Veterinary Medicines Information website

Ketodolor 100 mg/ml solution for injection for horses, cattle, pigs

Authorised
  • Ketoprofen
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Product identification

Medicine name:
Ketodolor 100 mg/ml solution for injection for horses, cattle, pigs
Active substance:
  • Ketoprofen
Target species:
  • Cattle
  • Pig
  • Horse
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Ketoprofen
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        0
        hour
    • Pig
      • Meat and offal
        4
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        1
        day
    • Horse
      • 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:
  • Belgium
Available in:
  • Belgium
Package description:
  • The product is packed in amber type II glass vial of 100 ml, fitted with red chlorobutyl stopper and aluminium cap.
  • The product is packed in amber type II glass vial of 50 ml fitted with red chlorobutyl stopper and aluminium cap.

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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V439695
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0621/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Hungary
  • Iceland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 16/08/2026
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Dutch (PDF)
Published on: 12/08/2026
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French (PDF)
Published on: 12/08/2026
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German (PDF)
Published on: 12/08/2026
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 12/08/2026
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German (PDF)
Published on: 12/08/2026
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Dutch (PDF)
Published on: 12/08/2026
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Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 12/08/2026
Download
German (PDF)
Published on: 12/08/2026
Download
Dutch (PDF)
Published on: 12/08/2026
Download

Combined File of all Documents

English (PDF)
Published on: 16/08/2026
Download

ie-puar-mr-iev0621001-ketodolor-100-mgml-solution-for-injection-for-hors-en.pdf

English (PDF)
Published on: 16/08/2026
Download