EU/3/14/1239

About

On 19 February 2014, orphan designation (EU/3/14/1239) was granted by the European Commission to Synovo GmbH, Germany, for 11-(4-dimethylamino-3-hydroxy-6-methyl-tetrahydro-pyran-2-yloxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-aza-cyclopentadecane-13,15-dione for the treatment of cystic fibrosis.

Key facts

Active substance
11-(4-Dimethylamino-3-hydroxy-6-methyl-tetrahydro-pyran-2-yloxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-aza-cyclopentadecane-13,15-dione
Disease / condition
Treatment of cystic fibrosis
Date of first decision
19/02/2014
Outcome
Positive
EU designation number
EU/3/14/1239

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

Synovo GmbH
Paul-Ehrlich-Str. 15
72076 Tübingen
Germany
Tel. +49 707 1964325
Fax +49 707 1964326
E-mail: contact@synovo.com

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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