Veterinary Medicines

DAXTON 100 mg/ml solution for injection for cattle, pigs and sheep

Authorised
  • Tulathromycin
Download as PDF

Product identification

Medicine name:
DAXTON 100 mg/ml solution for injection for cattle, pigs and sheep
Daxton 100 mg/ml solution injectable pour bovins, porcins et ovins
Daxton 100 mg/ml oplossing voor injectie voor rund, varken en schaap
Daxton 100 mg/ml Injektionslösung für Rinder, Schweine und Schafe
Active substance:
  • Tulathromycin
Target species:
  • Cattle
  • Pig
  • Sheep
Route of administration:
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Tulathromycin
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        22
        day
      • Milk
        no withdrawal period
  • Intramuscular use
    • Pig
      • Meat and offal
        13
        day
    • Sheep
      • Meat and offal
        16
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA94
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • box with 1 vial 100 ml
  • box with 1 vial 250 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Cenavisa S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Cenavisa S.L.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V663457
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0428/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Romania
Generic of:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 5/12/2024
Download
French (PDF)
Published on: 5/12/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 5/12/2024
Download
French (PDF)
Published on: 5/12/2024
Download
German (PDF)
Published on: 5/12/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 5/12/2024
Download
French (PDF)
Published on: 5/12/2024
Download
German (PDF)
Published on: 5/12/2024
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."