Veterinary Medicines

Nobivac KC nasal drops, lyophilisate and solvent for suspension for dogs

Authorised
  • Bordetella bronchiseptica, strain B-C2, Live
  • Canine parainfluenza virus, strain Cornell, Live
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Product identification

Medicine name:
Nobivac BbPi Lyofilisaat en oplosmiddel voor suspensie voor nasaal gebruik
Nobivac BbPi Lyophilisat et solvant pour suspension nasale
Nobivac BbPi Lyophyllisat und Lösungsmittel zur Herstellung einer Suspension zur nasalen Anwendung
Nobivac KC nasal drops, lyophilisate and solvent for suspension for dogs
Active substance:
  • Bordetella bronchiseptica, strain B-C2, Live
  • Canine parainfluenza virus, strain Cornell, Live
Target species:
  • Dog
Route of administration:
  • Nasal use

Product details

Active substance and strength:
  • Bordetella bronchiseptica, strain B-C2, Live
    9.70
    log10 colony forming unit(s)
    /
    0.40
    millilitre(s)
  • Canine parainfluenza virus, strain Cornell, Live
    5.80
    log10 tissue culture infective dose 50
    /
    0.40
    millilitre(s)
Pharmaceutical form:
  • Nasal spray, lyophilisate and solvent for suspension
Withdrawal period by route of administration:
  • Nasal use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI07AF
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Cardboard or plastic boxes with 50 glass (tiype I) vial closed with a halogenobutyl rubber stopper and aluminium cap, 25 x 1 dose of vaccine and solvent
  • Cardboard or plastic boxes with 10 glass (tiype I) vial closed with a halogenobutyl rubber stopper and aluminium cap, 5 x 1 dose of vaccine and solvent

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Intervet International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • INTERVET INTERNATIONAL B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V222817
Date of authorisation status change:
Reference member state:
  • Italy
Procedure number:
  • IT/V/0134/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Ireland
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 13/02/2024
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Summary of Product Characteristics

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Dutch (PDF)
Published on: 22/01/2024
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French (PDF)
Published on: 22/01/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/01/2024
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French (PDF)
Published on: 22/01/2024
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German (PDF)
Published on: 22/01/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/01/2024
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