Zerbaxa

RSS

ceftolozane / tazobactam

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

Overview

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 12/06/2018

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 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
7
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

08/05/2018 Zerbaxa - EMEA/H/C/003772 - N/0016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

How useful was this page?

Add your rating