Veterinary Medicines

Halofusol 0.5 mg/ml oral solution for calves

Authorised
  • Halofuginone lactate
Download as PDF

Product identification

Medicine name:
Halofusol 0.5 mg/ml oral solution for calves
Halofusol 0,5 mg/ml šķīdums iekšķīgai lietošanai teļiem
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:
  • Latvia
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:
  • Food And Veterinary Service
Authorisation number:
  • V/DCP/20/0029
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

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Latvian (PDF)
Published on: 18/09/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Latvian (PDF)
Published on: 18/09/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Latvian (PDF)
Published on: 18/09/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."