Vaxxitek HVT+IBD

live vHVT013-69 recombinant virus

  • Email
  • Help

About

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 Vaxxitek HVT+IBD?

Vaxxitek HVT+IBD is a recombinant vaccine intended for use against infectious bursal disease (also known as Gumboro disease) and Marek’s disease in chickens. It is presented as a frozen suspension to be reconstituted with diluent and injected into chickens and into eggs where chicks are developing.

What is Vaxxitek HVT+IBD used for?

Vaxxitek HVT+IBD is used to prevent the deaths of chickens and to reduce clinical signs and effects of infectious bursal disease which is a disease which damages the immune system of chickens. Vaxxitek HVT+IBD is also used to reduce mortality, clinical signs and effects of Marek's disease, a herpes virus infection of chickens.

How does Vaxxitek HVT+IBD work?

Vaxxitek HVT+IBD contains vaccine strains which induce an active immunity and a serological response (detected antibodies) against the two diseases. The product appears to show no interference with antibodies derived from the mother bird and can be safely administered to day-old chickens and chicks in the egg without presenting any apparent safety problem or inducing an immunosuppressive effect.

How has Vaxxitek HVT+IBD been studied?

The safety of the product has been demonstrated in several laboratory and field trials in specific pathogen-free and other chickens. The studies were performed according to the requirements of the appropriate European Pharmacopoeia monographs. Whilst the vaccine is unlikely to affect male fertility, a warning has nevertheless been included in the summary of product characteristics.

The safety for non-susceptible bird species (pheasants, ducks, partridges, quails and pigeons) and for mammalian species (mice and guinea-pigs) was also demonstrated. As for any turkey herpesvirus live vaccine, the product is excreted from vaccinated birds and may spread to turkeys. Studies have shown that the strain appears safe for turkeys, however precautionary measures should be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.

What benefit has Vaxxitek HVT+IBD shown during the studies?

The studies demonstrated that Vaxxitek HVT+IBD is effective in the active immunisation of chickens and chicks in the egg against infectious bursal disease. The onset of protection is from 2 weeks onwards and the protection extends to 9 weeks. The vaccine is also effective against Marek’s disease. The onset of protection is from 4 days onwards. A single vaccination is sufficient to provide protection during the risk period.

What is the risk associated with Vaxxitek HVT+IBD?

Only healthy birds should be vaccinated and the product should not be used in birds in lay and breeding birds. No information is available on the safety and efficacy from the concurrent use with any other vaccine, except Merial attenuated vaccines against Marek’s disease, Newcastle disease and infectious bronchitis. It is therefore recommended that no other vaccine than these should be administered within 14 days after vaccination with the product. In the absence of specific studies, no other vaccine should be administered at the same time when the product is injected into eggs.

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

As the product is stored in a tank under liquid nitrogen, particular instructions for reconstitution of the vaccine are provided in the product information module of the EPAR.

What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

Zero days.

Why has Vaxxitek HVT+IBD been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Vaxxitek HVT+IBD exceed the risks of its use in chickens and recommended that Vaxxitek HVT+IBD be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Vaxxitek HVT+IBD

The European Commission granted a marketing authorisation valid throughout the European Union, for Vaxxitek HVT+IBD to Merial S.A.S. on 9 August 2002. The marketing authorisation was subsequently renewed. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Vaxxitek HVT+IBD : EPAR - Summary for the public BG = bălgarski 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public ES = español 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public CS = čeština 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public DA = dansk 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public DE = Deutsch 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public ET = eesti keel 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public EL = elliniká 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public EN = English 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public FR = français 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public IT = italiano 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public LV = latviešu valoda 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public LT = lietuvių kalba 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public HU = magyar 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public MT = Malti 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public NL = Nederlands 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public PL = polski 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public PT = português 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public RO = română 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public SK = slovenčina 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public SL = slovenščina 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public FI = suomi 2007-08-02  
Vaxxitek HVT+IBD : EPAR - Summary for the public SV = svenska 2007-08-02  

This EPAR was last updated on 09/04/2018 .

Authorisation details

Product details

Product details for Vaxxitek HVT+IBD
NameVaxxitek HVT+IBD
Agency product numberEMEA/V/C/000065
Active substance

live vHVT013-69 recombinant virus

International non-proprietary name (INN) or common name

live vaccine against infectious bursal disease and Marek's disease

Species ChickenEmbryonated eggs
Anatomical therapeutic chemical veterinary (ATCvet) codes QI01AD15





Publication details

Publication details for Vaxxitek HVT+IBD
Marketing-authorisation holder

Merial

Revision10
Date of issue of marketing authorisation valid throughout the European Union09/08/2002

Contact address:

Merial
29 avenue Tony Garnier
69007 Lyon
France

Product information

Product information

15/02/2018  Vaxxitek HVT+IBD -EMEA/V/C/000065 -WS/1209/G

Name Language First published Last updated
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09
Vaxxitek HVT+IBD : EPAR - Product Information SV = svenska 2008-11-06 2018-04-09

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
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27
Vaxxitek HVT+IBD : EPAR - All Authorised presentations SV = svenska 2007-08-29 2010-05-27

Pharmacotherapeutic group

Immunologicals For aves

Therapeutic indication

For active immunisation of chickens:

  • to prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.
    The onset of protection is from 2 weeks and the protection extends to 9 weeks;
  • to reduce mortality, clinical signs and lesions of Marek’s disease.
    The onset of protection is from 4 days. A single vaccination is sufficient to provide protection during the risk period.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Vaxxitek HVT+IBD : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-04-24 2018-04-09

Initial marketing-authorisation documents

Name Language First published Last updated
Vaxxitek HVT+IBD : EPAR - Procedural steps taken before authorisation SV = svenska 2006-01-30  
Vaxxitek HVT+IBD : EPAR - Scientific Discussion SV = svenska 2006-01-30