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Edaravone / dexborneol

Sanbexin

Extended indication Acute ischaemic stroke
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Edaravone / dexborneol
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Antithrombotic medications
Extended indication Acute ischaemic stroke
Proprietary name Sanbexin
Manufacturer Simcere
Mechanism of action Antioxidant
Route of administration Sublingual
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

ATMP No
Submission date 2025
Expected Registration 2026
Registration phase Clinical trials
Additional remarks Ingediend bij NMPA (medicijnautoriteit van China) in juni 2023. Het is nog onbekend wanneer dit middel precies wordt ingediend bij EMA.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Nog niet genoeg studieresultaten bekend om een inschatting te maken.
Frequency of administration 2 times a day
Dosage per administration edaravone / dexborneol: 30 mg / 6 mg
References NCT04950920 (TASTE-SL) (1); Wang et al. Stroke Vasc Neurol. 2024 (2).

Expected patient volume per year

References Cijfers hart- en vaatziekten. Hartstichting. 2024 (1).
Additional remarks In 2022 werden ruim 38.000 mensen getroffen door een beroerte (1). Het is nog onduidelijk bij welke patiëntgroep dit middel precies ingezet gaat worden.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.