Veterinary Medicines

Tuloxxin 25 mg/ml solution for injection for pigs

Authorised
  • Tulathromycin
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Product identification

Medicine name:
Tuloxxin 25 mg/ml solution for injection for pigs
Tuloxxin 25 mg/ml Roztwór do wstrzykiwań
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:
  • Poland
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:
  • TAD Pharma GmbH
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 3040
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0396/002
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

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Polish (PDF)
Published on: 16/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 16/03/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 16/03/2022
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