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 mg/125 mg comprimate masticabile pentru caini
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
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:
  • Romania
Package description:
  • Box of 80 blisters of 6 chewable breakable tablets
  • Box of 80 blisters of 6 chewable breakable tablets
  • Box of 80 blisters of 6 chewable breakable tablets
  • Box of 80 blisters of 6 chewable breakable tablets
  • Box of 80 blisters of 6 chewable breakable tablets
  • Box of 80 blisters of 6 chewable breakable 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 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:
  • 180092
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

Summary of Product Characteristics

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Romanian (PDF)
Published on: 13/07/2023
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