Veterinary Medicines

RISPOVAL 2

Not authorised
  • Bovine parainfluenza virus 3, strain RLB103, Live
  • ALUMINIUM HYDROXIDE GEL
  • Bovine respiratory syncytial virus, strain 375, Live
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Product identification

Medicine name:
RISPOVAL 2
Rispoval 2/BRSV+Pi3, Lyofilizát a rozpouštědlo pro injekční suspenzi
Active substance:
  • Bovine parainfluenza virus 3, strain RLB103, Live
  • ALUMINIUM HYDROXIDE GEL
  • Bovine respiratory syncytial virus, strain 375, Live
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Bovine parainfluenza virus 3, strain RLB103, Live
    100000.00
    log10 50% tissue culture infectious dose
    /
    1.00
    Dose
  • ALUMINIUM HYDROXIDE GEL
    0.80
    millilitre(s)
    /
    1.00
    Dose
  • Bovine respiratory syncytial virus, strain 375, Live
    100000.00
    log10 50% tissue culture infectious dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and solvent 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:
  • QI02AD07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Czechia
Package description:
  • Cardboard box with 1 vial of lyophilisate (25 doses) and 1 vial of solvent (100 ml)
  • Cardboard box with 1 vial of lyophilisate (5 doses) and 1 vial of solvent (20 ml)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 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:
  • 97/076/20-C
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0420/001

Documents

Summary of Product Characteristics

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Czech (PDF)
Published on: 9/11/2022
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Package Leaflet

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Czech (PDF)
Published on: 9/11/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 9/11/2022
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