Veterinary Medicines

Poulvac Procerta HVT-IBD (--) - Concentrate and solvent for suspension for injection

Authorised
  • Turkey herpesvirus, strain HVT-IBD (cell-associated), expressing VP2 protein gene of Infectious bursal disease virus, Live
Download as PDF

Product identification

Medicine name:
Poulvac Procerta HVT-IBD (--) - Concentrate and solvent for suspension for injection
Active substance:
  • Turkey herpesvirus, strain HVT-IBD (cell-associated), expressing VP2 protein gene of Infectious bursal disease virus, Live
Target species:
  • Chicken
  • Chicken (embryonated eggs)
Route of administration:
  • In ovo
  • Subcutaneous use

Product details

Active substance and strength:
  • Turkey herpesvirus, strain HVT-IBD (cell-associated), expressing VP2 protein gene of Infectious bursal disease virus, Live
    3580.00
    plaque forming unit
    /
    1.00
    dose
Pharmaceutical form:
  • Concentrate and solvent for suspension for injection
Withdrawal period by route of administration:
  • In ovo
    • Chicken
      • Not applicable
        0
        day
    • Chicken (embryonated eggs)
      • Not applicable
        0
        day
  • Subcutaneous use
    • Chicken
      • Not applicable
        0
        day
    • Chicken (embryonated eggs)
      • Not applicable
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD15
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
Package description:
  • Packaging:ampoule (glass), Package_size:1 ampoule, Content:4000 doses
  • Packaging:ampoule (glass), Package_size:1 ampoule, Content:2000 doses

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - known active substance (Article 8 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Zoetis Belgium
Marketing authorisation date:
Manufacturing sites for batch release:
  • National Laboratory of health, environment and foodstuff
  • Institute for State Control of Veterinary Biologicals and Medicaments
  • National Food Chain Safety Office, Directorate of Veterinary Medicinal Products
  • Bulgarian Food Safety Agency
  • Health Products Regulatory Authority
  • NATIONAL VETERINARY RESEARCH INSTITUTE
  • Institute for Control of Biological Products & Veterinary Drugs
  • Danish Medicines Agency
  • Medical Products Agency
  • Zoetis Manufacturing & Research Spain S.L.
  • Sciensano
  • Paul-Ehrlich-Institute
  • Institute for State Control of Veterinary Biologicals and Medicaments
  • Austrian Federal Office For Safety In Health Care
  • EVIRA Virology, Animal Diseases and Food Safety
Responsible authority:
  • European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:

Documents

Combined File of all Documents

English (PDF)
Published on: 17/12/2024
Download
Bulgarian (PDF)
Published on: 17/12/2024
Download
Croatian (PDF)
Published on: 17/12/2024
Download
Czech (PDF)
Published on: 17/12/2024
Download
Danish (PDF)
Published on: 17/12/2024
Download
Dutch (PDF)
Published on: 17/12/2024
Download
Estonian (PDF)
Published on: 17/12/2024
Download
Finnish (PDF)
Published on: 17/12/2024
Download
French (PDF)
Published on: 17/12/2024
Download
German (PDF)
Published on: 17/12/2024
Download
Greek (PDF)
Published on: 17/12/2024
Download
Hungarian (PDF)
Published on: 17/12/2024
Download
Icelandic (PDF)
Published on: 17/12/2024
Download
Italian (PDF)
Published on: 17/12/2024
Download
Latvian (PDF)
Published on: 17/12/2024
Download
Lithuanian (PDF)
Published on: 17/12/2024
Download
Maltese (PDF)
Published on: 17/12/2024
Download
Norwegian (PDF)
Published on: 17/12/2024
Download
Polish (PDF)
Published on: 17/12/2024
Download
Portuguese (PDF)
Published on: 17/12/2024
Download
Romanian (PDF)
Published on: 17/12/2024
Download
Slovak (PDF)
Published on: 17/12/2024
Download
Slovenian (PDF)
Published on: 17/12/2024
Download
Spanish (PDF)
Published on: 17/12/2024
Download
Swedish (PDF)
Published on: 17/12/2024
Download

ema-puar-v6000-poulvac-procerta-hvt-ibd-en.pdf

English (PDF)
Published on: 8/01/2024
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."