Zerbaxa

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ceftolozane / tazobactam

Authorised
This medicine is authorised for use in the European Union.

Overview

Zerbaxa is an antibiotic used to treat adults with:

  • complicated (difficult to treat) infections of tissues and organs within the belly (intra-abdominal infections); serious kidney infection (acute pyelonephritis);
  • complicated infections of the urinary tract (structures that carry urine, such as the bladder);
  • hospital-acquired pneumonia (an infection of the lungs that is caught in the hospital), including ventilator-associated pneumonia (pneumonia in patients using a ventilator, a machine that helps a patient to breathe).

Zerbaxa contains the active substances ceftolozane and tazobactam.

This EPAR was last updated on 08/11/2019

Authorisation details

Product details
Name
Zerbaxa
Agency product number
EMEA/H/C/003772
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
J01
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
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
18/09/2015
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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