Veterinary Medicines

Avishield IB H120, lyophilisate for oculonasal suspension/use in drinking water, for chickens

Authorised
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
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Product identification

Medicine name:
Avishield IB H120, lyophilisate for oculonasal suspension/use in drinking water, for chickens
AVISHIELD IB H120 LYOPHILISAT POUR SUSPENSION OCULO-NASALE/ADMINISTRATION DANS L'EAU DE BOISSON POUR POULETS
Active substance:
  • 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:
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
    3.50
    log 10 50% embryo infective 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
  • In drinking water use
    • Chicken
      • Meat and offal
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • Carton box with 10 vials of 1000 doses of vaccine. Colourless glass vials (type I), which are closed with bromobutyl rubber stoppers and sealed with aluminium caps.
  • Carton box with 10 vials of 2500 doses of vaccine. Colourless glass vials (type I), which are closed with bromobutyl rubber stoppers and sealed with aluminium caps.
  • Carton box with 10 vials of 5000 doses of vaccine. Colourless glass vials (type I), which are closed with bromobutyl 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:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/0914917 1/2017
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0292/001
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

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French (PDF)
Published on: 29/08/2023
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