Veterinary Medicine Information website

Entemulin, 450mg/g, Granules for use in drinking water

Authorised
  • Tiamulin hydrogen fumarate
Download as PDF

Product identification

Medicine name:
Entemulin, 450mg/g, Granules for use in drinking water
Active substance:
  • Tiamulin hydrogen fumarate
Target species:
  • Pig
  • Chicken
  • Turkey
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
        4
        day
    • Chicken
      • Meat and offal
        2
        day
      • Egg
        0
        day
    • Turkey
      • Meat and offal
        6
        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
Available in:
  • Poland
Package description:
  • Plastic Bag 1 x 1.0 kilogram(s) papír/papír/HDPE
  • Plastic Bag 1 x 5.0 kilogram(s) papír/papír/HDPE
  • Plastic Bag 1 x 10.0 kilogram(s) papír/papír/HDPE
  • Plastic Bag 1 x 1.0 kilogram(s) PET/AL/LDPE
  • Plastic Bag 1 x 5.0 kilogram(s) PET/AL/LDPE
  • Plastic Bag 1 x 10.0 kilogram(s) PET/AL/LDPE

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
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2178
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0109/001
Concerned member states:
  • Hungary
  • Lithuania
  • Poland
  • Romania
  • Slovakia
  • Slovenia

Documents

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: 2/04/2025
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 2/04/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 2/04/2025
Download