Veterinary Medicines

Nobilis Gumboro D78 vet kuiva-aine, kylmäkuivattu, suspensiota varten, silmiin ja sieraimiin/juomaveteen sekoitettavaksi kanoille

Authorised
  • Infectious bursal disease virus, strain D78, Live
Download as PDF

Product identification

Medicine name:
Nobilis Gumboro D78 vet kuiva-aine, kylmäkuivattu, suspensiota varten, silmiin ja sieraimiin/juomaveteen sekoitettavaksi kanoille
Active substance:
  • Infectious bursal disease virus, strain D78, Live
Target species:
  • Chicken
Route of administration:
  • In drinking water use
  • Nebulisation use
  • Oculonasal use

Product details

Active substance and strength:
  • Infectious bursal disease virus, strain D78, Live
    4.00
    log10 tissue culture infective dose 50
    /
    1.00
    dose
Pharmaceutical form:
  • Lyophilisate for oculonasal suspension/use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken
      • Not applicable
        0
        day
  • Nebulisation use
    • Chicken
      • Not applicable
        0
        day
  • Oculonasal use
    • Chicken
      • Not applicable
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD09
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Finland
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:
  • Intervet International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Merck Sharp & Dohme Animal Health S.L.
Responsible authority:
  • Finnish Medicines Agency
Authorisation number:
  • 13559
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.
Finnish (PDF)
Published on: 28/01/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Finnish (PDF)
Published on: 28/01/2022
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."