Veterinary Medicines

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

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

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Romanian (PDF)
Published on: 11/09/2023
Updated on: 13/09/2023
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