Authorised

Product identification

Medicine name:
ACEGON 50 mcg/ml solution for injection
ACEGON 50 mikrogramm/ml oldatos injekció szarvasmarhák részére
Active substance:
  • Gonadorelin acetate
Target species:
  • Cattle (cow)
  • Cattle (heifer)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Gonadorelin acetate
    50.00
    microgram(s)/millilitre
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (cow)
    • Cattle (heifer)
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01CA01
Authorisation status:
  • Valid
Authorised in:
  • Hungary
Package description:
  • cardboard box containing 10 vials of 6 ml
  • cardboard box containing 1 vial of 100 ml
  • cardboard box containing 1 vial of 50 ml
  • cardboard box containing 1 vial of 20 ml
  • cardboard box containing 1 vial of 6 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Laboratorios Syva S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Syva S.A.U.
  • Laboratorios Syva S.A.U.
Responsible authority:
  • Directorate Of Veterinary Medicinal Products
Authorisation number:
  • 2896/X/11 MgSzH ÁTI
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0158/001
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Czechia
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 6/04/2023
Download
Hungarian (PDF)
Published on: 25/02/2022

Package Leaflet

English (PDF)
Published on: 6/04/2023
Download

Labelling

English (PDF)
Published on: 6/04/2023
Download

eu-PUAR-acegon-50-mcg-ml--solution-for-injection-en.pdf

English (PDF)
Published on: 6/04/2023
Download

Source URL: https://medicines.health.europa.eu/veterinary/600000016880