FDA.reportPublic FDA data

HUMAN C1-ESTERASE INHIBITOR Pharmacologic Class Indexing

Class set ID
cca45f8a-ceb0-45af-bbed-8d969a837664
Version
2
Effective date
20180813
Type
Indexing - Pharmacologic Class

Mapped DailyMed Labels#

Label, Manufacturer, Effective table
LabelManufacturerEffectiveSPL version
These highlights do not include all the information needed to use CINRYZE ® safely and effectively. See full prescribing information for CINRYZE. CINRYZE (C1 esterase inhibitor [human]) for intravenous use, freeze-dried powder for reconstitution Initial U.S. Approval: 2008.Takeda Pharmaceuticals America, Inc. | Takeda Manufacturing Italia SPA | BAXALTA US INC. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbH | Prothya Biosolutions Belgium | Prothya Biosolutions Netherlands B.V.2025112842
These highlights do not include all the information needed to use HAEGARDA safely and effectively. See full prescribing information for HAEGARDA. HAEGARDA ® (C1 Esterase Inhibitor Subcutaneous [Human]) For Subcutaneous Injection, Freeze-Dried Powder for Reconstitution Initial U.S. Approval: 2017CSL Behring GmbH202202048
These highlights do not include all the information needed to use BERINERT safely and effectively. See full prescribing information for BERINERT. BERINERT [C1 Esterase Inhibitor (Human)] For intravenous use. Freeze-Dried Powder for Reconstitution. Initial U.S. Approval: 2009CSL Behring GmbH2021092133