Veterinary Medicines

Novamune Concentrate and Solvent for Suspension for Injection for Chickens

Authorised
  • Infectious bursal disease virus, Live
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Product identification

Medicine name:
Novamune Concentrate and Solvent for Suspension for Injection for Chickens
NOVAMUNE CONCENTRADO Y DISOLVENTE PARA SUSPENSION INYECTABLE PARA POLLOS
Active substance:
  • Infectious bursal disease virus, Live
Target species:
  • Chicken
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Infectious bursal disease virus, Live
    4.20
    log 10 50% infective dose in chicken
    /
    1.00
    Dose
Pharmaceutical form:
  • Concentrate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Chicken
      • 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:
  • Spain
Package description:
  • bag containing 1600 ml
  • bag containing 1200 ml
  • bag containing 1000 ml
  • bag containing 800 ml
  • bag containing 400 ml
  • bag containing 200 ml
  • ampoule of 5 ml containing 2000 doses
  • ampoule of 5 ml containing 1000 doses
  • ampoule of 5 ml containing 500 doses
  • ampoule of 2 ml containing 1000 doses
  • ampoule of 2 ml containing 500 doses

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 Salud Animal S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva-Phylaxia Veterinary Biologicals Co. Ltd.
Responsible authority:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 3684 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0365/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
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Spanish (PDF)
Published on: 17/03/2023
Download

Combined File of all Documents

English (PDF)
Published on: 21/11/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 17/03/2023
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 17/03/2023
Download

eu-PUAR-novamune-concentrate-and-solvent-for-suspension-for-injection-for-chickens-en.pdf

English (PDF)
Published on: 12/04/2023
Download
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