Veterinary Medicines

Flordofen 300 mg/ml solution for injection for cattle and pigs

Authorised
  • Florfenicol
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Product identification

Medicine name:
Flordofen 300 mg/ml solution for injection for cattle and pigs
FLORDOFEN 300 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO
Active substance:
  • Florfenicol
Target species:
  • Pig (for fattening)
  • Cattle
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
    • Pig (for fattening)
      • Meat and offal
        18
        day
    • Cattle
      • Meat and offal
        30
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        44
        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
Package description:
  • Brown-coloured type II glass vial of 250 ml, closed by a type I bromobutyl stopper and sealed by an aluminium cap with centre hole.
  • Colourless type II glass vial of 100 ml, closed by a type I bromobutyl stopper and sealed by an aluminium cap with centre hole.
  • Colourless type II glass vial of 50 ml, closed by a type I bromobutyl stopper and sealed by an aluminium cap with centre hole.
  • Polypropylene vial of 250 ml, closed with bromobutyl stopper secured with flip off aluminium collar.

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:
  • Dopharma Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma B.V.
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2946 ESP
Date of authorisation status change:
Reference member state:
  • Portugal
Procedure number:
  • PT/V/0112/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Romania
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 28/07/2025
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