EU/3/17/1830:

5-(4,6-dimorpholino-1,3,5-triazin-2-yl)-4-(trifluoromethyl)pyridin-2-amine (bimiralisib)

Overview

On 27 February 2017, orphan designation (EU/3/17/1830) was granted by the European Commission to Voisin Consulting S.A.R.L., France, for 5-(4,6-dimorpholino-1,3,5-triazin-2-yl)-4-(trifluoromethyl)pyridin-2-amine (also known as PQR309) for the treatment of diffuse large B-cell lymphoma.

This medicine is now known as bimiralisib.

The sponsorship was transferred to SFL Pharmaceuticals Deutschland GmBH, Germany in June 2021

 

Key facts

Active substance
5-(4,6-dimorpholino-1,3,5-triazin-2-yl)-4-(trifluoromethyl)pyridin-2-amine (bimiralisib)
Intented use
Treatment of diffuse large B-cell lymphoma
Date of designation
27/02/2017
Orphan designation status
Positive
EU designation number
EU/3/17/1830

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

SFL Pharmaceuticals Deutschland GmbH
Marie-Curie-Strasse 8
79539 Loerrach
Germany
Email: sfl@sfl-services.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

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