Veterinary Medicine Information website

DORAFLOX 100 mg/ml solution for injection for cattle and pigs

Authorised
  • Enrofloxacin
Download as PDF

Product identification

Medicine name:
DORAFLOX 100 mg/ml solution for injection for cattle and pigs
Active substance:
  • Enrofloxacin
Target species:
  • Pig
  • Cattle
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Enrofloxacin
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        13
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        5
        day
      • Milk
        3
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        12
        day
      • Milk
        4
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Available in:
  • Germany
Package description:
  • Type II Amber glass vial of 250 ml closed with bromobutyl rubber stopper and aluminium seal.One vial of 250 ml is available in a cardboard box.
  • Type II Amber glass vial of 100 ml closed with bromobutyl rubber stopper and aluminium seal.One vial of 100 ml is available in a cardboard box.

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:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 401391.02.01
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0261/001
Concerned member states:
  • Belgium
  • Germany
  • Greece
  • Hungary
  • Netherlands
  • Romania
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 28/02/2025
Download