Veterinary Medicines

OVUCRON 25 �g/ml

Suspended
  • Lecirelin acetate
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Product identification

Medicine name:
OVUCRON 25 �g/ml
OVUCRON 0,025 mg/ml SOLUCION INYECTABLE PARA BOVINO Y CONEJOS
Active substance:
  • Lecirelin acetate
Target species:
  • Cattle (cow)
  • Rabbit (female for reproduction)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Lecirelin acetate
    0.03
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (cow)
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Rabbit (female for reproduction)
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01CA92
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Suspended
Authorised in:
  • Spain
Package description:

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:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 3507 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0269/001
Concerned member states:
  • Czechia
  • Slovakia

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
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Spanish (PDF)
Published on: 17/03/2023
Download

Combined File of all Documents

English (PDF)
Published on: 21/11/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 17/03/2023
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 17/03/2023
Download

eu-PUAR-esv0269001-dcp-ovucron-0-025-mg-ml-en.pdf

English (PDF)
Published on: 22/12/2023
Download

es-puar-ovucron-25-µg-ml-es.pdf

Spanish (PDF)
Published on: 17/03/2023
Download
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