Veterinary Medicines

RELOSYL 50 micrograms/ml solution for injection for cattle

Authorised
  • Gonadorelin acetate
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Product identification

Medicine name:
RELOSYL 50 micrograms/ml solution for injection for cattle
RELOSYL 50 mikrogramov/ml, injekčný roztok pre hovädzí dobytok
Active substance:
  • Gonadorelin acetate
Target species:
  • Cattle (cow)
  • Cattle (heifer)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Gonadorelin acetate
    52.50
    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:
  • Slovakia
Available in:
  • Slovakia
Package description:
  • box containing 10 vials of 6 ml
  • box containing 1 vial of 100 ml
  • box containing 1 vial of 50 ml
  • box containing 1 vial of 20 ml
  • 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.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/048/MR/18-S
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0262/001
Concerned member states:
  • Belgium
  • Czechia
  • Germany
  • Netherlands
  • Poland
  • Slovakia

Documents

Combined File of all Documents

English (PDF)
Published on: 30/08/2023
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Slovak (PDF)
Published on: 8/07/2024
Download

Summary of Product Characteristics

English (PDF)
Published on: 30/08/2023
Download

Package Leaflet

English (PDF)
Published on: 30/08/2023
Download

Labelling

English (PDF)
Published on: 30/08/2023
Download
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