🇪🇺 Xenleta in European Union

EMA authorised Xenleta on 27 July 2020

Marketing authorisation

EMA — authorised 27 July 2020

  • Application: EMEA/H/C/005048
  • Marketing authorisation holder: Nabriva Therapeutics Ireland DAC
  • Local brand name: Xenleta
  • Indication: Xenleta is indicated for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
  • Status: approved

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Xenleta 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 Xenleta approved in European Union?

Yes. EMA authorised it on 27 July 2020.

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

Nabriva Therapeutics Ireland DAC holds the EU marketing authorisation.