Authorised

Product identification

Medicine name:
KALAFEV, 50 mg/ml, ενέσιμο διάλυμα για βοοειδή, χοίρους και άλογα
Active substance:
  • Flunixin meglumine
Target species:
  • Cattle
  • Horse
  • Pig
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Flunixin meglumine
    82.95
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        10
        day
      • Milk
        24
        hour
    • Horse
      • Meat and offal
        7
        day
    • Pig
      • Meat and offal
        18
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        10
        day
      • Milk
        24
        hour
    • Horse
      • Meat and offal
        7
        day
    • Pig
      • Meat and offal
        18
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AG90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Greece
Available in:
  • Greece
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic (abridged application) - art 13(1)
Marketing authorisation holder:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • National Organization For Medicines
Authorisation number:
  • 69428/18/26-11-2019/K-0186601
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Greek (PDF)
Published on: 20/06/2022
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000096232