Letifend

recombinant protein Q from Leishmania infantum MON-1

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

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

What is Letifend and what is it used for?

Letifend is a veterinary vaccine used in dogs to protect them against leishmaniasis due to the parasite Leishmania infantum. The parasite is widespread in countries bordering the Mediterranean Sea and is transmitted by the bites of sand flies. Dogs that have been infected may show no signs of infection, but some have active disease with symptoms such as fever, hair and weight loss, and skin sores. Infected dogs can help spread the disease to humans.

Letifend contains the active substance protein Q, which is made of different fragments of proteins from Leishmania infantum.

For further information, see the package leaflet.

How is Letifend used?

Letifend is available as a freeze-dried powder (lyophilisate) and solvent that are made up into a solution for injection, and can only be obtained with a prescription.

Before vaccination, dogs should be tested for Leishmania infection. Only non-infected animals should be vaccinated.

The vaccine is given to dogs from 6 months of age as a single injection under the skin. A ‘booster’ injection should be given every year to maintain the vaccine’s effect. Protection starts four weeks after vaccination and lasts one year. Measures should be taken to reduce exposure to sand flies in vaccinated dogs since the vaccine does not prevent Leishmania infection.

For further information, see the package leaflet.

How does Letifend work?

Letifend is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When Letifend is given to dogs the immune system recognises the Leishmania protein as ‘foreign’ and makes defences against it. In the future, if the animals are exposed to the parasite, the immune system will be able to respond more quickly. This will help to protect against the disease.

What benefits of Letifend have been shown in studies?

In a field study in France and Spain 275 dogs were vaccinated with Letifend and 274 dogs received placebo (a dummy vaccination). The dogs were exposed to natural infection with Leishmania infantum. Over a two year period there were 8 confirmed cases of leishmaniasis in the vaccinated group compared with 19 cases in the placebo group, showing that Letifend was effective in reducing the occurrence of the disease.

What are the risks associated with Letifend?

The most common side effect with Letifend (which may affect more than 1 in 10 animals) is scratching at the injection site which resolves within four hours.

For the full list of restrictions, see the package leaflet.

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

None.

Why is Letifend approved?

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

Other information about Letifend?

The European Commission granted a marketing authorisation valid throughout the EU for Letifend on 20.04.2016.

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

Name Language First published Last updated
Letifend : EPAR - Summary for the public BG = bălgarski 2016-06-02  
Letifend : EPAR - Summary for the public ES = español 2016-06-02  
Letifend : EPAR - Summary for the public CS = čeština 2016-06-02  
Letifend : EPAR - Summary for the public DA = dansk 2016-06-02  
Letifend : EPAR - Summary for the public DE = Deutsch 2016-06-02  
Letifend : EPAR - Summary for the public ET = eesti keel 2016-06-02  
Letifend : EPAR - Summary for the public EL = elliniká 2016-06-02  
Letifend : EPAR - Summary for the public EN = English 2016-06-02  
Letifend : EPAR - Summary for the public FR = français 2016-06-02  
Letifend : EPAR - Summary for the public IT = italiano 2016-06-02  
Letifend : EPAR - Summary for the public LV = latviešu valoda 2016-06-02  
Letifend : EPAR - Summary for the public LT = lietuvių kalba 2016-06-02  
Letifend : EPAR - Summary for the public HU = magyar 2016-06-02  
Letifend : EPAR - Summary for the public MT = Malti 2016-06-02  
Letifend : EPAR - Summary for the public NL = Nederlands 2016-06-02  
Letifend : EPAR - Summary for the public PL = polski 2016-06-02  
Letifend : EPAR - Summary for the public PT = português 2016-06-02  
Letifend : EPAR - Summary for the public RO = română 2016-06-02  
Letifend : EPAR - Summary for the public SK = slovenčina 2016-06-02  
Letifend : EPAR - Summary for the public SL = slovenščina 2016-06-02  
Letifend : EPAR - Summary for the public FI = suomi 2016-06-02  
Letifend : EPAR - Summary for the public SV = svenska 2016-06-02  
Letifend : EPAR - Summary for the public HR = Hrvatski 2016-06-02  

This EPAR was last updated on 30/11/2017 .

Authorisation details

Product details

Product details for Letifend
NameLetifend
Agency product numberEMEA/V/C/003865
Active substance

recombinant protein Q from Leishmania infantum MON-1

International non-proprietary name (INN) or common name

canine leishmaniasis vaccine (recombinant protein)

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QI07A


Publication details

Publication details for Letifend
Marketing-authorisation holder

Laboratorios LETI, S.L.U.

Revision4
Date of issue of marketing authorisation valid throughout the European Union20/04/2016

Contact address:

Laboratorios LETI, S.L.U.
C/ Del Sol 5
Poligono Industrial Norte
Tres Cantos
28760 Madrid 
Spain

Product information

Product information

24/11/2017  Letifend -EMEA/V/C/003865 -IAIN/0009

Name Language First published Last updated
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30
Letifend : EPAR - Product Information HR = Hrvatski 2016-06-02 2017-11-30

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
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  
Letifend : EPAR - All Authorised presentations HR = Hrvatski 2016-06-02  

Pharmacotherapeutic group

Immunologicals for Canidae – dog

Therapeutic indication

For active immunisation of dogs from 6 months of age to reduce the risk of developing a clinical case of leishmaniasis.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Letifend : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-09-07 2017-11-30

Initial marketing-authorisation documents

Name Language First published Last updated
Letifend : EPAR - Public assessment report HR = Hrvatski 2016-06-02  
CVMP summary of positive opinion for Letifend HR = Hrvatski 2016-02-19