Veterinary Medicines

FLORTEKXIN 300/16.5 MG/ML SOLUTION FOR INJECTION FOR CATTLE

Authorised
  • Florfenicol
  • Flunixin
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Product identification

Medicine name:
FLORTEKXIN 300/16.5 MG/ML SOLUTION FOR INJECTION FOR CATTLE
FLORTEKXIN 300 MG/ML + 16,5 MG/ML SOLUTION INJECTABLE POUR BOVINS
Active substance:
  • Florfenicol
  • Flunixin
Target species:
  • Cattle
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Florfenicol
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Flunixin
    16.50
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        46
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01BA99
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • Cardboard box with 1 vial of 100 ml
  • Cardboard box with 1 vial of 250 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Laboratorios Karizoo S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Przedsiebiorstwo Wielobranzowe Vet-Agro Sp. z o.o.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/9551211 2/2024
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0427/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Portugal
Generic of:

Documents

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 15/10/2025
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Summary of Product Characteristics

English (PDF)
Published on: 27/06/2024
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French (PDF)
Published on: 13/05/2024
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Package Leaflet

English (PDF)
Published on: 27/06/2024
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Labelling

English (PDF)
Published on: 27/06/2024
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eu-PUAR-esv0427001-dcp-flortekxin-300-16.5-mg-ml-solution-for-injection-for-cattle-en.pdf

English (PDF)
Published on: 24/07/2025
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