🇪🇺 Xerava in European Union

EMA authorised Xerava on 20 September 2018

Marketing authorisations

EMA — authorised 20 September 2018

  • Marketing authorisation holder: TETRAPHASE PHARMS
  • Status: approved

EMA — authorised 20 September 2018

  • Application: EMEA/H/C/004237
  • Marketing authorisation holder: PAION Pharma GmbH
  • Local brand name: Xerava
  • Indication: 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). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
  • Status: approved

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Xerava in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Infectious Disease approved in European Union

Frequently asked questions

Is Xerava approved in European Union?

Yes. EMA authorised it on 20 September 2018; EMA authorised it on 20 September 2018.

Who is the marketing authorisation holder for Xerava in European Union?

TETRAPHASE PHARMS holds the EU marketing authorisation.