Veterinary Medicines

KETOPROCEN 300 mg/ml ORAL SOLUTION

Authorised
  • Ketoprofen
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Product identification

Medicine name:
KETOPROCEN 300 mg/ml ORAL SOLUTION
Kadir, 300mg/ml, Roztok pro podání v pitné vodě
Active substance:
  • Ketoprofen
Target species:
  • Cattle (calf)
  • Pig (for fattening)
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Ketoprofen
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Cattle (calf)
      • Meat and offal
        1
        day
    • Pig (for fattening)
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AE03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • bottle of 500 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:
  • Cenavisa S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Cenavisa S.L.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/018/21-C
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0397/001
Concerned member states:
  • Bulgaria
  • Czechia
  • Estonia
  • Greece
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Romania

Documents

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
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Czech (PDF)
Published on: 24/05/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 24/05/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 24/05/2024
Download
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