Nobilis Influenza H7N1

RSS

adjuvanted inactivated vaccine against avian influenza virus type A, subtype H7

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Nobilis Influenza H7N1 has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 26/07/2010

Authorisation details

Product details
Name
Nobilis Influenza H7N1
Agency product number
EMEA/V/C/000123
Active substance
inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99)
International non-proprietary name (INN) or common name
adjuvanted inactivated vaccine against avian influenza virus type A, subtype H7
Species
  • Chicken
  • Ducks
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI01AA23
Accelerated assessmentAccelerated 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.

Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Publication details
Marketing-authorisation holder
Intervet International BV
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
14/05/2007
Contact address
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

07/07/2010 Nobilis Influenza H7N1 - EMEA/V/C/000123 - S/0003

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 and ducks against avian influenza type A, subtype H7N1.

Efficacy has been evaluated on the basis of preliminary results in chickens and ringed teals.

  • In chickens, reduction of clinical signs, mortality, excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.
  • In ducks, reduction of excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.

Although it has not been investigated with this particular AI vaccine strain, studies performed with other strains show that protective levels of serum antibody titres would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine. The duration of immunity in ducks is unknown.

Assessment history

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