Veterinary Medicines

Luteoplan 0.25 mg/ml solution for injection for cattle and horses

Authorised
  • Cloprostenol sodium
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Product identification

Medicine name:
Luteoplan 0.25 mg/ml solution for injection for cattle and horses
Luteoplan 0,25 mg/ml Roztwór do wstrzykiwań
Active substance:
  • Cloprostenol sodium
Target species:
  • Cattle
  • Horse
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Cloprostenol sodium
    0.26
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        1
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        4
        day
      • Milk
        24
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • Container size: 20 ml.Container material: Amber Type I glass vials in a cardboard box.Closure: Grey elastomeric bromobutyl rubber stoppers sealed with a plastic flip off button and an aluminium cap.

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:
  • Syn Vet-Pharma Ireland Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Ovejero S.A.U.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 3294
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0771/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 16/02/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/10/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 1/07/2025
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