Veterinary Medicines

Ketosol-100, 100 mg/ml solution for injection for cattle, pigs and horses

Authorised
  • Ketoprofen
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Product identification

Medicine name:
Ketosol-100, 100 mg/ml solution for injection for cattle, pigs and horses
Ketochemie 100 mg/ml Oplossing voor injectie
Ketochemie 100 mg/ml Solution injectable
Ketochemie 100 mg/ml Injektionslösung
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
        4
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        4
        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
Package description:
  • 100 ml amber glass bottles (type II) closed with brombutyl rubber stopper and aluminium cap or flip-off cap with aluminium seal and polypropylene cover.
  • 50 ml amber glass bottles (type II) closed with brombutyl rubber stopper and aluminium cap or flip-off cap with aluminium seal and polypropylene cover.

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:
  • Interchemie Werken De Adelaar Eesti AS
Marketing authorisation date:
Manufacturing sites for batch release:
  • Interchemie Werken De Adelaar Eesti AS
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V597484
Date of authorisation status change:
Reference member state:
  • Estonia
Procedure number:
  • EE/V/0102/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden

Documents

Package Leaflet

English (PDF)
Published on: 20/10/2022
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Dutch (PDF)
Published on: 12/06/2023
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French (PDF)
Published on: 12/06/2023
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German (PDF)
Published on: 12/06/2023
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Summary of Product Characteristics

English (PDF)
Published on: 20/12/2023
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Dutch (PDF)
Published on: 12/06/2023
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French (PDF)
Published on: 12/06/2023
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German (PDF)
Published on: 12/06/2023
Download

Labelling

English (PDF)
Published on: 20/10/2022
Download
Dutch (PDF)
Published on: 12/06/2023
Download
French (PDF)
Published on: 12/06/2023
Download
German (PDF)
Published on: 12/06/2023
Download
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