Veterinary Medicines

CANIGEN PI/L LYOPHILISATE AND SUSPENSION FOR SUSPENSION FOR INJECTION FOR DOGS

Authorised
  • Leptospira interrogans, serogroup Canicola, serovar Canicola, strain 601903, Inactivated
  • Canine parainfluenza virus, strain Manhattan, Live
  • Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae, strain 601895, Inactivated
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Product identification

Medicine name:
CANIGEN PI/L LYOPHILISATE AND SUSPENSION FOR SUSPENSION FOR INJECTION FOR DOGS
Canigen Pi/L Liofilizat i rozpuszczalnik do sporządzania zawiesiny do wstrzykiwań
Active substance:
  • Leptospira interrogans, serogroup Canicola, serovar Canicola, strain 601903, Inactivated
  • Canine parainfluenza virus, strain Manhattan, Live
  • Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae, strain 601895, Inactivated
Target species:
  • Dog
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Leptospira interrogans, serogroup Canicola, serovar Canicola, strain 601903, Inactivated
    4350.00
    enzyme-linked immunosorbent assay unit
    /
    1.00
    Dose
  • Canine parainfluenza virus, strain Manhattan, Live
    63095.70
    cell culture infective dose 50
    /
    1.00
    Dose
  • Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae, strain 601895, Inactivated
    4250.00
    enzyme-linked immunosorbent assay unit
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and suspension for suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI07AI08
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • Plastic box of 10 vials of lyophilisate and 10 vials of suspension
  • Plastic box of 25 vials of lyophilisate and 25 vials of suspension
  • Plastic box of 50 vials of lyophilisate and 50 vials of suspension
  • Plastic box of 100 vials of lyophilisate and 100 vials of suspension
  • Cardbox of 1 vial of lyophilisate and 1 vial of suspension
  • Cardbox of 10 vials of lyophilisate and 10 vials of suspension
  • Cardbox of 25 vials of lyophilisate and 25 vials of suspension
  • Cardbox of 50 vials of lyophilisate and 50 vials of suspension
  • Cardbox of 100 vials of lyophilisate and 100 vials of suspension
  • Plastic box of 1 vial of lyophilisate and 1 vial of suspension

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:
  • Virbac
Marketing authorisation date:
Manufacturing sites for batch release:
  • Virbac
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2758
Reference member state:
  • France
Procedure number:
  • FR/V/0311/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • 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.
Polish (PDF)
Published on: 4/09/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/09/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/09/2023
Download
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