🇪🇺 Antibiotics in European Union

EMA authorised Antibiotics on 21 March 2024

Marketing authorisation

EMA — authorised 21 March 2024

  • Application: EMEA/H/C/005431
  • Marketing authorisation holder: Advanz Pharma Limited
  • Local brand name: Exblifep
  • Indication: Exblifep is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1): - Complicated urinary tract infections (cUTI), including pyelonephritis - Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
  • Status: approved

The European Medicines Agency (EMA) approved Exblifep, an antibiotic, for marketing in the European Union on 21 March 2024. Exblifep is indicated for the treatment of complicated urinary tract infections, including pyelonephritis, hospital-acquired pneumonia, including ventilator-associated pneumonia, and bacteraemia associated with these infections. The approval was granted to Advanz Pharma Limited, the marketing authorisation holder.

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Antibiotics 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 Antibiotics approved in European Union?

Yes. EMA authorised it on 21 March 2024.

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

Advanz Pharma Limited holds the EU marketing authorisation.