Innovax-ND-IBD

cell-associated live recombinant turkey herpesvirus expressing the fusion protein of ND virus and the VP2 protein of IBD viru,

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This is a summary of the European public assessment report (EPAR) for Innovax-ND-IBD.It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Innovax-ND-IBD.

For practical information about using Innovax-ND-IBD, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is Innovax-ND-IBD and what is it used for?

Innovax-ND-IBD is a veterinary vaccine used to protect chickens against Newcastle disease (ND), infectious bursal disease (IBD) and Marek’s disease (MD).

ND is a viral infection of chickens which causes gasping and coughing, nervous signs (drooping wings, twisting of the head and neck, circling and paralysis), swelling of the tissues around the eyes and neck, greenish watery diarrhoea and reduced egg production.

IBD, also known as Gumboro disease, is a viral infection of chickens associated with death at 3-6 weeks of age. It can make birds more prone to other diseases and can interfere with effective vaccination.

MD is a herpesvirus infection of chickens which can cause paralysis of the wings and legs and causes tumours in various organs. Chickens become infected at an early age via inhalation of dander (flakes of skin) containing the virus which can remain infectious for several months after being shed from the body. Birds infected with MD virus can be carriers and shedders of the virus for life.

Innovax-ND-IBD contains a live modified strain of turkey herpesvirus called strain HVP360. The turkey herpesvirus strain HVP360 has been modified so that it will produce proteins from ND virus and IBD virus.

How is Innovax-ND-IBD used?

Innovax-ND-IBD is available as a suspension and solvent to be made into a suspension for injection and can only be obtained with a prescription. The vaccine can be given to one-day-old chicks as a single injection under the skin in the neck. Protection against ND starts 4 weeks after vaccination and lasts 8 weeks. Protection against IBD starts 3 weeks after vaccination and lasts 8 weeks. Protection against MD starts 9 days after vaccination and lasts for life.

How does Innovax-ND-IBD work?

Innovax-ND-IBD is a vaccine containing turkey herpesvirus serotype 3, a type of herpesvirus which does not cause disease in chickens. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When Innovax-ND-IBD is given to chickens, the animals’ immune system recognises the virus as ‘foreign’ and makes antibodies against its proteins. In the future if the animals are exposed to similar proteins the immune system will be able to respond more quickly. This will help protect the chickens against ND, IBD and MD.

What benefits of Innovax-ND-IBD have been shown in studies?

Vaccinated chickens were taken from a field study and challenged (brought in contact with the viruses) in the laboratory to demonstrate protection after vaccination.

For ND 40 chickens were vaccinated with Innovax-ND-IBD and 20 chickens were non-vaccinated controls. 60% of vaccinated chickens did not develop ND when challenged at 4 weeks after vaccination and 95% of vaccinated chickens were protected 6 weeks after vaccination.

For IBD vaccinated and non-vaccinated birds were challenged at 3, 4, 6 and 8 weeks after vaccination. Vaccinated birds had a protection level of between 81% and 95% against disease signs.

For MD 60 chickens were vaccinated with Innovax-ND-IBD and 50 chickens were given a dummy injection. 87% of the vaccinated chickens were protected against challenge at 9 days after vaccination.

What are the risks associated with Innovax-ND-IBD?

Since Innovax-ND-IBD is a live vaccine, the vaccine strain can be passed into the environment from vaccinated chickens and may spread to turkeys. Safety studies have shown that the strain is safe for turkeys, however, precautionary measures must be followed to avoid direct or indirect contact between vaccinated chickens and turkeys.

There are no known side effects. For the full list of restrictions, see the package leaflet.

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

Safety information has been included in the summary of product characteristics and the package leaflet for Innovax-ND-IBD, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.

As the vaccine is stored in liquid nitrogen, it is important that any handling is done in a well-ventilated area and that precautions are taken when preparing the vaccine. For further information see the summary of product characteristics.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption. It is also the time required after administration of a medicine before eggs may be used for human consumption.

The withdrawal period for meat and eggs from chickens treated with Innovax-ND-IBD is ‘zero’ days, which means there is no mandatory waiting time.

Why is Innovax-ND-IBD approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Innovax-ND-IBD’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Innovax-ND-IBD:

The European Commission granted a marketing authorisation valid throughout the EU for Innovax-ND-IBD on 22 August 2017.

For more information about treatment with Innovax-ND-IBD, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Innovax-ND-IBD : EPAR - Summary for the public BG = bălgarski 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public ES = español 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public CS = čeština 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public DA = dansk 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public DE = Deutsch 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public ET = eesti keel 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public EL = elliniká 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public EN = English 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public FR = français 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public IT = italiano 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public LV = latviešu valoda 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public LT = lietuvių kalba 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public HU = magyar 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public MT = Malti 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public NL = Nederlands 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public PL = polski 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public PT = português 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public RO = română 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public SK = slovenčina 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public SL = slovenščina 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public FI = suomi 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public SV = svenska 2017-09-21  
Innovax-ND-IBD : EPAR - Summary for the public HR = Hrvatski 2017-09-21  

This EPAR was last updated on 21/09/2017 .

Authorisation details

Product details

Product details for Innovax-ND-IBD
NameInnovax-ND-IBD
Agency product numberEMEA/V/C/004422
Active substance

cell-associated live recombinant turkey herpesvirus expressing the fusion protein of ND virus and the VP2 protein of IBD viru,

International non-proprietary name (INN) or common name

cell-associated live recombinant turkey herpesvirus expressing the fusion protein of ND virus and the VP2 protein of IBD virus

Species Chicken
Anatomical therapeutic chemical veterinary (ATCvet) codes QI01AD



Publication details

Publication details for Innovax-ND-IBD
Marketing-authorisation holder

Intervet International B.V.

Revision0
Date of issue of marketing authorisation valid throughout the European Union22/08/2017

Contact address:

Intervet International B.V.
Wim de Körverstraat 35 5831 AN 
Boxmeer 
Netherlands

Product information

Product information

22/08/2017  Innovax-ND-IBD -EMEA/V/C/004422

Name Language First published Last updated
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - Product Information HR = Hrvatski 2017-09-21  

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
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Innovax-ND-IBD : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  

Pharmacotherapeutic group

Immunologicals for aves

Therapeutic indication

For active immunisation of one-day-old chicks: - to reduce mortality and clinical signs caused by Newcastle disease (ND) virus, - to prevent mortality and to reduce clinical signs and lesions of Infectious bursal disease (IBD), - to reduce mortality, clinical signs and lesions caused by Marek’s disease (MD) virus.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Innovax-ND-IBD : EPAR - Public assessment report HR = Hrvatski 2017-09-21  
CVMP summary of positive opinion for Innovax-ND-IBD HR = Hrvatski 2017-06-16  

Authorised

This medicine is approved for use in the European Union