Poulvac Flufend H5N3 RG

Withdrawn

This medicine's authorisation has been withdrawn

recombinant inactivated avian influenza virus

Overview

The marketing authorisation for Poulvac FluFend H5N3 RG has been withdrawn at the request of the marketing authorisation holder.

Poulvac Flufend H5N3 RG : EPAR - Summary for the public

Product information

Poulvac Flufend H5N3 RG : EPAR - Product Information

Poulvac Flufend H5N3 RG : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Poulvac Flufend H5N3 RG
• Active substance:
  recombinant inactivated avian influenza virus
• International non-proprietary name (INN) or common name:
  recombinant inactivated avian influenza virus
• Species:
  • Chicken
  • Ducks
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI01AA23

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5.

Chickens:
Reduction of mortality and virus excretion after challenge.
Onset of immunity: 3 weeks after the second injection.
Duration of immunity in chickens has not been established yet.

Ducks:
Reduction of clinical signs and virus excretion after challenge.
Onset of immunity: 3 weeks after the second injection.
Duration of immunity in ducks : 14 weeks after the second injection.

Authorisation details

• EMA product number:
  EMEA/V/C/000117
• 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:
  Pfizer Limited

  Ramsgate Road; Sandwich; Kent; CT13 9NJ; United Kingdom

• Marketing authorisation issued:
  01/09/2006
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

Poulvac Flufend H5N3 RG : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Poulvac Flufend H5N3 RG : EPAR - Procedural steps taken before authorisation

Poulvac Flufend H5N3 RG : EPAR - Scientific Discussion