Veterinary Medicines

Primun Gumboro W2512

Authorised
  • Infectious bursal disease virus, strain Winterfield 2512 (intermediate plus), Live
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Product identification

Medicine name:
Primun Gumboro W2512
Primun Gumboro W2512 Lyophilisat zum Eingeben über das Trinkwasser
Primun Gumboro W2512 Lyofilisaat voor gebruik in drinkwater
Primun Gumboro W2512 Lyophilisat pour administration dans l'eau de boisson
Active substance:
  • Infectious bursal disease virus, strain Winterfield 2512 (intermediate plus), Live
Target species:
  • Chicken (broiler)
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Infectious bursal disease virus, strain Winterfield 2512 (intermediate plus), Live
    3.00
    log 10 50% embryo infective 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:
  • Cardboard box containing 10 vials of 5000 doses
  • Cardboard box containing 1 vial of 5000 doses
  • box of plastic 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:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V594426
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0273/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania

Documents

Package Leaflet

English (PDF)
Published on: 12/04/2023
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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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Summary of Product Characteristics

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

English (PDF)
Published on: 12/04/2023
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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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eu-PUAR-primun-gumboro-w2512-en.pdf

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