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
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Product identification

Medicine name:
AviPro IB – ND C131 Lyophilisate for oculonasal suspension/use in drinking water for chicken
AviPro IB – ND C131 Liofilizzato per sospensione oculonasale/uso in acqua da bere per polli
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:
  • Italy
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:
  • Ministry Of Health
Authorisation number:
  • 105635
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

Documents

Combined File of all Documents

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Italian (PDF)
Published on: 28/03/2024
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