Veterinary Medicines

EDERAL 300 mg/ml Solution for use in drinking water for Cattle and Pigs

Authorised
  • Ketoprofen
Download as PDF

Product identification

Medicine name:
EDERAL 300 mg/ml Solution for use in drinking water for Cattle and Pigs
DANIDOL 300 mg/ml Lösung zum Eingeben über Trinkwasser für Rinder und Schweine
Active substance:
  • Ketoprofen
Target species:
  • Cattle (calf)
  • Pig (for fattening)
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Ketoprofen
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AE03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Austria
Package description:
  • bottle of 100 ml
  • bottle of 500 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Informed consent application (Article 13c of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ecuphar Veterinaria S.L.U.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 8-00841
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0148/001
Concerned member states:
  • Austria
  • Germany

Documents

Package Leaflet

English (PDF)
Published on: 22/12/2023
Download
German (PDF)
Published on: 17/06/2024
Updated on: 18/07/2024
Download

Summary of Product Characteristics

English (PDF)
Published on: 21/12/2023
Download
German (PDF)
Published on: 17/06/2024
Updated on: 18/07/2024
Download

Labelling

English (PDF)
Published on: 22/12/2023
Download
German (PDF)
Published on: 17/06/2024
Updated on: 18/07/2024
Download

Combined File of all Documents

English (PDF)
Published on: 24/07/2025
Download