Pharmaceuticals - Community Register

  

Community list of not active veterinary medicinal products


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Product information

Invented name: Poulvac FluFend H5N3 RG
Auth. number : EU/2/06/060
INN : Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04) 256 - 4046 HA Units
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI01 - Immunologicals for aves
Pharmacological subgroup: QI01A - Domestic fowl
Chemical subgroup: QI01AA - Inactivated viral vaccines
Chemical substance: QI01AA23 - Avian influenza virus
(See WHO ATCvet Index)
Indication: active immunisation of chickens and Pekin ducks against avian influenza virus type A, subtype H5.
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
07/09/2006 Centralised - Authorisation EMEA/V/C/117 (2006)4013 of 01/09/2006
11/10/2007 Centralised - Annual reassessment EMEA/V/C/117/S/1 (2007)5061 of 09/10/2007
05/08/2008 Centralised - Variation EMEA/V/C/117/II/2 (2008)4281 of 31/07/2008
23/09/2008 Centralised - Annual reassessment EMEA/V/C/117/S/3
19/06/2009 Centralised - Variation EMEA/V/C/117/IB/5
Updated with Decision(2010)159 of 14/01/2010
20/07/2009 Centralised - Annual reassessment EMEA/V/C/117/S/4
18/01/2010 Centralised - Variation (2010)159 of 14/01/2010
13/10/2010 Centralised - Annual reassessment EMEA/V/C/117/S/6 (2010)6904 of 30/09/2010
28/10/2010 Centralised - Variation EMEA/V/C/117/IA/8/G
Updated with Decision(2011)467 of 24/01/2011
23/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/117/IB/9
15/12/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/117/T/7 (2010)9287 of 13/12/2010
27/01/2011 Centralised - Variation (2011)467 of 24/01/2011
01/08/2011 Centralised - Renewal EMEA/V/C/117/R/10 (2011)5597 of 27/07/2011
04/04/2012 Centralised - Withdrawal (2012)2327 of 30/03/2012