Veterinary Medicines

Denagard 125 mg/ml Roztwór do podania w wodzie do picia

Not authorised
  • Tiamulin hydrogen fumarate
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Product identification

Medicine name:
Denagard 125 mg/ml Roztwór do podania w wodzie do picia
Active substance:
  • Tiamulin hydrogen fumarate
Target species:
  • Pig
  • Chicken (hen)
  • Turkey
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 (hen)
      • Eggs
        0
        day
      • Meat and offal
        2
        day
    • Turkey
      • Meat and offal
        4
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01XQ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Elanco France S.A.S.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1385
Date of authorisation status change:

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/05/2022
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Labelling

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Polish (PDF)
Published on: 25/05/2022
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/05/2022
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