CaniLeish

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Leishmania infantum excreted secreted proteins

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

Overview

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

This EPAR was last updated on 14/01/2016

Authorisation details

Product details
Name
CaniLeish
Agency product number
EMEA/V/C/002232
Active substance
Leishmania infantum excreted secreted proteins
International non-proprietary name (INN) or common name
Leishmania infantum excreted secreted proteins
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI07AO
Publication details
Marketing-authorisation holder
Virbac S.A
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
14/03/2011
Contact address
1ère avenue
2065 m L.I.D.
06516 Carros
France

Product information

07/01/2016 CaniLeish - EMEA/V/C/002232 - R/0004

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

Therapeutic indication

For the active immunisation of Leishmania-negative dogs from six months of age to reduce the risk to develop an active infection and clinical disease after contact with Leishmania infantum.

The efficacy of the vaccine has been demonstrated in dogs submitted to multiple natural parasite exposure in zones with high infection pressure.

Onset of immunity: 4 weeks after the primary vaccination course.

Duration of immunity: 1 year after the last re-vaccination.

Assessment history

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