EU/3/19/2154: Orphan designation for the treatment of fragile X syndrome
Table of contents
On 14 April 2019, orphan designation (EU/3/19/2154) was granted by the European Commission to Takeda Pharma A/S, Denmark, for balipodect for the treatment of fragile X syndrome.
The sponsor’s address was updated in August 2020.
Treatment of fragile X syndrome
|Orphan designation status||
|EU designation number||
|Date of designation||
Takeda Pharma A/S
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:
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: