GIVLAARI
These highlights do not include all the information needed to use GIVLAARI safely and effectively. See full prescribing information for GIVLAARI. GIVLAARI (givosiran) injection, for subcutaneous use Initial U.S. Approval: 2019
Approved
Approval ID
167e663c-11e1-497b-a3fc-951d65d58eaa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2023
Manufacturers
FDA
Alnylam Pharmaceuticals, Inc.
DUNS: 115524410
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
givosiran sodium
PRODUCT DETAILS
NDC Product Code71336-1001
Application NumberNDA212194
Marketing CategoryC73594
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 16, 2023
Generic Namegivosiran sodium
INGREDIENTS (2)
givosiran sodiumActive
Quantity: 189 mg in 1 mL
Code: 5XE21E41RT
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT