EU/3/07/516: Orphan designation for the treatment of acute myeloid leukaemia

Recombinant human histone H1.3 and recombinant human N-bis-met-histone H1.3

Table of contents

Overview

On 20 December 2007, orphan designation (EU/3/07/516) was granted by the European Commission to SymbioTec GmbH, Germany, for recombinant human histone H1.3 and recombinant human N-bis-met-histone H1.3 for the treatment of acute myeloid leukaemia.

The sponsorship was transferred to Xenetic Biosciences Plc, United Kingdom, in October 2012.

Key facts

Active substance
Recombinant human histone H1.3 and recombinant human N-bis-met-histone H1.3
Intended use
Treatment of acute myeloid leukaemia
Orphan designation status
Positive
EU designation number
EU/3/07/516
Date of designation
20/12/2007
Sponsor
Xenetic Biosciences Plc
London Bioscience Innovation Centre
2 Royal College Street
London
NW1 0NH
United Kingdom
Tel. +44 (0)20 7691 4906
Fax +44 (0)20 7916 9771
E-mail: bd@xeneticbio.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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