Veterinary Medicines

Latroxin 100 mg/ml solution for injection for cattle, pigs and sheeps

Authorised
  • Tulathromycin
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Product identification

Medicine name:
Latroxin 100 mg/ml solution for injection for cattle, pigs and sheeps
LATROXIN 100 mg/ml, soluție injectabilă pentru bovine, porcine și ovine
Active substance:
  • Tulathromycin
Target species:
  • Cattle
  • Sheep
  • Pig
Route of administration:
  • Subcutaneous use
  • Intramuscular 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:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        22
        day
      • Milk
        no withdrawal period
    • Cattle
      • Meat and offal
        22
        day
      • Milk
        no withdrawal period
  • Intramuscular use
    • Sheep
      • Meat and offal
        16
        day
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        13
        day
    • Sheep
      • Meat and offal
        16
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA94
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Available in:
  • Romania
Package description:
  • cardboard box containing 1 vial of 250 ml
  • cardboard box containing 1 vial of 100 ml

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:
  • Mevet S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Mevet S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 210058
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0393/001
Concerned member states:
  • Cyprus
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Poland
  • Portugal
  • Romania

Documents

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
Download

Package Leaflet

English (PDF)
Published on: 12/04/2023
Download

Labelling

English (PDF)
Published on: 12/04/2023
Download

Combined File of all Documents

English (PDF)
Published on: 24/07/2025
Download
Romanian (PDF)
Published on: 29/08/2025
Download

eu-PUAR-latroxin-100-mg-ml-solution-for-injection-for-cattle--pigs-and-sheeps-en.pdf

English (PDF)
Published on: 12/04/2023
Download
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