Veterinary Medicines

HIPRABOVIS-BALANCE

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

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

Product details

Active substance and strength:
  • Bovine parainfluenza virus 3, strain SF-4, Inactivated
    16.00
    haemagglutination inhibiting unit(s)
    /
    1.00
    Dose
  • Bovine viral diarrhoea virus, strain NADL, Inactivated
    20.00
    serum neutralising unit(s)
    /
    1.00
    Dose
  • Bovine respiratory syncytial virus, strain Lym-56, Live
    10000.00
    tissue culture infective dose 50
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and suspension for suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (calf)
      • Meat and offal
        0
        day
    • Cattle (cow)
      • Meat and offal
        0
        day
    • Cattle (heifer)
      • Meat and offal
        0
        day
  • Subcutaneous use
    • Cattle (calf)
      • Meat and offal
        0
        day
    • Cattle (cow)
      • Meat and offal
        0
        day
    • Cattle (heifer)
      • Meat and offal
        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:
  • Portugal
Package description:
  • Box with 1 vial lyophilised fraction (80 doses) + 1 vial of 250 ml of liquid fraction (containing 240 ml)
  • Box with 1 vial lyophilised fraction (30 doses) + 1 vial of 100 ml of liquid fraction (containing 90 ml)
  • Box with 1 vial of lyophilised fraction (5 doses) + 1 vial of 20 ml of liquid fraction (containing 15 ml)
  • Box with 1 vial lyophilised fraction (25 doses) + 1 vial of 100 ml of liquid fraction

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Informed consent application (Article 13c 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:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 837/10RIVPT
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0166/001
Concerned member states:
  • Portugal

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 10/10/2022
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Summary of Product Characteristics

English (PDF)
Published on: 5/04/2023
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Package Leaflet

English (PDF)
Published on: 5/04/2023
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Labelling

English (PDF)
Published on: 5/04/2023
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eu-PUAR-hiprabovis-balance-en.pdf

English (PDF)
Published on: 5/04/2023
Download
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