Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Doribax
Auth. number : EU/1/08/467
INN : doripenem
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J01 - Antibacterials for systemic use
Pharmacological subgroup: J01D - Other beta-lactam antibacterials
Chemical subgroup: J01DH - Carbapenems
Chemical substance: J01DH04 - Doripenem
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
29/07/2008 Centralised - Authorisation EMEA/H/C/891 (2008)4103 of 25/07/2008
08/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/891/IB/1
24/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/891/II/2
01/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/891/IB/4
26/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/891/IA/6
10/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/891/IA/7
16/07/2009 Centralised - Variation EMEA/H/C/891/II/3 (2009)5745 of 14/07/2009
05/08/2009 Centralised - Variation EMEA/H/C/891/IB/8
Updated with Decision(2010)1784 of 15/03/2010
21/09/2009 Centralised - Variation EMEA/H/C/891/II/5 (2009)7144 of 17/09/2009
17/03/2010 Centralised - Variation EMEA/H/C/891/II/X/9 (2010)1784 of 15/03/2010
29/04/2010 Centralised - Variation EMEA/H/C/891/II/10, 11 (2010)2832 of 27/04/2010
04/06/2010 Centralised - Variation EMEA/H/C/891/IA/12
Updated with Decision(2010)7730 of 03/11/2010
26/07/2010 Centralised - Variation EMEA/H/C/891/IB/13
Updated with Decision(2010)7730 of 03/11/2010
22/09/2010 Centralised - Variation EMEA/H/C/891/IG/23/G
Updated with Decision(2010)7730 of 03/11/2010
09/11/2010 Centralised - Variation EMEA/H/C/891/II/14 (2010)7730 of 03/11/2010
07/12/2010 Corrigendum (2010)7730 corr of 03/12/2010
16/06/2011 Centralised - Variation EMEA/H/C/891/II/16 (2011)4291 of 14/06/2011
03/08/2011 Centralised - Variation EMEA/H/C/891/II/15 (2011)5695 of 01/08/2011
27/08/2012 Referral EMEA/H/C/891/A-20/19 (2012)6008 of 23/08/2012
22/02/2013 Centralised - Variation EMEA/H/C/891/II/22
Updated with Decision(2013)2311 of 17/04/2013
19/04/2013 Centralised - Renewal EMEA/H/C/891/R/21 (2013)2311 of 17/04/2013
04/08/2014 Centralised - Withdrawal (2014)5624 of 31/07/2014