Veterinary Medicines

Avishield ND B1, lyophilisate for oculonasal suspension/use in drinking water for Chickens

Authorised
  • Newcastle disease virus, strain B1 Hitchner, Live
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Product identification

Medicine name:
Avishield ND B1, lyophilisate for oculonasal suspension/use in drinking water for Chickens
Avishield ND B1 Lyofilisaat voor suspensie voor oculonasaal gebruik/voor gebruik in drinkwater
Avishield ND B1 Lyophilisat pour suspension oculonasale/administration dans l'eau de boisson
Avishield ND B1 Lyophilisat zur Herstellung einer Suspension zur oculonasalen Anwendung/zum Eingeben �ber das Trinkwasser
Active substance:
  • Newcastle disease virus, strain B1 Hitchner, Live
Target species:
  • Chicken
Route of administration:
  • Oculonasal use
  • Oral use

Product details

Active substance and strength:
  • Newcastle disease virus, strain B1 Hitchner, Live
    6.00
    log10 50% tissue culture infectious dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for oculonasal suspension/use in drinking water
Withdrawal period by route of administration:
  • Oculonasal use
    • Chicken
      • Meat and offal
        no withdrawal period
  • Oral use
    • Chicken
      • Meat and offal
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Carton with 10 vials of 1000 doses of vaccine. Colourless glass vials (type I), which are closed with brombutyl rubber stoppers and sealed with aluminium caps.
  • Carton with 10 vials of 5000 doses of vaccine. Colourless glass vials (type I), which are closed with brombutyl rubber stoppers and sealed with aluminium caps.
  • Carton with 10 vials of 2500 doses of vaccine. Colourless glass vials (type I), which are closed with brombutyl rubber stoppers and sealed with aluminium caps.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Genera d.d.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V528960
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0293/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 8/12/2025
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French (PDF)
Published on: 8/12/2025
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German (PDF)
Published on: 8/12/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 8/12/2025
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French (PDF)
Published on: 8/12/2025
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German (PDF)
Published on: 8/12/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 8/12/2025
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French (PDF)
Published on: 8/12/2025
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German (PDF)
Published on: 8/12/2025
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Combined File of all Documents

English (PDF)
Published on: 24/10/2025
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