Veterinary Medicines

RISPOVAL 3 BRSV PI3 BVD LYOPHILISATE AND SUSPENSION FOR SUSPENSION FOR INJECTION FOR CATTLE

Not authorised
  • Bovine viral diarrhoea virus 1, strain 6309, Inactivated
  • Bovine respiratory syncytial virus, strain 375, Live
  • Bovine parainfluenza virus 3, strain RLB103, Live
  • Bovine viral diarrhoea virus 1, strain 5960, Inactivated
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Product identification

Medicine name:
RISPOVAL 3 BRSV PI3 BVD LYOPHILISATE AND SUSPENSION FOR SUSPENSION FOR INJECTION FOR CATTLE
Rispoval 3 BRSV Pi3 BVD liofilizat și suspensie injectabilă pentru bovine
Active substance:
  • Bovine viral diarrhoea virus 1, strain 6309, Inactivated
  • Bovine respiratory syncytial virus, strain 375, Live
  • Bovine parainfluenza virus 3, strain RLB103, Live
  • Bovine viral diarrhoea virus 1, strain 5960, Inactivated
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Bovine viral diarrhoea virus 1, strain 6309, Inactivated
    3.00
    log2 serum neutralising unit(s)
    /
    1.00
    Dose
  • Bovine respiratory syncytial virus, strain 375, Live
    100000.00
    50% cell culture infectious dose
    /
    1.00
    Dose
  • Bovine parainfluenza virus 3, strain RLB103, Live
    100000.00
    50% cell culture infectious dose
    /
    1.00
    Dose
  • Bovine viral diarrhoea virus 1, strain 5960, Inactivated
    3.00
    log2 serum neutralising unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and suspension for suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • All relevant tissues
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AH
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Romania
Package description:
  • Cardboard box with 1 vial of lyophilised fraction (25 doses) and 1 vial of liquid fraction (100 ml)
  • Cardboard box with 1 vial of lyophilised fraction (5 doses) and 1 vial of liquid fraction (20 ml)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Zoetis Belgium
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 130194
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0146/001/MR

Documents

Summary of Product Characteristics

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Romanian (PDF)
Published on: 24/08/2022
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