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
Download as PDF

Product identification

Medicine name:
Avishield IBD INT, lyophilisate for oculonasal suspension/use in drinking water for chickens
Avishield IBD INT, lyofilisaat voor oculonasale suspensie/gebruik in drinkwater voor kippen
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:
  • Netherlands
Package description:
  • Carton box with 10 vials of 5000 doses of vaccine
  • Carton box with 10 vials of 2500 doses of vaccine
  • Carton box with 10 vials of 1000 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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 122256
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0244/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 16/09/2024
Download
Dutch (PDF)
Published on: 19/01/2022
Download