EU/3/14/1299: Orphan designation for the treatment of systemic sclerosis



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Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in January 2019 on request of the Sponsor.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
Intended use
Treatment of systemic sclerosis
Orphan designation status
EU designation number
Date of designation

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

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:

  • 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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