Treosulfan

Extended indication	Extension of indication to include additional non-malignant transplant indications (non-malignant diseases in the paediatric population)
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Treosulfan
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Stem cell transplants
Extended indication	Extension of indication to include additional non-malignant transplant indications (non-malignant diseases in the paediatric population)
Proprietary name	Trecondi
Manufacturer	Medac
Mechanism of action	Alkylating agent
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Extramural (GVS)

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	Yes
Submission date	April 2022
Expected Registration	February 2023
Registration phase	Registration application pending

Therapeutic value	No estimate possible yet
Frequency of administration	1 times a day
Dosage per administration	10 g/m2
References	NCT02349906

There is currently nothing known about the expected patient volume.

References	farmacotherapeutisch kompas
Additional remarks	- Trecondi, 1000 mg poeder voor oplossing voor infusie: €135,15 - Trecondi, 5000 mg poeder voor oplossing voor infusie: € 670,33

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.