Veterinary Medicines

HIPRAGUMBORO CW Lyophilisate for use in drinking water

Authorised
  • Infectious bursal disease virus, strain CH/80, Live
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Product identification

Medicine name:
HIPRAGUMBORO CW Lyophilisate for use in drinking water
Hipragumboro CW Lyofilisaat voor gebruik in drinkwater
Hipragumboro CW Lyophilisat pour administration dans l'eau de boisson
Hipragumboro CW Lyophilisat zum Eingeben über das Trinkwasser
Active substance:
  • Infectious bursal disease virus, strain CH/80, Live
Target species:
  • Chicken (broiler)
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Infectious bursal disease virus, strain CH/80, Live
    31622800.00
    50% cell culture infectious dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken (broiler)
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD09
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • box containing 1 vial of 10000 doses
  • box containing 1 vial of 5000 doses
  • box containing 1 vial of 1000 doses
  • box containing 10 vials of 10000 doses
  • box containing 10 vials of 1000 doses
  • box containing 10 vials of 5000 doses

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra S.A.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V395333
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0162/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Estonia
  • France
  • Germany
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Slovakia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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eu-PUAR-hipragumboro-cw-en.pdf

English (PDF)
Published on: 6/04/2023
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