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 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:
  • Austria
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:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 8-20325
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

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 16/01/2024
Updated on: 18/07/2024
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 16/01/2024
Updated on: 18/07/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 16/01/2024
Updated on: 18/07/2024
Download

Combined File of all Documents

English (PDF)
Published on: 24/07/2025
Download

eu-PUAR-hipragumboro-cw-en.pdf

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