Veterinary Medicines

VERSICAN PLUS BB ORAL LYOPHILISAT AND SOLVENT FOR ORAL SUSPENSION FOR DOGS

Authorised
  • WATER, PURIFIED
  • Bordetella bronchiseptica, strain 92 B, Live
Download as PDF

Product identification

Medicine name:
VERSICAN PLUS BB ORAL LYOPHILISAT AND SOLVENT FOR ORAL SUSPENSION FOR DOGS
Versican Plus Bb Oral kuiva-aine, kylmäkuivattu, ja liuotin, oraalisuspensiota varten
Active substance:
  • WATER, PURIFIED
  • Bordetella bronchiseptica, strain 92 B, Live
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • WATER, PURIFIED
    1.00
    millilitre(s)
    /
    1.00
    Dose
  • Bordetella bronchiseptica, strain 92 B, Live
    140000000.00
    Colony forming unit
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and solvent for oral suspension
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI07AE01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Finland
Available in:
  • Finland
Package description:
  • Plastic box containing 5, vials of 1 dose of lyophilisate and 5, vials of 1ml of solvent
  • Plastic box containing 25 vials of 1 dose of lyophilisate and 25 vials of 1ml of solvent
  • Plastic box containing 10 vials of 1 dose of lyophilisate and 10 vials of 1ml of solvent

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 Animal Health ApS
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium SA
Responsible authority:
  • Finnish Medicines Agency
Authorisation number:
  • 36842
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0401/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • 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.
Finnish (PDF)
Published on: 11/01/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Finnish (PDF)
Published on: 11/01/2024
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."