Credelio

lotilaner

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

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

What is Credelio and what is it used for?

Credelio is a veterinary medicine used to treat flea and tick infestations in dogs. Credelio can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites). It contains the active substance lotilaner.

For further information, see the package leaflet.

How is Credelio used?

Credelio is available as chewable tablets of different strengths which are given to dogs with or after food. The tablet strength to give depends on the dog’s weight. After being given, Credelio kills fleas within 4 hours and ticks within 48 hours of attachment. It is effective for one month and treatment is repeated every month. The medicine can only be obtained with a prescription.

How does Credelio work?

The active substance in Credelio, lotilaner, 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. Lotilaner kills these parasites that have ingested the dog’s blood by acting on their nervous system. It blocks the normal movement of charged particles 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 parasites. Lotilaner kills fleas before they can lay eggs and so helps to reduce contamination of the dog’s environment.

What benefits of Credelio have been shown in studies?

In a 12-week field study involving dogs naturally infested with fleas, 128 dogs were treated with Credelio every four weeks and 64 dogs with a spot-on medicine containing fipronil, another medicine to treat flea infestation. The study showed Credelio to be as effective as the other medicine in reducing the flea counts over the 12 weeks and dogs treated with Credelio had flea counts reduced by 99%.

In a small field study involving dogs naturally infested with ticks, 47 dogs were treated once with Credelio and 35 dogs were treated with a spot-on medicine containing fipronil and (s)-methoprene. The study showed Credelio to be as effective as the other medicine in reducing tick counts over four weeks and tick counts were reduced by 100% for Credelio treated dogs.

A second larger field study of dogs naturally infested with ticks involved 127 dogs treated with Credelio monthly for 3 months whilst 68 dogs were treated with a spot-on medicine containing fipronil and (s)-methoprene. Credelio was as effective as the other medicine in reducing tick counts and reduced ticks by 99% during the study.

What are the risks associated with Credelio?

Because ticks must start feeding on the dog in order to be killed by the medicine, the risk of transmission of diseases that they may carry cannot be excluded.

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

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.

Hands should be washed after handling the medicine.

Why is Credelio approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Credelio’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Credelio

The European Commission granted a marketing authorisation valid throughout the EU for Credelio on 25 April 2017.

For more information about treatment with Credelio, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Credelio : EPAR - Summary for the public BG = bălgarski 2017-05-11  
Credelio : EPAR - Summary for the public ES = español 2017-05-11  
Credelio : EPAR - Summary for the public CS = čeština 2017-05-11  
Credelio : EPAR - Summary for the public DA = dansk 2017-05-11  
Credelio : EPAR - Summary for the public DE = Deutsch 2017-05-11  
Credelio : EPAR - Summary for the public ET = eesti keel 2017-05-11  
Credelio : EPAR - Summary for the public EL = elliniká 2017-05-11  
Credelio : EPAR - Summary for the public EN = English 2017-05-11  
Credelio : EPAR - Summary for the public FR = français 2017-05-11  
Credelio : EPAR - Summary for the public IT = italiano 2017-05-11  
Credelio : EPAR - Summary for the public LV = latviešu valoda 2017-05-11  
Credelio : EPAR - Summary for the public LT = lietuvių kalba 2017-05-11  
Credelio : EPAR - Summary for the public HU = magyar 2017-05-11  
Credelio : EPAR - Summary for the public MT = Malti 2017-05-11  
Credelio : EPAR - Summary for the public NL = Nederlands 2017-05-11  
Credelio : EPAR - Summary for the public PL = polski 2017-05-11  
Credelio : EPAR - Summary for the public PT = português 2017-05-11  
Credelio : EPAR - Summary for the public RO = română 2017-05-11  
Credelio : EPAR - Summary for the public SK = slovenčina 2017-05-11  
Credelio : EPAR - Summary for the public SL = slovenščina 2017-05-11  
Credelio : EPAR - Summary for the public FI = suomi 2017-05-11  
Credelio : EPAR - Summary for the public SV = svenska 2017-05-11  
Credelio : EPAR - Summary for the public HR = Hrvatski 2017-05-11  

This EPAR was last updated on 11/05/2017 .

Authorisation details

Product details

Product details for Credelio
NameCredelio
Agency product numberEMEA/V/C/004247
Active substance

lotilaner

International non-proprietary name (INN) or common name

lotilaner

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QP53BE04


Publication details

Publication details for Credelio
Marketing-authorisation holder

Elanco Europe Ltd

Revision0
Date of issue of marketing authorisation valid throughout the European Union24/04/2017

Contact address:

Elanco Europe Ltd
Lilly House Priestley Road 
Basingstoke 
Hampshire RG24 9NL 
United Kingdom

Product information

Product information

25/04/2017  Credelio -EMEA/V/C/004247

Name Language First published Last updated
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  
Credelio : EPAR - Product Information HR = Hrvatski 2017-05-11  

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
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  
Credelio : EPAR - All Authorised presentations HR = Hrvatski 2017-05-11  

Pharmacotherapeutic group

Ectoparasiticides for systemic use, isoxazolines

Therapeutic indication

For the treatment of flea and tick infestations in dogs.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Credelio : EPAR - Public assessment report HR = Hrvatski 2017-05-11  
CVMP summary of positive opinion for Credelio HR = Hrvatski 2017-02-17  

Authorised

This medicine is approved for use in the European Union