Doribax

doripenem

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The marketing authorisation for Doribax has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Doribax : EPAR - Summary for the public BG = bălgarski 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public ES = español 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public CS = čeština 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public DA = dansk 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public DE = Deutsch 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public ET = eesti keel 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public EL = elliniká 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public EN = English 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public FR = français 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public IT = italiano 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public LV = latviešu valoda 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public LT = lietuvių kalba 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public HU = magyar 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public MT = Malti 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public NL = Nederlands 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public PL = polski 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public PT = português 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public RO = română 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public SK = slovenčina 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public SL = slovenščina 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public FI = suomi 2008-07-31 2014-10-17
Doribax : EPAR - Summary for the public SV = svenska 2008-07-31 2014-10-17

This EPAR was last updated on 17/10/2014 .

Authorisation details

Product details

Product details for Doribax
NameDoribax
Agency product numberEMEA/H/C/000891
Active substance

doripenem

International non-proprietary name (INN) or common name

doripenem

Therapeutic area Cross InfectionBacterial InfectionsPneumonia, BacterialPneumonia, Ventilator-AssociatedUrinary Tract Infections
Anatomical therapeutic chemical (ATC) code J01DH04

Publication details

Publication details for Doribax
Marketing-authorisation holder

Janssen-Cilag International NV

Revision10
Date of issue of marketing authorisation valid throughout the European Union25/07/2008

Contact address:

Janssen-Cilag International NV
Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

Product information

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

Name Language First published Last updated
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17
Doribax : EPAR - Product Information SV = svenska 2009-12-02 2014-10-17

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.


Name Language First published Last updated
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17
Doribax : EPAR - All Authorised presentations SV = svenska 2008-08-01 2014-10-17

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

Name Language First published Last updated
Doribax : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-12-02 2014-10-17
Doribax-H-C-891-P46-25 : EPAR - Assessment Report SV = svenska 2013-03-27 2014-10-17
Doribax-H-C-891-P46-24 : EPAR - Assessment Report SV = svenska 2013-03-27 2014-10-17
Doribax-H-C-891-P46-26 : EPAR - Assessment Report SV = svenska 2014-10-17  
Doribax-H-C-891-P46-26.1 : EPAR - Assessment Report SV = svenska 2014-10-17  
Doribax-H-C-891-P46-31 : EPAR - Assessment Report SV = svenska 2014-10-17  
Doribax-H-C-P46-32 : EPAR - Assessment Report SV = svenska 2014-10-17  
Doribax-H-C-891-P46-30 : EPAR - Assessment Report SV = svenska 2014-10-17  
Doribax-H-C-891-A20-45 : EPAR - Assessment Report - Article 20 SV = svenska 2012-12-19 2014-10-17

Initial marketing-authorisation documents

Name Language First published Last updated
Doribax : EPAR - Public assessment report SV = svenska 2008-08-01 2014-10-17
Committee for medicinal products for human use summary of positive opinion for Doribax SV = svenska 2008-05-30 2014-10-17

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Doribax