Veterinary Medicines

Romefen 1% solução injectável para cães

Not authorised
  • Ketoprofen
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Product identification

Medicine name:
Romefen 1% solução injectável para cães
Active substance:
  • Ketoprofen
Target species:
  • Pig
  • Cattle
  • Horse
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Ketoprofen
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        4
        day
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        12
        day
  • Intravenous use
    • Horse
      • Meat and offal
        4
        day
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        12
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AE03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Revoked
Authorised in:
  • Portugal
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Saude Animal Produtos Farmaceuticos E Imunologicos Lda.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Merial
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 51135
Date of authorisation status change:

Documents

Combined File of all Documents

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Portuguese (PDF)
Published on: 13/06/2023
Updated on: 14/06/2023
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