
• International non-proprietary name (INN) or common name:
  eravacycline
• Therapeutic area (MeSH):
  • Infection
  • Bacterial Infections
• Anatomical therapeutical chemical (ATC) code:
  J01AA
• Marketing authorisation holder:
  PAION Pharma GmbH
• Date of opinion:
  13/11/2025
• Status:
  Positive