Authorised

Product identification

Medicine name:
Macrotil, 300 mg/ml süstelahus veistele ja lammastele
Active substance:
  • Tilmicosin
Target species:
  • Cattle
  • Sheep
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Tilmicosin
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        70
        day
      • Milk
        36
        day
    • Sheep
      • Meat and offal
        42
        day
      • Milk
        18
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Estonia
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:
  • Interchemie Werken De Adelaar Eesti AS
Marketing authorisation date:
Manufacturing sites for batch release:
  • Interchemie Werken De Adelaar Eesti AS
Responsible authority:
  • State Agency Of Medicines
Authorisation number:
  • 2156
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Estonian (PDF)
Published on: 22/04/2025
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000044863