Veterinary Medicines

PRIMUN NEWCASTLE HB1 Lyophilisate for suspension for chickens

Authorised
  • Newcastle disease virus, strain B1 Hitchner, Live
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Product identification

Medicine name:
PRIMUN NEWCASTLE HB1 Lyophilisate for suspension for chickens
PRIMUN NEWCASTLE HB1 Liofilizado para suspensão para galinhas
Active substance:
  • Newcastle disease virus, strain B1 Hitchner, Live
Target species:
  • Chicken
Route of administration:
  • Oculonasal use
  • Nebulisation use
  • In drinking water use

Product details

Active substance and strength:
  • Newcastle disease virus, strain B1 Hitchner, Live
    6.00
    log 10 50% embryo infective dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for suspension
Withdrawal period by route of administration:
  • Oculonasal use
    • Chicken
      • Meat and offal
        0
        day
      • Egg
        0
        day
  • Nebulisation use
    • Chicken
      • Egg
        0
        day
      • Meat and offal
        0
        day
  • In drinking water use
    • Chicken
      • Egg
        0
        day
      • 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:
  • Portugal
Package description:
  • (ID2) 10000 Dose: Box (board) with 10 Bottle (Glass type I) each with 1000 Dose, closed with Stopfen (bromobutyl rubber) and Kappe (aluminium)
  • (ID1) 1000 Dose: Box (board) with 1 Bottle (Glass type I) with 1000 Dose, closed with Stopfen (bromobutyl rubber) and Kappe (aluminium)
  • (ID5) 50000 Dose: Box (board) with 10 Bottle (Glass type I) each with 5000 Dose, closed with Kappe (aluminium) and Stopfen (bromobutyl rubber)
  • (ID4) 5000 Dose: Box (board) with 1 Bottle (Glass type I) with 5000 Dose, closed with Kappe (aluminium) and Stopfen (bromobutyl rubber)

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:
  • Calier Portugal Medicamentos E Produtos Veterinarios S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 945/01/17DIVPT
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0272/001
Concerned member states:
  • Italy
  • Poland
  • Portugal
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 18/12/2025
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Portuguese (PDF)
Published on: 7/07/2022
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