Doribax

Application under evaluation
CHMP opinion
European Commission decision

Overview

On 25 July 2008, the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Doribax, which had been approved for the treatment of nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections.

The marketing authorisation holder (MAH) responsible for Doribax was Janssen-Cilag International N.V.

On 31 July 2014, the European Commission issued a decision to withdraw the marketing authorisation for Doribax, following its receipt of a letter dated 6 July 2014 notifying the Commission of the MAH’s decision to voluntarily withdraw the marketing authorisation for this product for commercial reasons.

Doribax was marketed in the following European countries: Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Liechtenstein, Lithuania, Luxemburg, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden and United Kingdom.

Pursuant to this decision, the European public assessment report for Doribax is updated to reflect that the marketing authorisation is no longer valid.

Doribax : EPAR - Summary for the public

Reference Number: EMA/450072/2012

English (EN) (224.28 KB - PDF)

First published: 31/07/2008 Last updated: 17/10/2014

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Other languages (21)

Product information

Doribax : EPAR - Product Information

English (EN) (611.03 KB - PDF)

First published: 02/12/2009 Last updated: 17/10/2014

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Other languages (23)

Latest procedure affecting product information:II/0022

21/02/2012

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).

Product details

Name of medicine

Doribax

Active substance

doripenem

International non-proprietary name (INN) or common name

doripenem

Therapeutic area (MeSH)

Pneumonia, Ventilator-Associated
Pneumonia, Bacterial
Urinary Tract Infections
Bacterial Infections
Cross Infection

Anatomical therapeutic chemical (ATC) code

J01DH04

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

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

nosocomial pneumonia (including ventilator-associated pneumonia);
complicated intra-abdominal infections;
complicated urinary tract infections.

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

Authorisation details

EMA product number: EMEA/H/C/000891
Marketing authorisation holder: Janssen-Cilag International NV
Turnhoutseweg, 30
B-2340 Beerse
Belgium
Marketing authorisation issued: 25/07/2008
Withdrawal of marketing authorisation: 31/07/2014
Revision: 10

Assessment history

Doribax : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (287.25 KB - PDF)

First published: 02/12/2009 Last updated: 17/10/2014

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Doribax-H-C-P46-32 : EPAR - Assessment Report

Adopted Reference Number: EMA/594076/2014

English (EN) (465.01 KB - PDF)