Purevax Rabies

vCP65 virus

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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 Purevax Rabies?

Purevax Rabies is a vaccine that contains rabies recombinant canarypox virus (vCP65). Purevax Rabies is a liquid suspension for injection.

What is Purevax Rabies used for?

Purevax Rabies is used to vaccinate cats from 12 weeks of age to protect against rabies infection.

A 1-ml dose of Purevax Rabies is injected under the skin. The first injection should be given in cats aged at least 12 weeks. Protection starts at the latest four weeks after the injection and lasts for a year. The cats should be revaccinated every year.

How does Purevax Rabies work?

Purevax Rabies is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. The vaccine strain vCP65 in Purevax Rabies is a ‘carrier’ canarypox virus that has been given a gene that makes it able to produce part of a rabies virus called ‘glycoprotein G’. The canarypox viruses do not spread or multiply in the cats but they do produce the glycoprotein G of the rabies virus.

When a cat is given the vaccine, the immune system recognises the rabies glycoprotein G 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 rabies, and this helps to protect against mortality due to rabies infection.

How has Purevax Rabies been studied?

A number of studies, including laboratory studies and field trials, were performed in kittens and cats looking at Purevax Rabies used either on its own or together with other cat vaccines, for primary and booster vaccination. The main measure of effectiveness was the ability of the vaccine to trigger immunity against rabies.

When a cat is given the vaccine, the immune system recognises the rabies glycoprotein G 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 rabies, and this helps to protect against mortality due to rabies infection.

What benefit has Purevax Rabies shown during the studies?

The laboratory studies showed that Purevax Rabies can give protection against rabies, and that the protection lasts for up to a year. The field trials showed that the vaccine is safe, and that it triggers a significant increase of anti-rabies antibodies. The vaccine can boost the immune response in cats that have received primary vaccination with another rabies vaccine.

What is the risk associated with Purevax Rabies?

Occasionally, cats will develop temporary slight apathy (loss of interest in surroundings) and mild anorexia (loss of appetite) or 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 or oedema (swelling) which disappears within one or two weeks at most. For a full list of the side effects reported with Purevax Rabies, see the package leaflet.

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

Canarypox recombinants such as those contained in Purevax Rabies are known to be safe for humans. Transient mild local or general adverse reactions related to the injection itself may be observed. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the doctor.

Why has Purevax Rabies been approved?

The CVMP concluded that the benefits of Purevax Rabies outweigh the risks for the active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection, and recommended that Purevax Rabies be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Purevax Rabies:

The European Commission granted a marketing authorisation valid throughout the European Union, for Purevax Rabies to Merial on 18 February 2011. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Purevax Rabies : EPAR - Summary for the public BG = bălgarski 2011-03-23  
Purevax Rabies : EPAR - Summary for the public ES = español 2011-03-23  
Purevax Rabies : EPAR - Summary for the public CS = čeština 2011-03-23  
Purevax Rabies : EPAR - Summary for the public DA = dansk 2011-03-23  
Purevax Rabies : EPAR - Summary for the public DE = Deutsch 2011-03-23  
Purevax Rabies : EPAR - Summary for the public ET = eesti keel 2011-03-23  
Purevax Rabies : EPAR - Summary for the public EL = elliniká 2011-03-23  
Purevax Rabies : EPAR - Summary for the public EN = English 2011-03-23  
Purevax Rabies : EPAR - Summary for the public FR = français 2011-03-23  
Purevax Rabies : EPAR - Summary for the public IT = italiano 2011-03-23  
Purevax Rabies : EPAR - Summary for the public LV = latviešu valoda 2011-03-23  
Purevax Rabies : EPAR - Summary for the public LT = lietuvių kalba 2011-03-23  
Purevax Rabies : EPAR - Summary for the public HU = magyar 2011-03-23  
Purevax Rabies : EPAR - Summary for the public MT = Malti 2011-03-23  
Purevax Rabies : EPAR - Summary for the public NL = Nederlands 2011-03-23  
Purevax Rabies : EPAR - Summary for the public PL = polski 2011-03-23  
Purevax Rabies : EPAR - Summary for the public PT = português 2011-03-23  
Purevax Rabies : EPAR - Summary for the public RO = română 2011-03-23  
Purevax Rabies : EPAR - Summary for the public SK = slovenčina 2011-03-23  
Purevax Rabies : EPAR - Summary for the public SL = slovenščina 2011-03-23  
Purevax Rabies : EPAR - Summary for the public FI = suomi 2011-03-23  
Purevax Rabies : EPAR - Summary for the public SV = svenska 2011-03-23  

This EPAR was last updated on 04/12/2015 .

Authorisation details

Product details

Product details for Purevax Rabies
NamePurevax Rabies
Agency product numberEMEA/V/C/002003
Active substance

vCP65 virus

International non-proprietary name (INN) or common name

rabies recombinant canarypox virus (vCP65)

Species Cats
Anatomical therapeutic chemical veterinary (ATCvet) codeQI06AD

Publication details

Publication details for Purevax Rabies
Marketing-authorisation holder

Merial

Revision3
Date of issue of marketing authorisation valid throughout the European Union18/02/2011

Contact address:

Merial
29 avenue Tony Garnier
69007 Lyon
France

Product information

Product information

02/12/2015  Purevax Rabies -EMEA/V/C/002003 -R/0004

Name Language First published Last updated
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04
Purevax Rabies : EPAR - Product Information SV = svenska 2011-03-23 2015-12-04

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 Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27
Purevax Rabies : EPAR - All Authorised presentations SV = svenska 2011-03-23 2012-01-27

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection.

Onset of immunity: 4 weeks after the primary vaccination course.

Duration of immunity after primary vaccination: 1 year.

Duration of immunity after revaccination: 3 years.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Purevax Rabies : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2012-01-27 2015-12-04

Initial marketing-authorisation documents

Name Language First published Last updated
Purevax Rabies : EPAR - Public assessment report SV = svenska 2011-03-23  
CVMP summary of positive opinion for Purevax Rabies SV = svenska 2010-12-10