About
This is a summary of the European Public Assessment Report. 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 Duvaxyn WNV?
Duvaxyn WNV is a vaccine containing an inactivated West Nile virus (inactivated means that the virus has been killed so that it cannot cause the disease any more).
- What is Duvaxyn WNV used for?
Duvaxyn WNV is a vaccine used in horses to protect against West Nile virus disease. The vaccine reduces the number of viraemic horses (these are horses with virus circulating in their blood stream). The vaccine is injected intramuscularly (into a muscle) in the neck of the horse.
- How does Duvaxyn WNV work?
Duvaxyn WNV is a vaccine. When it is given to horses, the animal’s immune system (their natural defence mechanism) learns how to make antibodies (a special type of protein) to fight the disease. In the future, if the horses are exposed to the West Nile virus, the immune system will be able to make those antibodies quicker and this will help them fight the disease.
- How has Duvaxyn WNV been studied?
The company carried out laboratory safety studies in both young foals (6 months of age) and pregnant mares using the vaccine. These showed the safety of the use of the vaccine in horses in general and in young (6 months of age or older) and pregnant animals in particular. They then performed a number of field trials which further confirmed the safety of Duvaxyn WNV and proved its efficacy in reducing the number of viraemic horses and thereby protecting against the disease.
- What benefit has Duvaxyn WNV shown during the studies?
- The results of the safety studies indicated that the product is safe for horses.
- The vaccine has been shown to protect animals from the disease through a reduction of the number of viraemic horses.
- What is the risk associated with Duvaxyn WNV?
A small number of animals may show temporary local reactions, in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter), that resolve by themselves within 1 to 2 days. It is sometimes associated with pain and mild depression. In some cases a higher temperature may occur for up to 2 days.
- What are the precautions for the person who gives the medicine or comes into contact with the animal?
In case of accidental self-injection, ingestion or spillage onto skin, seek medical advice immediately and show the package leaflet or label to the physician.
- What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Zero days.
- What is the time to allow before milk can be taken from the animal for human consumption?
Zero days.
- Why has Duvaxyn WNV been approved?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Duvaxyn WNV outweigh the risks for the treatment of West Nile virus disease in horses and recommended that Duvaxyn WNV be given a marketing authorisation.
The benefit-risk balance can be found in module 6 of this EPAR.
- Other information about Duvaxyn WNV
The European Commission granted a marketing authorisation valid throughout the European Union, for Duvaxyn WNV to MAH on 21.11.2008. Information on the prescription status of this product may be found on the label/outer package.
| Name | Language | First published | Last updated |
|---|---|---|---|
| Duvaxyn WNV : EPAR - Summary for the public | 02/12/2008 |
This EPAR was last updated on 17/02/2011 .
More detail is available in the Summary of Product Characteristics
Authorisation details
Product information
Product information
13/01/2011 Duvaxyn WNV -EMEA/V/C/000137 -T/0004
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.
Pharmaco-therapeutic Group
Immunologicals For equidae
Therapeutic Indication
For the active immunisation of horses of 6 months of age or older against West Nile Virus disease by reducing the number of viraemic horses.
Assessment History
Changes since initial authorisation of medicine
| Name | Language | First published | Last updated |
|---|---|---|---|
| Duvaxyn WNV : EPAR - Procedural steps taken and scientific information after authorisation | EN = English | 24/09/2009 | 17/02/2011 |
Initial Marketing authorisation documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| Duvaxyn WNV : EPAR - Scientific Discussion | EN = English | 19/11/2008 | |
| Duvaxyn WNV : EPAR - Procedural steps taken before authorisation | EN = English | 30/11/2008 |
Authorised
This medicine is approved for use in the European Union