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
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:
  • Netherlands
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 Netherlands B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Animal Health France
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 10459
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

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Dutch (PDF)
Published on: 30/03/2023
Updated on: 31/03/2023
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