EU/3/06/364

Table of contents

About

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in November 2017 at the end of the 10-year period of market exclusivity.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 tosylate
Medicine name
Nexavar
Disease / condition
Treatment of hepatocellular carcinoma
Date of decision
11/04/2006
Outcome
Expired
Orphan decision number
EU/3/06/364

Sponsor's contact details

Bayer AG
51368 Leverkusen
Germany
Tel. +49 30 300 139 003
E-mail: clinical-trials-contact@bayer.com

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.

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