Veterinary Medicines

Tuloxxin 100 mg/ml solution for injection for cattle, pigs and sheep

Authorised
  • Tulathromycin
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Product identification

Medicine name:
Tuloxxin 100 mg/ml solution for injection for cattle, pigs and sheep
Tuloxxin 100 mg/ml injekčný roztok pre hovädzí dobytok, ošípané a ovce
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
      • Meat and offal
        16
        day
    • Pig
      • Meat and offal
        13
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        22
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA94
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Available in:
  • Slovakia
Package description:
  • Type I clear glass bottle of 50 ml with Type I chlorobutyl/butyl film laminated rubber stopper and aluminium cap with plastic tear/flip-off tab, in a cardboard box.
  • Type I clear glass bottle of 100 ml with Type I chlorobutyl/butyl film laminated rubber stopper and aluminium caps with plastic tear/flip-off tab, in a cardboard box.
  • Type I clear glass bottle of 250 ml with Type I chlorobutyl/butyl film laminated rubber stopper and aluminium cap with plastic tear/flip-off tab, in a cardboard box.

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:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • TAD Pharma GmbH
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/078/DC/18-S
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0396/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Slovak (PDF)
Published on: 10/06/2025
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Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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