Veterinary Medicines

Avishield IBD INT, lyophilisate for oculonasal suspension/use in drinking water for chickens

Authorised
  • Infectious bursal disease virus, strain VMG 91 (intermediate), Live
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Product identification

Medicine name:
Avishield IBD INT, lyophilisate for oculonasal suspension/use in drinking water for chickens
AVISHIELD IBD INT liofilizat za okulonazalno suspenzijo/dajanje v vodo za pitje za piščance
Active substance:
  • Infectious bursal disease virus, strain VMG 91 (intermediate), Live
Target species:
  • Chicken
Route of administration:
  • Oculonasal use
  • Oral use

Product details

Active substance and strength:
  • Infectious bursal disease virus, strain VMG 91 (intermediate), Live
    4.00
    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
      • All relevant tissues
        no withdrawal period
  • Oral use
    • Chicken
      • All relevant tissues
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD09
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • Carton box with 10 vials of 5000 doses of vaccine. Colourless glass vials (type I) filled with 10 ml (5000 doses) which are closed with brombutyl rubber stoppers and sealed with aluminium caps.
  • Carton box with 10 vials of 2500 doses of vaccine. Colourless glass vials (type I) filled with 10 ml (2500 doses) which are closed with brombutyl rubber stoppers and sealed with aluminium caps.
  • Carton box with 10 vials of 1000 doses of vaccine. Colourless glass vials (type I) filled with 4 ml (1000 doses) 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:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0624/001
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0234/001
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: 23/02/2022
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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: 23/02/2022
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