Veterinary Medicines

HIPRAGUMBORO-G97

Authorised
  • Infectious bursal disease virus, strain GM97, Live
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Product identification

Medicine name:
HIPRAGUMBORO-G97
Hipragumboro - GM 97 Liofilizat do sporządzania zawiesiny doustnej
Active substance:
  • Infectious bursal disease virus, strain GM97, Live
Target species:
  • Chicken (broiler)
  • Chicken (one day-old chick)
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Infectious bursal disease virus, strain GM97, Live
    100.00
    50% Embryo Infective Dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for suspension
Withdrawal period by route of administration:
  • Oral use
    • Chicken (broiler)
      • All relevant tissues
        0
        day
    • Chicken (one day-old chick)
      • All relevant tissues
        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:
  • Poland
Package description:
  • Pack with 1 vial of 1000 doses
  • Pack with 10 vials of 5000 doses
  • Pack with 10 vials of 1000 doses
  • Pack with 1 vial of 5000 doses

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra, S.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1617
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0352/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • 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.
Polish (PDF)
Published on: 4/02/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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