Veterinary Medicines

Avishield ND +IB H120

Authorised
  • Newcastle disease virus, strain La Sota, Live
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
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Product identification

Medicine name:
Avishield ND +IB H120
AVISHIELD ND + IB H120 liofilizat za okulonazalno suspenzijo/dajanje v vodo za pitje za piščance
Active substance:
  • Newcastle disease virus, strain La Sota, Live
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
Target species:
  • Chicken
Route of administration:
  • Oculonasal use
  • In drinking water use

Product details

Active substance and strength:
  • Newcastle disease virus, strain La Sota, Live
    6.00
    log10 50% tissue culture infectious dose
    /
    1.00
    Vial
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
    3.50
    log 10 50% embryo infective dose
    /
    1.00
    Vial
Pharmaceutical form:
  • Lyophilisate for oculonasal suspension/use in drinking water
Withdrawal period by route of administration:
  • Oculonasal use
    • Chicken
      • Meat and offal
        0
        day
  • In drinking water use
    • Chicken
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD11
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • The vaccine is filled into colourless glass vials (type I), which are closed with rubber stoppers (brombutyl) and sealed with aluminium caps. 10x2500 dose
  • The vaccine is filled into colourless glass vials (type I), which are closed with rubber stoppers (brombutyl) and sealed with aluminium caps. 10x1000 dose

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Immunological veterinary medicinal product application (Article 13d 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:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0628/001
Date of authorisation status change:
Reference member state:
  • Hungary
Procedure number:
  • HU/V/0130/001
Concerned member states:
  • Croatia
  • Slovenia

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 4/03/2024
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 4/03/2024
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