Authorised

Product identification

Medicine name:
Vaiol-Vac - atenuowany wirus ospy ptaków, szczep HP-2 nie mniej niż 10^4 EID50 i nie wiecej niż 10^5 EID50 Liofilizat i rozpuszczalnik do sporządzania zawiesiny do wstrzykiwań
Active substance:
  • Fowlpox virus, strain HP-2, Live
Target species:
  • Chicken (hen)
Route of administration:
  • Wing-web-stab use

Product details

Active substance and strength:
  • Fowlpox virus, strain HP-2, Live
    100000.00
    50% Embryo Infective Dose
    /
    1.00
    50% Embryo Infective Dose
Pharmaceutical form:
  • Lyophilisate for suspension for injection
Withdrawal period by route of administration:
  • Wing-web-stab use
    • Chicken (hen)
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD12
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1124
Date of authorisation status change:

Documents

Labelling

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Polish (PDF)
Published on: 16/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 16/03/2022
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000060021