Veterinary Medicines

FLUVEX 50 mg/ml Solution for injection for cattle, pigs and horses

Authorised
  • Flunixin meglumine
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Product identification

Medicine name:
FLUVEX 50 mg/ml Solution for injection for cattle, pigs and horses
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
      • Meat and offal
        4
        day
    • Horse
      • Meat and offal
        4
        day
    • Cattle
      • Milk
        1
        day
    • Horse
      • Milk
        no withdrawal period
  • 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:
  • Luxembourg
Package description:
  • Box containing 1 vial of 50 ml
  • Box containing 1 vial of 100 ml
  • box containing 1 vial of 250 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:
  • S P Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • S P Veterinaria S.A.
Responsible authority:
  • Ministere De La Sante Division De La Pharmacie Et Des Medicaments
Authorisation number:
  • V 505/10/09/1605
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0133/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Greece
  • Italy
  • Luxembourg
  • Netherlands
  • Poland
  • 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

eu-PUAR-esv0133001-mrp-fluvex-50-mg-ml-solution-for-injection-for-cattle--pigs-and-horses-en.pdf

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