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
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:
  • Germany
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:
  • Paul-Ehrlich-Institut
Authorisation number:
  • PEI.V.11967.01.1
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0295/001
Concerned member states:
  • Germany
  • Italy
  • Poland
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
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German (PDF)
Published on: 5/11/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 23/06/2023
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Labelling

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