Brineura
These highlights do not include all the information needed to use BRINEURA safely and effectively. See full prescribing information for BRINEURA. BRINEURA (cerliponase alfa) injection, for intraventricular use Initial U.S. Approval: 2017
Approved
Approval ID
485ab3c5-0359-4878-872f-2fe1e7df4047
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 2, 2020
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.
cerliponase alfa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68135-811
Application NumberBLA761052
Product Classification
M
Marketing Category
C73585
G
Generic Name
cerliponase alfa
Product Specifications
Effective DateJuly 2, 2020
FDA Product Classification