Veterinary Medicines

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

Authorised
  • Canine parvovirus 2b, strain CPV-2b Bio 12/B, Live
  • Canine adenovirus 2, strain CAV-2-Bio 13, Live
  • Canine distemper virus, strain CDV Bio 11/A, Live
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Product identification

Medicine name:
Versican Plus DHP lyophilisate and solvent for suspension for injection for dogs
Versican Plus DHP Lyofilisaat en oplosmiddel voor suspensie voor injectie
Versican Plus DHP Lyophilisat et solvant pour suspension injectable
Versican Plus DHP Lyophilisat und Lösungsmittel zur Herstellung einer Injektionssuspension
Active substance:
  • Canine parvovirus 2b, strain CPV-2b Bio 12/B, Live
  • Canine adenovirus 2, strain CAV-2-Bio 13, 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 adenovirus 2, strain CAV-2-Bio 13, Live
    3981.00
    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:
  • QI07AD02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
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 Belgium
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V496551
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0267/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Cyprus
  • Denmark
  • Finland
  • Greece
  • Hungary
  • Italy
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • 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.
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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Combined File of all Documents

English (PDF)
Published on: 24/05/2023
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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
Download
French (PDF)
Published on: 22/01/2024
Download
German (PDF)
Published on: 22/01/2024
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