Rabitec

attenuated live rabies vaccine virus, strain SPBN GASGAS

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This is a summary of the European public assessment report (EPAR) for Rabitec. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Rabitec.

What is Rabitec and what is it used for?

Rabitec is a veterinary vaccine used to protect wild foxes and raccoon dogs against rabies. Rabies is a life threatening viral disease that causes inflammation in the brain. It presents a risk for people since it can be transmitted by bites or saliva from an infected animal. Rabitec contains a modified live rabies virus which has been weakened so that it does not cause disease.

How is Rabitec used?

Rabitec is available as a liquid (suspension) contained in a bait pellet scented with fish meal to be chewed. It can only be obtained with a prescription.

The baits are distributed by land or air and the vaccination area should be larger than 5,000 km2. The number of baits distributed depends on the density of the fox and raccoon dog population and the nature of the vaccination area. Vaccination campaigns are conducted normally twice a year in spring and autumn for consecutive years, until at least 2 years after the last confirmed case of rabies in the area. To protect rabies free areas, vaccination may also be carried out at the border of these areas (vaccination belts) or in the form of spot vaccinations. Protection lasts at least 6 months after vaccination.

How does Rabitec work?

Rabitec is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Rabitec contains a weakened rabies virus that does not cause the disease. When a fox or raccoon dog chews a bait and the vaccine is released in the animal’s mouth, the immune system recognises the virus as ‘foreign’ and makes defences against it. In the future, if animals are exposed to the rabies virus, the immune system will be able to respond more quickly, which will help to protect against the disease.

What benefits of Rabitec have been shown in studies?

Laboratory studies showed that around 90% of foxes and raccoon dogs produce antibodies against the rabies virus within 15 days of eating the bait. The protection against the virus lasts at least 6 months.

What are the risks associated with Rabitec?

There are no known side effects. For the full list of restrictions, see the package leaflet.

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

Safety information has been included in the summary of product characteristics and the package leaflet for Rabitec, including the appropriate precautions to be followed by healthcare professionals and people who handle the product or come into contact with it.

Appropriate measures should be taken to prevent contamination such as wearing protective clothes and disposable rubber gloves, since the vaccine has been prepared with modified live virus. The baits should be handled with care. In case of skin or eye contact with the vaccine fluid the affected area should be rinsed immediately with water. Medical advice should be sought immediately and the package leaflet or label shown to the doctor, who should follow WHO recommendations for rabies exposure.

Why is Rabitec approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Rabitec’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Rabitec?

The European Commission granted a marketing authorisation valid throughout the EU for Rabitec on 1 December 2017.

The full EPAR for Rabitec can be found on the Agency’s website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. For more information about treatment with Rabitec, read the package leaflet.

This summary was last updated in October 2017.

Name Language First published Last updated
Rabitec : EPAR - Summary for the public BG = bălgarski 2017-12-18  
Rabitec : EPAR - Summary for the public ES = español 2017-12-18  
Rabitec : EPAR - Summary for the public CS = čeština 2017-12-18  
Rabitec : EPAR - Summary for the public DA = dansk 2017-12-18  
Rabitec : EPAR - Summary for the public DE = Deutsch 2017-12-18  
Rabitec : EPAR - Summary for the public ET = eesti keel 2017-12-18  
Rabitec : EPAR - Summary for the public EL = elliniká 2017-12-18  
Rabitec : EPAR - Summary for the public EN = English 2017-12-18  
Rabitec : EPAR - Summary for the public FR = français 2017-12-18  
Rabitec : EPAR - Summary for the public IT = italiano 2017-12-18  
Rabitec : EPAR - Summary for the public LV = latviešu valoda 2017-12-18  
Rabitec : EPAR - Summary for the public LT = lietuvių kalba 2017-12-18  
Rabitec : EPAR - Summary for the public HU = magyar 2017-12-18  
Rabitec : EPAR - Summary for the public MT = Malti 2017-12-18  
Rabitec : EPAR - Summary for the public NL = Nederlands 2017-12-18  
Rabitec : EPAR - Summary for the public PL = polski 2017-12-18  
Rabitec : EPAR - Summary for the public PT = português 2017-12-18  
Rabitec : EPAR - Summary for the public RO = română 2017-12-18  
Rabitec : EPAR - Summary for the public SK = slovenčina 2017-12-18  
Rabitec : EPAR - Summary for the public SL = slovenščina 2017-12-18  
Rabitec : EPAR - Summary for the public FI = suomi 2017-12-18  
Rabitec : EPAR - Summary for the public SV = svenska 2017-12-18  
Rabitec : EPAR - Summary for the public HR = Hrvatski 2017-12-18  

This EPAR was last updated on 18/12/2017 .

Authorisation details

Product details

Product details for Rabitec
NameRabitec
Agency product numberEMEA/V/C/004387
Active substance

attenuated live rabies vaccine virus, strain SPBN GASGAS

International non-proprietary name (INN) or common name

Rabies vaccine (live, oral) for foxes and raccoon dogs

Species Red foxes (Vulpes vulpes)Raccoon dogs (Nyctereutes procyonoides)
Anatomical therapeutic chemical veterinary (ATCvet) codes QI07BD


Publication details

Publication details for Rabitec
Marketing-authorisation holder

IDTBiologika GmbH

Revision0
Date of issue of marketing authorisation valid throughout the European Union01/12/2017

Contact address:

IDTBiologika GmbH
Am Pharmapark
06861 Dessau-Rosslau
Germany

Product information

Product information

01/12/2017  Rabitec -EMEA/V/C/004387

Name Language First published Last updated
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  
Rabitec : EPAR - Product Information HR = Hrvatski 2017-12-18  

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
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  
Rabitec : EPAR - All Authorised presentations HR = Hrvatski 2017-12-18  

Pharmacotherapeutic group

Immunologicals for canidae, live viral vaccines

Therapeutic indication

For the active immunisation of foxes and raccoon dogs against rabies to prevent infection and mortality.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Rabitec : EPAR - Public assessment report HR = Hrvatski 2017-12-18  
CVMP summary of positive opinion for Rabitec HR = Hrvatski 2017-10-06  

Authorised

This medicine is approved for use in the European Union