Versican Plus DHPPi/L4

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canine distemper, canine adenovirus, canine parvovirosis, canine parainfluenza virus (live attenuated) and canine leptospirosis (inactivated) vaccine

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

Overview

This is a summary of the European Public Assessment Report. 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 10/04/2017

Authorisation details

Product details
Name
Versican Plus DHPPi/L4
Agency product number
EMEA/V/C/003678
Active substance
canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B, canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091...
International non-proprietary name (INN) or common name
canine distemper, canine adenovirus, canine parvovirosis, canine parainfluenza virus (live attenuated) and canine leptospirosis (inactivated) vaccine
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI07AI02
Publication details
Marketing-authorisation holder
Zoetis Belgium SA
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
06/05/2014
Contact address
Rue Laid Burnait, 1
1348 Louvain-la-Neuve
Belgium

Product information

22/03/2017 Versican Plus DHPPi/L4 - EMEA/V/C/003678 - IG/0747

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 live and inactivated viral and bacterial vaccines

Therapeutic indication

Active immunisation of dogs from 6 weeks of age:

  • to prevent mortality and clinical signs caused by canine distemper virus,
  • to prevent mortality and clinical signs caused by canine adenovirus type 1,
  • to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2,
  • to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus,
  • to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus,
  • to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup Australis serovar Bratislava,
  • to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and to prevent clinical signs and reduce infection and urinary excretion caused by L. interrogans serogroup Grippotyphosa serovar Grippotyphosa.

Assessment history

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