Veterinary Medicines

Primun Bronchitis H120 Lyophilisate for oculonasal suspension/use in drinking water

Authorised
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
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Product identification

Medicine name:
Primun Bronchitis H120 Lyophilisate for oculonasal suspension/use in drinking water
Primun Bronchitis H120 żywy atenuowany wirus zakaźnego zapalenia oskrzeli (IBV), szczep Massachusetts IBV_H120: 3,0 - 4,0 log10 EID50*.(*) EID50 = 50% dawka zakaźna dla embrionów. Liofilizat do sporządzania zawiesiny
Active substance:
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
Target species:
  • Chicken
Route of administration:
  • Oculonasal use
  • Nebulisation use
  • In drinking water use

Product details

Active substance and strength:
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
    4.00
    log 10 50% embryo infective dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for suspension
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • box of pl�stico containing 10 vials of 1.000 doses
  • cardboard box containing 1 vial of 1.000 doses
  • Caja de plástico con 1 vial de 5.000 dosis, plastic box containing 1 vial of 5.000 doses
  • Caja de plástico con 10 viales de 5.000 dosis, plastic box containing 10 vials of 5.000 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:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 3063
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0295/001
Concerned member states:
  • Germany
  • Italy
  • Poland
  • Portugal

Documents

Package Leaflet

English (PDF)
Published on: 12/04/2023
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Polish (PDF)
Published on: 16/01/2025
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Labelling

English (PDF)
Published on: 12/04/2023
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Polish (PDF)
Published on: 16/01/2025
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Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
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Polish (PDF)
Published on: 16/01/2025
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