Veterinary Medicines

GESTAVET-PROST, 75μg/ml, Solution for injection

Authorised
  • R-cloprostenol
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Product identification

Medicine name:
GESTAVET-PROST, 75μg/ml, Solution for injection
GESTAVET-PROST, 75μg/ml, Injekční roztok
Active substance:
  • R-cloprostenol
Target species:
  • Cattle (cow)
  • Pig (sow)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • R-cloprostenol
    75.00
    microgram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (cow)
      • Milk
        0
        day
      • Meat and offal
        24
        hour
    • Pig (sow)
      • Meat and offal
        24
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD90
Legal status of supply:
This information is not available for this product.
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • Glass Vial 10 x 20.0 millilitre(s)
  • Glass Vial 10 x 10.0 millilitre(s)
  • Glass Vial 1 x 20.0 millilitre(s)
  • Glass Vial 1 x 10.0 millilitre(s)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Biogenesis Global S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra S.A.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicines
Authorisation number:
  • 96/047/08-C
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0102/001
Concerned member states:
  • Greece
  • Poland
  • Portugal
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/05/2022
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Czech (PDF)
Published on: 21/03/2023
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Package Leaflet

English (PDF)
Published on: 24/05/2022
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Czech (PDF)
Published on: 21/03/2023
Download

Labelling

English (PDF)
Published on: 24/05/2022
Download
Czech (PDF)
Published on: 21/03/2023
Download

eu-puar-czv0102001-mr-gestavet-prost-en.pdf

English (PDF)
Published on: 16/11/2023
Download
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