🇪🇺 F-18 florbetapir in European Union

EMA authorised F-18 florbetapir on 14 January 2013

Marketing authorisation

EMA — authorised 14 January 2013

  • Application: EMEA/H/C/002422
  • Marketing authorisation holder: Eli Lilly Nederland B.V.
  • Local brand name: Amyvid
  • Indication: This medicinal product is for diagnostic use only. Amyvid is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of ?-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. Amyvid 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.
  • Status: approved

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F-18 florbetapir in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is F-18 florbetapir approved in European Union?

Yes. EMA authorised it on 14 January 2013.

Who is the marketing authorisation holder for F-18 florbetapir in European Union?

Eli Lilly Nederland B.V. holds the EU marketing authorisation.