Veterinary Medicine Information website

Bioclanic 500 mg + 125 mg flavoured tablets for dogs

Authorised
  • Amoxicillin
  • Clavulanic acid
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Product identification

Medicine name:
Bioclanic 500 mg + 125 mg flavoured tablets for dogs
Active substance:
  • Amoxicillin
  • Clavulanic acid
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Amoxicillin
    500.00
    milligram(s)
    /
    1.00
    Tablet
  • Clavulanic acid
    125.00
    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:
  • Italy
Available in:
  • Italy
Package description:
  • oPA/Alu/PVC - PVC/Alu heat sealed blister containing 10 tablets each. Package sizes: Cardboard box of 10 tablets.
  • oPA/Alu/PVC - PVC/Alu heat sealed blister containing 10 tablets each. Package sizes: Cardboard box of 20 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 40 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 100 tablets.
  • oPA/Alu/PVC - PVC/Alu heat sealed blister containing 10 tablets each. Package sizes: Cardboard box of 150 tablets.
  • oPA/Alu/PVC - PVC/Alu heat sealed blister containing 10 tablets each. Package sizes: Cardboard box of 200 tablets.
  • oPA/Alu/PVC - PVC/Alu heat sealed blister containing 10 tablets each. Package sizes: Cardboard box of 250 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:
  • Axience
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 105779
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0788/003
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 14/03/2026
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Italian (PDF)
Published on: 24/11/2025
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Summary of Product Characteristics

English (PDF)
Published on: 28/09/2025
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ie-puar-mr-iev0788003-bioclanic-500-mg--125-mg-flavoured-tablets-for-dog-en.pdf

English (PDF)
Published on: 28/09/2025
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