Poulvac Flufend H5N3 RG


recombinant inactivated avian influenza virus

This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Poulvac FluFend H5N3 RG has been withdrawn at the request of the marketing authorisation holder.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
Poulvac Flufend H5N3 RG
Agency product number
Active substance
recombinant inactivated avian influenza virus
International non-proprietary name (INN) or common name
recombinant inactivated avian influenza virus
  • Chicken
  • Ducks
Anatomical therapeutic chemical veterinary (ATCvet) codes
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
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Ramsgate Road
CT13 9NJ
United Kingdom

Product information

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

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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic indication

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

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.

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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