Zactran
gamithromycin
Table of contents
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.
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 |
|
Anatomical therapeutic chemical veterinary (ATCvet) codes |
QJ01FA95
|
Publication details | |
---|---|
Marketing-authorisation holder |
Boehringer Ingelheim Vetmedica GmbH
|
Revision |
11
|
Date of issue of marketing authorisation valid throughout the European Union |
24/07/2008
|
Contact address |
Product information
19/12/2019 Zactran - EMEA/V/C/000129 - T/0043
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.