Versican Plus L4

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)

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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).

What is Versican Plus L4?

Versican Plus L4 is a veterinary vaccine that contains inactivated (killed) strains of Leptospira bacteria (Icterohaemorrhagiae, Canicola, Bratislavaand Grippotyphosa). Versican Plus L4 is available as a suspension for injection.

What is Versican Plus L4 used for?

Versican Plus L4 is used to protect dogs against leptospirosis, a bacterial disease that may be transmitted via infected urine and result in bleeding, hepatitis (inflammation of the liver) and jaundice or nephritis (kidney inflammation).

The vaccine is given to puppies from six weeks of age as an injection, under the skin, and repeated three to four weeks later. For revaccination a single dose of Versican Plus L4 is required annually.

How does Versican Plus L4 work?

Versican Plus 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 Versican Plus L4 are killed (inactivated) so that they do not cause disease. When Versican Plus L4 is given to dogs the animals’ immune system recognises the bacteria as ‘foreign’ and makes antibodies 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.

Versican Plus L4 contains an adjuvant (aluminium hydroxide) to enhance the immune response.

How has Versican Plus L4 been studied?

The effectiveness of Versican Plus L4 was investigated in a field study involving 129 dogs. The dogs were either vaccinated twice with a three or four week interval or they received a single annual booster vaccination. The measure of effectiveness was levels of antibodies before and after vaccination.

What benefit has Versican Plus L4 shown during the studies?

The field study showed that after vaccination with Versican Plus L4 the percentage of dogs with protective levels of antibodies for leptospira ranged from 59 to 96%. Responses in puppies were lower than adult dogs in some cases, because of antibodies inherited from their mothers.

What is the risk associated with Versican Plus L4?

The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus L4 is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.

Why has Versican Plus L4 been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus L4 exceed the risks for the approved indication and recommended that Versican Plus L4 be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Versican Plus L4:

The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus L4 on 31 July 2014. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Versican Plus L4 : EPAR - Summary for the public BG = bălgarski 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public ES = español 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public CS = čeština 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public DA = dansk 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public DE = Deutsch 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public ET = eesti keel 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public EL = elliniká 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public EN = English 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public FR = français 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public IT = italiano 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public LV = latviešu valoda 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public LT = lietuvių kalba 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public HU = magyar 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public MT = Malti 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public NL = Nederlands 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public PL = polski 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public PT = português 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public RO = română 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public SK = slovenčina 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public SL = slovenščina 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public FI = suomi 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public SV = svenska 2014-10-20  
Versican Plus L4 : EPAR - Summary for the public HR = Hrvatski 2014-10-20  

This EPAR was last updated on 10/04/2017 .

Authorisation details

Product details

Product details for Versican Plus L4
NameVersican Plus L4
Agency product numberEMEA/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

Publication details for Versican Plus L4
Marketing-authorisation holder

Zoetis Belgium S.A.

Revision2
Date of issue of marketing authorisation valid throughout the European Union31/07/2014

Product information

Product information

23/03/2017  Versican Plus L4 -EMEA/V/C/003680 -IG/0747

Name Language First published Last updated
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus L4 : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10

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
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus L4 : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Versican Plus L4 : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-09-26 2017-04-10

Initial marketing-authorisation documents

Name Language First published Last updated
Versican Plus L4 : EPAR - Public assessment report HR = Hrvatski 2014-10-20  
CVMP summary of positive opinion for Versican Plus L4 HR = Hrvatski 2014-06-06