Nobilis Influenza H7N1

Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

The marketing authorisation for Nobilis Influenza H7N1 has been withdrawn at the request of the marketing authorisation holder.

Nobilis Influenza H7N1 : EPAR - Summary for the public

Product information

Nobilis Influenza H7N1 : EPAR - Product Information

Latest procedure affecting product information: S/0003

07/07/2010

Nobilis Influenza H7N1 : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Nobilis Influenza H7N1
• 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) code:
  QI01AA23

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.

Authorisation details

• EMA product number:
  EMEA/V/C/000123
• 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

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

• Marketing authorisation issued:
  14/05/2007
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Nobilis Influenza H7N1 : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Nobilis Influenza H7N1 : EPAR - Procedural steps taken before authorisation

Nobilis Influenza H7N1 : EPAR - Scientific Discussion