ACEGON 50 mcg/ml solution for injection
ACEGON 50 mcg/ml solution for injection
Authorised
- Gonadorelin acetate
Product identification
Medicine name:
ACEGON 50 mcg/ml solution for injection
RELOSYL, 50 microgrammi/ml soluzione iniettabile per bovini
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
Authorised in:
-
Italy
Available in:
-
Italy
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:
- Ministry Of Health
Authorisation number:
- 104290
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
This document does not exist in this language (English). You can find it
in another language below.
Italian (PDF)
Published on: 3/06/2022
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
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