Veterinary Medicines Information website

DRALTEN 100 MG/ML SOLUTION INJECTABLE POUR BOVINS, PORCINS ET OVINS

Not authorised
  • Tulathromycin
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Product identification

Medicine name:
DRALTEN 100 MG/ML SOLUTION INJECTABLE POUR BOVINS, PORCINS ET OVINS
Active substance:
  • Tulathromycin
Target species:
  • Sheep
  • Pig
  • Cattle
Route of administration:
  • Intramuscular use
  • Subcutaneous 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:
  • Intramuscular use
    • Sheep
      • Milk
        no withdrawal period
      • Meat and offal
        16
        day
    • Pig
      • Meat and offal
        13
        day
  • Subcutaneous use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        22
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA94
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription except for some pack sizes
Authorisation status:
  • Surrendered
Authorised in:
  • France
Package description:

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:
  • Vetoquinol S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetoquinol S.A.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/5259747 1/2020
Date of authorisation status change:

Documents

Summary of Product Characteristics

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French (PDF)
Published on: 17/07/2023
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