Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Nobilis Influenza H5N2   
Auth. number : EU/2/06/061
INN : Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), inducing an HI titre of ≥6.0 log2 as tested according to the potency test.
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: For active immunisation of chickens against avian influenza type A, subtype H5.
Marketing Authorisation Holder: Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

  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/118 (2006)4012 of 01/09/2006
11/02/2008 Centralised - Annual reassessment EMEA/V/C/118/S/1 (2008)560 of 07/02/2008
10/04/2008 Centralised - Variation EMEA/V/C/118/IB/2
Updated with Decision(2008)7422 of 20/11/2008
24/11/2008 Centralised - Annual reassessment EMEA/V/C/118/S/3 (2008)7422 of 20/11/2008
08/10/2009 Centralised - Annual reassessment EMEA/V/C/118/S/4 (2009)7795 of 06/10/2009
11/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/118/IG/1
07/10/2010 Centralised - Annual reassessment EMEA/V/C/118/S/5 (2010)7026 of 05/10/2010
23/08/2011 Centralised - Renewal EMEA/V/C/118/R/6 (2011)6082 of 19/08/2011
12/12/2012 Centralised - Annual reassessment EMEA/V/C/118/S/10 (2012)9541 of 10/12/2012