EU/3/20/2329: Orphan designation for the treatment of cholangiocarcinoma

Infigratinib

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Please note that this product was withdrawn from the Union Register of orphan medicinal products in November 2022 on request of the Sponsor.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 21 August 2020, orphan designation EU/3/20/2329 was granted by the European Commission to YES Pharmaceutical Development Services GmbH, Germany, for infigratinib for the treatment of cholangiocarcinoma.

Key facts

Active substance
Infigratinib
Intended use
Treatment of cholangiocarcinoma
Orphan designation status
Withdrawn
EU designation number
EU/3/20/2329
Date of designation
21/08/2020
Sponsor

Helsinn Birex Pharmaceuticals Limited
Damastown Road 
Mulhuddart 
Dublin 15 
D15 X925 
Co. Dublin 
Ireland
Tel. +353 1 822 5404
E-mail: Info-HHC@helsinn.com

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

DateUpdate
November 2022Product withdrawn from the Union Register of orphan medicinal products on request of the Sponsor.
September 2021The sponsorship was transferred to Helsinn Birex Pharmaceuticals Limited, Ireland.

Documents related to this orphan designation evaluation

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.

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:

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