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.
EU/3/05/301: Public summary of positive opinion for orphan designation of chimeric monoclonal antibody to shiga-toxin 1 and 2 for the treatment of shiga-toxin producing bacterial infection (PDF/123.98 KB)
First published: 09/02/2006
Last updated: 27/02/2013
EMEA/COMP/246642/2005 Rev. 1
Chimeric monoclonal antibody to shiga toxin 1 and 2
|Disease / condition||
Treatment of shiga-toxin-producing bacterial infection
|Date of decision||
|Orphan decision number||
Sponsor's contact details
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;