Poulvac Flufend H5N3 RG

RSS

recombinant inactivated avian influenza virus

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Poulvac FluFend H5N3 RG has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 07/05/2012

Authorisation details

Product details
Name
Poulvac Flufend H5N3 RG
Agency product number
EMEA/V/C/000117
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) 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
Pfizer Limited
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
01/09/2006
Contact address
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

30/03/2012 Poulvac Flufend H5N3 RG - EMEA/V/C/000117 - R/0010

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

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.

Assessment history

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