Authorised

Product identification

Medicine name:
Syncroprost 0,250 mg/ml solution injectable pour bouvins, chevaux, porcins et chevres
Syncroprost, 0.250 mg/ml solution for injection for cattle, horses, pigs and goats
Active substance:
  • Cloprostenol
Target species:
  • Cattle (cow)
  • Cattle (heifer)
  • Horse (mare)
  • Pig (female)
  • Goat (adult female)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Cloprostenol
    0.25
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (cow)
      • Meat and offal
        1
        day
      • Milk
        0
        day
    • Cattle (heifer)
      • Meat and offal
        1
        day
      • Milk
        0
        day
    • Horse (mare)
      • Meat and offal
        1
        day
      • Milk
        0
        day
    • Pig (female)
      • Meat and offal
        1
        day
    • Goat (adult female)
      • Meat and offal
        1
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Luxembourg
Package description:
  • Box with 10 x 20 ml vials. Type I colourless glass vials sealed with bromo-butyl rubber stoppers closed by aluminium flip-off caps.
  • Box with one 20 ml vial. Type I colourless glass vial sealed with bromo-butyl rubber stopper closed by aluminium flip-off cap.
  • Box with one 10 ml vial. Type I colourless glass vial sealed with bromo-butyl rubber stopper closed by aluminium flip-off 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:
  • Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetem S.p.A.
Responsible authority:
  • Ministere De La Sante Division De La Pharmacie Et Des Medicaments
Authorisation number:
  • V 915/09/02/2023
Date of authorisation status change:
Reference member state:
  • Italy
Procedure number:
  • IT/V/0147/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Ireland
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 22/03/2023
Download

Combined File of all Documents

English (PDF)
Published on: 25/05/2022
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000093793