Veterinary Medicines

XEDEN VET 50 MG TABLET FOR DOGS

Authorised
  • Enrofloxacin
Download as PDF

Product identification

Medicine name:
XEDEN VET 50 MG TABLET FOR DOGS
Xeden 50 mg Tabletten für Hunde
Active substance:
  • Enrofloxacin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Enrofloxacin
    50.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Package description:
  • Cardboard box with 10 blisters of 10 tablets
  • Cardboard box with 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:
  • Ceva Tiergesundheit GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 401076.01.00
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0186/002
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Greece
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • 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.
German (PDF)
Published on: 4/12/2025
Download