Veterinary Medicines

MYCOFLOR, 300 mg/ml solution for injection for cattle and pigs

Authorised
  • Florfenicol
Download as PDF

Product identification

Medicine name:
MYCOFLOR, 300 mg/ml solution for injection for cattle and pigs
MYCOFLOR 300 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCINS
Active substance:
  • Florfenicol
Target species:
  • Cattle
  • Pig
Route of administration:
  • Intramuscular 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
        34
        day
    • Pig
      • Meat and offal
        18
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01BA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Available in:
  • France
Package description:
  • Vial size: 100 mlColourless Type II glass vial closed with bromobutyl rubber closure. Vials are individually packed in carton box.
  • Vial size: 250 mlColourless Type II glass vial closed with bromobutyl rubber closure. Vials are individually packed in carton box.
  • Vial size: 250 mlAn aluminium cap or polypropylene vial closed with bromobutyl rubber closure and an aluminium cap. Vials are individually packed in carton box.
  • Vial size: 100 mlAn aluminium cap or polypropylene vial closed with bromobutyl rubber closure and an aluminium cap. Vials are individually packed in carton 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:
  • S P Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • KELA Kempisch Laboratorium Kela Laboratoria
  • S P Veterinaria S.A.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/6291365 0/2011
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0486/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Cyprus
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Poland
  • Portugal
  • Romania
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 14/05/2024
Download

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: 20/03/2025
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."