Veterinary Medicines

Halofusol 0.5 mg/ml oral solution for calves

Authorised
  • Halofuginone lactate
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Product identification

Medicine name:
Halofusol 0.5 mg/ml oral solution for calves
Halofusol 0,5 mg/ml orale oplossing voor kalveren
Active substance:
  • Halofuginone lactate
Target species:
  • Cattle (newborn calf)
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Halofuginone lactate
    0.61
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Cattle (newborn calf)
      • Meat and offal
        13
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP51BX01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • bottle of 1000 ml
  • bottle of 500 ml
  • bottle of 250 ml
  • box containing 1 bottle of 1000 ml with a 4 ml metering pump
  • box containing 1 bottle of 1000 ml
  • box containing 1 bottle of 500 ml with a 4 ml metering pump
  • box containing 1 bottle of 500 ml
  • box containing 1 bottle of 250 ml with a 4 ml metering pump
  • box containing 1 bottle of 250 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Karizoo S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Karizoo S.A.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 124622
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0351/001
Concerned member states:
  • Belgium
  • Cyprus
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • United Kingdom (Northern Ireland)

Documents

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Dutch (PDF)
Published on: 2/02/2022
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