File downloaded on 2026-04-15
Source URL: https://medicines.health.europa.eu/veterinary/en/600000077486
Authorised

Product identification

Medicine name:
GONASYL, 50 µg/mL, otopina za injekciju, za goveda
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)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (cow)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Cattle (heifer)
      • Meat and offal
        0
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) 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.
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/18-01/299
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Croatian (PDF)
Published on: 2/04/2025
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