NexGard

afoxolaner

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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).

What is NexGard?

NexGard is a veterinary medicine that contains the active substance afoxolaner. It is available as chewable tablets in four different strengths for use in dogs of different weights.

What is NexGard used for?

NexGard is used to treat flea and tick infestations in dogs. It may be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites). NexGard is given as a tablet of the appropriate strength for the dog’s bodyweight. After being given, its actions last for 5 weeks against fleas and one month against ticks. Treatment should be repeated at monthly intervals during the flea or tick seasons. NexGard kills fleas within 8 hours and ticks within 48 hours.

How does NexGard work?

The active substance in NexGard, afoxolaner, acts as an ‘ectoparasiticide’. This means that it kills parasites that live on the skin or in the fur of animals, such as fleas and ticks. In order to be exposed to the active substance, fleas and ticks must attach to the skin and commence feeding on the dog’s blood.

Afoxolaner kills fleas and ticks that have ingested the dog’s blood by acting on their nervous system. It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA), a substance which conveys messages between nerves (neurotransmitter). This results in uncontrolled activity of the nervous system and the paralysis and death of the fleas and ticks. Afoxolaner kills fleas before they can lay eggs and so helps to reduce contamination of the dogs’ environment.

How has NexGard been studied?

The effectiveness of NexGard against fleas and ticks was investigated in both laboratory and field studies. One main field study in the EU involved 146 dogs with flea and/or tick infestations that were given a single treatment with NexGard or a spot-on medicine containing pyriprole that controls fleas and ticks. The measure of effectiveness was reduction in the number of fleas and ticks at day 7, 14, 21 and 30 after treatment.

What benefit has NexGard shown during the studies?

The EU field study showed that NexGard was effective in treating flea and tick infestations in dogs for up to 30 days after treatment. NexGard reduced the number of fleas and ticks by at least 98% and was at least as effective as pyriprole.

What is the risk associated with NexGard?

Because fleas and ticks must start feeding on the dog in order to be killed by the medicine, the risk of transmission of diseases with which they may be infected cannot be excluded.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Only one chewable tablet at a time should be removed from the blister to prevent children from accessing the product. The blister should be returned into the carton.

People handling the medicine should wash their hands after handling the product.

Why has NexGard been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of NexGard exceed the risks for the approved indications and recommended that NexGard be given a marketing authorisation. The benefit/risk balance may be found in the scientific discussion module of this EPAR.

Other information about NexGard:

The European Commission granted a marketing authorisation valid throughout the European Union, for NexGard on 11 February 2014. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
NexGard : EPAR - Summary for the public BG = bălgarski 2013-03-27  
NexGard : EPAR - Summary for the public ES = español 2013-03-27  
NexGard : EPAR - Summary for the public CS = čeština 2013-03-27  
NexGard : EPAR - Summary for the public DA = dansk 2013-03-27  
NexGard : EPAR - Summary for the public DE = Deutsch 2013-03-27  
NexGard : EPAR - Summary for the public ET = eesti keel 2013-03-27  
NexGard : EPAR - Summary for the public EL = elliniká 2013-03-27  
NexGard : EPAR - Summary for the public EN = English 2013-03-27  
NexGard : EPAR - Summary for the public FR = français 2013-03-27  
NexGard : EPAR - Summary for the public IT = italiano 2013-03-27  
NexGard : EPAR - Summary for the public LV = latviešu valoda 2013-03-27  
NexGard : EPAR - Summary for the public LT = lietuvių kalba 2013-03-27  
NexGard : EPAR - Summary for the public HU = magyar 2013-03-27  
NexGard : EPAR - Summary for the public MT = Malti 2013-03-27  
NexGard : EPAR - Summary for the public NL = Nederlands 2013-03-27  
NexGard : EPAR - Summary for the public PL = polski 2013-03-27  
NexGard : EPAR - Summary for the public PT = português 2013-03-27  
NexGard : EPAR - Summary for the public RO = română 2013-03-27  
NexGard : EPAR - Summary for the public SK = slovenčina 2013-03-27  
NexGard : EPAR - Summary for the public SL = slovenščina 2013-03-27  
NexGard : EPAR - Summary for the public FI = suomi 2013-03-27  
NexGard : EPAR - Summary for the public SV = svenska 2013-03-27  
NexGard : EPAR - Summary for the public HR = Hrvatski 2013-03-27  

This EPAR was last updated on 16/06/2015 .

Authorisation details

Product details

Product details for NexGard
NameNexGard
Agency product numberEMEA/V/C/002729
Active substance

afoxolaner

International non-proprietary name (INN) or common name

afoxolaner

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codeQP53BX04

Publication details

Publication details for NexGard
Marketing-authorisation holder

Merial

Revision4
Date of issue of marketing authorisation valid throughout the European Union11/02/2014

Contact address:

Merial
29 avenue Tony Garnier
BP 7123
69007 Lyon Cedex 07
FRANCE

Product information

Product information

05/06/2015  NexGard -EMEA/V/C/002729 -IB/0010

Name Language First published Last updated
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16
NexGard : EPAR - Product Information HR = Hrvatski 2013-03-27 2015-06-16

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.


Name Language First published Last updated
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  
NexGard : EPAR - All Authorised presentations HR = Hrvatski 2013-03-27  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
NexGard : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2014-09-17 2015-06-16

Initial marketing-authorisation documents

Name Language First published Last updated
CVMP summary of positive opinion for NexGard HR = Hrvatski 2013-12-13  
NexGard : EPAR - Public assessment report HR = Hrvatski 2013-03-27