Veterinary Medicines

HIPRABOVIS BALANCE

Authorised
  • Bovine viral diarrhoea virus, strain NADL, Inactivated
  • Bovine parainfluenza virus 3, strain SF-4, Inactivated
  • Bovine respiratory syncytial virus, strain Lym-56, Live
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Product identification

Medicine name:
HIPRABOVIS BALANCE
Active substance:
  • Bovine viral diarrhoea virus, strain NADL, Inactivated
  • Bovine parainfluenza virus 3, strain SF-4, Inactivated
  • Bovine respiratory syncytial virus, strain Lym-56, Live
Target species:
  • Cattle (calf)
  • Cattle (heifer)
  • Cattle (cow)
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Bovine viral diarrhoea virus, strain NADL, Inactivated
    20.00
    serum neutralising unit(s)
    /
    3.00
    millilitre(s)
  • Bovine parainfluenza virus 3, strain SF-4, Inactivated
    4.00
    log2 haemagglutination inhibiting unit(s)
    /
    3.00
    millilitre(s)
  • Bovine respiratory syncytial virus, strain Lym-56, Live
    4.00
    log10 cell culture infective dose 50
    /
    3.00
    millilitre(s)
Pharmaceutical form:
  • Lyophilisate for solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (calf)
      • Meat and offal
        0
        day
    • Cattle (heifer)
      • Meat and offal
        0
        day
    • Cattle (cow)
      • Meat and offal
        0
        day
      • Milk
        0
        day
  • Subcutaneous use
    • Cattle (calf)
      • Meat and offal
        0
        day
    • Cattle (heifer)
      • Meat and offal
        0
        day
    • Cattle (cow)
      • Meat and offal
        0
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AH
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 (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 170196
Date of authorisation status change:

Documents

Combined File of all Documents

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Romanian (PDF)
Published on: 26/06/2023
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