Naxcel

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ceftiofur

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Naxcel. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information regarding the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 30/06/2017

Authorisation details

Product details
Name
Naxcel
Agency product number
EMEA/V/C/000079
Active substance
ceftiofur
International non-proprietary name (INN) or common name
ceftiofur
Species
  • Pigs
  • Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes
QJ01DD90
Publication details
Marketing-authorisation holder
Zoetis Belgium SA
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
19/05/2005
Contact address
Rue Laid Burnait, 1
1348 Louvain-la-Neuve
Belgium

Product information

23/03/2017 Naxcel - EMEA/V/C/000079 - IG/0747

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.

Pharmacotherapeutic group

ANTIBACTERIALS FOR SYSTEMIC USE

Therapeutic indication

Pigs

  • 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.

Cattle

  • 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.

Assessment history

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