Zerbaxa
ceftolozane / tazobactam
Table of contents
Overview
Zerbaxa is an antibiotic used to treat adults and children 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).
It is also used to treat adults with 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.
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Zerbaxa : EPAR - Medicine overview (PDF/143.34 KB)
First published: 01/10/2015
Last updated: 06/09/2022 -
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Zerbaxa : EPAR - Risk-management-plan summary (PDF/2.49 MB)
First published: 01/10/2015
Last updated: 08/11/2019
Authorisation details
Product details | |
---|---|
Name |
Zerbaxa
|
Agency product number |
EMEA/H/C/003772
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Bacterial Infections
|
Anatomical therapeutic chemical (ATC) code |
J01
|
Publication details | |
---|---|
Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
|
Revision |
15
|
Date of issue of marketing authorisation valid throughout the European Union |
18/09/2015
|
Contact address |
Waarderweg 39 |
Product information
25/07/2022 Zerbaxa - EMEA/H/C/003772 - II/0036
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.