Nobilis Influenza H5N2
adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5
Table of contents
Overview
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).
Authorisation details
Product details | |
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Name |
Nobilis Influenza H5N2
|
Agency product number |
EMEA/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
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Species |
Chicken
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Anatomical therapeutic chemical veterinary (ATCvet) codes |
QI01AA23
|
Accelerated assessment |
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment. |
Publication details | |
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Marketing-authorisation holder |
Intervet International BV
|
Revision |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
01/09/2006
|
Contact address |
Intervet International B.V.
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands |
Product information
18/03/2021 Nobilis Influenza H5N2 - EMEA/V/C/000118 - IG/1348
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.