Authorised

Product identification

Medicine name:
MACROSYN 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND SHEEP
Macrosyn 100 mg/ml Injektionslösung für Rinder, Schweine und Schafe
Active substance:
  • Tulathromycin
Target species:
  • Sheep
  • Pig
  • Cattle
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Tulathromycin
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Sheep
      • Milk
        no withdrawal period
      • Meat and offal
        16
        day
    • Pig
      • Meat and offal
        13
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        22
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA94
Legal status of supply:
  • Medicinal product on medical prescription for non-renewable delivery
Authorisation status:
  • Valid
Authorised in:
  • Austria
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:
  • Bimeda Animal Health Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bimeda Animal Health Limited
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 840341
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0418/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Estonia
  • Germany
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Spain

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 1/04/2022
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 1/04/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 1/04/2022
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000040501