Veterinary Medicines

LABIXXIN 100MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND SHEEP

Authorised
  • Tulathromycin
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Product identification

Medicine name:
LABIXXIN 100MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND SHEEP
Labixxin, 100 mg/mL, otopina za injekciju, za goveda, svinje i ovce
Active substance:
  • Tulathromycin
Target species:
  • Pig
  • Cattle
  • Sheep
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Tulathromycin
    100.00
    milligram(s)/millilitre
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        13
        day
    • Cattle
      • Meat and offal
        22
        day
      • Milk
        no withdrawal period
    • Sheep
      • Meat and offal
        16
        day
      • Milk
        no withdrawal period
  • Subcutaneous use
    • Pig
      • Meat and offal
        13
        day
    • Cattle
      • Meat and offal
        22
        day
      • Milk
        no withdrawal period
    • 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:
  • Croatia
Package description:
  • Cardboard box containing 1 vial of 250 ml
  • Cardboard box containing 1 vial of 100 ml
  • Cardboard box containing 1 vial of 50 ml
  • Cardboard box containing 1 vial of 20 ml
  • Cardboard box containing 10 vials of 250 ml
  • Cardboard box containing 10 vials of 100 ml
  • Cardboard box containing 12 vials of 50 ml
  • Cardboard box containing 12 vials of 20 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Labiana Life Sciences S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/23-01/775
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0423/001
Concerned member states:
  • Croatia
This information is not available for this product.

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Croatian (PDF)
Published on: 5/01/2024
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