On 28 April 2016, orphan designation (EU/3/16/1646) was granted by the European Commission to Dr. Regenold GmbH Development Regulatory Market Access, Germany, for a combination of 4-hydroxyandrostenedione (also called formestane), Serenoa serrulata fruit extract and alpha lipoic acid (also called thioctic acid) for the treatment of multiple symmetric lipomatosis.
In July 2017, Dr. Regenold GmbH Development Regulatory Market Access changed name to Dr. Regenold GmbH.
The sponsor's name was updated in September 2021.
Treatment of multiple symmetric lipomatosis
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Review of designation
Documents related to this orphan designation evaluation
EU/3/16/1646: Public summary of opinion on orphan designation: Combination of 4-hydroxyandrostenedione, Serenoa serrulata fruit extract and alpha lipoic acid for the treatment of multiple symmetric lipomatosis (PDF/125.15 KB)
First published: 31/05/2016
Last updated: 31/05/2016
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: