Veterinary Medicines

Genestran 75 micrograms/ml solution for injection for cattle, horses and pigs

Authorised
  • R-Cloprostenol sodium
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Product identification

Medicine name:
Genestran 75 micrograms/ml solution for injection for cattle, horses and pigs
Genestran 75 mikrogramów/ ml roztwór do wstrzykiwań dla bydła, koni i świń
Active substance:
  • R-Cloprostenol sodium
Target species:
  • Cattle
  • Horse
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • R-Cloprostenol sodium
    78.88
    microgram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        1
        day
      • Milk
        0
        day
    • Horse
      • Meat and offal
        1
        day
      • Milk
        0
        hour
    • Pig
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Available in:
  • Poland
Package description:
  • Colourless vial of type I glass containing 20 ml of solution for injection, with chlorobutyl rubber stopper and aluminium cap.Presentation: Cardboard box of 1 vial of 20 ml
  • Colourless vial of type I glass containing 50 ml of solution for injection, with chlorobutyl rubber stopper and aluminium cap.Presentation: Cardboard box of 1 vial of 50 ml
  • Colourless vial of type I glass containing 20 ml of solution for injection, with chlorobutyl rubber stopper and aluminium cap.Presentation: Cardboard box of 5 vials of 20 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • aniMedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • aniMedica GmbH
  • Industrial Veterinaria S.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1890
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0228/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Estonia
  • France
  • Germany
  • Iceland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 25/09/2024
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Polish (PDF)
Published on: 27/12/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 27/12/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 27/12/2024
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