NexGard

RSS

afoxolaner

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 26/07/2018

Authorisation details

Product details
Name
NexGard
Agency product number
EMEA/V/C/002729
Active substance
afoxolaner
International non-proprietary name (INN) or common name
afoxolaner
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QP53BE01
Publication details
Marketing-authorisation holder
Merial
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
11/02/2014
Contact address
29 avenue Tony Garnier
BP 7123
69007 Lyon Cedex 07
FRANCE

Product information

06/07/2018 NexGard - EMEA/V/C/002729 - IB/0022/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

Ectoparasiticide for systemic use

Therapeutic indication

For the treatment of tick (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus) and flea (Ctenocephalides felis and Ctenocephalides canis) infestations in dogs.

The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).

Assessment history

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