EU/3/11/890: Orphan designation for the treatment of hepatocellular carcinoma



On 5 August 2011, orphan designation (EU/3/11/890) was granted by the European Commission to Kowa Pharmaceutical Europe Co. Ltd, United Kingdom, for peretinoin for the treatment of hepatocellular carcinoma.

The sponsorship was transferred to Kowa Pharmaceutical Europe GmbH, Germany, in July 2018.

Key facts

Active substance
Intended use
Treatment of hepatocellular carcinoma
Orphan designation status
EU designation number
Date of designation
Kowa Pharmaceutical Europe GmbH
Görreshof 151
53347 Alfter
Tel. +49 2287 1002776

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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