Veterinary Medicines

ORNIBUR lyofilizát na prípravu suspenzie pre kurčatá

Authorised
  • Infectious bursal disease virus, strain OP-23 (intermediate), Live
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Product identification

Medicine name:
ORNIBUR lyofilizát na prípravu suspenzie pre kurčatá
Active substance:
  • Infectious bursal disease virus, strain OP-23 (intermediate), Live
Target species:
  • Chicken
Route of administration:
  • In drinking water use
  • Ocular use

Product details

Active substance and strength:
  • Infectious bursal disease virus, strain OP-23 (intermediate), Live
    4.00
    log10 50% tissue culture infectious dose
    /
    0.05
    millilitre(s)
Pharmaceutical form:
  • Lyophilisate for oculonasal suspension/use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken
      • All relevant tissues
        0
        day
  • Ocular use
    • Chicken
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD09
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 97/097/99-S
Date of authorisation status change:

Documents

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Published on: 15/12/2021
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