EU/3/18/2072

About

On 26 October 2018, orphan designation (EU/3/18/2072) was granted by the European Commission to FGK Representative Service GmbH, Germany, for 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate (also known as ELX-02) for the treatment of cystic fibrosis.

Key facts

Active substance
6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate
Disease / condition
Treatment of cystic fibrosis
Date of first decision
26/10/2018
Outcome
Positive
EU designation number
EU/3/18/2072

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 Service GmbH
Heimeranstrasse 35
80339 Munich
Germany
Tel. + 49 89 893 119 22
Email: info@fgk-rs.com

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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