Purevax RCPCh FeLV

Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline Calicivirosis antigens (FCV 431 and G1 strains), attenuated Chlamydophila felis (905 strain), attenuated feline panleucopenia virus (PLI IV), FeLV 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 RCPCh FeLV?

Purevax RCPCh FeLV is a vaccine containing the following active substances:

  • attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain),
  • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains),
  • attenuated Chlamydophila felis (905 strain),
  • attenuated feline panleucopenia virus (PLI IV),
  • feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97).

Purevax RCPCh FeLV is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.

What is Purevax RCPCh FeLV used for?

Purevax RCPCh FeLV is used to vaccinate cats from the age of 8 weeks against the following diseases:

  • feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus),
  • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus),
  • chlamydiosis (a flu-like illness caused by the bacterium C. felis),
  • feline panleucopenia (a serious illness causing bloody diarrhoea caused by a parvovirus),
  • feline leukaemia (an illness affecting the immune system caused by a retrovirus). The vaccine helps to reduce the symptoms of the diseases. It also helps to reduce viral excretion in case of calicivirus infection. It can also prevent death due to panleucopenia and prevent FeLV from remaining in the blood.

After Purevax RCPCh FeLV has been made up, 1 ml is injected under the skin. The first injection should be given in cats aged at least eight weeks, with a second injection three to four weeks later. If the cat has high levels of antibodies inherited from the mother, the first vaccination should be delayed until 12 weeks of age. The cat should be revaccinated for all components one year after the first vaccination course, then every year for rhinotracheitis, calicivirosis, chlamydiosis and feline leukaemia, and every three years for panleucopenia.

How does Purevax RCPCh FeLV work?

Purevax RCPCh FeLV is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. Purevax RCPCh FeLV contains small amounts of weakened or killed viruses and bacteria that cause the diseases listed above, as well as two genes from the FeLV 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 weakened or killed viruses, the FeLV proteins, and the weakened bacteria as ‘foreign’ and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses or bacteria. The antibodies will help to protect against the diseases caused by these viruses or bacteria. When exposed to any of these viruses later in life, the cat will either not become infected or have a much less serious infection.

How has Purevax RCPCh FeLV been studied?

The effectiveness of Purevax RCPCh FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus, C. felis, parvovirus or leukaemia virus. In the field, the studies of Purevax RCPCh FeLV looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and the booster vaccination (only one injection). They included young and adult cats of various breeds, but not young kittens. The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine, with the exception of the FeLV component, whose effectiveness in preventing infection had already been demonstrated in other studies.

What benefit has Purevax RCPCh FeLV shown during the studies?

In laboratory conditions, Purevax RCPCh FeLV was demonstrated to provide protection against the diseases listed above. In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus, calicivirus infection, and feline panleucopenia viruses. It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study. In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection, feline panleucopenia and C. felis remained stable at a high level or increased slightly.

What is the risk associated with Purevax RCPCh FeLV?

Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days. There may be a local reaction at the injection site, with slight pain on touching, itching or oedema (swelling), which disappears within one or two weeks. For a full list of the side-effects reported with Purevax RCPCh FeLV, see the Package Leaflet. Purevax RCPCh 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. The vaccine should not be handled by people with a weak immune system. If self-injection does occur in these people, tell the doctor that self-injection with a living chlamydial vaccine has occurred.

Why has Purevax RCPCh FeLV been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCPCh FeLV exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RCPCh FeLV be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Purevax RCPCh FeLV

The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh FeLV to MERIAL on 23 February 2005.

Name Language First published Last updated
Purevax RCPCh FeLV : EPAR - Summary for the public BG = bălgarski 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public ES = español 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public CS = čeština 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public DA = dansk 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public DE = Deutsch 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public ET = eesti keel 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public EL = elliniká 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public EN = English 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public FR = français 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public IT = italiano 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public LV = latviešu valoda 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public LT = lietuvių kalba 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public HU = magyar 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public MT = Malti 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public NL = Nederlands 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public PL = polski 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public PT = português 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public RO = română 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public SK = slovenčina 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public SL = slovenščina 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public FI = suomi 2008-03-14  
Purevax RCPCh FeLV : EPAR - Summary for the public SV = svenska 2008-03-14  

This EPAR was last updated on 23/02/2015 .

Authorisation details

Product details

Product details for Purevax RCPCh FeLV
NamePurevax RCPCh FeLV
Agency product numberEMEA/V/C/000085
Active substance

Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline Calicivirosis antigens (FCV 431 and G1 strains), attenuated Chlamydophila felis (905 strain), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97)

International non-proprietary name (INN) or common name

Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia, feline leukaemia and feline Chlamydophila virus infections

Species Cats
Anatomical therapeutic chemical veterinary (ATCvet) codeQI06AX

Publication details

Publication details for Purevax RCPCh FeLV
Marketing-authorisation holder

Merial

Revision8
Date of issue of marketing authorisation valid throughout the European Union23/02/2005

Contact address:

Merial
29 avenue Tony Garnier
69007 Lyon
France

Product information

Product information

15/01/2015  Purevax RCPCh FeLV -EMEA/V/C/000085 -WS/0606

Name Language First published Last updated
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23
Purevax RCPCh FeLV : EPAR - Product Information SV = svenska 2010-01-26 2015-02-23

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 RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  
Purevax RCPCh FeLV : EPAR - All Authorised presentations SV = svenska 2008-02-11  

Pharmacotherapeutic group

Immunologicals For felidae

Therapeutic indication

Active immunisation of cats aged 8 weeks and older:
- against feline viral rhinotracheitis to reduce clinical signs,
- against calicivirus infection to reduce clinical signs and excretion,
- against Chlamydophila felis infection to reduce clinical signs,
- against feline panleucopenia to prevent mortality and clinical signs,
- against leukaemia to prevent persistent viraemia and clinical signs of the related disease.
Onsets of immunity have been demonstrated 1 week after primary vaccination course for
rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components, and 2 weeks after
primary vaccination course for feline leukaemia component.
The duration of immunity is 1 year after the last (re-)vaccination for rhinotracheitis, calicivirus,
Chlamydophila felis and feline leukaemia components, and 3 years for panleucopenia component.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Purevax RCPCh FeLV : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2010-01-26 2015-02-23

Initial marketing-authorisation documents

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