Veterinary Medicines

Flunixin 50 mg/ml Solution for Injection for Cattle, Horses and Pigs

Authorised
  • Flunixin meglumine
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Product identification

Medicine name:
Flunixin 50 mg/ml Solution for Injection for Cattle, Horses and Pigs
Flunixin 50 mg/ml Injektionslösung für Rinder, Pferde und Schweine
Active substance:
  • Flunixin meglumine
Target species:
  • Cattle
  • Horse
  • Pig
Route of administration:
  • Intravenous use
  • Intramuscular use

Product details

Active substance and strength:
  • Flunixin meglumine
    82.90
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Milk
        36
        hour
      • Meat and offal
        7
        day
    • Horse
      • Milk
        no withdrawal period
      • Meat and offal
        7
        day
  • Intramuscular use
    • Pig
      • Meat and offal
        22
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AG90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Available in:
  • Germany
Package description:
  • (ID10) 1250 millilitre(s): unspecified outer container with 5 Vial (Glass) each with 250 millilitre(s)
  • (ID9) 1200 millilitre(s): unspecified outer container with 12 Vial (Glass) each with 100 millilitre(s)
  • (ID8) 1000 millilitre(s): unspecified outer container with 10 Vial (Glass) each with 100 millilitre(s)
  • (ID7) 500 millilitre(s): unspecified outer container with 5 Vial (Glass) each with 100 millilitre(s)
  • (ID6) 600 millilitre(s): unspecified outer container with 12 Vial (Glass) each with 50 millilitre(s)
  • (ID5) 500 millilitre(s): unspecified outer container with 10 Vial (Glass) each with 50 millilitre(s)
  • (ID4) 250 millilitre(s): unspecified outer container with 5 Vial (Glass) each with 50 millilitre(s)
  • (ID3) 250 millilitre(s): unspecified outer container with 1 Vial (Glass) with 250 millilitre(s)
  • (ID2) 100 millilitre(s): unspecified outer container with 1 Vial (Glass) with 100 millilitre(s)
  • (ID1) 50 millilitre(s): unspecified outer container with 1 Vial (Glass) with 50 millilitre(s)

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:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories (Ireland) Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 401186.00.00
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0325/001
Concerned member states:
  • Iceland
  • Netherlands
  • Portugal
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 18/12/2024
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German (PDF)
Published on: 18/12/2024
Download

2401186-paren-20200629.pdf

English (PDF)
Published on: 18/12/2024
Download
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