Veterinary Medicines

MARBIFLOX 100 MG/ML SOLUTION FOR INJECTION FOR BOVINES AND PIGS (SOWS)

Authorised
  • Marbofloxacin
Download as PDF

Product identification

Medicine name:
MARBIFLOX 100 MG/ML SOLUTION FOR INJECTION FOR BOVINES AND PIGS (SOWS)
MARBIFLOX 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCINS (TRUIES)
Active substance:
  • Marbofloxacin
Target species:
  • Cattle
  • Pig (sow)
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Marbofloxacin
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        3
        day
      • Milk
        36
        hour
      • Meat and offal
        6
        day
      • Milk
        72
        hour
    • Pig (sow)
      • Meat and offal
        4
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        6
        day
      • Milk
        36
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA93
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription except for some pack sizes
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • Box of one 100 ml solution bottle for injection
  • Box of one 250 ml solution bottle for injection
  • Box of one 50 ml solution bottle for injection

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:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • Krka d.d. Novo Mesto
  • Virbac
Responsible authority:
  • National Veterinary Medicines Agency
Authorisation number:
  • FR/V/9951358 0/2011
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0222/002
Concerned member states:
  • Germany
  • Portugal
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 7/04/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."