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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Japanese encephalitis vaccine, inactivated, adsorbed
Trade Name: IXIARO
Date Designated: 09/25/2012
Orphan Designation: Prevention of Japanese encephalitis virus in pediatric patients.
Orphan Designation Status: Designated/Approved
Intercell AG
Campus Vienna Biocenter 3
A-1030
Vienna
Austria

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Japanese encephalitis vaccine, inactivated, adsorbed
Trade Name: IXIARO
Marketing Approval Date: 05/17/2013
Approved Labeled Indication: IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus (JEV). IXIARO is approved for use in individuals 2 months of age and older.
Exclusivity End Date: 05/17/2020 
Exclusivity Protected Indication* :  To extend the age range to include infants, children, and adolescents 2 months to less than 17 years of age for active immunization for the prevention of disease caused by Japanese encephalitis virus.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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