Veterinary Medicines

BIOBOVITUBAL 28000 solutie injectabila pentru bovine, ovine, caprine, porcine, cabaline, caini

Authorised
  • Mycobacterium bovis, strain AN5, bovine tuberculin purified protein derivative
Download as PDF

Product identification

Medicine name:
BIOBOVITUBAL 28000 solutie injectabila pentru bovine, ovine, caprine, porcine, cabaline, caini
Active substance:
  • Mycobacterium bovis, strain AN5, bovine tuberculin purified protein derivative
Target species:
  • Cattle
  • Sheep
  • Goat
  • Horse
  • Dog
  • Pig
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
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intradermal use
    • Cattle
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Sheep
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Goat
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Horse
      • Meat and offal
        0
        day
    • Dog
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AR01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Complete application (stand-alone) - Directive No 2001/82/EC
Marketing authorisation holder:
  • Bioveta Romania S.R.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta, a.s.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 230092
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Romanian (PDF)
Published on: 11/09/2023
Updated on: 13/09/2023
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."