Bravecto Plus

fluralaner / moxidectin

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An overview of Bravecto Plus and why it is authorised in the EU

Bravecto Plus is a veterinary medicine used in cats to treat mixed infestations with both ticks and other parasites that may be found on the skin or fur of cats, such as fleas, and/or worms that live inside the body. The medicine can be used:

  • to treat tick infestations
  • to treat flea infestations. It can also be used as part of a treatment for flea allergy dermatitis (an allergic reaction to flea bites)
  • to treat roundworm and hookworm in the gut
  • to prevent heartworm disease

Bravecto Plus must only be used when there is a need to treat ticks or fleas and one or more of the parasites listed above. Bravecto Plus contains the active substances fluralaner and moxidectin.

How is Bravecto Plus used?

Bravecto Plus is available as a spot-on solution in a pipette. The spot-on solution is available in different strengths for cats of different weights.

The content of one full Bravecto Plus pipette is applied to the cat’s skin at the base of the skull of the cat. The pipette to use is selected on the basis of the cat’s weight. Bravecto Plus kills fleas and ticks within 48 hours. The medicine’s actions against fleas and ticks lasts for 12 weeks after being applied. Treatment should be repeated every twelve weeks for optimal flea and tick control.

Bravecto Plus is effective at preventing heartworm disease for 8 weeks.

The medicine can only be obtained with a prescription.

For more information about using Bravecto Plus, see the package leaflet or contact your veterinarian or pharmacist.

How does Bravecto Plus work?

The active substances in Bravecto Plus, fluralaner and moxidectin, work via different routes to kill parasites. In order to be exposed to the active substance fluralaner, fleas and ticks must commence feeding on the cat.

Fluralaner acts as an ‘ectoparasiticide’. This means that it kills parasites present on the skin or in the fur of animals, such as fleas and ticks. Fluralaner kills fleas and ticks that have ingested the cat’s blood by causing uncontrolled activity of their nervous system. This results in paralysis and death of the parasites. Fluralaner kills fleas before they can lay eggs and so helps to reduce contamination of the cats’ environment.

Moxidectin acts as an ‘endoparasiticide’. This means that it kills parasites present in the body of animals such as roundworms, hookworms and heartworm. Moxidectin causes paralysis and death of these worms by interfering with the way signals are passed between nerve cells (neurotransmission) in the parasites’ nervous system.

Fluralaner and moxidectin, are already authorised on their own for the treatment of parasitic infestations.

What benefits of Bravecto Plus have been shown in studies?

A field study involving cats naturally infested with ticks and/or fleas showed treatment with Bravecto Plus to reduce tick and flea counts by more than 95% and to be as effective as treatment using fipronil, another medicine already licensed for the treatment of ticks and fleas.

Another field study involving cats naturally infected with roundworms and/or hookworms showed treatment with Bravecto Plus to reduce faecal egg counts by 100%. Bravecto Plus was as effective as another medicine containing emodepside and praziquantel.

Two laboratory studies involving healthy cats which were artificially infected with heartworm showed Bravecto Plus to be 100% effective in preventing heartworm disease during 8 weeks.

What are the risks associated with Bravecto Plus?

The most common side effects with Bravecto Plus (which may affect up to 1 in 10 animals) are mild and short-lived reactions at the application site such as hair loss, flaking skin and scratching.

For the full list of side effects and restrictions of Bravecto Plus, see the package leaflet.

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

This medicine is harmful if swallowed. The medicine should be kept in the original package until use, in order to prevent children directly accessing the medicine. Suitable gloves should be worn when handling or applying Bravecto Plus to cats. In case of spillage on table or floor surfaces, excess Bravecto Plus spot-on solution should be removed using paper tissue and the area cleaned with a detergent.

Used pipettes should be disposed of immediately. If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.

Skin rashes, tingling or numbness have been reported in a small number of individuals after skin contact, either when handling the product or when handling the treated animal. Contact with the application site should be avoided until it is no longer noticeable. This includes cuddling the animal and sharing a bed with the animal. It takes up to 48 hours for the application site to become dry but it will be noticeable for longer. In case of skin or eye contact the affected area should be rinsed immediately with water and any contaminated clothes should be removed. If skin reactions occur, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.

