Veterinary Medicines

Indupart 0.075 mg/ml solution for injection

Authorised
  • R-cloprostenol
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Product identification

Medicine name:
Indupart 0.075 mg/ml solution for injection
Indupart 75 µg/ml Oplossing voor injectie
Indupart 75 µg/ml Solution injectable
Indupart 75 µg/ml Injektionslösung
Active substance:
  • R-cloprostenol
Target species:
  • Horse (mare)
  • 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
    • Horse (mare)
      • Meat and offal
        2
        day
      • Milk
        0
        day
    • Cattle (cow)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Pig (sow)
      • 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:
  • Belgium
Available in:
  • Belgium
Package description:
  • cardboard box containing 5 vials of 20 ml
  • cardboard 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:
  • Vetpharma Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Mevet S.A.U.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V466951
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0203/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • Estonia
  • Germany
  • Hungary
  • Ireland
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia

Documents

Summary of Product Characteristics

English (PDF)
Published on: 26/12/2023
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Dutch (PDF)
Published on: 30/11/2023
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French (PDF)
Published on: 30/11/2023
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German (PDF)
Published on: 19/12/2023
Download

Package Leaflet

English (PDF)
Published on: 26/12/2023
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Dutch (PDF)
Published on: 30/11/2023
Download
French (PDF)
Published on: 19/12/2023
Download
German (PDF)
Published on: 19/12/2023
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 19/12/2023
Download
French (PDF)
Published on: 19/12/2023
Download
German (PDF)
Published on: 19/12/2023
Download

eu-PUAR-esv0203001-dcp-indupart-0.075-mg-ml-solution-for-injection-en.pdf

English (PDF)
Published on: 26/12/2023
Download
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