Turalio

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Pexidartinib

Refused
This medicine was refused authorisation for use in the European Union.

Overview

The European Medicines Agency has recommended the refusal of the marketing authorisation for Turalio, a medicine intended for the treatment of tenosynovial giant cell tumour.

The Agency issued its opinion on 25 June 2020. The company that applied for authorisation, Daiichi Sankyo Europe GmbH, may ask for re-examination of the opinion within 15 days of receiving the opinion.

This EPAR was last updated on 18/12/2020

Application details

Product details
Name
Turalio
Active substance
Pexidartinib
International non-proprietary name (INN) or common name
Pexidartinib
Therapeutic area (MeSH)
  • Giant Cell Tumor of Tendon Sheath
  • Synovitis, Pigmented Villonodular
Anatomical therapeutic chemical (ATC) code
L01XE
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Application details
Marketing-authorisation applicant
Daiichi Sankyo Europe GmbH
Date of opinion
25/06/2020
Date of refusal of marketing authorisation
28/10/2020

Assessment history

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