Veterinary Medicines

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

Not authorised
  • Tulathromycin
Download as PDF

Product identification

Medicine name:
Tulieve 100 mg/ml solution for injection for cattle, pigs and sheep
Tulieve 100 mg/ml oldatos injekció szarvasmarhák, sertések és juhok számára A.U.V.
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
  • Intramuscular use
    • Sheep
      • Milk
        no withdrawal period
      • Meat and offal
        16
        day
    • 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:
  • Surrendered
Authorised in:
  • Hungary
Package description:
  • (ID9): 1 Box with 1 Vial (Glass) with 500 millilitre(s) (500 millilitre(s))
  • (ID8): 1 Box with 1 Vial (Glass) with 250 millilitre(s) (250 millilitre(s))
  • (ID7): 1 Box with 1 Vial (Glass) with 100 millilitre(s) (100 millilitre(s))
  • (ID6): 1 Box with 1 Vial (Glass) with 50 millilitre(s) (50 millilitre(s))
  • (ID5): 1 Box with 1 Vial (High Density PolyEthylene) with 1 litre(s) (1 litre(s))
  • (ID4): 1 Box with 1 Vial (High Density PolyEthylene) with 500 millilitre(s) (500 millilitre(s))
  • (ID3): 1 Box with 1 Vial (High Density PolyEthylene) with 250 millilitre(s) (250 millilitre(s))
  • (ID2): 1 Box with 1 Vial (High Density PolyEthylene) with 100 millilitre(s) (100 millilitre(s))
  • (ID1): 1 Box with 1 Vial (High Density PolyEthylene) with 50 millilitre(s) (50 millilitre(s))

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:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Laboratories (Ireland) Limited
Responsible authority:
  • Directorate Of Veterinary Medicinal Products
Authorisation number:
  • 4167/X/20 NÉBIH ÁTI
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0322/001