Veterinary Medicines

DENAGARD 100 mg/g PREMEZCLA MEDICAMENTOSA

Authorised
  • Tiamulin hydrogen fumarate
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Product identification

Medicine name:
DENAGARD 100 mg/g PREMEZCLA MEDICAMENTOSA
Active substance:
  • Tiamulin hydrogen fumarate
Target species:
  • Pig
  • Rabbit
  • Chicken (chick, for replacement)
  • Chicken (for reproduction)
  • Chicken (broiler)
  • Turkey (for reproduction)
  • Turkey (for meat production)
  • Chicken (layer hen)
Route of administration:
  • In-feed use

Product details

Active substance and strength:
  • Tiamulin hydrogen fumarate
    100.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Premix for medicated feeding stuff
Withdrawal period by route of administration:
  • In-feed use
    • Pig
      • Meat and offal
        6
        day
    • Rabbit
      • Meat and offal
        0
        day
    • Chicken (chick, for replacement)
      • Meat and offal
        1
        day
      • Eggs
        0
        day
    • Chicken (for reproduction)
      • Meat and offal
        1
        day
      • Eggs
        0
        day
    • Chicken (broiler)
      • Meat and offal
        1
        day
      • Eggs
        0
        day
    • Turkey (for reproduction)
      • Meat and offal
        4
        day
    • Turkey (for meat production)
      • Meat and offal
        4
        day
    • Chicken (layer hen)
      • Meat and offal
        1
        day
      • Eggs
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01XQ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
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 Spain S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Andres Pintaluba S.A.
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2478 ESP
Date of authorisation status change:

Documents

Labelling

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Spanish (PDF)
Published on: 29/11/2023
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Summary of Product Characteristics

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Spanish (PDF)
Published on: 29/11/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 29/11/2023
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