Veterinary Medicines

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

Authorised
  • Florfenicol
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Product identification

Medicine name:
MYCOFLOR, 300 mg/ml solution for injection for cattle and pigs
Mycoflor 300 mg/ml Injektionslösung für Rinder und Schweine
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:
  • Germany
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:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 402112.00.00
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

Combined File of all Documents

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German (PDF)
Published on: 19/03/2025
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