Nexgard Spectra

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afoxolaner / milbemycin oxime

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

Overview

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

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

This EPAR was last updated on 21/12/2017

Authorisation details

Product details
Name
Nexgard Spectra
Agency product number
EMEA/V/C/003842
Active substance
  • afoxolaner
  • milbemycin oxime
International non-proprietary name (INN) or common name
afoxolaner / milbemycin oxime
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QP54AB51
Publication details
Marketing-authorisation holder
Merial
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
14/01/2015
Contact address
29 Avenue
Tony Garnier
69007 Lyon
France

Product information

29/11/2017 Nexgard Spectra - EMEA/V/C/003842 - IB/0013/G

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

  • Antiparasitic products
  • ENDECTOCIDES
  • milbemycin oxime combinations

Therapeutic indication

For the treatment of flea and tick infestations when the concurrent prevention of heartworm disease [Dirofilaria immitis larvae), angiostrongylosis (reduction in level of immature adults (L5) and adults of Angiostrongylus vasorum] and/or treatment of gastrointestinal nematode infestations is indicated.

Assessment history

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