Bravecto Plus spot-on solution should be kept away from heat, sparks, open flames or other fire sources as it is highly flammable.

Why is Bravecto Plus authorised in the EU?

The European Medicines Agency decided that Bravecto Plus’s benefits are greater than its risks and it can be authorised for use in the EU.

Other information about Bravecto Plus

Bravecto Plus received a marketing authorisation valid throughout the EU on 8 May 2018.

Name Language First published Last updated
Bravecto Plus : EPAR - Medicine overview BG = bălgarski 2018-06-07  
Bravecto Plus : EPAR - Medicine overview ES = español 2018-06-07  
Bravecto Plus : EPAR - Medicine overview CS = čeština 2018-06-07  
Bravecto Plus : EPAR - Medicine overview DA = dansk 2018-06-07  
Bravecto Plus : EPAR - Medicine overview DE = Deutsch 2018-06-07  
Bravecto Plus : EPAR - Medicine overview ET = eesti keel 2018-06-07  
Bravecto Plus : EPAR - Medicine overview EL = elliniká 2018-06-07  
Bravecto Plus : EPAR - Medicine overview EN = English 2018-06-07  
Bravecto Plus : EPAR - Medicine overview FR = français 2018-06-07  
Bravecto Plus : EPAR - Medicine overview IT = italiano 2018-06-07  
Bravecto Plus : EPAR - Medicine overview LV = latviešu valoda 2018-06-07  
Bravecto Plus : EPAR - Medicine overview LT = lietuvių kalba 2018-06-07  
Bravecto Plus : EPAR - Medicine overview HU = magyar 2018-06-07  
Bravecto Plus : EPAR - Medicine overview MT = Malti 2018-06-07  
Bravecto Plus : EPAR - Medicine overview NL = Nederlands 2018-06-07  
Bravecto Plus : EPAR - Medicine overview PL = polski 2018-06-07  
Bravecto Plus : EPAR - Medicine overview PT = português 2018-06-07  
Bravecto Plus : EPAR - Medicine overview RO = română 2018-06-07  
Bravecto Plus : EPAR - Medicine overview SK = slovenčina 2018-06-07  
Bravecto Plus : EPAR - Medicine overview SL = slovenščina 2018-06-07  
Bravecto Plus : EPAR - Medicine overview FI = suomi 2018-06-07  
Bravecto Plus : EPAR - Medicine overview SV = svenska 2018-06-07  
Bravecto Plus : EPAR - Medicine overview HR = Hrvatski 2018-06-07  

This EPAR was last updated on 06/06/2018 .

Authorisation details

Product details

Product details for Bravecto Plus
NameBravecto Plus
Agency product numberEMEA/V/C/004440
Active substance

fluralaner / moxidectin

International non-proprietary name (INN) or common name

 

fluralaner / moxidectin

 

Species Cats
Anatomical therapeutic chemical veterinary (ATCvet) codes QP54AB52



Publication details

Publication details for Bravecto Plus
Marketing-authorisation holder

Intervet International B.V.

Revision0
Date of issue of marketing authorisation valid throughout the European Union08/05/2018

Contact address:

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

Product information

Product information

08/05/2018  Bravecto Plus -EMEA/V/C/004440

Name Language First published Last updated
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - Product Information HR = Hrvatski 2018-06-07  

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 Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  
Bravecto Plus : EPAR - All Authorised presentations HR = Hrvatski 2018-06-07  

Pharmacotherapeutic group

Antiparasitic products, insecticides and repellents, endectocides, milbemycins

Therapeutic indication

For cats with, or at risk from, mixed parasitic infestations by ectoparasites (ticks and fleas) together with gastrointestinal nematodes or heartworm. The veterinary medicinal product is exclusively indicated when use against ticks or fleas and one or more of the other target parasites is indicated at the same time.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Bravecto Plus : EPAR - Public assessment report HR = Hrvatski 2018-06-07  
CVMP summary of positive opinion for Bravecto Plus HR = Hrvatski 2018-03-16  

Authorised

This medicine is approved for use in the European Union