Nobivac L4

Leptospira 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). 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 Nobivac L4?

Nobivac L4 is a vaccine available as a suspension for injection. It contains four inactivated (killed) strains of Leptospira bacteria.

What is Nobivac L4 used for?

Nobivac L4 is used to vaccinate dogs from six weeks of age to reduce the risk of developing an infection with certain Leptospira strains. Leptospirosis disease in dogs results in bleeding, hepatitis (infection of the liver) and jaundice (yellowing of the skin and eyes) or nephritis (kidney infection). The main infection source is from urine or urine-contaminated water or soil. The vaccine also reduces the excretion (shedding) of the virus into the urine by the infected dogs, thereby reducing the risk of transmission.

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.

How does Nobivac L4 work?

Nobivac L4 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When Nobivac L4 is given to dogs, the immune system recognises the bacteria contained in the vaccine as ‘foreign’ and makes defences against them. In future if the animals are exposed to the bacteria the immune system will be able to respond more quickly. This will help to protect against the disease.

How has Nobivac L4 been studied?

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.

What benefit has Nobivac L4 shown during the studies?

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 is the risk associated with Nobivac L4?

A mild and temporary increase in body temperature (≤ 1°C) may occur for a few days after vaccination, with some puppies showing less activity 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 has Nobivac L4 been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac L4 exceed the risks and recommended that it be given a marketing authorisation. The benefit / risk balance can be found in the scientific discussion module of this EPAR.

Other information about Nobivac L4

The European Commission granted a marketing authorisation valid throughout the European Union, for Nobivac L4 on 16 July 2012. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Nobivac L4 : EPAR - Summary for the public BG = bălgarski 2013-01-29  
Nobivac L4 : EPAR - Summary for the public ES = español 2013-01-29  
Nobivac L4 : EPAR - Summary for the public CS = čeština 2013-01-29  
Nobivac L4 : EPAR - Summary for the public DA = dansk 2013-01-29  
Nobivac L4 : EPAR - Summary for the public DE = Deutsch 2013-01-29  
Nobivac L4 : EPAR - Summary for the public ET = eesti keel 2013-01-29  
Nobivac L4 : EPAR - Summary for the public EL = elliniká 2013-01-29  
Nobivac L4 : EPAR - Summary for the public EN = English 2013-01-29  
Nobivac L4 : EPAR - Summary for the public FR = français 2013-01-29  
Nobivac L4 : EPAR - Summary for the public IT = italiano 2013-01-29  
Nobivac L4 : EPAR - Summary for the public LV = latviešu valoda 2013-01-29  
Nobivac L4 : EPAR - Summary for the public LT = lietuvių kalba 2013-01-29  
Nobivac L4 : EPAR - Summary for the public HU = magyar 2013-01-29  
Nobivac L4 : EPAR - Summary for the public MT = Malti 2013-01-29  
Nobivac L4 : EPAR - Summary for the public NL = Nederlands 2013-01-29  
Nobivac L4 : EPAR - Summary for the public PL = polski 2013-01-29  
Nobivac L4 : EPAR - Summary for the public PT = português 2013-01-29  
Nobivac L4 : EPAR - Summary for the public RO = română 2013-01-29  
Nobivac L4 : EPAR - Summary for the public SK = slovenčina 2013-01-29  
Nobivac L4 : EPAR - Summary for the public SL = slovenščina 2013-01-29  
Nobivac L4 : EPAR - Summary for the public FI = suomi 2013-01-29  
Nobivac L4 : EPAR - Summary for the public SV = svenska 2013-01-29  

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

Authorisation details

Product details

Product details for Nobivac L4
NameNobivac L4
Agency product numberEMEA/V/C/002010
Active substance

Leptospira 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

Vaccine to prevent Leptospira infections in dogs

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QI07AB01


Publication details

Publication details for Nobivac L4
Marketing-authorisation holder

Intervet International BV

Revision4
Date of issue of marketing authorisation valid throughout the European Union16/07/2012

Contact address:

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

Product information

13/07/2017  Nobivac L4 -EMEA/V/C/002010 -0008/G

Name Language First published Last updated
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 2017-07-25
Nobivac L4 : EPAR - Product Information SV = svenska 2013-01-29 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
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  
Nobivac L4 : EPAR - All Authorised presentations SV = svenska 2013-01-29  

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

For active immunisation of dogs against:

  • Leptospira 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
Nobivac L4 : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2015-08-13 2017-07-25

Initial marketing-authorisation documents

Name Language First published Last updated
Nobivac L4 : EPAR - Public assessment report SV = svenska 2013-01-29  
CVMP summary of positive opinion for Nobivac L4 SV = svenska 2012-05-21