title: Florbetapir (18F) for brain amyloid positron emission tomography: highlights on the European marketing approval.
abstract: Florbetapir (18F) for brain amyloid positron emission tomography (PET) imaging has been recently approved in Europe to estimate β-amyloid neuritic plaque density in the brain when the subject is still alive. Such density is one of the key issues for the definitive diagnosis of Alzheimer's disease (AD) at autopsy. This capability of florbetapir (18F) is regarded as a significant improvement in the diagnostic procedures for adult patients with cognitive impairment who are being evaluated for AD and other causes of cognitive impairment. The current paper highlights the specific characteristics of the European marketing authorization of florbetapir (18F).
authors.affiliation: Pharmacology and Clinical Evaluation Division, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain. Electronic address: acortesb_autonomo@aemps.es.
authors.forename: Anabel
authors.initials: A
authors.lastname: Cortes-Blanco
authors.affiliation: Pharmacology and Clinical Evaluation Division, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
authors.forename: Concha
authors.initials: C
authors.lastname: Prieto-Yerro
authors.affiliation: Nuclear Medicine Department, idcsalud Hospital Albacete, Albacete, Spain.
authors.forename: Raul
authors.initials: R
authors.lastname: Martinez-Lazaro
authors.affiliation: Clinical Biostatistics Department, Hospital Ramón y Cajal, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Zamora
authors.affiliation: Neurology Department, Hospital Ruber Internacional, Madrid, Spain.
authors.forename: Adolfo
authors.initials: A
authors.lastname: Jiménez-Huete
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.
authors.forename: Marion
authors.initials: M
authors.lastname: Haberkamp
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Pohly
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.
authors.forename: Harald
authors.initials: H
authors.lastname: Enzmann
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Zinserling
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.
authors.forename: Valerie
authors.initials: V
authors.lastname: Strassmann
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.
authors.forename: Karl
authors.initials: K
authors.lastname: Broich
mesh_terms: D000544:Alzheimer Disease / Q000175:diagnosis / Q000000981:diagnostic imaging; D000814:Aniline Compounds / Q000009:adverse effects; D001921:Brain / Q000000981:diagnostic imaging*; D003072:Cognition Disorders / Q000175:diagnosis / Q000000981:diagnostic imaging; D017277:Drug Approval; D005026:Ethylene Glycols / Q000009:adverse effects; D005060:Europe; D005462:Fluorine Radioisotopes / Q000009:adverse effects; D006801:Humans; D058225:Plaque, Amyloid / Q000000981:diagnostic imaging*; D049268:Positron-Emission Tomography / Q000009:adverse effects / Q000379:methods*; D019275:Radiopharmaceuticals / Q000009:adverse effects; D012306:Risk; D012680:Sensitivity and Specificity
chemical_list: D000814:Aniline Compounds; D005026:Ethylene Glycols; D005462:Fluorine Radioisotopes; D019275:Radiopharmaceuticals; C545186:florbetapir
keywords: Brain; European Medicines Agency; Florbetapir ((18)F); Marketing approval; Positron emission tomography; β-Amyloid