Zavicefta

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ceftazidime / avibactam

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

Overview

This is a summary of the European public assessment report (EPAR) for Zavicefta. 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 Zavicefta.

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

This EPAR was last updated on 29/11/2018

Authorisation details

Product details
Name
Zavicefta
Agency product number
EMEA/H/C/004027
Active substance
  • Ceftazidime
  • avibactam
International non-proprietary name (INN) or common name
ceftazidime / avibactam
Therapeutic area (MeSH)
  • Pneumonia, Bacterial
  • Soft Tissue Infections
  • Pneumonia
  • Urinary Tract Infections
  • Gram-Negative 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
Pfizer Ireland Pharmaceuticals
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
23/06/2016
Contact address
Operations Support Group
Ringaskiddy, County Cork
Ireland

Product information

24/10/2018 Zavicefta - EMEA/H/C/004027 - N/0013

Contents

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

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

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

  • Complicated intra-abdominal Infection (cIAI)
  • Complicated urinary tract infection (cUTI), including pyelonephritis
  • Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)

Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options.

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

Assessment history

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