The marketing authorisation for Doribax has been withdrawn at the request of the marketing authorisation holder.
Doribax : EPAR - Summary for the public (PDF/224.28 KB)
First published: 31/07/2008
Last updated: 17/10/2014
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Janssen-Cilag International NV
|Date of issue of marketing authorisation valid throughout the European Union||
21/02/2012 Doribax - EMEA/H/C/000891 - II/0022
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- 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).
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Antibacterials for systemic use
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.