Veterinary Medicines

Dinalgen 300 mg/ml solution for use in drinking water for cattle and pigs

Authorised
  • Ketoprofen
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Product identification

Medicine name:
Dinalgen 300 mg/ml solution for use in drinking water for cattle and pigs
Dinalgen 300 mg/ml oplossing voor oraal gebruik voor runderen en varkens
Active substance:
  • Ketoprofen
Target species:
  • Cattle (calf)
  • Pig (for fattening)
Route of administration:
  • Oral use
  • In drinking water use

Product details

Active substance and strength:
  • Ketoprofen
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Cattle (calf)
      • Meat and offal
        1
        day
    • Pig (for fattening)
      • Meat and offal
        1
        day
  • 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:
  • Netherlands
Package description:
  • box containing 1 bottle of 100 ml and 30 ml graduated dosing cup
  • box containing 1 bottle of 500 ml and 30 ml graduated dosing cup

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) 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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 102808
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0136/001
Concerned member states:
  • Belgium
  • Czechia
  • France
  • Hungary
  • Ireland
  • Netherlands
  • Poland
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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Dutch (PDF)
Published on: 6/08/2024
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Summary of Product Characteristics

English (PDF)
Published on: 5/04/2023
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Package Leaflet

English (PDF)
Published on: 5/04/2023
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Labelling

English (PDF)
Published on: 5/04/2023
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