Veterinary Medicines

KESIUM 500 MG / 125 MG CHEWABLE TABLETS FOR DOGS

Authorised
  • Amoxicillin trihydrate
  • Potassium clavulanate
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Product identification

Medicine name:
KESIUM 500 MG / 125 MG CHEWABLE TABLETS FOR DOGS
Kesium 500,00 mg + 125,00 mg Tabletki do rozgryzania i żucia
Active substance:
  • Amoxicillin trihydrate
  • Potassium clavulanate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    574.00
    milligram(s)
    /
    1.00
    Tablet
  • Potassium clavulanate
    149.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CR02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Available in:
  • Poland
Package description:
  • Available only in French
  • Available only in French
  • Available only in French
  • Available only in French
  • Available only in French
  • Box of 80 blisters (PA-AL-PVC – aluminium heat sealed) of 6 tablets

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:
  • Ceva Animal Health Polska Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2603
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0225/005
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 2/04/2025
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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: 2/04/2025
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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: 2/04/2025
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