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).
| Product ID | 42515-001_2b9ca64f-f730-4365-8e73-ff2ce802be4f |
| NDC | 42515-001 |
| Product Type | Vaccine |
| Proprietary Name | IXIARO |
| Generic Name | Japanese Encephalitis Vaccine, Inactivated, Adsorbed |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2009-03-30 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125280 |
| Labeler Name | Valneva Scotland Ltd. |
| Substance Name | JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) |
| Active Ingredient Strength | 6 ug/.5mL |
| Pharm Classes | Inactivated Japanese Encephalitis Virus Vaccine [EPC],Actively Acquired Immunity [PE],Japanese Encephalitis Vaccines [CS],Vaccines, Inactivated [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 2009-03-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA125280 |
| Product Type | VACCINE |
| Marketing Start Date | 2009-03-30 |
| Marketing End Date | 2015-03-03 |
| Marketing Category | BLA |
| Application Number | BLA125280 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2009-03-30 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) | 6 ug/.5mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 42515-001 | IXIARO | Japanese Encephalitis Vaccine, Inactivated, Adsorbed |
| 42515-002 | IXIARO | Japanese Encephalitis Vaccine, Inactivated, Adsorbed |
| 62195-051 | Ixiaro | Japanese Encephalitis Vaccine, Inactivated, Adsorbed |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IXIARO 79065162 3658393 Live/Registered |
Valneva Austria GmbH 2008-12-29 |
![]() IXIARO 78798170 3168727 Live/Registered |
VALNEVA AUSTRIA GMBH 2006-01-24 |
![]() IXIARO 78144167 2775583 Live/Registered |
VALNEVA AUSTRIA GMBH 2002-07-16 |
![]() IXIARO 77661317 3660894 Live/Registered |
VALNEVA AUSTRIA GMBH 2009-02-02 |