Veterinary Medicines

Cyclofin 300 mg/ml + 20 mg/ml solution for injection for cattle

Authorised
  • Flunixin
  • Oxytetracycline
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Product identification

Medicine name:
Cyclofin 300 mg/ml + 20 mg/ml solution for injection for cattle
CYCLOFIN 300 MG/ML + 20 MG/ML SOLUTION INJECTABLE POUR BOVINS
Active substance:
  • Flunixin
  • Oxytetracycline
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Flunixin
    20.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Oxytetracycline
    300.00
    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 except for some pack sizes
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • Type II, clear glass vial of 100 ml, with a 20 mm bromobutyl rubber stopper, and aluminium cap. One glass vial is packaged in a cardboard box.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/4576278 5/2023
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0773/001
Concerned member states:
  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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