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. |
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: