Canigen 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 (EPAR) for Canigen L4. 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 Canigen L4.

For practical information about using Canigen L4, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

This EPAR was last updated on 20/09/2018

Authorisation details

Product details
Name
Canigen L4
Agency product number
EMEA/V/C/004079
Active substance
Inactivated Leptospira strains: L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000); L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001); L. interrogans serogroup Australis serovar Bratislava (strain As-05-073); L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
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
Intervet International B.V.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
03/07/2015
Contact address
Wim de Körverstraat 35
5831 AN Boxmeer
Netherlands

Product information

20/09/2017 Canigen L4 - EMEA/V/C/004079 - IAIN/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 FOR CANIDAE
  • inactivated bacterial vaccines for dogs

Therapeutic indication

For active immunisation of dogs against:

  • L. interrogans serogroup Canicola serovar Canicola to reduce infection and urinary excretion;
  • L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection and urinary excretion;
  • L. interrogans serogroup Australis serovar Bratislava to reduce infection;
  • L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection and urinary excretion.

Assessment history

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