Veterinary Medicines

CALIERMUTIN (MACROMUTIN) 162 mg/ml SOLUTION FOR INJECTION FOR PIGS

Authorised
  • Tiamulin
Download as PDF

Product identification

Medicine name:
CALIERMUTIN (MACROMUTIN) 162 mg/ml SOLUTION FOR INJECTION FOR PIGS
MACROMUTIN 162 mg/ml SOLUCION INYECTABLE PARA PORCINO
Active substance:
  • Tiamulin
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Tiamulin
    162.20
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat
        14
        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:
  • Clear glass vials, quality type II (European Pharmacopoeia), of 100 ml, provided with grey brubber stoppers of bromobutyl, formulation PH 4001/45, and metallic aluminium coloured (silver) capsules with blue FLIP-OFF ring.
  • Clear glass vials, quality type II (European Pharmacopoeia), of 10 X 100 ml, provided with grey brubber stoppers of bromobutyl, formulation PH 4001/45, and metallic aluminium coloured (silver) capsules with blue FLIP-OFF ring.

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:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2124 ESP
Date of authorisation status change:
Reference member state:
  • Portugal
Procedure number:
  • PT/V/102/01/DC
Concerned member states:
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 12/11/2021
Download
Spanish (PDF)
Published on: 16/02/2023
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/02/2023
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/02/2023
Download