Table of contents
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.
Draxxin : EPAR - Summary for the public (PDF/95.82 KB)
First published: 03/10/2008
Last updated: 28/11/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Anatomical therapeutic chemical veterinary (ATCvet) codes||
Zoetis Belgium SA
|Date of issue of marketing authorisation valid throughout the European Union||
Rue Laid Burniat 1
16/07/2021 Draxxin - EMEA/V/C/000077 - IB/0049
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Antibacterials for systemic use
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.
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 10-12 May 202117/05/2021