EU/3/19/2146

About

This medicine is now known as futibatinib.

On 1 April 2019 orphan designation (EU/3/19/2146) was granted by the European Commission to Taiho Pharma Europe Limited, United Kingdom, for 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]-1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]-2-propen-1-one (also known as TAS-120) for the treatment of biliary tract cancer.

The sponsorship was transferred to Taiho Oncology Europe B.V., Netherlands, in September 2020.

The sponsorship was transferred to Taiho Pharma Netherlands B.V.  Netherlands, in June 2021.

 

Key facts

Active substance
1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]-1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]-2-propen-1-one (futibatinib)
Disease / condition
Treatment of biliary tract cancer
Date of first decision
01/04/2019
Outcome
Positive
EU designation number
EU/3/19/2146

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

Taiho Pharma Netherlands B.V.
Boulevard 359
1118 BJ Schiphol
Netherlands
Email: sruini@taiho.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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