Extended indication Treatment of prolonged, acute, convulsive seizures in infants from 3 months to adults
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Midazolam
Domain Neurological disorders
Reason of inclusion Indication extension
Main indication Epilepsy
Extended indication Treatment of prolonged, acute, convulsive seizures in infants from 3 months to adults
Proprietary name Buccolam
Portfolio holder Neuraxpharm
Route of administration Oromucosal
Therapeutical formulation Oromucosal gel
Budgetting framework Extramural (GVS)
Additional remarks Fabrikant: Neuraxpharm. Dit betreft de uitbreiding naar volwassenen voor Buccolam: een toediening van midazolam via een spuit voor oromucosaal gebruik.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2024
Expected Registration November 2024
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie in september 2024.

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

References GIPdatabank (1).
Additional remarks In 2022 waren er 78.033 gebruikers van midazolam (1).

Expected cost per patient per year

References GIPdatabank
Additional remarks Buccolam is in Nederland niet verkrijgbaar. Andere vormen van midazolam werden in 2023 voor €133 per patiënt vergoed.

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.