Veterinary Medicines

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

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

Product identification

Medicine name:
RISPOVAL RS+PI3 INTRANASAL NASAL SPRAY, LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR CATTLE
Rispoval TM RS+PI3 IntraNasal, Prášek a rozpoušťědlo pro suspenzi na intranazální aplikaci
Active substance:
  • Bovine parainfluenza virus 3, strain RLB103, Live
  • Water for injection
  • Bovine respiratory syncytial virus, strain 375, Live
Target species:
  • Cattle
Route of administration:
  • Nasal use

Product details

Active substance and strength:
  • Bovine parainfluenza virus 3, strain RLB103, Live
    5.00
    log10 cell culture infective dose 50
    /
    1.00
    unit(s)
  • Water for injection
    2.00
    millilitre(s)
    /
    1.00
    unit(s)
  • Bovine respiratory syncytial virus, strain 375, Live
    5.00
    log10 cell culture infective dose 50
    /
    1.00
    unit(s)
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:
This information is not available for this product.
Authorisation status:
  • Valid
Authorised in:
  • Czechia
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 Ceska Republika s.r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 97/042/06-C
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
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 4/06/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 4/06/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 4/06/2024
Download
How useful was this page?:
No votes yet
"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."