Veterinary Medicine Information website

Cunibiovac Myxo Liofilizat i rozpuszczalnik do sporządzania zawiesiny do wstrzykiwań

Authorised
  • Myxoma virus, strain Leon-162, Live
Download as PDF

Product identification

Medicine name:
Cunibiovac Myxo Liofilizat i rozpuszczalnik do sporządzania zawiesiny do wstrzykiwań
Active substance:
  • Myxoma virus, strain Leon-162, Live
Target species:
  • Rabbit
Route of administration:
  • Subcutaneous use
  • Intradermal use

Product details

Active substance and strength:
  • Myxoma virus, strain Leon-162, Live
    3162.28
    50% cell culture infectious dose
    /
    1.00
    50% cell culture infectious dose
Pharmaceutical form:
  • Lyophilisate for suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Rabbit
      • Meat and offal
        0
        day
  • Intradermal use
    • Rabbit
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI08AD02
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:
  • Similar biological application (Article 13(4) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Biowet Drwalew Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Drwalewskie Zaklady Przemyslu Bioweterynaryjnego S.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2742
Date of authorisation status change:

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
Download