Veterinary Medicines

Orafluke 5 % w/v Oral Suspension

Authorised
  • Fenbendazole
  • Rafoxanide
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Product identification

Medicine name:
Orafluke 5 % w/v Oral Suspension
Active substance:
  • Fenbendazole
  • Rafoxanide
Target species:
  • Cattle
  • Sheep
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Fenbendazole
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Rafoxanide
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral suspension
Withdrawal period by route of administration:
  • Oral use
    • Cattle
      • Meat and offal
        60
        day
    • Sheep
      • Meat and offal
        60
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AC13
  • QP52AG05
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • 2.5L (jerrican) HDPE white containers closed with a polypropylene screw cap with an induction heat seal liner.
  • 1L (flexipack) HDPE white containers closed with a polypropylene screw cap with an induction heat seal liner.
  • 5L (jerrican) HDPE white containers closed with a polypropylene screw cap with an induction heat seal liner.
  • 2.5L (backpack) HDPE white containers closed with a polypropylene screw cap with an induction heat seal liner.
  • 1L (jerrican) HDPE white containers closed with a polypropylene screw cap with an induction heat seal liner.

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:
  • Interchem (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Interchem (Ireland) Limited
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10555/003/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

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