Turalio

pexidartinib

Table of contents

Opinion

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.

Key facts

Name
Turalio
Agency product number
EMEA/H/C/004832
International non-proprietary name (INN) or common name
  • pexidartinib
Active substance
  • pexidartinib hydrochloride
Therapeutic area
Giant Cell Tumor of Tendon Sheath
Synovitis, Pigmented Villonodular
Date opinion adopted
25/06/2020
Company name
Daiichi Sankyo Europe GmbH
Status
Negative
Application type
Initial authorisation

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