Veterinary Medicines

AviPro ND C131 Lyophilisate for suspension

Authorised
  • Newcastle disease virus, strain Clone 13-1, Live
Download as PDF

Product identification

Medicine name:
AviPro ND C131 Lyophilisate for suspension
AviPro ND C131 liofilizat za suspenzijo za piščance in purane
Active substance:
  • Newcastle disease virus, strain Clone 13-1, Live
Target species:
  • Turkey
  • Chicken
Route of administration:
  • In drinking water use
  • Topical
  • Ocular use

Product details

Active substance and strength:
  • Newcastle disease virus, strain Clone 13-1, Live
    15848900.00
    50% Embryo Infective Dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for oculonasal suspension/use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Turkey
      • Meat and offal
        0
        day
      • Egg
        0
        day
    • Chicken
      • Meat and offal
        0
        day
      • Egg
        0
        day
  • Topical
    • Chicken
      • Meat and offal
        0
        day
      • Egg
        0
        day
  • Ocular use
    • Chicken
      • Meat and offal
        0
        day
      • Egg
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • (ID8): 1 Box with 10 Bottle (Glass) with 5000 Dose (50000 Dose)
  • (ID7): 1 Box with 1 Bottle (Glass) with 5000 Dose (5000 Dose)
  • (ID11): 1 Box with 1 Bottle (Glass) with 2000 Dose (2000 Dose)
  • (ID12): 1 Box with 10 Bottle (Glass) with 2000 Dose (20000 Dose)

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:
  • Lohmann Animal Health GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lohmann Animal Health GmbH
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0025/001
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0239/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Estonia
  • France
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
Download
Slovenian (PDF)
Published on: 27/02/2023
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 27/02/2023
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 27/02/2023
Download

Combined File of all Documents

English (PDF)
Published on: 29/01/2024
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."