EU/3/18/2097

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Please note that this product (marketed as Vitrakvi) was withdrawn from the Community Register of designated orphan medicinal products in July 2019 upon request of the marketing authorisation holder at the time of the granting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 19 November 2018, orphan designation (EU/3/18/2097) was granted by the European Commission to Bayer AG, Germany, for larotrectinib for the treatment of glioma.

Key facts

Active substance
Larotrectinib
Disease / condition
Treatment of glioma
Date of first decision
19/11/2018
Outcome
Withdrawn
EU designation number
EU/3/18/2097

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
51368 Leverkusen
Germany
Tel. +49 30 300 139 003
E-mail: clinical-trials-contact@bayer.com

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.

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