Veterinary Medicines

Versican Plus DP lyophilisate and solvent for suspension for injection for dogs

Authorised
  • Canine parvovirus 2b, strain CPV-2b Bio 12/B, Live
  • Canine distemper virus, strain CDV Bio 11/A, Live
Download as PDF

Product identification

Medicine name:
Versican Plus DP lyophilisate and solvent for suspension for injection for dogs
VERSICAN PLUS DP
Active substance:
  • Canine parvovirus 2b, strain CPV-2b Bio 12/B, Live
  • Canine distemper virus, strain CDV Bio 11/A, Live
Target species:
  • Dog
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Canine parvovirus 2b, strain CPV-2b Bio 12/B, Live
    19953.00
    tissue culture infective dose 50
    /
    1.00
    Dose
  • Canine distemper virus, strain CDV Bio 11/A, Live
    1259.00
    tissue culture infective dose 50
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI07AD03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Available in:
  • Italy
Package description:
  • (ID2): 1 Box with 50 Vial (Glass) with 1 Dose and 50 Vial (Glass) with 1 ml (50.0 Dose, 50.0 ml)
  • (ID1): 1 Box with 25 Vial (Glass) with 1 Dose and 25 Vial (Glass) with 1 ml (25.0 Dose, 25.0 ml)

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 Italia S.r.l
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 104901
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0266/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Cyprus
  • Greece
  • Hungary
  • Italy
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 24/05/2023
Download
Italian (PDF)
Published on: 8/08/2023
Updated on: 10/08/2023
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."