Nobilis Influenza H5N2

RSS

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

Authorised
This medicine is authorised for use in the European Union.

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).

This EPAR was last updated on 20/07/2016

Authorisation details

Product details
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
Species
Chicken
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
Marketing-authorisation holder
Intervet International BV
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
31/08/2006
Contact address
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

26/06/2016 Nobilis Influenza H5N2 - EMEA/V/C/000118 - R/0012

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.

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

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