Doribax

Withdrawn

This medicine's authorisation has been withdrawn

doripenem

Overview

The marketing authorisation for Doribax has been withdrawn at the request of the marketing authorisation holder.

Doribax : EPAR - Summary for the public

Reference Number: EMA/450072/2012

Product information

Doribax : EPAR - Product Information

Latest procedure affecting product information: II/0022

21/02/2012

This medicine’s product information is available in all official EU languages.
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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
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

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

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

AdoptedReference Number: EMA/594076/2014

Doribax-H-C-891-P46-26 : EPAR - Assessment Report

AdoptedReference Number: EMEA/594075/2014

Doribax-H-C-891-P46-31 : EPAR - Assessment Report

Adopted

Doribax-H-C-891-P46-26.1 : EPAR - Assessment Report

AdoptedReference Number: EMA/594074/2014

Doribax-H-C-891-P46-30 : EPAR - Assessment Report

AdoptedReference Number: EMA/594074/2014

Doribax-H-C-891-P46-25 : EPAR - Assessment Report

AdoptedReference Number: EMA/CHMP/193555/2013

Doribax-H-C-891-P46-24 : EPAR - Assessment Report

AdoptedReference Number: EMA/CHMP/193555/2013

Doribax-H-C-891-A20-45 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/549030/2012

Initial marketing authorisation documents

Doribax : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Doribax

Reference Number: EMEA/CHMP/185915/2008