EU/3/15/1565: Orphan designation for the treatment of hepatocellular carcinoma

2-Chloro-N6-(3-iodobenzyl)adenosine-5'-N-methyluronamide (namodenoson)


On 9 October 2015, orphan designation (EU/3/15/1565) was granted by the European Commission to PBS Regulatory Consulting Group Limited, United Kingdom, for 2-chloro-N6-(3-iodobenzyl)adenosine-5'-N-methyluronamide for the treatment of hepatocellular carcinoma.

Key facts

Active substance
2-Chloro-N6-(3-iodobenzyl)adenosine-5'-N-methyluronamide (namodenoson)
Intended use
Treatment of hepatocellular carcinoma
Orphan designation status
EU designation number
Date of designation

Propharma Group The Netherlands B.V.
Schipholweg 73
2316 ZL Leiden

Review of designation

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

Update history

August 2022The sponsorship was transferred from Southwood Research Limited, Netherlands to Propharma Group The Netherlands B.V., Netherlands in August 2022.
June 2021The sponsor's address was updated in June 2021.
March 2020The sponsorship was transferred to Southwood Research Ltd in March 2020. This medicine is now known as namodenoson. 

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:

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