Authorised

Product identification

Medicine name:
Amoxibactin 250 mg tablets for dogs
Amoxibactin vet 287,50 mg Tabletka
Active substance:
  • Amoxicillin trihydrate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    287.50
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • Cardboard box of 9 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 8 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 7 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 6 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 3 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 25 Aluminium - PVC/PE/PVDC blisters of 10 tablets
  • Cardboard box of 2 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 10 Aluminium - PVC/PE/PVDC blisters of 10 tablets
  • Cardboard box of 1 Aluminium - PVC/PE/PVDC blister of 10 tablets.
  • Cardboard box of 50 Aluminium - PVC/PE/PVDC blisters of 10 tablets
  • Cardboard box of 5 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 4 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box containing 10 separate cardboard boxes, each containing 1 blister of 10 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:
  • Le Vet. Beheer B.V.
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:
  • 2859
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0186/002
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/05/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/05/2022
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/05/2022
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000035743