Veterinary Medicines

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

Authorised
  • Florfenicol
Download as PDF

Product identification

Medicine name:
Introflor-300 300 mg/ml solution for injection for cattle, sheep and pigs
INTROFLOR VET 300 mg/ml SOLUCION INYECTABLE PARA BOVINO, OVINO Y PORCINO
Active substance:
  • Florfenicol
Target species:
  • Cattle
  • Sheep
  • Pig
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
    • Sheep
      • Meat and offal
        39
        day
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        18
        day
  • Subcutaneous use
    • 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:
  • Spain
Package description:
  • 100 ml: vial (glass) closed with stopper (bromobutyl rubber) and cap (Al or Al/PP), packed in a cardboard box

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic (abridged application) - art 13(1)
Marketing authorisation holder:
  • Interchemie Werken De Adelaar Eesti AS
Marketing authorisation date:
Manufacturing sites for batch release:
  • Interchemie Werken De Adelaar Eesti AS
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 4468 ESP
Date of authorisation status change:
Reference member state:
  • Estonia
Procedure number:
  • EE/V/0109/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Malta
  • Netherlands
  • Norway
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 19/11/2025
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 19/11/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 19/11/2025
Download