Veterinary Medicines

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

Authorised
  • Tulathromycin
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Product identification

Medicine name:
Doraxx 100 mg/ml solution for injection for cattle, pigs and sheep
Doraxx 100 mg/ml solução injetável para bovinos, suínos e ovinos
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
    • Cattle
      • Milk
        no withdrawal period
  • Intramuscular use
    • Pig
      • Meat and offal
        13
        day
    • Sheep
      • Meat and offal
        16
        day
    • Sheep
      • 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:
  • Portugal
Package description:
  • Cardboard box with 1 vial of 250 ml
  • Cardboard box with 1 vial of 100 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:
  • Dopharma Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Mevet S.A.
  • Dopharma B.V.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 1420/01/21DFVPT
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0390/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
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Package Leaflet

English (PDF)
Published on: 12/04/2023
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Labelling

English (PDF)
Published on: 12/04/2023
Download

eu-PUAR-doraxx-100-mg-ml-solution-for-injection-for-cattle--pigs-and-sheep-en.pdf

English (PDF)
Published on: 12/04/2023
Download
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