Veterinary Medicines

Adenipravac-ND/IB Emulsja do wstrzykiwań

Authorised
  • Newcastle disease virus, strain La Sota, Inactivated
  • Avian infectious bronchitis virus, strain H52, Inactivated
  • Eggdrop syndrome-1976 virus, strain V127, Inactivated
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Product identification

Medicine name:
Adenipravac-ND/IB Emulsja do wstrzykiwań
Active substance:
  • Newcastle disease virus, strain La Sota, Inactivated
  • Avian infectious bronchitis virus, strain H52, Inactivated
  • Eggdrop syndrome-1976 virus, strain V127, Inactivated
Target species:
  • Chicken (hen)
Route of administration:
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Newcastle disease virus, strain La Sota, Inactivated
    100000000.00
    50% Embryo Infective Dose
    /
    0.50
    millilitre(s)
  • Avian infectious bronchitis virus, strain H52, Inactivated
    1000000.00
    50% Embryo Infective Dose
    /
    0.50
    millilitre(s)
  • Eggdrop syndrome-1976 virus, strain V127, Inactivated
    500.00
    haemagglutinating units
    /
    0.50
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection/infusion
Withdrawal period by route of administration:
  • Subcutaneous use
    • Chicken (hen)
      • All relevant tissues
        0
        day
  • Intramuscular use
    • Chicken (hen)
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AA13
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (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:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1241
Date of authorisation status change:

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 8/04/2022
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Labelling

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Polish (PDF)
Published on: 8/04/2022
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 8/04/2022
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