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 300mg/ml ενέσιμο διάλυμα για βοοειδή και χοίρους
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:
  • Cyprus
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:
  • Veterinary Services, Ministry Of Agriculture, Natural Resources And Environment
Authorisation number:
  • CY00346V
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

This document does not exist in this language (English). You can find it in another language below.
Greek (PDF)
Published on: 5/05/2023
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Summary of Product Characteristics

English (PDF)
Published on: 20/04/2023
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