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BIAROMVAC PA liofilizat și solvent pentru suspensie pentru găini

Authorised
  • Infectious bursal disease virus, Live
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Product identification

Medicine name:
BIAROMVAC PA liofilizat și solvent pentru suspensie pentru găini
Active substance:
  • Infectious bursal disease virus, Live
Target species:
  • Chicken
Route of administration:
  • In drinking water use
  • Ocular use
  • Oral use

Product details

Active substance and strength:
  • Infectious bursal disease virus, Live
    3.50
    log 10 50% embryo infective dose
    /
    0.10
    millilitre(s)
Pharmaceutical form:
  • Lyophilisate for oculonasal suspension/use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken
      • Meat
        0
        day
      • Egg
        0
        day
  • Ocular use
    • Chicken
      • Meat
        0
        day
      • Egg
        0
        day
  • Oral use
    • Chicken
      • Meat
        0
        day
      • Egg
        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:
  • Romania
Package description:

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:
  • Romvac Company S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Romvac Company S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 120170
Date of authorisation status change:

Documents

Combined File of all Documents

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Romanian (PDF)
Published on: 19/11/2025
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