Veterinary Medicines

Resflam 300/20 mg/ml Solution for Injection for Cattle

Authorised
  • Flunixin meglumine
  • Oxytetracycline dihydrate
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Product identification

Medicine name:
Resflam 300/20 mg/ml Solution for Injection for Cattle
Active substance:
  • Flunixin meglumine
  • Oxytetracycline dihydrate
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Flunixin meglumine
    33.18
    milligram(s)
    /
    1.00
    millilitre(s)
  • Oxytetracycline dihydrate
    323.52
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        28
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01AA56
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • Supplied in 100 ml type I/II, amber glass vial, sealed with bromobutyl rubber bung and aluminium cap.
  • Supplied in 50 ml type I/II, amber glass vial, sealed with bromobutyl rubber bung and aluminium cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Informed consent application (Article 13c of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Manufacturing Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA22664/085/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 26/08/2024
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