Veterinary Medicines

CZV BOVINE TUBERCULIN PPD

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

Medicine name:
CZV BOVINE TUBERCULIN PPD
CZV Tuberculine Bovine PPD Oplossing voor injectie
CZV Tuberculine Bovine PPD Solution injectable
CZV Tuberculine Bovine PPD Injektionslösung
Active substance:
  • Mycobacterium bovis, strain AN5, bovine tuberculin purified protein derivative
Target species:
  • Cattle
Route of administration:
  • Intradermal use

Product details

Active substance and strength:
  • Mycobacterium bovis, strain AN5, bovine tuberculin purified protein derivative
    2500.00
    international unit(s)
    /
    0.10
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intradermal use
    • Cattle
      • 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:
  • Belgium
Available in:
  • Belgium
Package description:
  • cardboard box of 20 doses with 1 vial of 2 ml
  • cardboard box of 200 doses with 10 vials of 2 ml
  • cardboard box of 500 doses with 25 vials of 2 ml
  • cardboard box of 50 doses with 1 vial of 5 ml
  • cardboard box of 500 doses with 10 vials of 5 ml
  • cardboard box of 1250 doses with 25 vials of 5 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • CZ Vaccines S.A.U.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Cz Veterinaria S.A.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V401965
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0180/001
Concerned member states:
  • Belgium
  • Bulgaria
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Portugal
  • Romania
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/04/2023
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Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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Package Leaflet

English (PDF)
Published on: 11/04/2023
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Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
Download
German (PDF)
Published on: 22/03/2022
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Labelling

English (PDF)
Published on: 11/04/2023
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Combined File of all Documents

English (PDF)
Published on: 29/05/2023
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