Veterinary Medicines

Orazole 100 mg/ml Oral Drench

Authorised
  • Fenbendazole
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Product identification

Medicine name:
Orazole 100 mg/ml Oral Drench
Active substance:
  • Fenbendazole
Target species:
  • Cattle
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Fenbendazole
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral suspension
Withdrawal period by route of administration:
  • Oral use
    • Cattle
      • Meat and offal
        28
        day
      • Milk
        5
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AC13
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • 1 L high density polyethylene containers with tamper evident closures.
  • 2 L high density polyethylene containers with tamper evident closures.
  • 2.5 L high density polyethylene containers with tamper evident closures.
  • 5 L high density polyethylene containers with tamper evident closures.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Complete application (stand-alone) - Council Directive 81/851/EEC
Marketing authorisation holder:
  • Foran Healthcare Unlimited Company
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ballinskelligs Veterinary Products
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10484/012/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 2/07/2025
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