Veterinary Medicines

Prolusyn 50 micrograms/ml solution for injection for cattle

Authorised
  • Gonadorelin acetate
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Product identification

Medicine name:
Prolusyn 50 micrograms/ml solution for injection for cattle
Prolusyn 50 µg/ml Oplossing voor injectie voor runderen
Prolusyn 50 µg/ml Solution injectable pour bovins
Prolusyn 50 µg/ml Injektionslösung für Rinder
Active substance:
  • Gonadorelin acetate
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Gonadorelin acetate
    52.54
    microgram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
Package description:
  • Amber glass type I vial closed with a grey bromobutyl elastomeric rubber plug, sealed with a plastic flip off button and an aluminium capsule.Box containing 1 vial of 20 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:
  • Syn Vet-Pharma Ireland Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Ovejero S.A.U.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V584755
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0402/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 17/08/2025
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French (PDF)
Published on: 17/08/2025
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German (PDF)
Published on: 17/08/2025
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Summary of Product Characteristics

English (PDF)
Published on: 16/01/2026
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Dutch (PDF)
Published on: 17/08/2025
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French (PDF)
Published on: 17/08/2025
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German (PDF)
Published on: 17/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 17/08/2025
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French (PDF)
Published on: 17/08/2025
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German (PDF)
Published on: 17/08/2025
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