🇪🇺 [18F]Florbetaben in European Union

EMA authorised [18F]Florbetaben on 20 February 2014

Marketing authorisation

EMA — authorised 20 February 2014

  • Application: EMEA/H/C/002553
  • Marketing authorisation holder: Lantheus Germany GmbH
  • Local brand name: Neuraceq
  • Indication: This medicinal product is for diagnostic use only. Neuraceq 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. Neuraceq 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

Read official source →

[18F]Florbetaben in other countries

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

Other Neurology approved in European Union

Frequently asked questions

Is [18F]Florbetaben approved in European Union?

Yes. EMA authorised it on 20 February 2014.

Who is the marketing authorisation holder for [18F]Florbetaben in European Union?

Lantheus Germany GmbH holds the EU marketing authorisation.