Veterinary Medicines

KESIUM 400 MG / 100 MG CHEWABLE TABLETS FOR DOGS

Authorised
  • Amoxicillin trihydrate
  • Potassium clavulanate
Download as PDF

Product identification

Medicine name:
KESIUM 400 MG / 100 MG CHEWABLE TABLETS FOR DOGS
Kesium, 400 / 100mg, Žvýkací tableta
Active substance:
  • Amoxicillin trihydrate
  • Potassium clavulanate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    459.20
    milligram(s)
    /
    1.00
    Tablet
  • Potassium clavulanate
    119.10
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CR02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • Available only in French
  • Available only in French
  • Available only in French
  • Available only in French
  • Available only in French
  • 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
  • Box of 3 blisters (PA-AL-PVC – aluminium heat sealed) of 4 tablets
  • Box of 6 blisters (PA-AL-PVC – aluminium heat sealed) of 4 tablets
  • Box of 9 blisters (PA-AL-PVC – aluminium heat sealed) of 4 tablets
  • Box of 12 blisters (PA-AL-PVC – aluminium heat sealed) of 4 tablets
  • Box of 15 blisters (PA-AL-PVC – aluminium heat sealed) of 4 tablets
  • Box of 18 blisters (PA-AL-PVC – aluminium heat sealed) of 4 tablets
  • Box of 21 blisters (PA-AL-PVC – aluminium heat sealed) of 4 tablets
  • Box of 24 blisters (PA-AL-PVC – aluminium heat sealed) of 4 tablets
  • Box of 60 blisters (PA-AL-PVC – aluminium heat sealed) of 4 tablets

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/004/13-C
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0225/004
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

Summary of Product Characteristics

English (PDF)
Published on: 24/09/2024
Download
Czech (PDF)
Published on: 13/09/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 13/09/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 13/09/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."