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 10/03/2021

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
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V. 
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
18/09/2015
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

15/02/2021 Zerbaxa - EMEA/H/C/003772 - IAIN/0034

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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;
  • Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).

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

Assessment history

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