Veterinary Medicines

FLORFENIS 300 mg/ml solution for injection for cattle, sheep and pigs

Authorised
  • Florfenicol
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Product identification

Medicine name:
FLORFENIS 300 mg/ml solution for injection for cattle, sheep and pigs
Florfenis 300 mg/ml solução injetável para bovinos, ovinos e suínos
Active substance:
  • Florfenicol
Target species:
  • Cattle
  • Pig
  • Sheep
Route of administration:
  • Intramuscular use
  • Subcutaneous 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
        30
        day
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        18
        day
    • Sheep
      • Meat and offal
        39
        day
      • Milk
        no withdrawal period
    • Cattle
      • Meat and offal
        30
        day
      • Milk
        no withdrawal period
    • Sheep
      • Meat and offal
        39
        day
      • Milk
        no withdrawal period
  • Subcutaneous use
    • Cattle
      • Meat and offal
        44
        day
      • Milk
        no withdrawal period
    • Cattle
      • Meat and offal
        44
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01BA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Available in:
  • Portugal
Package description:
  • box containing 6 vials of 250 ml
  • box containing 6 vials of 100 ml
  • box containing 1 vial of 250 ml
  • box containing 1 vial of 100 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:
  • Laboratorios Syva S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Syva S.A.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 1393/01/21DFVPT
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0377/001
Concerned member states:
  • Belgium
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania

Documents

Summary of Product Characteristics

English (PDF)
Published on: 27/06/2024
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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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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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eu-PUAR-florfenis-300-mg-ml-solution-for-injection-for-cattle--sheep-and-pigs-en.pdf

English (PDF)
Published on: 12/04/2023
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