File downloaded on 2025-12-18
Source URL: https://medicines.health.europa.eu/veterinary/en/600000041016
Authorised

Product identification

Medicine name:
HatchPak Avinew
Hatchpak Avinew Diepgevroren suspensie voor vernevelsuspensie
Hatchpak Avinew Suspension congelée pour suspension pour inhalation par nébuliseur
Hatchpak Avinew Gefrorene Suspension zur Suspension für einen Vernebler
Active substance:
  • Newcastle disease virus, strain VG/GA, Live
Target species:
  • Chicken (one day-old chick)
Route of administration:
  • Coarse spray

Product details

Active substance and strength:
  • Newcastle disease virus, strain VG/GA, Live
    5.50
    log 10 50% embryo infective dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Nebuliser suspension
Withdrawal period by route of administration:
  • Coarse spray
    • Chicken (one day-old chick)
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Type I glass ampoule,15,000-doses
  • Type I glass ampoule, 10,000-doses

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Immunological veterinary medicinal product application (Article 13d 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-V320013
Date of authorisation status change:
Reference member state:
  • Hungary
Procedure number:
  • HU/V/105/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • France
  • Germany
  • Greece
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Slovakia
  • Slovenia

Documents

Summary of Product Characteristics

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Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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Package Leaflet

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Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Labelling

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Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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