FDA.reportPublic FDA data

.ALPHA.1-PROTEINASE INHIBITOR HUMAN Pharmacologic Class Indexing

Class set ID
d8a9282a-e7a8-48c5-b969-cd8fce7dc5cf
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 GLASSIA safely and effectively. See full prescribing information for GLASSIA. GLASSIA ® (Alpha 1 -Proteinase Inhibitor (Human)) Injection, For Intravenous Use Initial U.S. Approval: 2010Takeda Pharmaceuticals America, Inc. | Baxalta Belgium Manufacturing SA | BAXALTA US INC. | SGS Lab Simon | Takeda Manufacturing Austria AG2025120231
These highlights do not include all the information needed to use ARALAST NP safely and effectively. See full prescribing information for ARALAST NP. ARALAST ® NP (Alpha 1 -Proteinase Inhibitor (Human)) For Intravenous Use. Lyophilized Powder for Solution for Injection Initial U.S. Approval: 2002Takeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbH2025112520
31a53b86-857b-a2d9-e063-6394a90abfb8Fisher Clinical Services Inc. | Fisher Clinical Services202503311
These highlights do not include all the information needed to use ZEMAIRA safely and effectively. See full prescribing information for ZEMAIRA. ZEMAIRA ® (alpha 1 -proteinase inhibitor (human)) lyophilized powder for reconstitution for intravenous use Initial U.S. Approval: 2003CSL Behring LLC2024092327
These highlights do not include all the information needed to use PROLASTIN-C LIQUID safely and effectively. See full prescribing information for PROLASTIN-C LIQUID. PROLASTIN-C LIQUID (Alpha 1 -Proteinase Inhibitor [Human]) Solution for Intravenous Injection Initial U.S. Approval: 1987GRIFOLS USA, LLC | Grifols Therapeutics LLC | Instituto Grifols SA | GRIFOLS WORLDWIDE OPERATIONS LIMITED2022070514
These highlights do not include all the information needed to use PROLASTIN ® -C safely and effectively. See full prescribing information for PROLASTIN-C. PROLASTIN ® -C (Alpha 1 -Proteinase Inhibitor [Human]) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 1987GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA2022022525