Veterinary Medicine Information website

Poulvac AE lyophilisate for suspension for use in drinking water

Authorised
  • Avian encephalomyelitis virus, strain Calnek 1143, Live
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Product identification

Medicine name:
Poulvac AE lyophilisate for suspension for use in drinking water
Active substance:
  • Avian encephalomyelitis virus, strain Calnek 1143, Live
Target species:
  • Chicken
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Avian encephalomyelitis virus, strain Calnek 1143, Live
    1258.93
    50% Embryo Infective Dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken
      • Meat and offal
        0
        day
      • Egg
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • (ID2) 10000 Dose: Box (board) with 10 Bottle (borosilicate glass) each with 1000 Dose, closed with (chlorobutylrubber`) and (Aluminium)
  • (ID1) 1000 Dose: Box (board) with 1 Bottle (borosilicate glass) with 1000 Dose, closed with (chlorobutylrubber`) and (Aluminium)
  • (ID4) 20000 Dose: Box (board) with 10 Bottle (borosilicate glass) each with 2000 Dose, closed with (chlorobutylrubber`) and (Aluminium)
  • (ID3) 2000 Dose: Box (board) with 1 Bottle (borosilicate glass) with 2000 Dose, closed with (chlorobutylrubber`) and (Aluminium)

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:
  • Zoetis Italia S.r.l.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 104007
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0277/001
Concerned member states:
  • Austria
  • Estonia
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 24/07/2024
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Italian (PDF)
Published on: 20/04/2024
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