EU/3/16/1632: Orphan designation for the diagnosis of hepatocellular carcinoma

Florilglutamic acid (18F)


On 21 March 2016, orphan designation (EU/3/16/1632) was granted by the European Commission to Piramal Imaging GmbH, Germany, for florilglutamic acid (18F) for the diagnosis of hepatocellular carcinoma.

Key facts

Active substance
Florilglutamic acid (18F)
Intended use
Diagnosis of hepatocellular carcinoma
Orphan designation status
EU designation number
Date of designation
Piramal Imaging GmbH
Tegeler Straße 6-7
13353 Berlin
Tel. +49 30 4611 24603
Fax +49 30 4611 24629

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:

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

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

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:

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