Bravecto

Fluralaner

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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 Bravecto?

Bravecto is a veterinary medicine that contains the active substance fluralaner. It is available as chewable tablets in five different strengths for use on dogs of different weights.

What is Bravecto used for?

Bravecto 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). Bravecto is given around the dog’s feeding time as a tablet of the appropriate strength for the dog’s bodyweight. After being given its actions last for 12 weeks against fleas and 8 to 12 weeks against ticks. Treatment should be repeated every twelve weeks for optimal flea control. For optimal tick control treatment should be repeated every 8 to 12 weeks depending on the tick species. Bravecto kills fleas within 8 hours and ticks within 12 hours.

How does Bravecto work?

The active substance in Bravecto, fluralaner, 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.

Fluralaner 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) and glutamate, two substances that convey messages between nerves (neurotransmitters). This results in uncontrolled activity of the nervous system and the paralysis and death of the fleas and ticks. Fluralaner kills fleas before they can lay eggs and so helps to reduce contamination of the dogs’ environment.

How has Bravecto been studied?

The effectiveness of Bravecto against fleas and ticks was investigated in both laboratory and field studies.

In an EU field study involving 561 dogs with flea and/or tick infestations the effects of Bravecto were compared with those of another product, fipronil, that kills fleas and ticks, applied as a spot-on solution to the skin of the dogs. The main measure of effectiveness was the reduction in the number of fleas and ticks in the infested dogs measured at specific time points during the 3 months after receiving treatment.

What benefit has Bravecto shown during the studies?

The field study showed that Bravecto was effective in reducing the number of fleas and ticks in dogs with existing flea or tick infestations and that its effects against fleas and most tick species persisted for 3 months.

What is the risk associated with Bravecto?

Dogs may commonly show mild and short-lived diarrhoea, vomiting, lack of appetite and drooling. 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?

The product should be kept in the original package until use, in order to prevent children directly accessing the medicine.

People handling the medicine should not smoke, eat or drink and should wash their hands thoroughly after handling the product.

Why has Bravecto been approved?

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

Other information about Bravecto:

The European Commission granted a marketing authorisation valid throughout the European Union, for Bravecto 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
Bravecto : EPAR - Summary for the public BG = bălgarski 26/03/2014  
Bravecto : EPAR - Summary for the public ES = español 26/03/2014  
Bravecto : EPAR - Summary for the public CS = čeština 26/03/2014  
Bravecto : EPAR - Summary for the public DA = dansk 26/03/2014  
Bravecto : EPAR - Summary for the public DE = Deutsch 26/03/2014  
Bravecto : EPAR - Summary for the public ET = eesti keel 26/03/2014  
Bravecto : EPAR - Summary for the public EL = elliniká 26/03/2014  
Bravecto : EPAR - Summary for the public EN = English 26/03/2014  
Bravecto : EPAR - Summary for the public FR = français 26/03/2014  
Bravecto : EPAR - Summary for the public IT = italiano 26/03/2014  
Bravecto : EPAR - Summary for the public LV = latviešu valoda 26/03/2014  
Bravecto : EPAR - Summary for the public LT = lietuvių kalba 26/03/2014  
Bravecto : EPAR - Summary for the public HU = magyar 26/03/2014  
Bravecto : EPAR - Summary for the public MT = Malti 26/03/2014  
Bravecto : EPAR - Summary for the public NL = Nederlands 26/03/2014  
Bravecto : EPAR - Summary for the public PL = polski 26/03/2014  
Bravecto : EPAR - Summary for the public PT = português 26/03/2014  
Bravecto : EPAR - Summary for the public RO = română 26/03/2014  
Bravecto : EPAR - Summary for the public SK = slovenčina 26/03/2014  
Bravecto : EPAR - Summary for the public SL = slovenščina 26/03/2014  
Bravecto : EPAR - Summary for the public FI = suomi 26/03/2014  
Bravecto : EPAR - Summary for the public SV = svenska 26/03/2014  
Bravecto : EPAR - Summary for the public HR = Hrvatski 26/03/2014  

This EPAR was last updated on 30/09/2015 .

Authorisation details

Product details

Product details for Bravecto
NameBravecto
Agency product numberEMEA/V/C/002526
Active substance

Fluralaner

International non-proprietary name (INN) or common name

Fluralaner

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codeQP53BX05

Publication details

Publication details for Bravecto
Marketing-authorisation holder

Intervet International B.V

Revision1
Date of issue of marketing authorisation valid throughout the European Union11/02/2014

Contact address:

Intervet International B.V
Wim de Körverstraat 35
5831 AN Boxmeer
NETHERLANDS

Product information

Product information

11/09/2015  Bravecto -EMEA/V/C/002526 -IA/0006

Name Language First published Last updated
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - Product Information HR = Hrvatski 26/03/2014 30/09/2015

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
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015
Bravecto : EPAR - All Authorised presentations HR = Hrvatski 26/03/2014 30/09/2015

Pharmacotherapeutic group

Ectoparasiticide for systemic use

Therapeutic indication

For the treatment of tick (Ixodes ricinus, Dermacentor reticulatus, D. variabilis, Rhipicephalus sanguineus) and flea (Ctenocephalides felis) 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
Bravecto : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 30/09/2015  

Initial marketing-authorisation documents

Name Language First published Last updated
Bravecto : EPAR - Public assessment report HR = Hrvatski 26/03/2014  
CVMP summary of positive opinion for Bravecto HR = Hrvatski 13/12/2013