Canigen L4

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)

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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.

What is Canigen L4 and what is it used for?

Canigen L4 is a veterinary vaccine used to vaccinate dogs from six weeks of age to protect against leptospirosis caused by one of four specific types of Leptospira bacteria. In dogs, leptospirosis can cause bleeding, hepatitis (inflammation of the liver) and jaundice (yellowing of the skin and eyes) or nephritis (kidney inflammation). The bacteria are spread via the urine of infected animals. For some strains of Leptospira, the vaccine also reduces the excretion (shedding) of the bacteria into the urine by the infected dogs, thereby reducing the risk of transmission.

This vaccine is the same as Nobivac L4, which is already authorised in the European Union (EU). The company that makes Nobivac L4 has agreed that its scientific data can be used for Canigen L4 (‘informed consent’).

Canigen L4 contains four types of inactivated (killed) Leptospira strains: L. interrogans serogroup Canicola serovar Portland-vere, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, L. kirschneri serogroup Grippotyphosa serovar Dadas.

How is Canigen L4 used?

Canigen L4 is available as a suspension for injection and can only be obtained with a prescription. The vaccine is given to dogs as two injections, four weeks apart, under the skin. The first injection can be given from six to nine weeks of age and the second four weeks later. When puppies are known to have high levels of maternally derived antibodies (special type of proteins, received from the mother in the milk, that help the body to fight infection), it is recommended that the first vaccination is given at nine weeks of age. A single ‘booster’ injection should be given every year to maintain the vaccine’s effect.

Protection starts three weeks after vaccination and lasts one year.

How does Canigen L4 work?

Canigen L4 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. The strains of Leptospira bacteria in Canigen L4 are killed (inactivated) so that they do not cause disease. When Canigen L4 is given to dogs the animals’ immune system recognises the bacteria as ‘foreign’ and makes defences against them. In the future, if the animals are exposed to these Leptospira bacteria the immune system will be able to respond more quickly. This will help protect them against leptospirosis.

What benefits of Canigen L4 have been shown in studies?

The company has presented data from both laboratory and field studies to establish the safety and effectiveness of the vaccine, including how long it took for the dogs to be fully protected and how long the vaccine could provide protection.

The studies showed that the vaccine reduces infection with Leptospira and excretion of the bacteria into the urine. They also showed that the vaccine is safe to give to pregnant bitches.

What are the risks associated with Canigen L4?

A mild and temporary increase in body temperature (1°C or less) may occur for a few days after vaccination, with some puppies showing less activity and/or a reduced appetite. A small, temporary swelling may occur at the injection site, which will either disappear or reduce in size within two weeks after vaccination. An occasional temporary, acute (short-term) hypersensitivity (allergic) reaction may occur.

Why is Canigen L4 approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Canigen L4’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Canigen L4

The European Commission granted a marketing authorisation valid throughout the EU for Canigen L4 on 3 July 2015.

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

Name Language First published Last updated
Canigen L4 : EPAR - Summary for the public BG = bălgarski 2015-07-30  
Canigen L4 : EPAR - Summary for the public ES = español 2015-07-30  
Canigen L4 : EPAR - Summary for the public CS = čeština 2015-07-30  
Canigen L4 : EPAR - Summary for the public DA = dansk 2015-07-30  
Canigen L4 : EPAR - Summary for the public DE = Deutsch 2015-07-30  
Canigen L4 : EPAR - Summary for the public ET = eesti keel 2015-07-30  
Canigen L4 : EPAR - Summary for the public EL = elliniká 2015-07-30  
Canigen L4 : EPAR - Summary for the public EN = English 2015-07-30  
Canigen L4 : EPAR - Summary for the public FR = français 2015-07-30  
Canigen L4 : EPAR - Summary for the public IT = italiano 2015-07-30  
Canigen L4 : EPAR - Summary for the public LV = latviešu valoda 2015-07-30  
Canigen L4 : EPAR - Summary for the public LT = lietuvių kalba 2015-07-30  
Canigen L4 : EPAR - Summary for the public HU = magyar 2015-07-30  
Canigen L4 : EPAR - Summary for the public MT = Malti 2015-07-30  
Canigen L4 : EPAR - Summary for the public NL = Nederlands 2015-07-30  
Canigen L4 : EPAR - Summary for the public PL = polski 2015-07-30  
Canigen L4 : EPAR - Summary for the public PT = português 2015-07-30  
Canigen L4 : EPAR - Summary for the public RO = română 2015-07-30  
Canigen L4 : EPAR - Summary for the public SK = slovenčina 2015-07-30  
Canigen L4 : EPAR - Summary for the public SL = slovenščina 2015-07-30  
Canigen L4 : EPAR - Summary for the public FI = suomi 2015-07-30  
Canigen L4 : EPAR - Summary for the public SV = svenska 2015-07-30  
Canigen L4 : EPAR - Summary for the public HR = Hrvatski 2015-07-30  

This EPAR was last updated on 25/07/2017 .

Authorisation details

Product details

Product details for Canigen L4
NameCanigen L4
Agency product numberEMEA/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

Publication details for Canigen L4
Marketing-authorisation holder

Intervet International B.V.

Revision2
Date of issue of marketing authorisation valid throughout the European Union03/07/2015

Contact address:

Intervet International B.V.
Wim de Körverstraat 35 
5831 AN Boxmeer 
Netherlands

Product information

Product information

13/07/2017  Canigen L4 -EMEA/V/C/004079 -IB/0003/G

Name Language First published Last updated
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25
Canigen L4 : EPAR - Product Information HR = Hrvatski 2015-07-30 2017-07-25

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.


Name Language First published Last updated
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  
Canigen L4 : EPAR - All Authorised presentations HR = Hrvatski 2015-07-30  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Canigen L4 : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-08-15 2017-07-25

Initial marketing-authorisation documents

Name Language First published Last updated
Canigen L4 : EPAR - Public assessment report HR = Hrvatski 2015-07-30  
CVMP summary of positive opinion for Canigen L4 HR = Hrvatski 2015-05-08