Veterinary Medicines

Tialin 250 mg/ml solution for use in drinking water for Pigs, Chickens and Turkeys

Authorised
  • Tiamulin hydrogen fumarate
Download as PDF

Product identification

Medicine name:
Tialin 250 mg/ml solution for use in drinking water for Pigs, Chickens and Turkeys
TIALIN 250 mg/ml SOLUCION PARA ADMINISTRACION EN AGUA DE BEBIDA PARA PORCINO POLLOS Y PAVOS
Active substance:
  • Tiamulin hydrogen fumarate
Target species:
  • Chicken
  • Pig
  • Turkey
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Tiamulin hydrogen fumarate
    250.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken
      • Meat and offal
        2
        day
      • Eggs
        0
        day
    • Pig
      • Meat and offal
        2
        day
      • Meat and offal
        4
        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:
  • Spain
Package description:
  • White opaque high density polyethylene container of 5 liters closed with white opaque high density polyethylene screw-cap.
  • White opaque high density polyethylene bottle of 1 liter with transparent graduated scale closed with white opaque high density polyethylene screw-cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
Responsible authority:
  • Spanish Agency For Medicines And Health Products
Authorisation number:
  • 3681 ESP
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0287/002
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/02/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 7/03/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/02/2024
Download

Combined File of all Documents

English (PDF)
Published on: 27/07/2023
Download

PuAR Tialin 125 mg.ml en 250 mg.nl REG NL 121032, 121033 version 2023.pdf

English (PDF)
Published on: 27/07/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."