Authorised

Product identification

Medicine name:
CEVAC IBIRD LYOPHILISATE FOR SUSPENSION FOR CHICKENS
Cevac IBird liofilizāts suspensijas pagatavošanai vistām
Active substance:
  • Avian infectious bronchitis virus, type 793/B, strain 1/96, Live
Target species:
  • Chicken (broiler)
  • Chicken (layer hen)
  • Chicken (for reproduction)
Route of administration:
  • Oculonasal use
  • Oral use

Product details

Active substance and strength:
  • Avian 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 (broiler)
      • All relevant tissues
        0
        day
    • Chicken (layer hen)
      • All relevant tissues
        0
        day
    • Chicken (for reproduction)
      • All relevant tissues
        0
        day
  • Oral use
    • Chicken (layer hen)
      • All relevant tissues
        0
        day
    • Chicken (for reproduction)
      • 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:
  • Latvia
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-Phylaxia Zrt.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva-Phylaxia Veterinary Biologicals Co. Ltd.
Responsible authority:
  • Food And Veterinary Service
Authorisation number:
  • V/DCP/13/0031
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

Combined File of all Documents

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Latvian (PDF)
Published on: 23/03/2023
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Source URL: https://medicines.health.europa.eu/veterinary/600000032287