Veterinary Medicines

Baycox Direct 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten

Authorised
  • Toltrazuril
Download as PDF

Product identification

Medicine name:
Baycox Direct 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten
Baycox Direct 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten
Active substance:
  • Toltrazuril
Target species:
  • Turkey (hen)
  • Chicken
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Toltrazuril
    25.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Turkey (hen)
      • Meat and offal
        16
        day
    • Chicken
      • Meat and offal
        16
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP51BC01
Legal status of supply:
  • Medicinal product on medical prescription for renewable delivery
Authorisation status:
  • Valid
Authorised in:
  • Austria
Available in:
  • Austria
Package description:
  • 100 ml (available in cartons of 1 x 100 ml) white HDPE bottles closed with light green polypropylene screw cap with a red tamper evident seal.
  • 1000 ml white HDPE bottles closed with light green polypropylene screw cap with a red tamper evident seal.
  • 5000 ml white HDPE canister with an aluminium sealing disc, closed with a black polyethylene screw cap and a yellow tamper evident seal.

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:
  • Elanco Animal Health GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • KVP Pharma+Veterinär Produkte GmbH
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 835735
Date of authorisation status change:
Reference member state:
  • Austria
Procedure number:
  • AT/V/0012/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Portugal
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 2/05/2023
Download
German (PDF)
Published on: 21/03/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 21/03/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 21/03/2024
Download

at-puar-atv0012001-mr-baeycoex-en.pdf

English (PDF)
Published on: 5/03/2024
Download

at-puar-atv0012001-mr-baeycoex-de.pdf

German (PDF)
Published on: 5/03/2024
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."