Veterinary Medicine Information website

NORFLUNIX INJECTION

Not authorised
  • Flunixin meglumine
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Product identification

Medicine name:
NORFLUNIX INJECTION
Active substance:
  • Flunixin meglumine
Target species:
  • Pig
Route of administration:
  • 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:
  • 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:
  • Surrendered
Authorised in:
  • Greece
Package description:
  • box containing 1 vial of 250 ml
  • box containing 1 vial of 100 ml
  • box containing 1 vial of 50 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:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Laboratories (Ireland) Limited
Responsible authority:
  • National Organization For Medicines
Authorisation number:
  • 19784/21-02-2014/Κ-0173201
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0121/001

Documents

Summary of Product Characteristics

English (PDF)
Published on: 5/04/2023
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Greek (PDF)
Published on: 20/09/2023
Updated on: 21/09/2023
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Package Leaflet

English (PDF)
Published on: 5/04/2023
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Greek (PDF)
Published on: 20/09/2023
Updated on: 21/09/2023
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Labelling

English (PDF)
Published on: 5/04/2023
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eu-PUAR-norflunix-injection-en.pdf

English (PDF)
Published on: 5/04/2023
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