File downloaded on 2026-01-09
Source URL: https://medicines.health.europa.eu/veterinary/en/600000055547
Authorised

Product identification

Medicine name:
B-19 CZV SUBCUTANEA LIOFILIZADO Y DISOLVENTE PARA SUSPENSION INYECTABLE PARA BOVINO
Active substance:
  • Brucella abortus, strain B-19, Live
Target species:
  • Cattle
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Brucella abortus, strain B-19, Live
    10.00
    colony forming unit(s)/gram
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AE
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:

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 Vaccines S.A.U.
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2940 ESP
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.
Spanish (PDF)
Published on: 5/02/2025
Download

Package Leaflet

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Spanish (PDF)
Published on: 5/02/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 5/02/2025
Download