Pharmaceuticals - Community Register


Community register of veterinary medicinal products


Product information

Invented name: Naxcel   
Auth. number : EU/2/05/053
Active substance : ceftiofur
ATC: Anatomical main group: QJ - Antiinfectives for systemic use
Therapeutic subgroup: QJ01 - Antibacterials for systemic use
Pharmacological subgroup: QJ01D - Other beta-lactam antibacterials
Chemical subgroup: QJ01DD - Third-generation cephalosporins
Chemical substance: QJ01DD90 - ceftiofur
(See WHO ATCvet Index)
Indication: Treatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis.
Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.
Treatment of acute interdigital necrobacillosis in cattle also known as Panaritium or foot rot.
Treatment of acute post-partum (puerperal) metritis in cattle, in cases where treatment with another antimicrobial has failed.
Marketing Authorisation Holder: Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique
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
24/05/2005 Centralised - Authorisation EMEA/V/C/79 (2005)1566 of 19/05/2005
05/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/79/IA/1
13/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/79/IB/2
13/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/79/IB/3
23/08/2006 Centralised - Variation EMEA/V/C/79/II/4 (2006)3832 of 21/08/2006
26/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/79/IB/6
19/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/79/IB/5
05/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/79/IB/9
12/10/2009 Centralised - Variation EMEA/V/C/79/X/7 (2009)7881 of 08/10/2009
23/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/79/II/10
28/05/2010 Centralised - Renewal EMEA/V/C/79/R/11 (2010)3488 of 26/05/2010
16/06/2011 Centralised - Variation EMEA/V/C/79/II/12 (2011)4294 of 14/06/2011
30/05/2012 Centralised - Variation EMEA/V/C/79/IAIN/15
Updated with Decision(2012)7859 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7859 of 29/10/2012
11/01/2013 Centralised - Variation EMEA/V/C/79/IB/16
Updated with Decision(2013)3152 of 23/05/2013
27/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/79/T/18 (2013)3152 of 23/05/2013
05/09/2013 Centralised - Variation EMEA/V/C/79//IA/21/G
Updated with Decision(2014)6193 of 26/08/2014
28/08/2014 Centralised - Yearly update (2014)6193 of 26/08/2014
24/04/2015 Centralised - Variation EMEA/V/C/79/IA/27
Updated with Decision(2016)2699 of 27/04/2016
29/04/2016 Centralised - Yearly update (2016)2699 of 27/04/2016
23/03/2017 Centralised - Variation EMEA/V/C/79/IAIN/747
Updated with Decision(2018)2688 of 26/04/2018
30/04/2018 Centralised - Yearly update (2018)2688 of 26/04/2018