Veterinary Medicine Information website

Clavudale 40 mg/10 mg tablets for cats and dogs

Authorised
  • Amoxicillin trihydrate
  • Potassium clavulanate
Download as PDF

Product identification

Medicine name:
Clavudale 40 mg/10 mg tablets for cats and dogs
Active substance:
  • Amoxicillin trihydrate
  • Potassium clavulanate
Target species:
  • Dog
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    45.92
    milligram(s)
    /
    1.00
    Tablet
  • Potassium clavulanate
    11.91
    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:
  • Slovenia
Available in:
  • Slovenia
Package description:
  • Blister packs consisting of orientated Polyamide/Aluminium/Polyvinyl chloride film, heat sealed with aluminium foil (25micrometer) in strips of 6 tablets. Cartons containing 12 tablets.
  • Blister packs consisting of orientated Polyamide/Aluminium/Polyvinyl chloride film, heat sealed with aluminium foil (25micrometer) in strips of 6 tablets. Cartons containing 24 tablets.
  • Blister packs consisting of orientated Polyamide/Aluminium/Polyvinyl chloride film, heat sealed with aluminium foil (25micrometer) in strips of 6 tablets. Cartons containing 120 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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
  • Laboratorio Reig Jofre S.A.
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0685/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0504/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 29/03/2024
Download