Exzolt

RSS

fluralaner

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

Overview

This is a summary of the European public assessment report (EPAR) for Exzolt.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 Exzolt.

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

This EPAR was last updated on 20/10/2017

Authorisation details

Product details
Name
Exzolt
Agency product number
EMEA/V/C/004344
Active substance
fluralaner
International non-proprietary name (INN) or common name
fluralaner
Species
Chicken
Anatomical therapeutic chemical veterinary (ATCvet) codes
QP53BE02
Publication details
Marketing-authorisation holder
Intervet International B.V.
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
18/08/2017
Contact address
Wim de Körverstraat 35
5831 AN Boxmeer
Netherlands

Product information

18/08/2017 Exzolt - EMEA/V/C/004344 -

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

  • Ectoparaciticides
  • insecticides and repellents

Therapeutic indication

Treatment of poultry red mite (Dermanyssus gallinae) infestation in pullets, breeders and layer hens.

Assessment history

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