Veterinary Medicines

KETOSAN, 100 mg/ml solution for injection for cattle and pigs

Authorised
  • Ketoprofen
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Product identification

Medicine name:
KETOSAN, 100 mg/ml solution for injection for cattle and pigs
Ketosan, 100 mg/ml oplossing voor injectie voor runderen en varkens
Active substance:
  • Ketoprofen
Target species:
  • Cattle
  • Pig
Route of administration:
  • Intramuscular 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
      • Milk
        no withdrawal period
      • Meat and offal
        4
        day
    • Pig
      • Meat and offal
        5
        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:
  • Amber glass (type II) injection vials of 100 ml closed with a rubber stopper and an aluminium cap in a cardboard box

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 B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Interchemie Werken De Adelaar Eesti AS
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 121697
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0240/001
Concerned member states:
  • Belgium
  • Germany
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Dutch (PDF)
Published on: 25/01/2022
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