ceftolozane / tazobactam

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Zerbaxa. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zerbaxa.

For practical information about using Zerbaxa, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 11/10/2019

Authorisation details

Product details
Agency product number
Active substance
  • ceftolozane sulfate
  • tazobactam sodium
International non-proprietary name (INN) or common name
ceftolozane / tazobactam
Therapeutic area (MeSH)
Bacterial Infections
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Merck Sharp Dohme Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Hertford Road
Hoddesdon EN11 9BU
United Kingdom

Product information

23/08/2019 Zerbaxa - EMEA/H/C/003772 - II/0020


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Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Zerbaxa is indicated for the treatment of the following infections in adults:

  • Complicated intra-abdominal infections;
  • Acute pyelonephritis;
  • Complicated urinary tract infections.

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

Assessment history

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