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.
Application details
| Product details | |
|---|---|
| Name |
Turalio
|
| Active substance |
Pexidartinib
|
| International non-proprietary name (INN) or common name |
Pexidartinib
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
L01XE
|
Additional 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. |
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
| Application details | |
|---|---|
| Marketing-authorisation applicant |
Daiichi Sankyo Europe GmbH
|
| Date of opinion |
25/06/2020
|
| Date of refusal of marketing authorisation |
28/10/2020
|