Zuprevo

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tildipirosin

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

Overview

This is a summary of the European public assessment report (EPAR). 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 on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 25/04/2016

Authorisation details

Product details
Name
Zuprevo
Agency product number
EMEA/V/C/002009
Active substance
tildipirosin
International non-proprietary name (INN) or common name
tildipirosin
Species
  • Pigs
  • Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes
QJ01FA
Publication details
Marketing-authorisation holder
Intervet International BV
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
05/05/2011
Contact address
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

21/03/2016 Zuprevo - EMEA/V/C/002009 - R/0010

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

general anti infectives for systemic use

Therapeutic indication

40-mg/ml solution for injection for pigs

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

The presence of the disease in the herd should be confirmed before metaphylaxis is implemented.

180-mg/ml solution for injection for cattle

For the treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni sensitive to tildipirosin.

The presence of the disease in the herd should be confirmed before preventive treatment.

Assessment history

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