Veterinary Medicines

HATCHPAK IB H120 FROZEN SUSPENSION FOR OCULONASAL USE

Authorised
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
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Product identification

Medicine name:
HATCHPAK IB H120 FROZEN SUSPENSION FOR OCULONASAL USE
Hatchpak IB H120 Diepgevroren suspensie voor vernevelsuspensie
Hatchpak IB H120 Suspension congelée pour suspension pour inhalation par nébuliseur
Hatchpak IB H120 Gefrorene Suspension zur Suspension für einen Vernebler
Active substance:
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
Target species:
  • Chicken (one day-old chick)
Route of administration:
  • Oculonasal use

Product details

Active substance and strength:
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
    3.70
    log 10 50% embryo infective dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Concentrate for nebuliser solution
Withdrawal period by route of administration:
  • Oculonasal use
    • Chicken (one day-old chick)
      • 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:
  • Belgium
Package description:
  • Container of liquid nitrogen of canisters of 4 yellow ampoules of 10,000 doses
  • Container of liquid nitrogen of canisters of 4 yellow ampoules of 15,000 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:
  • Boehringer Ingelheim Animal Health Belgium S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Animal Health France
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V443082
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0171/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Romania
  • Slovakia
  • Slovenia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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German (PDF)
Published on: 22/03/2022
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