Veterinary Medicine Information website

Romefen PR 100 mg/ml Injektionslösung Pferde und Rinder

Authorised
  • Ketoprofen
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Product identification

Medicine name:
Romefen PR 100 mg/ml Injektionslösung Pferde und Rinder
Active substance:
  • Ketoprofen
Target species:
  • Horse
  • Cattle
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
    • Horse
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AE03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Ceva Tiergesundheit GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
  • Merial
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 26444.01.01
Date of authorisation status change:

Documents

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Published on: 9/01/2025
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