Imlygic
These highlights do not include all the information needed to use IMLYGIC safely and effectively. See full prescribing information for IMLYGIC . I MLYGIC ( talimogene laherparepvec ) Suspension for intralesional injection Initial U.S. Approval: 2015
Approved
Approval ID
64ffb680-ea8c-42fc-9649-9e8c0eb77ddb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 10, 2023
Manufacturers
FDA
Amgen Inc
DUNS: 039976196
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
talimogene laherparepvec
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-079
Application NumberBLA125518
Product Classification
M
Marketing Category
C73585
G
Generic Name
talimogene laherparepvec
Product Specifications
Route of AdministrationINTRALESIONAL
Effective DateFebruary 10, 2023
FDA Product Classification
INGREDIENTS (7)
TALIMOGENE LAHERPAREPVECActive
Quantity: 100000000 [PFU] in 1 mL
Code: 07730V90L6
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 15.4 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Quantity: 2.44 mg in 1 mL
Code: 5QWK665956
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SORBITOLInactive
Quantity: 20 mg in 1 mL
Code: 506T60A25R
Classification: IACT
INOSITOLInactive
Quantity: 40 mg in 1 mL
Code: 4L6452S749
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
talimogene laherparepvec
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-078
Application NumberBLA125518
Product Classification
M
Marketing Category
C73585
G
Generic Name
talimogene laherparepvec
Product Specifications
Route of AdministrationINTRALESIONAL
Effective DateFebruary 10, 2023
FDA Product Classification
INGREDIENTS (7)
TALIMOGENE LAHERPAREPVECActive
Quantity: 1000000 [PFU] in 1 mL
Code: 07730V90L6
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 15.4 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Quantity: 2.44 mg in 1 mL
Code: 5QWK665956
Classification: IACT
INOSITOLInactive
Quantity: 40 mg in 1 mL
Code: 4L6452S749
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Quantity: 20 mg in 1 mL
Code: 506T60A25R
Classification: IACT