Veterinary Medicines

Bioclanic 500 mg + 125 mg flavoured tablets for dogs

Authorised
  • Amoxicillin trihydrate
  • POTASSIUM CLAVULANATE DILUTED WITH CELLULOSE, MICROCRYSTALLINE (1:1)
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Product identification

Medicine name:
Bioclanic 500 mg + 125 mg flavoured tablets for dogs
Bioclanic 500 mg + 125 mg Tabletka
Active substance:
  • Amoxicillin trihydrate
  • POTASSIUM CLAVULANATE DILUTED WITH CELLULOSE, MICROCRYSTALLINE (1:1)
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    573.95
    milligram(s)
    /
    1.00
    Tablet
  • POTASSIUM CLAVULANATE DILUTED WITH CELLULOSE, MICROCRYSTALLINE (1:1)
    297.81
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • 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:
  • Poland
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:
  • Duggan Veterinary Supplies Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 3363
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

Summary of Product Characteristics

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

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 6/05/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 6/05/2025
Download

ie-puar-mr-iev0788003-bioclanic-500-mg--125-mg-flavoured-tablets-for-dog-en.pdf

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