EU/3/19/2154

About

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.

Key facts

Active substance
Balipodect
Date of first decision
14/04/2019
Outcome
Positive
EU designation number
EU/3/19/2154

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Takeda Pharma A/S
Dybendal Alle 10
2630 Taastrup
Denmark
Tel. +44 (0) 1252 842255
E-mail: regulatory.services@tmcpharma.com

Patients' organisations

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.

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