Veterinary Medicines

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

Authorised
  • Tulathromycin
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Product identification

Medicine name:
Tulieve 100 mg/ml solution for injection for cattle, pigs and sheep
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:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
Available in:
  • United Kingdom (Northern Ireland)
Package description:
  • (ID9) 500 millilitre(s): Box (Cardboard) with 1 Vial (Glass) with 500 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID8) 250 millilitre(s): Box (Cardboard) with 1 Vial (Glass) with 250 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID7) 100 millilitre(s): Box (Cardboard) with 1 Vial (Glass) with 100 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID6) 50 millilitre(s): Box (Cardboard) with 1 Vial (Glass) with 50 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID5) 1 litre(s): Box (Cardboard) with 1 Vial (High Density PolyEthylene) with 1 litre(s), closed with Stopper (bromobutyl rubber`)
  • (ID4) 500 millilitre(s): Box (Cardboard) with 1 Vial (High Density PolyEthylene) with 500 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID3) 250 millilitre(s): Box (Cardboard) with 1 Vial (High Density PolyEthylene) with 250 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID2) 100 millilitre(s): Box (Cardboard) with 1 Vial (High Density PolyEthylene) with 100 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID1) 50 millilitre(s): Box (Cardboard) with 1 Vial (High Density PolyEthylene) with 50 millilitre(s), closed with Stopper (bromobutyl rubber`)

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 Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Laboratories (Ireland) Limited
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • 02000/4441
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0322/001
Concerned member states:
  • Belgium
  • Estonia
  • France
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 24/03/2022
Download

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
Download
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