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Bovitubal 28000, 28000 IU Roztwór do wstrzykiwań

Authorised
  • Mycobacterium bovis, strain AN5, bovine tuberculin purified protein derivative
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Product identification

Medicine name:
Bovitubal 28000, 28000 IU Roztwór do wstrzykiwań
Active substance:
  • Mycobacterium bovis, strain AN5, bovine tuberculin purified protein derivative
Target species:
  • Pig
  • Cattle
Route of administration:
  • Intradermal use

Product details

Active substance and strength:
  • Mycobacterium bovis, strain AN5, bovine tuberculin purified protein derivative
    28000.00
    international unit(s)
    /
    1.00
    international unit(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intradermal use
    • Pig
      • Meat and offal
        0
        day
    • Cattle
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QV04CF01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Available 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:
  • Grabikowski-Grabikowska Przedsiebiorstwo Produkcyjno-Handlowo-Uslugowe Inex Sp. j.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2008
Date of authorisation status change:

Documents

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
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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
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