Veterinary Medicines

AviPro IB – ND C131 Lyophilisate for oculonasal suspension/use in drinking water for chicken

Authorised
  • Newcastle disease virus, strain Clone 13-1, Live
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
Download as PDF

Product identification

Medicine name:
AviPro IB – ND C131 Lyophilisate for oculonasal suspension/use in drinking water for chicken
Active substance:
  • Newcastle disease virus, strain Clone 13-1, Live
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
Target species:
  • Chicken
  • Chicken (layer hen)
Route of administration:
  • Oculonasal use
  • In drinking water use

Product details

Active substance and strength:
  • Newcastle disease virus, strain Clone 13-1, Live
    316227.00
    50% Embryo Infective Dose
    /
    1.00
    Dose
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
    2511.00
    50% Embryo Infective Dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for suspension
Withdrawal period by route of administration:
  • Oculonasal use
    • Chicken
      • Egg
        0
        day
      • Meat and offal
        0
        day
    • Chicken (layer hen)
      • Egg
        0
        day
      • Meat and offal
        0
        day
  • In drinking water use
    • Chicken
      • Egg
        0
        day
      • Meat and offal
        0
        day
    • Chicken (layer hen)
      • 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:
  • Hungary
Package description:
  • (ID4) 50000 Dose: Box (Cardboard) with 10 Bottle (Glass) each with 5000 Dose, closed with Lid and Stopper (Aluminium, Rubber)
  • (ID3) 5000 Dose: Box (Cardboard) with 1 Bottle (Glass) with 5000 Dose, closed with Lid and Stopper (Aluminium, Rubber)
  • (ID2) 20000 Dose: Box (Cardboard) with 10 Bottle (Glass) each with 2000 Dose, closed with Lid and Stopper (Aluminium, Rubber)
  • (ID1) 2000 Dose: Box (Cardboard) with 1 Bottle (Glass) with 2000 Dose, closed with Lid and Stopper (Aluminium, Rubber)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lohmann Animal Health GmbH
Responsible authority:
  • Directorate Of Veterinary Medicinal Products
Authorisation number:
  • 4385/x/23 NÉBIH ÁTI
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0291/001
Concerned member states:
  • Austria
  • Czechia
  • France
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain
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."