EU/3/16/1704: Orphan designation for the treatment of sporadic lymphangioleiomyomatosis
Table of contents
On 14 July 2016, orphan designation (EU/3/16/1704) was granted by the European Commission to Best Regulatory Consulting Ltd, United Kingdom, for sirolimus for the treatment of sporadic lymphangioleiomyomatosis.
The sponsorship was transferred to Drug Development and Regulation S.L, Spain, in October 2018.
The sponsorship was transferred to Maxia Strategies-Europe Limited, Ireland in February 2022.
Treatment of sporadic lymphangioleiomyomatosis
|Orphan designation status||
|EU designation number||
|Date of designation||
Maxia Strategies-Europe Limited
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Documents related to this orphan designation evaluation
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: