Veterinary Medicines

Nextmune concentrate and solvent for suspension for injection for chickens

Authorised
  • Infectious bursal disease virus, strain Winterfield 2512 (intermediate plus), Live
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Product identification

Medicine name:
Nextmune concentrate and solvent for suspension for injection for chickens
Nextmune koncentrat og solvens til injektionsvæske, suspension
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:
  • Denmark
Package description:
  • bag containing 1600 ml of solvent
  • bag containing 1200 ml of solvent
  • bag containing 800 ml of solvent
  • bag containing 400 ml of solvent
  • One ampoule of 5 ml containing 8000 doses
  • One ampoule of 5 ml containing 4000 doses
  • One ampoule of 5 ml containing 2000 doses
  • One ampoule of 2 ml containing 4000 doses
  • One ampoule of 2 ml containing 2000 doses
  • bag containing 1000 ml of solvent

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-Phylaxia Zrt.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva-Phylaxia Zrt.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 61869
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

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
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Danish (PDF)
Published on: 4/05/2022
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Package Leaflet

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

Labelling

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