Versican Plus L4

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Canine leptospirosis vaccine (inactivated)

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 L4
Agency product number
EMEA/V/C/003680
Active substance
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 (all inactivated)
International non-proprietary name (INN) or common name
Canine leptospirosis vaccine (inactivated)
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI07AB01
Publication details
Marketing-authorisation holder
Zoetis Belgium S.A.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
31/07/2014

Product information

23/03/2017 Versican Plus L4 - EMEA/V/C/003680 - 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
  • inactivated bacterial vaccines

Therapeutic indication

Active immunisation of dogs from six weeks of age to prevent clinical signs, infection and urinary excretion caused by Leptospira serovars bratislava, canicola, grippotyphosa and icterohaemorrhagiae. Onset of immunity: Immunity has been demonstrated from 4 weeks after completion of the primary course. Duration of immunity: At least one year following the primary vaccination course.

Assessment history

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