EU/3/20/2268: Orphan designation for the diagnosis of AL amyloidosis

florbetaben (18F)


On 22 April 2020, orphan designation EU/3/20/2268 was granted by the European Commission to Life Molecular Imaging GmbH, Germany, for florbetaben (18F) for the diagnosis of AL amyloidosis.

Key facts

Active substance
florbetaben (18F)
Intended use
Diagnosis of AL amyloidosis
Orphan designation status
EU designation number
Date of designation

Life Molecular Imaging GmbH
Tegeler Strasse 6-7
13353 Berlin
Tel: +49 30 461 124 604

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

How useful was this page?

Add your rating