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NDC 42515-0002-01 IXIARO 6 [arb'U]/.5mL Details
IXIARO 6 [arb'U]/.5mL
IXIARO is a INTRAMUSCULAR INJECTION, SUSPENSION in the VACCINE category. It is labeled and distributed by Valneva Scotland Ltd.. The primary component is JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED).
MedlinePlus Drug Summary
What is Japanese encephalitis? Japanese encephalitis (JE) is a serious infection caused by the Japanese encephalitis virus. It occurs mainly in rural parts of Asia. It is spread through the bite of an infected mosquito. It does not spread from person to person. Risk is very low for most travelers. It is higher for people living in areas where the disease is common, or for people traveling there for long periods of time. Most people infected with JE virus don't have any symptoms. Others might have symptoms as mild as a fever and headache, or as serious as encephalitis (brain infection). A person with encephalitis can experience fever, neck stiffness, seizures, and coma. About 1 person in 4 with encephalitis dies. Up to half of those who don't die have permanent disability. It is believed that infection in a pregnant woman could harm her unborn baby. JE vaccine can help protect travelers from JE disease.
Related Packages: 42515-0002-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Japanese Encephalitis Vaccine
Product Information
| NDC | 42515-0002 |
|---|---|
| Product ID | 42515-002_f3d13c93-5fce-43db-b25f-8e1c8cd1dfb8 |
| Associated GPIs | 17100025101800 |
| GCN Sequence Number | 064877 |
| GCN Sequence Number Description | Japanese encephalitis vacc/PF SYRINGE 6MCG/0.5ML INTRAMUSC |
| HIC3 | W7J |
| HIC3 Description | NEUROTOXIC VIRUS VACCINES |
| GCN | 16955 |
| HICL Sequence Number | 036478 |
| HICL Sequence Number Description | JAPANESE ENCEPHALITIS VACCINE/PF |
| Brand/Generic | Brand |
| Proprietary Name | IXIARO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Japanese Encephalitis Vaccine, Inactivated, Adsorbed |
| Product Type | VACCINE |
| Dosage Form | INJECTION, SUSPENSION |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 6 |
| Active Ingredient Units | [arb'U]/.5mL |
| Substance Name | JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) |
| Labeler Name | Valneva Scotland Ltd. |
| Pharmaceutical Class | Actively Acquired Immunity [PE], Inactivated Japanese Encephalitis Virus Vaccine [EPC], Japanese Encephalitis Vaccines [CS], Vaccines, Inactivated [CS] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125280 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42515-0002-01 (42515000201)
| NDC Package Code | 42515-002-01 |
|---|---|
| Billing NDC | 42515000201 |
| Package | .5 mL in 1 SYRINGE (42515-002-01) |
| Marketing Start Date | 2009-03-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |