Veterinary Medicines

POULVAC IB QX LYOPHILISATE FOR SUSPENSION FOR SPRAY FOR CHICKENS

Authorised
  • Avian infectious bronchitis virus, type QX, strain L1148, Live
Download as PDF

Product identification

Medicine name:
POULVAC IB QX LYOPHILISATE FOR SUSPENSION FOR SPRAY FOR CHICKENS
Poulvac IB QX
Active substance:
  • Avian infectious bronchitis virus, type QX, strain L1148, Live
Target species:
  • Chicken
Route of administration:
  • Oculonasal use

Product details

Active substance and strength:
  • Avian infectious bronchitis virus, type QX, strain L1148, Live
    1000.00
    50% Embryo Infective Dose
    /
    1.00
    unit(s)
Pharmaceutical form:
  • Lyophilisate for suspension
Withdrawal period by route of administration:
  • Oculonasal use
    • Chicken
      • 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:
  • Germany
Package description:
  • Box of 1 x 2000 doses
  • Box of 10 x 10000 doses
  • Box of 10 x 5000 doses
  • Box of 10 x 2000 doses
  • Box of 1 x 10000 doses
  • Box of 1 x 5000 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:
  • Zoetis Deutschland GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
  • Paul-Ehrlich-Institut
Authorisation number:
  • PEI.V.11668.01.1
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0253/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 31/07/2023
Updated on: 1/08/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."