EU/3/06/403: Orphan designation for the treatment of neonatal brain injury

5-(2,6-Difluoro-phenoxy)-3(R,S)-{2(S)-[2(S)-(3-methoxycarbonyl-2(S)-{3-methyl-2(S)-[(quinoline-2-carbonyl)-amino]-butyrylamino}-propionylamino)-3-methyl-butyrylamino]-propionylamino}-4-oxo-pentanoic acid methyl ester

Table of contents

Overview

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in March 2015 on request of the Sponsor.

On 23 October 2006, orphan designation (EU/3/06/403) was granted by the European Commission to Theraptosis, France, for 5-(2,6-Difluoro-phenoxy)-3(R,S)-{2(S)-[2(S)-(3-methoxycarbonyl-2(S)-{3-methyl-2(S)-[(quinoline-2-carbonyl)-amino]-butyrylamino}-propionylamino)-3-methyl-butyrylamino]-propionylamino}-4-oxo-pentanoic acid methyl ester for the treatment of neonatal brain injury.

The sponsorship was transferred to Chiesi Farmaceutici S.P.A., Italy, in February 2010.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

Key facts

Active substance
5-(2,6-Difluoro-phenoxy)-3(R,S)-{2(S)-[2(S)-(3-methoxycarbonyl-2(S)-{3-methyl-2(S)-[(quinoline-2-carbonyl)-amino]-butyrylamino}-propionylamino)-3-methyl-butyrylamino]-propionylamino}-4-oxo-pentanoic acid methyl ester
Intended use
Treatment of neonatal brain injury
Orphan designation status
Withdrawn
EU designation number
EU/3/06/403
Date of designation
23/10/2006
Sponsor

Chiesi Farmaceutici S.P.A.
Via Palermo 26/A
43100 Parma
Italy
Tel. + 39 052127 91
Fax + 39 0521774120
E-mail: info@chiesigroup.com

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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