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 150 mg Tabletten für Hunde
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:
  • Austria
Package description:
  • Available only in German
  • Box with 2 blisters (20 tablets); Alu- PVC.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.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.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.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.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 5 blisters (50 tablets); Alu- PVC.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:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 8-00889
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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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 17/06/2025
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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.
German (PDF)
Published on: 17/06/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 17/06/2025
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Floxabactin PuAR NL-V-0135-001_003-DC final.pdf

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