Veterinary Medicine Information website

Noroclav 500 mg Palatable Tablets for Dogs

Authorised
  • Potassium clavulanate
  • Amoxicillin trihydrate
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Product identification

Medicine name:
Noroclav 500 mg Palatable Tablets for Dogs
Active substance:
  • Potassium clavulanate
  • Amoxicillin trihydrate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Potassium clavulanate
    119.13
    milligram(s)
    /
    1.00
    Tablet
  • Amoxicillin trihydrate
    459.22
    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:
  • Belgium
Available in:
  • Belgium
Package description:
  • Aluminium/aluminium blister strips, each containing 5 tablets. Cartons of 10 tablets.
  • Aluminium/aluminium blister strips, each containing 5 tablets. Cartons of 20 tablets.
  • Aluminium/aluminium blister strips, each containing 5 tablets. Cartons of 25 tablets.
  • Aluminium/aluminium blister strips, each containing 5 tablets. Cartons of 100 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:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Manufacturing Limited
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V303624
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0547/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • France
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 9/03/2025
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Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Dutch (PDF)
Published on: 18/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 18/08/2025
Download
German (PDF)
Published on: 18/08/2025
Download
Dutch (PDF)
Published on: 18/08/2025
Download

Combined File of all Documents

English (PDF)
Published on: 9/03/2025
Download