Veterinary Medicine Information website

Nextmune concentrate and solvent for suspension for injection for chickens

Authorised
  • Infectious bursal disease virus, strain Winterfield 2512 (intermediate plus), Live
Download as PDF

Product identification

Medicine name:
Nextmune concentrate and solvent for suspension for injection for chickens
Active substance:
  • Infectious bursal disease virus, strain Winterfield 2512 (intermediate plus), Live
Target species:
  • Chicken (broiler)
  • Chicken (embryonated eggs)
Route of administration:
  • Subcutaneous use
  • In ovo

Product details

Active substance and strength:
  • Infectious bursal disease virus, strain Winterfield 2512 (intermediate plus), Live
    2.70
    log 10 50% embryo infective dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Concentrate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Chicken (broiler)
      • Meat and offal
        0
        day
  • In ovo
    • Chicken (embryonated eggs)
      • Meat and offal
        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:
  • Germany
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Tiergesundheit GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva-Phylaxia Zrt.
Responsible authority:
  • Paul-Ehrlich-Institut
Authorisation number:
  • PEI.V.11992.01.1
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0337/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • United Kingdom (Northern Ireland)

Documents

Labelling

English (PDF)
Published on: 22/12/2023
Download

Combined File of all Documents

English (PDF)
Published on: 24/07/2025
Download
German (PDF)
Published on: 6/06/2025
Download