EU/3/16/1713

About

On 29 August 2016, orphan designation (EU/3/16/1713) was granted by the European Commission to F2G Ltd, United Kingdom, for 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]-phenyl}-2-oxo-acetamide (also known as F901318) for the treatment of scedosporiosis.

This medicine is now known as olorofim.

The sponsorship was transferred to F2G Biotech GmbH, Austria, in March 2019.

Key facts

Active substance
2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]-phenyl}-2-oxo-acetamide (also known as F901318) (olorofim)
Disease / condition
Treatment of scedosporiosis
Date of decision
29/08/2016
Outcome
Positive
Orphan decision number
EU/3/16/1713

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

F2G Biotech GmbH
Goethegasse 3/2/2
Innere Stadt
Vienna 1010
Austria
Tel: +43 1997 4267
E-mail: contact@f2g.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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