EU/3/18/2057: Orphan designation for the treatment of acute myeloid leukaemia
1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt (onvansertib)
Table of contents
Overview
Please note that this product was withdrawn from the Union Register of orphan medicinal products in November 2022 on request of the Sponsor.
On 24 August 2018, orphan designation (EU/3/18/2057) was granted by the European Commission to Pharm Research Associates (UK) Limited, United Kingdom, for 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt (also known as PCM-075) for the treatment of acute myeloid leukaemia.
Key facts
Active substance |
1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt (onvansertib)
|
Intended use |
Treatment of acute myeloid leukaemia
|
Orphan designation status |
Withdrawn
|
EU designation number |
EU/3/18/2057
|
Date of designation |
24/08/2018
|
Sponsor |
Pharmaceutical Research Associates Group B.V. |
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Update history
Date | Update |
---|---|
November 2022 | Product withdrawn from the Union Register of orphan medicinal products on request of the Sponsor. |
May 2019 | The sponsorship was transferred to Pharmaceutical Research Associates Group B.V., The Netherlands. |
Patients' organisations
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: