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, Live2000000000.00/Colony forming unit1.00Dose
Pharmaceutical form:
-
Eye drops, powder and solvent for suspension
Withdrawal period by route of administration:
-
Ocular use
- Sheep
-
Meat and offal30day
-
- Goat
-
Meat and offal30day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI04AE
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
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)
Manufacturing sites for batch release:
- Cz Veterinaria S.A.
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
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 21/12/2023
French (PDF)
Published on: 5/06/2023
Combined File of all Documents
English (PDF)
Download Published on: 24/05/2023
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: 5/06/2023
Package Leaflet
English (PDF)
Download Published on: 21/12/2023
Labelling
English (PDF)
Download Published on: 21/12/2023