VIMIZIM
These highlights do not include all the information needed to use VIMIZIM safely and effectively. See full prescribing information for VIMIZIM .
Approved
Approval ID
0caa2565-12b2-0ad0-1f9a-273e81c3d4cc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 21, 2021
Manufacturers
FDA
BioMarin Pharmaceutical Inc.
DUNS: 079722386
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
elosulfase alfa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68135-100
Application NumberBLA125460
Product Classification
M
Marketing Category
C73585
G
Generic Name
elosulfase alfa
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 21, 2021
FDA Product Classification
INGREDIENTS (1)
ELOSULFASE ALFAActive
Quantity: 5 mg in 5 mL
Code: ODJ69JZG85
Classification: ACTIB