Purevax FeLV

feline leukaemia virus recombinant canarypox virus (vCP97)

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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 Purevax FeLV?

Purevax FeLV is a vaccine containing feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97). Purevax FeLV is presented as a suspension for injection.

What is Purevax FeLV used for?

Purevax FeLV is used to vaccinate cats from the age of eight weeks against feline leukaemia, an illness affecting the immune system caused by a type of virus known as a retrovirus. The vaccine is used to prevent the symptoms of the disease and to prevent FeLV from remaining in the blood.

A 1 ml dose of Purevax FeLV is injected under the skin. The first injection should be given in cats aged at least eight weeks, with a second injection three to five weeks later. Immunity starts at the latest two weeks after the second injection and lasts for a year. The cats should be revaccinated every year.

How does Purevax FeLV work?

Purevax FeLV is a vaccine. Vaccines work by priming the immune system (the body’s natural defences) how to defend itself against diseases. Purevax FeLV contains genes from the FeLV sub-group A called env and gag which have been inserted into another vector (carrier) virus called canarypox using ‘recombinant DNA technology’. The canarypox viruses do not spread or multiply in the cat but they do produce proteins from the FeLV genes.

When a cat is given the vaccine, the immune system recognises the FeLV proteins as ‘foreign’ and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is exposed to the FeLV. The antibodies will help to protect against the disease caused by the virus. Immunisation against FeLV sub-group A provides full protection against all three sub-groups of the virus: A, B and C.

How has Purevax FeLV been studied?

The effectiveness of Purevax FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with FeLV. In the field, efficacy has been studied in one main study of kittens aged eight weeks or older, in which the effects of Purevax FeLV were compared with those of another vaccine against FeLV. The vaccinated kittens were housed for up to 28 weeks with a group of kittens who were infected with FeLV. In all trials, the main measure of effectiveness was the presence of antibodies against the virus and infectious FeLV in the vaccinated kittens’ blood.

What benefit has Purevax FeLV shown during the studies?

Purevax FeLV vaccine provided protection against FeLV infection. The first evidence of FeLV infection occurred after six weeks in only a few of the kittens vaccinated with Purevax FeLV. Infection was seen from four weeks in non-vaccinated animals.

What is the risk associated with Purevax FeLV?

A temporary small nodule (hard lump) may appear at the site of injection. This usually disappears within one to four weeks. Temporary lethargy (listlessness) and hyperthermia (increased body temperature) may occur for one day, exceptionally for two days. For a full list of all side effects reported with Purevax FeLV, see the Package Leaflet. Purevax FeLV should not be used in pregnant cats.

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

In case of accidental self-injection seek medical advice immediately and show the Package Leaflet or the label to the doctor.

Why has Purevax FeLV been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax FeLV exceed the risks for active immunisation of cats eight weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease, and recommended that Purevax FeLV be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Purevax FeLV

The European Commission granted a marketing authorisation valid throughout the European Union for Purevax FeLV to MERIAL on 13 April 2000. The marketing authorisation was renewed on 18 April 2005. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Purevax FeLV : EPAR - Summary for the public BG = bălgarski 2008-02-13  
Purevax FeLV : EPAR - Summary for the public ES = español 2008-02-13  
Purevax FeLV : EPAR - Summary for the public CS = čeština 2008-02-13  
Purevax FeLV : EPAR - Summary for the public DA = dansk 2008-02-13  
Purevax FeLV : EPAR - Summary for the public DE = Deutsch 2008-02-13  
Purevax FeLV : EPAR - Summary for the public ET = eesti keel 2008-02-13  
Purevax FeLV : EPAR - Summary for the public EL = elliniká 2008-02-13  
Purevax FeLV : EPAR - Summary for the public EN = English 2008-02-13  
Purevax FeLV : EPAR - Summary for the public FR = français 2008-02-13  
Purevax FeLV : EPAR - Summary for the public IT = italiano 2008-02-13  
Purevax FeLV : EPAR - Summary for the public LV = latviešu valoda 2008-02-13  
Purevax FeLV : EPAR - Summary for the public LT = lietuvių kalba 2008-02-13  
Purevax FeLV : EPAR - Summary for the public HU = magyar 2008-02-13  
Purevax FeLV : EPAR - Summary for the public MT = Malti 2008-02-13  
Purevax FeLV : EPAR - Summary for the public NL = Nederlands 2008-02-13  
Purevax FeLV : EPAR - Summary for the public PL = polski 2008-02-13  
Purevax FeLV : EPAR - Summary for the public PT = português 2008-02-13  
Purevax FeLV : EPAR - Summary for the public RO = română 2008-02-13  
Purevax FeLV : EPAR - Summary for the public SK = slovenčina 2008-02-13  
Purevax FeLV : EPAR - Summary for the public SL = slovenščina 2008-02-13  
Purevax FeLV : EPAR - Summary for the public FI = suomi 2008-02-13  
Purevax FeLV : EPAR - Summary for the public SV = svenska 2008-02-13  

This EPAR was last updated on 21/05/2014 .

Authorisation details

Product details

Product details for Purevax FeLV
NamePurevax FeLV
Agency product numberEMEA/V/C/000056
Active substance

feline leukaemia virus recombinant canarypox virus (vCP97)

International non-proprietary name (INN) or common name

vaccine against feline leukaemia

Species Cats
Anatomical therapeutic chemical veterinary (ATCvet) codeQI06AD

Publication details

Publication details for Purevax FeLV
Marketing-authorisation holder

Merial

Revision6
Date of issue of marketing authorisation valid throughout the European Union13/04/2000

Contact address:

Merial
29 avenue Tony Garnier
69007 Lyon
France

Product information

Product information

06/05/2014  Purevax FeLV -EMEA/V/C/000056 -IG/0430

Name Language First published Last updated
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07
Purevax FeLV : EPAR - Product Information SV = svenska 2007-10-23 2015-05-07

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
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  
Purevax FeLV : EPAR - All Authorised presentations SV = svenska 2007-10-19  

Pharmacotherapeutic group

Immunologicals For felidae

Therapeutic indication

Active immunisation of cats of 8 weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.

Onset of immunity has been demonstrated 2 weeks after primary vaccination course.

The duration of immunity is one year after the last vaccination.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Purevax FeLV : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2008-11-19 2014-05-21

Initial marketing-authorisation documents

Name Language First published Last updated
Purevax FeLV : EPAR - Scientific Discussion SV = svenska 2007-10-23  
Purevax FeLV : EPAR - Procedural steps taken before authorisation SV = svenska 2005-11-22