Zactran

RSS

gamithromycin

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

Overview

This is a summary of the European public assessment report (EPAR) for Zactran. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Zactran.

For practical information about using Zactran, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

This EPAR was last updated on 07/03/2018

Authorisation details

Product details
Name
Zactran
Agency product number
EMEA/V/C/000129
Active substance
gamithromycin
International non-proprietary name (INN) or common name
gamithromycin
Species
  • Cattle
  • Pigs
  • Sheep
Anatomical therapeutic chemical veterinary (ATCvet) codes
QJ01FA95
Publication details
Marketing-authorisation holder
Merial
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
24/07/2008
Contact address
29 avenue Tony Garnier
69007 Lyon
France

Product information

12/01/2018 Zactran - EMEA/V/C/000129 - II/0036

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

Cattle

Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. The presence of the disease in the herd should be established before metaphylactic use.

Pigs

Treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Bordetella bronchiseptica.

Sheep

Treatment of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus and Fusobacterium necrophorum requiring systemic treatment.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating