Nobilis Influenza H5N2

inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86)

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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.

If you need more information about how this product may be used, you should consult your national veterinary authority. If you want more information on the basis of the CVMP's recommendations, read the scientific discussion (also part of the EPAR).

What is Nobilis Influenza H5N2?

Nobilis Influenza H5N2 is a vaccine containing an inactivated avian influenza virus H5N2 (inactivated means that the virus has been killed so that it cannot cause the disease any more).

What is Nobilis Influenza H5N2 used for?

Nobilis Influenza H5N2 is a vaccine used in chickens to protect against avian influenza. The vaccine reduces the signs of flu and the excretion (shedding) of the virus by the infected birds. The vaccine is injected intramuscularly (into a muscle) or subcutaneously (under the skin).

The vaccine will only be used as part of an approved national disease control programme. This is because control of avian influenza is the responsibility of national veterinary authorities in consultation with the European Commission.

How does Nobilis Influenza H5N2 work?

Nobilis Influenza H5N2 is a vaccine. When it is given to chickens, the birds’ immune system (their natural defence mechanism) learns how to make antibodies (a special type of protein) to fight the disease. In the future, if the birds are exposed to the avian flu virus, the immune system will be able to make those antibodies quicker and this will help them fight the disease.

The virus used for the vaccine carries the H5 (haemagglutinin 5) and N2 (neuramidase 2) antigens. This means that vaccinated birds make antibodies against these two antigens. This strain has been chosen because it protects birds against virulent H5N1 field strains (cross-protection), while allowing differentiation of vaccinated from infected birds. Vaccinated birds can be differentiated from infected birds by a diagnostic test for antibodies against the N2 component. This differentiation is important for disease surveillance and control.

How has Nobilis Influenza H5N2 been studied?

The company carried out laboratory safety studies using a vaccine very similar to Nobilis Influenza H5N2. This vaccine has some of the same ingredients but different antigens (viruses), two of which are produced using the same process to that used for the avian influenza antigen of Nobilis Influenza. It also tested the safety of three standard production batches of Nobilis Influenza H5N2.

Studies were carried out in one-day-old and two- to four-week-old chickens free of any infection. The data on the effectiveness of the vaccine was based on published scientific papers and internal company reports. They included studies in other avian species (ducks, turkeys, pheasants), and studies using either the subcutaneous or intramuscular routes.

The vaccine was assessed in the context of an emergency situation, which means that further studies with Nobilis H5N2 are still ongoing and will be assessed.

What benefit has Nobilis Influenza H5N2 shown during the studies?

The results of the safety studies indicated that the product is safe for chickens. When compared, the subcutaneous and intramuscular routes were shown to produce the same responses.

  • The vaccine has been shown to prevent clinical signs and mortality and reduce virus shedding in infected chickens.
  • The vaccine is able to induce antibodies in a wide range of birds.
  • If the circulating avian influenza field virus has a different N component to the N2 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect neuraminidase antibodies.
What is the risk associated with Nobilis Influenza H5N2?

In common with many adjuvanted vaccines swelling may occur at the vaccination site which may last for about 14 days.

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

The vaccine contains a mineral oil. The person who gives the vaccine should be careful to avoid accidental self-injection.

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

Zero days.

The vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated birds.

Why has Nobilis Influenza H5N2 been approved?

The Committee for Medicinal Products for Veterinary Use concluded that the vaccine has been shown to be effective in preventing clinical disease in poultry and could be a useful tool in controlling an outbreak of avian influenza infection. Because of the current epidemiological situation of avian influenza and the consequent threat to both human and animal health, the Committee recommended the granting of a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Nobilis Influenza H5N2 has been authorised under 'exceptional circumstances'. This means that it has yet not been possible to obtain complete information about the product. The European Medicines Agency will review additional information that will become available according to an agreed timetable and this summary will be updated as necessary.

Other information about Nobilis Influenza H5N2

The European Commission granted a marketing authorisation valid throughout the European Union for Nobilis Influenza H5N2 to Intervet International BV on 1 September 2006.

Name Language First published Last updated
Nobilis Influenza H5N2 : EPAR - Summary for the public BG = bălgarski 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public ES = español 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public CS = čeština 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public DA = dansk 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public DE = Deutsch 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public ET = eesti keel 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public EL = elliniká 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public EN = English 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public FR = français 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public IT = italiano 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public LV = latviešu valoda 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public LT = lietuvių kalba 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public HU = magyar 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public MT = Malti 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public NL = Nederlands 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public PL = polski 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public PT = português 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public RO = română 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public SK = slovenčina 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public SL = slovenščina 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public FI = suomi 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Summary for the public SV = svenska 2006-09-19  

This EPAR was last updated on 20/07/2016 .

Authorisation details

Product details

Product details for Nobilis Influenza H5N2
NameNobilis Influenza H5N2
Agency product numberEMEA/V/C/000118
Active substance

inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86)

International non-proprietary name (INN) or common name

adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5

Species Chicken
Anatomical therapeutic chemical veterinary (ATCvet) codeQI01AA23
Accelerated procedure

Accelerated procedures are intended to speed up access to new medicines of major public-health interest. Eligible products must either responds to unmet medical needs or constitute a significant improvement over the available methods of prevention, diagnosis or treatment of a condition.

Publication details

Publication details for Nobilis Influenza H5N2
Marketing-authorisation holder

Intervet International BV

Revision7
Date of issue of marketing authorisation valid throughout the European Union01/09/2006

Contact address:

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

Product information

Product information

27/06/2016  Nobilis Influenza H5N2 -EMEA/V/C/000118 -R/0012

Name Language First published Last updated
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20
Nobilis Influenza H5N2 : EPAR - Product Information SV = svenska 2009-10-22 2016-07-20

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
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11
Nobilis Influenza H5N2 : EPAR - All Authorised presentations SV = svenska 2006-09-19 2010-11-11

Pharmacotherapeutic group

Immunologicals for aves

Therapeutic indication

For active immunisation of chickens against avian influenza type A, subtype H5.

Efficacy has been evaluated on the basis of preliminary results in chickens. Reduction of clinical signs, mortality and excretion of virus after challenge were shown by three weeks after vaccination.

Serum antibodies could be expected to persist for at least 12 months after administration of two doses of vaccine.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Nobilis Influenza H5N2 : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-10-22 2016-07-20

Initial marketing-authorisation documents

Name Language First published Last updated
Nobilis Influenza H5N2 : EPAR - Procedural steps taken before authorisation SV = svenska 2006-09-19  
Nobilis Influenza H5N2 : EPAR - Scientific Discussion SV = svenska 2006-09-19