Veterinary Medicines

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

Authorised
  • Tulathromycin
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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: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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eu-PUAR-esv0428001-dcp-daxton-100-mg-ml-solution-for-injection-en.pdf

English (PDF)
Published on: 24/07/2025
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