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 soluție injectabilă pentru bovine, porci și oi
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:
  • Romania
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:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 240123
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:

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Romanian (PDF)
Published on: 18/09/2024
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