Invanz
ertapenem
Table of contents
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.
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) |
|
Anatomical therapeutic chemical (ATC) code |
J01DH03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
|
Revision |
23
|
Date of issue of marketing authorisation valid throughout the European Union |
18/04/2002
|
Contact address |
Product information
03/12/2020 Invanz - EMEA/H/C/000389 - II/0062
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.