Lamzede
These highlights do not include all the information needed to use LAMZEDE safely and effectively. See full prescribing information for LAMZEDE . LAMZEDE ( velmanase alfa - tycv ) for injection , for intravenous use Initial U.S. Approval: 2023
Approved
Approval ID
36d50a08-60bd-40eb-807c-778d69bf2d2e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 21, 2023
Manufacturers
FDA
Chiesi USA, Inc.
DUNS: 088084228
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Velmanase alfa-tycv
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10122-180
Application NumberBLA761278
Product Classification
M
Marketing Category
C73585
G
Generic Name
Velmanase alfa-tycv
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 27, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Quantity: 2.47 mg in 1 1
Code: GR686LBA74
Classification: IACT
GLYCINEInactive
Quantity: 10.1 mg in 1 1
Code: TE7660XO1C
Classification: IACT
MANNITOLInactive
Quantity: 227.5 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Quantity: 0.088 mg in 1 1
Code: 3980JIH2SW
Classification: IACT
VELMANASE ALFA-TYCVActive
Quantity: 10 mg in 1 1
Code: M91TG242P2
Classification: ACTIB
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 2/21/2023
WARNING: SEVERE HYPERSENSITIVITY REACTIONS
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 2/21/2023
4****CONTRAINDICATIONS
None.
Key Highlight
None. (4)