EU/3/12/967: Orphan designation for the treatment of pulmonary arterial hypertension

Sodium nitrite


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
Intended use
Treatment of pulmonary arterial hypertension
Orphan designation status
EU designation number
Date of designation
FGK Representative Services GmbH
Heimeranstrasse 35
80339 Munich
Telephone: +49 89 893 119 22
Telefax: +49 89 893 118 20

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:

  • 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.

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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