Veterinary Medicines

Tulaxa 25 mg/ml solution for injection for pigs

Authorised
  • Tulathromycin
Download as PDF

Product identification

Medicine name:
Tulaxa 25 mg/ml solution for injection for pigs
Tulaxa 25 mg/ml Oplossing voor injectie
Tulaxa 25 mg/ml Solution injectable
Tulaxa 25 mg/ml Injektionslösung
Active substance:
  • Tulathromycin
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Tulathromycin
    25.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        13
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA94
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Cardboard box containing one clear type I glass vial of 50 ml with a type I chlorobutyl/butyl film laminated rubber stopper and aluminium cap with plastic tear tab (flip-off).
  • Cardboard box containing one clear type I glass vial of 100 ml, with a type I chlorobutyl/butyl film laminated rubber stopper and aluminium cap with plastic tear tab (flip-off).
  • Cardboard box containing one clear type I glass vial of 250 ml, with a type I chlorobutyl/butyl film laminated rubber stopper and aluminium cap with plastic tear tab (flip-off).

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:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V573022
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0411/002
Concerned member states:
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download
Dutch (PDF)
Published on: 13/05/2022
Download
French (PDF)
Published on: 13/05/2022
Download
German (PDF)
Published on: 13/05/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 17/08/2025
Download
French (PDF)
Published on: 17/08/2025
Download
German (PDF)
Published on: 17/08/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 17/08/2025
Download