EU/3/15/1484: Orphan designation for the treatment of cystic fibrosis

Nitric oxide


On 24 April 2015, orphan designation (EU/3/15/1484) was granted by the European Commission to Biological Consulting Europe Ltd, United Kingdom, for nitric oxide for the treatment of cystic fibrosis.

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in March 2019 on request of the Sponsor.

Key facts

Active substance
Nitric oxide
Intended use
Treatment of cystic fibrosis
Orphan designation status
EU designation number
Date of designation
Biological Consulting Europe Ltd
15 Station Road, Unit 1
St Monans
Fife KY10 2BL
United Kingdom
Tel. +44 (0)1333 730 170

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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