Veterinary Medicines

KESIUM 400 MG / 100 MG CHEWABLE TABLETS FOR DOGS

Authorised
  • Amoxicillin trihydrate
  • Potassium clavulanate
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Product identification

Medicine name:
KESIUM 400 MG / 100 MG CHEWABLE TABLETS FOR DOGS
KESIUM 400 mg/100 mg comprimate masticabile pentru câini
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CR02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
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 Romania S.R.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 160388
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

Combined File of all Documents

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Romanian (PDF)
Published on: 29/01/2025
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