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
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Product identification

Medicine name:
RISPOVAL RS+PI3 INTRANASAL NASAL SPRAY, LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR CATTLE
Rispoval RS+PI3 IntraNasaal
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:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
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 B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 10424
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

Combined File of all Documents

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Dutch (PDF)
Published on: 29/06/2022
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