EU/3/15/1569

About

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.

Key facts

Active substance
pentetrazol
Disease / condition
Treatment of idiopathic hypersomnia
Date of first decision
11/11/2015
Outcome
Positive
EU designation number
EU/3/15/1569

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
Sweden
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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