Veterinary Medicines

Niglumine, 50mg/ml, Injekční roztok

Authorised
  • Flunixin
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Product identification

Medicine name:
Niglumine, 50mg/ml, Injekční roztok
Active substance:
  • Flunixin
Target species:
  • Horse
  • Cattle
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Flunixin
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Horse
      • Meat and offal
        no withdrawal period
    • Cattle
      • Meat and offal
        7
        day
      • Milk
        48
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AG90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Available in:
  • Czechia
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a 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:
  • Institute For State Control Of Veterinary Biologicals And Medicines
Authorisation number:
  • 96/023/02-C
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 26/10/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 26/10/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 26/10/2022
Download
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