Veterinary Medicine Information website

Rafazole Oral Suspension

Not authorised
  • Rafoxanide
  • Levamisole hydrochloride
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Product identification

Medicine name:
Rafazole Oral Suspension
Active substance:
  • Rafoxanide
  • Levamisole hydrochloride
Target species:
  • Cattle
  • Sheep
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Rafoxanide
    30.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Levamisole hydrochloride
    30.00
    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:
  • QP52AE51
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Ireland
Package description:
  • 10 litre. High density polyethylene containers with polyethylene closures.
  • 5 litre. High density polyethylene containers with polyethylene closures.
  • 2.5 litre. High density polyethylene containers with polyethylene closures.
  • 1 litre. High density polyethylene containers with polyethylene closures.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Informed consent (abridged application) - Council Directive 81/851/EEC
Marketing authorisation holder:
  • Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chanelle Pharmaceuticals Manufacturing Limited
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10987/012/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

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