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Biomutin 10% Premix 100 mg/g Premiks do sporządzania paszy leczniczej

Authorised
  • Tiamulin hydrogen fumarate
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Product identification

Medicine name:
Biomutin 10% Premix 100 mg/g Premiks do sporządzania paszy leczniczej
Active substance:
  • Tiamulin hydrogen fumarate
Target species:
  • Pig
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
        11
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01XQ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Biowet Drwalew Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Drwalewskie Zaklady Przemyslu Bioweterynaryjnego S.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1199
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Polish (PDF)
Published on: 4/02/2022
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Labelling

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Polish (PDF)
Published on: 4/02/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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