Invanz

RSS

ertapenem

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

Overview

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

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

This EPAR was last updated on 08/06/2018

Authorisation details

Product details
Name
Invanz
Agency product number
EMEA/H/C/000389
Active substance
ertapenem sodium
International non-proprietary name (INN) or common name
ertapenem
Therapeutic area (MeSH)
  • Community-Acquired Infections
  • Streptococcal Infections
  • Staphylococcal Infections
  • Gram-Negative Bacterial Infections
  • Surgical Wound Infection
  • Pneumonia, Bacterial
Anatomical therapeutic chemical (ATC) code
J01DH03
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
18/04/2002
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

08/05/2018 Invanz - EMEA/H/C/000389 - T/0058

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

Treatment

Treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required:

  • intra-abdominal infections;
  • community-acquired pneumonia;
  • acute gynaecological infections;
  • diabetic foot infections of the skin and soft tissue.

Prevention

Invanz is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.

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

Assessment history

How useful was this page?

Add your rating