Veterinary Medicine Information website

CEVAC IBIRD LYOPHILISATE FOR OCULONASAL SUSPENSION/ USE IN DRINKING WATER FOR CHICKENS

Authorised
  • Infectious bronchitis virus, type 793/B, strain 1/96, Live
Download as PDF

Product identification

Medicine name:
CEVAC IBIRD LYOPHILISATE FOR OCULONASAL SUSPENSION/ USE IN DRINKING WATER FOR CHICKENS
Active substance:
  • Infectious bronchitis virus, type 793/B, strain 1/96, Live
Target species:
  • Chicken (layer hen)
  • Chicken (broiler)
Route of administration:
  • Oculonasal use
  • Oral use

Product details

Active substance and strength:
  • Infectious bronchitis virus, type 793/B, strain 1/96, Live
    2.80
    log 10 50% embryo infective dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for oculonasal suspension/use in drinking water
Withdrawal period by route of administration:
  • Oculonasal use
    • Chicken (layer hen)
      • All relevant tissues
        0
        day
    • Chicken (broiler)
      • All relevant tissues
        0
        day
  • Oral use
    • Chicken (layer hen)
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • Cardboard box of 1 bottle of 500 doses
  • Cardboard box of 20 bottles of 10000 doses
  • Cardboard box of 20 bottles of 5000 doses
  • Cardboard box of 20 bottles of 2500 doses
  • Cardboard box of 20 bottles of 1000 doses
  • Cardboard box of 20 bottles of 500 doses
  • Cardboard box of 10 bottles of 10000 doses
  • Cardboard box of 10 bottles of 5000 doses
  • Cardboard box of 10 bottles of 2500 doses
  • Cardboard box of 10 bottles of 1000 doses
  • Cardboard box of 10 bottles of 500 doses
  • Cardboard box of 1 bottle of 10000 doses
  • Cardboard box of 1 bottle of 5000 doses
  • Cardboard box of 1 bottle of 2500 doses
  • Cardboard box of 1 bottle of 1000 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 Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva-Phylaxia Zrt.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 51056
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0245/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Danish (PDF)
Published on: 12/08/2024
Download

Combined File of all Documents

English (PDF)
Published on: 14/04/2025
Download