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
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Review of designation
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: