Not authorised

Product identification

Medicine name:
MACROMUTIN 450 mg/g POLVO ORAL AVES Y CERDOS
Active substance:
  • Tiamulin hydrogen fumarate
Target species:
  • Pig
  • Turkey
  • Chicken (broiler)
  • Chicken (hen)
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Tiamulin hydrogen fumarate
    450.00
    milligram(s)
    /
    1000.00
    gram(s)
Pharmaceutical form:
  • Powder for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Pig
      • Meat and offal
        6
        day
    • Turkey
      • Meat and offal
        6
        day
    • Chicken (broiler)
      • Meat and offal
        6
        day
    • Chicken (hen)
      • Meat and offal
        6
        day
      • Eggs
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01XQ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Spain
Package description:

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:
  • Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 1733 ESP
Date of authorisation status change:

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: 9/11/2022
Download

Package Leaflet

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

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 9/11/2022
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000058982