File downloaded on 2026-04-11
Source URL: https://medicines.health.europa.eu/veterinary/en/600000047859
Authorised

Product identification

Medicine name:
Marbocare flavour 80 mg tablets for dogs
Active substance:
  • Marbofloxacin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Marbofloxacin
    80.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA93
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • The product is packaged in Aluminium- PVC/aluminium/polyamide blisterBox containing 2 blisters of 6 tablets (12 tablets)
  • The product is packaged in Aluminium- PVC/aluminium/polyamide blisterBox containing 12 blisters of 6 tablets (72 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:
  • Emdoka
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 112473
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0563/003
Concerned member states:
  • Austria
  • Belgium
  • Germany
  • Luxembourg
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 27/01/2022
Download

Summary of Product Characteristics

English (PDF)
Published on: 25/09/2024
Download