EU/3/17/1868

About

On 20 April 2017, orphan designation (EU/3/17/1868) was granted by the European Commission to Sentinel Oncology Limited, United Kingdom, for N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine for the treatment of fragile X syndrome.

The sponsorship was transferred to Diamond Roc EOOD, Bulgaria, in March 2019.

Key facts

Active substance
N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine
Disease / condition
Treatment of fragile X syndrome
Date of first decision
20/04/2017
Outcome
Positive
EU designation number
EU/3/17/1868

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

Diamond Roc EOOD
Bul. Gen. Totleben 53-55
Office 311
Kriva Reka
Sofia 1606
Bulgaria
Tel: + 359 2 805 7121
E-mail: zborisova@diamondpharmaservices.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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