EU/3/15/1606

About

Please note that this product (marketed as Vitrakvi) was withdrawn from the Community Register of designated orphan medicinal products in July 2019 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

 

On 11 January 2016, orphan designation (EU/3/15/1606) was granted by the European Commission to TMC Pharma Services Ltd, United Kingdom, for (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate (also known as LOXO-101) for the treatment of soft tissue sarcoma.

The sponsorship was transferred to Loxo Oncology Limited, United Kingdom in November 2017.

This medicine is now known as larotrectinib.

The sponsorship was transferred to Bayer AG - Germany, in June 2018.

Key facts

Active substance
(S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate (larotrectinib)
Disease / condition
Treatment of soft tissue sarcoma
Date of first decision
11/01/2016
Outcome
Withdrawn
EU designation number
EU/3/15/1606

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Vitrakvi at the time of marketing authorisation.

The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the PDF iconorphan designation withdrawal assessment report .

Sponsor's contact details

Bayer AG
Kaiser-Wilhelm-Allee 1
Wiesdorf
51373 Leverkusen
Tel. +49 2143 051564
E-mail: clinical-trials-contact@bayer.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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