Amyvid

Product manufactured by Eli Lilly And Company

Application Nr Approved Date Route Status External Links
NDA202008 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Amyvid Is Indicated For Positron Emission Tomography (Pet) Imaging Of The Brain To Estimate Β-Amyloid Neuritic Plaque Density In Adult Patients With Cognitive Impairment Who Are Being Evaluated For Alzheimer's Disease (Ad) And Other Causes Of Cognitive Decline. A Negative Amyvid Scan Indicates Sparse To No Neuritic Plaques And Is Inconsistent With A Neuropathological Diagnosis Of Ad At The Time Of Image Acquisition; A Negative Scan Result Reduces The Likelihood That A Patient's Cognitive Impairment Is Due To Ad. A Positive Amyvid Scan Indicates Moderate To Frequent Amyloid Neuritic Plaques; Neuropathological Examination Has Shown This Amount Of Amyloid Neuritic Plaque Is Present In Patients With Ad, But May Also Be Present In Patients With Other Types Of Neurologic Conditions As Well As Older People With Normal Cognition. Amyvid Is An Adjunct To Other Diagnostic Evaluations. Amyvid Is A Radioactive Diagnostic Agent For Positron Emission Tomography (Pet) Imaging Of The Brain To Estimate Β-Amyloid Neuritic Plaque Density In Adult Patients With Cognitive Impairment Who Are Being Evaluated For Alzheimer's Disease (Ad) And Other Causes Of Cognitive Decline. A Negative Amyvid Scan Indicates Sparse To No Neuritic Plaques, And Is Inconsistent With A Neuropathological Diagnosis Of Ad At The Time Of Image Acquisition; A Negative Scan Result Reduces The Likelihood That A Patient's Cognitive Impairment Is Due To Ad. A Positive Amyvid Scan Indicates Moderate To Frequent Amyloid Neuritic Plaques; Neuropathological Examination Has Shown This Amount Of Amyloid Neuritic Plaque Is Present In Patients With Ad, But May Also Be Present In Patients With Other Types Of Neurologic Conditions As Well As Older People With Normal Cognition. Amyvid Is An Adjunct To Other Diagnostic Evaluations ( 1 ). Limitations Of Use A Positive Amyvid Scan Does Not Establish A Diagnosis Of Ad Or Other Cognitive Disorder ( 1 ). Safety And Effectiveness Of Amyvid Have Not Been Established For: Predicting Development Of Dementia Or Other Neurologic Condition; Monitoring Responses To Therapies ( 1 ). Limitations Of Use: A Positive Amyvid Scan Does Not Establish A Diagnosis Of Ad Or Other Cognitive Disorder. Safety And Effectiveness Of Amyvid Have Not Been Established For: Predicting Development Of Dementia Or Other Neurologic Condition; Monitoring Responses To Therapies.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Florbetapir F-18

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