Veterinary Medicines

Clavusan 50 mg + 12.5 mg tablets for dogs and cats

Authorised
  • Amoxicillin trihydrate
  • Potassium clavulanate
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Product identification

Medicine name:
Clavusan 50 mg + 12.5 mg tablets for dogs and cats
Clavusan 50 mg + 12,5 mg comprimidos para cães e gatos
Active substance:
  • Amoxicillin trihydrate
  • Potassium clavulanate
Target species:
  • Dog
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    57.40
    milligram(s)
    /
    1.00
    Tablet
  • Potassium clavulanate
    14.89
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CR02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Package description:
  • oPA/Alu/PVC - PVC/Alu heat sealed blister containing 10 tablets each. Package sizes:Cardboard box of 250 tablets.
  • oPA/Alu/PVC - PVC/Alu heat sealed blister containing 10 tablets each. Package sizes:Cardboard box of 100 tablets.
  • oPA/Alu/PVC - PVC/Alu heat sealed blister containing 10 tablets each. Package sizes:Cardboard box of 50 tablets.
  • oPA/Alu/PVC - PVC/Alu heat sealed blister containing 10 tablets each. Package sizes:Cardboard box of 30 tablets.
  • oPA/Alu/PVC - PVC/Alu heat sealed blister containing 10 tablets each. Package sizes:Cardboard box of 10 tablets.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
  • Alfasan Nederland B.V.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 1567/01/23DFVPT
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0778/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Portuguese (PDF)
Published on: 17/10/2024
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Summary of Product Characteristics

English (PDF)
Published on: 25/09/2024
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