File downloaded on 2026-01-24
Source URL: https://medicines.health.europa.eu/veterinary/en/600000083146
Authorised

Product identification

Medicine name:
OCUREV eye drops, powder and solvent for suspension
OCUREV LYOPHILISAT ET SOLVANT POUR SUSPENSION
Active substance:
  • Brucella melitensis, strain REV 1, Live
Target species:
  • Sheep
  • Goat
Route of administration:
  • Ocular use

Product details

Active substance and strength:
  • Brucella melitensis, strain REV 1, Live
    2000000000.00
    Colony forming unit
    /
    1.00
    Dose
Pharmaceutical form:
  • Eye drops, powder and solvent for suspension
Withdrawal period by route of administration:
  • Ocular use
    • Sheep
      • Meat and offal
        30
        day
    • Goat
      • Meat and offal
        30
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI04AE
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Available in:
  • France
Package description:
  • 1 box containing 1 vial of 25 doses and 1 vial of 1 ml of solvent
  • 1 box containing 1 vial of 50 doses and 1 vial of 2 ml of solvent
  • 1 box containing 1 vial of 10 doses and 1 vial of 0.5 ml of solvent

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:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/1723018 6/2017
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0107/001
Concerned member states:
  • France
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 26/06/2025
Download
French (PDF)
Published on: 16/04/2025
Download

Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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: 15/10/2025
Download

Package Leaflet

English (PDF)
Published on: 26/06/2025
Download

Labelling

English (PDF)
Published on: 26/06/2025
Download