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 microgram/ml oplossing voor injectie
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:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Available in:
  • Netherlands
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.
  • Laboratorios Syva S.A.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 107265
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 17/01/2022
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Summary of Product Characteristics

English (PDF)
Published on: 6/04/2023
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Package Leaflet

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

English (PDF)
Published on: 6/04/2023
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eu-PUAR-acegon-50-mcg-ml--solution-for-injection-en.pdf

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