Veterinary Medicines

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

Authorised
  • Canine parvovirus 2b, strain CPV-2b Bio 12/B, Live
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Product identification

Medicine name:
Versican Plus P lyophilisate and solvent for suspension for injection for dogs
Versican Plus P liofilizat in vehikel za suspenzijo za injiciranje za pse
Active substance:
  • Canine parvovirus 2b, strain CPV-2b Bio 12/B, 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
    3981070.00
    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:
  • QI07AD01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • (ID1): 1 Box with (1 Vial (Glass) with 25 Dose and 1 Vial (Glass) with 25 Dose) (25.0 Dose, 25.0 Dose)
  • (ID2): 1 Box with (1 Vial (Glass) with 50 Dose and 1 Vial (Glass) with 50 Dose) (50.0 Dose, 50.0 Dose)

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:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0537/001
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0265/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Luxembourg
  • Malta
  • Romania
  • Slovenia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 14/02/2022
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German (PDF)
Published on: 14/02/2022
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Slovenian (PDF)
Published on: 9/11/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 9/11/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 9/11/2023
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Combined File of all Documents

English (PDF)
Published on: 24/05/2023
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