Veterinary Medicines

BRONIPRA-ND/IBD

Authorised
  • Avian infectious bronchitis virus, strain H52, Inactivated
  • Newcastle disease virus, strain La Sota, Inactivated
  • Infectious bursal disease virus, strain Winterfield 2512 (intermediate plus), Inactivated
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Product identification

Medicine name:
BRONIPRA-ND/IBD
Active substance:
  • Avian infectious bronchitis virus, strain H52, Inactivated
  • Newcastle disease virus, strain La Sota, Inactivated
  • Infectious bursal disease virus, strain Winterfield 2512 (intermediate plus), Inactivated
Target species:
  • Chicken (layer hen)
  • Chicken (for reproduction)
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Avian infectious bronchitis virus, strain H52, Inactivated
    16.00
    serum neutralising unit(s)
    /
    1.00
    Dose
  • Newcastle disease virus, strain La Sota, Inactivated
    1024.00
    haemagglutination inhibiting unit(s)
    /
    1.00
    Dose
  • Infectious bursal disease virus, strain Winterfield 2512 (intermediate plus), Inactivated
    13500.00
    enzyme-linked immunosorbent assay unit
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Chicken (layer hen)
      • Meat and offal
        0
        day
    • Chicken (for reproduction)
      • Meat and offal
        0
        day
  • Subcutaneous use
    • Chicken (layer hen)
      • Meat and offal
        0
        day
    • Chicken (for reproduction)
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AA08
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:

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 For Medicines And Medical Devices
Authorisation number:
  • 2297 ESP
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 20/08/2024
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Package Leaflet

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Spanish (PDF)
Published on: 20/08/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 20/08/2024
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