Veterinary Medicines

Tialin 250 mg/ml solution for use in drinking water for pigs, chickens and turkeys

Authorised
  • Tiamulin hydrogen fumarate
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Product identification

Medicine name:
Tialin 250 mg/ml solution for use in drinking water for Pigs, Chickens and Turkeys
Tialin 250 mg/ml solution for use in drinking water for pigs, chickens and turkeys
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:
  • Ireland
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:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA22622/019/002
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

Combined File of all Documents

English (PDF)
Published on: 27/07/2023
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PuAR Tialin 125 mg.ml en 250 mg.nl REG NL 121032, 121033 version 2023.pdf

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