Veterinary Medicines

FLORKEM 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS

Authorised
  • Florfenicol
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Product identification

Medicine name:
FLORKEM 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
FLORKEM 300 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO
Active substance:
  • Florfenicol
Target species:
  • Cattle
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Florfenicol
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        37
        day
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        18
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01BA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:
  • Box containing one glass vial of 20 ml
  • Box containing one plastic vial of 500 ml
  • Box containing one plastic vial of 250 ml
  • Box containing one plastic vial of 100 ml
  • Box containing one plastic vial of 50 ml
  • Box containing one glass vial of 500 ml
  • Box containing one glass vial of 250 ml
  • Box containing one glass vial of 100 ml
  • Box containing one glass vial of 50 ml

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 Salud Animal S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • CEVA Santé Animale
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 2051 ESP
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0197/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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Spanish (PDF)
Published on: 13/12/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 13/12/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 13/12/2024
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