Veterinary Medicines

WELLICOX 50 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND HORSES

Not authorised
  • Flunixin meglumine
Download as PDF

Product identification

Medicine name:
WELLICOX 50 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND HORSES
Wellicox 50 mg/ml solução injetável para bovinos, suínos e cavalos
Active substance:
  • Flunixin meglumine
Target species:
  • Cattle
  • Pig
  • Horse
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Flunixin meglumine
    83.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        31
        day
      • Milk
        36
        hour
    • Pig
      • Meat and offal
        20
        day
    • Horse
      • Meat and offal
        10
        day
      • Milk
        no withdrawal period
  • Intravenous use
    • Cattle
      • Meat and offal
        10
        day
      • Milk
        24
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AG90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Revoked
Authorised in:
  • Portugal
Package description:

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:
  • Ceva Saude Animal Produtos Farmaceuticos E Imunologicos Lda.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
  • Vetem S.p.A.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 652/01/13DFVPT
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0241/001

Documents

Combined File of all Documents

English (PDF)
Published on: 11/12/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."