On 23 August 2017, orphan designation (EU/3/17/1910) was granted by the European Commission to Best Regulatory Consulting Ltd, United Kingdom, for sirolimus for the treatment of tuberous sclerosis.
The sponsorship was transferred to FGK Representative Service GmbH, Germany, in March 2019.
|Disease / condition||
Treatment of tuberous sclerosis
|Date of first decision||
|EU designation number||
Review of designation
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.