Veterinary Medicines

Lutalyse

Authorised
  • Dinoprost trometamol
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Product identification

Medicine name:
Lutalyse
Active substance:
  • Dinoprost trometamol
Target species:
  • Cattle
  • Horse
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Dinoprost trometamol
    6.71
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        2
        day
      • Milk
        0
        day
    • Horse
      • Meat and offal
        1
        day
    • Pig
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Available in:
  • Ireland
Package description:
  • 30 ml multi-dose, Type I, glass vial with red chlorobutyl rubber stopper and aluminium overseal.Pack sizes: 30 ml vial.
  • 10 ml multi-dose, Type I, glass vials with red chlorobutyl rubber stopper and aluminium overseal.Pack sizes: 5 x 10 ml vials.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Complete application (stand-alone) - Council Directive 81/851/EEC
Marketing authorisation holder:
  • Zoetis Belgium S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10387/042/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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