On 11 November 2015, orphan designation (EU/3/15/1569) was granted by the European Commission to Dr Jens Steinbrink, Germany, for pentetrazol for the treatment of idiopathic hypersomnia.

The sponsorship was transferred to Balance Therapeutics, Limited, United Kingdom, in January 2016.

The sponsorship was transferred to Pharma Gateway AB, Sweden in October 2019.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in November 2020 on request of the Sponsor.

Key facts

Active substance
Disease / condition
Treatment of idiopathic hypersomnia
Date of first decision
EU designation number

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

Pharma Gateway AB
Johanneslundsvägen 2
194 61 Upplands Väsby
Stockholms Lan
Tel. +46 8 590 778 00

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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