EU/3/05/301: Orphan designation for the treatment of shiga-toxin-producing bacterial infection

Chimeric monoclonal antibody to shiga toxin 1 and 2

Table of contents

Overview

On 26 August 2005, orphan designation (EU/3/05/301) was granted by the European Commission to Albany Regulatory Consulting Ltd, United Kingdom, for chimeric monoclonal antibody to shiga-toxin 1 and 2 for the treatment of shiga-toxin-producing bacterial infection.

The sponsorship was transferred to LFB-Biotechnologies, France, in March 2012.

The sponsorship was transferred to Albany Regulatory Consulting Ltd, United Kingdom, in June 2013.

The sponsorship was transferred to Taro Pharmaceuticals Europe B.V., The Netherlands, in February 2019.

Key facts

Active substance
Chimeric monoclonal antibody to shiga toxin 1 and 2
Intended use
Treatment of shiga-toxin-producing bacterial infection
Orphan designation status
Positive
EU designation number
EU/3/05/301
Date of designation
26/08/2005
Sponsor

Taro Pharmaceuticals Europe B.V.
Naritaweg 165, Telestone 8G
1043BW Amsterdam
The Netherlands
Tel. +31 20 572 2341
E-mail: gillian@albanyregulatory.co.uk

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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