EU/3/06/364: Orphan designation for the treatment of hepatocellular carcinoma

Sorafenib tosilate

Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in November 2017 at the end of the 10-year period of market exclusivity.

On 11 April 2006, orphan designation (EU/3/06/364) was granted by the European Commission to Bayer HealthCare AG, Germany, for sorafenib tosylate for the treatment of hepatocellular carcinoma.

The sponsorship was transferred to Bayer Shering Pharma AG, Germany, in April 2009. Bayer Shering Pharma AG changed its name to Bayer Pharma AG in October 2011.

The sponsorship was transferred to Bayer AG, Germany, in August 2017.

Sorafenib tosylate for the treatment of papillary thyroid cancer has been authorised in the EU as Nexavar since 29 October 2007.

Key facts

Active substance
Sorafenib tosilate
Medicine name
Intended use
Treatment of hepatocellular carcinoma
Orphan designation status
EU designation number
Date of designation

Bayer AG
51368 Leverkusen
Tel. +49 30 300 139 003

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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