Vaccines, Blood & Biologics
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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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Supporting Documents
Summary Basis for Regulatory Action - Ixiaro
September 23, 2010October 14, 2010 Approval Letter - Ixiaro
Efficacy Supplement for Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed, Pediatric RequirementOctober 23, 2009 Approval Letter - Ixiaro
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, 2009Ixiaro - Summary Basis for Regulatory Action Approval History, Letters, Reviews, and Related Documents - Ixiaro Intercell Biomedical
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
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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