Overview

The marketing authorisation for Poulvac FluFend H5N3 RG has been withdrawn at the request of the marketing authorisation holder.

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Product information

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Latest procedure affecting product information: R/0010

30/03/2012

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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

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