Veterinary Medicines

HIPRAVIAR-B1 lyophilisate for oculonasal suspension/use in drinking water for chickens

Authorised
  • Newcastle disease virus, strain B1 Hitchner, Live
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Product identification

Medicine name:
HIPRAVIAR-B1 lyophilisate for oculonasal suspension/use in drinking water for chickens
HIPRAVIAR-B1 LIOFILIZADO PARA SUSPENSION OCULONASAL Y PARA ADMINISTRACION EN AGUA DE BEBIDA PARA POLLOS
Active substance:
  • Newcastle disease virus, strain B1 Hitchner, Live
Target species:
  • Chicken (broiler)
  • Chicken (pullet for egg production, future layer)
  • Future breeder pullet
Route of administration:
  • Nebulisation use
  • In drinking water use
  • Oculonasal use

Product details

Active substance and strength:
  • Newcastle disease virus, strain B1 Hitchner, Live
    5011870000.00
    50% Embryo Infective Dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for oculonasal suspension/use in drinking water
Withdrawal period by route of administration:
  • Nebulisation use
    • Chicken (broiler)
      • Meat and offal
        0
        day
    • Chicken (pullet for egg production, future layer)
      • Meat and offal
        0
        day
    • Future breeder pullet
      • Meat and offal
        0
        day
  • In drinking water use
    • Chicken (broiler)
      • Meat and offal
        0
        day
    • Chicken (pullet for egg production, future layer)
      • Meat and offal
        0
        day
    • Future breeder pullet
      • Meat and offal
        0
        day
  • Oculonasal use
    • Chicken (broiler)
      • Meat and offal
        0
        day
    • Chicken (pullet for egg production, future layer)
      • Meat and offal
        0
        day
    • Future breeder pullet
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • box containing 10 vials of 1000 doses + box containing 10 bottles of solvent
  • box containing 10 vials of 5000 doses
  • box containing 10 vials of 2500 doses
  • box containing 10 vials of 1000 doses
  • box containing 10 vials of 500 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:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2242 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0275/001
Concerned member states:
  • Germany

Documents

Summary of Product Characteristics

English (PDF)
Published on: 6/04/2023
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Spanish (PDF)
Published on: 20/11/2024
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Package Leaflet

English (PDF)
Published on: 6/04/2023
Download
Spanish (PDF)
Published on: 20/11/2024
Download

Labelling

English (PDF)
Published on: 6/04/2023
Download
Spanish (PDF)
Published on: 20/11/2024
Download

eu-PUAR-hipraviar-b1-en.pdf

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

es-puar-hipraviar-b1-es.pdf

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