Veterinary Medicines

Tyawalt 450 mg/g granules for use in drinking water for pigs

Authorised
  • Tiamulin hydrogen fumarate
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Product identification

Medicine name:
Tyawalt 450 mg/g granules for use in drinking water for pigs
Tyawalt 450 mg/g Granulaat voor gebruik in drinkwater
Tyawalt 450 mg/g Granulés pour administration dans l'eau de boisson
Tyawalt 450 mg/g Granulat zum Eingeben über das Trinkwasser
Active substance:
  • Tiamulin hydrogen fumarate
Target species:
  • Pig
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Tiamulin hydrogen fumarate
    450.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Granules for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Pig
      • Meat and offal
        2
        day
      • 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:
  • Valid
Authorised in:
  • Belgium
Package description:
  • (ID2) 5 kilogram(s): unspecified outer container with 1 Bag (Low Density PolyEthylene; Aluminium; PolyEthylene TerePhthalate) with 5 kilogram(s)
  • (ID1) 1 kilogram(s): unspecified outer container with 1 Bag (Low Density PolyEthylene; Aluminium; PolyEthylene TerePhthalate) with 1 kilogram(s)

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:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
  • TAD Pharma GmbH
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V526124
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0264/001
Concerned member states:
  • Belgium
  • Denmark
  • France
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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Dutch (PDF)
Published on: 9/11/2022
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French (PDF)
Published on: 9/11/2022
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German (PDF)
Published on: 9/11/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 9/11/2022
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French (PDF)
Published on: 9/11/2022
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German (PDF)
Published on: 9/11/2022
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