United States - English - NLM (National Library of Medicine)

medi-physics, inc. dba ge healthcare - flutemetamol f-18 (unii: l49m066s0o) (flutemetamol f-18 - unii:l49m066s0o) - flutemetamol f-18 4.05 mci in 1 ml - vizamyl 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 vizamyl 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 vizamyl 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 in older people with normal cognition. vizamyl is an adjunct to other diagnostic evaluations. limitations of use: - a positive vizamyl scan does not establish a diagnosis of ad or other cognitive disorder. - safety and effe

European Union - English - EMA (European Medicines Agency)

ge healthcare as - flutemetamol (18f) - radionuclide imaging; alzheimer disease - diagnostic radiopharmaceuticals - this medicinal product is for diagnostic use only.vizamyl is a radiopharmaceutical medicinal product indicated for positron emission tomography (pet) imaging of β amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for alzheimer’s disease (ad) and other causes of cognitive impairment. vizamyl should be used in conjunction with a clinical evaluation.a negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of ad.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - flutemetamol [18f] - injection, solution (radiopharmaceutical) - flutemetamol [18f] 150 mbq/ml at reference time