Nobilis Influenza H7N1

inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99)

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The marketing authorisation for Nobilis Influenza H7N1 has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Nobilis Influenza H7N1 : EPAR - Summary for the public BG = bălgarski 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public ES = español 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public CS = čeština 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public DA = dansk 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public DE = Deutsch 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public ET = eesti keel 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public EL = elliniká 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public EN = English 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public FR = français 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public IT = italiano 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public LV = latviešu valoda 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public LT = lietuvių kalba 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public HU = magyar 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public MT = Malti 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public NL = Nederlands 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public PL = polski 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public PT = português 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public RO = română 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public SK = slovenčina 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public SL = slovenščina 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public FI = suomi 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Summary for the public SV = svenska 2007-06-01 2010-07-26

This EPAR was last updated on 26/07/2010 .

Authorisation details

Product details

Product details for Nobilis Influenza H7N1
NameNobilis Influenza H7N1
Agency product numberEMEA/V/C/000123
Active substance

inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99)

International non-proprietary name (INN) or common name

adjuvanted inactivated vaccine against avian influenza virus type A, subtype H7

Species ChickenDucks
Anatomical therapeutic chemical veterinary (ATCvet) codeQI01AA23
Accelerated procedure

Accelerated procedures are intended to speed up access to new medicines of major public-health interest. Eligible products must either responds to unmet medical needs or constitute a significant improvement over the available methods of prevention, diagnosis or treatment of a condition.

Exceptional Circumstances

There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Publication details

Publication details for Nobilis Influenza H7N1
Marketing-authorisation holder

Intervet International BV

Revision2
Date of issue of marketing authorisation valid throughout the European Union14/05/2007

Contact address:

Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

Product information

07/07/2010  Nobilis Influenza H7N1 -EMEA/V/C/000123 -S/0003

Name Language First published Last updated
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26
Nobilis Influenza H7N1 : EPAR - Product Information SV = svenska 2009-08-24 2010-07-26

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - All Authorised presentations SV = svenska 2007-06-01 2010-07-26

Pharmacotherapeutic group

Immunologicals For aves

Therapeutic indication

For active immunisation of chickens and ducks against avian influenza type A, subtype H7N1.

Efficacy has been evaluated on the basis of preliminary results in chickens and ringed teals.

  • In chickens, reduction of clinical signs, mortality, excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.
  • In ducks, reduction of excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.

Although it has not been investigated with this particular AI vaccine strain, studies performed with other strains show that protective levels of serum antibody titres would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine. The duration of immunity in ducks is unknown.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Nobilis Influenza H7N1 : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-08-24 2010-07-26

Initial marketing-authorisation documents

Name Language First published Last updated
Nobilis Influenza H7N1 : EPAR - Procedural steps taken before authorisation SV = svenska 2007-06-01 2010-07-26
Nobilis Influenza H7N1 : EPAR - Scientific Discussion SV = svenska 2007-06-01 2010-07-26