Nobivac LeuFel

purified Rp-45 FeLV-envelope antigen

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This is a summary of the European public assessment report (EPAR) for Nobivac LeuFel. 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 Nobivac LeuFel.

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

What is Nobivac LeuFel and what is it used for?

Nobivac LeuFel is a veterinary vaccine used in cats from eight weeks of age to protect them against feline leukaemia. Feline leukaemia is an infectious disease of cats caused by the feline leukaemia virus (FeLV). Signs of the disease can include loss of appetite, weight loss, poor fur condition, fever, pale gums and diarrhoea; cats persistently infected with the virus may spread it to other cats. The vaccine is used to prevent the disease signs and to prevent persistent viraemia (the presence of FeLV in the blood).

The medicine contains a protein from the outer layer of FeLV.

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

How is Nobivac LeuFel used?

Nobivac LeuFel is available as a suspension for injection and can only be obtained with a prescription.

The vaccine is given to cats as an injection under the skin. The initial vaccination course is two injections 3 or 4 weeks apart from 8 weeks of age. In cases where the kitten may have antibodies passed from the mother, a third injection can be given from 15 weeks of age. An annual booster vaccination of a single injection is necessary. Protection starts 3 weeks after the primary course of vaccination and lasts one year.

How does Nobivac LeuFel work?

Nobivac LeuFel is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Nobivac LeuFel contains small amounts of a protein from the outer layer of the virus called ‘envelope p45 protein’. The FeLV protein used in the vaccine is not extracted from viruses but is made in a bacterium using ‘recombinant technology’. When a cat is given the vaccine, the cat’s immune system recognises the protein as ‘foreign’ and makes antibodies against it. In the future, the immune system will be able to produce antibodies more quickly when it is exposed to FeLV, which will help to protect against the disease caused by the virus.

Nobivac LeuFel also contains aluminium hydroxide gel and extract of Quillaja saponaria as adjuvants (ingredients that strengthen the immune response).

What benefits of Nobivac LeuFel have been shown in studies?

In one field study kittens aged 8 to 9 weeks were given an initial vaccination course of Nobivac LeuFel with 2 injections 3 weeks apart and an annual booster injection 1 year later. After the first injection 69% of the kittens had antibodies to FeLV and this increased to 100% after the second injection. Some 64% of cats still had FeLV antibodies before the annual booster, and 100% of cats had FeLV antibodies after the booster.

In a second study, kittens aged 8 to 9 weeks were given an initial vaccination course of a combination vaccine consisting of one dose of Feligen RCP (against feline rhinotracheitis virus, feline calici virus and feline panleucopaenia virus) with one dose of Nobivac LeuFel. After the second injection, 100% of kittens had antibodies to FeLV.

What are the risks associated with Nobivac LeuFel?

The most common side effect with Nobivac LeuFel (which may affect more than 1 in 100 cats) is a moderate and short-lived swelling or lump after the first injection. This usually resolves on its own within three to four weeks. This reaction is reduced after subsequent injections.

Nobivac LeuFel must not be used in pregnant cats.

For the full list of restrictions and all side effects reported with Nobivac LeuFel, see the package leaflet.

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 is Nobivac LeuFel approved?

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

Other information about Nobivac LeuFel:

The European Commission granted a marketing authorisation valid throughout the EU for Nobivac LeuFel on 6 November 2017.

This authorisation was based on the authorisation granted to Leucogen in 2009 (‘informed consent’).

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

Name Language First published Last updated
Nobivac LeuFel : EPAR - Summary for the public BG = bălgarski 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public ES = español 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public CS = čeština 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public DA = dansk 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public DE = Deutsch 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public ET = eesti keel 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public EL = elliniká 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public EN = English 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public FR = français 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public IT = italiano 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public LV = latviešu valoda 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public LT = lietuvių kalba 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public HU = magyar 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public MT = Malti 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public NL = Nederlands 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public PL = polski 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public PT = português 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public RO = română 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public SK = slovenčina 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public SL = slovenščina 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public FI = suomi 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public SV = svenska 2017-11-28  
Nobivac LeuFel : EPAR - Summary for the public HR = Hrvatski 2017-11-28  

This EPAR was last updated on 28/11/2017 .

Authorisation details

Product details

Product details for Nobivac LeuFel
NameNobivac LeuFel
Agency product numberEMEA/V/C/004778
Active substance

purified Rp-45 FeLV-envelope antigen

International non-proprietary name (INN) or common name

purified Rp-45 FeLV-envelope antigen

Species Cats
Anatomical therapeutic chemical veterinary (ATCvet) codes QI06AA01



Publication details

Publication details for Nobivac LeuFel
Marketing-authorisation holder

Virbac

Revision0
Date of issue of marketing authorisation valid throughout the European Union06/11/2017

Contact address:

Virbac
1ère Avenue - 2065m - L.I.D.
06516 Carros Cedex
France

Product information

Product information

06/11/2017  Nobivac LeuFel -EMEA/V/C/004778

Name Language First published Last updated
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - Product Information HR = Hrvatski 2017-11-28  

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 LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  
Nobivac LeuFel : EPAR - All Authorised presentations HR = Hrvatski 2017-11-28  

Pharmacotherapeutic group

Immunologicals for felidae, inactivated viral vaccines for cats

Therapeutic indication

Active immunisation of cats from eight weeks of age against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Nobivac LeuFel : EPAR - Public assessment report HR = Hrvatski 2017-11-28  
CVMP summary of positive opinion for Nobivac LeuFel HR = Hrvatski 2017-09-08  

Authorised

This medicine is approved for use in the European Union