Veterinary Medicines

RISPOVAL RS+PI3 INTRANASAL NASAL SPRAY, LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR CATTLE

Authorised
  • Bovine respiratory syncytial virus, strain 375, Live
  • Bovine parainfluenza virus 3, strain RLB103, Live
Download as PDF

Product identification

Medicine name:
RISPOVAL RS+PI3 INTRANASAL NASAL SPRAY, LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR CATTLE
RISPOVAL RS+PI3 INTRANASAL
Active substance:
  • Bovine respiratory syncytial virus, strain 375, Live
  • Bovine parainfluenza virus 3, strain RLB103, Live
Target species:
  • Cattle
Route of administration:
  • Nasal use

Product details

Active substance and strength:
  • Bovine respiratory syncytial virus, strain 375, Live
    5.00
    log10 50% cell culture infectious dose
    /
    1.00
    Dose
  • Bovine parainfluenza virus 3, strain RLB103, Live
    5.00
    log10 50% cell culture infectious dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for nasal administration
Withdrawal period by route of administration:
  • Nasal use
    • Cattle
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AD07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Available in:
  • Italy
Package description:
  • Cardboard box with 1 glass vial of 5 doses of powder accompanied by 1 vial containing respectively 10 ml liquid component
  • Cardboard box with 1 glass vial of 25 doses of powder accompanied by 1 vial containing respectively 50 ml liquid component
  • Plastic box with 5 glass vial(s) of 1 dose of powder accompanied by 5 vial(s) containing 2 ml liquid component

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Zoetis Italia S.r.l
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 103860
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0335/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 24/06/2024
Download