Nobivac Myxo-RHD

live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009

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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 Myxo-RHD?

Nobivac Myxo-RHD is a vaccine that contains live myxoma-vectored rabbit-haemorrhagic-disease (RHD) virus strain 009. It is available as a lyophilisate (freeze-dried substance) and a solvent that are made up into a suspension for injection.

What is Nobivac Myxo-RHD used for?

Nobivac Myxo-RHD is used in rabbits aged five weeks or more to reduce the number of deaths and clinical signs due to myxomatosis (skin tumours caused by the myxoma virus) and to prevent death due to RHD, a disease resulting in blood clot formation caused by the RHD virus.

How does Nobivac Myxo-RHD work?

Nobivac Myxo-RHD, like all vaccines, works by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. It contains a weakened strain of the myxoma virus which has been genetically modified so that it can produce a protein of the RHD virus. When it is given to rabbits the immune system recognises the myxoma and RHD materials as ‘foreign’ and makes antibodies against them. In the future, if the rabbits are exposed to any of the viruses, the immune system will be able to respond more quickly. This will help to protect against the diseases.

How has Nobivac Myxo-RHD been studied?

Fifteen field and laboratory studies were carried out, in which rabbits vaccinated with Nobivac Myxo-RHD were compared with unvaccinated rabbits to establish the onset and duration of immunity against myxoma and RHD viruses.

What benefit has Nobivac Myxo-RHD shown during the studies?

The studies showed that Nobivac Myxo-RHD was effective in providing immunity against myxomatosis and RHD three weeks after vaccination and that the immunty was still present after one year. Rabbits that were vaccinated with Nobivac Myxo-RHD had fewer signs of myxomatosis, more antibodies against RHD virus in their blood and a lower death rate than unvaccinated rabbits.

What is the risk associated with Nobivac Myxo-RHD?

A temporary increase in body temperature of 1-2°C can occur. There may also be a small, painless swelling at the injection site within the first two weeks after vaccination. The swelling will resolve completely by the end of the third week.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption. The withdrawal period for Nobivac Myxo-RHD is zero days.

Why has Nobivac Myxo-RHD been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac Myxo-RHD exceed the risks when used to reduce the number of deaths and clinical signs due to myxomatosis and prevent death due to rabbit haemorrhagic disease. The Committee recommended that Nobivac Myxo-RHD be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Nobivac Myxo-RHD

The European Commission granted a marketing authorisation valid throughout the European Union, for Nobivac Myxo-RHD to Intervet International BV on 7 September 2011. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Nobivac Myxo-RHD : EPAR - Summary for the public BG = bălgarski 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public ES = español 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public CS = čeština 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public DA = dansk 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public DE = Deutsch 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public ET = eesti keel 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public EL = elliniká 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public EN = English 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public FR = français 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public IT = italiano 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public LV = latviešu valoda 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public LT = lietuvių kalba 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public HU = magyar 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public MT = Malti 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public NL = Nederlands 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public PL = polski 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public PT = português 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public RO = română 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public SK = slovenčina 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public SL = slovenščina 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public FI = suomi 26/09/2011  
Nobivac Myxo-RHD : EPAR - Summary for the public SV = svenska 26/09/2011  

This EPAR was last updated on 18/08/2016 .

Authorisation details

Product details

Product details for Nobivac Myxo-RHD
NameNobivac Myxo-RHD
Agency product numberEMEA/V/C/002004
Active substance

live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009

International non-proprietary name (INN) or common name

live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009

Species Rabbits
Anatomical therapeutic chemical veterinary (ATCvet) codeQI08AD

Publication details

Publication details for Nobivac Myxo-RHD
Marketing-authorisation holder

Intervet International BV

Revision3
Date of issue of marketing authorisation valid throughout the European Union07/09/2011

Contact address:

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Netherlands

Product information

Product information

05/08/2016  Nobivac Myxo-RHD -EMEA/V/C/002004 -IAIN/0006

Name Language First published Last updated
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - Product Information SV = svenska 26/09/2011 18/08/2016

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 Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016
Nobivac Myxo-RHD : EPAR - All Authorised presentations SV = svenska 26/09/2011 18/08/2016

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

For active immunisation of rabbits from five weeks of age onwards to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease.

Onset of immunity: 3 weeks.

Duration of immunity: 1 year.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Nobivac Myxo-RHD : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 23/04/2014 18/08/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Nobivac Myxo-RHD : EPAR - Public assessment report SV = svenska 26/09/2011 20/12/2011
CVMP summary of positive opinion for Nobivac Myxo-RHD SV = svenska 15/07/2011