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 solution injectable pour bovins et chevaux

Luteoplan 0,25 mg/ml oplossing voor injectie voor runderen en paarden

Luteoplan 0,25 mg/ml Injektionslösung für Rinder und Pferde

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:

Belgium

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:

20/03/2023

Manufacturing sites for batch release:

Laboratorios Ovejero S.A.U.

Responsible authority:

Federal Agency For Medicines And Health Products

Authorisation number:

BE-V661231

Date of authorisation status change:

20/03/2023

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)

To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet

Documents

Summary of Product Characteristics

English (PDF)

Published on: 16/02/2025

Other languages (3)

Dutch (PDF)

Published on: 18/08/2025

French (PDF)

Published on: 18/08/2025

German (PDF)

Published on: 18/08/2025

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.

Other languages (3)

Dutch (PDF)

Published on: 18/08/2025

French (PDF)

Published on: 18/08/2025

German (PDF)

Published on: 18/08/2025

Labelling

This document does not exist in this language (English). You can find it in another language below.

Other languages (3)

Dutch (PDF)

Published on: 18/08/2025

French (PDF)

Published on: 18/08/2025

German (PDF)

Published on: 18/08/2025