Veterinary Medicines

Versican Plus BbPI IN nasal drops, lyophilisate and solvent for suspension for dogs

Authorised
  • Bordetella bronchiseptica, strain MSLB 3096, Live
  • Canine parainfluenza virus 2, strain CPiV-2-Bio 15, Live
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Product identification

Medicine name:
Versican Plus BbPI IN nasal drops, lyophilisate and solvent for suspension for dogs
Versican Plus BbPi IN neusdruppels, lyofilisaat en oplosmiddel voor suspensie voor honden
Active substance:
  • Bordetella bronchiseptica, strain MSLB 3096, Live
  • Canine parainfluenza virus 2, strain CPiV-2-Bio 15, Live
Target species:
  • Dog
Route of administration:
  • Nasal use

Product details

Active substance and strength:
  • Bordetella bronchiseptica, strain MSLB 3096, Live
    9.80
    log10 colony forming unit(s)
    /
    1.00
    Dose
  • Canine parainfluenza virus 2, strain CPiV-2-Bio 15, Live
    5.80
    log10 tissue culture infective dose 50
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and solvent for oral suspension
Withdrawal period by route of administration:
  • Nasal use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI07AF01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • (ID2): 1 Box with (10 Vial (Glass) with 1 Dose and 10 Vial (Glass) with 0.5 millilitre(s)) (10.0 Dose, 5.0 millilitre(s))
  • (ID1): 1 Box with (5 Vial (Glass) with 1 Dose and 5 Vial (Glass) with 0.5 millilitre(s)) (5.0 Dose, 2.5 millilitre(s))

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Zoetis B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 124572
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0288/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • Czechia
  • Estonia
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

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Dutch (PDF)
Published on: 5/04/2024
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