Veterinary Medicines

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

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

Medicine name:
Versican Plus DP lyophilisate and solvent for suspension for injection for dogs
Versican Plus DP lyofilisaat en oplosmiddel voor suspensie voor injectie bij honden
Active substance:
  • Canine parvovirus, type 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, type 2b, strain CPV-2b Bio 12/B, Live
    19953.00
    50% tissue culture infectious dose
    /
    1.00
    Dose
  • Canine distemper virus, strain CDV Bio 11/A, Live
    1259.00
    50% tissue culture infectious dose
    /
    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:
  • Netherlands
Available in:
  • Netherlands
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 B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 117278
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
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Dutch (PDF)
Published on: 30/08/2023
Updated on: 1/09/2023
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Summary of Product Characteristics

English (PDF)
Published on: 14/02/2022
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