Veterinary Medicines

ORNIMIX CLONE B1+H120, Lyofilizát pro suspenzi

Authorised
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
  • Newcastle disease virus, strain Bio 52:NDV B1, Live
Download as PDF

Product identification

Medicine name:
ORNIMIX CLONE B1+H120, Lyofilizát pro suspenzi
Active substance:
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
  • Newcastle disease virus, strain Bio 52:NDV B1, Live
Target species:
  • Chicken
Route of administration:
  • In drinking water use
  • Oculonasal use
  • Nebulisation use

Product details

Active substance and strength:
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
    4.80
    log 10 50% embryo infective dose
    /
    1.00
    Dose
  • Newcastle disease virus, strain Bio 52:NDV B1, Live
    7.50
    log 10 50% embryo infective dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for suspension
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken
      • Meat and offal
        0
        day
      • Egg
        0
        day
  • Oculonasal use
    • Chicken
      • Meat and offal
        0
        day
      • Egg
        0
        day
  • Nebulisation use
    • Chicken
      • Meat and offal
        0
        day
      • Egg
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD11
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
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:
  • Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 97/065/08-C
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.
Czech (PDF)
Published on: 3/02/2025
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 3/02/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 12/05/2025
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."