On 5 March 2012, orphan designation (EU/3/12/967) was granted by the European Commission to FGK Representative Service GmbH, Germany, for sodium nitrite for the treatment of pulmonary arterial hypertension.

Key facts

Active substance
Sodium nitrite
Disease / condition
Treatment of pulmonary arterial hypertension
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

FGK Representative Services GmbH
Heimeranstrasse 35
80339 Munich
Telephone: +49 89 893 119 22
Telefax: +49 89 893 118 20

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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