Nobilis Influenza H7N1
adjuvanted inactivated vaccine against avian influenza virus type A, subtype H7
Table of contents
Overview
The marketing authorisation for Nobilis Influenza H7N1 has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Nobilis Influenza H7N1
|
| Agency product number |
EMEA/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 |
|
| 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 |
Intervet International BV
|
| Revision |
2
|
| Date of issue of marketing authorisation valid throughout the European Union |
14/05/2007
|
| Contact address | |
Product information
07/07/2010 Nobilis Influenza H7N1 - EMEA/V/C/000123 - S/0003
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
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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.