Veterinary Medicines

Avishield IB GI-13, lyophilisate for oculonasal suspension/use in drinking water for chickens

Authorised
  • Avian infectious bronchitis virus, type 793/B, strain V-173/11, Live
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Product identification

Medicine name:
Avishield IB GI-13, lyophilisate for oculonasal suspension/use in drinking water for chickens
Avishield IB GI-13
Active substance:
  • Avian infectious bronchitis virus, type 793/B, strain V-173/11, Live
Target species:
  • Chicken
Route of administration:
  • Oculonasal use
  • Oral use

Product details

Active substance and strength:
  • Avian infectious bronchitis virus, type 793/B, strain V-173/11, Live
    2.70
    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
      • All relevant tissues
        no withdrawal period
  • Oral use
    • Chicken
      • All relevant tissues
        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:
  • Germany
Package description:
  • Cardboard box with 10 colourless glass vials (type I), which are closed with bromobutyl rubber stoppers and sealed with aluminium caps, of 1000 doses of vaccin
  • Cardboard box with 10 colourless glass vials (type I), which are closed with bromobutyl rubber stoppers and sealed with aluminium caps, of 5000 doses of vaccine
  • Cardboard box with 10 colourless glass vials (type I), which are closed with bromobutyl rubber stoppers and sealed with aluminium caps, of 2500 doses of vaccine

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:
  • Paul-Ehrlich-Institut
Authorisation number:
  • PEI.V.11998.01.1
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0301/001
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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German (PDF)
Published on: 23/02/2022
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