Authorised

Product identification

Medicine name:
XEDEN 200 MG TABLET FOR DOGS
Xeden vet 200 mg tabletti
Active substance:
  • Enrofloxacin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Enrofloxacin
    200.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Finland
Package description:
  • Cardboard box with 20 blisters of 6 tablets
  • Cardboard box with 2 blisters of 6 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 Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Finnish Medicines Agency
Authorisation number:
  • 27822
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0186/004
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Greece
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Portugal
  • Romania
  • Spain
  • United Kingdom (Northern Ireland)
Source URL: https://medicines.health.europa.eu/veterinary/600000043513