Extended indication Extension of indication to include additional non-malignant transplant indications (non-malignant
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

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

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

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

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

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.