EU/3/19/2154: Orphan designation for the treatment of fragile X syndrome

Balipodect

Overview

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.

Key facts

Active substance
Balipodect
Intended use
Treatment of fragile X syndrome
Orphan designation status
Positive
EU designation number
EU/3/19/2154
Date of designation
14/04/2019
Sponsor

Takeda Pharma A/S
Delta Park 45
2665 Vallensbaek Strand
Hovedstaden
Danmark
Tel: +45 4677 1111
E-mail: kristina.stovring@takeda.com

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

Patients' organisations

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:

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