Ixiaro

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Japanese-encephalitis vaccine (inactivated, adsorbed)

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

Overview

This is a summary of the European public assessment report (EPAR) for Ixiaro. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ixiaro.

This EPAR was last updated on 11/01/2018

Authorisation details

Product details
Name
Ixiaro
Agency product number
EMEA/H/C/000963
Active substance
Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells)
International non-proprietary name (INN) or common name
Japanese-encephalitis vaccine (inactivated, adsorbed)
Therapeutic area (MeSH)
  • Encephalitis, Japanese
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07BA02
Publication details
Marketing-authorisation holder
Valneva Austria GmbH
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
31/03/2009
Contact address
Campus Vienna Biocenter 6
A-1030 Vienna
Austria

Product information

08/01/2018 Ixiaro - EMEA/H/C/000963 - PSUSA/00001801/201703

Contents

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

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Ixiaro is indicated for active immunisation against Japanese encephalitis in adults, adolescents, children and infants aged two months and older.

Ixiaro should be considered for use in individuals at risk of exposure through travel or in the course of their occupation.

Assessment history

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