Veterinary Medicines

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

Authorised
  • R-Cloprostenol sodium
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Product identification

Medicine name:
Galapan 75 micrograms/ml solution for injection for cattle, horses and pigs
GALAPAN 75 microgramos/ml SOLUCIÓN INYECTABLE PARA BOVINO, CABALLOS Y PORCINO
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
        hour
    • 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:
  • Spain
Package description:
  • Colourless vials of type I glass containing 20 ml of solution for injection, with chlorobutyl rubber stoppers and aluminium caps. Presentation: Cardboard box of 1 vial of 20 ml
  • Colourless vials of type I glass containing 50 ml of solution for injection, with chlorobutyl rubber stoppers and aluminium caps. Presentation: Cardboard box of 1 vial of 50 ml
  • Colourless vials of type I glass containing 20 ml of solution for injection, with chlorobutyl rubber stoppers and aluminium caps. Presentation: Cardboard box of 5 vials of 20 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Informed Consent application (Article 21 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Industrial Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Industrial Veterinaria S.A.
  • Industrial Veterinaria S.A.
  • aniMedica GmbH
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 4422 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0630/001
Concerned member states:
  • Spain
Informed consent reference:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/08/2025
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Spanish (PDF)
Published on: 25/08/2025
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Combined File of all Documents

English (PDF)
Published on: 24/08/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 25/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 25/08/2025
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ie-puar-mr-iev0630001-galapan-75-microgramsml-solution-for-injection-for-en.pdf

English (PDF)
Published on: 24/08/2025
Download
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