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EMA Product

Xenleta

Product approved by European Medicines Agency (EU)

Basic Information

Xenleta

Regulatory Information

EMEA/H/C/005048

Authorised

July 27, 2020

2

April 29, 2025

Company Information

Ireland

Alexandra House Office 225/227 The Sweepstakes Ballsbridge Dublin 4, D04 C7H2

Nabriva Therapeutics Ireland DAC

Active Ingredients

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic 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.

Overview Summary

Xenleta is an antibiotic used in adults to treat community-acquired pneumonia (a lung infection caught outside of hospital) when other antibiotic medicines are not suitable or do not work. Xenleta contains the active substance lefamulin.

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