Zolvix

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monepantel

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

Overview

This is a summary of the European Public Assessment Report. 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 13/11/2018

Authorisation details

Product details
Name
Zolvix
Agency product number
EMEA/V/C/000154
Active substance
monepantel
International non-proprietary name (INN) or common name
monepantel
Species
Sheep
Anatomical therapeutic chemical veterinary (ATCvet) codes
QP52AX09
Publication details
Marketing-authorisation holder
Elanco GmbH
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
04/11/2009
Contact address

Heinz-Lohmann-Str 4
27472 Cuxhaven
Germany

Product information

30/10/2018 Zolvix - EMEA/V/C/000154 - T/0024

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

Anthelmintics

Therapeutic indication

Zolvix oral solution is a broad spectrum anthelmintic for the treatment and control of gastro-intestinal nematode infections and associated diseases in sheep including lambs, hoggets, breeding rams and ewes.

Spectrum of activity includes fourth larvae and adults of:

  • Haemonchus contortus*;
  • Teladorsagia circumcincta*;
  • Teladorsagia trifurcata*;
  • Teladorsagia davtiani*;
  • Trichostrongylus axei*;
  • Trichostrongylus colubriformis;
  • Trichostrongylus vitrinus;
  • Cooperia curticei;
  • Cooperia oncophora;
  • Nematodirus battus;
  • Nematodirus filicollis;
  • Nematodirus spathiger;
  • Chabertia ovina;
  • Oesophagostomum venulosum.

* including inhibited larvae.

The veterinary medicinal product is effective against strains of these parasites resistant to (pro)benzimidazoles, levamisole, morantel, macrocyclic lactones and H. contortus strains resistant to salicylanilides.

Assessment history

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