EU/3/04/207: Orphan designation for the treatment of renal-cell carcinoma

Sorafenib tosilate

Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in July 2016 at the end of the period of market exclusivity.

On 29 July 2004, orphan designation (EU/3/04/207) was granted by the European Commission to Bayer Healthcare AG, Germany, for sorafenib tosylate for the treatment of renal cell 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.

Update: sorafenib tosylate for treatment of renal cell carcinoma has been authorised in the EU as Nexavar since 19 July 2006.

Key facts

Active substance
Sorafenib tosilate
Medicine name
Intended use
Treatment of renal-cell carcinoma
Orphan designation status
EU designation number
Date of designation
Bayer Pharma AG
13342 Berlin
Tel. +49 2143 051348
Fax +49 2143 051603

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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