Rabigen SAG2

live attenuated rabies virus, SAG2 strain

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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).

What is Rabigen SAG2?

Rabigen SAG2 is a vaccine againts rabies. It is presented as baits.

What is Rabigen SAG2 used for?

Rabigen SAG2 is used for the active immunisation of red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides) to prevent infection by rabies virus. The baits are distributed by land or by air. The number of baits distributed depends on the number of foxes or raccoon dogs and varies between 13 and 20 per square kilometre. Rabigen SAG2 can only be used by authorised personnel within the framework of vaccination campaigns against rabies.

How does Rabigen SAG2 work?

Rabigen SAG2 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Rabigen contains live rabies viruses. The viruses have been selected because of their ‘low virulence’ (limited ability to cause the disease). The viruses are contained in a sachet within a bait matrix. As the foxes or raccoon dogs eat the bait, they get exposed to the viruses and make antibodies against them. If the foxes or racoon dogs are then exposed to the rabies virus later in life, they do not become infected.

How has Rabigen SAG2 been studied?

Foxes
The distribution of almost four million baits of the product during the field trials over four years have been followed by an intensive surveillance of the vaccination areas.

Raccoon dogs
As raccoon dogs are considered a minor species, no field trials were carried out. Efficacy was based on the efficacy results from laboratory studies and the extensive use of the vaccine in the field for foxes.

What benefit has Rabigen SAG2 shown during the studies?

When distributed in the wild, the SAG2 rabies vaccine bait was readily taken by free ranging foxes and raccoon dogs. Following bait uptake, adult and fox cubs and raccoon dogs showed significant antibody response. As a result, rabies decreased significantly in the vaccinated areas until its complete elimination. Moreover, the use of this vaccine has been efficiently preventing the vaccinated area from re-infection from still contaminated neighbouring areas. No case of vaccine induced rabies was reported, confirming the safety of the vaccine in the field. The vaccine confers 6-month protection against rabies.

What is the risk associated with Rabigen SAG2?

No undesirable effects have been shown for Rabigen SAG2.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

It is recommended to wear rubber gloves when handling the bait. People handling and distributing this vaccine should be vaccinated against rabies. People whose immune system is weakened must not be allowed to handle this vaccine.

In the event of human exposure to the active substance of the vaccine, seek medical advice immediately and show the package leaflet or the label to the doctor.

Why has Rabigen SAG2 been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Rabigen SAG2 exceed the risks for its use in red foxes and raccoon dogs to prevent infection by rabies virus and recommended that Rabigen SAG2 be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Rabigen SAG2

The European Commission granted a marketing authorisation valid throughout the European Union, for Rabigen SAG2 to Virbac S.A. on 6 April 2000. The marketing authorisation was subsequently renewed in 2005 and varied in April 2008 to include raccoon dogs as a new target species. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Rabigen SAG2 : EPAR - Summary for the public BG = bălgarski 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public ES = español 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public CS = čeština 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public DA = dansk 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public DE = Deutsch 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public ET = eesti keel 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public EL = elliniká 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public EN = English 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public FR = français 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public IT = italiano 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public LV = latviešu valoda 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public LT = lietuvių kalba 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public HU = magyar 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public MT = Malti 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public NL = Nederlands 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public PL = polski 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public PT = português 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public RO = română 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public SK = slovenčina 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public SL = slovenščina 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public FI = suomi 2008-05-29  
Rabigen SAG2 : EPAR - Summary for the public SV = svenska 2008-05-29  

This EPAR was last updated on 30/01/2017 .

Authorisation details

Product details

Product details for Rabigen SAG2
NameRabigen SAG2
Agency product numberEMEA/V/C/000043
Active substance

live attenuated rabies virus, SAG2 strain

International non-proprietary name (INN) or common name

live vaccine against rabies

Species Red foxes (Vulpes vulpes)Raccoon dogs (Nyctereutes procyonoides)
Anatomical therapeutic chemical veterinary (ATCvet) codes QI07AA02






Publication details

Publication details for Rabigen SAG2
Marketing-authorisation holder

Virbac S.A.

Revision8
Date of issue of marketing authorisation valid throughout the European Union06/04/2000

Contact address:

Virbac S.A.
1ère Avenue 2065 M
06516 Carros
France

Product information

Product information

21/12/2016  Rabigen SAG2 -EMEA/V/C/000043 -IG/0724

Name Language First published Last updated
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30
Rabigen SAG2 : EPAR - Product Information SV = svenska 2008-05-29 2017-01-30

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.


Name Language First published Last updated
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  
Rabigen SAG2 : EPAR - All Authorised presentations SV = svenska 2008-05-29  

Pharmacotherapeutic group

Immunologicals For canidae

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Rabigen SAG2 : EPAR - Procedural steps taken before authorisation SV = svenska 2006-07-31  
Rabigen SAG2 : EPAR - Scientific Discussion SV = svenska 2006-07-31