EU/3/18/2095

About

On 19 November 2018, orphan designation (EU/3/18/2095) was granted by the European Commission to United Neuroscience Limited, Ireland, for Ile-Ser-Ile-Thr-Glu-Ile-Lys-Gly-Val-Ile-Val-His-Arg-Ile-Glu-Thr-Ile-Leu-Phe-Lys-Lys-Lys-Lys-Glu-Met-Pro-Ser-Glu-Glu-Gly-Tyr-Gln-Asp (also known as UB-312) for the treatment of multiple system atrophy.

The sponsor’s address was updated in May 2020.

Key facts

Active substance
Ile-Ser-Ile-Thr-Glu-Ile-Lys-Gly-Val-Ile-Val-His-Arg-Ile-Glu-Thr-Ile-Leu-Phe-Lys-Lys-Lys-Lys-Glu-Met-Pro-Ser-Glu-Glu-Gly-Tyr-Gln-Asp
Disease / condition
Treatment of multiple system atrophy
Date of first decision
19/11/2018
Outcome
Positive
EU designation number
EU/3/18/2095

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

United Neuroscience Limited
International Financial Services Centre
9 Exchange Place
I.f.s.c.
Dublin 1
Co. Dublin
Ireland
Tel. +353 (0)15175929
E-mail: info@unitedneuroscience.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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