File downloaded on 2025-12-06
Source URL: https://medicines.health.europa.eu/veterinary/en/600000055038
Authorised

Product identification

Medicine name:
RB-51 CZV LIOFILIZADO Y DISOLVENTE PARA SUSPENSION INYECTABLE PARA BOVINO
Active substance:
  • Brucella abortus, strain RB51, Live
Target species:
  • Cattle
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Brucella abortus, strain RB51, Live
    9.00
    Colony forming unit
    /
    1.00
    Dose
Pharmaceutical form:
  • Powder 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 - New 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:
  • 1431 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: 13/03/2025
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Package Leaflet

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Spanish (PDF)
Published on: 13/03/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 13/03/2025
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