EU/3/19/2224

About

On 13 November 2019, orphan designation EU/3/19/2224 was granted by the European Commission to Pharma Gateway AB, Sweden, for ganaxolone for the treatment of CDKL5 deficiency disorder.

Key facts

Active substance
Ganaxolone
Disease / condition
Treatment of CDKL5 deficiency disorder
Date of first decision
13/11/2019
Outcome
Positive
EU designation number
EU/3/19/2224

Review of designation

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

Sponsor's contact details

Pharma Gateway AB
Johanneslundsvägen 2
Hammarby
194 61 Upplands Väsby
Stockholms Lan
Sweden
Tel. +46 8 590 778 00
E-mail: info@pharmagateway.eu

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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