Veterinary Medicines

Floxabactin 150 mg tablets for dogs

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
Floxabactin 150 mg tablets for dogs
Floxabactin Vet. 150 mg tabletter
Active substance:
  • Enrofloxacin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Enrofloxacin
    150.00
    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:
  • Denmark
Available in:
  • Denmark
Package description:
  • Box with 2 blisters (20 tablets); Alu-PVC.PE.PVDC blister with 10 tablets
  • Box with 2 blisters (20 tablets); Alu- PVC.PVDC blister with 10 tablets
  • Box with 15 blisters (150 tablets); Alu-PVC.PE.PVDC blister with 10 tablets
  • Box with 15 blisters (150 tablets); Alu- PVC.PVDC blister with 10 tablets
  • Box with 10 blisters (100 tablets); Alu-PVC.PE.PVDC blister with 10 tablets
  • Box with 10 blisters (100 tablets); Alu- PVC.PVDC blister with 10 tablets
  • Box with 1 blister (10 tablets); Alu-PVC.PVDC blister with 10 tablets
  • Box with 1 blister (10 tablets); Alu-PVC.PE.PVDC blister with 10 tablets
  • Box with 3 blisters (30 tablets); Alu-PVC.PE.PVDC blister with 10 tablets
  • Box with 5 blisters (50 tablets); Alu-PVC.PE.PVDC blister with 10 tablets
  • Box with 3 blisters (30 tablets); Alu- PVC.PVDC blister with 10 tablets
  • Box with 5 blisters (50 tablets); Alu- PVC.PVDC blister with 10 tablets
  • Box with 6 blisters (60 tablets); Alu-PVC.PE.PVDC blister with 10 tablets
  • Box with 6 blisters (60 tablets); Alu- PVC.PVDC blister with 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. B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 44734
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0135/003
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Hungary
  • Ireland
  • Italy
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 24/01/2025
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Danish (, TABLETTER 50 MG OG 150 MG)
Published on: 7/04/2025
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Floxabactin PuAR NL-V-0135-001_003-DC final.pdf

English (PDF)
Published on: 24/01/2025
Download