Veterinary Medicines

HIPRABOVIS-4

Authorised
  • Bovine herpesvirus 1, strain LA, Inactivated
  • Bovine parainfluenza virus 3, strain SF-4, Inactivated
  • Bovine viral diarrhoea virus, strain NADL, Inactivated
  • Bovine respiratory syncytial virus, strain Lym-56, Live
Download as PDF

Product identification

Medicine name:
HIPRABOVIS-4
Active substance:
  • Bovine herpesvirus 1, strain LA, Inactivated
  • 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
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Bovine herpesvirus 1, strain LA, Inactivated
    39810700.00
    tissue culture infective dose 50
    /
    3.00
    millilitre(s)
  • Bovine parainfluenza virus 3, strain SF-4, Inactivated
    500.00
    haemagglutinating units
    /
    3.00
    millilitre(s)
  • Bovine viral diarrhoea virus, strain NADL, Inactivated
    3981070.00
    tissue culture infective dose 50
    /
    3.00
    millilitre(s)
  • Bovine respiratory syncytial virus, strain Lym-56, Live
    1995260.00
    tissue culture infective dose 50
    /
    3.00
    millilitre(s)
Pharmaceutical form:
  • Powder and solvent for suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • 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:
  • Ireland
Package description:
  • Freeze-dried fraction: the container is composed by neutral colourless glass flasks of 10 ml (30 doses) classified as TypeI (Eur. Phar.), grey elastomer Type I closures (Eur. Phar.) and detachable aluminium caps.Liquid fraction: the container is composed by coloured glass flasks of 100 ml (30 doses) Type II (Eur. Phar.), grey elastomer Type II closures (Eur. Phar.) and capsules made of anodised aluminium.
  • Freeze-dried fraction: the container is composed by neutral colourless glass flasks of 10 ml (5 doses) classified as TypeI (Eur. Phar.), grey elastomer Type I closures (Eur. Phar.) and detachable aluminium caps.Liquid fraction: the container is composed by coloured glass flasks of 20 ml (5 doses) Type I (Eur. Phar.), grey elastomer Type II closures (Eur. Phar.) and capsules made of anodised aluminium.

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:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10846/003/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download
How useful was this page?:
Average: 1 (2 votes)
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."