Veterinary Medicines

Primun Gumboro W2512

Authorised
  • Infectious bursal disease virus, strain Winterfield 2512, Live
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Product identification

Medicine name:
Primun Gumboro W2512
PRIMUN GUMBORO W2512 LIOFILIZADO PARA ADMINISTRACION EN AGUA DE BEBIDA PARA POLLOS
Active substance:
  • Infectious bursal disease virus, strain Winterfield 2512, 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, 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:
  • Spain
Package description:
  • Cardboard box containing 10 vials of 5000 doses
  • Cardboard box containing 1 vial of 5000 doses
  • Cardboard box containing 1 vial of 5000 doses
  • Cardboard box containing 1 vial 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 Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • Spanish Agency For Medicines And Health Products
Authorisation number:
  • 3822 ESP
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

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
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Spanish (PDF)
Published on: 2/02/2024
Download

Package Leaflet

English (PDF)
Published on: 12/04/2023
Download
Spanish (PDF)
Published on: 2/02/2024
Download

Labelling

English (PDF)
Published on: 12/04/2023
Download
Spanish (PDF)
Published on: 2/02/2024
Download

eu-PUAR-primun-gumboro-w2512-en.pdf

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

es-puar-primun-gumboro-w2512-es.pdf

Spanish (PDF)
Published on: 17/03/2023
Download
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