Veterinary Medicines

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

Authorised
  • Flunixin meglumine
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Product identification

Medicine name:
WELLICOX 50 MG/ML SOLUTION FOR INJECTION FOR CATTLE, HORSES, PIGS
Wellicox 50 mg/ml Roztwór do wstrzykiwań
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
        24
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        24
        hour
    • Horse
      • Meat and offal
        5
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AG90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
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 Animal Health Polska Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
  • Vetem S.p.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2321
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0241/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 16/03/2022
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Labelling

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Polish (PDF)
Published on: 16/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 16/03/2022
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