Doribax

RSS

doripenem

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Doribax has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 17/10/2014

Authorisation details

Product details
Name
Doribax
Agency product number
EMEA/H/C/000891
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
Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
25/07/2008
Contact address

Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

21/02/2012 Doribax - EMEA/H/C/000891 - II/0022

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

Changes since initial authorisation of medicine

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