Veterinary Medicines

Tildosin 250 mg/ml Solution for Use in Drinking Water or Milk Replacer for Cattle, Pigs, Chickens and Turkeys

Authorised
  • Tilmicosin
Download as PDF

Product identification

Medicine name:
Tildosin 250 mg/ml Solution for Use in Drinking Water or Milk Replacer for Cattle, Pigs, Chickens and Turkeys
Tildosin
Active substance:
  • Tilmicosin
Target species:
  • Chicken
  • Pig
  • Turkey
  • Cattle
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Tilmicosin
    250.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for use in drinking water
Withdrawal period by route of administration:
  • Oral use
    • Chicken
      • Meat and offal
        12
        day
    • Pig
      • Meat and offal
        14
        day
    • Turkey
      • Meat and offal
        19
        day
    • Cattle
      • Meat and offal
        42
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Available in:
  • Germany
Package description:
  • High-density polyethylene can with high-density polyethylene screw cap containing 5040 ml of product
  • High-density polyethylene bottles with low-density polyethylene screw cap containing 960 ml of product

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:
  • Dopharma International B.V.
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 402410.00.00
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0289/001
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 18/07/2024
Download
German (PDF)
Published on: 20/12/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."