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 microgram/ml oplossing voor injectie voor runderen
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:
  • Netherlands
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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 129254
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

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Dutch (PDF)
Published on: 29/05/2023
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