Veterinary Medicines

PRIMUN GUMBORO Lyophilisate for use in drinking water for chickens

Authorised
  • Infectious bursal disease virus, strain IBDV_IGS (intermediate), Live
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Product identification

Medicine name:
PRIMUN GUMBORO Lyophilisate for use in drinking water for chickens
Primun Gumboro Wirus zakaźnego zapalenia torby Fabrycjusza ptaków (IBD), żywy, atenuowany, pośredni szczep IBDV_IGS, 3 - 4,5 log10 EID50/1 Liofilizat do podania w wodzie do picia
Active substance:
  • Infectious bursal disease virus, strain IBDV_IGS (intermediate), Live
Target species:
  • Chicken
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Infectious bursal disease virus, strain IBDV_IGS (intermediate), Live
    4.50
    log 10 50% embryo infective dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for use in drinking water
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:
  • Cardboard box containing 10 vials of 5000 doses
  • cardboard box containing 1 vial of 5000 doses
  • cardboard box containing 10 vials of 1.000 doses
  • cardboard box containing 1 vial of 1.000 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 Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2910
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0272/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania

Documents

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
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Polish (PDF)
Published on: 16/03/2022
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Package Leaflet

English (PDF)
Published on: 12/04/2023
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Polish (PDF)
Published on: 4/02/2022
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Labelling

English (PDF)
Published on: 27/06/2024
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Polish (PDF)
Published on: 4/02/2022
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eu-PUAR-primun-gumboro-en.pdf

English (PDF)
Published on: 12/04/2023
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