Letifend

RSS

canine leishmaniasis vaccine (recombinant protein)

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 23/10/2018

Authorisation details

Product details
Name
Letifend
Agency product number
EMEA/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
Marketing-authorisation holder
Laboratorios LETI, S.L.U.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
19/04/2016
Contact address
C/ Del Sol 5
Poligono Industrial Norte
Tres Cantos
28760 Madrid
Spain

Product information

03/10/2018 Letifend - EMEA/V/C/003865 - IB/0011

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.

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

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