Veterinary Medicines

Tuberculin PPD Kit

Authorised
  • TUBERCULIN PURIFIED PROTEIN DERIVATIVE, AVIAN
  • TUBERCULIN PURIFIED PROTEIN DERIVATIVE, BOVINE
Download as PDF

Product identification

Medicine name:
Tuberculin PPD Kit
TUBERCULIN PPD KIT
Active substance:
  • TUBERCULIN PURIFIED PROTEIN DERIVATIVE, AVIAN
  • TUBERCULIN PURIFIED PROTEIN DERIVATIVE, BOVINE
Target species:
  • Cattle
Route of administration:
  • Intradermal use

Product details

Active substance and strength:
  • TUBERCULIN PURIFIED PROTEIN DERIVATIVE, AVIAN
    25000.00
    international unit(s)
    /
    0.10
    millilitre(s)
  • TUBERCULIN PURIFIED PROTEIN DERIVATIVE, BOVINE
    30000.00
    international unit(s)
    /
    0.10
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intradermal use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AR01
  • QI02AR02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Available in:
  • France
Package description:
  • The 50-doses presentation of the Tuberculin PPD Kit: Polystyrene box with 10 vials (hydrolytic Type I) of Bovine Tuberculin PPD 3000 and 10 vials (hydrolytic Type I) of Avian Tuberculin PPD 2500. Each vial contains 50 doses of 0.1 ml.
  • The 20-doses presentation of the Tuberculin PPD Kit: Polystyrene box with 20 vials (hydrolytic Type I) of Bovine Tuberculin PPD 3000 and 20 vials (hydrolytic Type I) of Avian Tuberculin PPD 2500. Each vial contains 20 doses of 0.1 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:
  • Prionics Lelystad B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Prionics Lelystad B.V.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/1007311 1/2021
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0322/001
Concerned member states:
  • France
  • Hungary
  • Ireland
  • United Kingdom (Northern Ireland)

Documents

Labelling

English (PDF)
Published on: 13/06/2022
Download

Summary of Product Characteristics

English (PDF)
Published on: 13/06/2022
Download
French (PDF)
Published on: 10/10/2025
Download

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 10/10/2025
Download

tuberculin pil.pdf

English (PDF)
Published on: 13/06/2022
Download

tuberculin par.pdf

English (PDF)
Published on: 13/06/2022
Download