Nobilis Influenza H5N6

Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

The marketing authorisation for Nobilis Influenza H5N6 has been withdrawn at the request of the marketing authorisation holder.

Nobilis Influenza H5N6 : EPAR - Summary for the public

Product information

Nobilis Influenza H5N6 : EPAR - Product Information

Nobilis Influenza H5N6 : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Nobilis Influenza H5N6
• Active substance:
  inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84)
• 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) code:
  QI01AA23

Pharmacotherapeutic group

Immunologicals for aves

Therapeutic indication

For active immunisation of chickens against avian influenza type A, subtype H5.
Reduction of clinical signs, mortality and excretion of virus after challenge with a virulent H5N1 strain, were shown by two weeks after a single dose vaccination.
Serum antibodies have been shown to persist in chickens for at least 7 months and studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.

Authorisation details

• EMA product number:
  EMEA/V/C/000125
• 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.

• Exceptional 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.

• Marketing authorisation holder:
  Intervet International BV

  Wim de Körverstraat 35; 5831 AN Boxmeer; The Netherlands

• Marketing authorisation issued:
  31/01/2008
• Revision:
  1

Assessment history

Changes since initial authorisation of medicine

Nobilis Influenza H5N6 : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Nobilis Influenza H5N6 : EPAR - Procedural steps taken before authorisation

Nobilis Influenza H5N6 : EPAR - Scientific Discussion