Veterinary Medicines

FATROMINE 50 MG/ML SOLUCION INYECTABLE

Authorised
  • Flunixin meglumine
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Product identification

Medicine name:
FATROMINE 50 MG/ML SOLUCION INYECTABLE
Active substance:
  • Flunixin meglumine
Target species:
  • Cattle
  • Horse
  • Pig
Route of administration:
  • Intravenous use
  • Intramuscular use

Product details

Active substance and strength:
  • Flunixin meglumine
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Meat and offal
        4
        day
    • Horse
      • Meat and offal
        4
        day
    • Cattle
      • Milk
        24
        hour
    • Horse
      • Milk
        no withdrawal period
  • Intramuscular use
    • Pig
      • Meat and offal
        24
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AG90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:

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:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro Iberica S.L.
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 1565 ESP
Date of authorisation status change:

Documents

Labelling

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Spanish (PDF)
Published on: 11/07/2025
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Summary of Product Characteristics

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Spanish (PDF)
Published on: 11/07/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 11/07/2025
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