Veterinary Medicines

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

Authorised
  • Tulathromycin
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Product identification

Medicine name:
Tulaxa 100 mg/ml solution for injection for cattle, pigs and sheep
TULAXA 100 mg/ml SOLUCION INYECTABLE PARA BOVINO, PORCINO Y OVINO
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:
  • Spain
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 cap 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:
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 3769 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0411/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
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Spanish (PDF)
Published on: 8/04/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 8/04/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 8/04/2024
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