Authorised

Product identification

Medicine name:
CZV REV-1
Active substance:
  • Brucella melitensis, strain REV 1, Live
Target species:
  • Sheep
  • Goat
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Brucella melitensis, strain REV 1, Live
    9.00
    Colony forming unit
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Sheep
      • Meat and offal
        0
        day
    • Goat
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI04AE
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 Veterinaria S.A.
Responsible authority:
  • Spanish Agency For Medicines And Health Products
Authorisation number:
  • 2292 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: 9/11/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 9/11/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 9/11/2022
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000055282