Rabigen SAG2

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live vaccine against rabies

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 06/11/2018

Authorisation details

Product details
Name
Rabigen SAG2
Agency product number
EMEA/V/C/000043
Active substance
Rabies vaccine (live, oral) for foxes and raccoon dogs
International non-proprietary name (INN) or common name
live vaccine against rabies
Species
  • Raccoon dogs (Nyctereutes procyonoides)
  • Red foxes (Vulpes vulpes)
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI07AA02
Publication details
Marketing-authorisation holder
Virbac S.A.
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
06/04/2000
Contact address

1ère Avenue 2065 M - L.I.D.
06516 Carros Cedex
France

Product information

06/11/2018 Rabigen SAG2 - EMEA/V/C/000043 - IG/0984

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Live viral vaccines

Therapeutic indication

For the active immunisation of red foxes and raccoon dogs to prevent infection by rabies virus.
The duration of protection is of at least 6 months.

Assessment history

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