On 29 July 2014, orphan designation (EU/3/14/1299) was granted by the European Commission to Bayer Pharma AG, Germany, for riociguat for the treatment of systemic sclerosis.

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

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in January 2019 on request of the Sponsor.

Key facts

Active substance
Disease / condition
Treatment of systemic sclerosis
Date of first decision
EU designation number

Review of designation


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

Sponsor's contact details

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

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.

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