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Vaccines, Blood & Biologics
Ixiaro
Proper Name: Japanese Encephalitis Vaccine, Inactivated, Adsorbed
Tradename: IXIARO
Manufacturer: Intercell Biomedical, License # 1790
STN: 125280/0
Approval Date: March 30, 2009
Indication:
- For the prevention of disease caused by Japanese encephalitis virus in persons 17 years of age and older.
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Product Information
- Package Insert (Military) (PDF - 389KB)
Updated: October 2009 - Package Insert (Commercial) (PDF - 191KB)
Updated: January 2009
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Supporting Documents
- October 23, 2009 Approval Letter - Ixario
Revisions to the military version of the package insert. - March 30, 2009 Approval Letter
Indication: For the prevention of disease caused by Japanese encephalitis virus in persons 17 years of age and older. - FDA Approves New Vaccine to Prevent Japanese Encephalitis
Press Release: March 30, 2009 - Ixiaro - Summary Basis for Regulatory Action
- Approval History, Letters, Reviews, and Related Documents - Ixiaro
Intercell Biomedical
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Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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