Licensed vaccine
Ixiaro
FDA-licensed vaccine · Valneva Austria GmbH · STN BL 125280
Key facts
| Trade name | Ixiaro |
|---|---|
| Proper name | Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed |
| Manufacturer | Valneva Austria GmbH |
| Submission tracking number (STN) | BL 125280 |
| Recent FDA documents | October 4, 2018 Approval Letter - IXIARO, October 2, 2018 Summary Basis of Regulatory Action - IXIARO, April 12, 2018 Summary Basis of Regulatory Action - IXIARO, April 13, 2018 Approval Letter - IXIARO, Statistical Review - IXIARO, Clinical Review -IXIARO, Toxicology Review - IXIARO, Approval History, Letters, Reviews, and Related Documents - Ixiaro, Package Insert and Patient Information - IXIARO, Supporting Documents older than three years - IXIARO |
| FDA page updated | Nov 15, 2019 |
| FDA product page | fda.gov |
At a glance
- 1–9 FDA approval letters
- 1–9 Supporting documents
- 1–9 Product information documents
- Yes Document full text searchable in Orca1
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-licensed vaccines
The FDA's CBER licenses vaccines for use in the United States. Each product page links the approval letters, package inserts and supporting documents for that vaccine.
Source: U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Vaccines Licensed for Use in the United States · Source date: