Poulvac Flufend H5N3 RG
recombinant inactivated avian influenza virus
Table of contents
Overview
The marketing authorisation for Poulvac FluFend H5N3 RG has been withdrawn at the request of the marketing authorisation holder.
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 |
|
| Anatomical therapeutic chemical veterinary (ATCvet) codes |
QI01AA23
|
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. |
| 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
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
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.