Veterinary Medicines

Avituberculin 25000 IU/ml Roztwór do wstrzykiwań

Authorised
  • Mycobacterium avium, subsp. avium, strain D4ER, avian tuberculin protein derivative
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Product identification

Medicine name:
Avituberculin 25000 IU/ml Roztwór do wstrzykiwań
Active substance:
  • Mycobacterium avium, subsp. avium, strain D4ER, avian tuberculin protein derivative
Target species:
  • Cattle
Route of administration:
  • Intradermal use

Product details

Active substance and strength:
  • Mycobacterium avium, subsp. avium, strain D4ER, avian tuberculin protein derivative
    25000.00
    international unit(s)/millilitre
    /
    1.00
    international unit(s)/millilitre
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intradermal use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        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
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Biowet Pulawy Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Biowet Pulawy Sp. z o.o.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2627
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Polish (PDF)
Published on: 6/02/2023
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Labelling

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Polish (PDF)
Published on: 6/02/2023
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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: 6/02/2023
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