Veterinary Medicines

ACEGON 50 mcg/ml solution for injection

Authorised
  • Gonadorelin acetate
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Product identification

Medicine name:
ACEGON 50 mcg/ml solution for injection
ACEGON, 50 μικρογραμμάρια / ml, ενέσιμο διάλυμα για βοοειδή
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
Legal status of supply:
  • Medicinal product subject to medical prescription
Authorisation status:
  • Valid
Authorised in:
  • Cyprus
Available in:
  • Cyprus
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
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
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:
  • Veterinary Services, Ministry Of Agriculture, Natural Resources And Environment
Authorisation number:
  • CY00489V
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
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Greek (PDF)
Published on: 3/05/2022
Download

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
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