Draxxin

RSS

tulathromycin

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

Overview

This is a summary of the European Public Assessment Report (EPAR) for Draxxin. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.

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

This EPAR was last updated on 23/07/2019

Authorisation details

Product details
Name
Draxxin
Agency product number
EMEA/V/C/000077
Active substance
tulathromycin
International non-proprietary name (INN) or common name
tulathromycin
Species
  • Pigs
  • Cattle
  • Sheep
Anatomical therapeutic chemical veterinary (ATCvet) codes
QJ01FA94
Publication details
Marketing-authorisation holder
Zoetis Belgium SA
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
11/11/2003
Contact address

Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium

Product information

19/07/2019 Draxxin - EMEA/V/C/000077 - IB/0045

Contents

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, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment.

Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin.

Pigs: Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment. Draxxin should only be used if pigs are expected to develop the disease within 2–3 days.

Sheep: Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment.

Assessment history

Changes since initial authorisation of medicine

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