Veterinary Medicines

Avishield ND lyophilisate for oculonasal suspension/use in drinking water for chickens and turkeys

Authorised
  • Newcastle disease virus, strain La Sota, Live
Download as PDF

Product identification

Medicine name:
Avishield ND lyophilisate for oculonasal suspension/use in drinking water for chickens and turkeys
Avishield ND Lyofilisaat voor suspensie
Avishield ND Lyophilisat pour suspension
Avishield ND Lyophilisat zur Herstellung einer Suspension
Active substance:
  • Newcastle disease virus, strain La Sota, Live
Target species:
  • Turkey
  • Chicken
Route of administration:
  • Oculonasal use
  • Oral use

Product details

Active substance and strength:
  • Newcastle disease virus, strain La Sota, 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
    • Turkey
      • All relevant tissues
        no withdrawal period
    • Chicken
      • All relevant tissues
        1
        day
  • Oral use
    • Turkey
      • All relevant tissues
        no withdrawal period
    • Chicken
      • All relevant tissues
        1
        day
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:
  • Cardboard or plastic box with 10 vials of 2500 doses of vaccine. Colourless glass vials (type I), which are closed with rubber stoppers and sealed with aluminium caps.
  • Cardboard or plastic box with 10 vials of 1000 doses of vaccine. Colourless glass vials (type I), which are closed with rubber stoppers and sealed with aluminium caps.
  • Cardboard or plastic box with 10 vials of 5000 doses of vaccine. Colourless glass vials (type I), which are closed with 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-V500764
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0300/001
Concerned member states:
  • Belgium
  • Croatia
  • Germany
  • Greece
  • Hungary
  • Poland
  • Portugal
  • Romania
  • 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: 22/09/2025
Download
French (PDF)
Published on: 22/09/2025
Download
German (PDF)
Published on: 22/09/2025
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/09/2025
Download
French (PDF)
Published on: 22/09/2025
Download
German (PDF)
Published on: 22/09/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/09/2025
Download
French (PDF)
Published on: 22/09/2025
Download
German (PDF)
Published on: 22/09/2025
Download

Combined File of all Documents

English (PDF)
Published on: 8/10/2025
Download
How useful was this page?:
Average: 1 (3 votes)
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."