Veterinary Medicines

DENAGARD 125 mg/ml SOLUCION PARA ADMINISTRACION EN AGUA DE BEBIDA

Not authorised
  • Tiamulin hydrogen fumarate
Download as PDF

Product identification

Medicine name:
DENAGARD 125 mg/ml SOLUCION PARA ADMINISTRACION EN AGUA DE BEBIDA
Active substance:
  • Tiamulin hydrogen fumarate
Target species:
  • Pig
  • Chicken (layer hen)
  • Chicken (for reproduction)
  • Chicken (chick, for replacement)
  • Chicken (broiler)
  • Turkey (for reproduction)
  • Turkey (for meat production)
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Tiamulin hydrogen fumarate
    125.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Pig
      • Meat and offal
        4
        day
    • Chicken (layer hen)
      • Meat and offal
        6
        day
      • Eggs
        0
        day
    • Chicken (for reproduction)
      • Meat and offal
        6
        day
      • Eggs
        0
        day
    • Chicken (chick, for replacement)
      • Meat and offal
        6
        day
      • Eggs
        0
        day
    • Chicken (broiler)
      • Meat and offal
        6
        day
      • Eggs
        0
        day
    • Turkey (for reproduction)
      • Meat and offal
        6
        day
      • Eggs
        no withdrawal period
    • Turkey (for meat production)
      • Meat and offal
        6
        day
      • Eggs
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01XQ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Argenta Dundee Limited
  • Elanco France S.A.S.
Responsible authority:
  • Spanish Agency For Medicines And Health Products
Authorisation number:
  • 1873 ESP
Date of authorisation status change:
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."