Veterinary Medicines

OCUREV

Authorised
  • Brucella melitensis, strain REV 1, Live
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Product identification

Medicine name:
OCUREV
OCUREV
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:
  • Portugal
Available in:
  • Portugal
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 Veterinaria S.A.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • R744/05DGV
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0107/001
Concerned member states:
  • France
  • Portugal

Documents

Combined File of all Documents

English (PDF)
Published on: 24/05/2023
Download
Portuguese (PDF)
Published on: 26/08/2022
Download

Package Leaflet

English (PDF)
Published on: 21/12/2023
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Labelling

English (PDF)
Published on: 21/12/2023
Download

Summary of Product Characteristics

English (PDF)
Published on: 21/12/2023
Download
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