Veterinary Medicines

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

Authorised
  • Ketoprofen
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Product identification

Medicine name:
Ketosol 100 mg/ml solution for injection for horses, cattle and pigs
KETOSOL
Active substance:
  • Ketoprofen
Target species:
  • Cattle
  • Horse
  • Pig
Route of administration:
  • Intravenous use
  • 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:
  • Intravenous use
    • Cattle
      • Meat and offal
        1
        day
      • Milk
        0
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        1
        day
      • Milk
        no withdrawal period
  • Intramuscular use
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        0
        day
      • Milk
        0
        hour
    • Pig
      • 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:
  • Italy
Available in:
  • Italy
Package description:
  • (ID2) 100 millilitre(s): unspecified outer container with 1 Vial (Glass) with 100 millilitre(s)
  • (ID1) 50 millilitre(s): unspecified outer container with 1 Vial (Glass) with 50 millilitre(s)

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:
  • CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • CP-Pharma Handelsgesellschaft mbH
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 104408
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0166/001
Concerned member states:
  • Hungary
  • Italy

Documents

Combined File of all Documents

English (PDF)
Published on: 5/07/2024
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Italian (PDF)
Published on: 3/06/2022
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Summary of Product Characteristics

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Italian (PDF)
Published on: 14/05/2022
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