Veterinary Medicines

NIGLUMINE

Authorised
  • Flunixin meglumine
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Product identification

Medicine name:
NIGLUMINE
Niglumine 50 mg/ml, oplossing voor injectie voor runderen, paarden en varkens
Active substance:
  • Flunixin meglumine
Target species:
  • Cattle
  • Horse
  • Pig
Route of administration:
  • Intramuscular use
  • Intravenous 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:
  • Intramuscular use
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        24
        hour
    • Horse
      • Meat and offal
        28
        day
    • Pig
      • Meat and offal
        28
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        24
        hour
    • Horse
      • Meat and offal
        28
        day
    • 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:
  • Netherlands
Available in:
  • Netherlands
Package description:
  • box containing 1 vial of 50 ml
  • box containing 1 vial of 250 ml
  • box containing 1 vial of 100 ml

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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 101828
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

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
Download

Package Leaflet

English (PDF)
Published on: 22/12/2023
Download

Labelling

English (PDF)
Published on: 22/12/2023
Download
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