FDA.reportPublic FDA data

GADOPICLENOL - Food and Drug Administration

Set ID
7de6d8a6-e2ca-4b92-a0a2-a9fccba6d53a
Type
Indexing - product concept
Effective date
2023-09-05
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use Vueway ® safely and effectively. See full prescribing information for Vueway. Vueway ® (gadopiclenol) injection, for intravenous use Initial U.S. Approval: 2022Product nameBRACCO DIAGNOSTICS INC | BIPSO GmbH | Liebel-Flarsheim Company LLC | Guerbet2026-04-03
These highlights do not include all the information needed to use Vueway® safely and effectively. See full prescribing information for Vueway. Vueway® (gadopiclenol) injection, for intravenous use Initial U.S. Approval: 2022Product nameBIPSO GmbH | Guerbet2026-03-19
These highlights do not include all the information needed to use Vueway® safely and effectively. See full prescribing information for Vueway. Vueway® (gadopiclenol) injection, for intravenous use Initial U.S. Approval: 2022Product nameBRACCO DIAGNOSTICS INC | BIPSO GmbH | Liebel-Flarsheim Company LLC | Guerbet2026-03-18
These highlights do not include all the information needed to use ELUCIREM TM safely and effectively. See full prescribing information for ELUCIREM. ELUCIREM TM (gadopiclenol) injection, for intravenous use Initial U.S. Approval: 2022Product nameGuerbet LLC | Liebel-Flarsheim Company LLC | Guerbet | BIPSO GmbH2026-02-22
These highlights do not include all the information needed to use ELUCIREM TM safely and effectively. See full prescribing information for ELUCIREM. ELUCIREM TM (gadopiclenol) injection, for intravenous use Initial U.S. Approval: 2022Product nameGuerbet LLC | Liebel-Flarsheim Company LLC | Guerbet | BIPSO GmbH2025-12-12
These highlights do not include all the information needed to use ELUCIREM TM safely and effectively. See full prescribing information for ELUCIREM. ELUCIREM TM (gadopiclenol) injection, for intravenous use Initial U.S. Approval: 2022Product nameGuerbet LLC | Liebel-Flarsheim Company LLC | Guerbet2025-11-18