Veterinary Medicines

NIGLUMINE 50mg/ml solution for injection for cattle, horses and pigs

Authorised
  • Flunixin meglumine
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Product identification

Medicine name:
NIGLUMINE 50mg/ml solution for injection for cattle, horses and pigs
NIGLUMINE 50 mg/ml SOLUCION INYECTABLE PARA BOVINO, CABALLOS Y PORCINO
Active substance:
  • Flunixin meglumine
Target species:
  • Cattle
  • Horse
  • Pig
Route of administration:
  • Intravenous use
  • Intramuscular use

Product details

Active substance and strength:
  • Flunixin meglumine
    5.00
    gram(s)
    /
    100.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        24
        hour
      • Meat and offal
        4
        day
      • Milk
        24
        hour
    • Horse
      • Meat and offal
        28
        day
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        24
        hour
      • Meat and offal
        4
        day
      • Milk
        24
        hour
  • Intramuscular use
    • Pig
      • Meat and offal
        28
        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:
  • Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 1727 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0127/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Portugal
  • Romania

Documents

Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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Summary of Product Characteristics

English (PDF)
Published on: 30/10/2025
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Spanish (PDF)
Published on: 29/04/2025
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Package Leaflet

English (PDF)
Published on: 30/10/2025
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Spanish (PDF)
Published on: 29/04/2025
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Labelling

English (PDF)
Published on: 30/10/2025
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Spanish (PDF)
Published on: 29/04/2025
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es-puar-niglumine-es.pdf

Spanish (PDF)
Published on: 17/03/2023
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