Veterinary Medicines

GALLIVAC IB88 NEO EFFERVESCENT TABLET FOR OCULONASAL SUSPENSION

Authorised
  • Avian infectious bronchitis virus, type 793/B, strain CR88121, Live
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Product identification

Medicine name:
GALLIVAC IB88 NEO EFFERVESCENT TABLET FOR OCULONASAL SUSPENSION
Gallivac IB88 brusetablet til okulonasal suspension
Active substance:
  • Avian infectious bronchitis virus, type 793/B, strain CR88121, Live
Target species:
  • Chicken (broiler)
Route of administration:
  • Oculonasal use

Product details

Active substance and strength:
  • Avian infectious bronchitis virus, type 793/B, strain CR88121, Live
    4.00
    log 10 50% embryo infective dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Effervescent tablet
Withdrawal period by route of administration:
  • Oculonasal use
    • Chicken (broiler)
      • Meat and offal
        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:
  • Carton box of 1 blister of 10 tablets of 2 000 doses
  • Carton box of 10 blisters of 10 tablets of 1 000 doses
  • Carton box of 10 blisters of 10 tablets of 2 000 doses
  • Carton box of 1 blister of 10 tablets of 1 000 doses

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Animal Health France
Responsible authority:
  • Danish Health And Medicines Authority
Authorisation number:
  • 67067
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0450/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Cyprus
  • Denmark
  • Finland
  • Greece
  • Iceland
  • Norway
  • Slovenia
  • Sweden

Documents

Summary of Product Characteristics

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Danish (PDF)
Published on: 16/11/2023
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