Veterinary Medicines

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

Authorised
  • Canine parainfluenza virus, strain CPiV-2-Bio 15, Live
  • Bordetella bronchiseptica, strain MSLB 3096, Live
Download as PDF

Product identification

Medicine name:
Versican Plus BbPi IN gouttes nasales, lyophilisat et solvant pour suspension pour chiens
Versican Plus BbPI IN nasal drops, lyophilisate and solvent for suspension for dogs
Active substance:
  • Canine parainfluenza virus, strain CPiV-2-Bio 15, Live
  • Bordetella bronchiseptica, strain MSLB 3096, Live
Target species:
  • Dog
Route of administration:
  • Nasal use

Product details

Active substance and strength:
  • Canine parainfluenza virus, strain CPiV-2-Bio 15, Live
    3.50
    log10 tissue culture infective dose 50
    /
    1.00
    Dose
  • Bordetella bronchiseptica, strain MSLB 3096, Live
    8.00
    log10 colony forming unit(s)
    /
    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:
  • Luxembourg
Available in:
  • Luxembourg
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 Belgium
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Ministry Of Health And Social Security
Authorisation number:
  • V 087/20/04/1802
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

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 16/03/2023
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."