NDC 42515-002

IXIARO

Japanese Encephalitis Vaccine, Inactivated, Adsorbed

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 ID42515-002_d1e52f69-cbbb-4824-b384-7e38ccf5b98f
NDC42515-002
Product TypeVaccine
Proprietary NameIXIARO
Generic NameJapanese Encephalitis Vaccine, Inactivated, Adsorbed
Dosage FormInjection, Suspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2009-03-30
Marketing CategoryBLA / BLA
Application NumberBLA125280
Labeler NameValneva Scotland Ltd.
Substance NameJAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active Ingredient Strength6 [arb'U]/.5mL
Pharm ClassesInactivated Japanese Encephalitis Virus Vaccine [EPC],Actively Acquired Immunity [PE],Japanese Encephalitis Vaccines [CS],Vaccines, Inactivated [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42515-002-01

.5 mL in 1 SYRINGE (42515-002-01)
Marketing Start Date2009-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42515-002-01 [42515000201]

Ixiaro INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125280
Product TypeVACCINE
Billing UnitML
Marketing Start Date2009-03-30

Drug Details

Active Ingredients

IngredientStrength
JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED)6 [arb'U]/.5mL

Pharmacological Class

  • Inactivated Japanese Encephalitis Virus Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Japanese Encephalitis Vaccines [CS]
  • Vaccines
  • Inactivated [CS]
  • Inactivated Japanese Encephalitis Virus Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Japanese Encephalitis Vaccines [CS]
  • Vaccines
  • Inactivated [CS]

NDC Crossover Matching brand name "IXIARO" or generic name "Japanese Encephalitis Vaccine, Inactivated, Adsorbed"

NDCBrand NameGeneric Name
42515-001IXIAROJapanese Encephalitis Vaccine, Inactivated, Adsorbed
42515-002IXIAROJapanese Encephalitis Vaccine, Inactivated, Adsorbed
62195-051IxiaroJapanese Encephalitis Vaccine, Inactivated, Adsorbed

Trademark Results [IXIARO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IXIARO
IXIARO
79065162 3658393 Live/Registered
Valneva Austria GmbH
2008-12-29
IXIARO
IXIARO
78798170 3168727 Live/Registered
VALNEVA AUSTRIA GMBH
2006-01-24
IXIARO
IXIARO
78144167 2775583 Live/Registered
VALNEVA AUSTRIA GMBH
2002-07-16
IXIARO
IXIARO
77661317 3660894 Live/Registered
VALNEVA AUSTRIA GMBH
2009-02-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.