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 acetate50.00microgram(s)/millilitre1.00millilitre(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
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)
Manufacturing sites for batch release:
- Laboratorios Syva S.A.U.
- Laboratorios Syva S.A.U.
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
Summary of Product Characteristics
English (PDF)
Download Published on: 6/04/2023
Package Leaflet
English (PDF)
Download Published on: 6/04/2023
Labelling
English (PDF)
Download Published on: 6/04/2023
eu-PUAR-acegon-50-mcg-ml--solution-for-injection-en.pdf
English (PDF)
Download Published on: 6/04/2023